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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 (I)

Dr. Martin Wang, MD. Ph.D.

Registered Acupuncturist

Edmonton, Canada

(PDF format of this article)

 

 

Abstract:

Currently, some researchers stated that acupuncture is merely a placebo effect. Theoretically, a placebo effect needs a person (patient) to be clear in mind being able to react to the emotional or actual hint, and to response to believe the hint. A large number of acupuncture studies from China reported that acupuncture can work on clinic conditions, in which the patient is with almost no, or very weak consciousness, such as coma, shock, dementia, persistent vegetative state. These data strongly support that acupuncture can work by itself without need to depend on a placebo effect. Unfortunately, it is very rare in the Western countries to have acupuncture trial on these clinic conditions.

Our analysis of acupuncture studies in the Western counties and in China suggests that the most possible reason for the failure in acupuncture studies in the Western countries is not in the side of sham group, but in the side of acupuncture group: the poor and unstable healing effect in the acupuncture group, which again is due mostly to the low treatment of and less total sessions of the acupuncture treatment. 

We found that most of acupuncture studies from Western countries were performed once or  twice per week for less or about 10 sessions (Western style acupuncture), while that in China was mostly five to six sessions per week for more than 12 sessions, mostly 20-30 sessions (Chinese style). The average daily stimulation dose in the first treatment course in the Western countries is as average 0.25, while that in China, 0.80. The total stimulation dose in the Western countries is 2.4, while that in China, 18.0. Both stimulation doses of acupuncture treatment in China are much higher than those in the Western countries.

Currently data suggest that, with the high frequency of, and high total sessions of acupuncture treatment, the healing effect of acupuncture groups tends to be more than 45% for most tested diseases, much higher than the healing effect of acupuncture on the same kinds of diseases. The healing effect of sham group is largely variable among studies, and the placebo effect is influenced by various factors. However, it was found that the difference between the inserted and non-inserted sham group is very small or no major difference. With the high frequency and the high total number of treatment sessions, the healing effect in the sham does not increase, and remained in about 23%; therefore the difference between the acupuncture group and the sham group is significantly large. This phenomenon can also be seen in the treatment by TENS or laser.

For the reasons above, we believe that it is too careless to tell that acupuncture effect is just a placebo effect. 

For future studies in acupuncture, we recommend: the easiest way to tell if acupuncture is a placebo effect or not is to test the effect of acupuncture during a general anesthesia (starting after induction of the general anesthesia). For the study of the healing effect of acupuncture in any other diseases, to increase the successful rate, the following should be considered: (1), have a run-in phase to wash out high placebo participates (if the symptom reduction is more than 30% in the participates); (2), take high treatment frequency (have acupuncture 5 days per week, for more than 20 sessions); (3),  consider the re-use of inserted sham group (insert needle shallowly in non-points, so as to avoid the blinding and to reduce the complex design of the study), (4), test the personal skill of acupuncturists before start of a study.

We hope that our article here able to bring the acupuncture researchers in the Western world out of confusion and to stop the continuing positive-negative result circles in acupuncture research. 

 

 

Contents


Chapter 1. Foreword
Chapter 2. Analysis of clinic studies
2.1. Colquhoun group
2.2. Acute and chronic neck and low back pain group
2.3. Migraine and tension headache group
2.4. Menopause syndrome
2.5. Other disease groups
2.6. Current acupuncture research status in China
2.7. Acupuncture on Nausea and vomiting
 
2.7.1. Post-operative nausea and vomiting
 
2.7.2. Nausea and vomiting after chemotherapy or radiation therapy
 
Chapter 3. Various sham groups in acupuncture studies
3.1. Commonly used sham groups
3.1.1. Needle-inserted sham groups (in or beside acupuncture points)
3.1.2. Needle-inserted (in shallow layer of skin)
3.1.3. Light-touch Sham (non-inserted needles)
3.1.4. TENS and Laser stimulation
3.1.5. Acupuncture on non-points but connected to electric stimulation
3.1.6. Fake TENSfake laser, fake magnetic, fake electrical needle, fake dermal needles 

3.2. Sham groups in other kinds of medical remedies 
3.2.1. Sham and placebo in Western medicine 
3.2.2. Sham and placebo in surgery
3.2.3. Sham and healing effect of hypnosis or alike remedies

3.2.4. Sham physiotherapy

3.2.5. sham chiropractic

3.3. The size of placebo effect

3.3.1. Difference between different types of sham groups

3.3.2. Sesceptibility of population 

3.3.3. Influence of sham group to verum acupuncture group 

3.4. Characteristics of a placebo effect 
3.5. Side effect of sham groups

3.6. Double effects of a placebo effect 
3.7. Exaggeration of healing effects by patients
3.8. Placebo effect may not always present in, or contribute to, a total healing effect 
3.9. Total healing effect of two or more remedies may not be the sum of them when they are used alone  
3.9.1. The amount of the placebo effect in combined group may not be the sum of that in each therapy. 

3.9.2. The amount of specific healing effect in the combined group might not be the sum of that in each group

3.9.3. The specific healing effect in a combined group may not be the difference between the total healing effect and that in sham group.

3.9.4. Reduction of healing effect in a combined group.

3.10. The final effect (direction and quantity) of a placebo in a sham group and in an acupuncture group may not be the same  

3.11. Influence of placebo to subjective or objective parameter

3.11.1. Continuous parameter and binary parameter

3.11.2. Physical parameter and biochemical parameter

3.11.3. Cure or symptom improvement

3.11.4. Brain image study

3.11.5. Peripheral (autonomic) effects of acupuncture versus sham acupuncture

3.12. When to accept a therapy (standard of acceptance)
3.13. Credibility of a study

Chapter 4.  Healing effects of acupuncture and sham in high frequency schedule 

4.1. Acupuncture and Electrical acupuncture

4.2. TENS and laser therapy


Chapter 5.  What we need to know and to be careful in acupuncture treatment
5.1. What is acupuncture
5.2. Choose of acupuncture points
5.3. The specific and non-specific effects of acupuncture points 
5.4. Needle feeling/sensation (acupuncture sensation)
5.5. Acupuncture sensation along meridians  
5.6. Accuracy of acupuncture points
5.7. Size of acupuncture points on body surface
5.8. Nourishing and depleting manipulation technique of acupuncture needles
5.9. Depth of acupuncture needles
5.10. Number of acupuncture points needed
5.11. Time length of needle manipulation
5.12. Time length of needle Retention
5.13. Frequency of acupuncture
5.14. Proper time to start acupuncture
5.15. Evaluation of long term of acupuncture treatment effects
5.16. Accompanying therapies or necessary care during acupuncture treatment
5.17. Proper and improper disease categories for acupuncture treatment

 

 

Part I: Chapter 1 - 5

Chapter 1. Foreword

I am an acupuncturist for many years. From the comments of clients and their introduction of attitude of their friends and relatives about acupuncture, we can feel that the acceptance to acupuncture is largely increasing in Western world. If people asked "what is acupuncture?" 10 years ago, they would be asking "How much cost is your acupuncture treatment?" nowadays. People become familiar to the word "acupuncture" and get to know that acupuncture is kind of alternative therapy, similar to something as physiotherapy or massage. If their family doctor cannot help to stop their pain, they can try acupuncture treatment as well. Only after the pain is reduced, would they start to ask question such as "how acupuncture works?" while lying on the table in acupuncture clinic.

Until several months ago, one of my acupuncturist friends told me that he write an article to argue for acupuncture, since he got know that some acupuncture research paper said that acupuncture is merely a placebo effect, meaning that acupuncture has no its own specific healing effect. So far as I knew at that time, any medical therapy, regardless of Western medicine drugs, surgery, physiotherapy, massage... can have placebo effect. As I remembered, the placebo effect in a medicine drug can be as much as 25% to 30%. This means that about 25% to 30% patients may feel better after take a fake medicine (drug). Therefore, his words made me confusing: is it true that the healing effects of acupuncture treatment in those articles are just about such 25% to 30%? This is absolutely not matching our clinic practice. If our clinic healing effect is just as low as such, we could not keep our acupuncture business at all.

So, I searched Google and right away I fund an article which is a review by Colquhoun D.[1,2] The title of the article is "Acupuncture doesn't work and "Acupuncture is theatrical placebo.” From his web page, I got know that the number of research papers is as much as more than 3000.  

The author wrote: "It is clear from meta-analyses that results of acupuncture trials are variable and inconsistent, even for single conditions. After thousands of trials of acupuncture and hundreds of systematic reviews, arguments continue unabated. In 2011, Pain published an editorial that summed up the present situation well."

"Since it has proved impossible to find consistent evidence after more than 3000 trials, it is time to give up. It seems very unlikely that the money that it would cost to do another 3000 trials would be well-spent."

“Is there really any need for more studies? Ernst et al. point out that the positive studies conclude that acupuncture relieves pain in some conditions but not in other very similar conditions. What would you think if a new pain pill was shown to relieve musculoskeletal pain in the arms but not in the legs? The most parsimonious explanation is that the positive studies are false positives. In his seminal article on why most published research findings are false, Ioannidis points out that when a popular but ineffective treatment is studied, false positive results are common for multiple reasons, including bias and low prior probability.”

"The best controlled studies show a clear pattern; with acupuncture the outcome does not depend on needle location or even needle insertion. Since these variables are those that define acupuncture, the only sensible conclusion is that acupuncture does not work. Everything else is the expected noise of clinical trials, and this noise seems particularly high with acupuncture research. The most parsimonious conclusion is that with acupuncture there is no signal, only noise."

Actually, there are more researchers believe that acupuncture is just a placebo effect,[3-5] and more and more negative report against acupuncture efficacy are still publishing (2016). [6-8]

We further fund the article by Wang SM (2013) [9], auguring for acupuncture. The author emphasized the healing effects of acupuncture in the treatment of post-operative nausea and vomiting, post-operative pain, chronic low back pain; the different mechanisms of acupuncture and sham acupuncture in stopping pain; the similarity in extensity of the healing effectiveness between the acupuncture and Western medicine drugs; and the safety and low costs of acupuncture treatment, and so on. However, all of the augments appear cannot convince Colquhoun and his colleges. The later responded that " the benefits of acupuncture are likely nonexistent, or at best are too small and too transient to be of any clinical significance. It seems that acupuncture is little or no more than a theatrical placebo. "

Apparently, both sides cannot convince each other, both sides believe that they found the truth, but no any side can find the errors or mistakes of opposite arguments. Furthermore the researchers who do the review can neither feel confidence to make a clear conclusion about acupuncture. They do not think that they can do so with additional 3000 more acupuncture studies.

It appears that the big curtain in acupuncture stage should be closed, at least for a while.

I am not intending to pull up the curtain again. However, as a medicine doctor and an acupuncturist for many years, I would like to spend some time to have a look at the research data about acupuncture, to see how comes people can draw the conclusion that acupuncture is only a placebo effect, especially to read and check the published papers cited by Colquhoun that are negative to acupuncture. I wish to find some clear reasons that cause the negative results in acupuncture research. That means, in our clinic, our overall healing effects among the patients visiting us, our clinic effectiveness can come up to 80%, and how come the healing effect of acupuncture in acupuncture research showed only about or around 25% to 30%. If our practical healing effect is just as such, it is impossible for us to continue an acupuncture clinic for so many years with more and more clients visiting to us. In other words, if acupuncture is just a placebo effect with more than 80% of healing effect, it should be developed into medical treatment, and it should be admitted in formal therapy in hospitals. How comes that the mainstream of Western medicine does not even admit the hypnosis that works exclusively applying active placebo effect for treatment?

During the literature reading, I have following questions in my mind:

1. How the acupuncturist performed the acupuncture treatment, how did they choose acupuncture points, did they manipulate the needle during the treatment session, how long time they leave and keep the needle inside the acupuncture spots, did they also use some other remedies, such as moxibustion, cupping, bleeding, Guasha, etc.

2.  How frequent the acupuncture treatment, e.g. the acupuncture schedules. It was done once a day, or once or twice a week? If the study was to check the long term healing effect of acupuncture, did the acupuncturists have some maintenance treatment after stop the formal acupuncture sessions? If they had the maintenance treatment, how often the acupuncture was performed during the observation period?

 3. During acupuncture treatment period, did the acupuncture paid attention to ask patients aware of some factors that may make them feel worse in their symptoms, such as to sit or stand for too long, walk or run too much, list heavy stuff, or have exhausted physical exercise, and so on?

4. When there is control group, if the control can really work as a control? If the control group can have some similar healing effect as well?

5. If the disease studied belongs to the proper disease category that can be treated by acupuncture in clinic?

6. How do we know the quality of the acupuncturist participating the studies? If they are not a real acupuncturist, and have no enough clinic experience, the person should not represent acupuncture society to participate a study on acupuncture. No use to tell me that they are family doctors or physician, or physiotherapist for many years, neither tell me that have had acupuncture license for many years. All of those does not necessary tell how good they are in acupuncture treatment. If the person performed the acupuncture in a study had acupuncture license for 5 years or 10 years, but they did the acupuncture only to one to two of his daily clients and for most of his clients, he still proscribe medicine or do physiotherapy, it only suggests that his personal acupuncture skill is not as good as an typical acupuncturist, since he has no enough confidence to use acupuncture to solve most clinic conditions as most of our typical acupuncturist do.    

Chapter 2. Analysis of clinic studies

2.1. Data from Colquhoun group

Bring all of these questions in mind, I first read the articles cited by Colquhoun D, [1],  as well as those cited by Wang SM, such as the articles summarized by Madsen MV(2009) [10] and Vicker AJ (2012).[11]

Right away, we found that the acupuncture treatments in those papers are, generally speaking, once or twice a week (Attached list  1). This is quite different from what we do in clinic.

To be able to measure the dose of acupuncture stimulation, we suggest the concept of average daily dose (ADD) [1] of healing course and the total course dose (TCD). In acupuncture treatment, especially in China, the acupuncture treatment was performed as a course. Each course consists of, in most case, 7 days (one week), or 10 days. Within each course, the acupuncture might be performed daily or once every day (Chinese style), or once or twice a week (Western style). The treatment might be the same for several courses (China style), or it is a tailed courses, e.g. in the beginning courses, the acupuncture was performed for more times, while it becomes less and less in later courses (Western style). For example, in the beginning, acupuncture was done twice a week for four weeks (the first courses), then once a week for another four weeks (the second courses). The ADD might therefore be different in each course. Take an example, if the acupuncture was done in the first course is twice in first four weeks (e.g. the first course, 28 days), and once every week in the next four weeks, the ADD in the first course is 2/7= 0.28 (or 8/28=0.28) and in the second course is 1/7= 0.14 (or 4/28=0.14). Then, the course dose of the first course is 0.28x8=2.24 and that of the second course is 0.14x4=0.56. Therefore the TCD is 2.24+0.56=2.80  (TCD is the sum of the course dose of all the courses).

Because the acupuncture treatment is mostly importantly related to the acupuncture frequency in the first course, we choose the ADD in the first course, as well as the TCD of the whole treatment course, to compare the acupuncture stimulation in each study.

By this way, we found that the ADD of the first healing course (Note 2) is 0.26±0.12 (Mean ± SD), while the TCD is 2.43±1.71. [2]

In this article, we have no way to calculate the stimulation dose of acupuncture treatment in each session, e.g. a session dose, because the session dose is largely variable among acupuncturists, among sessions, depending on the personal skill, the intensity of needle manipulation, the length of needle retention in the acupuncture points, and so on. In clinic, the session dose should match the nature of a disease, the tolerability of a patient to the needle stimulation and so on. The session simulation dose is therefore not asked to be always the same during the acupuncture treatment.

Additionally, we found that the so called acupuncture groups in these articles are actually electrical acupuncture or the acupuncture is mixed with other therapies, such as auricular pressure, auricular acupuncture, medicine, physiotherapy, massage, etc. Therefore, the credit of acupuncture group cannot be contributed solely to the acupuncture treatment. For this reason, we should exclude those groups from pure acupuncture group.

For the evaluation of healing effect of acupuncture treatment, we choose the symptom reduction level just at the end of the acupuncture treatment, not those effective mark collected several weeks or months after stop of acupuncture treatment. We also first of all choose the reduction of pain level. Since there are several different marks to tell the level of pain, we choose first of all the data on VAS scale. To make a summary of the data from these articles, we get Fig. 1. 

Fig. 1 shows the improve rate of pain after treated with various therapies. The diseases included are chronic lower back pain, tension headache, should pain, neck pain, knee pain and migraine, etc.. The "acupuncture plus others" means the co-use of acupuncture with medicine, or exercise, or auricular acupuncture, etc...

From Fig. 1, we can see that the healing effect of acupuncture group in deed is just about 10% higher than the sham acupuncture group. No wonder why it would be pretty easy to happen that in some articles the acupuncture group works better than the sham group (statistically), while in others, not. Also, it is no wonder that, when sham acupuncture group is mixed with other therapy, the healing effect becomes higher (37.2%), making the difference between the acupuncture group and the sham group smaller to lose statistically significant. The Fig. 1. also shows that the healing effect of electrical acupuncture (E-acup group) worked better than acupuncture group (48.1% versus 42.5%), though not as much. The reason might be due to the fact that the schedule dose of acupuncture in both groups is too small. We will discuss this in later chapters. However, the electrical acupuncture works much better than the sham (48.1% versus 33.4%). It is agreed by the authors of the three studies with the use of electrical acupuncture that the electrical acupuncture works better than the sham groups in their studies.

Placebo.Fig.1

Fig.1. n = number of experiment groups. AcupAcupuncture. E-Acup: electrical acupuncture. Acup+others: Acupuncture with medicine, exercise, or auricular acupuncture, etc. Acup + Physio: Acupuncture plus physiotherapy.

The diseases treated in these articles are largely variable and also some articles come from the same research groups. For example, Linde K (2005),[12] Melchart D (2005),[13] Witt C (2005),[14] and Brinkhaus B (2006) [15] as a group, Vas J (2004),[16] Vas J (2006),[17] Vas J (2008) [18] as a group. Scharf HP (2006),[19] and Foster NE (2007) [20] was a group; Diener HC (2006), [21] Endres HG (2007),[22] Haake (2007) [23] as a group; while Kerr DP (2003),[24] Kennedy (2008) [25] as group.

 If these groups keep the same kind of research design and the acupuncture was performed by the same person, it would no wonder that they would publish the similar articles again and again. For this reason, we need to first to narrow the disease category studied and to increase the number of published articles, to test the relationship between the acupuncture schedule dose and healing effects, e.g. to test if what we observed in the Fig. 1. bears common significance (not by chance).  

For convenience in later discussion, we call the articles discussed above as Colquhoun group.

2.2. Acute and chronic low back pain and neck pain

Analysis of data from the review by Furlan AD (2010) [26] 

Furlan AD (2010) [26] published a review on the treatment of back pain and neck pain by acupuncture treatment. [3] The goodness for his review is that it also included the articles published in China. (Attached list: 2, 3)

So far as we know, this is the only review that include data published also from China. However the author did not find the reasons that cause the difference between the data from Western countries and that from China.

If we also make a calculation of the total- course dose and the schedule dose of acupuncture treatment in his review (Attached list 3 and 4 ), we could find that the ADD of the first course of the acupuncture treatment in the Western world and in China is 0.27±0.17 (n=56) and 0.79±0.33 (n=68), respectively. The TCD in the former and in the later is 2.41±2.20 (n=56) and 17.61±11.42 (n=68), respectively. Apparently, either for the ADD of the first course and the TCD of acupuncture treatment in China is much higher than those parameters in the Western world.

How such bigger difference in the acupuncture stimulation would affect the overall healing effect?

We found that, the mark for the healing effect used by the researchers in the Western world and in China is different somehow. Researchers in the Western world usually used continuous scale, such as VAS, which is to let patient point out the pain level from a scale from 0 to 100 mm. While Chinese researchers used grade mark, such as cure rate, much improved rate, kind of improved rate, and no change, even a worsen rate, though such grade scale is also developed firstly from VAS or similar scales.

Both marks have advantage and disadvantage. For example, the use of VAS does not tell how much patients have been cured and they do no need any longer to visit doctor for treatment. The disadvantage with current grade scale in Chinese literature is that the level to separate these rates may not be the same from study to study and from disease to disease. They may not be standardized yet.

In summary of data from Western world, we still focus on the changes of pain (not functional changes) after acupuncture treatment; the symptom change at the end of acupuncture sessions (not the changes several weeks or months after stop of acupuncture); the healing effect of acupuncture alone (not that by the combination of acupuncture with other therapies, such as acupuncture point injection, or TENS, or trigger point acupuncture), treatment with several sessions of acupuncture treatment (not just one time acupuncture treatment), aimed at treatment (not for methodology test). Our aim is to test, with acupuncture alone (so called textbook acupuncture), [4] how the acupuncture healing effect would be affected by acupuncture stimulation doses. All of these paper identification principles are throughout our paper here. 

Let us see firstly the summary from reports from Western world. In the articles in the Western group, the healing effect of sham group and real acupuncture group are 25.1%±16.8% and 37.2%±21.0%, respectively. The healing effect of the acupuncture group is also just about 10% more than that in the sham group. The electrical acupuncture group is better than the ordinary acupuncture (45.2% versus 37.2%), and much more than the sham group (45.2% versus 25.1%).

Now let us see the reports from China. Among the 59 articles, only 13 of them reported continuous healing effect scale and most of the used grade scale. Let us see the healing effect tested by the continuous scale first. See figure 3.  

Placebo.Fig.2

Fig. 2. n = number of experiment groups. E-Acup: electrical acupuncture. Advanced Acup: special manner of acupuncture , Acupoint injection. Acup + others: Acupuncture plus auricular acupressure, or TENS, or plus physiotherapy.

