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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.
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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 TENS,fake
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
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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.
Fig.1.
n =
number of experiment groups. Acup:Acupuncture.
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.
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).
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.
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 group(28.0%
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 group(42.7%
vs 28.0%).
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).
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).
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. 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).
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.
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.
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.
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.
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).
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,
3,6,7,10
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).
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.
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).
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).
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).
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 CBT,Alpha-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.
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) .
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).
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).
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%.
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).
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).
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).
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%).
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).
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 cases)and
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.
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.
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
As for any medical therapy,
acupuncture works for some diseases but not for others. For
example for the treatment of fibromyalgia, acupuncture may
not work as good as it is expected.
There has been a
survey
showing that, according to the number of published articles
for the disease of muscle-bone and connective tissue and
among total 3576 studies, there are only 13 studies related
to the treatment of fibromyalgia, which is only 0.4% of all
of the publications.
To meet the need of acupuncture clinic and research, WHO
hold a meeting in Milan in 1996.
In the meeting, it
was proposed 64 kinds of diseases/disorders as the suitable
categories for acupuncture treatment.
The meeting stated:
(1). Diseases that are claimed as the suitable to
acupuncture treatment, supported by randomization studies:
Quit alcohol, allergic nasitis, competitive syndrome, facial
paralysis, cholecystalgia, asthma, Heart neurosis, cervical
spondylosis, chronic pain in motor system, depression, quit
drugs, dysmenorrhea, headache, hemiplegic paralysis or other
post-stroke syndromes, herpes zoster, hypertension, primary
hypotension, impotency, induction, insomnia,
hypoleucocytosis, low back pain, migraine, reaction of
pregnancy, nausea or vomit, periarthritis of shoulder,
post-operative pain,premenstrual tension, Nerve root pain
syndrome, renal colic, arthritis pauperum, sprain or strain,
dysfunction of mandibular joint, tension headache, quit
smoking, trigeminal Neuralgia, and urinary stone.
(2). Diseases that are claimed to be suitable for the
acupuncture treatment by studies with sufficient number of
participants but no randomized study design:
Acute paristhmitis, acute pharyngolaryngitis, back
pain, ascariasis of biliary tract, chronic pharyngitis,
malposition, infantile enuresis, tennis elbow,
gall-stone, Irritable bowel syndrome, Meniere disease,
myofascitis, children myopia, simple obesity, pain
after amygdalectomy, chronic dementia, sciatica.
(3).
Diseases that are supported for acupuncture treatment, by
repeated clinic studies as acupuncture works faster, or
there are some experimental evidence:
Constipation, hypogalactia, diarrhea, infertility,
bathygastry, hiccup, urinary incontinence, painless labor,
retention of urine, nasosinusitis.
According
to
the survey
done in 2013 to acupuncturists in Jiangsu province, China,
the most suitable diseases for acupuncture treatment are:
Facial paralysis, stroke, low back pain, headache, neck
pain, stiffness of shoulder, insomnia, stomach pain, herpes
zoster and various knee pain.
Other data
suggest that the suitable diseases for acupuncture treatment
are:
(1). Digestive diseases: hiccup, stomach pain, diarrhea,
constipation, nausea, intestinal pseudo-obstruction and
haemorrhoids.
(2). Skin diseases: acne, urticaria chronica, and
neurodermitis. Most possible effective diseases: chloasma,
corn, cutaneous pruritus. Possible effective: pelada,
eczema, psoriasis, leucoderma, bedsore.
(3). Psychiatric and behavior disorder: dementia, abstinence
syndrome, mental retardation, obsession, dyssomnia,
gastrointestinal neurosis, depression, alcoholism, and
globus hysteriocus.
The category of dominant diseases for acupuncture treatment
is not unchanged. Along with the effort of acupuncturists in
China, the dominant list is enlarging. On the other side, if
an acupuncturist gets only hundreds of hours of acupuncture
training and practices acupuncture according only to what
they learned from text book, he/she may not be able to solve
these diseases. In this point, the so called dominant
diseases for others may not be the dominant disease for
him/her.
A good knowledge about acupuncture is not at all enough to
become an acupuncture expert. Practice, practice and
practice to gain sufficient experience is the way to be an
expert. Acupuncture is not as simple as to prescribe a pain
killer or sleeping pill to patients. It is as to drive a
car: having 10 year driver license does not mean that the
person can drive a racing car for competition.
For this reason, if an acupuncture research studies the
acupuncture healing efficiency on a not dominated kind of
disease, not dominate for either the whole acupuncture
society or for the given acupuncturist who participates the
study, the chance to fail in the study would be high.
Brief
summary:
(1).
To get
as high as possible the healing effect of acupuncture
treatment, acupuncturist not only need to pay attention to:
the acupuncture point to choose, the depth of the needles,
the Deqi needle sensation to induce, but also an
along-meridian needle sensation to induce, the frequency of
the treatment, the proper time to start the treatment, the
proper treatment schedules, etc.
(2). There are different acupuncture systems in China. Each
system may require different technique attention.
