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Millwoods Acupuncture Center
102, 2603 Hewes Way
Edmonton AB,   Canada

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'Acupuncture is a placebo'? Are you kidding?

 - Errors and mistakes in acupuncture researches in Western countries (II)

Dr. Martin Wang, MD. Ph.D.

Registered Acupuncturists

Edmonton, Canada

 

Part II: Chapter 6 to 17

 



Chapter 6. The ability of an acupuncturist 
6.1. Length to have an acupuncturist license does not represent the personal clinic skill of an acupuncturist 
6.2. Stress of acupuncturist in acupuncture study

6.3. Choose of acupuncturist to participate in an acupuncture study

Chapter 7. Similarities and differences between acupuncture studies in China and in the Western world 
7.1. Design of studies
7.2. Operators of acupuncture treatments 
7.3. Use of pain killer during study
7.4. Sources of patients in a study 

Chapter 8. Why the acupuncture healing effects could be better in acupuncture clinic than in a study 

Chapter 9. The direct evidence that acupuncture is not a placebo effect 

9.1. Acupuncture in the treatment of coma
9.2. Acupuncture in the treatment of shock
9.3. Acupuncture in persistent vegetative state
9.4. Acupuncture before and during anesthesia
9.5. Acupuncture during general anesthesia
9.6. Acupuncture in delayed wake-up after general anesthesia
9.7. Acupuncture anesthesia in shock patients
9.8. Acupuncture in dementia

9.9. Acupuncture-induced anesthesia or acupuncture-combined anesthesia 


Chapter 10. Different healing effects with different ways of acupuncture 
10.1. Different acupuncture points 
10.2. Acupuncture points versus non-points
10.3. Different needle-manipulation technique
10.4. Acupuncture versus sham acupuncture

Chapter 11. More examples supporting that acupuncture are not merely a placebo 
11.1. Acupuncture in children

11.2. Acupuncture in animal


Chapter 12. Why some researchers could feel that acupuncture is merely a placebo effect

12.1. The healing effects of acupuncture group and sham group are pretty close in the studies in Western countries 

12.2. Comparing between different treatment frequency, between different acupuncture points, between acupuncture points and non-points, between different technique, no significant difference

12.3. Simply contribute the most part of the healing effect in the acupuncture group into a placebo effect, only a small part into the acupuncture specific effect

12.4. Improperly choose acupuncture points, contribute its low effect to that of acupuncture

12.5. Study on a disease that is not in the working scope of acupuncture treatment

12.6. Confuse the healing effect of cupping, moxi, electrical acupuncture, auricular acupuncture, TENS, massage, all as acupuncture

12.7. Superstitious belief on large scale experiments

12.8.  Co-exit of opposite ways in acupuncture treatment

12.9. Not care or omit large amount of positive results

Chapter 13. Arguments among researchers and in the internet world 

Chapter 14. Opinions and comments from Chinese acupuncture community 

Chapter 15. Our own opinion and suggestions about acupuncture research  

15.1. Selection of acupuncturist in study

15.2. Special acupuncture study

15.3. Ordinary acupuncture study

15.3.1. Pre-test phase

15.3.2. No-treatment group

15.3.3. Sham group

15.3.4. Acupuncture group

15.3.5. Location of study

15.3.6. Supervisor

15.3.7. Recommended acupuncture experts or masters
15.3.8. Multiple research location versus single location but more clients
15.3.9. Aim and goal of the acupuncture study for the current time   


Chapter 16. Specificity of acupuncture study
Chapter 17. Summary
Chapter 18. Explanations about this article

Chapter19. Consideration and suggestion for future medical service system

 

Chapter 20. Letter to editors

 

Chapter 21. Comments and suggestions from readers

Footnotes

References

 

Chapter 6: The ability of an acupuncturist 

6.1. The length of license does not represent clinic skill of acupuncturist

Colquhoun D noticed that the positive articles about acupuncture come mostly from mainland of China, Taiwan, Hong Kong, and Japan, and so on. We also noticed that the negative articles mostly come from Western countries and from the hands of physician or physiotherapists. In such Western articles, the healing effect of acupuncture in acupuncture groups is about 30% to 40% higher than no-treatment groups, and about 10% to 15% higher than sham acupuncture groups. Such healing effect is much less than our own clinic efficiency, and also much less than the reports from China or other parts of Asian countries.

The ability of an acupuncturist is not determined by how long time the person hold acupuncture license, or where the person get acupuncture training. These should not be the absolute parameters to tell the clinic skill of an acupuncturist. We believe that, the acupuncturist in an acupuncture research should be the one of higher level of clinic skill. It would be better if the acupuncturist is recommended by Acupuncture associations.

Acupuncture is a profession of highly personal skill dependence. It does not mean that high academic level or longer education in acupuncture would ensure the higher clinic skill.  

In the Western countries, some physiotherapist, chiropractic, or physician, can also get the license for acupuncture after taking part in acupuncture training for some time. For example, a physician has an acupuncture certificate after 140 hours training would be allowed to participate acupuncture study.  Some times, even new graduated students can participate the research. ,

In review the acupuncture studies in the Western countries, it seems that anyone may act as an "acupuncturist" in the study, if they get hundreds of hours of acupuncture training and get acupuncture license for some years. It seems that they feel that, to practice acupuncture, it is already enough if they choose the acupuncture points used by other researchers, and if they indeed induced the Deqi needle sensation. Under this condition, whether the results are positive or negative is the credit of the acupuncture, nothing related to their own level of skill in acupuncture.

The acupuncturists in China who participate the acupuncture study is ensured by their published articles. Their articles would not at all be accepted for publish, if their acupuncture study cannot improve the healing effect of current acupuncture technique, or if their work does not allow better understanding of acupuncture mechanism or other aspects of acupuncture. However, any articles about acupuncture can be published in the Western countries, if the article meets the need of some basic requirements for the publication, such as randomization, blindness, with a sham acupuncture group, or a waiting group, more than 20 to 30 patients in each group, and statistically analysis of the data. To the view of acupuncturists in China, they learned almost nothing from so many published articles from Western countries.

If we do not pay attention to the personal skill of acupuncturist, no any acupuncture studies of best design would reach truth. Such as to let a new person shoot a gun, the best gun does not ensure that the person would shoot to the target.

Unlike medical research in Western medicine, which mostly studies uniform of chemical tables, any study involving personal skill, such as acupuncture, massage, chiropractic, physiotherapy (if it is manual therapy), needs to choose the highest level of practitioners to take part in. We cannot just pick up a student infighter from US school to match the infighter of national level in Tailand. If the US infighter lost, can we say that US infighter level is lower than that of a Tailand infighter?

White P (2012) had a study of acupuncture for the treatment of osteoarthritic pain. The study involved three acupuncturists. The healing effects of the three practitioners are 37%, 17% and 62%. Though it was explained by the author that the highest healing effect by the third acupuncturist might be due to the impression of him by patients more professional and more like an expert, it cannot exclude that his personal skill in acupuncture might be really highest. No matter what could be the reason, the huge difference in the healing effects by the three acupuncturists will affect the data analysis for sure. It is possible that to compare the healing effect by the third acupuncturist with sham acupuncture, it would show statistically significant difference (63% vs 28.4%, or 63% vs 39.2%), rather than no difference as reported.

Hawk C (2002) reposted their chiropractic study on chronic pelvic pain. The study involved 3 clinic locations. After 6 weeks of chiropractic treatment, the pain level reduced by 59.1%26.9%84.6%, in the three locations, respectively, average of 56.6%, while the reduction rate in sham group is 68.5%. The healing effect of the treatment group is even less than the sham group! The practitioners in the 3 clinic locations were reported to have 20, 10 and 12 years of clinic experience. Having no alternative but the author have to admit that "The technical and personnel resources required to achieve adequate standardization of procedures at multiple sites may make a placebo-controlled trial unfeasible, given our current lack of knowledge about the active agent in manual chiropractic procedures. It might be more efficient to reverse the traditional order of experimentation used for pharmaceuticals, which begins with safety, proceeds to efficacy and finally to effectiveness. Because chiropractic—a CAM profession using manual methods for more than 100 years—can scarcely be considered in the same category as a newly developed medication, it might be reasonable to first investigate effectiveness. If chiropractic care that is provided by experienced chiropractors who are allowed to use their best clinical judgment of how to apply the procedures is documented in such studies to improve patient outcomes compared to standard medical care alone, more in-depth and controlled studies would then be warranted to identify specific aspects of that gestalt of care that are most responsible for the outcomes or if there are certain subpopulations of patients who benefit most from them."

Apparently, it is not reliable to tell the personal skill of chiropractic practitioners by license holding time, neither of acupuncturist.

Forbes A reported their acupuncture study. Acupuncturist A treated 12 patients with IBS, 50% patients had the symptom level reduced by 4. Acupuncturist B treated 15 such patients and 33.3% of patients had the symptom level reduced by 4. The author had no alternative by to combine the data together, so as to reduce the unlikelihood of the study conclusion.

So, for these of large scale clinic researches involving many clinic locations and many practitioners, how high level of the creditability for their study conclusion?

Another example is from report of Deng G (2007) for the treatment of hot flash by acupuncture. During the study, the acupuncturist was changed and the reduction curve of the hot flash even reversed up. They had acupuncture twice a week for 4 weeks. The hot flash reduced by about 30% to 35%, similar to that in sham group.

Fregni F (2010) pointed out, in an international placebo symposium working group, that "a great number of interventions used in PRM depend on the technician’s or clinician’s skills such as the application of acupuncture, injections, and nerve blocks. Therefore, controlling for these interventions becomes difficult with this important source of variability. This makes it even more difficult to design an appropriate placebo in these situations. To control for skills and levels of experience, it would be necessary to conduct multicentric studies with various levels of skills and experiences and perform multivariate analyses to adjust for these variables. In this scenario, a large number of patients would be necessary, increasing the difficulties to conduct such studies."

If the personal skills among several acupuncture operators are so different, how can we trust the stuy involving 67 physiotherapists, 122 physician, or 320-340 physician?

As pointed out by Forbes (2005) that the possibility that simplified acupuncture as delivered by Western-medicine-trained acupuncturists might have given a different result is intriguing and may warrant further study.

 

6.2. Additional issue for acupuncturists in acupuncture studies

Of course there is another possibility that the acupuncture in a study is requested by acupuncture researcher, not accepted by the acupuncturists themselves. The acupuncturists in an acupuncture study may suffer from emotional stress, that may affect their perform of acupuncture treatment.

McManus CA (2007) have dad a survey to the acupuncturists in thir acupuncture study. They send surveys to 12 acupuncturists and get 8 responded.

They reported that  “all respondents reported feeling challenged by their work as investigators as opposed to their “normal” roles as clinicians. Although all agreed that the protocol was reasonable at the outset, in particular, they still felt strong urges to apply the typical tools of their clinical practices such as active needling, heat, external herbal treatments, treatments for the “whole” person, and counseling. (To our best knowledge, none of them acted on these urges.) During monitoring interviews, many acupuncturists indicated how difficult it was not to be permitted to offer dietary, ergonomic, or physical advice to the participants. Several acupuncturists reported that they frequently hoped that participants would be randomized to the genuine acupuncture group after the placebo run-in had been completed. In one instance, an acupuncturist actually called the clinical coordinator and requested that a patient be re-randomized to the genuine treatment group. Unwilling to comply with the rigors of RCTs, this acupuncturist (whose responses are included here) was not assigned to treat more participants in the study.

Although 12 acupuncturists were originally trained for the RCT, 5 did not stay with the trial for its entire course. Study coordinators ceased assigning participants to 3 acupuncturists because they broke the protocol (e.g., for using nonprotocol points in the active phase, failing to keep accurate records, or for being unclear about the study’s procedures.) Two (2) other acupuncturists resigned from the trial: 1 because of the ethical concerns with administering the sham treatment and the other because of re-locating out of the state.”

Apparently, the mode of acupuncturists in an acupuncture study could be different from their routine clinic work. Could this unstable emotion condition of acupuncturists affect the acupuncture efficacy?

 

6.3. Selection of acupuncturist for acupuncture research

Certainly we should not carelessly image, as others, the level of personal skill of any acupuncturists. We propose a preliminary idea for the selection of  acupuncturist for acupuncture study:

Basic selection: the acupuncturist should have a comprehensive healing effect for most of diseases in his/her clinic as high as 75% (within one to two months). The comprehensive therapies mean the use of acupuncture, cupping, moxibustion, bleeding therapy or whatever commonly used therapies in an acupuncture clinic.

It should not be difficult to find such acupuncturists.

Specific selection: the acupuncturist should have at least 75% of an average healing effect (as published data, for example from China) for the disease/symptom to be studied, when only the acupuncture was used in a pilot study. The average healing effect by acupuncture is different for different disease/symptom. For example, if an average healing effect for non-specific low back pain, treated by acupuncture alone, reported from China, is 55%, the healing effect of the candidate acupuncturist for the same kind of low back pain should be more than 41%.

The reasons for the basic selection is: if the acupuncturist cannot reach such healing effect with their own natural matter, it would be impossible for them to create a positive result in a Western style of acupuncture study [16], in which only acupuncture, not moxi, not cupping, or any other kind of therapies, are allowed. What is the use to create so many negative data by untrustable ways of studies?

The reasons for the special seletion is that even if the acupuncturist passes the basic selection, it still does not mean that he or she is able to treat the disease to be studied. For example, if an acupuncturist never treated coma patients (due to stroke), it would be hard to believe that the acupuncturist can treat such patients in a study.

If there is no any people passes such selections, it would mean that the conditions for an acupuncture study are not met. The acupuncture study should not be started. Can any surgeon perform a craniotomy without anesthesia by an anaesthetist?

The ability of the acupuncturist can be tested in a pilot study or in a large scale study with a free-treatment group, in which the acupuncturist can treat the patient by whatever his natural way. If the healing effect in the free-manner could not exceed 45% ,[17] it is ready to tell that the study fails at least because the poor skill of the acupuncturist. Before the study, the researcher should ask the acupuncture if the acupuncture has confidence for the disease to be studied by acupuncture. If the acupuncture said yes, then the researcher would mean "show to me".

In the acupuncture study, we should not only pay attention to the diagnosis of the disease to be studied, the selection of patients, randomization, blindness, or cross-group, such organizing issue, but also the quality of an acupuncturist.

Brief summary:

The personal skill of an acupuncturist is one of the most important factors determining the success of an acupuncture study. It is needed to set up a role for the selection of an acupuncturist for an acupuncture study. 

 

Chapter 7. Similarity and difference between acupuncture studies in and out China

There are several differences between the acupuncture studies in and out of China, beside what we have discussed above .

7.1. Design of study

For acupuncture study in the Western countries, the so called high quality studies means: randomization, blindness (single or double), with sham group (plus waiting group). If there is a sham group, it is better to also have a cross design.

If there is no waiting group, it would be hard to exclude natural regress of the disease from the sham group. This might be true since the acupuncture studies in the Western need a long time to finish, up to 1 to 2 years. A disease might get better by itself. With a sham group, it would be not so ethical to "cheat" patient, so a cross design was used and the patient initially in the sham group can be later treated with real acupuncture.

Actually, no matter for acupuncture or for Western medicine or surgical studies in Western countries, only little studies met these standards. Most of acupuncture studies do have randomization, blindness, using Western medicine as control group but no sham group or no waiting group (no-treatment group). The presumption of such design is that the healing effect of the control group (Western medicine group) have been tested to be effective by "strict" randomization, blindness, compared with sham group. Therefore, if the healing effect of acupuncture group is equal to, or higher than, the control group, the healing effect of acupuncture group should be accepted. This is true especially for the treatment of some difficult diseases, for which the current Western medicine shows some effectiveness but also terrible side effects.

Unfortunately, this presumption might not be true. The medicine in the control group may not be tested by the "strict" studies at all. It is not a long time that FBA of US asked a new medicine to compare with a sham group. Many medicine are still in use for a long time though they have never been tested comparing with a sham.  It may cause an uncertainty to compare acupuncture with such non-tested medicine. Secondly, someone might ask if the placebo effect in the medicine group and in the acupuncture group are not the same level.

The acupuncture studies in China mostly have also a randomization, but compared with Western medicine, or compared with other type of acupuncture technique. Rarely there is blind design, or a sham group. This might be because the acupuncturists in China do not believe their own acupuncture could be a placebo effect. The data we could collect (Fig. 20a, 20b, 20c, 20d) appear to support their confidence.

Because the healing effect of acupuncture group is only 10% to 15% higher than the sham group, after analyzed by statistic, the dada are easy to loss significant. Acupuncturists in the Western did not realize that it is due to the low healing effect of the acupuncture group, but to an improper sham group. So, they have paid much attention to modify the sham group and study the mechanism of the placebo effects. While acupuncturists in China do not believe that acupuncture could be placebo effect, and they do not believe that to insert needle to a non-point could result in a higher healing effect than insert the needle into typical acupuncture points. So, they usually use inserted needle (into non-point) as sham group. In such sham, the sham needle is even inserted the same depth as real acupuncture group. (see Attached list 19a,19b, 19c.

Acupuncture study in the Western uses sham treatment. This cause a ethical problem. It is therefore needed to tell the patient that he or she might be allocated into a sham group, or a new treatment group and so triggers patient expect for healing. Researchers have to try to bind the patient from which group he was allocated, to eliminate the communication between the acupuncturist and the patient, to design a cross design, all of which increase the complex of the study and also largely "modified" the real acupuncture treatment course. For this reason, we would say that the acupuncture study in the west is an "modified" acupuncture, not a real one.

The healing effect of acupuncture in China is usually more than 40% to 50%. The aim is to test if a new way of acupuncture (Chinese modified acupuncture) would work better than currently used ordinary acupuncture. Generally speaking, the effectiveness of the modified acupuncture is usually 50% to 65%, better than the ordinary acupuncture. The paper would not be published if the effectiveness of the modified acupuncture is no more than ordinary acupuncture. That means, acupuncture study in China is to find better and higher efficient acupuncture, not to test if acupuncture is a placebo effect. Therefore, acupuncturist can learn from the modified acupuncture to update their technique again and again.

When there is a sham group in acupuncture study in China, the needle is inserted. Current data (Fig.20a, 20b, 20c, 20d) showed that, with higher treatment frequency, the healing effect of acupuncture group is much higher than the sham group. This makes it not important to use either inserted or not inserted needle in the sham group. So, it is not needed to blind the patients. The healing process would be much less complex than that in Western studies.

Acupuncture study in China is to compare the healing effect of the modified acupuncture with ordinary acupuncture. Why we cannot regard the ordinary acupuncture as also a sham? In this way, we do not need to specifically design a sham group, no need to tell patients that they may come into a no-real treatment group, so no need to design a cross study, because the patient will get either a ordinary acupuncture as usually for any other patients, or an even better way of acupuncture. We did not interrupt the patient expectation at all.

Acupuncture study in China usually takes a short time to finish (2 to 3 months). For a chronic disease and due to many years of clinic experience that the disease cannot get 30% to 50% improvement without proper medical help, so that the 30% to 50% improvement in the acupuncture group is not regarded as natural regression, so no need to have a non-treatment group as a control.

7.2. Acupuncture operator

In the acupuncture studies in the Western, many times the acupuncture was performed by physician, next by physiotherapist. If we make a summary from Attached list 14, we can see that, half of the performers are acupuncturists, one third is physician, 12% is physiotherapist (Fig. 21), e.g. half by acupuncturists and another half by non-acupuncturists.

It is quite common that we have clients come from physiotherapy or chiropractic clinic. According to the story told by the patients, during the whole healing course there, (more than 10 times), they got only 1 to 2 times of acupuncture treatments. Apparently these practitioners still use their own original professional way for the treatment and acupuncture is only some complementary way in their clinic. While for the acupuncturists in China, they use acupuncture everyday for all the patients in their clinic/department. They have chance to reach lots of book/literature on acupuncture to update knowledge, have chance to be guided and supervised by top level experts. They can have 60 – 100 patient every day (spend 20-30 min to each patient). It is clear for how rich their clinic experience could be.

7.3. Use of pain killer

One of the apparent characteristics of acupuncture study in the West is to allow the use of pain killer by patients during the study. This is easy to understand: if the acupuncture healing effect is not high enough, we cannot stop the patients from the use of pain killer. If we have a review of the data from Colquhoun D Madsen MV (2009), and Vicker AJ (2012) it can be seen that in total 22 articles, in 86.4% of the studies, the pain killer is allowed to use.

In the articles published from China, it is usually not indicated if the pain killer is allowed or not allowed. However, due to higher treatment frequency and higher healing effect, the symptoms were improved much faster and patient most possibly no longer use the pain killer after start of the acupuncture treatment. Our own experience supports this presumption.

Placebo.Fig.21

Fig. 21. n = experiment groups.

 

7.4. Sources of patients in study

 

Patients in the Western acupuncture studies mostly come from an advertise. This may create a higher expectation of patients to the acupuncture so to cause some level of placebo effect. Also, most possibly, the patients do not need to pay for the treatment, and they may give an exaggerated positive comments to the treatment in the sham group and the treatment group too.

The patients in acupuncture studied in China come by themselves to the clinic. They are then allocated into different groups by randomization. They do not know if they are in an ordinary acupuncture group, or in a specially modified acupuncture group, except if there is a sham group. They need to pay for the treatment by themselves, so they tend to give relatively more conservative comment to the healing consequence. Many patients, when they see doctors, no matter it is TCM doctor, acupuncturist, or a Western medicine doctor, they tend to tell "I am still feeling pain". While most of Western patients in our clinic tend to say "better", or "though still pain, but better". They are more optimistic than patients in China.

Though the patients in both the sham group and the acupuncture group may give exaggerated positive comments, because the healing effect of the acupuncture in the acupuncture group is too low in these Western studies, the extent of the healing effect in the acupuncture group is only slightly higher than that in the sham group and it is so easy to result in a negative result of the study.   

Brief summary:

(1). Beside the difference in treatment frequency between the acupuncture studies in the Western countries and in China, there are some other differences between them, which may also affect the study outcome.

(2). The acupuncture studies in the west emphasize the randomization, blindness, sham group as a control group. The aim is to test if the acupuncture effect is a placebo effect. The acupuncture studies in China are mostly comparing special or modified acupuncture technique with Western medicine or with ordinary acupuncture. The aim is to find more effective ways of acupuncture treatment, or to see if acupuncture can be a better alternative therapy to the conventional medicine: same or higher healing effect and less side effect.

(3). The operators of acupuncture treatment in the acupuncture studies in the west is half acupuncturists and half non-acupuncturists. The personal skill of these practitioners are unknown. That in China is all most all are acupuncturist. The personal skill is reasonable.

(4). In the acupuncture group in the Western studies, the patients are still taking pain killer, so affecting the evaluation of the healing effect. In that in China,  patients may not continue the use of pain killer soon after the start of the study, so the result of evaluation of healing effect is relatively more trustable.