 

It can be seen that in the Chinese group, the healing effect in the sham group is only 12.3%, while that in the acupuncture group is 50.8%. However, the number of article is too small (there is only one paper that contained sham group as control) so as not allow us to make a concrete conclusion yet. But, the healing effect of the acupuncture group is higher than the Western medicine group (50.8% vs 34.6%), and the electrical acupuncture is better than the ordinary acupuncture (66.3% vs 50.8%), while the modified acupuncture is even better than the electrical acupuncture (72.3% vs 50.8%). So, overall speaking, the acupuncture in China appears much better than that in the Western world. (compare the figure 2 and 3).

Placebo.Fig.3

Fig. 3. n=number of experiment groups. Acup: Acupuncture. Modified Acupuncture: Acupuncture plus various special hand manipulation techniques or electric acupuncture, or laser knigh-needle. Acup plus others: Acupuncture plus extraction, or electric acupuncture or acupoint injection.

If we make a summary for the healing effect using grade scales, only focus on the cure rate (e.g. not include much improve rate, improve rate, or not change rate), the pattern in figure 3 remains the same (see figure 4). 

In Fig 4, the modified acupuncture refers to knife needle technique, abdomen acupuncture, deep penetrating acupuncture, warm acupuncture, acupuncture on healthy side, dermal acupuncture, etc.  "Acupuncture plus others" means acupuncture is used together with other therapy, such as massage or traction, etc. Actually, these modified acupuncture and acupuncture combined with other such therapies are quite common in acupuncture clinics in China.

Placebo.Fig.4

Fig. 4. n = number of experiment groups.

Data from review of Furlan AD  allow us to see the big difference in the acupuncture healing effect between that from Western countries and that from China and the acupuncture frequency in China is also much higher than that in the Western countries, suggesting that the high healing effect might bear some relationship with the high frequency (close acupuncture sessions plus more times of acupuncture). Because most of the articles published in China did not use continuous scale to test the healing effect, the data in figure 2, 3, and 4 have to be further more tested with more information from more sources. 

2.3. Migraine and tension headache group

We further choose articles about acupuncture treatment for migraine and tension headache, because these diseases are quite common in the Western countries and they are also within the recommendation scope of acupuncture treatment. Our data come from the reviews by Linde K (2009) [27,28], while data from China, come from Wanfang Med online using key word acupuncture, migraine and tension headache.[29-71]

See attached list 5 and 6 .

In literature, the parameters to tell the healing effect of the acupuncture treatment include the reduction of pain level; shorten of pain time/period, reduction in the times of pain onset and reduction in the days with pain. We choose firstly to use the reduction in pain level as mark, secondly the shorten of the pain period. This is because the fact that, if the pain level is not reduced and the pain period is not shortened, the number of the days with headache could not be expected to reduce.

First of all, we pay attention to the total-course dose and schedule dose of acupuncture treatment in the articles published in the Western countries (the Western group) and in China (China group). This has become our most attention now.

The ADD of the first course in the Western group is 0.18±0.10 (n=21), while that in the China group is  0.84±0.40 (n=44). The TCD in the China group is 4.6 times more than that in the Western group.

The TCD in the former is 1.66±1.14 (n=21), and that is 18.57±10.45 (n=44) in the latter group. The TCD in the China group is 11 times more than that in the Western group.

Now let us see the healing effect for migraine and tension headache in the Western countries and in China. Similarly, Chinese acupuncture research mostly use grade scale. Continuous scale is not used popularly by them.

Using reduction in pain level as effective mark (Fig. 5), the healing effect from the sham in the Western group and in the Chinese group are very close: (22.3% vs 18.3%). In the Western group, the effect of acupuncture group is also very close to the sham group (28.0% vs 22.3%)and close to the Western medicine group28.0% vs 32.2%). No wonder how comes that in the research of acupuncture treatment for migraine and tension headache, negative results are quite popular.

In Chinese group, ordinary acupuncture group is better than its sham control group (42.7% vs 18.3%). Electrical acupuncture (61.8%), modified acupuncture (55.3%), and combined acupuncture group (54.5%) are all better than ordinary acupuncture group.

The healing effect of acupuncture group in China is much better than that in Western group42.7% vs 28.0%.

Placebo.Fig.5

Fig. 5. n = experiment groups. Sham: Sham acupuncture. Acup: Acupuncture. E-Acup: electrical acupuncture. Acup + others: acupuncture plus herbs, or medicine, or cupping.

Now, let us see the acupuncture healing effect expressed as cure rate (Attached list 7 , Fig. 6).

Placebo.Fig.6

Fig. 6. n = experiment groups. Acup + others: Acupuncture plus herbs, or scalp acupuncture, or Chinese Tuina massage.

Fig. 6 again shows that the healing effect of acupuncture group in China is higher than that in Western medicine group (33.4% vs 25.2%); electrical acupuncture is better than ordinary acupuncture group (50.5% vs 33.4%); and modified acupuncture is also better than the ordinary acupuncture group (58.8% vs 33.4%). It should be pointed out that the data source for Fig. 5 and 6 are not the same (Check Attached list 5 and 6 ).

2.4. Menopause syndrome group

We noted that some Western articles claimed that acupuncture works for the treatment of menopause syndrome [72][73] or no better (Ee C 2016). [74,75] There is still no convinced conclusion yet for this question.[76-78]

When we turn our eye on Chinese literatures, [79-124] (see Attached list 8 ,9) we found that the average daily dose of acupuncture treatment is 0.73±0.26 (n=42)while the TCD is 21.5±16.85 (n=42).

When the healing effect is evaluated using Kupperman points, acupuncture treatment in China could bring this point down by 61.7% ±13.0%. Auricular acupuncture alone can also reduce the points by 63.7% ± 6.0% (See Fig. 7).  Electrical acupuncture can work similarly well (62.0%±10%).

Apparently, the preliminary conclusion drawn from low back pain group (the Furlan AD group) has been reproduced in this migraine and tension headache group again, though the healing effect by acupuncture appears better for neck pain and low back pain, than for migraine and tension headache. As an acupuncture practitioner, we agree that this is true in clinic. 

It is needed to note that in these articles, the healing effect of electrical acupuncture is not better than ordinary acupuncture group (62% vs 61.7%). Comparing the cure rate by the electrical acupuncture and ordinary acupuncture, this is also true (Fig. 8a). We noted that the electrical acupuncture was performed in most researches as once every other day (or three times a week) with the ADD of 0.54±0.25. In the ordinary acupuncture group, it is performed mostly once a day with the ADD of 0.80±0.23 (Fig. 8). However, the TCD for the electrical acupuncture and ordinary acupuncture groups are similar: 19.1±15.39 and 22.36±17.49, respectively. This suggests that closer acupuncture treatment sessions are more effect than higher total number of sessions of acupuncture treatment (as stimulated by electrical stimulation).

  Placebo.Fig.7

Fig.7. n = experiment groups.

That a closer acupuncture session is better than longer time stimulation during each session can also be verified by our clinic experience with auricular pressure treatment. We asked our clients to press the beard on the ear more frequent (such as press it once every hour and 3-5 seconds each time) and found that overall healing effect is better than to press it once a day and 5 min each time.

Fig. 8.

Fig. 8. n = published articles. No sham group.

2.5. Other diseases tested and studied in Western countries

When we continue search the published articles about acupuncture treatment, such as high blood pressure, asthma, depression, etc., we found that most of the studies done in the Western countries were performed either once a week or twice a week, very little number of the articles said that they used more than three times of acupuncture per week, though the schedule of once or twice a week of acupuncture is stated by Western acupuncturists and researchers as the minimum requirement.[125] Such acupuncture schedule and such clinic results have therefore been regarded as Western style acupuncture, because it is not at all the acupuncture style in China by Chinese acupuncturists. The healing effects of acupuncture for these diseases in the Western countries are similar to those we have already discussed before (the neck pain, low back pain, migraine, tension headache and menopause syndrome): some paper reported positive results, while others, negative. It appears that no any disease scope that has been studied by Western acupuncture researchers so far showed a conclusive agreement.

2.6. Current status of acupuncture research in China

After review the acupuncture research in the Western countries, let us open our eye to bigger view to see how acupuncture is studied in China. For this, we chosen the articles that were published in Shang Hai Acupuncture and Moxibustion, from January 2015 to August 2015.[5]

We only choose the articles on clinic research (excluding those about animal study, expert experience, data review, or acupuncture instrument test and development, etc. We get totally 128 articles. This group is therefore called Chinese journal group. (see Attached list 10 and 11 ).

By calculation, the ADD of the first course and the TCD of acupuncture treatment reported in these Chinese publications are 0.86±0.28 (n=125) and 22.04±16.76 (n=118), respectively. 

These publications plus those from the review by Furlan AD (2010)[19] are regarded as a new China group. As comparison, we also collected the articles cited in Colquhoun D ,[1] Madsen MV (2009), [10] Vicker AJ (2012),[11] Furlan AD (2010), Linde K (2009) as a Western group (after deletion of repeated articles, we got totally 90 articles).

Placebo.Fig.8a

Fig. 8a. n = published articles. E-Acup: electrical acupuncture. Acup: acupuncture.

  

We have also calculated the total-course dose and the average daily dose of the first course of acupuncture in menopause syndrome group above and summarized all of the total-course dose, including those from China, [23,73,76,78,90,126-246] in Fig. 9.

  Placebo.Fig.9

Fig. 9. Course dose = average daily dose X number of acupuncture session. If it is not mentioned in the article for how many times of acupuncture were performed, the session number is estimated as 1.5 times of the number in the first-circle of treatment.
 

Placebo.Fig.10

Data in Fig. 9 suggested that, no matter it is for the treatment of neck pain, low back pain, migraine, tension headache, or menopause syndrome, the ADD of the first course of acupuncture treatment in the Western groups is very similar, as average of 0.25. For the similar diseases, even include more various kinds of diseases, the ADD of the first course of acupuncture treatment in China is also pretty much the same, as average of 0.8. The ADD in China is much higher than that in the acupuncture treatment in Western countries. The ADD of first course in China is 3.2 times higher than that in Western countries. Fig. 10 suggests: no matter for the treatment of various diseases as above, the TCD in the Western groups are also very similar, as average of 2.4, while that in China, about 18 to 20. The TCD in China is about 8.3 times higher than that in Western countries.

Comparing the schedule of acupuncture treatment in the first circle, we found that about 80% of the acupuncture treatment reported in the published papers in China are 5 to 6 sessions a week, while also about 80% of the acupuncture treatment reported in Western journals are once or twice a week (Fig. 11). This means: in the first 7 to 10 days, Chinese acupuncturist performed acupuncture treatment nearly every day to their patients, while the Western acupuncturist leave their patients at home to wait for next acupuncture treatment several days later.

Placebo.Fig.11

Fig. 11. n = number of published articles. Note: Duplicated articles have been deleted. Articles indicating the acupuncture treatment such as “10 times over 3 months” are hard to interpret, so they are not included in the summary.  

In the data included in the Fig. 12, the acupuncture treatment for only once in the Western groups comes mostly from Japanese studies to test the healing effect of trigger point stimulation. Such acupuncture is usually with long treatment interval between each session. In Chinese group, one time of acupuncture is mostly a methodology study, not a clinic study.

Placebo.Fig.12

Fig. 12 shows that, most (76%) of the acupuncture treatment in the Western groups are within 10 times, while most of acupuncture in China is between 11-20 or more times (sessions). This conclusion is true even if we include the data from the Chinese journal group (Fig. 13). 

Placebo.Fig.13

Now, we can make a summary of the characteristic of the acupuncture in the Western countries: they perform acupuncture once or twice a day for about 10 times. That of Chinese acupuncture in China is once a day (or 5 to 6 days a week) for more than 10 times and even up to 20 or 30 times.

By the Western style acupuncture, the healing effect in the acupuncture group is either higher than sham group (as in the neck pain and low back pain group), or similar to that in the sham group (as in the migraine and tension headache group). The Chinese style of acupuncture with the concentrated acupuncture schedule is not the best way either, since the ordinary acupuncture (with such schedule) is usually used as control group to test other better (supposed) acupuncture techniques (see Attached list  2 36710 and  11 ).

Not only in the acupuncture researches, but also in practical acupuncture clinic treatment, do Chinese acupuncturists use such concentrated acupuncture schedule? Only when the disease is not so sever, when the patient is with difficulty in financial situation, or when the acupuncture is used together with other therapies, would the Chinese acupuncturists do the acupuncture once every 2 or 3 days.

Napadow V (2004) [247] has reported what he noticed the acupuncture treatment in China when he was in China visiting 2 acupuncture clinics. He reported that the most common diseases treated there were Bell paralysis, various nerve-muscle diseases. Acupuncturists there performed acupuncture for 7-10 patients every hour. Each patient had acupuncture for about 25 min. According to the type and severity of the disease, patient had acupuncture once a day, or once every other day. On the contract, acupuncturists in US see 1.2 patients per hour. Each patient had acupuncture for about 1 hour. The most common diseases are muscle and joint pain. 

The diseases treated by acupuncturists in China is migraine, primary dysmenorrhea, acute or chronic gout, herpes zoster, hyperplasia of mammary glands, post stroke syndrome, functional disorders after cerebral infarction, spastic cerebral palsy, foot inversion after stroke (see Attached list 10 and 11). Overall, the subjective disease is in about 40.7% (35/86) of articles and objective diseases and physical disorders, 59.3% (51/86), as shown in the Chinese journal group.

This means that acupuncture is not only used for the treatment of diseases, the healing effect of which is evaluated by patient subjective mark, but also those with objective marks. The way of treatment for those diseases are also very multiple, such as acupuncture, traction, herbs, Tuina, and moxibustion, with or without the combination with Western medicine.  

We indeed also found an article by Leibing E (2002) ,[248]  who did acupuncture once a day for 5 days for totally 2 weeks, followed by acupuncture once a week. Unfortunately, the acupuncture group is contaminated with physiotherapy. It is not a pure acupuncture study. 

In the Chinese journal group, there are also two kinds of scales to tell the healing effects of acupuncture, the continuous scale, and grade scale. There are 82 articles used the continuous scale, and 98 articles used grade scale. We summarized the healing effect of acupuncture in the articles that used the continuous scale in Fig. 14 (after exclusion those of articles in which the studies has not been finished or only tested methodology difference).

Placebo.Fig.14

Fig. 14. n=experiment groups.

From the Fig. 14, we can see that the healing effect of acupuncture is about 42.3%, similar to that of Western medicine (39%) and Chinese herbal therapy (39%), while that by electrical acupuncture (57.3%), warm needle acupuncture (54.9%), special modified acupuncture (54.4%), joint injection (55.7%), or acupuncture plus Western medicine (54.4%), acupuncture plus herbals (65.75), acupuncture plus Tuina massage (52.2%), are all better than the ordinary acupuncture. The healing effect of sham group is only 29.7%. If the sham is contaminated with other therapy (here is the sham plus Western medicine plus rehabilitation), its healing effect is of course higher (33.4%), further more indicating that it is not proper to contaminate the sham group with other therapy.  We cannot say that acupuncture will work for every kind of diseases, but Fig. 14 allow us to have a better understanding for what kinds of diseases are tested and treated by Chinese acupuncturists in China nowadays.  

 

2.7. Nausea and vomiting treatment by acupuncture

To test and discuss acupuncture, one of the topics that we cannot avoid is the acupuncture treatment for nausea and vomit. We pointed out that for the diseases discussed above, we suggested that the high frequency of acupuncture treatment might work better than low such frequency. However, it is true that for the acupuncture treatment for some other clinic conditions, only one time of acupuncture also works and it may even have no need for the second treatment session. One of these examples is the nausea and vomit. Other such examples are as acute gastro-intestinal diarrhea, car sick, or headache in a common cold.

2.7.1. Nausea and vomit after surgical operation

To stop nausea and vomit after a general anesthesia in surgical operation, Western acupuncturists commonly use a single acupuncture point named Neiguan. The way of stimulation of the point can be acupuncture needle, [249- 260] point injection, [261] point massage, [262-278] acupuncture plus point pressure, [279-280] electrical stimulation, [281-282] TENS, [261,283] laser, [284] or dermal needle. As the Neiguan point, it was stimulated either before or after the anesthesia, or after finish of the whole surgical operation.

We found that, in the treatment of the post-operation nausea and vomit by acupuncture, some reported positive,    but others reported negative results for the effect of acupuncture, compared with the sham group. This is even true when compare the effect of acupuncture with non-treatment groups. Acupuncture works better to reduce the incidence of nausea/vomit, or no different. However, electrical acupuncture seems always work better than sham group and more than one acupuncture point acupuncture seems better than single point.

If we pool all data together (Attached list 12)we can see that without treatment, the incidence of nausea/vomit after operation is 67.2%. Sham acupuncture can only reduce it down to 56.5% and antiemetic drug can reduce it to 37.2%, acupuncture, to 35.6%, and TENS works better, to 25% (Fig. 15).

To treat the nausea/vomit after a surgical operation, acupuncturists in China also choose the same point Neiguan (Attached list 13 ). But they mostly use injections into the points,[285-291] or use TENS, [292-295] or combine acupuncture with antiemetics. [296-298] It is not common by them to use ordinary acupuncture or to compare acupuncture with non-treatment groups. [299-302]  It is hard for us to find a comparison between acupuncture with sham. Only two papers compare TENS with sham. Even in these two papers, they also had electrical stimulation to the sham group, so they are not a good comparison. Another study is to inject Vitamin B1 into acupuncture point. Another one is to inject drugs into non-acupuncture-point.

Placebo.Fig.15

Fig. 15. n = experiment groups. Data not include articles that use grade scale for healing effects.

Now let us have a look at the healing effect of acupuncture on this clinic condition in China (Fig. 16).

Placebo.Fig.16

Fig.16. n = experiment groups. Sham + others: Sham acupuncture plus Ondansetron, or vitamin B1 injection into either acupuncture points or into non-acupuncture points. Acupuncture + others: acupuncture plus acupressure.

Fig. 16 shows that, without treatment, the incidence of nausea/vomit after a surgery could be as much as 73%, similar to that summarized in the Western group. Antiemetic medicine can reduce the incidence down to 30.2%, and acupuncture reduces it to 17.7%. Other forms of acupuncture (including electrical acupuncture, TENS, joint injection) worked the same as ordinary acupuncture. The combination of acupuncture with antiemetics could not further more reduce the incidence (still is 16.7%).

Comparing the Fig. 15 and 16, it can be seen that the incidence of nausea/vomit after a surgical operation in both the Western group and Chinese group are similar in the non-treatment group and in the antiemetic group. Acupuncture alone is not commonly used in the treatment, since there are only 4 papers. Even though, one study used acupuncture from the start to the end of anesthesia; another used more than three times of acupuncture. It appears that, even using ordinary acupuncture, acupuncturists in China tend to have stronger stimulation to the acupuncture points (leaving needle for a longer time, or having acupuncture more times), than the acupuncturists out of China.

Comparing the Fig. 15 and 16, it can be seen that the incidence of nausea/vomit after a surgical operation in both the Western group and Chinese group are similar in the non-treatment group and in the antiemetic group. For the 4 acupuncture studies, one used acupuncture from the start to the end of anesthesia; another used more than three times of acupuncture. It appears that, even using ordinary acupuncture, acupuncturists in China tend to have stronger stimulation to the acupuncture points (leaving needle for a longer time, or having acupuncture more times), than the acupuncturists in the Western countries.

Acupuncturists in China have tried and successfully reduced the incidence of postoperative nausea/vomit to less than 20%, while the acupuncturists in Western countries can only reduce it to about 35.6%.

Data in Fig. 15 and 16 suggest that, for the treatment of postoperative nausea/vomit, the ordinary acupuncture only one time using a single point can also work to reduce the incidence. This is in consistence with the reviews by Lee A (2009, [303] BaoT (2011), [304] Stoicea N  (2015). [305]  Acupuncture treatment of postoperative nausea/vomit might be one of the research areas, in which the experiment results are largely consistent: acupuncture works. This might be the reason Wang SM (2013) cannot agree with Colquhoun D  and insisted strongly argument for acupuncture.

As pointed out by Pettersson H (2012) that acupuncture may reduce the incidence of postoperative nausea but not that of vomit, probably this is due to relatively less stimulation to the acupuncture point by acupuncturists in Western countries.

Possibly because the ordinary acupuncture works well to reduce the incidence of postoperative nausea/vomit, acupuncturists in Western countries tried to simplify the acupuncture into acu-pressure on the same points. However, acu-pressure is not the same as acupuncture. It is not reliable as acupuncture by professional acupuncturist, especially if the acupressure is asked to be pressured by patient themselves at home. It is no wonder that the healing effect of an acupressure in treatment of postoperative nausea/vomit could be reported either positive or negative again and again.

 It should be reminded that the treatment of postoperative nausea/vomit is also a new area for acupuncture, since in China for thousands of years, Chinese herbal therapy has been used mostly. Chinese surgical operation (Yes we have) was not continued to be the main stem of Chinese medicine system. Many kinds of diseases that are currently treated with Western style surgical operation, such as thyromegaly, lacteal cyst, oophoritic cyst, etc., are treated with Chinese herbal therapy.

This means that the use of anesthesia in China is not at all common in old time. To treat the anesthesia-caused nausea/vomit is also a new topic for acupuncturists in China to try for a proper schedule for acupuncture treatment. However as we see from current literature from China, the acupuncturists there tend not to use single point acupuncture or one-time-only acupuncture for the treatment, probably for the reason that they have already realized that such ways of acupuncture do not yield consistent and satisfied healing results. 