(3). For many kinds of diseases, to reach the aim of cure,
there should be a maintenance treatment period, after the
initial concentrated treatment.
(4). To test the long term healing effect of acupuncture
treatment, the observation should start after the symptom(s)
have already been reduced to very low level or to zero.
(5).
There are dominant and not-dominant diseases for
acupuncture treatment. The dominant disease that is dominant
for some acupuncturists may not for some others yet. So, it
is necessary to test practical skill of the acupuncturist
who participates in acupuncture study.
(6).
It is too early for acupuncture researchers in Western
countries to test those of diseases that do not belong to
dominant diseases for acupuncture treatment, before they
have already agreed that acupuncture works for these
dominant diseases and that acupuncture effect is not only a
placebo effect.
Footnotes:
[1]
The average daily stimulation dose is the number of
acupuncture sessions in a healing course divided by
the days in the course. For example, if the
acupuncture is done once a day for one week (7
days), the average daily dose is 1 (e.g. 7/7=1). If
the acupuncture is done once a week in the first
week, the average daily dose of the first circle
dose is 0.14 (1/7=0.14). Total course dose is the
sum of course dose in each course. The course dose
=average daily dose times the number of treatment
sessions in that course.
[2]
The data present in this article is
principally as
Mean ± SD.
[3]
For the reference list, please refer to the original
article of
Furlan A.
[4]
Textbook acupuncture does not necessarily mean
practical acupuncture.
[5]
This article started from August 2015.
[6]
The healing effect of some operation after a surgery
does not belong to that of the surgery. For example,
the clinic effect of a remote ischemic
preconditioning
after
in
patients undergoing coronary-artery bypass graft
(CABG) surgery does not belong to the heart surgery
per se.
[7]
If the laser or TENS works on acupuncture pints,
they are included into acupuncture groups.
[8]
Check
Pubmed using keyword “chiropractic”, we can get 6787
articles, but with “acupuncture”, 24692 articles.
[9]
Check Pubmed, using keywords “placebo chiropractic”
yielded 149 articles, “sham chiroopracitc”, 103
articles. “placebo acupuncture” yielded 1469
articles, and “sham acupuncture”, 1635 articles.
[11]
If in a paper, some parameter reaches significant
difference while some other is not yet, the paper is
listed as negative paper to acupuncture.
[12]
This meansthat the healing effect in a sham group is
higher if the study contains more than two
experiments groups.
[13]
Some kinds of disease might become
better automatically, such as allergic rhinitis
becomes better in summer.
[14]
Some disease may cure by it self
without any medical intervention.
[15]
Even the acupuncture association
should show evidence for their recommendation.
[16]
e.g. it is limited and restricted for the number of
needles, time of acupuncture sessions, communication
with patients, and so on.
[17]
The exact number depends on the type
of disease. If the maximum
healing effect of a sham group is 20%, the
acupuncture group should be more than 45%.
[18]
In attached list 14, some study is
to compare laser or TENS, not acupuncture, so that
it is omitted in Fig.21.
[19]
Personal consult with an acupuncture
department in Beijing.
[20]
In
fact, Chinese acupuncturists not only paid attention
to the wake-up of the patients with PVS, but also
the recovery of their body function and life ability
later. The use of acupuncture, massage, Tuinea and
herbal therapy are all for this aim.
[21]
Acupuncture point Neiguan is not
normally used for pain.
[22]
Some paper only reported grade
effectiveness change, some showed only MMSE change,
therefore, the basic data for each figure might not
be the same.
[23]
Date are deduced from figure in the
article.
[24]
The original text is:Placebo
needles consist of a blunted needle that moves up
inside its handle instead of into the skin.
[25]
In clinic,
many people suffered from painful muscle and pain is
very broad in size. It might be diagnosed as
fibromyalgia but patient can well tolerate the
needle stimulation. Many times, according to us, it
is not fibromyalgia.
[26]
This is average amount for most sham groups.
[27]
The acupuncturist in the western countries might be
family doctor, or physiotherapy, not professional
acupuncturist.
[28]
The names of the acupuncture experts
are collected from internet from their published
articles. We have no bias or preference to any
acupuncturists listed here or not.
[29]
It has
been mentioned in the studies published in the
western countries that the Deqi sensation was induced
out during the acupuncture, but we suspected if it
is really induced, since they may regard the slight
pain feeling as Deqi.
[30]
Chinese medicine is, of course, not miracle. It can
work for most of chronic diseases, not every kind of
diseases. This does not exclude that some doctor can
still work for such obstacle diseases that are to
cure by most of doctors.
See whole paper here:
(1).
Errors and mistakes in acupuncture
researches in Western countries
(2).
Factors influencing acupuncture researches
(3).
Acupuncture is not placebo effect
(4).
Placebo, sham acupuncture and acupuncture
researches
Continue to Chapter 6 to 17
References:
1-510
References:
511-1048
A
ttached Lists
:
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
18a,18b,18c,19a,19b,
19c,
20a,
20b,20c,
20d,
21a,
21b,
21c,
22,
23a,
23b,
23c