(5). Patients in the Western studies come mostly from advertising and no need for them to pay for the treatment, so there is high chance for them to have higher expectation to acupuncture, and give exaggerated positive comments to acupuncture treatment. The patients in the studies in China come mostly be the patients themselves, and have reasonable level of expectation to the acupuncture and give reasonable level of comment to acupuncture.

Chapter 8. Why the healing effect of acupuncture is higher in clinic than in a study

 

8.1. Acupuncture in a study in most time is a single form of acupuncture

Acupuncture performed in an acupuncture study is usually just the acupuncture per se. While the acupuncture in clinic is usually combined with other therapies, such as moxibustion, cupping, Guasha, Tuina, acupressure, auricular acupressure, traction, bleeding therapy, bleeding-cupping therapy, or electrical acupuncture, warm acupuncture, or TENS, and so on. 

8.2. Acupuncture in a study is a fixed manner

Acupuncture in a study is usually performed in a fixed manner: fixed treatment schedule, fixed acupuncture points selected, fixed numbers of needles, and fixed treatment length, etc. with the aim to standardize the treatment course, so as to reduce the variation of healing effect from patient to patient. While the acupuncture in clinic is in a flexible manner, it can be changed among patients, and during the treatment for a given patients, the acupuncture points, the number of the acupuncture points, the length of each session, combined or not combined with other therapies, etc. The aim of the flexibility is to make the acupuncture treatment match the conditions of the patients: the tolerability of patients to the needle stimulation, the change of the severity of the disease, the life schedule of the patients, the financial situation of the patients, etc.

Even for the acupuncture, we may use different acupuncture points rather than those introduced in acupuncture text book. For example, we may choose trigger points, start-end point of a muscle group, and so on.

Sometimes, we may even combine the acupuncture with Chinese herbal therapy, especially by those of acupuncturists who come from China but now work in the Western countries, when we feel that Chinese herbal therapy might work better than acupuncture. In this case, the acupuncture treatment could be a complimentary therapy to the herbal therapy.

 8.3. Acupuncture in a study is for a limited group of patients

Acupuncture study is performed usually to a given group of patients: patients with the same diagnosis (Western medicine disease category), and within a given severity of the diseases, a given age of range, a given sex and so on. However, the patients in clinic are largely variable. For example, the patients with knee pain in clinic might belong to different categories of arthritis, or sprain, or strain, with various level of severity, various length of the disease, and so on. Especially speaking, some diseases we see their research from a study may not be seen in a clinic often. For example in our clinic, most popular diseases we see are various pain syndrome, poor sleep, stress, anxiety, constipation, hot body or cold body (hands), menopause syndrome, disorders in menstruation, infertility, overweight, quit smoking, but very little of some other kinds of diseases, such as cancer, AIDS, post-stroke syndrome. We mentioned in the early of this article that our clinic effectiveness could be up to 85%. This does not mean that we can treat every kind of disease with such successful rate.

All of these mean that, if it does not work for the acupuncture in an acupuncture study, it does not mean that the acupuncture in clinic neither work; or if the acupuncturist in that study cannot improve the disease condition, it does not mean other acupuncturist can not either.

The acupuncturists in an acupuncture study should tell the researchers what the difference is between the experimental acupuncture and the actual acupuncture. It is not fare and injustice to test the "artificial' Western style of acupuncture and contribute its study results to clinic acupuncture or Chinese style of acupuncture. If the acupuncturist in the study tells that this is indeed their own way of acupuncture in clinic, we would have to suspect and question about the healing effect of acupuncture in their clinic.

 Brief Summary:

(1). The acupuncture used in an acupuncture study could be different from that in a clinic.

(2). Acupuncture in an acupuncture study is a single form of acupuncture, while that in a clinic is a combined therapies.

(3).  Acupuncture in an acupuncture study is a fixed manner, while that in clinic is flexible manner.

(4). The healing effect of acupuncture in an acupuncture study may not be necessarily represent that in a clinic.

Chapter 9. Direct evidence that acupuncture is not a placebo effect 

9.1. Treatment of coma with acupuncture

It should have no argument that a placebo effect only happens when a person is in a consciousness condition and with a clear mind to able to analyze stimulations from out side of the body. Now let us see how and if acupuncture can be used to treat some special clinic conditions in which the person is out of consciousness, such as coma, shock, persistent vegetative state, anesthesia, etc.  

For the treatment of coma patients with brain trauma and stroke, we collected about 40 articles., For such coma patients, acupuncture (Attached list 21a), together with conventional rehabilitation therapies, can speed up the wake-up rate from 51%±17% increased to 79%±12% (Fig.22a), or to increase the degree of consciousness (the GCS index increased from 3.02±1.2 to 4.73±1.3) (Attached list 21b Fig.22b). Or, it can be said that acupuncture treatment can shorten the time needed to wake-up from 35.74±16.7days down to 22.78±11.7 days (Attached list 21cFig. 22c).

Placebo.Fig.22a

Placebo.Fig.22b

Placebo.Fig.22c

Acupuncture alone can also reach such healing effect. The combination of  Western conventional treatment with acupuncture treatment can no doubt increase the cure rate and to reduce the sequela rate.

It should be pointed out that, when acupuncture is used for the treatment of such severe conditions, as coma, shock, persistent vegetative state (see later), it is the modified acupuncture that was used. The acupuncture treatment is at least once a day. It would not be possible to reach such healing effect if it is till performed once a week as current Western style acupuncture.

蔡化理 (1961) treated 27 patients with shock due to toxic dysentery. Within 10-30 min of acupuncture, the blood pressure started to increase. Only 2 cases needed blood pressure increasing medicine.  

9.2. Treatment of shock with acupuncture

Doctors in Second Affiliated Hospital of Hunan Medical College (1973) reported their way of treatment of shock for 160 cases. Based on ordinary conventional ways, all cases were given acupuncture treatment first. If the blood pressure did not increase within 30 min, then started the addition of pressor agent. By this way, blood pressure in 122 cases (76.3%) clearly increased. The apparent effective rate was 76.3% and total effective rate is 87.5%. This means that the blood pressure in only 23.7% of patients did not respond to the acupuncture treatment. This suggests that acupuncture treatment has a function to increase blood pressure in shock patients. These doctors found that for half of patients, their blood pressure can start to increase within 30 min, some after 60 min. There had been 9 patients, for whom the use of pressor agent did not work satisfactory, after addition of acupuncture, blood pressure increased in 8 cases (systolic pressure up to 90 mmHg). This suggests that for those cases whose blood pressure increase is not stable, acupuncture can work to help the pressor agent. For some patients, if the manipulation of the needles (by twisting) stop for a longer time, the blood pressure would tend to reduce. After stronger manipulation, the blood pressure would increase again, suggesting that manipulation of needle can influence the healing effect.

 

俞勤龙 (1997) reported that doctors in the department of gynaecology and obstetrics in the Jiangyin Hospital of traditional Chinese Medicine treated 52 cases of shock patients after induced abortion. The patients showed, during or after the operation, pale face, cold hands and feet, palpitation, press in chest, nausea or vomit, even reduction in blood pressure, come, etc. The body condition became worse very quickly and changed very fast. The blood pressure of the 52 cases all increased after stimulation of Sanyinjiao point for several seconds. The patients then turned conscious to recovery. No one case needed intravenous infusion or other conventional emergency treatment.

宋智静 (1996) treated 40 cases of shock patients due to allergic reaction to penicillin by using acupuncture and epinephrine. For all of the patients, after injection of epinephrine and acupuncture on Neiguan point for 5 min, the face turned pink, sweat stopped, consciousness turned back, blood pressure increased, and pulse increases. The healing effect showed as average 10 min (as fast as 5 min). Except for one case who needed additional intravenous infusion and steroid medicine, other 39 cases got recovered within 5 to 15 min. No any death case. It can be commented that in this clinic report, there is no control group to tell how much death rate might be without use of acupuncture in the emergency treatment. However, according to our own previous work experience in emergency department in China, it has been a very effective emergency treatment for those patients who is already in a coma status, for the fact that their live were saved within 5 to 15 min.  

刘应柯 (1999) and his colleagues  treated hemorrhagic shock 33 cases with acupuncture (no pressor agent). After half hour, systolic pressure increased from average 62.6 mmHg to average 98.3 mmHg. At the same condition, similar shock patients 31 cases were treated without acupuncture (with pressor agent). Their systolic pressure increased from average 67.7 mmHg to average only 77.9 mmHg.  

赵滨 (2008) and his colleagues treated various kinds of shock 40 cases. After acupuncture for 30 hour (no pressor agent), systolic pressure increased from average 70.9 mmHg to average 95.6 mmHg. At the same condition for another 40 cases using pressor agent (no acupuncture), systolic pressure increased from average 68.9 mmHg to only average 85.5 mmHg. For diastolic pressure in the acupuncture group, within half hour treatment, it increased form average 42.3 mmHg to average 58.7 mmHg. In the pressor agent group, it increased from average 43.2 mmHg to only 55.24 mmHg.

傅立新 (2008) treated various shock patients 138 cases. Within less than 30 min of acupuncture (no pressor agent), systolic pressure increased from average 83.1 mmHg to average 101.1 mmHg. Under the same condition with pressor agent use on another 138 shock patients, systolic pressure increased from 83.3 mmHg to 89.2 mmHg. In the acupuncture group and within less than 30 min of acupuncture (no pressor agent), the diastolic pressor increased from average 49.5 mmHg to average 59.3 mmHg. The diastolic pressure in the pressor agent group increased from average 48.8 mmHg to 50.4 mmHg.

冀慧霞 (1999) treated allergic shock 50 cases. With conventional emergency treatment, the total effectiveness rate is 76%, while it is 90%, when the conventional way is combined with acupuncture.

The successfulness of acupuncture treatment is of course also related to the intensity of the shock. The effectiveness to low to mild level of shock is higher than severe shock. It is also related to the type of shock.  Generally speaking, the effectiveness in allergic shock and infective shock is higher, but that in cardiac shock and hypovolemic shock, lower.

吴敬 (2000) reported their treatment of cardiac shock, hypovolemic shock, infectious shock and allergic shock with conventional medicine plus acupuncture. The total effectiveness for these different types of shock is 80%82.6%100% and 100%, respectively.  

张从道 (1989) reported that, treated with acupuncture alone (no pressor agent) for cardiac shock, the total effective rates for hypovolemic shock, infectious shock, allergic shock, nervous shock and traumatic shock are 90%, 95%, 93.3%, 95%, 93.3% and 96%, respectively. 

It should be noticed that acupuncture can not only work together with pressor agent to increase the emergency treatment of the shock, but also solve the emergency condition by itself alone.

Clinic studies suggested that in the treatment of shock with acupuncture, the blood pressure increase occurs mostly within 30 min, while with pressor agent, mostly after 3 hour. With acupuncture treatment, the blood pressure increased earlier and higher. Especially it happened in the earlier stage of shock. This is very important to improve functions of important organs, such as heart, brain and kidney, so as to prevent irreversible damage to these organs.  

To treat shock, every minute is very important to patient's life. No time to allow us to have a sham group or a non-treatment group. It should be accepted to compare acupuncture-alone group and the acupuncture plus pressor agent group, e.g. to compare conventional treatment with or without acupuncture. Studies here all tried half hour of acupuncture first. If the blood pressure does not increase, it is added right away with pressor agent. The results showed that combination with acupuncture worked much better than without acupuncture. Indeed sham acupuncture and no-treatment groups have been used in animal shock models. There are many such animal studies, but animal model study (instead of clinic study) is not used as data sources for our articles here.

Patient in low level shock appears anxiety, cloudy consciousness and slow reaction. Upon middle to severe shock, patients lose consciousness. That acupuncture can increase blood pressure when the patients is with very low level consciousness suggests that a placebo effect is not the only mechanism by which acupuncture works, and that acupuncture works not only for subjective disorders, such as pain, but also objective disorders, such as blood pressure.  

 9.3. Treatment of persistent vegetative state by acupuncture

Along with the development of medical diagnosis technique and emergency treatment, the death rate of emergency patients has been dramatically reduced. At the same time it also induces a new social and medical problem: there are more patients with persistent vegetative state. There are higher death rate and cripple rate in such group of patients. The persistent vegetative state is hard to treat, causes heavy burden to patient's family and society, even if after lots of efforts of medical services. It has become a very serious social concern in and out China.

Estraneo A 2010 observed 50 cases of persistent vegetative state. Under the treatment of conventional medicine, only 10% of patients regressed into shallow consciousness, another 14% returned consciousness, but all happened after one year of treatment. Before the publication of his paper, it was commonly believed that it is almost impossible to get recovery of consciousness for persistent vegetative state due to brain trauma for more than one year, or due to other reasons for more than half year. For a long time, due to no effective way of treatment, the attitude of medical society is negative and passive for persistent vegetative state. In US, the doctors can stop any treatment and nurse service to allow the patient to euthanasia, according to patient's willingness before sick and to the agreement of patient's family.

However, it is a quite different picture of the treatment of persistent vegetative state in China. A lot of studies and clinic reports suggest that acupuncture can work to speed up the wake-up of patients with the persistent vegetative state (Attached list 22).  

We can make a summary of these data into Fig. 23.  

 Placebo.Fig.23

Fig. 23. n = number of experiments. Acupuncture in the “Mixture with Acup” and “Mixture without Acup” groups are ordinary acupuncture. Con: conventional supportive therapies. HPO: high pressure oxygen. Mixture: high pressure oxygen, rehabilitation therapy (exercise), tuina, massage, physiotherapy, sound-light simulation therapy.

Data in Fig. 23 suggest: if treated with traditional conventional medicine, the wake-up rate for the persistent vegetative state is 25%. Conventional medicine plus high pressure oxygen, the wake-up rate can increase to 43%. When the conventional medicine combined with high pressure oxygen, rehabilitation, sound-light stimulation, it increases furthermore to 54%. With high pressure oxygen plus acupuncture, the wake-up rate is 67%. When high pressure oxygen plus ordinary acupuncture, is combined with rehabilitation, plus sound-light stimulation, the wake-up rate remained the same (64%). Conventional medicine plus special acupuncture, the wake-up rate reaches 70%, suggesting that the special acupuncture technique works much better than the ordinary acupuncture technique, and also better than combination of complex and expensive therapies. Even with ordinary acupuncture, its combination with high pressure oxygen works better than combination with other more rehabilitation remedies.

The effectiveness of acupuncture treatment of the persistent vegetative state is related to the length, the severity and the cause of the disorder, the length of treatment course of acupuncture, the age of the patient, etc.  The longer the disorder before acupuncture treatment, the harder the treatment. The persistent vegetative state due to brain trauma is easier to treat than that due to cerebrovascular accident. The persistent vegetative state due to cerebral infarction is the most difficult to treat. Acupuncture does not work if the length of treatment is not long enough.

There are data suggest that 37% to 43% of patients with persistent vegetative state may still have slight or shallow consciousness and be able to respond to the doctor's order. However, such shallow consciousness is not complete consciousness. It is similar to the consciousness in early stage of shock, in which it can be doubted for the ability of patient to remember things or to analyze outside stimulation, not to speak of a hint to them. We can image our own consciousness and ability to respond to a hint when we did not have sleep for two nights. Yes, we have consciousness, but our response to outside stimulation would be very slow and our mind is cloudy to a hint. Therefore, it would be very difficult to link the increased wake-up rate of those patients after treatment with acupuncture to a hint or to a placebo effect.

Here we paid attention to the wake-up rate, not to the recovery of body function or life ability after wake up. We emphasize that acupuncture can work when a patient is no, or almost no, consciousness [20]. Some paper reported not the wake-up rate, but a PVS scale. Some reported a grade mark, such as the rate of basically cured, dramatically cured, improved, or no change, or such as improved, effective, no effective. For former grade report, we choose their  "basically cure + dramatically improved" as indication of wake-up. In the later grade paper, we only choose their "improved" as wake-up rate.

Therefore, in the calculation of wake-up rate, we have tried to exclude those patients who only come into a shallow consciousness state after treatment.  

9.4. Acupuncture used before or during anesthesia

梁洁 (2007) reported the use of transcutanious electrical stimulation (HANS machine, 30 min before anesthesia until the end of operation, stimulating acupuncture points) for 30 cases of breast cancer undergoing radical masectomy (HANS group). The patients were given intravenous induction plus general anesthesia. Another 30 similar cases were only give intravenous induction plus general anesthesia but no acupuncture (control group). It was found that, 12 hours after operation, the pain level (VAS scale) in the HANS group is dramatically less than control group (2.14±0.85 vs 3.38±0.91) . The HANS group showed much less rate of nausea/vomit than the control group (19% vs 34%).

谢健 (2009) treated 30 cases of patients for radical resection of colon cancer. The patients were given general anesthesia plus scalp acupuncture (Acupuncture group). Another 30 similar patients were given general anesthesia only (no acupuncture, control group). Acupuncture started 20 min before anesthesia and lasted until the end of the operation. They found that the involvement of scalp acupuncture reduced the pain during skin incision (isoflurane MAC is 0.75 and 0.88, respectively), showed some level of pain inhibit and anesthesia (the isoflurane MAC during operation is 0.95 and 1.29, respectively). It means that the use of acupuncture reduced the use of anesthesia drug by 26%.

欧阳铭文 (2009)  allocated 100 patients who were for Laparoscopic gastrointestinal surgery, randomly and blindly into two anesthesia groups: general anesthesia plus acupuncture (acupuncture group, 50 cases) and general anesthesia only (control group, 50 cases). The acupuncture (on Neiguan point both sides) was started before induction and lasted until the end of operation. After operation, the needle was removed. The acupuncture points were covered with an opaque tape. It was found that the incidence of nausea for 6 hours after the operation was 12% and 28% in the acupuncture group and the control group, respectively. The postoperative pain level was no difference between the two groups .

池浩 (2014)  randomly allocated 160 patients who were to have heart valve replacement operation, into general anesthesia plus electrical acupuncture (acupuncture group, 80 cases) and general anesthesia only (control group, 80 cases). Electrical acupuncture (on Zhongfu, Chize and Ximen points) were started 20 to 30 min before induction, lasted until the end of the operation. The anesthesia in acupuncture group did not use trachea cannula, only use little amount of anesthesia. The result is: the acupuncture group and the control group had similar level of anesthesia, but the acupuncture group showed less amount of anesthesia drug, less case who needed blood infusion, earlier time to get up the bed, short time to stay in observation room, less days in hospital, less expense for medical cost, less case with lung infection, earlier time to start to eat, less days to use antibiotics, all of which were significant different.

吴群 (2013) randomly allocated 40 cases of craniotomy into two groups: 20 cases were given general anesthesia (control group) and 20 cases of general anesthesia plus electrical acupuncture (Acupuncture group). The acupuncture started 20 min before anesthesia until the end of the operation. For the control group, electrical patch was adhered to the acupuncture points, but no electrical was connected. They found that, compared with the control group, the acupuncture group showed shorter time to wake up (15 min vs 20 min) after operation, and needed less amount of anesthesia drugs (average 2000 mg vs 2500 mg). Note that the control group is a sham group.

幸志强 (2012) and his colleague randomly allocated 60 patients undergoing subtotal thyroidectomy surgery into two groups of anesthesia: general anesthesia group (control group, 30 cases) and general anesthesia plus transcutaneous acupoint electrical stimulation ( TAES)(Acupuncture group, 30 cases). TAES started 20 min before induction of anesthesia and lasted until the end of the operation. They found that the use of TEAS could significantly stabolize the blood circulation (heart rate, blood pressure), reduce the time of the extubation (6.43±1.08 vs 10.83±2.64 min), and shorten the time to stay in observation room (12.31±1.79 vs 17.83±2.87 min), reduced the usage of anesthesia drugs (46.7±6.3 mg vs 67.5±5.6 mg) , and reduced the cost of medicine (211.78±34.5 vs 291.53±22.81 yuan).

张兆伟 (2014) randomly and blindly allocated 60 patients undergoing Gynecologic laparoscopic surgery into two groups: electrical acupuncture plus general anesthesia (acupuncture group, 30 cases) and general anesthesia alone group (control group, 30 cases). Electrical acupuncture started 30 min before induction and lasted until the end of the operation. They observed the effect of electrical acupuncture on the gastric function of these patients, by observing the changes of gastric mucosal partial pressure of C02 (PgC02), arterial partial pressure of C02 (PaC02), and the partial pressure difference [P(g-a)C02] during surgery. They found that after intervention, there were significant differences in comparing PgC02 and [P(g-a)C02] (P<0.01, P<0.05). The intra-group differences in comparing all indexes were statistically significant between both groups (p<0.01). They commented that electrical acupuncture adopted in laparascopic surgery with general anesthesia can guarantee the supply of blood oxygen to gastric mucosa, thus protecting the gastric function. Please note that the control group is also a sham group.

安立新 (2011)  and his colleagues randomly and double blindly allocated 80 patients undergoing supratentorial tumor resection into two anesthesia groups: general anesthesia group (control group, 40 cases) and general anesthesia plus electrical acupuncture (acupuncture group, 40 cases). The electrical acupuncture were started from the beginning of the induction until the end of the operation. In the control group, only attached electric line to the acupuncture points (on skin) but no connection to electric. Compared with the control group, the acupuncture group showed less consumption of anesthesia drugs, less time needed to restore automatic breath, time to extubation, to open eyes, to restore automatic movement, automatic direction, and shorter time to stay in operation room. After operation, the incidence of irritation, nausea and vomit, all were less in the acupuncture group. For example, the time needed to open eyes in acupuncture group and in the sham group was 18.5±8.5 min and 28.5±13.4, respectively.

安立新 (2013)  randomly allocated 120 patients undergoing supratentorial tumor resection into three anesthesia groups: electrical acupuncture plus general anesthesia (acupuncture group, 40 cases); TENS plus general anesthesia (TENS group, 40 cases) and general anesthesia only group (control group, 40 cases). Acupuncture and TENS started before induction and lasted until the end of the operation. In the control group, there were electrical wire attached to the acupuncture points, but no electric connected. They found that, during the recovery period, the time needed for automatic breath, extubation time, time to open eyes, time to have automatic movement, time to have direction ability, time to leave operation room, all were shorter in the acupuncture group and the TENS group, than that in the control group. The postoperative pain level (VAS scale) in the acupuncture group (3.33±1.09) and the TENS (3.40±1.30) group was lower than that in the control group (6.43±1.52) .

虞慧畅 (2009)  randomly allocated 60 patients undergoing modified radical mastectomy into two groups of anesthesia: TENS plus general anesthesia (TENS group, 30 cases), and general anesthesia (control group, 30 cases). TENS started before induction and lasted until the end of operation. They found that the heart rate, the blood pressure, blood concentration of catecholamin, and cortisol after extubation are all increased compared that at the end of operation in each group. The increment in the TENS group is significantly less than that in the control group. The Airway adverse reaction is also much less in the TENS group than that in the control group.