For the treatment of postoperative nausea/vomit, much is needed to determine if it is proper to use a single acupuncture point for the treatment; if it is needed to choose acupuncture points according to the types of surgical operation, such as operation on the heart and chest, on the abdomen, on the pelvic cavity or on the head area (brain); or to the type of disease that are diagnosed according to Traditional Chinese medicine theory. So far as we know, the acupuncture points that can be used also in the treatment of postoperative nausea/vomit are, as example, point Yongquan, Zusanli, Zhongwan, and Hegu, etc. The use of multiple acupuncture points works better single point.

Furthermore, why not to perform acupuncture several times instead of just one time by starting the acupuncture 2 to 3 days before anesthesia and one more time after the surgical operation? The aim of acupuncture by this way is not only to reduce the postoperative nausea/vomit, but also to release patients from stress before operation, stabilize life parameter, reduce the use of amount of anesthesia drugs during the operation, speed up the wake-up after anesthesia, speed up the healing of wound, reduce the chance of wound infection and bleeding, reduce the use of pain killer after operation, as well as to reduce the incidence of not only the postoperative but also during surgery the incidence of nausea/vomit. Because the single time acupuncture required higher personal skill of an acupuncturist, it might be better to use electrical acupuncture to standardize the stimulation dose of acupuncture, so as also to increase the reproducibility of the acupuncture treatment.

2.7.2. Nausea/vomit after chemotherapy or radiation therapy

For the treatment of nausea/vomit after chemotherapy or radiation therapy, acupuncturists in the Western countries also use point-pressure,  auricular needle, electrical acupuncture, TENS, combination of acupuncture and antiemetics,  electrical acupuncture plus antiemetics,[320] acupuncture alone (no sham group),[321-325] acupuncture plus point-pressure.[326] While only the studies by Enblom A (2011) [327] and Enblom A (2012) [328] compared the acupuncture and sham acupuncture. These two publications however seems to be the same article.

As for acupuncture treatment, the acupuncturists in the Western countries basically used single Neiguan point for the treatment as well (most of articles are as such). The acupuncture was done only twice a week, once to twice per week, or 3 times per week.  Only one paper stated the use of acupuncture every day for 5 days.  From the view of acupuncturists in China, the stimulation dose is not enough. 

On the other side, acupuncturists in China tend to use multiple acupuncture points, such as Zusanli, or Yongquan points, for the treatment, rarely using single points. They also tend to use point injection, [329-334] electrical acupuncture,[335,336] or TENS,[337]or acupuncture plus auricular pressing plus antiemetic.[338]  No matter for the Zusanli point injection, or electrical acupuncture, or long time TENS, or multiple point injection, all suggest that acupuncturists in China realized and tended to apply higher dose of simulation to the acupuncture point for the treatment, than those in the Western countries.  

As for the treatment of nausea/vomit after anesthesia, that of nausea/vomit during chemotherapy or radiation therapy is also a new topic to the acupuncturists in China. Because the fact that the side effects due to the chemotherapy and radiation therapy are not only nausea/vomit, but also bleeding, infection, extreme fatigue, depression, insomnia, bone marrow suppression (reduced blood WBC, anemia, bleeding, etc.), the aim of the treatment should consider and include all of these side effects the same time. So, how can we expect a single acupuncture point and one or two sessions of acupuncture treatments would be sufficient to solve all of these side effects? If we do not think things as the acupuncturists in China did, and try to solve all of these side effects the same time, the treatment of nausea/vomit alone may most possibly not be successful.

2.7.3. Nausea/Vomit during early stage of pregnancy

Matthews A (2015) [339] collected 55 articles about acupuncture treatment of nausea/vomit in early stage of pregnancy. From these articles, the author had chosen 27 articles for review. Among the 27 articles, only 2 articles are acupuncture study. Others are using Fresh-ginger press (10 articles), finger-press (5 articles), TENS (1 article), auricular press (1 article), moxibustion (1 article), Vitamin B6 (2 articles) and antiemetic (6 articles).

Among the two articles using acupuncture, one is from Knight B (2001). [340] The authors used multiple acu-points, twice a week for two weeks, then once a week for another two weeks. The authors reported no difference for reducing the nausea/vomit rate between the real acupuncture and sham acupuncture.

Another one is by Smith C (2002), [341] using acupuncture the same frequency as above. The author reported that the healing effect by using multiple acu-points works better than single point (Neiguan point), and much better than the sham group and the no-treatment group.

These two studies used the typical Western style acupuncture: twice a week, less than 10 sessions. As we suspected before that the healing effects would be variable between studies. With such way of acupuncture, some study works and others may not.

When we see how acupuncturists in China solve this clinic problem, we again found that they tend to use multiple acu-points, and more importantly, they do acupuncture once a day, [342-349] and reported much higher success rate. However, we cannot tell if such higher healing effect is better than a sham acupuncture, since as for most clinic studies in China, they did not design sham group as control.

Apparently, to treat nausea/vomit in any of these three clinic conditions, acupuncture in Western countries tends to perform acupuncture based on single acu-point Neiguan. Rarely did they use other acu-points. The reason might go back to Dundee JW (1989). [350] Dundee reported that, upon visiting in China, he noticed that Chinese doctor asked patient to press acu-point Neiguan to solve nausea/vomit in early stage of pregnancy. Since then acupuncture researchers in Western countries knew that to press Neiguan might be able to release nausea/vomit and they then tried this technique on all kinds of clinic conditions with nausea/vomit. What they did not know is that acu-point Neiguan is not the only acu-point that are used by acupuncturists in China to solve nausea/vomit, and that difference reasons of nausea/vomit might need different acu-points, or in a combination of the acu-points, for the treatment.

Using single point as Neiguan may be good enough for the nausea/vomit after anesthesia, but apparently not enough for that in early stage of pregnancy and during chemotherapy or radiation therapy. The nausea/vomit is due to the use of anesthesia medicine (side effects). Along the time pass, blood concentration of the medicine in blood will reduce (usually within 24 hours) and the nausea/vomit will subside. One time with single acu-point might be good enough, along with subside of the anesthesia medicine in blood, to stop the nausea/vomit. However, the nausea/vomit in pregnancy is due to the disorder of hormones in the body that could last for several weeks or months. The nausea/vomit in chemotherapy and radiation therapy is due to the side effect of the highly toxic therapies. The chemotherapy has to be used several days in a roll, and repeated again and again. Radiation therapy is once each time but the toxic material from damaged and dead cells needs several days to excret out of the body, which is the reason to cause nausea/vomit. Therefore, to expect a one-time acupuncture with a single point stimulation for 20 to 30 min is too optimism to the acupuncture treatment.

Brief summary:

(1). The way of acupuncture by acupuncturists in the Western countries and in China are largely different: the former tend to perform acupuncture 1 or 2 times per week and for totally less than 10 times (sessions), while the later tend to do it 5-6 times per week for more than 10-20 sessions. Acupuncturists in China tend to use much higher ADD of first course and TCD of acupuncture stimulation than those in Western countries.

(2). In acupuncture studies in Western countries, the healing effect of acupuncture is about 35%, with only about 10% higher than the sham acupuncture group. A large amount of positive reports about acupuncture and also a large amount of negative reports about acupuncture co-exist in the literature. In China, the healing effect of acupuncture group is usually more than 45% and the difference between the acupuncture group and sham group (if any) are significant. Even so, the ordinary acupuncture in Chinese literature is not the main form, neither the best form, of acupuncture. It is usually used as a control to test more efficient acupuncture form (modified acupuncture technique).

(3). The healing effect of acupuncture may be related to the ADD of the first course and the TCD of acupuncture.

(4). Acupuncture works better in neck pain, low back pain, menopause syndrome, than in migraine or tension headache, currently, both in the Western countries and in China.

(5). For the same clinic disorder, say nausea/vomit, acupuncture has to be down in different ways, according to the reasons that cause the clinic disorder. 

(6). Attention needs to be paid to acupucture stimulation doses, especially when a single acupuncture point is used.

Chapter 3: Placebo effect in acupuncture treatment/ researches

3.1. Commonly used placebo groups

The aim of the acupuncture research in China is to find better way of acupuncture, than the ordinary way of acupuncture (traditional way of acupuncture), in the treatment of various obstacle diseases, rather than to see if acupuncture works or not, or if acupuncture is a placebo effect or not. To them, to say that acupuncture is a placebo effect is absolutely not acceptable, and unbelievable. Therefore, they do not include any sham acupuncture group, even not a non-treatment group, in their acupuncture researches. What they did is to compare the healing effect of a special form of acupuncture (modified acupuncture group) with ordinary acupuncture, or ordinary acupuncture with Western medicine.

Because the healing effect of acupuncture in the acupuncture researches in the Western countries (about 30%-40%) is close to the sham acupuncture group, it is no wonder that it is doubted if the acupuncture effect is a placebo effect. To clear this suspect, researchers there have tried various ways and tested a lot of kinds of sham acupuncture groups, with the aim to let the sham group exercises a placebo effect, but not at all any healing effect. In the sham group, patients were pretended (hinted) to get a similar procedure as real acupuncture, but actually they did not get it. Researchers are with the hope that any healing effect in the sham group would be reasonable to be contributed to a placebo effect.

There are various kinds of sham groups. For example, in a sham group, acupuncture needles were inserted into a non-point (point that does not belong to commonly believed acupuncture point) and avoid a Deqi feeling (so called acupuncture sensation by the patients). Or, the acupuncture needles were inserted into the acu-points but only very shallow, or the needles used in blunted, not sharp; or use tooth-picks in dead of an actual acupuncture needle. Others may use fake laser, fake TENS, or fake electric acupuncture, or TENS (transcutaneous electrical stimulation) etc.

 

3.1.1. Inserted sham (inserted into non-point)

In inserted sham group, the acupuncture needle was inserted into either acu-points that belong to different meridian (the other-point), or into some points that do not belong to any currently known meridian lines (the non-point). The non-points are used mostly by acupuncture researchers in the Western countries, and the other-point, mostly by those in China.

The precondition to use the non-points as sham is that the stimulation of a non-point will not create any healing effect. Any healing effect after stimulation of the non-point can be contributed to a placebo effect. The question is: how do we know that the non-point has no any its own specific healing effect, beside of the placebo effect? When and who has tested the credibility of the non-point before it was used as a sham point? [353]

There are several different ways to choose acupuncture point for the acupuncture treatment. The way introduced in acupuncture text book(s) is only one of the ways. It cannot be excluded that the acu-points used in a sham group still bear healing effect in some other acupuncture systems. This concern has been expressed by other researches as Liu WH, [361]  Lund I (2009),[362] Lund I (2006), [363]  White PJ (2004), [364] and MacPherson H (2014). [365]

 

3.1.2. Inserted sham (inserted in acu-points, but in shallow)

In some sham group, the needle was inserted into the same acu-points as acupuncture group, but shallower than the acupuncture group. [366-368]  Because the shallow stimulation is also a kind of way of acupuncture in China and in Japan [369,370] this sham is neither a proper sham group. [363, 371]

3.1.3. Light-touch sham (non-inserted sham)

In this sham group, the needle used is blunt needle, not typical sharp needle in acupuncture group. Therefore, this kind of sham is believed by most researchers as a proper way of sham, [372-376]though its credibility is also questioned by others. Because currently, most acupuncture researchers still believe that it is due to the variation of the use of sham needle and the choose of non-point that cause the conflict in the acupuncture research results, many people still pay their much attention to develop proper sham needles and to standardize the design of sham group.[378]

The non-inserted sham can also be separated into non-touch or skin-touch groups. Study showed that no difference between two groups in the reduction of pain level in health volunteers.

 

3.1.4. TENS and laser stimulation

Grant D (1999) [379] used TENS as a sham in acupuncture study. TENS per se can exert healing effect and it is one of ways used in physiotherapy in the Western countries, [380-385] so it is not at all a good sham for acupuncture study. It can only be used to compare the healing effect between the two therapies: TENS and acupuncture.

This is also true to use laser as sham in acupuncture research. Laser is also a kind of therapy, [386-388] similar to the finger press on acu-points, or reflexology. As for TENS, the laser is not at all a proper sham in the acupuncture researches. Also as TENS, the laser group can only tell if the laser therapy works better than acupuncture.

 

3.1.5. Acupuncture on non-points but with electric stimulation

In some sham group, the acupuncture needles were inserted into non-points and it is connected with electrical stimulation.[389] In this group, the electrical stimulation certainly increases the possible specific healing effect of the needle. 

 3.1.6. Fake TENS, fake laser, fake magnetic, and fake intradermal needle stimulation 

Another groups of sham is to use TENS but no electric is connected,[17,390] or use laser but no laser energy is given,[391] use magnetic patch but no magnetic contained,[392]  use electric acupuncture but no electric conducted,  use intradermal needle but the needles were not inserted,[393]  or use fake massage technique [394] etc. These kinds of sham groups might be relatively proper to be used as a sham in acupuncture study.

If we put the data all together from above Colquhoun D, Madsen MV(2009), Vicker AJ (2012), Linde K (2009), [27,28] Azad A (2013),[395]  Moffet HH (2009) as well as from other sources,  we can separate all of these sham groups into three major categories: inserted (in which the acupuncture needles were inserted into the skin) , non-inserted sham groups (in which no anything has been inserted into the skin, such as those fake sham), and sham plus others (such as sham group is used together with other therapies, such as medicine, physiotherapy, or doctor-guided exercise,13 etc.). By this way, we can make a preliminary summary of the extent of the different sham group in the acupuncture studies. It is found that, the extent of the healing effect by inserted and non-inserted sham is pretty much the same, say, 23%. Once the sham is contaminated with other therapy, of course as expected, the extent of the healing effect (the sham plus others) will be higher, up to 30.9% (Attached list 14 and Fig. 17).

Placebo.Fig.17

Fig. 17. n = experiment groups.

That the similar extent of the healing effect in the inserted and non-inserted sham groups suggests that, even if it is overall believed that the stimulation of non-point might yield some extent of healing effect, and that the heterogeneous of sham groups used in acupuncture studies may affect the conclusion of the review, [416] it appears not to exert dramatic effect. Also that the healing effect from the inserted and non-inserted sham suggests that the loss of the significant difference between the acupuncture group and the sham group may not be possibly due to too high effect of the sham group (but due to too low effect from the acupuncture group).  Other researchers also expressed similar opinion. [417] In clinic, if the dose of stimulation is not sufficient enough, such as very shallow needle acupuncture, similar to the shallow stimulation sham group, the healing effect is not dramatic (see later). 

It is easy to understand that the healing effect of the sham-plus-others group shows higher number, since the extra healing effect is contributed by the "other" therapies that are commonly used in clinic practice too. For this reason, we have to and have had separate it from the pure sham groups that do not contain any other therapies in it.

3.2. Sham group in other medical systems

3.2.1. Healing effect of sham group in Western medicine

Placebo effect will happen not only in acupuncture treatment, but also in the treatment by all most all the medical therapies including Western medicine drugs and surgical operation, and so on, whenever the patients are in clear mind condition and have mental ability to accept a physical or emotional hint, to and to believe the hint.

As early as year 1955, there was report that during Western medicine treatment, the placebo effect can come up as much as 35.2%.[418] We found a complementary website about the Western medicine (http://www.druglib.com), which, as claimed by the owner of the web, only collects the "well designed studies on Western medicine". From this website, it is found that majority of the clinic studies on Western medicine drugs do not contain a sham group (Attached list 15 ). For example, in the research on the pain-killer Acetaminophen and Oxicodone, only half of the studies contained sham groups. In the studies on antibiotics, the number of the sham groups is further less. For example, in the clinic studies on Penicillin, there is only 6.7% of studies contained a sham group. In the studies on chemotherapy drug Fludora, the number of sham is also very little: 5.7% (Fig. 18). 

Placebo.Fig.18

Fig. 18. n = number of published articles.

This means that in current CLINICAL medical studies in Western medicine, the inclusion of a sham group is not at all an obligated requirement to be as a "high quality designed study". This is true especially when the study is to test a clinic healing effect of a new drug. The new drug group is compared with that of an old or a currently used drug, which is used as a control. A sham group or a non-treated (waiting list) group are usually not designed or included in the study.

It has been reported that about 35% to 39% of patients may feel less pain by a placebo effect only, [419,420]  or 38.4% of patients could feel less depression. [421] A placebo effect only can reduce the pain by 15.9%,[422] 18.6%,[423] 18.9%, [424]  20%, [425,426] 20.6%, [427] 28.2%, [428] 39.6%. [429] From another point, it is estimated that the healing effect of about 80% of anti-depression drugs can be explained by a placebo effect. Because so high placebo effect, about half of the clinic studies on anti-depression drugs failed to approve its unique (specific) anti-depression effect and so being knocked out.

It was said that such placebo effect is increasing in past several ten years. It is also believed that the increasing placebo effect might also be due to the advertising campaigns through medians to collect people in the medical studies. [430]

We collected some Western medicine studies that contain sham group (Attached list 16). By calculation, it was found that the average placebo effect in Western medicine clinic studies is about 31%±18% (n=22) (Fig.17).

 3.2.2. Sham in surgical operation therapy

For a long time, it was not expected that there might be a placebo effect in the surgical therapy. However, a sham surgery could bring the pain level down by 29.6% [431] or 36.1%, [432] in patient suffering from osteoporotic vertebral fractures or to reduce migraine pain by 57.7%. [433] It was found that except of very little number of clinic studies, the sham group was not used or involved in majority of surgical studies[6]. Sham group was only used in animal studies mostly, not human being clinic study stages.

Wartolowska K (2014) [434] collected 2969 articles that contained sham group. After exclude some articles that do not meet the need of the review standards, eventually he could use 53 articles for review.

Among the 53 articles, 74% was published after year 2000. In majority of the articles, the diseases that studies were not severe diseases, or they are not so severe to risk the life, such as heavy obesity and esophageal regurgitation. The most studied is endoscopic surgery. In most articles, the mark for the healing effect is patient's subjective mark, such as pain level changes (32% articles), symptom or functional change (32%), or the change in quality of life (15%). 42% of articles used objective mark for the healing effect evaluation. Most studies involved small number of patients, between 10-298 patients, as an average of 60 cases in a study. No any article studies placebo effect in an open surgery, such as open abdomen surgery, open chest surgery, open brain surgery or other surgery than needs large area of cutting of skin. 49% of the articles reported that the healing effect of surgical groups was higher than the sham surgery group, while 51% of the articles reported that there was no significant difference between the two groups. Generally speaking, even if the healing effect in the surgical group is higher than that in the sham group, it is not a big high.

The review of Wartolowska K (2014) clearly tells that the number of articles that contain a sham group to test the effectiveness and necessity of a surgical operation is very little. The author believed that for a typical surgery that needs a big open of skin, such as open-chest, laparotomy, craniotomy, and other similar surgeries, the involvement of a sham group bears very big risk to the life of patients, but for current and future patients, and for the sake of insurance companies and government whoever need to pay the huger costs for the surgery, it is still needed to test the reality, certainty of these surgical operations by using a sham group and a non-treated group. 

With more collection of data in surgical studies (Attached list 17) , we can calculate the healing effect of the sham surgery group as 37%±18%(n=16)(Fig. 17). If we cannot make a conclusion, based on the current data, that the placebo effect in a sham acupuncture group is less than those in sham medicine or sham surgery group, we can say that the healing effect of sham acupuncture group is not more than those in the latter two sham groups.

Hennessey S (2012) [418] made a thorough discussion on the history of sham group in the researches on Western drugs and surgery. He wrote on his webpage:

"History shows that many standard medical treatments were never initially subjected to blind controlled studies. The list includes: episiotomy, carotid endarterectomy, and hormone replacement therapy. Treatments which were commonly administered when finally studied have been shown to be not only ineffective, but in some cases as deadly as the diseases they were intended to advert. These include tonsillectomy, hysterectomy, frontal lobotomy, and radical mastectomy. They also include x-­ray screening for lung cancer, proton pump inhibitors for ulcers, high-­dose chemo therapy for breast cancer, and the stent as a prophylactic procedure to prevent cardiac death While doctors may espouse the mantra of evidence-­based medicine, much of what they do has never been examined by a blind scientific study."

"There are long lists of surgical procedures that have become the standard of care without ever being subjected to controlled research. A recent search of the ClinicalTrials.gov database revealed that studies using a sham control are infrequent, with only 465 of 9553 device trials actively recruiting protocols or 4.8% involving a sham control. Medical journals are filled with reports of procedures that are introduced into general practice without the RCT and without any sham procedure to account for efficacy. For a drug the FDA asks only that manufacturers produce evidence that their product is more effective than a placebo. With a device manufacturers must only show it performs as well as an existing device. The FDA does not exclude poorly conducted research; that is the aim of peer review. Nor does the agency have much control over academic research or doctors, though patients often believe otherwise, assuming the FDA has vetted a product for efficacy and safety."

