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12 Reections on the German Acupuncture studies Journal of Chinese Medicine Number 83 February 2007

Reections on the German

Acupuncture studies
By: Stephen Abstract
Birch The author discusses the recent German acupuncture trials showing how there remain difficulties in understanding
their results. Among these are unresolved questions about the acupuncture/sham acupuncture interventions,
Keywords: and the issue of whether their results can be generalised outside of the practice of acupuncture as an adjunctive
German treatment by physicians.
trials; sham

acupuncture; linical research into acupuncture can be a studies and those done through collaboration
GERAC, ART. critical aspect of how acupuncture is accepted between Munich and Berlin based research groups
by society. A number of large controlled trials (ART studies) were initiated because of a desire to
of acupuncture have been undertaken in Germany, maintain national insurance coverage for acupuncture
some of which have been recently published [Diener in Germany [Ernst 2004, Haake et al. 2003]. The
et al. 2006, Linde et al. 2005, Melchart et al. 2005, Scharf social insurance system had declared acupuncture of
et al. 2006, Witt et al. 2005]. Several of these studies questionable effectiveness and stated their intention
are perhaps the largest controlled trials to date of to stop paying for it. In response to this, negotiations
acupuncture [Haake et al. 2003, Streng 2007]. It is thus between the physician acupuncture groups and these
important to fully understand the results and their authorities decided that acupuncture could still be
implications. Trials of acupuncture have been plagued paid for provided the patient was being treated for one
by problems in the past, making interpretation of their of four medical conditions and that the patient was
results often difcult. Below I discuss how problems enrolled in a trial of acupuncture for that condition.
with these large trials also make such interpretation The four medical conditions that were judged to
difcult. have a promising evidence base were low back pain,
When clinical research studies are undertaken migraine, tension headache and osteoarthritis of the
it is important to know why the studies were done knee [Stux G, personal communication, Molsberger A,
and for whom. Sometimes the reasons and target personal communication]. But even this is somewhat
audience for a study become confused as researchers controversial. For example, one German physician
try to answer different questions for different reasons reports participating in an early meeting about the
in the same study. Additionally, in acupuncture trials trials where the stated reason for the trials was quite
there have been calls for many years to ensure that different: the insurance companies wanted to make
the tested treatment is valid and that an appropriate compensation for acupuncture treatments part of a
control is used, with various recommendations about package, resulting in signicantly less payment per
study design requirements depending upon the treatment for the physician. Many physicians did not
type of question and study. It is my contention that want this and, after negotiations, these studies were
these big German acupuncture studies on low back the result [Prost C, personal communication]. Further,
pain, migraine, tension headache and osteoarthritis the judgment about which four medical conditions to
of the knee raise many questions and give rise to focus on is also somewhat controversial. When these
contradictory interpretations of results, lingering four medical conditions were chosen because they had
controversies and unresolved questions. sufcient evidence to warrant further investigation
Why were the studies done? Acupuncture has for their inclusion in future insurance reimbursement,
historically been paid for by the social insurance the clinical trial evidence for acupuncture had drawn
system in Germany, provided that it is administered different conclusions. At that time only two medical
by a physician who meets the minimum training conditions (nausea and vomiting and post operative
required by the association the doctor is a member of. acute dental pain) had demonstrated treatment
There have been as many as 20,000-50,000 physicians effectiveness in trials [Acupuncture 1998, Birch et al.
using acupuncture in their practices in Germany as 2004, BMA 2000], neither of which has been included
a result of this [Streng 2007]. The so-called GERAC in either trials or the new insurance coverage in
Journal of Chinese Medicine Number 83 February 2007 Reections on the German Acupuncture studies 13