宫丽荣 (2013) randomly allocated 80 patients undergoing elder abdominal operation into two groups: general anesthesia plus acupuncture (acupuncture group, 40 cases) and general anesthesia only (control group, 40 cases). The electrical acupuncture started 20 min before induction and lasted until the end of the operation. They found that the usage of anesthesia drugs, the time to open eyes, the time to finish order, and the time to restore normal direction, the restless rate, are all lower in the acupuncture group than those in control group. For example, the time to wake up in the acupuncture group is 7.18±2.73 but that in the control group is 12.81±4.42 min. They concluded that combined acupuncture assisted general anesthesia could stabilize the hemodynamics, reduce the stress to the surgery in elderly patients undergoing abdominal surgery, thus being suitable and favorable for these patients.

林舜艳 (2013) randomly allocated 75 elderly patients undergoing colorectal cancer resection surgery into two groups: general anesthesia plus acupuncture (acupuncture group, 38 cases) and general anesthesia only (control group, 37 cases). The electrical acupuncture started 20 min before induction and lasted until the end of the operation. They found the time needed to wake-up was shorter in the acupuncture group than that in the control group (20.35±6.05 min vs 28.24±7.68 min). The rate of disorder of recognition is also low in the acupuncture group than that in the control group (23.7% vs 35.1%).

杨琼卉 (2012) randomly allocated 90 patients undergoing gynecologic laparoscopic surgery into three groups: general anesthesia plus HANS (acupuncture group I, on Zusanli and Sanyinjiao points, 30 cases) and general anesthesia plus HANS (acupuncture group II, on Hegu and Taizhong points, 30 cases) and general anesthesia only (control group, 30 cases). The TENS acupuncture started 30 min before induction and lasted until the end of the operation. They found that the Sevoflurane concentration during operation is much less in the two acupuncture group (acupuncture group I is much less than that in acupuncture group II). The blood pressure and heart rate were more stable in the acupuncture group. The time before opening eyes and removing the tube were shorter; the anxiety scale, pain level, nausea scale, and incidence to hold lower jaw, are all lower, in the two acupuncture groups than those in the control group. The time before passing gas was also less in the two acupuncture groups than that in the control.

周红 (2002) randomly allocated 66 cases undergoing video assistant thoracoscopy into two groups: acupuncture plus pain-killer anesthesia group (acupuncture-drug group, 33 cases) and general anesthesia group (control group). The acupuncture started 30 min before induction and lasted until the end of the operation. they found that the consumption of the pain killer is much less in the acupuncture-drug group than that in the control group (0.039±7.419 ml/kg vs 0.068±0.023 ml/kg).  The blood pressure and heart rate were similar in both group. The good anesthesia rate of the acupuncture-drug group is 78.8%. 

顾陈怿 (2004) randomly allocated 22 patients undergoing tumorectomy into two groups: general anesthesia plus acupuncture (acupuncture group, 11 cases) and general anesthesia only (control group, 11 cases). The acupuncture started 20 min before induction and lasted until the end of the operation. They found that the inhibition effect of the surgical operation was less in the acupuncture group than that in the control group. The blood circulation is more stable during the operation in the acupuncture group than that in the control group.

顾陈怿 (2010) randomly allocated 90 patients undergoing cholecystectomy into three groups: general anesthesia plus traditional electrical acupuncture (acupuncture group, 30 cases), general anesthesia plus sham acupuncture (sham group, non-acupuncture points, also with electric stimulation, 30 cases),  and general anesthesia only (control group, 30 cases). The acupuncture started 15-30 min before induction and lasted until the end of the operation. The acupuncture needles in the sham group were inserted into non-acupuncture points and also connected with electrical stimulation. They found that the consumption of anesthesia drug in the acupuncture group is much less than that in the sham group and the control group. For example, the consumption of Propofolum in the acupuncture group, the sham and the control groups are 451.33±136.30 mg, 524.57±180.66 mg, and 600.47±153.84 mg, respectively. The time before opening eyes, before extubation, and before recovery of direction ability, all were shorter in the acupuncture group, than those in the sham group and in the control group. The use of pain killer after the operation is also much less in the former than that in the later two groups. The postoperative pain level was less in the former than that in the later two groups. Acupuncture at acupoints can enhance the anesthetic effect of compound general anesthesia and prolong the analgesia period. Acupuncture at non-points has certain effect , but their effectiveness is less than that of acupoints. Thus, the acupoint has the specificity and accurate acupoint selection is the key factor affecting analgesia effect.

丁依红 (2013)  randomly allocated 90 patients undergoing cholecystectomy into three groups: general anesthesia plus traditional electrical acupuncture (acupuncture group, 30 cases), general anesthesia plus sham acupuncture (sham group,  non-acupuncture points, also with electric stimulation, 30 cases),  and general anesthesia only (control group, 30 cases). The acupuncture started 15-30 min before induction and lasted until the end of the operation. They found that the acupuncture group can stabilize blood circulation, reduce CO2 pneumoperitoneum, reduce postoperative stress reaction, enhance postoperative pain-reducing effect, compared with the sham and control groups. The time before  opening the eyes, time before extubation, and time before recovery of direction ability, all are significantly shorter than sham group and the control group. The acupuncture groups worked better than the sham group. 

Wang You-jing (2012)  randomly allocated 80 patients undergoing pneumonectomy into four groups: sham group (sham acupuncture plus general anesthesia, 20 cases), acupuncture (2 Hz) plus anesthesia (2 Hz Acupuncture group, 20 cases), acupuncture (100 Hz) plus anesthesia (100 Hz acupuncture group, 20 cases), and 2/100 Hz acupuncture plus anesthesia (2/100 Hz acupuncture group, 20 cases). The acupuncture started 30 min before induction and lasted until the end of the operation. In the sham group, electrical patch was attached to the acupuncture point spots, but no electric connected. They found that the consumption of fentanyl during surgery is less in 2 Hz acupuncture group and 100 Hz acupuncture group than in the sham and the 2/100 Hz acupuncture group. In all groups, the average arterial pressure increased after intubation, compared to that before induction, but the increase range in all acupuncture groups were less than that in the sham group. For similar comparison, the heart rate increased significantly in the sham group, but not so in all the acupuncture groups. After the surgery, the index for auto-immune function reduced, but not so in all the acupuncture groups. They concluded that, with the use of acupuncture during surgery, with less amount use of anesthesia drugs, the body circulation and immune function can be more stable, so as to reduce body stress reaction and to protect body important organ function. The electrical frequency of 2 Hz and 2/100 Hz were better than the 100 Hz.

唐育民 (2001) randomly allocated 45 patients undergoing radical operation of carcinoma of esophagus into three groups:  electrical acupuncture group plus general anesthesia (acupuncture group, 15 cases), electrical patch plus anesthesia (patch on acupuncture points, connected with electrical stimulation) (patch group, 15 cases), and general anesthesia only (control group, 15 cases).The acupuncture and the patch stimulation started 10-30 min before induction and lasted until the end of the operation. They observed anesthesia effect in the tree groups. The results were: the number of patient reached anesthesia level I in acupuncture group, patch group and control group were 11 (73.3%), 10 (66.7%), and 4 (26.7%), respectively. The efficiency of the electrical acupuncture plus general anesthesia, electrical patch stimulation plus general anesthesia worked better than general anesthesia alone. The authors commented that acupuncture point stimulation can adjust body function status, to increase pain threshold. Using acupuncture alone, there is possibility that the suppression of pain is not complete, muscle is not completely relax, and the contract reaction is strong, so that its application in the surgical area is limited somehow. On the other side, anesthesia drug tends to inhibit functions of cardiovascular system and respiratory system. Its inhibition effect is related to the dose used. Inhibition is risk to patients with cardiovascular diseases, if it is over used. When the acupuncture point stimulation technique (needle or electrical patch stimulation) is used together with general anesthesia, the patients' heart rate and blood pressure are stable. The patients loss consciousness without painful face and do not realize the surgical course. The usage of the anesthesia drug is reduced. The safety of the combined anesthesia is increased; the anesthesia effect is remained or improved; the cost of the anesthesia is also reduced.

付建峰 (2002) randomly allocated 40 patients, after general anesthesia, into two groups: TENS group (20 cases) and control group (no TENS stimulation, 20 cases). The electrical stimulation on acupuncture points started 10 min before skin incision, and lasted for 30 min. They found that, the heart rate and average arterial pressure were increased in both groups 10 min after skin incision, but the increment range in the TENS group in much less than that in the control group. For example, for average arterial pressure 10 min after skin incision, it was increased by 25% and 35% in the TENS group and in control group, respectively. Mean while, the heart rate increased by 15.9% and 27.6%, in the two groups, respectively. This result suggested that stimulation of acupuncture points by electrical stimulation could stabilize and buffer the body stress reaction due to skin incision. Because the fact that the electrical stimulation started after anesthesia when the patients lost consciousness, the stabilization effect of acupuncture point stimulation cannot be understand as any placebo effect.

郭继龙 (2002) reported electrical stimulation of acupuncture points one hour after general anesthesia on five patients undergoing excision of intracranial tumor. The electrical acupuncture could increase systolic blood pressure by 22.40±3.19 mmHg, diastolic blood pressure by 12.00±1.41 mmHg, mean arterial pressure by 15.99±1.65 mmHg, and heart rate by 24.00±6.66 bpm. They commented that after anesthesia, stimulation of acupuncture can still improve cardiovascular function.

尹利华 (2005)   randomly allocated 69 patients undergoing rectal cancer surgery into three groups: acupuncture before anesthesia (pre-acupuncture group, 23 cases), acupuncture after anesthesia (post-acupuncture group, 23 cases) and anesthesia alone (control group). They found that the efficiency of anesthesia is better in pre-acupuncture group than that in post-acupuncture group, and much better than that in control group. Although it cannot be excluded that this is due to the longer stimulation of acupuncture points in the pre-acupuncture group than in the post-acupuncture group, it indicated that stimulation of acupuncture points after induction of anesthesia could also enhance anesthesia level, and to reduce the consumption of anesthesia drugs. 

王庚显 (1959) have reported long time ago the acupuncture treatment of surgical accidents, such as stop of breath (2 cases), diaphragmatic spasm (11 cases), tachyrhythmia (2 cases), hypotension (2 cases) and shock (3 cases). Though the earlier reports did not design control group, sham group, blind group, they suggested that, under the anesthesia condition, acupuncture can still exercise healing effects. Such implication has been well documented in later researchers.

Based on the reports above, it can be said that the combination of general anesthesia with acupuncture (ordinary acupuncture, electrical acupuncture or TENS), could stabilize blood circulation, immune system, reduce the consumption of anesthesia drugs, while enhance anesthesia effect. It might be due to the reduction of the consumption of  anesthesia drugs, which makes possible shorter the time before opening eyes, time stay in the observation rooms, the time before extubation, the time to recover direction ability, the lower level of postoperative pain, and the lower incidence of postoperative nausea and vomit.

欧阳铭文 (2009) 301 study showed that the reduction of postoperative nausea/vomit rate is much more in the acupuncture group than that in the sham group, suggesting that acupuncture has its own specific healing effect.

Data from吴群 (2013), 安立新(2011), 安立新(2013), 顾陈怿(2004), 顾陈怿 (2010), 丁依红(2013), Wang You-jing (2012) all showed that the benefit of acupuncture group is much higher in the acupuncture group than in the sham group (no matter the sham is inserted or non-inserted needles), also suggesting that acupuncture indeed has unique healing effect in such non-conscious patients.

Then, the question is, is the reduction in the consumption of anesthesia drugs (and other benefit of acupuncture) due to the acupuncture stimulation in the period before anesthesia, or to that during anesthesia, or both? Data from付建峰 (2002) , 郭继龙(2002) 和尹利华(2005 indicated that even if the patients were under anesthesia condition (without consciousness), acupuncture can still work to stabilize blood circulation and to buffer stress reaction of the body to surgical operation. The acupuncture in the period before anesthesia surely would also work for this effect, [918-924] and the only thing we do not know is how long such effect could prolong into the period during anesthesia (during operation) and after operation. A review article also supports the positive function of acupuncture during the anesthesia.

9.5. Acupuncture started after general anesthesia

Alizadeh R (2014) randomly allocated 227 patients undergoin g general anesthesia into two groups: acupuncture on Neiguan points (112 patients) and acupuncture on Neiguan and Hegu points (115 patients). The acupuncture started after the induction of general anesthesia and lasted until the end of the operation. They found that both groups can reduce the incidences of postoperative nausea/vomit.

Arnberger M (2007) randomly allocated 220 patients undergoing general anesthesia into two groups: electrical acupuncture group (110 cases) and sham group (electrical stimulation on non-point spots, 10 cases). Both stimulation started after general anesthesia and continued until the end of the operation. They found that the incidence of postoperative nausea in the acupuncture group and the sham group were 33% and 51%, respectively, and that of vomit is 16% and 25%, respectively.

Certainly, there was a report by Liodden I (2015) that acupuncture started after the induction of anesthesia showed no more effect than a sham group. However, as pointed out by Alraek T (2015) that the acupuncture stimulation dose in this study was not at all sufficient to create a healing effect in the acupuncture group. When applied after anesthesia, the acupuncture stimulation should be kept during the whole course of the operation.

All of these data clearly suggested that, when the acupuncture started after general anesthesia, in which the patient has no consciousness, the acupuncture still works to reduce the post-operative incidence of nausea/vomit, suggesting that acupuncture has its own specific healing effect, not a placebo effect. The reduced incidence of nausea/vomit is not due to the aware of patient before anesthesia for which group they were allocated in.

Streitberger K (2004)  used acupuncture before and after general anesthesia to patients undergoing abdomen and breast surgical operation. They stimulate Neiguan point for 20 min before or after induction of general anesthesia. They found that the post-operative incidence of nausea/vomit in acupuncture group are 38.9%48.1%, while those in placebo group are 47.3% and 54.9%, suggesting that acupuncture did not induced significant healing effect. However, most of the acupuncture studies on this topic using acupuncture either started before general anesthesia or after induction of general anesthesia, and lasted until the end of the surgical operation and the incidence of post-operative nausea/vomit reported is between 17.7% to 21% (see the current article). Therefore, the Streitberger (2004) experiment does not mean that acupuncture does not work, but that the 20-min acupuncture is not sufficient to bring out a healing or preventive effect for post-operative nausea/vomit.

9.6. Delayed wake-up after general anesthesia

After stop giving the general anesthesia medicine for 90 min, that the patient still does not wake-up can be regarded as delayed wake-up. This is a common complication after general anesthesia and one of the reasons that risk patient's life.

翟文生 (2011)   randomly allocated 30 patients in the delayed wake-up status into two groups: conventional medicine plus acupuncture treatment (acupuncture group, 15 cases) and conventional medicine only (control group, 15 cases). The acupuncture is a kind of modified acupuncture technique. The needles were kept for 30 min, with manipulated by hands once every 10 min. The acupuncture was repeated once every 2 hours until the consciousness returned. In the acupuncture group, the mean wake-up time is 150 min (30-380 min), while that in the control group is average 300 min (90-1080 min). The difference is significant. 

张全霞 (2014)   randomly allocated 50 patients in the delayed wake-up status into two groups: conventional medicine plus acupuncture treatment (acupuncture group, 30 cases) and conventional medicine only (control group, 20 cases). The acupuncture is similar as above: the needles were kept for 30 min, with manipulated by hands once every 10 min. The acupuncture was repeated once every 2 hours until the consciousness returned. The average wake-up time in the acupuncture group is 90 min (30 min to 380 min) and in the control group, 300 min (90 min to 1080 min).

Delayed wake-up is commonly seen in elderly patients. The reasons are varied. The old patients are with declined body function, slower metabolic rate, and are sensitive to anesthesia, so that it is easy to have remaining of anesthesia drugs in the body to cause the delayed wake-up.

王春爱 (2014) randomly allocated 80 elderly patients (after general anesthesia and surgical operation) into two groups: conventional medicine plus acupuncture (acupuncture group, 40 cases, acupuncture started after operation) and conventional medicine only (control group, 40 cases). They found that the average time before wake-up was 15.3±1.9 min in acupuncture group, while it was 18.7±2.4 min in the control group. The difference was significant.

 9.7. Anesthesia in shock patients

Acupuncture used in anesthesia can not only have pain-reducing effect, but also clear anti-shock effect. When the blood pressure of the patients are very low or no blood pressure, it would be very dangerous to give anesthesia drugs, since the anesthesia medicine tend to inhibit never system, and the medicine has side effects too, both of which could make the shock condition worse, bring risk to the surgical operation and cause complication after the surgery.

吴蓉蓉 (1980)   treated 99 shock patients who need surgical operation. The systolic pressure was all below 90 mmHg. The reasons for the shock included hypovolemic shock, toxic shock, traumatic shock, and so on. They treated the patients with conventional medical ways, such as infusion, oxygen, infusion of blood, antibiotics, correction of electrolyte disturbances, and so on. Meantime, they used body acupuncture, ear acupuncture, nose acupuncture, or mouth lip acupuncture to the patients. After induction with acupuncture for 15-25 min, it was observed increase in the blood pressure. During the induction period, blood pressure increased between 10-20 mmHg, 21-30 mmHg, 31-40 mmHg and more than 41 mmHg were 41, 22, 7, and 14 cases. In 3 cases, the blood pressure went down, and in 12 cases, no change. Among the 99 cases, only 11 cases changed to epidural anesthesia due to incomplete anesthesia with acupuncture. 15 cases needed addition of 0.5% procaine (local anesthesia medicine). The authors pointed out that acupuncture can not only have pain inhibition effect, but also relatively apparent anti-shock effect. After acupuncture, 84.85% of patients have had blood pressure increased, while at the same time, similar patients with continuous epidural anesthesia, no any case had blood pressure increased and 81% of patients with blood pressure decreased, and 72% of the patients with blood pressure down to zero. During acupuncture, blood pressure, pulse and breath were relatively stable (less variable). The recovery after surgery was faster. No side effects happened. The inhibition to respiratory system and cardiovascular system by the anesthesia medicine was prevented.

Doctors in the department of anesthesia in the Furth Hospital of Harbin City (1973)  reported their treatment of 30 shock patients who needed anesthesia. The reasons for the shock were toxic shock and hypovolemic shock. Acupuncture was mostly body acupuncture. 12 cases were also with auricular acupuncture. Upon skin incision, 21 cases was given little amount of local anesthesia medicine. During surgical operation, there was no accident as respiratory inhibition as easily seen in medicine anesthesia. For anesthesia efficiency level, 2 cases reached excellent level, 10 cases reached good level, 13 reached acceptable level, and 5 cases failed and changed to medical anesthesia. The blood pressure-increasing effect by acupuncture is gradual with less variation. After increase, it was easy to keep consistent, unlike the blood pressure increased by pressor agents in which the blood pressure could largely fluctuate. Except for 1 case whose blood pressure did not increase, in all other 29 cases, the blood pressure increased and kept in some level as well. The acupuncture could work in coordination with pressor agents. Under acupuncture, the use of pressor agents was much less than when pressor agent alone was used; the pulse was stronger; the difference between systolic and diastolic pressure was larger, and breath was stronger. All of these are helpful to solve shock condition. In hypovolemic shock, the use of acupuncture reduced the volume of blood infusion needed. It reduced the blood infusion average about 400 ml. Shock patients have failure of functions of liver and kidney. Under such condition, the use of medical anesthesia tends to make the condition worse, especially after the operation to cause severe consequence. Upon the acupuncture use, no any case was with worse liver-kidney function due to anesthesia, since the internal environment was disturbed less with acupuncture anesthesia.

Doctors in the department of anesthesia in An-yi Affiliated Hospital (1973) reported the treatment of 50 cases of shock or severe patients undergoing surgery. The shock included hypovolemic shock, toxic shock, and traumatic shock. To the 50 cases, used were auricular acupuncture (27 cases), auricular acupuncture plus body acupuncture (7 cases), nose acupuncture (6 cases), nose acupuncture plus auricular acupuncture (4 cases), auricular acupuncture plus ear-root point injection (1 case), auricular acupuncture plus body acupuncture plus ear-root point injection (1 case), and nose acupuncture plus intradermal acupuncture (4 case). After acupuncture for about 10 to 15 min, the blood pressure could start to increase. Together with intravenous infusion of liquid and blood, correction of acid toxic, and pressor agent, the blood pressure returned to normal gradually. In all the 50 cases, blood pressure increased 10-20 mmHg, 21-30 mmHg, 31-40 mmHg, and more than 41 mmHg were 21, 16, 7, and 5 cases, respectively. Only one case was with no change in blood pressure. The whole course of the operation was stable. For the acupuncture anesthesia level, 43 cases are satisfied and 7 cases were with incomplete anesthesia and had changed the way of anesthesia. Among the 43 success cases, 8 cases used local anesthesia in the skin incision spot with 0.5% procaine.  

It was commented that the adrenal gland point on ear has stronger blood pressure-increasing effect. Nose acupuncture works better for surgical operation in lower abdomen for loss muscle. Nose acupuncture plus intradermal acupuncture works satisfied for reducing pain during skin incision. Using acupuncture in hypovolemic shock, the volume of blood to infusion can be reduced but the blood pressure goes up gradually. It was commonly found that, with medical anesthesia, the increased blood pressure can reduce again, so that the use of pressor agents is very common. But it would be dangerous to use large amount of pressor agents. With acupuncture for anesthesia, it is rare that the blood pressure would go down again. The author[1] reported that they treated 50 cases of shock or severe patients, except for only one case, other patients had blood pressure increased after acupuncture induction. Only 12 out of the 50 cases used little amount of pressor agents, which was much less than with ordinary medical anesthesia. Therefore, acupuncture used in shock patients also prevented the side effect of pressure agents (especially as noradrenalin), such as skin necrosis and reduced volume of urine. With intratracheal anesthesia, the chance of complications increased, but with acupuncture anesthesia, it was never seen such complication as respiratory inhibition as seen with former.  

Doctors in the department of anesthesia in Affiliated Hospital of Shandong Medical College (1973) reported their treatment of 45 shock patients undergoing anesthesia. Among the 45 cases, light shock, middle shock and severe shock were 8, 26, and 12 cases, respectively. Most of patients did not get any medicine before acupuncture. Several patients got pain killer Sauteralgyl, or sedative Phenergan, or atropine or Dong Lang scopolamine. Among the 45 cases, 33 cases combined with local anesthesia (73.3%); 27 cases with Sauteralgyl (60%). 12 cases did not use any of these medicine (26.7%). The anesthesia efficiency: very good is 71.1%, not good is 28.9%. Blood pressure increased in 82.2% of patients; not changed in 6.7%; reduced in 11.1% of patients, at the end of the surgical operation. 