 ……

 "Surgical studies that actively evaluate a procedure like this are rare [435] because of cost, ethical considerations, and enticing patients to enroll. No one wants to do them; not doctors, patients, or university researchers, and nor does any group have an incentive to pay for them, leaving the bulk of surgical procedures and without ever have been subjected to the gold standard of the blind controlled study. "

"Another example is spinal fusion. " Spinal fusion may be the radical mastectomy of our time, “writes Groopman, both a doctor and recipient of a spinal fusion, and also author of How Doctor’s Think. Spinal fusion is a common procedure. More than 150,000 lower lumbar spine fusions were done in 2006 at approximately $42,000 per surgery, not counting follow up care. This procedure involves removing the spinal disc and bracing the spine with rods and screw; an effective surgery for people who have had spinal problems, but not always a solution for chronic back pain. This is a widely performed procedure with no substantial body of supporting medical evidence. While X-­Rays, MRI, or CT scans often show some architectural problem such as a disc protrusion or spinal degeneration, the source of pain is often undetermined. Typically back pain improves within two to seven weeks without specific therapy. With a disc protrusion, eventually the disc will retract on its own, stop pressing on the nerves, and the inflammation will subside. For the majority of patients with chronic lumbar pain, fusion surgery has no positive impact on either their pain or their function. Both groups, those who elect to have surgery and those who opt out of surgery, improve substantially over a two-year period. So is a lumbar discectomy an expensive sham procedure or placebo for someone suffering from a lot of pain? When researchers dismiss acupuncture as an ineffective procedure for disc problems or general back pain, this should be reviewed in the larger context of how ineffective most interventions are for back pain. A series of acupuncture treatments for two years incur significantly less physical hardship and less health care dollars than an ineffective discectomy and spinal fusion. "

3.2.3. Healing effect of hypnosis or similar therapies

Placebo means that the person gets a "cheated/hinted" stimulation suggestion while the person does not actually get that stimulation. Hypnosis is however a clear suggestion to the person and clearly suggest the patient to image a result on his/her body. The similarity between the placebo (through sham action) and the hypnosis is that both aim to affect the body condition through a person’s emotional believing, while medicine, surgery, physiotherapy, chiropractic, and acupuncture, is to influence body function in physical level.  

Not many articles about the healing effect of hypnosis can be found online. Based on the articles we can reach [436-449] (Attached list 18 )it was found that the healing effect of hypnosis is 39.6%±19.0% (n=14). If we include some other therapies similar to hypnosis, such as CBTAlpha-feedback, the average healing effect is 32.8%±20.0% (n=20). This result suggests that the maximum extent by which an emotional believing or a spiritual imagination can exercise on a physical body is between 32% - 39%, similar to that by a sham surgery. It also means that, with either a positive suggestion through a hypnosis-like process, or a placebo, the maximum healing effect will be around 40%.

3.2.4. Sham group in a physiotherapy

Physiotherapy is very common in the Western countries. It includes the use of laser, TENS, ultrasound, massage, or special exercise, etc.[7]

We collected from Medline using key words "physiotherapy" and "placebo" or "sham", along with more source, and got totally 31 articles (Attached list 18a )

It was found that the average amount of the healing effect of sham group in physiotherapy (mostly in the form of sham laser and sham TENS) is 20.1%±14%, while the average healing effect of physiotherapy per se is 44.6±21% (Fig. 18a).

In the study of physiotherapy, majority of articles with the sham group supports the healing effect of the physiotherapy over a sham. 

 Placebo.Fig.18a

Fig. 18a. n = number of experiment groups.

How comes there are more positive reports about physiotherapy over a sham and the difference in the healing effect between a treatment group and a sham group can reach a statistically significant in most of the articles? Considering that the healing effect of sham group in physiotherapy studies and that the healing effect in acupuncture studies are pretty similar in extent (23%, see Fig. 17 for acupuncture), the reason here might be due to higher healing effect by the physiotherapy. By check the frequency of the physiotherapy treatment, it was found that, in the physiotherapy studies, most of articles (58.4%) performed the treatment 3 or more times per week. In about 39.6% of the articles, the physiotherapy was performed once a day (Fig. 18b) .

 Placebo.Fig.18b

Fig. 18b. n = experiment groups.

Why most of the studies on physiotherapy took the schedules of once a day or once every other day, while most of studies on acupuncture took the schedule of once or twice a week, by the Western researchers? 

Upon a summary of the healing effect on chronic non-specific low back pain by the TENS physiotherapy, it was found that the healing effect of a sham TENS group did not increase along with the increase in treatment frequency, but that of physiotherapy treatment group did (Fig. 18c).

Placebo.Fig.18c

Fig. 18c. n = experiment groups.

3.2.5. Sham group in chiropractic

Chiropractic and massage are the two major alternative therapies in Western countries. The chance to patients to visit acupuncture clinic is much less than they visit chiropractic and massage. [489-491]

There are also more payments to the health cost, by insurance companies, on to these two therapies. There is a survey by journal Consumer Reports in year 2011.[492] It found that for patients suffered from back pain, 36% visited chiropractic, 24% tried massage, and only 8% tried acupuncture. Similarly, for patients suffered from headache or migraine, 15% tried the chiropractic, 14% tried massage, and only 7% tried acupuncture before. Acupuncture is not so popular in the Western countries, even not in Taiwan, as a well-known alternative therapy. 

However, it is surprised that there is very little studies on the healing effect of chiropractic, or massage, comparing with that on acupuncture. [8] It is even much little for the number of studies that contain a sham group. [9]

From the articles that we can reach, after excluding those that involve too little number of participants, or the studies that have not been finished, or the studies not aimed for healing effect comparison, we can get total 20 articles only (Attached list 18b ).

It was found that the healing effect of the sham group in the chiropractic is 17.3%±16% (n=12, when the sham is fake chiropractic), or 19.6%±9.0% (n=4, when the sham is fake TENS or fake ultrasound). The healing effect of the chiropractic alone is 23.3%±14% (n=19)(Fig. 18d).

Placebo.Fig.18d

Fig. 18d. n = number of experiment groups. Sham (other form): sham ultrasound, sham laser,or sham other form of instrument.  

Check attached list 18b, it can be found that the number of the healing effect for chiropractic is generally low. It is rare that the symptom-reducing effect could reach more than 40%.

Placebo.Fig.18e

Fig. 18e. n = experiment groups.

However, compared with physiotherapy and acupuncture, the chiropractic might be more depending on personal skill for a good healing effect. The stimulation dose in physiotherapy can be standardized by using the same instruments (TENS or laser) with the same stimulation parameter. The acupuncture treatment can also be relatively standardized by the use of electrical acupuncture.  For chiropractic, if the personal skill is not high enough and if the treatment frequency is also low, the chance of failure for the treatment would certainly be high. According to our own experience and response from our patients who visited chiropractic before, the personal skill of chiropractic practitioners are largely variable.

 

3.3. Comparison of sham effect in various therapies

3.3.1. Comparison in size of difference sham groups

Now we can pull all of sham groups discussed above together (Fig. 18f).

 Placebo.Fig.18f

Fig.18f. n = experiment groups. * Laser or TENS used in physiotherapy studies.

It can be seen from the Fig. 18f that the healing effect of sham groups in either sham acupuncture (inserted sham or non-inserted sham), sham physiotherapy and sham chiropractic is no more than 25%. It is about 31% in sham Western medicine, 37% in sham surgery, and in hypnosis, 39.6%.

The healing effect in the sham pill here is similar to that reported by Beecher HK (1955): [511]  35.2%±2.2%.

Inserted or non-inserted sham groups

Now, what we concern is if the healing effect of the inserted and the non-inserted sham groups are the same, and if that between the sham acupuncture and sham pill is the same. 

To answer these questions, we have to be careful if the comparisons are from a review study comparing different experiment groups, or if they are compared within the same study. It is already known that, the placebo effect of a sham medicine might be different with different ways of giving, such as oral, or injection, or skin application.[512,513]

Madsen MV (2009) have demonstrated that the type of placebo acupuncture employed in studies has no significant effect on efficacy in pain trials whether or not the needling is shallow, incompatible with the principles of TCM, or even entirely nonpenetrating.

Chen H (2016) [514] by review, found that inserted sham acupuncture group tended to have the lowest tendency of positive conclusions (to support acupuncture healing effect) was observed (37.8% of reviewed articles), compared with non-inserted sham acupuncture group (53.3%), suggesting that the type of control is likely to affect the conclusion in acupuncture analgesic trials. It is not known if they included data from China or not.

White P (2012) [515] compared 2 types of sham needles (Streitberger needle and mock transcutaneous electrical stimulation to acupoints via electrodes fixed to the surface of the patient’s skin). No significant difference between these two groups in the healing effect of osteoarthritis pain.  

Yeung WF (2011) [516]  compared the healing effect of inserted sham and non-inserted sham in the treatment of insomnia. The treatment is three times a week for total three weeks. The effect of non-inserted sham is 12.8% and that of inserted sham is 24.8%. The difference is very small and both are in a low level.

Current data suggest that, even if the inserted sham procedure exercised some level of specific healing effect (beyond the placebo effect), such effect is as small and limited as to be compared with that of a non-inserted sham group. The specific healing effect of the inserted sham may not be the major reason to cause the loss of significant difference between acupuncture group and the sham group. Therefore, it can be predicted that the loss of significant difference between an acupuncture group and a sham acupuncture group is not due to the kind of sham group used, but to the low healing effect of the acupuncture group. In consideration of this, we may suggest to use the inserted sham group, so as to avoid the procedure of blind and the complex of study design.

Sham acupuncture versus sham pill

Linde K (2010) [517] believed, in his review, that the sham effect in an acupuncture study might be larger than those associated with pharmacological and other physical placebos. 

de Craen AJM (2000) [518] reported, in their review, that injected sham medicine worked better than oral sham medicine (32% vs 26%).

Meissner K (2013) [519] also reported, in a review study, that the healing effect of sham acupuncture and sham surgery is higher than sham pill.

Fässler M (2015) [520] analyzed 12 articles that compared the healing effect of different sham groups. They found that 7 articles showed no difference among the sham groups compared, only 4 articles showed only one index with difference, and 1 article showed the difference for the entire index monitored.

Thomas M (1991) [521] compared the healing effect of acupuncture, sham acupuncture, medicine, and sham medicine in the treatment of osteoarthritis. They found that the healing effect of sham acupuncture is higher than sham pill.  

Kaptchuk, TJ (2006) [125] compared sham acupuncture (133 cases) and sham pill (133 cases) for the treatment of far arm pain. Sham acupuncture was twice a week, and the sham pill is one pill per day. The research assistant checked the patients once every two weeks for their medical conditions. After 6 weeks, the pain level in the sham acupuncture group (60 cases) reduced by 36%, and that in the sham pill (59 cases), by 22%. The study suggested that the placebo effect in the sham acupuncture might be larger than the sham pill.

Whether the sham acupuncture has larger placebo effect than sham pill bears importance meaning. If we compare the healing effect of an acupuncture group with conventional medicine, as most of Chinese researchers do, we have to ask if the higher healing effect in the acupuncture group is due to larger placebo effect in it.

To answer this question, we have to know that there are too many factors influencing the placebo effect (see below). There could be a theoretical comparison or a practical comparison. For the theoretical comparison, everything should be kept the same in both sham groups, except using sham needle in the sham acupuncture group and sham pill in the sham medicine group, including the treatment frequency, the sessions to see the doctor, the background of the doctor, even the sex of the doctor, etc. For the practical comparison, the sham acupuncture is performed as in acupuncture clinic by acupuncturist, 1 to 2 sessions per week for 10 sessions (Western style), or 5-6 sessions per week for 20 sessions (Chinese style), and the sham pill was given to the patients, taking it three times a day, for 10 or 20 days. This is because the size of placebo effect in the sham acupuncture groups might also be difference depending on its treatment frequency and total number of sessions. In the Fig. 18f, it is showed that the effect of sham acupuncture is lower than the sham medicine. It might be due to the inclusion of many sham acupuncture groups that were performed in high treatment frequency. 

 3.3.2. Variations of placebo susceptibility

Thought it can be seen that the average sham effect is pretty stable among sham acupuncture (inserted or non-inserted), sham TENS, sham laser, or sham chiropractic, all around about 23%,  the variations of the sham effects among studies are very large. For inserted sham acupuncture, it is from 2.6% to 59.1%; for non-inserted sham, from -3.8% to 55.6%; sham chiropractic, from -2.0% to 59.1%; sham physiotherapy, from -5.4% to 50.0%; also for sham medicine, 6.0% to -58%; and sham surgery, from 10.0% to 70.0%. All suggest that different groups of participants or different nations might have difference level of placebo susceptibility.[10]

The large placebo susceptibility among groups can also be reflected as reactor rate. Normally, it means the percentage of participates who got more than 50% of symptom reduction after a placebo hint.

Beecher HK (1955) reported that the placebo reactor rate is  35.2%±2.2%. This means that there was about 35.2% of participants got their symptoms reduced by more than 50%. 

Dorn SD (2009) [522] stated in a review that among the patients taking herbal medicine for the treatment of IBS, the reactor rate is as average 42.6%. However, the reactor rates among articles are very large and the reactor rate to an herb therapy seems the same as to a sham pill.

Peciña M (2015) [523] reported that the reactor rate in participants taking part in the anti-depressive drug experiment is 31-45% and this rate seems increasing in recent years.

 

3.3.3. Influence of the healing effect of a sham group to the evaluation of specific healing effect of an acupuncture group

It should be pointed out that the healing effect of sham acupuncture is 23% in our article here, while that reported in the Colquhoun group is about 33.4%, with more negative papers against acupuncture healing effect. Such higher sham effect certainly tends to reduce the difference between the real acupuncture group and the sham group, to cause negative results in acupuncture study. Is there any relationship between the higher sham effect and the higher chance to yield negative results in acupuncture researches?

After pool all the data so far we discussed above, we found that when the healing effect of a sham acupuncture group is low, there is higher chance to result in a positive result to support a specific healing effect of acupuncture treatment. [11]  This is a similar phenomenon as in Western medicine studies, in which the specific healing effect of a drug can be easier to show up when the healing effect of the sham group is low. [524,525]

If we separate the articles by using the 23% of healing effect in sham acupuncture group, it is found that when the healing effect of a sham acupuncture is below 23%, 75% of such articles showed positive results, while if that is more than 31%, there would be also 75% articles giving negative results.

This means, when the healing effect from a sham acupuncture reaches and more than 23%, it comes into an alert zone to get a negative result. After it reaches and becomes more than 31%, it comes into a high risk zone to get a negative result in acupuncture studies. In the risk zone, if the healing effect of the acupuncture is not brought out for some reasons, such as with low frequency of treatment schedule, it would be much easier to fail in acupuncture study (Fig. 18g). 

Fig.18g.

Of course, this is preliminary summary for the acupuncture studies in the Western countries. It may not be the same with acupuncture studies in China.

The healing effect of sham acupuncture groups in the five articles cited by Colquhoun D, such as Linde K (2005),[12] Melchart D (2005), Haake M (2007), Witt C (2005), Cherkin DC (2009), [526]  are all more than 23%. Among these articles, the Linde K (2005), Melchart D (2005), Witt C (2005)  belong to the same research groups (in Germany) and they all performed acupuncture twice a week.

 

In our article here, there are 8 articles that are from Germany, all of which had healing effect of a sham acupuncture group over 23%, belong the "high risk zone". If we include these articles into a review, it would not only reduce the difference between the acupuncture and the sham acupuncture group, but also lend to a conclusion that sham acupuncture might be higher than sham pill.

What makes that the Germany group had such higher effect of sham acupuncture group? Is it due to higher placebo constitution of Germany population, or to the fact that these studies were supported and paid by insurance companies in Germany, so that the study participants might tend to give an exaggerated comment to acupuncture healing effect? It is hard to tell at this movement and it is beyond the scope of discussion in this article here.

Now that the healing effects of sham acupuncture groups are so largely variable among studies, which study result we should trust most? Should the result of the study with low healing effect of a sham group or that with high healing effect of a sham group be accepted?

Now that we aim is to test if the acupuncture is a placebo effect and how high the specific healing effect of an acupuncture therapy is, we may had better to exclude off the placebo effect from acupuncture study. Can we separate the population with high and low placebo effect and perform acupuncture treatment separately? Can we have a pre-test phase [527-530] to find out those of proper participants who got less than 30% of symptom reduction after a 3-4 weeks of the sham acupuncture treatment?

If we still take a more than 50% symptom improvement rate as a mark to separate placebo reactor or non-reactor [531] we may tend to include more reactors into the following randomized sham group to increase the healing effect of the sham group. The primary aim to exclude the influence of high sensitive reactor from acupuncture study will fail.

 

3.4. Characteristics of placebo

A lot of factors could affect the extent of the placebo effect. It was found that people in sick showed higher response to a placebo implication [532,533] than people in healthy; that patient with acute disease have higher placebo response than those with chronic disease [534]; patients with pain have stronger placebo effect than healthy people with experimental pain [535-537] and that patient with stronger pain has higher placebo response than those with less level of pain.[538] This might be because those patients have higher expects than others to get better sooner. For this reason, the results of studies on a healthy person may not exactly be the same on a patient,[539] so that we typically do not involve the data from healthy persons into our evaluation and discussion in the article here.  

Placebo effect is easier to occur in a study with more experiment groups,[12] or in a study with higher treatment frequency, or with variable treatment frequency. It is also easy to occur in a study, in which the participants come from advertising, rather than from recommendation from doctors. [407]

The less the severity of a disease, the higher the effective rate of a tested drug (the difference between the effective rate of the tested drug and that of a sham group), [407] though this might be conflict with other's finding.[540] The higher the rate of completion of a study, the lower the effective rate of a tested drug. [407]

The higher the completion rate of a study, the higher the healing effect of a sham group, so less the rate of specific effect of a drug. This was believed to be due to the patients who finished the study got more placebo hint. [407]

The longer the patients were with a doctor, and the more times the patients to visit his doctor, the higher the placebo effect in those patients [522]

The more times the hints, the less the reduction of symptoms. [511]

Highly compliant patients may have better outcomes than noncompliant patients, even when complying with a placebo. In a randomized trial to evaluate the efficacy of lipid-lowering drugs in the therapy of coronary heart disease, patients in the placebo arm were divided between those who were highly compliant (took at least 80% of placebo capsules) and those who were less compliant (took less than 80% of capsules). [541]

People of different culture background may have different placebo effect.[542]

The same kind of sham treatment may have different effect rate in different disease conditions. [549]

It is believed that the healing effect of a sham group might be higher in actual clinic condition than in experiment condition. This is because under experiment condition, the patients were told that they would have 50% chance to be allocated into a sham group, e.g. their expect to have a real treatment would be 50% less than in an actual clinic. [542]

The sex of a doctor can also affect the healing effect of a sham group. If the sham acupuncture is performed by a female acupuncturist, the patient would be more ready to believe it is a real acupuncture, not a sham.[543]

 The warm care from doctor also increases the placebo effect.

Wise RA (2009) [545] reported that, if give patient more hint stimulation (enhanced placebo stimulation), the healing effect can be increased in the sham group, but not in the acupuncture group. [546]

It is interesting that even if patients are aware that they are to receive an inert pill, they are not likely to expect symptom improvement. A study of open-label placebo administration in irritable bowel syndrome (IBS) was recently undertaken. [547] Investigators truthfully informed subjects that they would be receiving an inert pill but they explained that a significant body of research has documented patient improvement with the same placebo treatment. This study demonstrated a significant improvement in symptom reports following placebo administration as compared to usual care, despite patients’ knowledge that they had received pharmacologically inert pills. This proof-of-concept trial demonstrates that the placebo response can be evoked as long as its use is paired with convincing rationale. [548]

The extent of the placebo is also related to the years in which the article was published, since 30 years ago, the placebo response of the public appeared lower than nowadays. Patients who come through an advertise showed clearly higher rate of placebo effect than those who come from recommendation of a medical clinic. All of these factors make the current clinic study easily be denied due to the placebo effect. [549]

Dutile S  (2014) [550]  have had a summary for the personal characteristics of the high-placebo person: easy to feel anxiety, self-concentrated, like to talk, sensitive to spiritual information, like to have social activity, extrovert personality, easy to be affected by others, younger.  

The factors that could influence the occur and the size of placebo effect are multiple, from personal characteristics, the kind and the status of a disease, the way of hint, the times and the frequency of the hint, the success rate of initial hint (or treatment), to the personal influence of the doctor or practitioners, etc. The final size of the placebo effect is the comprehensive results of so many various aspects.

All of the factors work together to bring out the person’s believe and expectation to the hinted outcome.

However, it should be pointed out that most of the placebo-related basic studies are performed either on laboratory animals, on health volunteers, and on a short term experiments. Vary really has a study following a high acupuncture treatment frequency as in China. 

As pointed out by Mill FG (2009) :[551]   Although suggestive, the relevance of these experiments (e. g, animal studies, healthy volunteer studies, and short-term studies) to placebo effects in clinical pain conditions is unclear. Those mechanistic studies that have enrolled patients with various medical conditions have, with a few exceptions, examined very short-term effects of placebo interventions, lasting from several minutes to a few hours to, on occasion, a few days in duration. Especially lacking and needed is translational placebo research involving patient-subjects, aimed at understanding clinical implications of placebo effects over time and at testing hypotheses relating to how placebo effects can be tapped and enhanced in service of patient care.”

The placebo effect is believed to relate to people believing, expectation and learning process. The high the expectation, the placebo effect would be.

Recently, there is also a report [552] that the level of the expectation of patient with migraine before acupuncture treatment is not related to the deduction of headache after acupuncture treatment, though it did in the sham group. Note that the acupuncture is performed five sessions a week for 4 week. It is the high frequent treatment schedule.

Bauml J (2014) [553] also reported that electoral acupuncture produced consistent and clinically important pain reduction (30% or greater) regardless of baseline expectancy while sham acupuncture only produced clinically important pain reduction for those with higher expectancy. Expecting a positive outcome (expectancy) at the beginning of the trial was associated with the response to sham acupuncture. In contrast, patients who responded to electoral acupuncture had increased expectancy over the course of their acupuncture treatment as compared with nonresponders, suggesting that positive responses during the process of electoral acupuncture increased the expectations of positive outcomes. Our findings imply that distinct mechanisms underlie the apparently similar clinical effect of electoral acupuncture and sham acupuncture.  

Due to that fact that the effect of placebo effect in the sham group and the acupuncture group might not be the same, the healing effect of sham group might be the same as, or even higher than, the acupuncture group, though in most cases, it is less than that in the acupuncture group. 

 We ourselves also feel that, current placebo studies have not tested the possible platform phase and the reduction phase of the placebo effect, in low and high treatment frequency of sham acupuncture studies.

In clinic studies of placebo effect, the size of the placebo effect is estimated from the healing effect of a sham group. However, the effect of a sham group also contains other factors, such as the natural turnover of a disease, the self-cure of a disease,  the expectation of a patient, the behavior of the doctor, the extent of the doctor's care to the patient, the credibility of the mark used to evaluate the severity of a disease, and proper or not the patient participated in a study.

3.5. Side effect of placebo

Placebo treatment can also cause some side effect, even if originally the patient expected or accepted the hint for an improvement of symptoms. The side effect of a placebo effect can not only occur in a sham surgery  but also in sham pill studies.

Beecher HK (1055)  reported that after giving placebo pill, their patients can feel dry mouth (in 9% of patients), nausea (10%), heaviness feeling (18%), headache (25%), difficulty concentration (15%), drowness (50%), warm glow (8%), relaxation (9%), fatigue (18%), and sleep (10%).

Sometimes the side effect can be severe as overwhelming weakness, palpitation, and nausea both after taking the placebo and also after the tested (therapeutically ineffective ) drug; diffuse rash—itchy, erythematous, and maculopapular; and epigastric pain followed by watery diarrhea, urticaria, and angioneurotic edema.

 

3.6. Placebo and nocebo

A psychological hint can work for human being as a placebo or a nocebo. The placebo effect means that if we hint to a person that he gets something that will be good to him, for example, good to reduce weight, the person believes, and the person may really loss some body weight. A nocebo means if the person is hinted that he gets something that may cause a diarrhea, he believes, and he may really have loss stool or diarrhea. In clinic, a typical nocebo effect is when a doctor told his cancer patient that he/she will live for only another half year. The patient believes it and indeed the patient dies after half year. If a person believes that acupuncture may cause more pain, he may really get more pain during or after acupuncture treatment. This is a typical nocebo effect in acupuncture. The placebo and nocebo effect has been well understood in Chinese culture and in Traditional Chinese medicine. Therefore, doctors in Traditional Chinese medicine usually pay much attention to encourage his patient to participate and to finish a treatment, instead of scaring his patient for a future possible worse outcome of the disease.

However, currently the researchers paid more attention to the effect of placebo to the healing result of a remedy, not much to that of a nocebo. A placebo effect may be useful to speed up the healing and to get better healing result but a nocebo effect will affect the treatment course and result.

Another psychological phenomenon is the fear of patient to the needle, especially in children. The person may not believe that an acupuncture needle may make his/her disease worse, the person still is with strong hope to get better from the acupuncture treatment, but the person just fears the needle.  How such feeling would affect the extent of the placebo effect? No one knows yet. We are unable to find any paper studied on this phenomenon but we can expect that this phenomenon happens mostly in the acupuncture treatment group, not much in the sham group, especially not in the non-inserting sham groups where no any needle or any stimulation to cause pain to the skin.

In practice, acupuncturist needs to talk and to communicate with his patient to solve any doubt about the feeling and possible questions about acupuncture treatment. However in the acupuncture researches in Western countries, the communication between the patient and the acupuncturist is limited to a very low level. The patient lied on the healing table, pretty much as a cabby in a laboratory, with a lot of doubt and questions in mind. How this patient's such emotion may affect the healing effect by acupuncture? At least from this point, we can say that the acupuncture in the acupuncture researches in Western countries is a 'modified' acupuncture. It is not a real acupuncture or acupuncture in practice. Therefore, in addition to low total schedule of acupuncture treatment, what acupuncture being studied in the Western countries is a Western, modified and non-real acupuncture in Western countries, not a real and true acupuncture in China.

 

3.7. Exaggerate of patients to healing effect

Most of the participants to an acupuncture research become interested to participate and come from advertising for the study.  Such participation is also free in charge.

We have experience that, when we are in an exhibition to show to the public the auricular press treatment, or a brief acupuncture treatment to reduce visitor's pain, the visitor tried, in  most of time, reported good or very good after our treatment to them, so that they come to our clinic for continuous treatment. However, in our clinic, even if we have started a typical full time acupuncture treatment or continue the auricular press treatment to them, the speed of the recovery from the pain is not as fast or as dramatic as when they tried the first time for free during that exhibition time. We have strongly suspected that these persons gave an exaggerated report for the healing effect of auricular press or acupuncture during the exhibition time. After they come into the real treatment and they need to pay for the treatment, their evaluation of the treatment outcome appears more "reasonable and reliable". Such exaggerating report can come in both real acupuncture and sham acupuncture group in an acupuncture study.   

Other researchers have also found such exaggeration phenomenon.They pointed out that the patients in the sham group exaggerated healing effect, for making the doctors glad, while their symptoms were not improved actually.

3.8. Placebo may not always contribute to a healing

A placebo effect can happen in any kinds of therapy, but also in many cases a healing effect can occur without the involvement of a placebo effect. Let us see some clinic examples for this:

(1). In the early stage of the use of antibiotics, such as penicillin, the cure rate of penicillin is very high. Even if the patient is in coma, it can well prevent the growth of bacteria and to reduce inflammation. Can we say that about 30% of the healing effect after the use of penicillin is contributed to a placebo, while only the 70% of the healing effect is contributed to the penicillin?

(2). Heavy bleeding from uterus. After removal of uterus, the bleeding stops. Can we say that for the stop of bleeding, 30% of the result is due to the believing of patient that the removal of uterus will stop the bleeding and the remaining 70% of the result is due to the actually physical removal of the uterus by surgery?

(3). A person feels pain due to a decayed tooth. After removal of it, the pain stopped. Can we say that the subside of the pain is not due to the removal of the tooth. 30% of the stop is due to the patient's believing in the dental operation and 70% of it is due to the dental operation?

(4). Acupuncture has been used in the treatment of patients with coma, shock, or persistent vegetative state (PVS). Patients with PVS still have body functions of heart beat and breath but no, or very mild of, consciousness. Acupuncture can speed up the wake-up of such patients. Can we say that the wake-up of the patients is that 30% of the reason is due to the believing of the patients in the acupuncture effect and 70% is due to the specific healing effect of the acupuncture?

(5). In clinic, patient comes to doctor with strong expect to get better. The doctor tried a lot but vain. Later, the doctor tried different way of treatment, such as a new medicine, or new herbal formula, or acupuncture and the patient get much better. Can we say that it is not due the specific healing effect of the last therapy tried, but due to increased expect or believing of patient to that latest therapy? In fact in clinic, when the doctor tried the last therapy, the patient has already developed kind of disappointment feeling for the further trying. This is true in acupuncture clinic since, before a client comes to us, the client has tried various ways of treatments including Western medicine, surgery, physiotherapy, chiropractic, or massage. They come just for a trying. They have no strong expectation that acupuncture may help. They almost know nothing about what the acupuncture can do. This means that the healing effect of acupuncture occurs in later stage of patient trying, at which time the patient has disappointed feeling, not in an early stage when the patient is with strong hope to medicine. 

All of the examples above suggest that a placebo effect may contribute to the overall healing effect of a medical therapy, but it is not at all necessarily an obligation to the success of a therapy. Therefore, the specific healing effect of a therapy is not necessarily the result after subtracting the placebo effect or a natural turn-over effect from the overall healing effect.  

 

3.9. Evaluation of the healing effect of a therapy in a combined group

3.9.1. The total amount of placebo effect in a combined therapy group is not the sum of that from each individual therapy group.

Currently, it is assumed that the placebo effect in a therapy is the same as that evidenced from the paralelly tested sham group.  This means, if the placebo effect from a sham group is 30%, the placebo effect in an acupuncture group is also 30%. Then, the specific healing effect of acupuncture in acupuncture group should be calculated by deducting the 30% placebo effect from the overall healing effect of the acupuncture group. Now we say that, if this is correct, we cannot expect that the total amount of placebo effect in a combined therapy group would be the accumulation of the placebo effects from each individual therapy in the combined group.

For example, if the placebo effect in acupuncture group is 26%, and that in a medicine group is 31% (see Fig. 18f), the total amount of placebo effect would not be 57% (26%+31%), when both therapies are used together in a combined program. Similarly, if there is more therapies are combined in the program, say, physiotherapy with a placebo effect of 22%, the total placebo effect in the combined group (acupuncture +medicine+physiotherapy) would be not possible to reach to 79% (26%+31%+22%). If it indeed so, the healing effect in a combined group is 79%, and plus the specific healing  effect, more or less, from the three individual therapy, should come up to 100%! Apparently this is not possible. 

3.9.2. The total amount of specific healing effect in a combined group is not the sum of that in individual group

This means that, if the specific healing effect of one therapy is 1, the specific healing effect of another therapy is also 1, after combining them together for the treatment, the total specific healing effects from the two therapies in the combined group would not be doubled as 1+1=2.

For example, if there are three medicine drugs, the specific healing effect of them are all 20% (e.g. after deduction of sham effect from each group, whichever amount of the sham effect is), would the total specific healing effect in the combined group come up to 60%? If we add the sham effect into the combined group, say 30%, would the total healing effect of the combined group sum up to 20%+20%+20%+30%=90%? This is neither possible.

3.9.3. The specific healing effect of acupuncture in the acupuncture group many not be the difference between the total healing effect and the healing effect in sham group

When comparing the healing effect of acupuncture group and sham acupuncture group, if the healing effect of acupuncture group is 45% and that in the sham group is 30%, it would be believed that the specific healing effect of acupuncture in the acupuncture group would be just 15%.   The question is, how do we know that the placebo effect in the acupuncture group remained the same as 30% and not less, and how comes the specific healing effect of acupuncture in the acupuncture group is not just the 15%, but may be more?

Let us see an actual example:

Freitag F (2008) treated 55 cases of patients with acute migraine with Rizatriptan plus Acetaminophen (RA group), 48 cases with Rizatriptan (R group), 48 cases with Acetaminophen (A group), and another 49 cases with a sham medicine (sham group).After the treatment, 15% of patients in sham group had no pain, 42% in group R, 53% in group A, and 62% in group RA had no more pain (Fig. 19a).

  Placebo.Fig.19a

Theoretically, the combined healing effect in the group RA should be 95% (since 53%+42%=95%), but actually it is only 62%, suggesting that the healing effect of individual therapy cannot be kept in the same extent as it is used alone, in a combined healing program. It is also hard to tell that among the 62% healing effect, how much is contributed by the group R, group A, and the sham group.

If the placebo effect in the three groups kept the same, say always the 15%, and if we delete the 15% from each group to obtain the so called specific healing effect for each treatment group (Fig. 19b), we can see that the specific effect of group R is 27% (42%-15%=27%), that of group A is 38% (53%-15%=38%), and that of group RA is 47% (62%-15%=47%).

Placebo.Fig.19b

The actual specific effect of group RA (47%) is less than the supposed total specific effect (65%) in the combined group RA (65%), (27%+38%=65%). This calculation suggests that, to reach the total specific healing effect in a combined group, the sum of the specific healing effect from each therapy should be much more than the actual total specific healing effect in the combined group.

In acupuncture study, the acupuncture group can be regarded as a "combined" group, because it is believed that it compromised of the placebo effect and acupuncture specific effect. To reach the total healing effect in the acupuncture group, the sum of the placebo effect plus the acupuncture specific effect before combination should be much more than the total healing effect of the actual acupuncture group. However, because it is supposed that the placebo effect is the same amount in the sham group and in the actual acupuncture group, it would mean that the specific acupuncture healing effect in the actual acupuncture group is underestimated.

Freitag F (2008)  study is very typical phenomenon in clinic studies, in which two or more working therapies are used in a combination, but the total healing effect in the combined group is less than the sum of each therapy when they are used alone. It is very rare that the total healing effect in a combined group can be equal to, or more than, the sum of each therapy.

Even if there is a calculated only 10% to 15% specific healing effect in the acupuncture group over a sham, the totally 40% to 50% healing effect is induced by the use of the acupuncture, not by anything else. Without the triggering by the acupuncture, the sham can only have a healing effect of 30%, not the 40% to 50%, an amount which is similar to those achieved by a Western medicine for the treatment of many kinds of diseases. The 10% specific healing effect of acupuncture can be seen as a trigger instrument of a car, or a blasting cap, or a burning match that starts a mountain fire. Without the trigger instrument the car cannot start to run. Without the blasting cap, the land mine will not blast. Without the burning of the match, the mountain fire would not start. We cannot deny the effect of the trigger instrument for the car, the blasting cap for a land mine, or of the match for a mountain fire. A placebo effect can reduce the symptoms by 30%, but the 40% of total healing effect cannot be reached without the contribution of the specific effect of acupuncture.

3.9.4. The total healing effect of combined therapies may even less than when the therapies used separately

In the combination of various therapies, one question is to use exercise in the combination or not. This is not big question among Western medicine, physiotherapy, massage, or chiropractic practitioners, who always recommend patients to have exercise, but indeed a conflicting problem between TCM (Traditional Chinese medicine) doctor and those practitioners.

The TCM doctors believe that extra or exhausted physical exercise may make a painful disease worse. They ask their patient to be relaxed from physical activities until the pain is dramatically reduced. 

Cheing GLY (2002)   treated 16 patients with chronic osteoarthritic (OA) knee pain by TENS. 15 patients were asked to have exercise only, 15 patients were treated with both TENS and exercise and additional 15 patients were treated with sham TENS. After 20 sessions of treatments, the pain reduced in the TENS group by 57.8%, in exercise group, by 36.8%, in the TENS-exercise group, by 44.4% and in the sham group, by 49.6% (Fig. 19c.). This study suggests that a combination of two working therapies may not increase the healing effect after being used together. More specifically, exercise makes the healing effect of TENS reduced, and the combination of the TENS with exercise makes both no specific healing effects at all (as compared with the 49.6% healing effect from the sham group).

Placebo.Fig.19c

 

This is additional example that the combination of more therapies may not increase the healing result as expected, but may reduce the healing effect of each single therapy. This example also suggests that the effect of placebo effect in different healing groups might not be the same.

It is common in clinic that the overall healing effect of two or more therapies when they are used together is not more than when the therapy is used alone.

3.10. The extent and the direction of a placebo effect might be different in the sham and in a treatment group

In acupuncture studies, we need to realize that emotional reaction of patients in a sham group and an acupuncture group might not be the same to influence the final healing effect. In the sham group, the patients may have a placebo effect, so as to report a kind of healing effect from a sham treatment. They may also develop a disappoint feeling to the sham treatment sometimes later due to no improvement of their symptoms.

This is true in the acupuncture group. Furthermore in acupuncture group, some patient may have a fear feeling to the acupuncture, or feel disappointed after know they had real acupuncture but no improvement of their symptoms (especially with a low frequency of acupuncture schedule). Such feeling may work as nocebo effect to affect the healing effect.  

Therefore, the extent and the direction of the placebo effect in the sham and in the acupuncture group might not be the same. So, we cannot predict the amount of specific healing effect of acupuncture in the acupuncture group by simply subtracting the amount of sham effect from the total effect of the acupuncture group.

3.11. Effect of placebo effect on subjective or objective index of healing effect

3.11.1.  Effect on continuous parameter and binary parameter

Hróbjartsson A (2001, 2004, 2010) has paid attention to the relationship in the healing effects between the sham group and the non-treatment group for some years. The authors separate the healing effect into continuous index and threshold index. The example of the continuous index is as the commonly used VAS score and the threshold index is usually an incidence rate to tell the rate, such as smoking rate, pregnancy rate, alcohol rate, nausea rate, and so on, in which the patient can only answer yes or no.

They collected the articles that involve as much as 46 kinds of clinic conditions, such as depression, insomnia, pain, nausea, phobia, smoking, vitiligo, hypertension, obesity, jet lag, secondary erectile dysfunction, dry eye, patient involvement in adolescent diabetic care, difficulty of colonoscopy, alcohol abuse, Alzheimer's disease, anemia, anxiety, asthma, attention-deficit hyperactivity disorder, bacterial infections, benign prostatic hyperplasia, carpal tunnel syndrome, common cold, compulsive nail biting, enuresis, epilepsy, faecal soiling, herpes simplex infection, hypercholesterolemia, hyperglycemia, ileus, infertility, insufficient cervical dilatation, labor, marital discord, menopause, mental handicap, orgasmic difficulties, Parkinson's disease, poor oral hygiene, Raynaud's disease, schizophrenia, sea sickness, stress related to dental treatment and undiagnosed ailments.

The author found that, among the 44 articles using threshold index, there is no clear relationship between the sham group and the non-treatment group, e.g. the healing effect of the sham group is not statistically significant more or less than that of the non-treatment group. In the articles using continuous index (158 articles), the effect of the sham becomes smaller along with the increase of the sample size. Analysis showed that there are large variations among the articles that tested the pain level changes (even among the articles that belong to well-designed articles) from very significant to almost can be omitted. Even in the significant reports, the sham group can only reduce the pain level for 6 mm (0-100 mm scale). There is a mild level and consistent influence on the nausea rate. For phobia and asthma, the influence is largely variable and very inconsistent among articles.  

Hróbjartsson A reports suggest: (1), the influence of the sham group is largely variable among different diseases and for the same disease among different studies; (2), it is very hard to tell if the sham group is more affecting a subjective index or an objective index of the healing effect. The placebo effect in a sham group might affect pain, but not dry eye syndrome, difficulty of colonoscopy, prostate enlargement, carpal tunnel syndrome, herpes simplex infection, menopause syndrome, Raynaud's disease, etc. For many emotional or psychometric syndromes, the sham treatment seems to have no effect or the effect is small and inconsistent: depression, phobia, insomnia, smoking, alcohol abuse, patient involvement in adolescent diabetic care, jet lag, secondary erectile dysfunction, compulsive nail biting, faecal soiling, marital discord, orgasmic difficulties, poor oral hygiene, sea sickness, and stress related to dental treatment, etc.

Wood L (2008)  also found that, there was little evidence of bias associated with lack of blinding in trials assessing all-cause mortality or other objectively assessed outcomes.

Manheimer E (2011)  believed that for the outcomes of pregnancy and birth, which are probably the most objective of all outcomes with the possible exception of mortality, there is a low risk of bias due to lack of blinding and that the use of sham group as control in acupuncture facilitated studies in IVF is unnecessary, since most kinds of sham acupuncture methods are not inert to work as an ideal control. Acupuncture indeed can improve the success rate of IVF, as verified by many studies.

Kaptchuk TJ (2006) compared sham acupuncture and sham pill. They also found that the placebo effect was confined to self-reported, subjective outcomes (e.g., pain) and that there was no placebo effect (i.e., no improvement from baseline) for either the placebo acupuncture or placebo pill on the completely objective outcome that they measured (i.e., grip strength). Their findings suggest that an enhanced placebo effect of acupuncture, or indeed any placebo effect of acupuncture, is confined to subjective outcomes. Indeed, Kapchuk and colleagues concluded, ‘‘That the differential placebo effect was confined to self reported measures (and not to grip strength) suggests an effect that may be confined to subjective outcomes.”

It has been well accepted that when compare acupuncture with non-treatment group, the acupuncture treatment indeed works to improve the clinic conditions, for most of the conditions above, even if it is with Western style acupuncture. Only after the involvement of a sham group, which per se is very largely variable in healing effect, makes it variable in the comparison between the acupuncture group and the sham group. Therefore, we would ask: how can be use an unstable index (sham group) to tell other index (acupuncture and other therapies).

For above conditions using threshold index to tell healing effects, acupuncture treatments in China, generally speaking, work effectively (comparing to non-treatment group and/or Western medicine treatment), no matter it is a subjective or objective index. We have listed a lot of data in this article. It should be pointed out that the acupuncture again is performed mostly at a high treatment frequency.

In the articles from China, the healing effect is most time expressed as a grade index, which is transferred from a continuous index, such as cure rate, much improved rate, improved rate, or no effect rate and so on. Here, the cure rate can be regarded as a threshold index as well, since it tells if the disease has been cured or not yet. Check the data we included here, it can be found that the cure rate with Chinese style of acupuncture is pretty high (Fig. 4, 6, and 8). The commonly used continuous index in the Western clinic studies cannot tell how many patients have been really cured without more need to come back.

 

3.11.2.  Effect on physical parameter and biochemical parameter

Meissner K (2007)  reported that the placebo effect affected more on physical parameters(such as blood pressure, swelling after surgical operation, etc.), but not more on biochemical parameters (such as blood sugar, blood RBC content, or blood cholesterol level, etc.), in peripheral diseases. They found that, in total, 50% of trials (8 of 16 trials) measuring physical parameters showed significant placebo effects, compared with 6% of trials (1 of 18 trials) measuring biochemical parameters.

魏倩 (2016)  treated type II diabetes with acupuncture. Acupuncture is once every other day, continuous 12 sessions as one course, totally 3 courses. After the treatment, blood sugar level reduced more than 30% in 22.9% patients, and reduced more than 10% in 41.6% patients. With the combination of acupuncture and moxibustion, the reduction in the blood sugar was more apparent: the blood sugar level reduced more than 30% and 10%, in 66.6% and 29.2% of patients, respectively.