Doctors in the anesthesia group of the Fifth People's Hospital of Guangzhou City (1975) reported their treatment of 55 shock patients who needed surgical operation. The operation included cesarean, subtotal gastrectomy, ectopic pregnancy, ovariocystectomy, cholecystectomy, intestinal resection and anastomosis, splenectomy, debridement and suture fixation. Before operation, used was only sedative luminal. Before and during the operation, used only the acupuncture for anesthesia (did not use anesthesia). The anesthesia efficiency: very good level is 67.3% of patients; more than 100 mg of Sauteralgyl was needed in another 25.4% of patients. Acupuncture anesthesia failed in 7.3% of patients. Postoperative blood pressure increased more than 100 mmHg in 87.2% of patients; increased 80-90 mmHg in 10.9% of patients and failed to increase in 1.8% of patients. Only in 2 cases needed pressor agents.

杨生泰 (1987) reported their treatment of 60 shock patients undergoing anesthesia and surgical operation. Among the 60 cases, 28 were hypovolemic shock and 32 infectious shock.14 cases used 50 mg Sauteralgyl, 0.5 mg atropine. 16 cased used 50 mg Sauteralgyl only. 7 cased used 0.5 mg atropine only. They did not use any other pain killer or sedative. 56 cases used auricular acupuncture, and 4 cases used body acupuncture. The anesthesia efficiency: reached level I, II, III, and IV were 21, 22, 12, and 5 cases, respectively. The authors stated that for abdomen surgery, auricular acupuncture worked better.

Doctors in the acupuncture anesthesia group in the Shanggao County People's Hospital of Jiangxi Province (1977) reported their treatment of 37 shock patients who needed surgical operation. They used acupuncture to 37 patients (acupuncture group), and medical anesthesia (medical anesthesia group) to 15 cases (including general anesthesia, lumbar anesthesia, Epidural anesthesia, and local anesthesia). In the acupuncture group, most of the patients did not use sedative, little patients used pain killer 25-50 mg Sauteralgyl and used local anesthesia during operation. The shock was mostly hypovolemic shock and toxic shock. In the 37 patients, blood pressure increased after acupuncture was 70.3%; no change was 24.3%; reduced was 2.7%; and fluctuated was 2.7%. In the medical group, the blood pressure increased in 13.3%; not changed in 26.7%; reduced in 40% and fluctuated in 20% of patients. Anesthesia efficiency reached level I, II, and III in the acupuncture group was 29.7%, 56.8%, and 13.5%, respectively.

The Acupuncture-anesthesia cooperation group in Yuling, Guangxi Province (1977) reported acupuncture anesthesia to 88 shock patients who needed surgical operation. The shock was hypovolemic and toxic shock. The surgery was stomach, intestine, gall bladder, and uterine surgery. During acupuncture and operation, blood pressure increased less than 10 mmHg was 39 cases; increased 11 - 20 mmHg was 10 cases; increased 21-30 mmHg was 7 cases and no change was 32 cases. 

胡宗泽 (1978) reported acupuncture anesthesia to 60 shock patients who needed surgical operation. Among the patients, 26 were hypovolemic shock; 28 were toxic shock; and 6 were traumatic shock. 30 min before the operation, patients were given 0.5 mg atropine, 0.1 g luminal sodium intramuscular injection. The acupuncture anesthesia was: nose acupuncture plus auricular acupuncture 49 cases; nose acupuncture plus auricular acupuncture plus body acupuncture 8 cases. Before operation, Sauteralgyl was injected intramuscularly. It was not used if the condition was not severe. The anesthesia efficiency reached level I, II, III, and IV, was 10, 19, 29, and 2 cases, respectively. After acupuncture started, intravenous infusion of liquid and blood, and oxygen inhalation, and others were started too. After 15-20 min of acupuncture, blood pressure started to increase. At the end of operation, 91.6% of patients had blood pressure increased gradually with larger difference between the systolic and diastolic pressure. The heart beat sound stronger gradually and the microcirculation started to be improved gradually too. In the 32 patients with hypovolemic and traumatic shock, the systolic pressure increased average 24 mmHg, in which 12 patients increased 30 mmHg. In the 26 hypovolemic shock, the hemochrome was average 7.6 g, average loss of blood 1500-1800 ml, while the blood infusion needed was only 230 ml, which was less than 1/6 of the lost blood volume.

Doctors in the People's Hospital of Guangxi Province (1975)  reported acupuncture use to 61 shock patients who needed surgical operation. The reasons of the shock were hypovolemic (14 cases), toxic (19 cases), traumatic (2 cases), and severe diseases (26 cases). The acupuncture included: body acupuncture 27 cases; body acupuncture plus auricular acupuncture 15 cases; body acupuncture plus mouth lip acupuncture 4 cases, body acupuncture plus nose acupuncture 5 cases, auricular acupuncture 2 cases, mouth lip acupuncture 5 cases, and no record 3 cases. The anesthesia efficiency was excellent 55.7%, accepted 37.7%, and failed 6.5%.

For the use of acupuncture to shock patients, as summarized by doctors in the department of anesthesia in the Affiliated Hospital of Shandong Medical College (1973): (1), acupuncture could clearly increase blood pressure. The most safe anesthesia in shock patients is local anesthesia but it was found that when the operation area is too large, the local anesthesia is hard to produce complete anesthesia and satisfied relax of muscle. During the operation, blood pressure could reduce due to the operation stimulation, the pain reaction, and the pulse could become faster, so as to make the shock worse, even cause accident death. In the intravertebral anesthesia, it is inhibited the use of intraspinal anesthesia in the shock patients. The epidural anesthesia is neither good choice for shock patients. Because the shock patients had poor tolerance to the medicine used in epidural anesthesia, personal variation is very large, it is very easy to cause relative over-dose of anesthesia due to improper anesthesia, so as to cause blood pressure reduced to accident die. Ether inhalation is hard to keep stable and even shallow anesthesia and the breath tract is hard to keep smoothly open. It is also not good choice for a shock patient and it should be prevented to use in shock patient. The most ideal anesthesia might be the combination of ether and muscle relaxer. It can not only induce satisfied muscle relax and keep opening breath tract, but also reduce the use of ether and keep longer time and evenly shallow anesthesia; block the operation stimulation to the brain, to provide satisfied muscle relax and keep open the breach tract. However, this way of anesthesia need expert skill of the anesthesia operator and the equipment is complex. The advantage of acupuncture used in the shock patients is (1), it does not use medicine, so no possibility to inhibit respiratory or blood circulation system, so not interfere the body function. (2), acupuncture per se has no side effect, but has benefit to the body function (as to stabilize body internal environment). (3), for acute patients, especially for acute traumatic upper digestive tract bleeding, acute intestine obstruction, there is no way to inhibit food intake to empty stomach. Because during the acupuncture, the patients are awake, so prevented the chance of vomit or mis-inhalation accident. (4), acupuncture to shock patients, the anesthesia efficiency is satisfied, and it is simple to operate. The most realization with the acupuncture anesthesia is safe and ensured no worry about possible overdose of medicine or block of breath tract, etc. Therefore, it is easy to be handled by ordinary anesthesia operators, and it is a better choice for shock patient undergoing surgical operation.

From above reports, it can be seen that, acupuncture alone can be used in shock patients, to reduce the amount of usage of pain killer and sedative medicine, the volume of blood infusion, to reach satisfied anesthesia level and to improve shock condition the same time.

Because the shock patients are in severe diseased condition, their consciousness are cloudy, or even lost, they are hard to react to outside language or action hint to cause a placebo effect.

Someone may have questioned that for the acupuncture anesthesia, there is still the use of pain killer and sedative medicine. The above data showed that for most patients and in most reports, the pain killer and sedative are not used. Even they are used, the amount are in a level, in which it cannot normally produce satisfied anesthesia effect by them.

 

 9.8. Dementia treatment by acupuncture

Dementia can be separated at least into senile dementia and vascular dementia. Vascular dementia is one of the common kinds of dementia in China, which is caused by disorder in brain blood circulation. The word dementia describes a set of symptoms that can include memory loss and difficulties with thinking, problem-solving or language. In vascular dementia, these symptoms occur when the brain is damaged because of problems with the supply of blood to the brain. It has become a serious problem to human mental health, and has caused a severe burden to the family life and society too. It is a hard task for medical society to solve. It was reported that among patients over 65 years of age, about one third (25% - 41%) would develop into vascular dementia within three months after acute cerebral accident. Epidemiologic study in US showed that among survivors over 60 years of age from acute cerebral accident, about 26.3% developed vascular dementia. 951

Currently, there is no effective therapy for the treatment of any kind of dementia. Because dementia patients have slow mental reaction, analysis, and poor memory, it would be hard to believe that those patients can react to a hint, as normal people, to develop a placebo effect during treatment. So, let us have a look at how acupuncture can work for dementia.

Data in Attached list 23a, 23b, 23c are collected from China. As usual, the effective rate from China was either reported as grade improvement (cure, much improved, improved, or no effect), or as MMSE scale (or HDS scale) change. For the grade reports, we combined the "cure rate" and "much improved rate" together and got Fig. 24a. For the later, we got Fig. 24b. 

Placebo.Fig.24a

Fig. 24a. n = experiment groups.

Placebo.Fig.24b

Fig. 24b. n = experiment groups.

Data showed as MMSE change (Fig. 24b) also showed similar results [22]. The effective rate of acupuncture group (20.6%±11%) is higher than conventional medicine alone (14.3%±8%). With the combination of conventional medicine with acupuncture, the MMSE scale increased by 23.8%±8%. With the combination of acupuncture with Chinese herbal therapy, MMSE can be increased by 27.1%±10%.

When the healing effect is expressed with the HDS scale, the results were similar (Fig. 24c).

Placebo.Fig.24c

Fig. 24c. n = experiment groups.

Apparently, acupuncture has its one specific healing effect. Combination of acupuncture with either conventional medicine or Chinese herbal therapy can further increase the healing effect.  

Fig. 24a showed that, treated with conventional medicine, the Cure-much-improved rate is 33.4%±19%. With the treatment with acupuncture, it was 44.7%±20%. With Chinese herbal therapy, it was 40.0%±24%. With combination of conventional medicine and acupuncture, it was increased to 61.8%±19%. With combination of acupuncture and Chinese herbal therapy, it is similarly increased to 57.2%±20%.

9.9. Anesthesia by acupuncture alone or combined with local anesthesia

Acupuncture can not only work during general anesthesia to reduce the consumption of anesthesia drugs, enhance anesthesia effect, and reduce the post-operative side effect of surgical operation, but also work alone or together with nerve blocking anesthesia or local anesthesia to enhance the anesthesia effect and reduce side effect of the anesthesia drugs

It has been reported in earlier years that, when acupuncture alone was used in 138 patients undergoing nose surgical operation, the anesthesia efficiency reached level I was 39 cases (28.2%), level II 72 cases (52.1%). Most of the operation is correction of nasal septum (58 cases) and nasal polypectomy (42 cases). The patients were given 0.06 g of phenobarbital (sedative drugs) before going to bed the day before the operation, and again the same dose one hour before the surgical operation. Only in 28 cases (20.2%), it was used pain killer Sauteralgyl.

Another clinic report stated that to use acupuncture alone for local anesthesia to 254 patients undergoing nose surgical operation (did not use electrical stimulation), the anesthesia level reached level I, II were 203 cases (79.9%) and 30 cases (11.8%), respectively.  They did not report whether the patients were given any sedative drugs.  

周继福 (1989)  summarized their use of electrical acupuncture anesthesia to patients undergoing ear-nose-through surgical operation. Among their 2046 patients, the anesthesia efficiency level reached level I and II are 90.2%. They did not mention if their patients were given sedative or not before acupuncture. The author stated that the anesthesia efficiency and the acupuncture stimulating dose had close relationship. The anesthesia efficiency (especially muscle relax) and pain reduction effect under longer time acupuncture induction (30-60 min) is better than short time induction (less than 30 min). Acupuncture anesthesia not only stimulates clear pain reduction and muscle relaxation effect, but also works to modulate or adjust functions of various organs and has some other biophysiological effects. To perform endoscopic examination under mucosal surface anesthesia, the patients usually feel palpitation, short of breath, difficulty feeling in chest, etc. This phenomenon was never observed during acupuncture anesthesia.

孙鎏熙 (2001)  randomly allocated 96 patients undergoing nasal polypectomy into two anesthesia groups: electrical acupuncture anesthesia (acupuncture group, 50 cases) and local anesthesia alone (control group, 46 cases). The anesthesia efficiency: 100%. In the acupuncture group, the surgical operation was finished without use of any complementary medicine in 46 cases. Only 4 cases were given 10 mg diazepam  or 50 mg pethidine. The anesthesia efficiency reached level excellent, good, and no effect, was 92%, 8%, and 0%, while those number in the control group was 60%, 40%, and 0%.

张道武 (2002) randomly allocated 60 patients undergoing nasal polypectomy into two anesthesia groups: acupuncture anesthesia (acupuncture group, 30 cases) and local anesthesia (control group, 30 cases). In the acupuncture group, 36.7% of the operation reached local anesthesia level I with acupuncture alone. In 63.3% of cases, it was added with local anesthesia drugs, but the amount of the drugs were less than used with typical local anesthesia group. The incidence of postoperative pain was less in the acupuncture group than in the control group.

童秋瑜 (2012) randomly allocated 60 patients undergoing nasal endoscopy into two anesthesia groups: acupuncture plus amethocaine anesthesia (combined group, 30 cases) and amethocaine anesthesia (control group, 30 cases). In the combined group, the usage of amethocaine is 71.33±8.90 mg, while that in the control group, 118.33±26.21 mg. Pain level was lower than in the combined group than in the control group, and the satisfied rate was higher in the former than in the latter group.

It has been reported that 80% patients had stress; some had depression or fear, before surgical operation. Some patients undergoing local anesthesia showed anxiety or shock, or changes in heart rate and blood pressure, etc., due to too heavy emotional stress. There are rich nerves in the nose-throat area and it is very tender to pain in this area. The way of local anesthesia in this area is mostly surface anesthesia or local infiltration anesthesia.354

Some researchers had a survey to 100 patients undergoing nasal surgery under local anesthesia and found that 32 patients showed heavy sweat, anxiety, nausea, palpitation, short of breath, fast pulse, change in heart rate and blood pressure, etc., affecting the continuing of the operation. Apparently local anesthesia cannot reach satisfied anesthesia effect. The use of general anesthesia is used in the nasal endoscopic surgery can avoid the incomplete anesthesia (as by local anesthesia), so to ensure the continuing and finish of the surgery operation. However, it needs trachea cannula to help keep smooth breath. Because the trachea cannula is close to the operation area, it can cause difficulty for the manipulation of operation. Also due to trauma and stimulation to the throat, it is easy to cause bleeding and swelling. There is rich nerves and blood in the face, mouth, and jaw, it is easy to cause bleeding, so to cause block of breath tract after general anesthesia. After nasal endoscopic surgery, it is needed to fill the nose cavity; the patient has to breathe by mouth. If the throat has swelling or other trauma, the postoperative reaction would be very strong. Therefore, the general anesthesia is neither a perfect way of anesthesia in nasal surgery, though it can create complete no pain status. The data above suggests that, acupuncture anesthesia can dramatically reduce the dosage of anesthesia medicine during the surgical operation. The combination of acupuncture with local anesthesia medicine used less amount of the local anesthesia medicine, so reduced the chance of swelling of local tissue, while the pain reduction level is still satisfied. Apparently, the combination of acupuncture and local anesthesia medicine could reduce the side effect and weakness of the local anesthesia and improve the quality of surgical operation.  

雷健 (2000)   and his colleagues randomly allocated 532 patients undergoing thyroid operation into two anesthesia groups: acupuncture anesthesia group (acupuncture group, 324 cases, with sedative before acupuncture) and Superficial cervical plexus block anesthesia (control group, 208 cases). It is reported that the usage of meperidine in the control group is more than that in the acupuncture group. There was no difference for the average arterial pressure and heart rate in each stage of the operation between the two groups. There were no complications in the acupuncture group, while there were 12 cases of recurrent laryngeal nerve paralyses and 6 cases of diaphragmatic paralysis in the control group.

马越英 (2005)   randomly allocated 100 patients undergoing thyroid operation into three anesthesia groups: electrical acupuncture anesthesia (acupuncture group, 20 cases), cervical plexus block anesthesia (plexus group, 40 cases) and the combined acupuncture and cervical plexus block anesthesia (combined group, 40 cases). They found that the heart rate and blood pressure in the acupuncture group and the combined group was more stable than that in the plexus group. There are no recurrent laryngeal nerve paralyses or diaphragmatic paralysis in the acupuncture group. There are 3 patients with recurrent laryngeal nerve paralyses and 1 diaphragmatic paralysis in the plexus group. There is 1 patient with recurrent laryngeal nerve paralyses and no diaphragmatic paralysis in the combined group. 

There are also large amount of other studies ,reported that with acupuncture anesthesia in the thyroid surgical operation, the vital sign is stable and there is no side effect as those caused by medical anesthesia drugs. The complication is little, so favoring the recovery of patients after the operation. However, upon handling the upper part of the thyroid or separating the tissues around the trachea, most of patients showed more or less tractive reaction, suggesting that the acupuncture anesthesia is not a complete anesthesia yet. cervical plexum anesthesia does not affect the breath of patients; the anesthesia efficiency is ensured; and is simple to manipulate. So it is wildly used in the surgical operation of neck area. However, after cervical plexum block, the heart rate and blood pressure increase, so that the heart consumption of oxygen also increases, which is not good for patients with hyperthyroidism, hypertension and coronary heart disease. The combination of acupuncture with cervical plexum block anesthesia, the pain reduction was enhanced and the usage of the drugs was reduced about 40%-50% , so also prevented increase in the heart rate and blood pressure caused by cervical plexum block anesthesia alone.

高成杰 (2004) randomly allocated 60 patients undergoing appendectomy into two anesthesia groups: acupuncture plus epidural anesthesia (combined group, 20 cases), and sauteralgyl alone (sauteralgyl group, 20 cases) and epidural anesthesia alone (epidural group, 20 cases). Their results were that the pain reduction effect of the combined group was much better than the other two groups. The pain reduction excellent rate was 100%, 85%, and 70% in the combined group, the sauteralgyl group, and the epidural group, respectively. In the combined group, the heart rate, blood pressure, mean arterial pressure, all were stable, but those parameters in the other two groups, increased. .

吴焕淦 (2007) summarized the experience of doctors in their hospital (1960-1987) about the use of acupuncture anesthesia in lobectomia pulmonalis. The skin incision was 24-27 cm long. The process of the surgical operation included skin incision, muscle incision, strip of bone membrane, cutting of rib, open of chest, separation of adherence, clearing of sick tissues, clearing of blood vessels, separation of space of lobs, prevention of mediastinal flutter, prevention of cough, close of chest, sew of muscle, sew of skin, insert of drainage-tube and so on for 15 steps. Acupuncture was used mostly to reduce pain when the operation touched the skin, muscle, and bone, and to control the fluttering of mediastinal. In this early stage, they used mostly manual acupuncture for anesthesia. The patients were completely clear in mind. No tubulation used, no medicine used and very rarely used local anesthesia drugs. They finished totally 1385 cases. The excellent anesthesia rate was 65.12%. In later stage, they studied the use of acupuncture plus general anesthesia in 1089 patients for lobectomia pulmonalis. They found that by this combination, the dosage of anesthesia drug was reduced by 42%-45%, compared with the medical anesthesia alone. With intramuscular injection of weak opioid analgesic drugs Tramadol 100 mg and acupuncture-effective enhancing cerucal 20 mg, the dose of the medical anesthesia can be further reduced by 45%, while the pain reduction effect was further improved. The combined anesthesia can not only reduce cardiovascular reaction during trachea cannula and tracheal extubation during induction of general anesthesia, but also reduce the total amount of the use of the anesthesia drugs, so as to make the blood circulation more stable and the wake-up earlier after the operation. From year 2001 till now, they turned to study the influence of acupuncture on the immune system in lung cancer patients undergoing surgical operation. They have finished the combined acupuncture and general anesthesia 898 cases. The dosage of the general anesthesia in the combined group is the same as that used in the general anesthesia group alone. They found that acupuncture can not only work to reduce pain, but also has immune adjusting effect, so as to improve the healing to the lung cancer, to be benefit to the recovery of such patients after surgical operation. They found that the acupuncture anesthesia can increase the number of the subgroup of T8 lymph cells at the 8th day after operation, increase the number of the subgroup of T3 lymph cells on the forth chemotherapy, increase the activity of NK cells, and increase the serum γ-interferon, so to increase the immune function of the cancer patients.

吴玉芳 (2002) randomly allocated 40 patients undergoing colonoscopy into two anesthesia groups: acupuncture anesthesia (acupuncture group, 20 cases), and general anesthesia (control group, 20 cases). They found that acupuncture induced better pain deduction.

When acupuncture was used alone or combined with various local anesthesia methods, the patients are clear in mind. So, those of people who insist that acupuncture is only a placebo effect would again say that the effect of acupuncture in the local anesthesia is also a placebo effect. We do not deny that there could be some placebo effect that could contribute to the good anesthesia effect in the acupuncture group, but it appears hard to set up a sham acupuncture group to test this hypothesis. Can we hint the patient that he will have acupuncture which could reduce his pain to zero during the operation, and we do a sham acupuncture (pseudo-acupuncture, such as just put a patch on the skin but no any electrical stimulation connected to the patch), pretend that we are perform an acupuncture to him, and then to cut a 24-27 cm open on the skin of the patient? Who had ever and who dare to study sham acupuncture as such? Remember that even in a sham surgical operation, the researchers used local anesthesia before they cut the skin and then sewed the cut, to pretend that a surgical operation was done! That is a sham surgical operation, in which the operation per se was not performed. But here, it means a sham anesthesia, the anesthesia was not given, but the patient would get the skin cut.

Surely in some studies, there was a use of sedative before the acupuncture. Colquhoun D mentioned this, and hinted that acupuncture per se does not work but the sedative. This is a misleading to the public. Sedative can work to calm down anxiety but not to reduce the pain level. Also, the sedative can also produce some placebo effect. Can anyone only use sedative (even little amount of pain killer, such as Sauteralgyl 50-100 mg) to start a surgical operation? Why you dare not to use the placebo effect from the sedative and pain killer as such, but dare to use the placebo of acupuncture to finish the surgical operation?

Because it is hard to design a sham group in the acupuncture-induced local anesthesia study, we indicated that the data here is indirect evidence that acupuncture is not a placebo effect. We can only prove our opinion by the effect of acupuncture used before, during, or after a surgical operation (above), in which the patients were without consciousness but acupuncture still worked. If we accept the conclusion from these previous studies with general anesthesia, we should now comment that, even if there could be some level of placebo effect in the acupuncture-induced local anesthesia, acupuncture still exercises its unique anesthesia effect.  