李志明 (2016)  treated hypercholesteromia patients with acupuncture. The acupuncture was once a day, 10 sessions as one course, totally 2 courses. After treatment, blood total cholesterol level reduced from 6.59 to 4.81; LDL down from 4.68 to 3.55; HDL increased from 1.08 to 1.22 mg/dl.

王玉洁 (2016)  treated patients with blood leucopenia with acupuncture (39 patients). The treatment was once a day, 6 sessions per week for two weeks. The reasons for the disease: chemotherapy or radiation therapy (12 patients),  hypersplenia (4 patients), side effects of drugs (4 patients), aplastic anemia (2 patients), no clear reasons (17 patients). The white blood cells before the treatment was <3.5 x109/L. After the treatment, the BWC was ≥4.0x109/L in 19 patients. WBC increased on the top of original level for 1.0x109/L in 17 cases.  

Sunay D (2011)  allocated 53 menopause syndrome patients into two acupuncture treatment groups: an acupuncture group (27 casesand a sham acupuncture group (26 cases). The acupuncture was twice a day for 10 days. After the treatment, the Menopause Rating Scale (MRS) reduced by 60% and 4.0%, respectively in the acupuncture group and the sham group. Meantime, the FSH and LH hormone reduced while Oestradiol dramatically increased in the acupuncture group, but almost not in the sham group. That acupuncture could change the blood concentrations of these hormones was confirmed by other studies.  These studies suggested that it might be due to the change of the hormone secretion function of the hypophysis-hypothalamus-ovary axis, which changes the balance of female hormones, so as to be benefit for the correction of menopause syndrome.

The data showing that the acupuncture treatment can correct the blood biochemical marks are very popular in Chinese literature. But please note again that the acupuncture was performed with high frequency schedule and more than 20 sessions mostly.

 

3.11.3.  Cure or not

Spiro (1997)  suggested that placebo effects have the power to ameliorate illness but not to cure or control disease. Considerable scientific evidence supports this hypothesis.

Miller FG (2009) stated that the best evidence for placebo effects derives from two situations. First, laboratory experiments have demonstrated short-term symptomatic relief, especially pain. Second, patients with chronic conditions marked by pain or distress have obtained significant and lasting symptomatic relief following sham acupuncture, as compared with no-treatment and usual care control groups. There is little reliable evidence that the placebo effect can cure or control disease by modifying pathophysiology. Several meta-analyses of observed placebo response rates in cardiovascular conditions (including hypertension) have shown changes in both symptoms and pathophysiology, but these trials have not controlled for natural history. For oncological diseases, a systematic review of randomized trials found that placebo treatment is associated with improvement in subjective complaints like pain and appetite (Chvetzoff and Tannock 2003). Slight rates of tumor response in placebo-treated patients were attributable to changes normally associated with “spontaneous remission.” This cursory examination of observed placebo responses in randomized trials without solid and consistent evidence of objective improvement in disease outcomes could easily be extended.

Miller FG (2009)  suggests that placebo effects that derive from other psychological mechanisms may inherently lack the potential to produce therapeutic benefit beyond symptomatic relief. Acupuncture can not only control the symptoms, but also cure disease. The simplest example is the wake-up of patients with coma, persistent vegetative status, delayed wake-up after general anesthesia, and the restore of blood pressure in shock patients. It can also cure many other diseases, such as Bell syndrome, herpes zoster, etc.

王旭慧 (2008)  treated patients with the post-stoke shoulder-hands syndrome with ordinary acupuncture (63 cases) and special acupuncture technique (77 cases). The acupuncture was once a day. 30-day was one healing course. After the treatment, the cure rate in the ordinary acupuncture and the special acupuncture group wass 34.9% and 44.1%, respectively. The index for the cure was the disappearance of pain and swelling, no restrict on joint movement, no wastage for small muscle in hands.

林雪 (2007)  treated the post-stroke shoulder-hand syndrome with acupuncture (40 cases) and joint-injection (40 cases). Acupuncture was once a day, with 30-day as a healing course. Joint-injection was twice a week. After treatment, the cure rate for acupuncture and the joint-injection group was 45% and 25%, respectively. The index for cure is the same as above report.

The clinic reports for the principle cure of such post-stroke shoulder-hand syndrome are more.

吴晓兰 (2011) treated Bell syndrome with acupuncture plus moxibustion (67 cases) and Western medicine (67 cases). Acupuncture was once a day for 20 days. After treatment, the cure rate in the acupuncture group and the medicine group was 56.7% and 17.9%, respectively.

刘少华 (2016) treated Facial nerve paralysis in children, with acupuncture (51 cases) and Western medicine (51 cases). Acupuncture was once a day, 5-day as a course, with 2-day break between the courses, totally 6 courses. After the treatment, the cure rate in the acupuncture group and the medicine group were 62.7% and 35.2%, respectively.

王文礼 (2016) treated acute facial nerve paralysis 128 cases. Acupuncture was once every other day, 12 day as a course, for totally one to two courses. The cure rate for the patients in acute state, stable state and recovery state, were 88.2%, 62.6% and 51.8%, respectively.

王世惠 (1996) also treated the facial nerve paralysis. The acupuncture was once a day, or once every other day, 10 days as a course. The average cure rate was 74%.

It was found that the cure rate of specific facial nerve paralysis is closely related to the start time of the acupuncture treatment. The cure rate for starting within 5 days of the onset of the disease is much higher than starting after 7 days.

There are more articles reporting that acupuncture can cure or to speed up the cure of facial nerve paralysis.

李海林 (2016)  treated herpes zoster 80 cases. Acupuncture was once a day, 6 sessions is a course. After 3 courses, the cure rate (skin rash disappears, no clinic sign disappears, no sequel of pain) was 40%-57.5%.  

Also, there are more reports suggest that acupuncture can cure the herpes zoster.

The above examples indicate that, if placebo effect (in a sham group) can only improve symptom but not cure diseases, acupuncture can not only improve the symptoms but also cure diseases. This is additional difference between acupuncture and sham acupuncture.

 

3.11.4.  Brain imaging study

For the different influence of the sham and verum acupuncture on brain, Enck P (2010) 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E0000005F005200650066003400360037003000350031003100320032000000  had a good summary:

Acupuncture but not sham acupuncture was found to induce both cerebellar as well as limbic cortex activation indicating both motor as well as affective component modulation of the pain matrix. Acupuncture resp. electroacupuncture at non-acupuncture points and tactile stimulation alone served as controls in early fMRI studies (Wu et al., 2002; Yoo et al., 2004). Verum acupuncture in contrast to non-penetrating placebo needles activated cortical centers involved in affective painmodulation also in more recent studies (Chae et al., 2009). It was, however, noted that cortical activation following acupuncture shows substantial within as well as between-subject variations across different sessions (Kong et al., 2006).

Differences between true and sham acupuncture were also found for the same regions by Napadow et al. (2009a); these authors also noted greater activation of sensorimotor areas (S1,S2, insula) by their sham procedure (superficial manipulation at acupuncture points) than by true acupuncture. In another study of the same group, Napadow et al. (2009b) noted variances in time of central activation between verum and sham acupuncture that they attributed to stronger peripheral actions of true acupuncture (see Section 4.2).

In a recent 11C-carfentanil PET study with fibromyalgia patients (Harris et al., 2009), acupuncture therapy but not sham acupuncture (at non-acupuncture points) elicited significant activation of muopioid receptor binding capacity in typical areas of the “pain matrix”, the cingulate, the caudate, the thalamus and the amygdala both shortterm (after one session) as well as long-term (after 4 weeks) while with sham acupuncture, small deactivations of this matrix was noted, an effect that has been seen also with placebo analgesia (Zubieta et al., 2005) (see Section 4.2).

Chae Y (2009) :  compared with a sham acupuncture group, verum acupuncture stimulation elicited significant activation in both motor function-related brain areas, including the caudate, claustrum, and cerebellum, and limbic-related structures, such as the medial frontal gyrus, the cingulate gyrus, and the fusiform gyrus.

Harris RE (2009):  Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on μ-opioid receptors (MORs). Acupuncture therapy evoked short-term increases in MOR binding potential, in multiple pain and sensory processing regions including the cingulate (dorsal and subgenual), insula, caudate, thalamus, and amygdala. Acupuncture therapy also evoked long-term increases in MOR binding potential in some of the same structures including the cingulate (dorsal and perigenual), caudate, and amygdala. These short- and long-term effects were absent in the sham group where small reductions were observed, an effect more consistent with previous placebo PET studies. Long-term increases in MOR BP following TA were also associated with greater reductions in clinical pain.

Kong J (2009)  investigated acupuncture and sham acupuncture (Streitberger needle) with and without expectancy

manipulation in healthy subjects in a cross-over design and found that both acupuncture and sham acupuncture – when coupled with high expectation – produce analgesia of similar magnitude, but the verum acupuncture elicits higher deactivation of the painmatrix than did sham acupuncture and expectancy analgesia alone. This also underlines different central mechanisms of analgesia between expectancy and acupuncture.

Chu WC (2012)  reported that rectal distension induced significant activation of the anterior cingulated cortex, prefrontal cortex, thalamus, temporal regions and cerebellum at baseline. During and immediately after electro-acupuncture, increased cerebral activation from baseline was observed in the anterior cingulated cortex, bilateral prefrontal cortex, thalamus, temporal regions, and right insula in both groups. However, true electro-acupuncture led to significantly higher activation at right insula, as well as pulvinar and medial nucleus of the thalamus when compared to sham acupuncture.

Napadow V (2014)  reported that Acupuncture reduced itch and itch-evoked activation in the insula, putamen, and premotor and prefrontal cortical areas. Neither itch sensation nor itch-evoked brain response was altered following antihistamine or placebo acupuncture. Greater itch reduction following acupuncture was associated with greater reduction in putamen response, a region implicated in motivation and habitual behavior underlying the urge to scratch, specifically implicating this region in acupuncture's antipruritic effects.

There are more data showing that the brain imaging in acupuncture is different from that in sham acupuncture treatment.

 

3.11.5. Peripheral (autonomic) effects of acupuncture versus sham acupuncture

Schneider A (2006) and (Schneider A 2007) tested the effect of acupuncture and sham acupuncture in the treatment IBS. They found significant differences between true acupuncture compared to controls (sham acupuncture) in   (diurnal profile of saliva cortisol) and phasic autonomic responses (heart rate variability following a cardiac challenge) .

“While with acupuncture, both measures were significantly correlated, this was not the case with sham acupuncture indicating a sustained and consistent parasympathic activation after acupuncture treatment while the response in the control groups resembles more the effects of a placebo response. The placebo and verum effects not only with acupuncture treatment often look similar with clinical efficacy endpoints (e.g. in depression treatment when the Hamilton Anxiety Depression Scale is used, see Leuchter et al., 2002), and require the inclusion of moderators of efficacy for better distinction of true treatment and placebo effects.”

 

3.12. Conditions to accept or to deny a therapy

If we agree that any therapies could come with more or less placebo effect that can also cause a reduction in symptoms to some level, how much extent of the specific healing effect of this therapy over the placebo effect can be accepted as a useful therapy?

So far as data we can reach, almost no any people discussed this question.

If a placebo healing effect is 25% and the healing effect of a treatment group is 50%, e.g. the specific healing effect of the treatment group is 25% or more over the placebo effect; it could be commonly accepted as a useful therapy. If the total healing effect of the treatment group is pretty close and without statistically significant difference in almost all the studies, it is easy to be denied. However, if the placebo effect is 30% (or 30% to 35% as in those negative acupuncture studies), and the specific healing effect of the treatment group is very close (statistically significant though), how we make the decision?

Let us presume the following condition:

(1). The placebo effect is low (between 25% - 30%) and the calculated specific healing effect in the treatment group is about 10% to 15%, such as those reported in many of the studies from Western countries.

(2). The placebo effect is about 40%, the calculated specific healing effect in the treatment group is also about 10% to 15%, such as those reported in some of negative studies from Western countries.

(3). The placebo effect can reach 50%, the calculated specific healing effect in the treatment group is about 10% to 15%, such as those reported in some of the studies, in which the doctor is allowed to exercise as much as possible care to the patient. Of course such condition is rare.

Theoretically, if majority of study results are one of the three conditions above, this therapy should be accepted, especially if the therapy is used for the treatment of some obstacle diseases (such as persistent generative states, AIDS, chronic migraine, etc.), or if the current therapy for the treatment of these disease is with lot of serious side effects. The reason for this opinion is: (1), even if the healing effect of the treatment group is only 10% to 15% higher than that of the sham group (placebo effect), it is the specific effect of the therapy in the treatment group created the total effect; (2), The way to calculate the specific healing effect in the treatment group might underestimated the actual specific healing effect of the treatment group.

This suggestion might be more realistic to acupuncture, chiropractic, massage, such therapies that depend more on personal skill. Different practitioner may have quite different success rate in the treatment so that the reproducibility of the study could be less than in a medical drug study. This is the reality of current medical study before, current and in future too.

3.13. The credibility of a study

Apparently, the variation in the healing effect of a sham group is largely variable among clinic studies. It can be as less as zero, or more than 60% (occasionally).

It can be deduced that, if the healing effect of a sham group is high (under the condition that the blind to the patents is successful), it means that the patients tend to have high susceptibility to a placebo effect. If the acupuncture does not work properly, the difference in the healing effect between the sham and the acupuncture group would not be as much as to reach statistically significant. This is the basic characteristic of the negative articles cited by Colquhoun D.

On the other side, as we introduced, if the healing effect of the sham group is low (also under the condition that the blind to the patients is successful), for example lower than 23%, about 75% of the articles are positive results. This means that such group of patients is less affected by a placebo effect, and belongs to low susceptibility group to placebo. In this case, even if the healing effect of acupuncture is as the same as above, it is easy to reach a significant difference between the sham and the acupuncture group.

While when the acupuncture per se works well, such as in most of acupuncture researches in China (especially for the modified acupuncture technique), it is not hard to reach a significant difference between the sham and the acupuncture group, since the healing effect is usually more than 50%.

Then, if the susceptibility to placebo is so different among the patients in various studies, and the healing effect of the sham group so largely affects the final summary for a therapy, which study results we should trust and believe more: the study involving high susceptibility group, or the study involving low susceptibility group? Apparently Colquhoun believed the former.

If we accept the results of those studies involving high susceptibility group, it would be possible that we deny the therapy. This is the current trouble and challenge to Pharmacia industry to develop a new drug. If we trust more the studies that involved the low susceptibility to placebo, it would be more possible that we accept this therapy. Do we have strong reason to trust the high susceptibility group, not the low susceptibility group (under the condition that the blind is successful in both groups)?

We support to accept the study results more from a low susceptibility group, rather than from a high susceptibility group. If this therapy works in a low susceptibility group, it means that it indeed has its own specific healing effect and the overall healing effect is not due to a placebo effect. Our aim to test the effect of a placebo effect to this therapy has been met. Then, when the therapy is used to patients with high susceptibility to a placebo, the placebo effect would contribute to the overall healing effect, rather than to reduce the overall healing effect. Why we deny such "benefit" from a placebo effect to the overall healing effect? In this point, we agree with Walach H (2001).

Colquhoun D thought only from one side of the susceptibility group, so his comment and conclusion is not comprehensive and not proper. Because the negative data cited by him mostly come from Germany, we feel necessary to test the placebo susceptibility in difference nations, so as to prevent the possibility of bias due to the improper group of patients. For this reason, we also suggest to take the level of placebo susceptibility as one of the index to tell the reliability of a study result. For example, the reliability index in a study in which the healing effect of the sham group is less than 23%, is marked as 3; that is between 24% to 31%, marked as 2; and that more than 32%, marked as 1. Currently, the reliability of a study is tested by its study design mostly; such as random, blinding, sample size, correct statistic treatment of data, etc., not the placebo reliability yet.

Brief summary:

(1). Placebo effect could happen in all kinds of medicine therapies, such as Western drugs, surgical operation, physiotherapy, chiropractic, as well as acupuncture. A sham group has not been used popularly in any of these therapies. This means that, even with drugs and surgery, most of clinic studies do not have a sham group to exclude the placebo effect.

(2). In acupuncture studies, the healing effect of the sham group, e.g. the placebo effect, is about 23%, regardless whether the sham is inserted or not inserted needle. The placebo effect in physiotherapy and chiropractic is similarly about 20% to 25%; Western medicine is about 30% and in surgery, 35%. The healing effect of hypnosis is about 40%. This means that, in most studies on acupuncture, the placebo effect is no more than in a study on drug and on surgery.

 (3). When placebo effect is more than 31%, it is easy to create a negative result towards the healing effect of acupuncture. However, such negative study is not the major part of the whole studies on acupuncture.

(4). The current way to calculate the specific healing effect of acupuncture in an actual acupuncture group, by subtracting the placebo effect from the total healing effect of the acupuncture group might underestimated the specific healing effect of acupuncture.

(5). Studies on the treatment by use of TENS and laser in physiotherapy suggest that, with high frequency of treatment, the healing effect is increased but the placebo effect not. 

 

Chapter 4. Healing effect at high frequency of treatment

4.1. Middle-high frequency treatment with acupuncture or E-acupuncture

We already know that for the Western style acupuncture, the treatment is in most cases once a week or twice a week for no more than 10 sessions, with low healing effects. For the acupuncture in China (the Chinese style acupuncture), the treatment is basically 5 to 6 times per week for 10-20 sessions, with higher healing effect. The question is: if in the Chinese high frequency treatment schedule, the placebo effect will also increase? That means if the higher healing effect of the Chinese style acupuncture is due also to an increased placebo effect. 

It is not easy to answer this question right away with current data. Currently, it is hard to find an acupuncture study in the Western groups that do the acupuncture as 5-6 times per week for 10-20 times. On the other hand, acupuncture studies in China normally do not involve a sham group. We have tried to search such data from Pubmed, Google, and so on, but failed to find sufficient data for a review.

From the data we can found, after exclusion of the following articles: that belong to thesis of a Ph.D. or master student; that involve study on animal or healthy person; that use grade parameter as a mark for healing effect; that use continuous parameter as mark but the parameter is increased at the end of the study,  and that is mixed with other therapies, eventually we get 27 articles

Among the articles, 15 from Western countries, and 12 from China (Attached list 19a).Within the Western articles, 4 were laser treatment, 5 were TENS, 2 as acupuncture and 4 as electrical acupuncture. Among the Chinese groups, 1 was with laser, 1 was with TENS, 7 as acupuncture and 3 with electrical acupuncture treatment.

Let us see if the healing effect of the sham groups would increase with the higher treatment frequency and if the difference between the acupuncture group and the sham group would become larger to reach significant.

Placebo.Fig.20a

Fig. 20a. n = experiment groups. E-Acup: electrical acupuncture.

Fig. 20a showed that, with acupuncture or electrical acupuncture for three sessions or more per week, the healing effect of the sham group is only 17% to 20%. The healing effect of the inserted and the non-inserted sham group were the same. For the inserted sham group, one article was from Western country, one from Taiwan, one from Hong Kong, and 6 from Mainland of China. For the non-inserted sham group, two articles were from Western countries, 3 from Hong Kong, and 3 from Mainland of China.

With the treatment of three or more sessions per week, the healing effect of both acupuncture group and the E-acupuncture group reached 45%, which is much higher than both the sham group. Clearly, with high treatment frequency, the healing effect of the acupuncture groups was higher and that of sham groups remained not increase, so that the difference between the acupuncture and sham acupuncture groups was larger.

4.2. Middle-high frequency treatment with TENS or laser

If we also make a summary for the healing effect of TENS or laser at the middle or high treatment frequency, we can get Fig. 20b, which showed that, with the middle frequency (3 sessions per week), the healing effect of either the TENS or laser treatment is less than that with higher treatment frequency (5 to 6 sessions per week). Again, the healing effect of the sham TENS or the sham laser groups remained at the low level: 13% to 18%.  The difference between the TENS or laser group is clearly bigger. In the sham group, all of which were non-inserted sham group and were not connected with either electric or laser energy, 7 articles were from Western countries, 2 from Hong Kong, and another 2 from the Mainland of China. 

Placebo.Fig.20b

N=experiment groups

Apparently, the data from the TENS and laser treatment also showed that at higher treatment frequency, the healing effect of the treatment groups was high and that in the sham groups remained low.

Brief summary:

Along with increase in the treatment frequency, the healing effect of various sham groups does not increase but that of acupuncture, E-acupuncture, TENS, or laser groups do. Therefore, when compare the healing effect of different therapies, it is needed not only to keep all conditions the same, but also to compare it upon a higher treatment frequency (such as the treatment schedule of once a day).

Chapter 5: Something that an acupuncture researcher should know

It shows a lot of misunderstanding about acupuncture among acupuncture researchers in the Western countries, including what is acupuncture, how to choose acupuncture points; if non-acupuncture points have also a healing effect; if the acupuncture sense is a require for acupuncture to work; how many acupuncture points should be used; how often the acupuncture treatment should be repeated; how high the healing effect of a traditional Chinese acupuncture treatment can reached, etc. 

5.1. What is acupuncture

From the research articles published from Western countries, it was found that the acupuncture researchers confused the acupuncture, electrical acupuncture, finger-press, acupuncture point massage, point injection, ear point press, etc. They contribute the healing effects by these various therapies all into acupuncture. This is not fare and improper. Acupuncture is a therapy different from herbal therapy, Tuina-massage, Qigong-Daoying, since it is to use needle to stimulate acupuncture points for healing. Electrical acupuncture and warm acupuncture, TENS, or laser acupuncture, are the developed forms of traditional acupuncture. Finger-press and ear-point press (auricular acupress, or auricular acupuncture), though they all work on acupuncture points, can be regarded as branches of traditional Chinese acupuncture. These therapies work some time as better as traditional acupuncture, sometime not.

Our paper here aims to discuss whether traditional Chinese acupuncture has its own specific (unique) healing effect, e.g. if the healing effect of the traditional acupuncture technique is a placebo effect. We therefore must make clear what the traditional Chinese acupuncture is, how it is performed, and what we have to be careful in the use of acupuncture for a clinic treatment and study.

5.2. Choose of an acupuncture point

In acupuncture, there are various forms/styles/systems of acupuncture. Some styles of acupuncture need to choose acupuncture points according to the theory of Chinese medicine or that of meridians, some not. Traditional and classic acupuncture basically need to choose acupuncture points on meridians, but also some acupuncture points that are located out of the meridians (such as Jing Wai Qi Xue and A Shi point). Some local acupuncture styles (such as ear acupuncture, face acupuncture, nose acupuncture, tongue acupuncture, wrist/ankle acupuncture), Ping Hen Zhen Fa style, or Dong Shi Qi Xue style of acupuncture however, do not exactly follow the meridian to choose acupuncture points. Some styles of acupuncture only focus on the painful points (e.g. A Shi point acupuncture), or on the skin that feels numbness, touches a mass, or shows skin rash (such as Surrounding needle acupuncture).

 (1). Whole body acupuncture

One of the principles in the chose of acupuncture points is the combination of basic points plus complementary points.

Basic acupuncture points can be on meridians, such as Zusanli point for disorders in abdomen area; Neiguan point for disorder in heart beat and nausea; or Hegu point for disorders in face and head. In the treatment of any kinds of disorder in the feeling and movement of legs, in the Jin-San-Zhen acupuncture system, the basic points are Zusanli, Snayinjiao and Taichong. In the treatment of pain in the knee, in the Ping-Hen-Zhen-Fa system, the basic point is the Jianzhong point. The basic point can be one point or more points. The number of complementary acupuncture points can also be little or more, depending on the disease treated.

For most of chronic diseases, such as chronic migraine, menopause syndrome110 etc., it is needed to combine more complementary acupuncture points. There are two ways to choose complementary points:  the diagnosis according to TCM basic theory or that according to meridian theory. In acupuncture treatment, the meridian diagnosis is relatively more important.

Generally speaking, acute disease needs less number of either basic or the complementary acupuncture points but chronic disease needs more. For example in the treatment of menopause syndrome, the basic points are Guanyuan, Qihai, Zhongyuan, Shenshu, Hegu, Zusanli, Yingtang. The diagnosed points (based on TCM diagnosis) would be Taixi, Ganshu, Baihui (Liver-kidney Yin deficiency); or Xinshu, Tongli, Zhishi (in Heart-kidney un-connection syndrome), or Pishu, Yinlingquan, Sanyinjiao (in Spleen-kidney Yang deficiency).

In the treatment of migraine, the meridian diagnosis is mostly used. Some basic points plus so chosen complementary points together is necessary to reach better healing results. For example, if the migraine pain is mostly located on the side of the head, it belongs to Shaoyang meridian, acupuncture points on the Shaoyang meridian would be chosen. Furthermore, if the pain expands down to the arm, it belongs to hand Shaoyang meridian, the acupuncture points on the hand Shaoyang meridian should be used. Otherwise, if such pain expands down to shoulder or also has muscle spasm on calf, the pain belongs to foot Shaoyang meridian, and the acupuncture points on the foot Shaoyang meridian should be chosen.

We noticed that most of the acupuncture studies in the Western countries have basic acupuncture points but not the complementary points, or they use the same basic point and the complementary points for all the patients. By this way, there should be some healing effect, but it is not as good as the typical acupuncture treatment needed: the choose of acupuncture points should match the need of each individual.

To use the same acupuncture points to every patient is the typical way of Western medicine. For example in the treatment of menopause syndrome, we must use complementary acupuncture points according to TCM diagnosis. This is tough task for a doctor with Western medicine back group or for someone who has not got used to evaluate patient condition in the view of TCM. But, even if in Western medicine, for an infectious disease, should we also make a distinguishing diagnosis to see if the infection is due to bacteria, virus, fungus, or something else, so as to be able to use proper anti-biotics? Even if it is due to a bacteria infection, should we continue to know if it is due to gram positive bacteria or to gram negative bacteria? How come when these researchers come to acupuncture research, they refuse or omit or neglect to make a further TCM distinguishing diagnosis to choose more proper acupuncture points? 

For the treatment of hot flash and night sweat, if it is due to a chemotherapy or radiation therapy, due to the use of Estrogen, or due to surgical removal of uterus/ovaries, to use only a basic acupuncture point is definitely not enough.

Similarly, in the treatment of a nausea/vomit, if it is caused after eating something wrong (acute gastritis), or due to a car-sick, or plane-sick, or if it happens after anesthesia, one Neiguan point (or plus a Zusanli point) might be good enough to solve the problem. If it happens during a chemotherapy/radiation therapy, one Neiguan point acupuncture usually is not enough to solve the problem. A combination of the Neiguan with more complementary acupuncture points, or absolutely with different acupuncture point combination would be necessary.

In the whole body acupuncture system, the acupuncture point used can be more than 12 or 20 points, or can be only one point, such as the treatment of acute stiff neck with only Houxi point.

(2). Local point acupuncture

Some acupuncture systems focus the acupuncture points on a small area of the body, such as only to use acupuncture points on scalp, around an eye, nose, face, tongue, palm, on wrist/ankle, or on abdomen only. They are called scalp acupuncture, eye acupuncture, nose acupuncture, facial acupuncture, tongue acupuncture, wrist/ankle acupuncture, or abdomen acupuncture system, respectively. 

The effectiveness of the local acupuncture system supports the rationality of Holographic theory. This theory believes that any local part of a body (it can be called a small body) contains the information of the whole body (the big body). The local information in the small body and the whole body information is connected and exchanged. Stimulation on a local spot can work or influence the corresponding part on the whole body, so as to influence the function of that part on the whole body.

For example, a front arm contains the information of the whole body. If the far end of the arm (close to the wrist end) represents the "head" of the whole body, the near end of the arm (close to the elbow) would represent the "feet" of the whole body. According to this theory, acupuncture on the acupuncture point on the wrist can be used to treat disease of the head, such as headache, while stimulating on the acupuncture points on the elbow can treat disease on the foot of the whole body. Similarly, if we regard a hand as a small "body" and the tip of finger represents the head of the whole body, the acupuncture points on the wrist can be used to treat disease on the foot of the whole body.

The Holographic theory can well explain why stimulation on local part of the body can work to correct disorders in the big body. This is because every individual eye, ear, nose, tongue, face, abdomen, palm, sole... contains the concentrated information of the whole body.

The practice of the Ping-Hen-Zhen-Fa system, Dong Shi Qi Xue style, and the Hot moxibustion-sense therapy further suggest that the Holographic phenomenon is multiple layers in the body, and the different information layers are overlapped. Our body seems as a multiple colorful picture, from which we can identify out different picture. It also likes a cubic structure. One dimensional structure is part of the second dimensional structure and the second dimensional structure is also part of the third dimensional structure. Each dimensional structure has its individual structure and function, but they are also connected and influenced each other.

For this reason, the kind of diseases that an acupuncture point can be used to treat could be largely different among different acupuncture systems.

For example the Lougu point in the body acupuncture system is used to treat stomach bloating, intestine noise, infection in urine tract, leg paralysis, hot feeling in abdomen, depression, Qi inverse feeling, bloating and urgent feeling in lower abdomen, harsh urination, consumption of essence, head pain on the top of the head, swelling and pain on ankle. It is used however in the Dong Shi Qi Xue acupuncture system to treat nephritis, diabetes, gonorrhea, impotency, premature ejaculation, spermatorrhea, nocturnal emission, protein urine, urinary hemorrhage, hysteroma, irregular menses, and low back pain.

Traditionally acupuncture points are the spots on meridians. However, there is still more and new acupuncture points are found that are out of the traditional meridians. For this reason, we cannot say that to insert a needle beside the traditional acupuncture points would have no any treatment effect. 

5.3. Specificity and universality of acupuncture point

The effect of acupuncture points has specificity and universality. The healing effects of an acupuncture point are usually shared more or less by its neighbor points too. These neighbor points can belong to the same meridian, or to different meridians. For example, the Zusanli and Yanglingquan points, both of which are located under the knee, outside of the knee, and belong to the Foot Yangming meridian, can be used to treat stomach pain, bloating in abdomen. The Yinlingquan and Diji points are located also under and inside of the knee, belong to Foot Spleen meridian, can also be used to treat the stomach pain and bloating.

However, acupuncture point has also specificity in the healing function. It is reported that to acupuncture on the Shuigou point of the rabbit can increase the blood pressure of the rabbit with hemorrhagic shock, but acupuncture on Zusanli point, cannot. 

Also, acupuncture mainly on the Suliao point can treat severe craniocerebral injury coma.  Its wake-up effect is clearly stronger than Renzhong point, even if the two points located very close and also belong to the same meridian, Dumai meridian.

There are a lot of data support the acupuncture point specificity and universality.

5.4. Needling sensation

To obtain reasonable level of healing effect, it is needed that patient feels some special sensation on the acupunctured spots. The typical acupuncture sensation is described as something as a tingling, slight numbness, slight bloating, slight pressure, or slight tired feeling on and around the acupunctured spot. Such feeling is called Deqi sensation.

There are three types of acupuncture sensations. The first one is as above, the Deqi feeling. Any people learned acupuncture knows that it is the basic need for the acupuncture treatment to work. In clinic, we found that, the Deqi sensation is not difficult to be induced out, except for those patients who are very weak in body condition.

We noticed that in majority of the acupuncture studies, it has been indicated that the researchers have paid attention to induce such Deqi sensation for the patients. However it is hard to tell if the acupuncturist in the studies stimulated out the Deqi sensation to every acupuncture points, or only some points. Our doubt comes from the single blinded study design (single or double blind): if we do not want the patient and/or the acupuncturist knows whether the patient gets a real acupuncture treatment, how do we know if the patient feels the Deqi sensation or not?

The second kind of acupuncture sensation is the feeling of Deqi (or some other kinds of feeling) along a meridian. Such acupuncture sensation is called along-meridian sensation. Whenever there is such along-meridian sensation, the healing effect usually is pretty good. It is the aim for an acupuncture master to induce out such along-meridian sensation, as it is the key point to have marvelous healing effect of acupuncture treatment.

For example in the treatment of periarthritis of shoulder by stimulating Dazhui points, after manipulate the needle to induce the Deqi sensation, we will turn the needle tip towards the affected shoulder and continue to manipulate the needle to let the patient feel the Deqi sensation passing towards the affected shoulder. Clinic experience tells us that, the far such along-meridian sensation passes, the better the healing effect would be. The ability of an acupuncture master is reflected, at least, in his ability to induce such along-meridian sensation. Just because the association of much higher healing effect with such along-meridian sensation, acupuncture masters do not need to use lots of numbers of acupuncture needles or acupuncture points for the treatment, nor need to repeat the treatment for many times.

The third kind of acupuncture sensation is far-away acupuncture sensation. It means that upon acupuncture on a point, the patient feels some strange feeling far way in some other part of the body. The feeling can be typical Deqi feeling, or something else. Such far-away acupuncture sensation does not need to manipulate the needle for a long time to happen. People feel such far-away sensation pretty easy. They may belong to a special group of people, whom we call as “meridian-sensitive people”. If such far-away acupuncture sensation happens, the healing effect is also usually very good, no matter who is the acupuncturist for the treatment.

Though we believe that the acupuncture sensation is very important for higher healing effect, it is hard to have a study on it, since it is hard to standardize the intensity of the feeling. If it is not standardized, it would be hard to have a study on it.

To understand the effect of various manipulation of acupuncture needle on the healing result,  please check Attached list 20a .

 5.5. Along-meridian acupuncture sensation

As we said, the first kind of acupuncture sensation (Deqi) is not difficult to induce, while the second acupuncture sensation, the along-meridian needling sensation would be hard. It needs the acupuncturist focuses his mind on the needle handling with various manual skills. The ability of an acupuncturist is told by whether the acupuncturist can induce out such along-meridian sensation and if the sensation can pass on to the diseased spot of the body. It is a commonly accepted clinic experience that if such sensation could reach the diseased spot, the disorder on that spot would get improved much sooner. [663-667]

These special techniques are just some examples for the "Special Acupuncture" cited in the figures in this article. Most of the clinic observations on acupuncture anesthesia also showed that, if the along-meridian sensation reached the area of the surgical operation, the effect of the acupuncture anesthesia would be better. Such pain-eliminating effect of acupuncture is not related to the types of the surgical operations.

To induce out such along-meridian sensation, an acupuncture master would use different acupuncture manual technique on different acupuncture points. He would manipulate the needle for different insert direction or different depth. He would twist the needle, pull, and push the needle up and down, with various frequencies. He may manipulate the needle for one minute or even longer time. He may use various special manipulating technique, such as Slow-inserting technique,  Fei-Jing-Zou-Qi technique, Short-Distance-Following technique, Jie-Qi-Tong-Jing technique, Needle-Detaining technique, Yi-Teng-Zhu-Tong technique, or Both-Hand-Manipulation technique and so on.

Currently it is found that the patch of the along-meridian sensation mostly follows that of a meridian, though there could be some diversion or difference between persons, meridians, or some part of a meridian, but not follows the direction of muscle, blood vessels, or nerves. People may feel a mixture of sour, bloating, or numbness. Small part of people may feel as water flowing, ant crumbing, or cold or warm. It passes slower than that of a nerve signal. The width of the patch is variable among people. Most of the path is a belt, not a line. The belt can be narrow or broad too. The depth of the along-meridian sensation can be variable from person to person. The direction of the sensation mostly is as the same as that of a meridian. Depending on the acupuncture point stimulated, the direction of the feeling goes either single direction or both directions. The sensation can be stopped by external influence. The along-meridian sensation can induce internal organ reaction. The presence of the along-meridian sensation supports the meridian theory but we still do not know much about it, though a lot of studies have been done about it.

An experiment on 97 cases of youth with shortsightedness found that the extensity of the along-meridian sensation could increase with increase of the times of the stimulation. Younger students have stronger such sensation than older students. Pure numbness feeling of the along-meridian sensation is better than mixed feeling of numbness, tingling, bloating, or sour. Remote acupuncture point plus local acupuncture point is easier to induce the sensation than local acupuncture point alone.

The along-meridian acupuncture sensation is related with patient body constitution and nation of the people. It was found that person in a diseased condition is less easy to feel the along-meridian sensation, than the same person in healthy condition. However, it is easier when the person is in a diseased condition than in healthy condition when it is stimulated via Hot-moxibustion-sensitive stimulation.

The incidence of the along-meridian sensation in Chinese is 12%-24%; in Japanese,  4%; in Mozambique,  81.8% and in Guinea, 30%. It is not known how much the incidence is in Western people.

We found that when we have acupuncture on the back of a patient and if there is a pink color on skin around the needle inserted, the healing effect of the acupuncture is usually pretty good. This is clinic experience. This means that the healing effect is related to the body constitution of the patients. We also noticed in Chinese herbal therapy that, if the patient has been using a steroid medicine for a long time (including steroid injection into an acupuncture point or a trigger point), the healing reaction of the patient to the herbal therapy is poor. We do not know yet if the long term use of steroid will affect the healing effect of acupuncture treatment or not.

Because the acupuncture with acupuncture sensation works better, so beginners of acupuncture tend to use more number of acupuncture needle to compensate the possible poor acupuncture sensation of patient. In some other acupuncture systems, we may use various different ways to compensate the poor acupuncture sensation, so as to keep a higher healing effect. For example we may use Reverse-horse needle technique, Paralleling-needle technique, Needling-in-circle technique. We may also use electrical acupuncture or warm-needle acupuncture (to warm up the needle by a burning moxi cone) , electrical-warm needle, or hot needle (burn or heat the needle on fire, then inserted into the acupuncture point very quickly and pulling out very quickly too). Someone may use Needle-detaining technique, or Yang-Ci technique, or insert several needles around a painful spot or a diseased spot of the body. If the healing effect is still not so satisfied, we may increase the acupuncture frequency and times, by doing acupuncture every day, or even twice a day.

That acupuncture with acupuncture sensation would work better does not mean that if there is no acupuncture sensation, there will have no healing effect.

For some acupuncture systems, it is not required, or even prevented, to have the acupuncture sensation as above, such as in the wrist-ankle acupuncture system, abdomen acupuncture system, shallow-needling system. However, for the wrist-ankle acupuncture and the shallow-needle system, the needle is in between the skin and the muscle, not in the muscle layer of the body. They are different acupuncture systems from what we are discussed here.

Apparently, Chinese style of acupuncture either emphasizes on acupuncture sensation or not at all a sensation. We should know this, though we do not know exactly why both work every good (beyond a placebo effect). When we practice either system of the acupuncture, we must follow what that system required. Otherwise, we cannot expect a reasonable level of the healing effect as claimed by that acupuncture system.

5.6. Accuracy of acupuncture points

Chinese style of acupuncture aims to the highest healing effect of acupuncture treatment. They aim to use as little number of acupuncture needle to reach the highest healing effect. To reach this goal, it is needed to insert the needle to the right spot of the acupuncture point, otherwise, as tested,  the healing effect would not be high.

It is found that, when the needle is in the right spot, it would be easier to induce the acupuncture sensation. The farer from the acupuncture point, the less chance and less intensity of the acupuncture needling sensation. But it is not a yes-or-no phenomenon. Needling on a spot away from the acupuncture point shows less intensity of acupuncture sensation, so less healing effect as well.

Traditionally, the pathway of acupuncture meridian on an acupuncture meridian chart only showed the main stem of the meridians. The first and the second level of branches of meridians were not marked out. Such branch meridian is called Luo-meridian. It is explained and indicated clearly in text in acupuncture books. In addition, in the text book of acupuncture, what is introduced is the vertical distribution of the meridians, except the Dai meridian, which goes horizontally in the body. While the current studies indicated that there are also many meridians that distributed in the body in a horizontal manner. Such meridians going vertically and horizontally build up not only a platen-form meridian network, but also a shallow-to-deep three dimensional network structure.

For this reason, in a sham acupuncture group, the inserted needle, though not touch and not stimulate the typical acupuncture point/meridian, may do so on the branch meridians. But, because it is anyway not on typical acupuncture spot or meridian, the healing effect of the sham group is not as high as that in a typical acupuncture group. Chinese style of acupuncture never tells that there is no any healing effect without touching a correct acupuncture point.

The location of acupuncture points may be variable somehow from person to person. For a given person, the acupuncture point (meridians) might be variable in depth in different seasons. It is shallow in the body surface and deeper in winter. Therefore, the needle should be inserted shallow in summer but deeper in winter. Apparently the location and the position of the acupuncture point/meridian are in a dynamic manner. Therefore, acupuncture on a so called non-point theoretically still cannot exclude the possibility that it is an acupuncture point under some special conditions. 

In addition, the acupuncture point has a silent status and a sensitive status upon moxibustion stimulation. In a disease condition, the number of acupuncture points in sensitive status increases and chance to find such sensitive points increases. To perform moxibustion on such sensitive points would be easier to induce the along-meridian sensation with higher healing effect. However, such sensitive points are not necessary located on the acupuncture points and they seem not always present on that point. Along with the development or subside of a disease, its location may also change. All of these indicate that the hot-sensitive points are in a dynamic status. It also suggests that the spot or the zone on body surface that connect to body disease may not be only those spot or zone introduced in text book. 

5.7. Size of acupuncture point on body surface

The effective surface area of an acupuncture point means two points: first, it means the size of the skin area, within which an inserted acupuncture needle could exercise a healing effect; second, it mean the size under the skin area, within which an inserted acupuncture needle can also exercise a healing effect.

Generally it is believed that if the acupuncture needle is inserted into the acupuncture point, the healing effect would be highest. If it is inserted into the surrounding area of the acupuncture spot, the healing effect would be less. The far away from the acupuncture point, the less the healing effect. The acupuncture point might be a small spot in some acupuncture points, but in most points, they might be a zone or an area of some size. 

In clinic, if the location of an acupuncture point is not correctly chosen, the overall healing effect of the acupuncture treatment could be compensated by choosing more acupuncture points, use electrical acupuncture, or moxi acupuncture to increase the stimulation to the points. We may also insert the needle vertically into the skin first, and then insert the needle obliquely to different directions under the skin. This means that, even if the point chosen to insert the needle is not exactly the acupuncture point, move the needle under the skin can still be able to stimulate the effective area of the acupuncture point under its skin spot, so as to induce a healing effect.

5.8. Nourishing or depleting technique of acupuncture manipulation

It is very important the way of manipulation of the acupuncture needle to reach highest healing effect. The way of needle manipulation include the speed in which to insert the needle; the direction to insert the needle; to pull or to push, to bend or to tease the needle, after it being inserted into the skin, and so on. The aim is to re-balance the status of the Qi-blood movement to correct the disorder of the body function.

There are more than ten kinds of ways of needle manipulation. Different ways can be combined in the use. It is believed by some acupuncturists that mostly, to twist the needle inner-wards means nourishing, and out-wards means depletion.

Studies on human and animal showed that different way of the nourishing or depleting technique of acupuncture treatment could influence body function differently. It was also found that the overall effect of the nourishing or depleting technique depends on the body condition, which was the most important determining factor for the final effect of the acupuncture technique. If a patient is in a weak condition, no matter what kind of acupuncture technique is used, the overall effect is to nourishing, though the nourishing technique induces highest nourishing effect, the depleting technique, less. For a patient in an excess or an overwhelming condition, either the nourishing or the depleting technique induces a depleting effect, but the depleting technique induces more depleting effect than the nourishing technique.