Brief summary:

(1). Placebo effect needs that the person is in a clear mind condition. Data here showed that acupuncture works in a condition when a person is without or with very week level of consciousness, such as coma, shock, persistent vegetative state, general anesthesia (before, during, of after operation). This is direct evidence that acupuncture has its own specific healing effect.

(2). Data in the acupuncture treatment of dementia and in local anesthesia are listed as indirect evidence, since in the dementia, low level of patient could still have clear mind though they could have less ability to remember; in the local anesthesia, there is no sham data allowing a direct comparison between the acupuncture group and the sham group.   

Chapter 10. Different healing effect with different acupuncture technique

If acupuncture is only a placebo effect, then under the same experiment conditions, acupuncture on different acupuncture points, or manipulate the needle by different ways, or use different frequency of electrical stimulation... should yield a statistically similar or the same results. Indeed, there are some studies by acupuncturists in the Western countries on this topic, which showing so. However, when we review these studies, we again found that they performed acupuncture in a quite low treatment frequency, while similar studies by acupuncturists in China were performed in higher treatment frequency, and found quite different results, suggesting that acupuncture points have relative specificity, and that acupuncture is not a placebo effect.

10.1. Different acupuncture points

于慧娟 (2014) randomly and single-blindly allocated 50 patients with cardiac premature beat into two acupuncture groups: electrical acupuncture on Neiguan points (Neiguan group, 30 cases) and on Xuanzhong points (Xuanzhong group, 20 cases). They found that the total effective rate in the Neiguan group is 50%, while that in the Xuanzhong group, 5%. They did the acupuncture once a day for 10 days.

许凯声 (2014)  randomly allocated 82 coma patients due to severe traumatic craniocerebral injury into two groups: acupuncture on Suliao-focused point (Suliao group, 42 cases) and on Shuigou-focued point (Shuigou group, 40 cases). Under the same way of acupuncture, the cure-improve rate in the Suliao group is 45.2%, while that in the Shigou point is 22.5%. The acupuncture was performed once a day, five-day a week, two-week as a course.

Yiu  E (2004) randomly allocated 24 dysphonias patients into two electrical acupuncture treatment groups: acupuncture on Renyin, Lieque and Zhaohai points (12 cases) and on Kunlong and Houxi points (control, 12 cases). The acupuncture was 10 sessions within 20 days. After treatment, the voice frequency range in the former increased by 28.8%, while almost no change in the control group.

Yu YP (2010)   randomly allocated 66 cases of primary dysmenorrhea women into two acupuncture treatment groups: acupuncture on Sanyinjiao (33 cases) and on Xuanzhong points (33 cases). The acupuncture was performed during the menstruation for 5 min. They found that, the deduction in the pain level and the increase in the arterial blood flow in the Sanyinjiao group was much dramatic than that in the Xuanzhong group.

岑珏 (2007) randomly allocated 138 patients with unstable urine bladder function into two acupuncture treatment groups: acupuncture on Huiyang points (93 cases) and on Huantiao point (45 cases). After three times of acupuncture, various symptoms in the Huiyang group were significantly improved, while only urine retention feeling and urgent feeling were improved in the Huangqtiao group. Both groups could reduce  I-PSS scale and to improve quality of life but the Huiyang group worked better than the Huantiao group. After 5 times of acupuncture, the healing effect was even better than that for acupuncture for 3 times in the Huiyang group. They commented that, acupuncture on Huiyang points could adjust the function of urine bladder and the effect can be accumulated with more times of acupuncture treatment.

赖新生 (2006) randomly allocated 50 VD patients into five electrical acupuncture groups: conventional acupuncture group (Convention group); conventional acupuncture plus Baihui points (Baihui group); plus Shuigou point (Shuigou group); plus Shenmen points (Shenmen group), or plus Baihui, Shuigoud and Shenmen points (combined group). Each group was 10 patients. The acupuncture was performed once a day for 5 days, had a break for 2 days. Repeated this way for 6 courses. They found that after treatment, the SECF sore in the combined group was dramatically increased. In the Baihui group, the ability of direction, short term memory, long term memory, animal name memory, calculation, classification and category separation, etc. improved dramatically. In the Suigou group, the ability of direction, money spending, calculation, classification, and grouping were much improved. In the Shenmen group, the range of figure, name of animals, classification and grouping were much improved. They summarized that the acupuncture points Baihui, Shuigou, and Shenmen could improve the recognition of VD patients. There was relative specificity of their healing effects. The combination of the tree points worked better than use them individually.

余明哲 (2001) randomly allocated 64 patients with duodenal ulcer into 4 acupuncture treatment groups: point Zusanli plus ranitidine (Zusanli group, 16 cases), point Shangjuxu plus ranitidine (Shangjuxu group, 16 cases), point Xiajuxu ranitidine (Xiajuxu group 17 cases), and ranitidine alone group (15 cases). They found that the three acupuncture groups worked better than the ranitidine group in the improvement of pain-cessation time, clear rate of Helicobacter pylori and some other symptoms. Again the Zusanli group worked better than the Shangjuxu group and Xiajuxu group. But the Shangjuxu group and the Xiajuxu group worked similar. They commented that acupuncture worked in the treatment of duodenal ulcer using the Zusanli, Shangjuxu and Xiajuxu points, but there was relative specificity in the extent of healing effect among the three points.

王德军 (2012) randomly allocated 116 functional indigestion patients into three acupuncture treatment groups: acupuncture on Zuyangming stomach meridian points (point group, 36 cases), on other points on the same meridian but they are normally not used for the treatment of indigestion (non-points group, 39 cases), and on spots that does not belong to any acupuncture points or meridians (non-meridian-non-points group, 41 cases, shallow insertion). Acupuncture was performed once a day for five days, with a break of 2 days before next healing course. Totally 4 courses. After the treatment, the improvement in FDI score and SF-36 scour in the point group was much better than that in the other two groups. The improvement of these two parameters in non-points was also better than that in the non-point-non-meridian points. Apparently there are relative specificity among acupuncture points and between the acupuncture points and sham points.

兰蕾 (2010)   randomly allocated 60 patients who suffered from functional indigestion, into two acupuncture treatment groups: acupuncture on specific acupuncture points that are normally used for the treatment of indigestion (acupuncture group, 30 cases) and acupuncture on non-points. The acupuncture was performed once a day for 5 times, and continued for 4 courses. They found that, after the treatment, the improvement of symptoms of upper stomach bloating feeling, early fullness, upper stomach pain and upper stomach burning sensation, were 85.72%78.26%94.11%60% in the acupuncture group, while they were 19.23%20%6.25%7.69%, in the non-point groups, respectively. Though the non-point stimulation also showed some improvement compared with before-acupuncture, but the improvement in the acupuncture group always much better than the non-point group.

马婷婷 (2015) randomly allocated 230 patients with functional indigestion into two acupuncture groups: acupuncture on far-away points (far-away group, 116 cases) and acupuncture on local points (local group, 114 cases). The acupuncture was once a day for 5 days, total 4 weeks. After treatment, the healing effects of the far-away group were much better than the local group.

何希俊 (2006) randomly allocated 278 peripheral facial palsy patients into two acupuncture groups: acupuncture on far-away points (far-away group, 145 cases) and acupuncture on local points (local group, 133 cases). The acupuncture was once a day for 6 days per week, total 3 weeks. After treatment, the healing effects of the far-away group were much better than the local group. The cure-much-improvement rate in the far-away group was 88.3%, while that in the local group, 64.7%.

We noticed that acupuncturists in the Western countries also did some comparison studies to test if there is difference in the healing effect between different acupuncture points, or between acupuncture points and non-points. For example, Allen JJ (2006) randomly allocated 105 severe depression patients into 3 acupuncture treatment groups: acupuncture on traditional acupuncture points that are normally used for the treatment of depression (acupuncture group, 53 cases), and acupuncture on non-specific points that are normally not used for the treatment of depression (non-specific group, 52 cases), and that on non-points that do not belong to any acupuncture point/meridian (non-points group, 52 cases). The acupuncture was performed twice a week for 4 weeks, than once a week for another 4 weeks (typical Western style acupuncture).  After the treatment, the improvement rates in the three groups were 43.5%, 47.8% and 21.7%, respectively. They said that there is no specificity among acupuncture points. As we mentioned above, the failure for them to find relative specificity among acupuncture points could well be due to low treatment frequency in this study.

10.2. Between acupuncture points and non-points

It was reported that acupuncture on different acupuncture points, or using different acupuncture technique, the healing effects are similar. Some other studies showed that acupuncture on traditional acupuncture points or on non-points, the healing effects were similar.

Berman BM (2004) allocated 336 patients suffering from osteoporosis of knee joint into two acupuncture groups: acupuncture on points that are normally used for the treatment of osteoporosis of knee joint (acupuncture group, 173 cases), and that on non-points (non-point group, 163 cases). The acupuncture was twice a week for 8 weeks, then once a week for two weeks, again once every two weeks for 4 weeks (total 23 sessions). WOMAC functional score was improved in the acupuncture group much more than that in the non-point group, but not WOMAC pain scale.

Melchart D (2005)  randomly allocated 195 tension headache patients into two acupuncture treatment groups: traditional acupuncture group (132 cases), and non-acupuncture point group (63 cases). The acupuncture was twice a week for 4 weeks, then once a week for 4 weeks. After 8 weeks, the headache score reduced in the acupuncture group by 47.2%, while that in the non-acupuncture points was also 44.3%. No significant difference between the two groups.

Assefi NP (2005) randomly allocated 99 patients with fibromyalgia into four acupuncture treatment groups: traditional acupuncture group (25 cases), on non-point acupuncture group (24 cases), acupuncture needle not inserted group (25 cases) and non-specific acupuncture group (e.g. the acupuncture points normally not used for the treatment of fibromyalgia, 25 cases). The acupuncture was twice a week for 12 weeks. They found that the pain deduction rate in the acupuncture group, the non-specific group, non-points group and non-inserted group, were 21.4%,20.3%,41.1% and 33.8%, respectively. No significant difference between each groups [23].

Witt C (2005) randomly allocated 224 patients who suffered from osteoarthritis of the knee into two acupuncture treatment groups: acupuncture group (150 cases) and non-acupuncture point group (74 cases). The acupuncture was twice a week for 4 weeks, then once a week for 4 weeks. After the treatment, the pain reduced by 62.4% and 51.5% in the acupuncture group and in the non-point group, respectively, without significant difference.

Macklin EA (2006) treated primary hypertension by acupuncture and said that the healing effect is similar in the acupuncture group and the non-point group. We noticed that the acupuncture was performed in this study was twice a week. While for the treatment of hypertension in China, it is mostly once a day, even twice a day for 28 days.

Cabrini L (2006) randomly allocated 32 patients undergoing branchofiberoscope into two acupuncture groups, both were performed 20 min before the surface anesthesia: acupuncture on traditional points (acupuncture group, 16 cases), and that on non-points (non-point group, 16 cases). In both groups, the needles were kept until the end of the exam. The results showed that, after acupuncture for 20 min, the anxiety level was reduced by 42.7% in the acupuncture group, but did not change in the non-point group.

The studies above are mostly done with acupuncture once a week or twice a week, rarely three times a week. The difference between the acupuncture group and the non-point group are in most time insignificant. When the acupuncture was performed with higher frequency of treatment, the difference between the two groups tended to be significant. Such data are mostly from China. 

万明雨 (2014) randomly allocated 28 patients with primary migraine (hyperactivity of liver-Yang type in TCM) into two acupuncture treatment groups: acupuncture group (14 cases), and other-points group (points that are normally not used for the treatment of migraine, 14 cases). The acupuncture was once a day for 10 days. The number of points in both groups was the same (4 points). After the treatment, the pain level was reduced in the acupuncture group and in the other-point group was 50.0% and 26.2%, respectively.

章海凤 (2013) randomly allocated 59 migraine patients into two acupuncture treatment groups with the same numbers of acupuncture points: acupuncture group (30 cases) and non-acupuncture point group (29 cases). The acupuncture was once a day for 5 days. Have a two-day break between healing courses. It was totally 4 courses. They found that the pain was reduced by 42% and 10.4%, in the acupuncture group and in the non-point group, respectively.

张智龙 (2007) [1080] randomly allocated 255 constipation patients into two electrical acupuncture treatment groups: acupuncture group (126 cases) and non-point group (129 cases). The acupuncture was once a day for 28 days. The result showed that the electrical acupuncture treatment can dramatically improve the symptom, speed up the content passing speed inside intestine, reduce the usage of Constipation Relief Suppositories Glycerol and evacuant. The total effectiveness rate in the acupuncture group was 94.4% and that in the non-point group, 61.3% .

樊莉 (2005) randomly allocated 53 depression patients into two acupuncture plus auricular acupressure treatment groups: acupuncture group (28 cases) and non-point group (25 cases). Acupuncture was twice per week for 3 months. After treatment, the cure rate and the much-improve rate in the acupuncture group was 28.6% and 28.6%, respectively, while those in the non-point groups, 8.0% and 20.0%, respectively.

Chou CY (2005) randomly allocated 40 patients with later stage of uraemia with itch into two acupuncture treatment groups: acupuncture group (20 cases) and non-point groups (20 cases). Acupuncture was three times a week for one month. They reported that the itch level was reduced by 54.7% and 2.6%, in the acupuncture group and in the non-point group, respectively.

The results of some studies that also compare the healing effect of acupuncture group and the non-point group was cited as not support the relative specificity between acupuncture points. But actually they are not a proper study to function as such. For example in the study by Vickers AJ (2005), they used non-inserted needle, not the inserted needles into the skin.

Also in the study by Scharf HP (2006),  the used acupuncture points or non-points is together with physiotherapy. It is hard to evaluate the actual amount of healing effect in a mixed treatment program. Again, both acupuncture and manual therapy of the physiotherapy are much depending on personal skill. The overall healing effect could be even more largely variable. Again, in the Western style of physiotherapy, the practitioners usually ask client to do physical exercise, while in Chinese acupuncture, we ask patients stop physical activity whenever the pain is very severe. Too much physical activity would make the pain worse, rather than better. The way of the treatment and the requirement to patients are quite different among these two therapies.

10.3. Between different acupuncture techniques

There are many studies in China compared the healing effect of acupuncture by its ordinary technique or by its various modified techniques.

梅麟凤 (2008) randomly allocated 56 patients who suffered from coma due to severe cerebral trauma into two acupuncture treatment groups: one is with comprehensive combined treatment (including scalp acupuncture, auricular acupuncture and body acupuncture, 36 cases) and another with body acupuncture alone (20 cases). The acupuncture was once a day. 10-day was one course, with 3-day break between courses. They found that the effective rate in the two groups was 69.4% and 40%, respectively.

崔新华 (2005) randomly allocated 100 persistent vegetable states patients into two acupuncture treatment groups: one was with ordinary acupuncture (50 cases), and another was with special acupuncture technique (50 cases). The acupuncture was twice a day for 24 sessions. They found that the wake-up rate in the two groups were 62% and 86%, of significantly different.

睢明河 (2012) randomly and blindly allocated 293 patients of high blood pressure into different treatment groups. This is one time acupuncture. They found that, though the control group (in this group the patients do not feel Deqi sensation) showed some deduction of blood pressure, the blood pressure deduction was much more in the Deqi acupuncture treatment groups.

In the above studies in the comparison between a special acupuncture technique and a conventional acupuncture technique, the common characteristic of them is that they are real and inserted treatment. This means that, the group that was used as a control (the ordinary acupuncture group), can also be regarded as a sham group (though it is not a perfect sham, because it has its own healing effect too). The similarity between the two groups is that both are performed with the same treatment frequency and same level of emotional influence to the patients. However, readers might still question that the number of acupuncture points used, the amount of stimulation to the points, all are different between the two groups, so that the placebo effect might be more in the group, in which more number of acupuncture points were used, and stronger simulation was given.

For this question, we can also show some other studies, in which the kind of acupuncture points, the number of the points, and treatment frequency between the groups, were exactly the same. The differences between the groups are the direction of needles after they are inserted into the point. It sill showed that the acupuncture of special technique worked better than a conventional acupuncture.

 孙懿君 (2015) randomly allocated 200 patients with cervicalspondylotic radiculopathy into two acupuncture treatment groups: one was with conventional treatment (100 cases) and another with a special acupuncture technique (100 cases). The acupuncture was once a day. 10-session was one course for total 2 courses. They found that the pain level reduced by 79% and 45.4%, respectively in the special group and in the conventional group.

尚艳杰 (2011) randomly allocated 64 patients with shoulder periarthritis into two acupuncture treatment groups: one was with a special acupuncture technique (32 cases), and another with conventional technique (32 cases). The acupuncture points used were the same, and the acupuncture was done once a day for 6 days, with one day break before next course, for total 2 courses. They found that the cure rates were 53.1% and 31.2%, in the special acupuncture group and the conventional group, respectively.

时晓燕 (2014) randomly allocated 150 stomach pain patients into three acupuncture groups: special acupuncture technique I  (special group I, 50 cases), special acupuncture technique II (special group II, 50 cases), and conventional acupuncture (conventional group, 50 cases). They used the same acupuncture points, but the different ways of manipulating the needles. The acupuncture was once a day for one week. They reported that the effective rate was 96%, 94%, and 60%, in the special I, special II, and the conventional group, respectively. 

李伟 (2015) randomly allocated 160 patients who suffered from prolapse of lumbar intervertebral disc into two acupuncture treatment groups: special acupuncture technique (Wen-tong technique, 80 cases) and conventional acupuncture (80 cases). The acupuncture points used were the same. The acupuncture was once a day, 15-day as a course. They reported the excellent healing rate was 97.8% and 78.8% in the special acupuncture group and the conventional group, respectively.

陈美仁 (2007) randomly allocated 165 sciatica patients into two acupuncture treatment groups: one was with a special acupuncture technique (special group, 82 cases), and another with conventional electrical acupuncture technique (83 cases). Both groups used the same acupuncture points. The acupuncture was performed once every other day. Ten-session was one healing course. They reported that the cure-much-improved rates in the special group and the conventional group were 88.7% and 57.5%, respectively.  

10.4. Different influence of acupuncture and pseudo-acupuncture

A lot of studies have indicated that there happened many neurohumor changes in the body after acupuncture, but no such changes with a sham acupuncture (or a pseudo-acupuncture). For example, acupuncture can induce secretion of some nerve-chemical substances, such as Beta-Internal polyphenol, enkephalins, and serotonin.

Animal studies showed that acupuncture can change the transportation of nerve transmitter, such as opioid and monoamines in the brainstem, cerebral ganglia, hypothalamus and hypophysis.

Therefore it is deduced that acupuncture can work through changing the autonomic nervous system. For example, electrical acupuncture can reduce the sympathetic nervous activity. Because those effects and changes could not be observed in sham group, the effects of acupuncture treatment were induced to be due to the stimulation of acupuncture points or meridians.

If acupuncture is merely a placebo effect, how could be the difference between different acupuncture point(s), between acupuncture point and non-point, between different acupuncture techniques, and between different manipulating technique on the needle in the same acupuncture pointAlso how can acupuncture stimulate various hormone secretion but the sham acupuncture not? In fact, the above comparison studies are reproducible. It should be pointed out again that these results were obtained with frequent acupuncture treatment schedules, e.g. the acupuncture was performed mostly once a day, or at least once every other day. If it is performed as once or twice a week, they may be hard to be reproduced.

Brief summary:

Another way to test if an acupuncture treatment is a placebo effect is to compare the healing effect between different acupuncture points, between acupuncture points and non-points, between different acupuncture techniques, under the same experimental conditions. Again, such comparison must be compared with higher treatment frequency. In low treatment frequency, such comparison might or might be significantly different. In higher treatment frequency, it tended to be statistically significant. This is additional evidence that acupuncture is not a placebo effect.

Chapter 11. More examples that acupuncture is not a placebo effect

We have already discussed why  Colquhoun D could make a summary that acupuncture is only a placebo effect, because the acupuncture in the studies that he cited are not the kind of acupuncture in clinic in China. What he means the acupuncture is not what we mean the acupuncture.

We can cite more evidence that acupuncture is not a placebo effect, such as acupuncture used in children and in animal.

11.1. Acupuncture in children

Acupuncture can not only be used to treat diseases in adult, but also those in nursling and children. It can be used for the treatment of various diseases including various pain, migraine, infant catatonia, bedwetting, constipation, allergic rhinitis, saliva incontinence, spastic paralysis, laryngismus, postoperative vomit,  nausea/vomit after chemotherapy and so on.

Ecevit A (2011) reported that, by only acupuncture on Yintang point, it can reduce the pain level in premature with the pain in heels due to blood sample taking for analysis. The crying time can reduce from average 138.1 seconds down to 72.8 seconds. At the same time, the heart rate reduced from 152.2 times per min down to 138.3 times per min. The pain index reduced from 6.1 down to 4.2, suggesting that the tolerance of the premature to pain increased.

Liodden I (2011) did acupuncture to 77 children undergoing tonsillectomy and adenoidectomy. The acupuncture started after induction of general anesthesia on Neiguan points. The needles were taken out before wake-up of the children and a plastic needle was put on the same points for 24 hours (covered) . There was another group as a sham group. It was found that the incidence of postoperative nausea/vomit in the acupuncture group was 46.8% but that in the sham group, 66.2%. It is interesting that the incidence in the children aging 1-3 years of old (26.7%) is less (59.6%) than that in older children (4-11 years of old). Generally speaking, we should expect that the older children of 4-11 years of old should be more affected by the placebo effect of treatment, but the results here showed opposite. The possible explanation is that the acupuncture stimulation in the younger children group is relatively more than that in the older children. 

A survey in North America for 43 children hospitals showed that, about one third of the hospitals supply acupuncture treatment . Most of other studies said that the number of children who are suggested to use acupuncture treatment is also large. Generally speaking, the parents of the children also accepted this therapy and satisfied the healing effect. This is quite different from most of people thought, since generally speaking, children may fear the needles, and the parents may not want to increase pain and fear to the children

The age of the children who accepted acupuncture treatment can be as little as one month.  For so youth children, how can we expect that the baby can accept a placebo effect?   

Weimer K (2013) had a review, from which we know several other reviews about placebo effect in children and adolescence. We learned that the placebo responder rate is generally higher than that in adult, that the mechanisms behind the placebo effect in children might be different from that in adult, and that the clinic study design in children might need to be different from that in adult too. However, it seems that it is very rare that the studies included paid attention to compare children younger than one year old with those age more than , for example, 6 years or 12 years of old. We suspect that, the placebo responder rate and placebo effect in these groups might be different.

Someone may believe that the placebo effect can also happen in children younger than 2 years of old. However, this is not accepted by others, the later suggested that the placebo effect in such younger children might be due to the parent placebo effect, as proxy-placebo effect, which cause the bias report in the younger children.

11.2. Acupuncture on animal

If we are still not convinced by data of acupuncture on children, and still suspect that the acupuncture effect is a placebo effect, let us see the animal studies on acupuncture. Acupuncture not only works in human being, but also on animals. A lot of clinic studies supported this. 

Gakiya HH (2011) randomly allocated 30 dogs undergoing mastectomy into three groups. One is electrical acupuncture group, one is sham group, and another is no-acupuncture control groups. Each group is 10 dogs. After the treatment, the number of dogs that need pain killer in the electrical acupuncture group, the sham group, and the non-treatment group was 2, 6, and 6, respectively. They summarized that acupuncture could reduce the postoperative consumption of morphine and promote satisfactory analgesia in dogs undergoing mastectomy.

Cho SJ and Kim O (2008) did acupuncture for a dog suffered from cervical sympathetic paralysis syndrome, once a day for two days. After two days, all the symptoms disappeared. (This data suggested that acupuncture everyday worked better).

Ceccherelli F (1996) randomly allocated rats into three groups: acupuncture group (14 cases), morphine group (10 cases), and non-treatment control (20 cases). They found that acupuncture can significantly reduce the experimental swelling in the feet of the rats. Data from Zhang RX (2005) reported similar findings.

Carneiro ER (2010) randomly allocated rats into acupuncture group, non-point acupuncture group, activity-limited group, and no-treatment group. All rats were sensitized with heat-solidified hen egg white implant. Using clinical acupuncture points, EA treatment began 2 days after antigen priming and was repeated on alternate days for 2 weeks. They found that electrical acupuncture efficiently diminishes the bronchial immune-mediated inflammation induced in rats and that this effect is dependent on the choice of specific acupoints.

Luna SP (2015) had a study on dogs undergoing ovariohysterectomy. They found that acupuncture or pharmacopuncture were equally effective as morphine or carprofen to control postoperative pain in bitches undergoing ovariohysterectomy.

Cassu RN (2008)  compared the analgesic effect of uni- and bi-lateral electroacupuncture  in response to thermal and mechanical nociceptive stimuli and investigated the cardiorespiratory, endocrine, and behavioral changes in dogs submitted to electroacupuncture. They found that bilateral electroacupuncture produced a shorter latency period, a greater intensity, and longer duration of analgesia than unilateral stimulation, without stimulating a stress response. The effect of electrical acupuncture for pain reduction was confirmed by their later studies again. Although Gakiya HH did not find difference between the acupuncture group and the non-point group for the pain level reduction, but they did find that the pain killer used in the acupuncture was less than non-acupuncture group.  

Groppetti D (2011)   found that plasma β-endorphin levels in dogs receiving electroacupuncture increased significantly against baseline values after 1 and 3 h after surgery. Moreover, the end-tidal isoflurane concentration needed for second ovary traction was significantly lower in acupuncture-treated dogs than control animals. All animals having electroacupuncture experienced prolonged analgesia, over 24 h at least, while four out of six dogs treated with butorphanol needed post-surgical ketorolac and tramadol supplementation to their pain relief.  

Koh RB (2014) studied the effects of maropitant, acepromazine, and electroacupuncture on vomiting associated with administration of morphine in dogs. They found that maropitant treatment was associated with a lower incidence of vomiting and retching, compared with control treatments, and acepromazine and electroacupuncture appeared to prevent an increase in severity of nausea following morphine administration in dogs.

Jaeger GT (2006) reported their study: seventy-eight dogs with pain due to hip dysplasia were studied in a controlled, double-blind clinical trial to evaluate gold bead implantation as a pain-relieving treatment. The dogs were randomly assigned to two groups, 36 in the gold implantation group and 42 in the placebo group. Both groups were treated equally regarding anesthesia, hair clipping, and penetration of the skin with the same type of needle. The gold implantation group had small pieces of 24 carat gold inserted through needles at five different acupuncture points and the placebo group had the skin penetrated at five non-acupuncture points so as to avoid any possible effect of stimulating the acupuncture points. A certified veterinary acupuncturist marked the points, and two surgeons performed the implantations according to a randomization code made in advance. After 14 days, three months and six months, the owners assessed the overall effect of the treatments by answering a questionnaire, and the same veterinarian examined each dog and evaluated its degree of lameness by examining videotaped footage of it walking and trotting. The treatment was blinded for both the owners and the veterinarian. There were significantly greater improvements in mobility and greater reductions in the signs of pain in the dogs treated with gold implantation than in the placebo group. The veterinarian’s and the owners’ assessments corresponded well.

Laim A (2009)   studied the effects of adjunct electroacupuncture on severity of postoperative pain in dogs undergoing hemilaminectomy because of acute thoracolumbar intervertebral disk disease. Dogs were alternately assigned to treatment (conventional analgesics and adjunct EAP) and control (conventional analgesics alone) groups. Analgesic treatment was adjusted as necessary by the attending clinician, who was not aware of group assignment.  They found that total dose of fentanyl administered during the first 12 hours after surgery was significantly lower in the treatment group than in the control group, though dosages of analgesics administered from 12 through 72 hours after surgery did not differ between groups. Pain score was significantly lower in the treatment group than in the control group 36 hours after surgery, though did not differ significantly between groups at any other time.

Some people explained the healing effect of acupuncture in animal as conditioning. Due to a repeated conditioning, animals could also have psychological and physiological responses, so as to have improvement in their symptoms. For example, to bring a dog to a veterinary station, the dog may shack in body. This might be because the dog had been brought to the station before and suffered from pain stimulation, such as injection. If bring the dog to quiet and peace environment, the dog could show less level of the symptoms. This might be easy to understand.

For this, Ramey D explained that conditioning theory proposes that bodily changes result following exposure to a stimulus that previously produced that change. This is perhaps the most intuitively acceptable explanation for any placebo effects in animals. Indeed, animal studies support such a model for placebo effects, starting with the first descriptions on salivating dogs by Pavlov. Both human and animal studies support the idea that conditioning forms some basis for placebo responses. Since conditioning requires learning, it would be expected that repeated visits to a practitioner (of any particular persuasion) might increase the strength of the association between a learned stimuli and response in animals, good or bad. There are numerous examples of dogs shaking in fear when being taken into a veterinary clinic; on the other hand, a dog that enjoyed being handled in a soothing environment might appear to receive some relief from a chronic condition; as it learned to associate its visits with the comforting handling, conditioning effects could occur. This could certainly serve as reasonable explanations for purported placebo effects in animals. Nevertheless, the hypothesis that a healing or therapeutic effect can be dependably provoked as a result of conditioning cannot be supported at this time by any evidence.

Expectancy theory proposes that bodily changes may occur to the extent that the person receiving the therapy expects them to. There is considerable overlap between expectancy and conditioning, because learning is one of the major ways that expectancies are formed. To the extent that therapies are expected to provide relief from disease, or at least provide the client and/or veterinarian with a feeling of control over the disease process, they may alleviate adverse mental states (in the humans). Certainly, in humans, therapies that help restore patient control may evoke therapeutic effects, at least short term, but studies that investigate the expectancy model in animals have so far not been performed. Still, if animals were able to form an association between treatment-related signals (the attention and handling received, the way that the owner behaves towards the animal when it is receiving treatment) and the relief of its distress, expectancies of treatment effects might develop (on the part of both animal and owner).

There is a good body of research that demonstrates that human contact has measurable effects on animals. For example, petting by humans reduces heart rates in dogs and horses and causes major vascular changes in dogs. Gentle handling increases productivity in dairy heifers and increases reproductive efficiency in sows. Thus, it is plausible that human-animal contact might play an important role in the observed responses to therapeutic interventions. To take an “alternative” example, it has been shown that a single acupuncture treatment is as effective as petting a horse, when it comes to relief of signs of chronic airway disease; that is, there’s no demonstrable effect of acupuncture beyond simple handling. (9) On the other hand, handling may also be stressful to animals, so responses to handling may not necessarily be beneficial. Still, there’s no question that human contact can invoke responses from animals and animals may behave quite differently when they are not being observed; those shouldn’t be confused with placebo-effects, however.

It was reported that, after taking sedative, a dog was left in a room but its owner left the room, then let a stranger comes in the room, the dog showed quiet, rather than anxiety or stressful as if it was not given a sedative before. On the third time, the dog was given a vitamin, not a sedative; again the coming in of a stranger in the room does not create the same level of anxiety and stress reaction of the dog. This experiment suggested that, once a therapy worked, the following similar therapy or a sham therapy could produce the same healing effect. Here, it should be noticed that, precondition for such "replacing phenomenon" to happen is that the previous therapy worked. While in the experiments above, animal had acupuncture only once before surgery. No previous healing effect for the dog to remember in its brain.

It is the same in human being.

Goebel M (2008) has a study. Patients with allergic rhinitis underwent a conditioning protocol, receiving desloratadine, an H1 receptor antagonist, paired with a novel drink, for five consecutive days. After the washout period, patients who were reexposed to the novel drink plus placebo showed improved symptom scores, decreased wheal size on the skin prick test, and diminished basophil activation. Numerous other pharmacological conditioning trials have shown that these placebo responses mimic active drug effects and that prior exposure to an effective treatment is an important part of the conditioned placebo response. 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F005200650066003400360037003100350034003600320031000000

However, no matter for the expectancy, conditioning, or such replace effect, the animal needs a pre-experience to the stimulation. For acupuncture treatment, the question is, the acupuncture is only one time treatment, before the surgery, and it worked to reduce the incidence of postoperative nausea/vomit. The animal did not receive repeated acupuncture. The expectancy, the conditioning, or the replacement effect should not be established.

Another explanation is that the animal might get more care after sick, they would become quiet and calm, and so the symptom would be reduced. They explain this possibility as broad concept of a placebo effect. However, this theory has no any experiment to support, neither be able to answer how much extent a care could calm down a symptom. In addition, such care to calm down a symptom should not be confused with what is discussed here the placebo effect.

Based on the current data, it is most possibly that, the disease-treatment reaction in an animal is similar to that in an infant or children. They are not easily affected by a placebo effect (hint effect). They may be more affected by a calm effect. That means that the reduction of a symptom in an animal or in a child might become less after they get care and conciliation from the owner or parents. They may have reduced heart rate and reduced blood pressure. However, the pain level may not really be reduced by such conciliation. Such calm of animal or child might be regarded as an evidence of a reduction of pain. But we, as adult, know that, under conciliation, the emotion may become calm, but the pain level may not really reduce.

Therefore, the results of acupuncture studies on animal or on children support less as a placebo effect but some kind of conciliation effect. If, under the conciliation, the animal still is not willing to move, or a child is still crying, it should be regarded as the pain level (symptoms) is not improved yet. If, after acupuncture, the animal starts more motion, or a child stop to cry, it should be regarded that the symptom has been improved. Animal or children belong to not-cheating group. We do not really need to insist that the improvement of symptom after acupuncture is an exaggeration of the improvement by owner or parents.

Brief summary:

Small children or animal is less apt to a placebo effect. Especially for them, that only one or two times of acupuncture treatment could reduce their symptoms suggests that the healing effect of acupuncture cannot be simply explained by a placebo effect or a conditioning effect. The only explanation is that acupuncture indeed has its own specific healing effect.

Chapter 12. Why people made the comment that acupuncture is a placebo effect

Now, we can see that there are several reasons that made some of acupuncture researchers in the Western countries believe that acupuncture is a placebo effect. Let us make a summery for these possible reasons.

12.1. In the acupuncture studies in the Western world, the difference in the healing effect between the acupuncture and the sham group is not large 

In the study reports from Western countries, the healing effects of acupuncture group are in a low level. Therefore, once the effect in the sham group is higher, it would be easy to lose statistically significant between the two groups.

Then the question is why the healing effect in the acupuncture group is low in the studies reported in the Western countries, compared with that reported in China?

According to the data we collected here, we believe that the reasons might be the followings:

(1). Too low treatment frequency. Most of the studies applied acupuncture once or twice a week in the Western countries, while it is once a day or once every other day (5-6 sessions per week) in China. The total course dose of acupuncture in the Western countries is 3-4, while that in China is more than 8. Too low stimulation of acupuncture could not yield sufficient healing effect. It is needed for the acupuncturists in the Western countries to visit acupuncture researchers in China, to see how the acupuncturist in China did acupuncture study and clinic work there. They need to perform acupuncture the same ways as acupuncturists in China, rather than a Western modified acupuncture.

According to the current data, with higher treatment frequency, the healing effect of acupuncture group tends to be higher and that of a sham group, lower, so that it is easy to yield a positive report. While with low treatment frequency, the healing effect of acupuncture group usually was not high (so many data showed this), while that in the sham group tends to be higher, so it is easy to result in a negative report. It was found that a negative report is easy to happen in a study where the healing effect of sham group is high. Therefore, we recommend that acupuncture should be performed at a high treatment frequency, for most of diseases. For some special diseases, even acupuncture once a day is not sufficient. We have to use special acupuncture technique, pay attention to proper involving time, etc. to get higher healing effect. The examples for such diseases are cancer, migraine, post-stroke coma, persistent vegetative state, etc. 

Why in the most of the studies in the Western countries, the acupuncture was performed once or twice a week, instead of five or six times a week? Most of the researchers mentioned that the way of the acupuncture are referred from a published article, or had consulted with an expert in acupuncture. Very rarely they mentioned that they referred from articles published from China. Language barrier might be the most reason for this?

(2). Single or double blind design of the study. Such design blocked the communication between the acupuncturist and the patient. This makes it impossible for the acupuncturist to know the feeling of the patients to the needle manipulation, so it is hard for the acupuncturist to induce along-meridian feeling to reach the highest healing effect. The acupuncturist would also feel hard to get response from the patients so as to be able a change the treatment schedule or the way of the acupuncture to match the individual need for the treatment.

For this reason, we say that this is a researcher-modified acupuncture. It is not a "real" and "clinical" acupuncture. It is an "imaged" acupuncture in the acupuncture researchers in the Western countries.


(3). The personal skill of acupuncturist is not guaranteed. For a therapy that depends mostly the personal skill, if the person is not good enough skillful, the result of a study can be expected not good.  

12.2. Comparing between different treatment frequency, between different acupuncture points, between acupuncture points and non-points, between different technique, no significant difference

Generally speaking, there are not many studies to compare these different groups. But once there is such comparison study, its influence is very big to the research society.
Among them, one is the study by Yuan J (2009), who compared two treatment frequencies: twice a week for five weeks and once a day for five day per week for two weeks. The author did not find difference between the two groups. However, they used moxibution and cupping together with the acupuncture. It was a comprehensive treatment, not acupuncture-alone comparison. It can only mean that, with the combination of other therapies as in real clinic situation with moxibustion or cupping, the acupuncture treatment can be done twice per week. Also in this study, the healing effect in the 5-session group was better than the 2-session group in the treatment of severe cases. Moreover, the healing effect in the 2-session group stayed no more improvement in the following weeks, but the treatment in the 5-session group may have further more improvement if the treatment was continued in more weeks. This means possible that after five weeks, the healing effect in the 5-session group might be better than the 2-session group.

There is only limited number of such comparison studies in the Western countries, and they were mostly performed at low treatment frequency, so that it is easy to get negative reports showing that there was not difference between the comparisons. This easily brings people to create an wrong impression that acupuncture does not depend on proper choice of acupuncture points, not on the Deqi feeling, not on treatment frequency either.

There are lots of comparison studies in China however (see above) and they are mostly performed at high treatment frequency. Their results clearly showed difference between the compared groups. This is one of the major reasons for acupuncturists in China do not believe that there is no relative specificity between acupuncture points/meridians, and that the non-point could work evenly to, or even better than, a typical acupuncture point.

12.3. Simply contribute the most part of the healing effect in the acupuncture group into a placebo effect, only a small part into the acupuncture specific effect  


Generally, it is believed that the total healing effect of an acupuncture group is the sum of the acupuncture specific effect and the placebo effect
(deduced from sham group). Therefore, if we know the amount of healing effect from a sham group, we can get the amount of the specific acupuncture effect by deducting the sham effect from the total effect in the acupuncture group. This consumption omits a common phenomenon: when two or more therapies are used the same time, the total effect is usually not the sum of the healing effect of each therapy when they are used alone, no matter the placebo effect has been deducted from the total effect or from each of the therapy or not. Therefore, in the acupuncture group, we cannot tell exactly how much is sham and how much is the contribution of the acupuncture specific effect, even if we know the amount of the sham group. Current way of estimation of acupuncture specific effect in the acupuncture group underestimated it.

12.4. Improperly choose acupuncture points, contribute its low effect to that of acupuncture

Some researchers heard that acupuncture point Neiguan can be used to treat nausea or vomit; they then use this point to treat nausea/vomit of any reasons, such as postoperative nausea, post-chemotherapy/radiation therapy nausea, and so on. They also observed the healing effect of only one such acupuncture point, rather than used more other complementary points according to different reasons for the symptom. If the acupuncture they tried this way does not work, they will comment that acupuncture does not work.

Chang CH (2005) used electrical acupuncture on the Zusanli points of healthy volunteers, to see if the acupuncture could adjust the heart rate after the person was given atropine. The result was that there is no effect. In TCM theory, the acupuncture meridian that may affect heart function mostly is the Xin Jueyin meridian, especially the Neiguan points. The Zusanli point used in this study belongs to Stomach meridian. We normally do not use this point to affect the heart rate or heart function. Therefore, the result of such study should not be regarded as evidence that acupuncture does not work.

Cho CY (2005) treated refractory skin itch due to late stage of uraemia with acupuncture. Although it was showed that the healing effect of the acupuncture group was higher than the sham group, this study might be hard to be reproduced by other researchers. This is because the patients were in late stage of disease. The basic reason for the skin itch remained not change during and after acupuncture treatment. Also, the acupuncture was three times per week for one month. It is not a high-reproductive study design for acupuncture treatment. The positive result in this study is very much by a chance.

12.5. Study on a disease that is not in the working scope of acupuncture treatment

Acupuncture is only one of the therapies, not the main therapy in Chinese medicine used in China. It can be used for the treatment for some kinds of diseases, but as any types of therapy, not for all kinds of diseases. This is the same as for Western medicine. For example, Western medicine cannot solve the AIDS. We cannot therefore deduce that the Western medicine does not work. For the acupuncturists in the Western countries, it is not proper to study the diseases that are not in the list of recommended list of diseases for acupuncture treatment (by acupuncturists in China). Otherwise, the failure of the trial can be summarized as that acupuncture does not work for the disease tested (in the authors’ hands), but not that acupuncture does not work.

Some diseases might not be proper to use acupuncture for the treatment, at least for the movement, or for most of the acupuncturists, such as fibromyalgia.  Patients with fibromyalgia are very sensitive to skin touch[25]. They cannot tolerate even slight touch on this tender skin, not to speak of the needle insertion and the Deqi feeling. For this reason, that some studies showed negative results should not be regarded as acupuncture not work for any other disease condition.

12.6. Confuse the healing effect of cupping, moxi, electrical acupuncture, auricular acupuncture, TENS, massage, all as acupuncture

Indeed, all of these therapies belong to traditional Chinese medicine and used in acupuncture clinic broadly. But each therapy has its own proper way to use and with favorite disease scope. To include their healing effect into that of acupuncture is not a proper way. Acupuncture may work better than them, or not, depending on many things.  

In many review articles on acupuncture these various therapies are involved into the review as acupuncture. For example they are included in the review by Colquhoun D,  Furlan AD (2010) and by Linde K (2009).  Therefore, in our article here, we tried to separate the healing effect of acupuncture from that by other therapies. Acupuncture can work by itself, not always need to be combined with other therapies to exercise healing effect. 

Liu WH (2015) had a review about acupuncture. They collected randomly designed articles from year 2011 from Science Citation Index Expanded (SCIE), excluded those published from China, or the first author is from China. By this way, they got 33 articles from totally 867 articles. Among these, 17 articles are negative and 23 articles are positive. From the 33 articles, we could remove the studies using electrical acupuncture, auricular press, auricular acupuncture, or finger press, acupuncture injection or cupping, acupuncture being not the main therapy, only paying attention to the treatment cost changes, observing the residence days and cost of acute disease (Painovich J)only observing long term healing effect,  and wrong summary for the study results (such as to comment a negative result as a positive result). Then, the negative articles become 7, and positive articles, 14.

 Azad A (2013) listed 25 so called negative articles about acupuncture. Among them, there are 8 articles that used intradermal needling, acupuncture point press, auricular press, or magnetic therapy. The diseases treated by acupuncture are four categories: the fatigue and hot flash due to cancer or due to chemotherapy, or postoperative pain (8 articles); nausea/vomit after chemotherapy (5 articles), xerostomia after chemotherapy or radiation therapy (3 articles), and leucocytopenia after chemotherapy (1 article).

In the first category, the acupuncture was mostly done once or twice a week. Only one study was three times a week. Among this, clearly positive articles are 5, , and negative results are 2 articles (both are acupuncture once or twice a week). While in one article, some parameters were positive and others were negative.[1149] In the 8 articles, the healing effect in the sham group was average 12%±16%, but that in the acupuncture group (including 2 electrical acupuncture groups) was 35%±19%, higher than the sham group.

In the Azad A (2013)   review, in the articles about nausea/vomit after chemotherapy or radiation therapy, 2 articles are positive, 3 are negative in which 2 articles are the same author, the basic data and summary are exactly the same). In the articles about xerostomia after chemotherapy or radiation therapy, 2 articles are positive, another article is partly positive and partly negative.

The one article about leucocytopenia after chemotherapy is positive: acupuncture can increase blood number of white blood cells. 

Therefore, in the 25 articles cited by Azad A (2013) review, only 4 articles can be used as negative to acupuncture. For the diseases studied by these 4 articles (the side effects of chemotherapy and/or radiation therapy), there are also a lot of positive studies against their negative results.

Apparently, in the current review articles, there are many non-acupuncture studies. This is a common phenomenon of the review articles in the Western countries. They regard such largely variable therapies all as acupuncture.

12.7. Superstitious belief on large scale experiments

Theoretically, in a clinic study, the larger the sample size, the more believable the results are.  This can be verified in Western drug studies, but may not be so in studies on acupuncture.

The reason is that, in the drug studies, the kind, the quality and the quantity of the drug can be and is standardized. For example in the study of Aspirin in the prevention of cardiovascular diseases, the Aspirin produced in US and in Germany is believed the same quality. The Aspirin used US and China is not doubted to have any big difference. The difference is the people who receive it, for example the age, sex, history of diseases, history of smoking, habit of diet, etc.