To pay more attention to the nourishing or depleting technique would yield higher healing effect than not to pay attention to it,  even higher healing effect than electrical acupuncture. If we do not pay attention to the importance of the acupuncture technique, just insert the needle into the acupuncture point, pull or insert the needle little bit to induce some kind of Deqi sensation, then stop the handling of the needle further, there would also be some extent of healing effect. However, such way of acupuncture can only exercise low level of healing effect. This has been verified by the Western style of acupuncture again and again.  

5.9. Depth of acupuncture needle under skin

In Traditional acupuncture treatment, different acupuncture points need the acupuncture needle inserted into different depth under skin. Basically, in area where there is more muscle mass, the needle will be inserted deeper; where the muscle mass is less, the needle will be inserted shallow. This suggests that a shallow insertion of needle can also have healing effect. Furthermore in some acupuncture systems, such as in the wrist-ankle acupuncture system, [702-706],floating acupuncture system, [707-713] all the needles are required to be inserted in shallow, no matter where to insert the needle. Also, in some Japanese style of acupuncture, they practice acupuncture by inserting needle in shallow too. It was also found that, to use local acupuncture points, the needle can be inserted in shallow, while to use remote acupuncture points, the needle needs to be inserted deeper. For this reason, it is very hard for acupuncturists in China to accept a shallow acupuncture group as a sham group in acupuncture studies. 

Furthermore, even if for a given acupuncture point, different depth of needle stimulation may induce different healing effect. For example in the Dr. Dong’s out-meridian acupuncture system, to stimulate the point Ren Shi, Tian Shi and Di Shi points in 0.5 inch shallow, it treats asthma; in 1 chin, treat heart failure. For Di Zong point, shallow stimulation in 1 inch, treat mild disease; deeper stimulation at 2 inches, treat severe disease. The Ren Zong, Tian Zong and Di Zong points, stimulate them at 0.8 inch, treat common cold; at 1 inch, treat upper arm pain; at 1.2 inch, treat disease in liver, spleen, and gall bladder.

5.10. Number of acupuncture needle to be used

In the acupuncture text books, generally speaking, it is only mentioned the function of each acupuncture point. It does not talk about how many acupuncture points should be used for the treatment. This might be because the acupuncture treatment depends on the severity of the disease, the body tolerance to the needle stimulation, and the personal skill of the acupuncturist, and so on.

For example, every acupuncturist knows that the Neiguan point can be used to treat nausea/vomit. But the reasons that cause the nausea or vomit are largely variable. It can be due to improper diet, car sick or ship sick, surgical operation or anesthesia, pregnancy, drug side effect, or due to chemotherapy or radiation therapy and so on. For an acute nausea or vomit, one point might be enough, or two points are enough. But for other conditions, one point may not work well. Without knowing this and only use one acupuncture point, it would get higher chance to fail in the acupuncture treatment and result in a conclusion that acupuncture has only short term effect but not a long term effect.

马玉侠 (2013) treated 34 patients with primary dysmenorrhea by acupuncture on single acupuncture point, once a day for three days in a role, repeated for three circles. The pain level reduced by 70% (VAS value down from 68.75 to 21.42), suggesting that one acupuncture point can also work well.

However, it would be strange that some researchers did acupuncture only once (on dog) and wish to see if a single acupuncture treatment could reduce the swelling of post-operative wound (Saarto EE 2010). If acupuncturists in China do it, they most possible will not perform acupuncture only once.

Vas J (2008) treated patients with unilateral subacromial syndrome. The treatments consisted of five times of physiotherapy and one time acupuncture (single point only) every week, for totally 3 weeks. Though the results showed that the improvement of pain scale is more in the physiotherapy-acupuncture group, compared with the physiotherapy-sham TENS control group, the chance to fail is high.

Another example for a good healing effect by a single acupuncture point is the acupuncture treatment of acute sprain, acute neck pain, or the pain induced due to the acupuncture per se.  In these examples, one acupuncture point works enough. There are many of such cases, especially if the acupuncture was done by an acupuncture expert. However, for most of chronic diseases, single point is not sufficient to solve the disorder.

For a given symptom, if a basic point is sufficient to use, or it is needed for more complementary points, depends on the symptom and the reason that causes the symptom. This has been well discussed above.

Which acupuncture point(s) and how many acupuncture points are needed not depending on the Western medicine diagnosis of the disorder, but mostly on TCM diagnosis and evaluation of the disorders? For example in the treatment of a joint arthritis, we not only need to know that it is an arthritis, but also  need to know which part of the joint with most pain, so as to determine which meridian the pain is associated to. We also need to know if the body is strong or weak, to know how strong the acupuncture stimulation that the patient can tolerate. During a treatment, if the patient cannot tolerate a given acupuncture point, we will not use that point but use alternative point(s).

5.11. Length of acupuncture treatment each session to induce Deqi sensation

One unclear question about the acupuncture treatment by acupuncturists in the Western countries is how long time they manipulate the needle during the treatment. Do they stop the needle manipulation right away after the patient feel the Deqi sensation, or, do they continue the manipulation for a while after the induction of the Deqi sensation? Chinese style of acupuncture requests the continuous manipulation of needle for a while after the Deqi sensation, so as to get as much as possible the along-meridian sensation. If such along-meridian sensation cannot be induced out, we may need to leave the needle for a longer time, use electrical acupuncture, or warm-needle acupuncture to increase the stimulating dose. 

The time to manipulate the needle might be several seconds,  one minute, two minutes,[722,723]  1-3 minutes, or 3-5 minutes.

It was found[726] that, in the treatment of patient in recovery period after a stroke, after getting the Deqi sensation, continue to manipulate the needles for 30 seconds works much better than to stop the manipulation right away.

 5.12. Retention time

In most articles published either in or out of China, the needles were left on spot for 30 minutes. Some are for 20 minutes. However, it was stated that acupuncturists in UK did not leave the needle for some retention time, after manipulate the needle to reach a Deqi sensation.

柳春梅 (2014) treated 30 cases of primary dysmenorrhea. The pain reduction started from 10 min after acupuncture. The pain-less period prolonged with the stay of the needle remained in the spot. The healing effect of acupuncture to stop the pain with 30 min retention time is better than that with 20 min retention.

何扬子 (1999) treated post-stroke syndrome. He found that retention time of 60 min or 30 min is better than that of 20 min.  

For the relationship between the retention time and the healing effect, acupuncturists in China have done a lot of studies (Attached List 20b ). The overall results showed that the proper length of retention time is related to the type of the disease treated.

(1). Post-stroke syndrome: retention of 60 min is better than 40 min and 20 min.

(2). Acute cerebral infarction: 12 hours is better than 15 min.

(3). Cervical vertigo: 60 min is better than 45 min or 30 min.

(4). Trigeminal Neuralgia: 1.5 to 3 hours is better than 30 min.

(5). Intractable facial pain: 60 to 90 min is better than 30 min.

(6). Primary dysmenorrhea: 30 min is better than 20 min.

(7). Acute ankle sprain: 20-40 min is better than 5 min or 60 min.

(8). Chronic ankle sprain: 60 min is better than 5 - 40 min.

(9). Prolapse of lumbar intervertebral disc: 45 min is better than 15 - 30 min.

(10). Intractable hiccup: 60 min is better than 30 min.

(11). Vertebral basilar artery insufficiency vertigo: 4 hours is better than 30 min.

For these diseases, it seems that longer time of retention works better than shorter time. However, each disease seems to have its own proper retention time for the highest healing effect. In some other diseases, shorter retention seems to work even better than longer time instead.  

(1). Simple facial nerve palsy: 10 min is better than 40 min; 20 min is better than 10 min or 40 min.

(2). Trigeminal neuralgia (by electrical acupuncture): 20-30 min works better than 2-3 hours, 10 min is better than 30 min.

(3). Acute fever diseases: Without retention, the reduction effect of fever has already reached 59.6%.

Apparently, it is hard to get a unique proper retention time for all types of diseases. For a given disease, once the way of the acupuncture treatment is changed, the proper retention time would also change. For example for the treatment of trigeminal neuralgia, with ordinary manual acupuncture, the retention of 1.5 to 3 hour is better than 30 min, but with electrical acupuncture, the retention of 10-30 min works better than longer time retention. Therefore, for the acupuncture treatment of a given disorder, it is needed to check the literature for available data for the proper retention time tested.

5.13. Frequency of acupuncture treatment

Based on the published studies above, we can see that acupuncturists in China performed acupuncture in a different way as those in the Western countries. Among the differences, the most apparent one is that the former used much high ADD of the first course, as well as the TCD. The healing effect of acupuncture is not only determined by the stimulation dose of each session, but also by the frequency of the acupuncture treatment and total number of sessions.

In the treatment of chronic pain, we found that the healing effect of the first treatment could subside to some extent after 24 hours. Therefore, we always asked our clients to have acupuncture treatment again on the next day. After the second treatment, the healing effect can remain for about 3 o 4 days.

In clinic, for the treatment of acute diseases or disorders, such as acute neck pain, acute low back pain, acute ankle sprain, etc., it can be said that acupuncture for one to two times can stop the pain dramatically even down to zero.

However for the treatment of chronic disease, such as chronic shoulder pain, chronic low back pain, chronic sciatic pain, chronic migraine, chronic knee pain, etc., it is needed to have a concentrated treatment, such as acupuncture for once a day. Generally, repeat the treatment as such for 3 to 5 times, the pain level can be reduced down to 20% to 30%. After that, the treatment can be shifted to once every two to three days, until the pain disappear completely. After that, we still need a maintenance course of once every week for 3 to 4 weeks. To do acupuncture by this way, a cure of the chronic disease is not impossible. During the treatment, we asked client do not have any physical exercise, nor any ice patch use. Since the pain was reduced within 7 to 10 days, the patient by himself will stop the use of any painkiller and no need to visit his family doctor for the same problem.

Indeed, someone has compared the healing effect of acupuncture by twice a week for five weeks and that by five times a week for two week. This was done by Yuan J. They did not find any difference. However, they used moxibution and cupping together with the acupuncture. It was a comprehensive treatment, not acupuncture alone. It can only mean that, with the combination of other therapies as in clinic, the acupuncture treatment can be done twice a week.

Meng Zh (2012) reported that, when they treated cancer patient with acupuncture, three times per week for 6 weeks, the incidence of dry mouth in acupuncture group, one month after stop of the treatment, is 25%, while that in the sham group, 90%, suggesting that the high treatment frequency and more times of the treatment could yield dramatic prevention effect on dry mouth in cancer patient after chemotherapy.

Streitberger K (2003) treated nausea after chemotherapy on breast cancer patients. They did acupuncture once a day for two day only. The nausea rate in the acupuncture group and the sham group is 61% and 64%, no significant difference. While Shen J (2000) performed acupuncture also for breast cancer patients after chemotherapy, once a day for 5 days, together with electrical stimulation, the days with nausea is 5 day in the acupuncture group, much less than 10 day in the sham group and 15 days in the no-treatment group.

In the treatment of hot flash, Vincent A (2007) used acupuncture once every two weeks for 5 weeks. The incidence of hot flash in the acupuncture group and the sham group has no significant difference.

However, Huang MI (2006) also treated hot flash with acupuncture, but they did acupuncture twice a week for two weeks, than once a week for following 5 weeks. After 7 weeks of such treatment, hot flash was reduced significantly in the acupuncture group than in the sham group. 

In the treatment of chronic low back pain, Ceccherelli F (2003) used acupuncture, five sessions per week, the pain reduction rate is 68.7%, while when the acupuncture was done 10 times a week, and the rate is 86.7%.

Acupuncturists in China did much more study on the influence of treatment frequency on the healing effect of acupuncture treatment.

齐宇 (2004) suspected the possible relationship between the low treatment frequency and the low healing effect of acupuncture treatment in the Western countries. They treated 33 cases of stroke patient with acupuncture, five times a week (first treatment group); 32 cases, twice a week (second treatment group), and another 30 cases with conventional Western medicine (medicine group) , all for three weeks. After three months, they found that the Barthel scale reduced by 70.5% in the first treatment group; 31.5% in the second treatment group; and only 26.1% in the medicine group.

李丹 (2015) treated 30 cases of slight cognitive disorder with acupuncture. They found that the acupuncture as once a day, 5 days a week for 3 weeks, works better than that as 3 times a week for 5 weeks. 

徐振华 (2006) tested how an acupuncture treatment as once a day (treatment group A, 32 cases)or twice a day (treatment group B, 35 cases) would influence the healing effect of acupuncture treatment on functional recovery (using Fugl-Meyer scale and ADL scale) of arm or legs of post-stroke patients. They found that after two courses, the treatment group B showed much more improved functional recovery than the treatment group A. They summarized that, twice a day of acupuncture works much better than once a day of acupuncture in those patients.

When we use acupuncture to quit smoking, we ask acupuncture every day for 7 to 10 days. By this way, the cigarette smoking can be reduced from more than 20 cigarettes per day down to 0 to 1 per day. If we have acupuncture once a week for 7 to 10 weeks, nothing will happen for the amount of daily cigarette smoking. Therefore, when we check the published studies on quit smoking by acupuncture, we have to point out that in most   studies, the poor result is due to too low treatment frequency.

There are data showing that, the half-life of acupuncture treatment is 3-6 hours. So, to maintain a continuing stimulation of acupuncture, it is needed to increase the acupuncture treatment frequency. This opinion is supported by 邢艳丽 (1993) study. The author found that to treat post-stroke syndrome, acupuncture as three times per day works better than once a day. For the same type of disease, 焦阳 (2008) reported that acupuncture as twice a day with a retention time of 30 min works better than that as once a day with a retention time of 6 hours. These findings suggest that frequency of the acupuncture treatment is more important than the length of retention time.

张秉芬 (2014) believed that surely acupuncture treatment needs  an interval between each session. For some acute diseases, such as acute iaryngopharyngitis, acute conjunctivitis, or acute appendicitis, the acupuncture can be performed twice to three times per day. For chronic diseases, it can be performed once a day, with 7-day as a healing course and with 2-3 days break between each course. The author noticed that in the treatment of some chronic disease, such as post-stroke hemiplegia, facial paralysis, the healing effect usually is not apparent during the treatment, but it is so if there is an interval between the healing courses.

On one side, a shorter interval time between acupuncture sessions is important to reach higher healing effect. On the other side, it was observed in clinic that it does not always mean that the shorter interval between each session, the better the healing effect for all kinds of diseases. Long time and no interval treatment, or continuous treatment for many days, may make the patients tired, so as to reduce the Deqi sensation and the healing results.

Current data show that different diseases need different treatment frequency. Even for a given disease, the interval of acupuncture session might also be different between the acute phase or the chronic phase of the diseases (see Attached List 20c ). It has been reported that, for the treatment of chronic fatigue after stroke, cervical spondylopathy, peripheral facial paralysis, Bell's palsy, three times a week of acupuncture (or once every other day) has already reached the highest healing effect. To increase the treatment frequency to once a day does not increase the healing effect further more.  

In most of the acupuncture studies in Western countries, the acupuncture was done for once or twice a week and the difference between the acupuncture group and the sham group is not large enough to show statistically significant different. It would be very strange why the acupuncturists in the Western countries do not increase the treatment frequency. How come they did not think about that their low healing effect might be improved by increase in the healing frequency?

According to these articles, the acupuncture treatment frequency in studies is referred from that of Western style of physiotherapy, or from Traditional Chinese acupuncture. For example, Yuan J (2009) learned from others that it was determined that participants should receive a minimum of four and a maximum of 10 treatments in total.

Harris RE (2005) compared the influence of treatment frequency and healing effect of acupuncture for patient with fibromyalgia. They fund that an overall dose effect of treatment was observed, with three sessions weekly providing more analgesia than sessions once weekly. The authors however, did not come to the suggestion to test if more frequency treatment, such as five sessions per week or six sessions per week, might be much better to increase the healing effect of acupuncture. Three sessions of acupuncture per week seems a broad line between the low frequency and high frequency treatment schedule.

How comes that researchers in the Western countries choose to perform acupuncture as once or twice a week for about 10 sessions? Some indicated their articles that they consulted with so called acupuncture experts, or following the way of physiotherapy.

Juan J (2009) explained that someone has tested that acupuncture for at least 4 sessions, and maximum 10 sessions is enough. However, from the books published from China or out of China about acupuncture, In Chinese or English, it is hard to find a chapter talking about treatment frequency of acupuncture. Most possibly, they did not check and they did not know how the acupuncture was studied by acupuncturists in China.

5.14. Time to start acupuncture treatment

When to start acupuncture treatment is a practical question. Generally speaking for the treatment of chronic diseases, acupuncture can be started anytime. However, for paroxysmal diseases, such as paroxysmal hemicrania, or for periodic diseases, such as lower abdomen pain before period, the time to start the acupuncture is a question needed to be discussed and concerned. For the treatment of those diseases, we normally start the acupuncture 2 to 3 days before the onset of the diseases (once a day), rather than to start the acupuncture after the onset.

For example for the treatment of dysmenorrhea, we start the acupuncture 3 days before the period, once a day for three to four days, or until the pain completely disappears (mostly it needs only 1-2 day, rarely needs for 4 days). After that, acupuncture was performed once or twice a week until next period. This is one course. Such treatment plan was repeated for about 2 to 3 months. The level of the pain could be dramatically reduced to disappear. The studies by马玉侠, 杜冬青, 蔡培云 support such schedule. This treatment plan is also suitable for the treatment of infertility, but the acupuncture should be started 3 days before ovulation day.

张小莉 (2010) reported their ways of treating acute stage of cerebral infarction plus cognitive dysfunction. They found that acupuncture started within 7 days of the infarction (20 cases) works better than started after 7 to 30 days of the infarction (20 cases).

Acupuncturists in China have had lot of studies on this topic (see Attached list 20d ). Generally speaking, acupuncture works better in acute phase than in chronic phase, the earlier the better. For the treatment of acute cerebral infarction or cerebral hemorrhage, the healing effect is the highest if the acupuncture started within 72 hours of the onset.

The data above suggest that the starting time for acupuncture treatment is also one of the determining factors affecting healing effect.

5.15. Evaluation of long term healing effect

For how long the healing effect of acupuncture treatment could remain is one of the topics in many acupuncture studies in Western countries. It is strange that it is hard to find an article to calculate the long term healing effect from the time when the symptom disappears. In most of the articles, it is calculated starting from a fixed time after acupuncture treatment started. For example, they give patient acupuncture treatment for 8 weeks, or 3 months, or 6 months, then observe the healing effect after one year (starting from the first day of acupuncture). They do no care if the symptom has been reduced to zero or not yet. Someone even tested the cure rate of wound after only one time acupuncture treatment. It is too optimistic for acupuncture.

Someone even performed acupuncture only once and wanted to see the wound healing. It is too over-look the power of acupuncture treatment.

Bokmand S (2013) treated dysmenorrhea with acupuncture for 3 months. The painful time was reduced from 53.8 hours to 31.5 hours. The pain level is still severe but the treatment was terminated. Then the author wanted to observe the long term healing effect of the treatment. To acupuncturists in China, if the pain was not reduced to zero or to minimum level, to observe long term healing effect seems a joke.

Sánchez-Araujo M (2011) tested if acupuncture prevents relapses of recurrent otitis in dogs. The dogs were given acupuncture treatments once every three days, for totally 4 times (without manipulation of needles). They observed the recurrent rate by such treatment schedule. To us, the success rate would be too low is the otiis was not improved dramatically with acupuncture after the end of the acupuncture treatment.

Acupuncture is not a miracle. If the symptom has not been reduced to zero or to a very mild level, the chance for the relapse is very high, especially if the factors that cause the symptom were not removed or not eliminated completely yet. For example for the pain on the knee, if it is due to long time of bending of the knee to work (for example for worker who worked to repair floor), and the patient needs to continue the same work style daily after acupuncture treatment, the long term healing effect is of course poor, even if acupuncture indeed worked to reduce the knee pain to zero.

Acupuncturist should also ask his clients to change life style or work style that cause the diseases, to eliminate the factors that cause the disease. By this way, the disease can be really "cured". Otherwise, no one on the earth can cure the knee pain for such patients. Therefore, it is meaningless to evaluate long term healing effect of acupuncture.

5.16. Complementary treatment

For the treatment of many kinds of diseases, it is needed to ask patients to have a break from heavy labor work or stressful work. Especially for the treatment of painful diseases, patients are asked to have a break, to reduce or to stop physical exercise, and not use ice on the pain spot. This is to reduce the chance to cause more damage to the painful tissue. Pain is a signal of our body asking us to stop the current way of life, not to increase or to continue the current way of life! However in many articles, it is not mentioned whether the researchers asked patients to stop heavy physical activity and not to use ice, both of which are very common in physical therapy and in chiropractic treatments.

It is very common in our clinic work that, if we do not emphasize not to continue physical exercise or not to use ice patch, our clients may continue exercise and continue the use of ice patch on the painful spot. Long term or frequent use of ice on painful spot could reduce blood circulation on the affected area to cause accumulation of metabolic waste material in the tissue, so as to slow down repair by body to the painful spot. Therefore, Chinese medicine mostly recommends the use of hot/warm patch. The only condition in which we also use ice patch, is sprain (on knee or on ankle, for instance). In such case, the ice patch would be only applied for once or for less than 20 min, and neither be repeated again and again.

5.17. Suitable and non-suitable diseases for acupuncture treatment