While in acupuncture studies, beside the variations from the receiver, even if the choose of acupuncture points, the number of the points and the treatment frequency, are all the same, the personal skill among the acupuncturists could still be largely variable. Such operator’s variation is not easy to control. Therefore in large scale acupuncture, when the study involve large number of acupuncturists and large number of clinics or hospitals, the results of the study would tend to narrow the difference in the healing effects between the acupuncture group and the sham group, so as to produce a negative summary. While in the acupuncture study, as in other medical studies, the data from a large scale study is highly praised.

12.8.  Co-exit of opposite ways in acupuncture treatment

In the acupuncture treatment, there are some quite different or opposite ways to handle the needle or to choose acupuncture points. It seems that both works and this phenomenon is very difficult to understand. Even for us, we cannot explain all of the opposite ways but both works. For example, we focus on the deep insertion of the needles, but there are also some other styles of acupuncture in which the needle is asked to insert in shallow, such as in Wrist-ankle acupuncture, floating acupuncture, or some Japanese shallow needle acupuncture; we use body acupuncture, in which we may choose acupuncture points in any part of the body, but we may also only use local acupuncture technique, in which the acupuncture points are chosen from a very small part of the body, such as from one ear, one eye, the nose, the tongue, one hand, or one feet. The acupuncture point chosen can be only one point, such as the Neiguan point than is used in the treatment of nausea/vomit, or we may need to choose many acupuncture points for the treatment. We may need only one time acupuncture treatment but we may need many times of treatment. We said that the acupuncture needle should be inserted into a so called acupuncture point, but it may also work if the needle is inserted into a non-point. The acupuncture points might be chosen from the sick side of the body, or from non-sick side of the body; or from upper part of the body, or from lower part of the body; or from local points, or from distance points. It is said it should be considered to choose the first acupuncture point according to the time of the day (Zi Wu Liu Zhu), but it apparently not needs to be so.

All of these discrepancies certainly bring people to question if acupuncture is a placebo effect, because this is the simplest and easiest way to explain all of these discrepancies.

12.9. Not care or omit large amount of positive results

Almost in all diseases studied in the Western countries on acupuncture, there are some amounts of negative studies, but also a large amount of positive studies too. If we include those articles published in China, the number of positive studies is much larger.

Acupuncture is only one of the therapies, not at all the main therapy, in Chinese medicine used in China. It can be used for the treatment for some kinds of diseases, but as any kind of therapy, not for all of the diseases. This is the same as for Western medicine: Western medicine cannot solve the AIDS; we cannot therefore deduce that the Western medicine does not work. For the acupuncturists in the Western countries, before it has been established that acupuncture worked for treatment of diseases, as reported from China, it is not proper to study the diseases not in the proper recommended disease list by acupuncturists in China, and to contribute the negative result to acupuncture.

When in a study, negative and positive data showed up again and again, it suggests that there is some factor(s) that we have not realized and that really affect the reproducibility of the study. If one study cannot reproduce the data of another one, especially in the study of acupuncture, it might be due to the difference in the study design, the steps of the study, or the personal skills. The reviewers, if he or she is really qualified scientific researcher, must be very careful and patient to make a conclusion, not just push the 3000 articles out of the desk to leave for coffee. 

After we collect more data, especially those from China, we can easily find the difference in the way of acupuncture between Western countries and China. In China, high frequency of acupuncture treatment may be associated with high healing effect, while a relatively low treatment frequency is associated with unstable results (positive or negative). It is needed for acupuncturists in the Western countries to test the acupuncture effect with higher treatment frequency. 

Brief summary:

There are many reasons that make the acupuncturists in the Western countries believe that acupuncture is a placebo effect. Most importantly is the low healing effect in acupuncture group, which is due mostly to the low treatment frequency by acupuncturists in the Western countries.

Chapter 13. Argue about acupuncture on the internet

During collection of data for this article, we found that many people have already affirmatively believed that acupuncture (and many other kinds of alternative medicine) is a placebo effect.

There are cut-throat discussions about whether the acupuncture is a placebo or not; if the clinic doctor should use positive placebo to patients or not; and if a medical study should involve a sham group or not, and so on. The argument is big as a sea wave on the internet.

The representative who believes that acupuncture is a placebo is Colquhoun D. He believes that the healing effect of acupuncture group and the sham group is similar. Even if some study showed that acupuncture is significantly higher than sham group, it is only about 10% higher, which is not big meaning to clinic work. To enhance his argument, he gave an example that "Although it is commonly claimed that acupuncture has been around for thousands of years, it has not always been popular, even in China. For almost 1000 years, it was in decline, and in 1822, Emperor Dao Guang issued an imperial edict stating that acupuncture and moxibustion should be banned forever from the Imperial Medical Academy. "

He also commented that " Acupuncture continued as a minor fringe activity in the 1950s. After the Chinese Civil War, the Chinese Communist Party ridiculed Traditional Chinese Medicine, including acupuncture, as superstitious. Chairman Mao Zedong later revived Traditional Chinese Medicine as part of the Great Proletarian Cultural Revolution of 1966.2 The revival was a convenient response to the dearth of medically trained people in postwar China and a useful way to increase Chinese nationalism. It is said that Chairman Mao himself preferred Western medicine. His personal physician quotes him as saying “Even though I believe we should promote Chinese medicine, I personally do not believe in it. I do not take Chinese medicine.”"

He believed that "The political, or perhaps commercial, bias seems to still exist. It has been reported (by authors who are sympathetic to alternative medicine) that “all trials [of acupuncture] originating in China, Japan, Hong Kong, and Taiwan were positive.”

People in other websites who argue against acupuncture as a placebo effect but cannot answer why acupuncture study in China, Japan and other Asian countries showing high healing effect in acupuncture group, and why even in the Western countries, the number of positive study is much more than that of negative study.

Apparently Colquhoun D knew that acupuncture studies from Asian countries are more as positive to acupuncture, but he did not spend time to check why more positive results are from acupuncturists there. He did not pay attention that acupuncture in these countries is with higher treatment frequency than that in the Western countries. This might be understandable, that he may not know Chinese. Even most of the acupuncturists in the Western countries do not know Chinese either. They do acupuncture as their imaged way. The question is: acupuncture is created from China; acupuncturists in China claimed that it works but the acupuncturists in the Western countries cannot reproduce it, then, why they do not check how acupuncture experiment was performed by acupuncturists in China?

About the attitude of a historical figure to acupuncture should not be used as supporting evidence. In Chinese history, there were so many emperor, who supported or at least not oppose against acupuncture, how comes only the Emperor Dao Guang is so clear to know that acupuncture does not work? Emperor Dao Guang was not a doctor or not an acupuncturist. If the attitude of a nonprofessional man can be used as supporting evidence, the attitude of a professional man should be more convinced. Doctor Robert S. Mendelsohn published a book namedConfessions of a Medical Heretic. In the book, the author argued against many Western medicine therapies. If we should trust layman Emperor Dao Guang, shouldn't we more trust doctor Robert?

To take Chairman Mao's attitude as supporting evidence is neither proper. He is for sure one of the greatest in Chinese history, but he is also a human being. He also committed big mistake, as he started the Great Cultural Revolution. In the early time of New China, the Western medicine was dominant in China too. Its healing effect is indeed very high; we have no reason not to use it. However, the country was very short of medical doctors, as well as the Western medicine. To solve this, Chinese government tried some ways, including training Western medicine doctor to learn Chinese medicine as well. It means that the Chinese government admitted the usefulness of the Traditional Chinese Medicine. That previous policy is even correct nowadays. For example, currently many bacteria developed drug-resistant. Western medicine is basically no effect to virus diseases. There are a lot of side effects of Western medicine. The patients suffered from a lot of troubles, such as poor sleep, anxiety, various pan, chronic fatigue, disorder in menstruation..., but no positive finding in exam or lab test to establish which disease it is, so no way to solve it. However, all of these conditions are the dominated disease/disorder for Traditional Chinese medicine to solve.

The theory that acupuncture is only a placebo effect cannot explain many clinic phenomenons. For example, in clinic, it is quite common that in the beginning when a patient came for acupuncture, the patient feared acupuncture needle very much for possible pain. Upon acupuncture, the patient may shake body. Will such fear affect overall healing effect of acupuncture? It seems not. Our experience is that, after acupuncture, their pain will also be reduced, so that they are willing to continue with more sessions of acupuncture. If the acupuncture is placebo effect, then the fear to acupuncture should have a nocebo effect. How such nocebo effect does not really block the healing effect by acupuncture?

Another example is: a patient has visited several acupuncturists but the improvement of his disease is not dramatic. Finally, the patient visited the last acupuncturist and even did not hold any hope for cure. However, this time, the improvement is much apparent. How can we explain that, with the last acupuncturist, when the patient did not hold any hope for improvement but he got improvement? Does that mean that a placebo effect not happened in previous acupuncture clinic at which time the patient expected very much for healing, but a placebo effect happened with the latest acupuncturist, though the patient did not hold any hope for improvement? Does that mean that the placebo effect is not associated with person’s expectation and hope?

Similarly, patients have tried Western medicine doctors for years without any change in their symptoms. After visited an acupuncture treatment, he got improved a lot. Should we think that there is no placebo effect during visit to Western medicine, and the visit to the Western medicine could even not create a 30%-40% reduction of his symptoms (the extent that a Western medicine could create due to trust of patient to Western medicine)? The placebo effect only happened with acupuncture but not with Western medicine?

The only explanation is that acupuncture has its own specific healing effect. The overall healing effect for sure would be better when the patients strongly believe and trust the acupuncture therapy to create some level of placebo effect, but acupuncture has also its own specific healing effect.

Kavoussi B (2015) [1154] also had a review. The data cited and the comment is very much the same as by Colquhoun D. The former depended more on a large scale experiments to support his idea, but did not realize the possible weakness of a large scale experiments in which the personal skill of acupuncturists were not ensured enough. e.g. he did not realize the possible bias due to the variation in personal skill of the acupuncturists.

Of course, their opinion is disagreed by others. Hennessey S (2012) pointed out that "The placebo has been used to evaluate the benefit of a host of drugs, but very few studies of accepted interventions or surgeries are ever done with sham or placebo intervention. Most studies of interventions are designed without a sham, and many surgical procedures have never been subjected to evidence-­based rigor. And yet acupuncture is continually subjected to RCT to prove its efficacy as a valid therapy. By its nature any sham intervention or surgery has the potential to create patient bias. The sham or placebo effect is deeply influenced by expectation, branding, and any other kind of hype, easily creating participant bias. Acupuncture, along with surgery, and tech devices are all big generators of hype and expectation.

Meta-­analysis of acupuncture studies suggests that the sham treatment adopted by acupuncturists may not be the most effective way to demonstrate the benefits of true acupuncture. Sham acupuncture may function as an ‘active placebo’, diminishing the effect of true acupuncture. Acupuncturists might do better to choose an objective measurement as convincing evidence, rather than a subjective symptom such as pain relief, quality of life, etc. Subjective symptoms can be the hostage of expectation, other influences, or bias. Perhaps, brain imaging, a chemical marker, or a comparison of outcomes of procedures used to treat same conditions should be the indicator for the effect of true acupuncture, rather than a study form designed to measure the efficacy of a pharmaceutical drug. "

Based on others studies (Berm BM 2004), [1071] Hennessey S thought that acupuncture treatment may need acupuncture stimulation doses (with longer times of treatment and more times of treatment), could the specific healing effect of acupuncture separated from the placebo effect. He stated that “Investigators concluded that (for the treatment of asthma) at least 30 sessions in 3 months should be offered to have an effect, followed by 10 more sessions per year to prevent a relapse. The extensive treatment with acupuncture could explain the lack of effect seen in other studies.” However, as we have been discussed, the treatment schedule used in the Bern BM (2004) study is a typical Western acupuncture: acupuncture twice a week for 8 weeks, then once a week for 2 weeks, again once every other week for 4 weeks. The treatment frequency is too low.  

Horn B (2011) [353] stated that the misuse of sham controls in examining the efficacy or effectiveness of Complementary and Alternative Medicine has created numerous problems. The theoretical justification for incorporating a sham is questionable. The sham does not improve our control of bias and leads to relativistic data that, in most instances, has no appropriate interpretation with regards to treatment efficacy. Even the concept of a sham or placebo control in an efficacy trial is inherently paradoxical. Therefore, it is prudent to re-examine how we view sham controls in the context of medical research. Extreme caution should be used in giving weight to any sham-controlled study claiming to establish efficacy or safety.

Linde K (2010) [417] pointed out that: "Sham acupuncture interventions are often associated with moderately large nonspecific effects, which could make it difficult to detect small additional specific effects. Compared to inert placebo interventions, effects associated with sham acupuncture might be larger, which would have considerable implications for the design and interpretation of clinical trials. Total effects of acupuncture interventions including both specific and nonspecific effects often seem to be at least moderate in size. We believe that there has to be a discussion involving scientists, decision makers, health care providers and patients whether and when the evidence for clinically relevant total effects from non-blinded comparisons is sufficient to consider a treatment effective, even if specific effects due to the postulated mechanism of action might be minor or even nonexistent."

Brief summary

(1). Because there are large amount of positive and negative data to support or to deny acupuncture as a useful therapy, the conclusion and opinions by researchers in the Western countries are also largely variable. Neither side can convince another. So far, the positive and negative studies are still publishing year by year.

(2). Acupuncture researchers in the Western countries seem to develop a weary to acupuncture study.

 

Chapter 14. Opinions of acupuncturists in China

吕君玲 (2015) [1155] stated that, ... The reasons for the non-significant difference between the acupuncture and sham group might be due to the study design. For example, sham treatment in different studies is different. The sham group may use non-points, tooth-stick, shallow stimulation, etc. suggesting that currently there is no all-agreed way of "sham acupuncture" design. In addition, there is difference among studies, in parameters in patient involvement, exclusion, treatment schedule, standard to evaluate the study results. Therefore, current data cannot be used to tell if the effect of acupuncture is a placebo effect. It is urgently needed to set up a study design that matches TCM basic theory.... Before a proper "sham acupuncture" is designed, we can change our mind and turn research emphasis to study acupuncture by comparing it with currently most advanced therapy."

陈勤 (2008) [1156]  noticed that 'there are large difference in the treatment frequency and the length of treatment courses, between the acupuncture studies in and out China. Is this difference associated with the healing effect? Currently no study tells how long healing it may last for the effect of the acupuncture treatment in each individual disease condition. However, induced from our study here, the healing effect of migraine by acupuncture would start to subside after 24 hours. So, deduced from this, long time in between an acupuncture treatment is not good to accumulate the healing effect and to maintain it. Another difference between studies in and out China is that it is allowed for patients to continue use of pain killer in most studies. This cannot exclude that the patients continued the use of pain killer by themselves at home. Studies out of China mostly compare acupuncture with sham group. To ensure the quality of the study, the study is double-blind and mostly use shallow needle in the sham group. But there is data suggesting that the healing effect from a shallow insertion group is significantly different from a waiting group. So, before it becomes clear for the mechanism of the shallow insertion acupuncture, it is not suitable to be used as a sham. '

鲍金英 (2015) [1157] studied that data on the treatment of migraine by acupuncture in and out China, pointed out various factors that a researcher should be aware to pay attention, but did not mention that the researchers should also pay attention to the treatment frequency.

刘京 (2007) [1158] noticed that the acupuncture studies in the Western countries usually are with a sham group but not so in acupuncture studies in China. He believed that current sham design does not meet the special need for acupuncture study. He pointed out that: in year 2000, in the world medicine conference and in its modified version of "Ethical principle for biological medical study in human being", it was stated that when test a new therapy, it should be compared with the current most effective therapy, though it is not exclude the comparison with a sham therapy, but the sham therapy is used if there is no effective therapy available. This principle is suitable to be a reference when design acupuncture study.

刘京 (2007) commented: in acupuncture study, we can continue the design of proper sham group for acupuncture comparison, but the data from traditional sham or a pseudo-acupuncture should not be used as absolute evidence to make a conclusion. Also, the studies that did not involving a sham group should not be regarded as "not scientific" or "not reliable.”  

王京京 (2009) think that, among the negative acupuncture studies in the Western countries, the most powerful ones are the tree articles; Lind K (2005), Diener HC (2006) and Alecrim-Andrade J (2006). The most difference between these three studies and the positive studies are the design of the sham group. Currently, the most popular sham acupuncture groups are using non-point, shallow stimulation, or non-insertion of needles. However, any of such sham group has its own disadvantage and none can reach complete placebo effect. 

 王永洲 (2012) [1159] think that, the current acupuncture studies did not follow the tradition of Chinese medicine of its body-mind coexist theory, to separate the biological effect from emotional effect of acupuncture. It also is against the current new biology-emotion-society model of medicine. No need to stick to the Western medicine model of separating body and mind apart. It is still premature to use a sham group as a comparison. It should not be used as model of acupuncture study. 王永洲 agreed to make comparison, as suggested by Chinese Acupuncture Journal, firstly with current conventional medicine, the current most effective therapy, so find out the advantage and disadvantage of acupuncture. This might be more realistic and useful.

田小平 (2008) [1160]  analyzed the non-point sham studies in the Western countries and believed that the weakness of these sham groups are: (1), the way of choosing the non-points were not standardized even for the study of the same disease. The way of choosing point or non-point does not meet the acupuncture meridian theory. (2), more emphasized on local effect of acupuncture, not the whole body effect. Mostly compare the acupuncture points with non-points, less to compare the overall and comprehensive effect of acupuncture. (3), rarely have studies of high quality and of large scale size. For many studies, the study design is not careful, such as small sample size, unclear the way of random allocation, not proper disease for acupuncture treatment, not explain in detail the way of acupuncture manipulation, not sensitive index was used to evaluate healing results, etc. All of these make it impossible to reflect the whole body adjustment or re-balance effect of the acupuncture. The comparison between the acupuncture group and the sham group in the healing effect is non-comparable, so that the conclusion of the studies is not credible.

 李春华 (2013) [1161] stated that currently there is no standard way to choose a non-points in acupuncture studies. In China, the non-points are usually chosen the point about 0.5-1 cm apart of a typical acupuncture point, or the middle spot between two acupuncture meridians. From the point of anatomy, it is not reasonable to choose non-points beside acupuncture spot, and the non-points in between the two meridians, though for sure not on the meridians, but if the two meridians are too close, the non-point chosen would work similar to the acupuncture point. 

杨明晓 (2015) [789] specifically tested and analyzed the article by Hinman RS (2014). Hinman randomly allocated 282 patients with chronic knee arthritis into four groups: acupuncture group, Laser group, sham laser, and non-treatment group. Among several possible weakness in the Hinman study, the Chinese acupuncturist pointed that, the patients in the acupuncture group is with longer term of this disease than in other groups. The acupuncture was not aimed to stimulate out the Deqi acupuncture sensation. These could be the main reason that the study did not find significant difference between the acupuncture and sham group.

Our comments to the Hinman study are: actually, the acupuncture in the Hinman study is also once or twice a week for 12 weeks (totally 8-12 sessions). The Chinese acupuncturist apparently did not notice that this could be the main, or an additional main reason for failure of the study. This is because, if the low healing effect is only due to the not Deqi, the laser stimulation should also produce higher healing effect than sham laser and than the non-treatment group. Actually, even the laser group did not produce significant improvement than the two comparing groups. Therefore, low treatment frequency might be the major reason for the failure of the Hinman study.

项燕 (2012) [1162] thought that the critical reason for the failure of acupuncture studies in the Western countries, is that acupuncturists in the Western countries do not really understand the meaning of "conducting meridian and balancing Qi and Blood".

Li DZ (2014) [1163] analyzed articles published in the Western countries up to 2012 about acupuncture treatment of primary hypertension. They collected totally 2407 articles and among them, they found only 4 so called high quality articles. The conclusion of these articles is that acupuncture, when used alone, can reduce diastolic pressure, but only together with medicine, could also reduce systolic pressure. However, many articles published in China showed that acupuncture alone can reduce both systolic and diastolic pressure, and the extent of the reduction is much larger than reported in these 4 articles. The author believed that, the main reason for the less favorite results from Western countries is not due to what kind of sham groups used (inserted or not inserted), but due to low treatment frequency (once or twice a week) and the less total sessions (only 6 to 10 weeks), because there is study showing that, acupuncture five sessions per week for 12 weeks can dramatically reduce blood systolic and diastolic pressure. 

李享 (2014) [1164] believed that the reasons for the failure in acupuncture studies in the Western countries is that they do not really understand the meaning of TCM theory; do no choose the non-points carefully and reasonably; did not following the TCM acupuncture principle of "even the acupuncture point chosen is not exactly correct, the meridian chosen and touch should be followed exactly"; the non-points chosen did not avoid the meridian pathway. In addition, in acupuncture treatment by acupuncture either in and out China, researchers did not consider the classification of the hypertension according to TCM theory.

Liu WH (2015) analyzed 17 negative articles and 23 positive articles. The author said that it is not proper to include moxibustion, wrist press into the evaluation of healing effect by acupuncture; not proper to let women who have no medical knowledge to perform finger press at home. In addition, the author pointed out that there is NO clear difference in the methodology used for acupuncture study in and out China. The difference in the methodology is not the main reason for the difference in study results. However, in each study, there is more or less weakness, for example, improper choose of acupuncture points, the uneven personal skill of acupuncturists, no attention to induce Deqi sensation, too low treatment frequency, or improper design of the sham or control groups.

郝洋 (2014) [1165] reported that, to standardize the study design, and to properly report study results, are still the urgent aspect in acupuncture study for acupuncturist all over the world. They analyzed 10 negative articles and found that there is no statistically significant in the methodology (Jadad score) between the negative studies and positive studies. But there are some weakness in the negative articles in detail: such as the treatment is not proper; did not follow the TCM diagnosis to separate a disease into different subgroups according to TCM theory; the acupuncture points chosen is not proper, did not pay attention to Deqi sensation; did not control the personal skill of acupuncturists in the study; too low frequency of acupuncture treatment; and the sham is not properly designed.

毛文超 (2013) [1166] stated that, the reasons for small difference in the healing effect between the acupuncture group and the sham group could be due to weakness in methodology. The weaknesses are: the treatment plan is not proper; too small sample size; improper randomization; the standard for inclusion and exclusion of patients, and that for evaluating study results, is not clear; improper way of blindness; too short follow-up period; and improper way of statistic analyses, etc.

李永明 (2013) [1167] proposed a "broad point theory" to explain why in clinic studies, to stimulate a body surface that does not belong to traditional acupuncture points but can also show some level of healing effect. He stated that "everywhere of the body surface is acupuncture points" might be an overly and generally a biological phenomenon. That means: to stimulate any part of the body could produce some kind of biophysiological reaction of the body to produce a healing effect. The acupuncture point is a relative point. The traditional and typical acupuncture point obtains a relatively stronger such biophysiological reaction than the nearby non-points. This hypothesis can explain how comes that, to stimulate acupuncture point or non-point can both show clinically healing effect. ... Acupuncturists in the Western countries mostly use thin needles, while those in China use thick needles. The intensity of the stimulation by the thin and soft needle is less than the thick needles. The thin-soft needle may even enhance the placebo effect, so that it is hard to verified significant difference in the healing effect between acupuncture group and the sham group. This theory might be able to explain the difference in the acupuncture studies in and out China.

霍蕊莉 (2016) [1168] believed that there could be many reasons causing the failure in acupuncture studies in the Western countries, such as too long interval between acupuncture treatment and too small the treatment sessions. They also doubt the way of acupuncture, in terms of needle depth, nourishing or depleting technique, the length of needle retention time, the quality of the acupuncturists in studies, etc. But they did not discuss in detail or gave examples from the studies published in the Western countries.

Deng S (2015) [1169] stated that certain problems observed in acupuncture RCTs also occurred in RCTs in other fields, including insufficient sample size, high dropout rates, inadequate follow-up, and randomization. The study of acupuncture is so complex that specific methodological challenges are raised, which are frequently overlooked, including sham interventions, blinding, powerful placebo effects (even stronger than an inert pill) and variations in acupuncture administration. The aforementioned problems may contribute to bias, and researchers systematically attempt to solve these problems.

Apparently, only small number of the acupuncturists, questioned that the low treatment frequency of acupuncture might be the major reason for low healing effect in the acupuncture group, that again is the major reason to cause the non-significant between acupuncture group and sham group in the acupuncture studies in the Western countries.

Most of the acupuncturists in China apparently do not accept the fact that there could be a kind of placebo effect in clinic study and work. They explained and focused on the sham group as improperly designed and used. They tended to accept the idea to compare acupuncture with currently most effective therapy for a given disease. They cannot explain the possible discomfiture if the current "effective therapy" is also a placebo effect. [1170]

Brief summary:  

(1). Acupuncturists in China seemed hesitated to accept that there could be a placebo effect during acupuncture treatment, which can be as higher as to affect the comparison in the healing effect between an acupuncture treatment and a sham treatment.

(2). Most of them do not accept the current way of design for a sham group. They think that the current sham group is not a proper sham to test acupuncture healing effect.

(3). Only a small number of acupuncturists in China believe that the major reason for the failure in acupuncture studies in Western countries is due to low acupuncture treatment frequency and less total acupuncture sessions in the Western countries.

Chapter 15. Our own comments

15.1. Selection of acupuncturist

In the acupuncture clinic research, one of the most important parts is acupuncturist for his/her personal skill in acupuncture treatment. If the personal skill of an acupuncturist is poor, there will be very higher chance to fail in the study.

We recommend having a selection process for a proper candidate of acupuncturist. All the acupuncturist to use his/her actual way of acupuncture treatment in the clinic, such as the use of acupuncture, cupping, moxibustion, fire-needle, auricular acupuncture/pressure, TDP lamp, etc., and allow the acupuncturist to decide the way of acupuncture, including the acupuncture points, the number of needle, the frequency of the treatment, to see if the acupuncturist can improve the symptom (in non-specific low back pain) by more than 55% (giving 20 patients), or by more than 85% of the healing effect reported in literature for the same disease by others [26]. If the healing effect cannot come to such level, the acupuncturist is not suitable to be involved in acupuncture clinic study, regardless of how many year the acupuncturist has been in clinic work.

15.2. Special acupuncture study

Special acupuncture study means to test if acupuncture is placebo effect or not. This is urgent question for acupuncture researchers in the Western countries. The simplest way to test it is to have acupuncture in general anesthesia (start acupuncture after the induction of the general anesthesia). It can be tested for the treatment of coma, shock, persistent vegetative state, or dementia, but the treatment of such conditions needs higher personal skill of an acupuncturist.

For study in these conditions, it is no longer significant to have a sham group. It is also impossible to get agreement for the patient before the acupuncture. It will have no drop-off cases either.

15.3. Ordinary acupuncture study 

For ordinary acupuncture studies, we recommend the researcher could consider the following:

15.3.1. Wash-up phase

Have a wash-up phase. To give patients a sham treatment for 3-4 weeks with the same treatment frequency as the following true study phase. Better to have the sham acupuncture once a day, 5 days per week, for 3-4 week.[527,528,550,1171-1173] Exclude those of patients who had symptoms reduced by more than 30%. These patients belong to placebo-sensitive patients. They are not good candidates to test the healing effect of any therapy (inducing new drugs, surgery, chiropractic, or physiotherapy, etc.). These placebo-sensitive patients can be given true acupuncture parallel to those who will come into the following study phase, but the data in this group is not the primary aim of the study.

Those of patients who did not have more than 30% reduction in their symptoms can be treated with true or sham acupuncture in study phase (acupuncture phase).  

15.3.2. No-treatment group

Depending on the aim of the study, this group may or may not be omitted.

If the primary aim is to test if the acupuncture group is better than a sham group, this no-treatment can be omitted as for most clinic studies.

However, if we want to know exactly how much effect of a placebo effect in a sham group, the no-treatment group has to be included. This is because that the healing effect from a sham group contains placebo effect, natural turn-over, and regression-to-normal, etc.

15.3.3. Sham group

The difference between the acupuncture group and the sham group should be that there is acupuncture performance in the former but not in the later.

Current data strongly suggest that the failure of acupuncture study is due to the poor healing effect in the acupuncture group, rather than the kinds of sham group used. Therefore, either inserted or non-inserted sham group can be used under the condition that the acupuncture and the sham acupuncture are performed once a day, 5 days per week, for more than 20 sessions (depending on the disease to study).

The advantage of insert-needle sham group (shallowly inserted needle on non-points or other-points) over non-inserted sham groups is that the procedure much closely mimics to verum acupuncture procedure. Even a person had previous experience with acupuncture treatment may be hard to tell the insert sham group, so it can eliminate the need to find acupuncture neive paticipants.

15.3.4. Acupuncture group

Only use acupuncture, not use moxibustion, cupping, bleeding therapy, massage, of Tuina. But allow the acupuncture to select the acupuncture basic points or special points, the number of the points during each session, the frequency of the treatment, and length of each session.

The acupuncture should be performed once a day, 5-6 days per week, for totally 20-30 days (referring to the way used by acupuncturists in China for the disease to study) . Allow the acupuncturists keep the same way of communication with patients. [790]

One of the characteristics of Chinese medicine, acupuncture or herbal therapy, is individual treatment.[1174] TCM regards each patient differently. This is quite opposite from Western medicine, which wants to standardize everything to every patients. Test acupuncture by a Western medicine way, not change treatment plan according to each patient's condition, might be one of reasons for the failure of many acupuncture studies. It could also be one of the importance reasons for high fall-off rate in acupuncture studies in the Western countries. For example, if a patient cannot tolerate 10 needles each time, or cannot tolerate the intensity of the needle stimulation as it is previously designed, but we insist to do it, the patient will have no way but escape.

The stimulation of acupuncture in each session is also very important but it is hard to standardize the stimulation dose among each session and among acupuncturists. We recommend using E-acupuncture, especially in large scale acupuncture studies.

15.3.5. Location of study

We recommend having acupuncture study in China first. This is because the large population in China. It is easy to collect sufficient number of patients to participate the study, as to be able to finish the study within a short time. Anyway the acupuncture is developed in China. Acupuncturists in China have responsibility to show the real healing effect of acupuncture to the world. If the study is indeed positive, than transfer the study to the Western countries. If the acupuncturists are from the Western countries, [27] we have to question the personal skill of the acupuncturist, among other possible reasons.

15.3.6. Monitor or Supervisor

The acupuncture should be performed by professional acupuncturist but need supervisor and monitor by some researchers who currently do not believe acupuncture specific effect. If it is performed by those people whose profession is not pure acupuncturist, the result of the study is largely questionable. If it is performed and finished all by acupuncturist, the result should be more credible, but the data treatment might be questionable. Monitored by those who do not believe acupuncture, the data would be more credited. By this way, it only needs to blind the patient, not the acupuncturist, or the data analyzers. As pointed out by others, that it is impossible to blind the acupuncturist. The feasibility to have a monitor is that there are already some researchers1 who do not believe acupuncture.

As we discussed, this should be an internationally observed study about acupuncture to finally answer if acupuncture is placebo effect or not. We should invite both the acupuncture experts from China and those from the Western countries who do not believe acupuncture, to finish the study, and report it in an international conference. 

After established that acupuncture is not a placebo effect, the setup of a monitor can be omitted.

 15.3.7. Acupuncturist recommended

It is needed to invite acupuncture experts to participate the international acupuncture study, so as to make sure that any failure from the study is not due to quality of the acupuncturist for his poor personal acupuncture skill. Any acupuncture study should not only convince acupuncturists and researchers in the Western countries but also those in China. If with the participation of the well-recognized acupuncturists from China, the study is still failed, we all will accept that acupuncture is indeed a placebo effect. We stop the acupuncture and discontinue any more studies on acupuncture.

At least, we can recommend the following experts: [28] professor 石学敏,梁繁荣教授;吕景山教授;韦立富教授;方剑乔教授;张道宗教授;张侬教授王升旭教授;方晓丽教授;纪青山教授; 石印玉, and so on.

Of course we cannot invite expert level of acupuncturists to participate every acupuncture study, but we need a scale to know what the highest healing effect is, by acupuncture in the current time, and then to know what is the average level for local acupuncturist. They are not the same meaning. If the healing effect of the local acupuncturists is too low, even if I am also an acupuncturist, I would not argue if an insurance company does not reimburse the cost for acupuncture treatment.

Therefore, we need acupuncture experts to participate the acupuncture study, so as to give a clear answer to the question if acupuncture is merely a placebo effect, a question which should have not been a question to acupuncturists in China.

15.8. Multiple study locations

For the treatment of an ordinary disease by Western medicine, once the diagnosis is established, the treatment would be pretty much the same no matter it is in New York, or in Vancouver. But for Chinese medicine, it may not be so. The personal ability of practitioners in Chinese medicine, acupuncture or herbal therapy, is largely variable. If one TCM doctor cannot solve the disease, it does not mean that another TCM doctor cannot either. This is reality.

To solve the variation among acupuncturists from different clinic locations, one way is to test their personal skill before or during experiment (such as with the clinic group). Another way is to allow the use of electrical acupuncture or warm acupuncture, so as to standard the stimulation in each acupuncture session. [29] Of course, the electrical acupuncture is not the traditional acupuncture. But if with the electrical acupuncture, the healing effect is not reasonably high,  it would be hardly expected that with manual acupuncture the healing effect would be higher (for most of acupuncturist).

Instead of designing a large scale study involving more clinic locations, we would recommend to finish the large scale experiment in a single location by a given and limited number of acupuncture experts. This is not difficult in China.

15.2.6. Goal of future acupuncture study

There are several remaining questions in acupuncture study that we need to answer one after another:

(1). If acupuncture is a placebo effect? If it is not a placebo, can we omit it in future study? Can we then compare the acupuncture group with the currently most effective therapy and accept it if it works equal or better than the compared therapy?

(2). How can we trust the healing result from a study in which the healing effect of the sham group (e.g. the placebo effect) is high? Should we think about to involve a credibility index in evaluate the quality of a study? Sham group with higher healing effect should get higher credibility than that with lower healing effect?

(3). How to evaluate the amount of placebo in a group of combined therapies, such as acupuncture group (which include a healing effect due to the placebo and to specific acupuncture effect), or a group with acupuncture plus physiotherapy (the total placebo effect in the combined group should be considered the same, doubled, or triples of that in the single sham group)?

(4). Difference in susceptibility rate of placebo in different nations, especially such in Germany, since most of the negative studies seemed from there. The susceptibility of placebo is negatively related to amount of the specific healing effect of acupuncture.

(5). Difference in incidence rate of along-meridian feeling in different nations. The along-meridian feeling is positively related to the healing effect of acupuncture.

All of these questions are closely related to future acupuncture studies and need to be clarified.

Brief summary:

To answer if acupuncture is placebo effect, we recommend having an international cooperated study, involving both acupuncture researchers from Western countries and acupuncture experts from China. Best way is to start the study in China, to study the effect of acupuncture during general anesthesia. This is also the easiest way and quickest way to answer this question.  

Chapter 16. Difficulty in acupuncture study

Now, we can make a comparison between acupuncture clinic study and Western drug clinic study. In the clinic drug study, the shape, size, and the color of sham drug to study can be made the same as the true drug. It is hard for patient to verify between the true and the sham durg tablets. Such true and sham drug can be produced in large scale and be used to thousands of patients the same time and in different part of the world.

However in the clinic acupuncture study, most of the non-inserted sham groups have more or less difference to the verum acupuncture group, except possibly for inserted sham group, in the way of operation of the treatment. The dose of stimulation of the acupuncture group could be different from session to session (even by the same acupuncturist). The dose of such stimulation can also be different among different acupuncturists. Therefore the efficiency of acupuncture treatment is largely variable from session to session, and from acupuncturist to acupuncturist.

There are data suggest that sham acupuncture might induce more placebo effect (enhanced placebo effect) than placebo pills (may be because the sham acupuncture belongs to action-type hint process). The placebo effect in the verum acupuncture group might be higher than the sham acupuncture group (due to the pain feeling, that might induce stronger and enhanced placebo effect), or less than the sham acupuncture group (due to fear to pain induced by needles). Therefore the relationship between the verum acupuncture and the sham acupuncture are unstable and variable.  

If the relationship of the factors in the medical study can be regarded as patient-medicine (and or placebo pill)-doctor, the relationship in the acupuncture study would be patient-acupuncture (and or sham acupuncture)-doctor. The acupuncture (and or sham acupuncture) would be the same position as the medicine (and or placebo pill). The medicine (and or placebo pill) can be regarded as fixed and under controlled factor, the acupuncture (and or sham acupuncture) is not at all a fixed and under controlled factor.

Therefore, the clinic study of acupuncture is more difficult and more complex than that of medicine. Currently, no matter how much the healing effect obtained in the acupuncture group, it is regarded as the normal and accepted healing effect of acupuncture. Rarely is it questioned as the failure of acupuncture group.

Chapter 17. Conclusion

We, from a clinic acupuncturist point of view, reviewed the current data about acupuncture and tried to see the possible reason(s) that may bring out a comment that acupuncture is a placebo effect. 

We found that:

(1), the healing effect of a sham group in the Western countries, is as average 23%, while that in acupuncture group is about 35%.

(2), acupuncture in the Western countries is mostly once or twice a week for less than 12 times.

(3). the healing effect in the sham group in China is about 23% too, but that in the acupuncture group is more than 50% or more.

 (4). Acupuncture in China is mostly once a day, 5-6 sessions a week, for more than 10 sessions (usually more than 15-20 sessions). Apparently in the Western, the acupuncture stimulation is lower and healing effect is lower too, while the stimulation dose is higher and healing effect is also higher in China.

Current data suggest that, with higher stimulation dose, the healing effect of sham group tends to be lower but that of acupuncture group, higher, so as it tends to yield a positive result about acupuncture study. Therefore, we predict that the reason(s) for the failure of acupuncture studies in the Western countries is at least originally due to low treatment frequency and lower dose of stimulation of acupuncture. Under the high treatment frequency, there is no major difference between the inserted or non-inserted sham groups in the extent of healing effect.

The direct evidence support that acupuncture is not a placebo effect is the treatment of acupuncture in patients with coma, shock, persistent vegetative state, and during and after anesthesia, in which the patients are with no consciousness or very weak consciousness, so as not being able to produce a placebo effect. Such disease conditions are very rarely studied in the Western countries.

Further evidence is that acupuncture can also work for dementia patients. In addition, with high treatment frequency, it is significantly difference in the healing effects between different acupuncture points, between the acupuncture points and non-points, between different ways of acupuncture. 

Moreover, acupuncture can well work for young children and for animals. Both should be hardly affected by a hint (placebo influence). Especially when the acupuncture is only one time and the conditioning reaction cannot be established among them.

The healing effects of sham groups are a largely broad rang. This means that the susceptibility of people to a hint (sham treatment) is largely variable, and in reality there are both high and low susceptibility people. To test if any therapy, including new drug, surgery, physiotherapy, chiropractic, as well as acupuncture, the placebo effect should be excluded. One of the ways to exclude the placebo effect from the acupuncture treatment is to have a pre-test phase, in which to give patient a sham treatment for 3-4 weeks, and exclude those of patients who have their symptoms reduced more than 30% (not up to 50%). This means to test specific healing effect of any therapy among placebo non-sensitive patients.

Beside the weakness of acupuncture studies in the Western countries as above, there are several other weaknesses: (1), to fix acupuncture treatment plan to all the patients without any variation according to patient individual need; (2), limit the communication between the acupuncturist and patients, so makes it impossible for the acupuncturist to change treatment plan according to the variation of the disease severity and the need of the patient personal conditions; (3), the acupuncture operators are in a large part not professional acupuncturists. The personal skill is questionable. 

Because the poor healing effect (improper study design and/or poor personal skill), acupuncture researchers in the Western countries rarely study objective indexed diseases, not to speak of the severe conditions, such as coma, shock, persistent vegetative state, post-stroke syndrome, bell paralysis, etc., so that leave an impression that acupuncture can only be used to treat subjective diseases, such as pain. This again enhances the suspect that acupuncture is a placebo effect. 

To prevent the mutual distrust between the acupuncturists in and out China, we suggest to have an international cooperated study on acupuncture, by involving acupuncture researchers from Western countries and acupuncture experts from China, so to answer the question permanently if acupuncture is a placebo effect or not.

Acupuncture needs to go ahead and not stands at the same spot, or goes around and around.

Chapter 18. Several comments and explanations

1. The reaction to a treatment for a healthy people and a sick people might not be the same,[1175,1176] so we try not to use data deduced from healthy volunteers. For the same reason, we tried also not to use data from a lab healthy animal.

2. Generally speaking, for the treatment of an acute disease, one time treatment with acupuncture is possible, especially by an acupuncture expert. But for most of acupuncturists and for most of chronic diseases, they need more times of acupuncture treatments. Therefore, we do not include the data of only one time acupuncture (except the data for the treatment of nausea).

3. We paid more attention to the healing effect when the healing plan finished. Very rarely is there a disease which did not get better at the end of the treatment course but better several months or years after the stop of acupuncture courses. The healing effect after stop of acupuncture could be largely variable due to many reasons, especially if this disease has not been brought to a cure or near cure status. So, we choose the data just after finish of the acupuncture treatment plan. 

4. Principally, we do not include the data by a TCM master student or doctoral student. Acupuncture is a healing technique highly dependent on personal skill. The credibility of data by people in student period is not as high as that in clinic practice period. However, we include their review data. 

3. We paid more attention to the healing effect when the healing plan finished. Very rarely is there a disease which did not get better at the end of the treatment course but better several months or years after the stop of acupuncture courses. The healing effect after stop of acupuncture could be largely variable due to many reasons, especially if this disease has not been brought to a cure or near cure status. So, we choose the data just after finish of the acupuncture treatment plan. 

6. We look at the data from the point view of an acupuncture clinic practitioner. This is not a strict review paper. We did not have statistical analysis of our data yet, since the data collected here is extremely largely variable for many aspects, which makes the statistical analysis less meaningful.

All the comparisons here are for the use of later professional researchers for a reference. We only paid attention to the overall healing effect of acupuncture in and out China, and how the acupuncture was performed generally by acupuncturists in and out of China. What we did seems as a much larger size "regression analysis,” a "smear analysis,” or a "non-linear regression analysis.”

 7. Data from Hong Kong are in most cases different from that in mainland of China for experiment design and more, so they are included in the "Western countries.” No any political meaning for us to do so.

8. Thanks very much for internet, for Google, Medline, BJM, Research Gate, CNKI.net, and Wan fang Med Online. We look the world on the shoulder of a giant.

 

Chapter19. Consideration and suggestion for future medical service system

It is well known that, no matter it is in China or in the Western worlds; the cost for healthcare occupies more and more the GDP part. Theoretically, the current medical services are much more advanced than that hundreds of years ago. Indeed, the life span of the population is increased. However, the number of the sick elderly is also more and more, since more and more people live longer due to their long term intake of the medicine. One way to explain this phenomenon is that current medicine saved life-threatening diseases and emergency conditions for sure, but fails to solve chronic disease or the diseases from which they saved. Many acute diseases and emergency diseases became chronic disease later (such as persistent vegetative state). Once a disease cannot be cured by a surgical operation treatment, it would be hard to solve by an internal medicine as well: chronic just mean that it is hard to cure. So, the disease can come again and again and the patients need to take medicine again and again, and so that the healthcare cost goes up sharply. In addition to the increase in the payment to pension to more population that comes into old age, the burden from healthcare would soon or later crash the whole national social service system.

How to solve this problem? Can we depend on the current Western medical system? The current situation happens when the Western medicine has been in authority and dominated. Its history has already showed and proven that it cannot solve all of these problems. It is also hardly to see glimmers of hope on the horizon for future.

According to our own understanding to the Western medicine and Chinese medicine, we believe that the best way to solve this problem is to adapt both Western medicine and Chinese medicine. This idea is to let the Western medicine do what they can do best: surgical operation and allow Chinese medicine to solve most of the chronic diseases, unless it is also hard for the Chinese medicine to solve the diseases concerned.

Chinese medicine includes, at least, the herbal therapy and the acupuncture therapy. Among the various therapies in Chinese medicine, the herbal therapy is apparently the major therapy actually. Of course, the final healing effect of the herbal therapy depends on the personal skill of the herbalist and that of the acupuncture depends on the personal skill of the acupuncturist. For some kinds of diseases, acupuncture might work better than acupuncture.

Our idea is: for the following conditions let the Western medicine to work first: any disease that can be for surely cured with surgical operation.

If the disease cannot be cured by the surgical operation, if it normally needs the patient to take medicine almost forever, if the patient is also prescribed for pain-killer, sleeping pill or sedative for the treatment; or if the diagnosis is uncertain, but the patient suffers much from discomfort, it is better to see if Chinese medicine can work, such as most of chronic diseases, except of some that might also be hard for the Chinese medicine (e.g. Cancer, AIDS, etc.).[30] 

The goodness is that there are already a large number of acupuncturists in most cities in the US and Canada. For example in Edmonton, Canada, the population is 870000, while there are at least 250 acupuncturists in the city. It means that every 3480 population is with one acupuncturist. This number is much higher than that in China: at least 1300,000,000 populations are associated with about 270000 Chinese medicine doctor (among them, most is herbalists, not acupuncturists). This means that every 48000 Chinese is associated with one Chinese medicine doctor.

The weakness so far is that most of the acupuncturists in the Western countries do not use herbal therapy. Or they only use simple herbal patch, herbal oil, or herbal pill for the treatment. The healing effect of these easily-use herbal products is limited somehow, compared with typical oral herbal therapy. With update of their herbal therapy skill, the overall healing effect should be much higher than it is now. 

 

 

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