Germany. Several other conditions showed similar

levels of positive evidence such as tempero-mandibular The training requirements for acupuncture vary
disorder, stroke rehabilitation, bromyalgia [Birch et considerably according to who is practising it, in
al. 2004] yet these were not included in the German
studies. At the time of these discussions in Germany,
what context and as part of what overall system of
systematic reviews had drawn contradictory health care. This makes it quite difcult to generalise
conclusions regarding osteoarthritis of the knees, low
back pain and migraine, with single studies drawing
results of acupuncture practice in one situation to
tentative positive conclusions, but other studies not, practice in other situations
while the evidence for tension headache has lagged
behind those three [Birch et al. 2004]. The decision of more natural, less constrained and as real-world as
what conditions to focus on have been made partly on possible, with minimal limitations on the techniques
scientic grounds and partly socio-political grounds. that are applied and no concern about interactions
There are clear study designs for answering between the therapist and his staff with the patient
questions that arise on socio-political grounds. Typical [Thomas, Fitter 2002]. In the acupuncture versus sham
questions and models are: How effective is acupuncture comparison, studies tend to a very constrained model
compared to standard care? [e.g. Carlsson, Rosenhall with more rigid treatment protocols and complex
1990]. How effective is acupuncture in addition to requirements to maintain the blinding [Thomas, Fitter
standard care compared to standard care? [e.g. Hu 2002]. They also have to pay considerable attention to
et al. 1993]. How effective is the offer of acupuncture the interactions between patient and therapist and his
compared to not offering it? [e.g. Eisenberg et al. 2005, staff so that they can limit and attempt to control for
Vickers et al. 2004]. How cost effective is acupuncture? the non-specic effects that arise in clinical practice
[Ratcliffe et al. 2006, Wonderling et al. 2004]. These [Birch 2004, Lewith, Vincent 1996, Margolin et al.
questions are of particular socio-political interest and 1998, Vincent, Lewith 1995]. These are contradictory
compare acupuncture to no treatment or a standard approaches for a study. Naturally, the researchers
treatment [Thomas, Fitter 2002]. conducting these studies attempted a compromise,
The German federal committee that decided on thereby introducing potentially fatal aws and
these studies required the inclusion of sham arms in leaving us with difculty in interpreting the results.
the trials [Streng 2007] which answers a different type For example, the ART study on tension headache
of question: how effective are the active ingredients was proclaimed to be a success for acupuncture since
of acupuncture treatment? This kind of question both the acupuncture and sham were signicantly
is generally thought to be of interest to academics more effective than standard therapy [Melchart et
[Haselen 2005] and uses a sham comparison design al. 2005], and similarly for the ART migraine study
intended to control for placebo effects [Thomas, [Linde et al. 2005]. On the other hand, others outside
Fitter 2002]. This is important because the use of of Germany have proclaimed these studies very
the acupuncture versus no treatment or standard negative for acupuncture since acupuncture was not
treatment has been widely used outside of Germany more effective than the sham [Ernst 2004, Henderson
in reimbursement related trials in the US and UK 2005]. On the surface it seems that both interpretations
[Cherkin et al. 2001, Eisenberg et al. 2005, Thomas et are correct since the rst is related to the more socio-
al. 2006, Vickers et al. 2004, Wonderling et al. 2004] political insurance question and the second to the
and is usually thought to be the preferred design more academic question [Haselen 2005].
for this kind of question [Thomas, Fitter 2002]. The However, appearances are deceptive. The second
GERAC and ART studies ended up using a three-arm major problem with these studies lies in the question:
design where acupuncture was compared to sham what is acupuncture? This is a complex question as
acupuncture and a wait-list or standard therapy. its practice varies in different countries and among
They tried to address scientic and socio-political different traditions and practitioners [Birch Felt 1999,
questions at the same time. Unfortunately the Birch, Kaptchuk 1999, MacPherson, Kaptchuk 1997].
requirements of the two study designs, acupuncture Sometimes it is used as a stand-alone complete medical
versus sham acupuncture and acupuncture versus no system, sometimes as part of a complete medical
or standard treatment are quite different. In normal system alongside, for example, herbal medicine, and
clinical studies of drugs, these are not such huge sometimes it is used simply as a technique, added by
issues, but in acupuncture studies, where design medical personnel to their treatment toolbox [Birch,
issues are far more complex, these designs do not t Felt 1999]. The training requirements for acupuncture
well, if at all, together. In the acupuncture versus no vary considerably according to who is practising it,
or standard therapy design, the acupuncture can be in what context and as part of what overall system of
14 Reections on the German Acupuncture studies Journal of Chinese Medicine Number 83 February 2007

health care. This makes it quite difcult to generalise rather do the minimum necessary since they only use
results of acupuncture practice in one situation acupuncture occasionally as an auxiliary technique
to practice in other situations. In some countries, in their medical practice. It is thus rather convenient
such as China, the US, Japan and parts of Australia, for those arguing for less hours of training that the
acupuncture education is regulated by government acupuncture did not outperform the sham acupuncture
established or approved agencies. There are minimum as it supports their argument. Did this issue play any
standards of education required for different kinds of role in the trials and how the participating physicians
practitioners. In other countries regulation of training performed their treatments?
is more internally controlled: to join organisation X The various studies conducted in Germany
one must meet its minimal educational requirements recruited physicians from among the professional
after which one can enjoy the benets of being a organisations to perform the acupuncture. In the
member of that organisation, for example insurance GERAC low back pain study, as many as 50 physicians
reimbursement of treatment. This is the situation in private practice were recruited [Haake et al. 2003],
for acupuncture when practised by physicians in a similar number were recruited for the GERAC
Germany. migraine study [Stux G, personal communication]
and 320 for the knee osteoarthritis study [Scharf et al.
2006]. The basic training of many of these will have
In analyses of the treatments that were provided in been similar to or less than that recommended by the
two of the ART studies, the researchers acknowledged WHO for a physician who wants to use acupuncture
that an important percentage of the participating as an auxiliary technique within their medical
practice. Further, some of the studies attempted to
acupuncturists felt that they would have performed provide TCM type acupuncture [e.g. Haake et al.
the treatments differently than they were allowed by 2003, Stux 2007]. The minimum training programmes
to learn TCM acupuncture involve many hundreds
the study design of hours of study. Acupuncture programmes in the
UK and Canada are a minimum of 1,200 and 1,900
The World Health Organisation in consultation with hours of study respectively, while acupuncture and
numerous international acupuncture organisations TCM programmes in the US, Australia and New
(medical and non-medical) developed international Zealand are a minimum of 2,625, 2,500 and 3,600
educational guidelines for acupuncture [WHO 1999]. hours respectively [Moir 2007b] The numbers in
For any non-physician to practise acupuncture they Japan recently were a minimum of 2,235 hours [Birch,
recommend a minimum of 2,500 hours of study Ida 1998:305-307]. If the physicians who performed
(including 1000 hours of biomedical studies). For the acupuncture in these studies had completed the
a physician who wants to work primarily as an basic training required in Germany to join one of the
acupuncturist they recommended a minimum of 1,500 associations, it is quite probable that they were not
hours of acupuncture study and for physicians who trained in TCM sufciently to be able to make full TCM
want to use acupuncture techniques in their medical diagnostic decisions and apply treatment accordingly.
practice, they recommend not less than 200 hours of Furthermore, in analyses of the treatments that were
acupuncture study [Moir 2007a]. Of course these are provided in two of the ART studies, the researchers
guidelines only, but they are relevant when we look at acknowledged that an important percentage of the
how acupuncture was tested in the German studies, participating acupuncturists felt that they would
the probable training of the practitioners in these have performed the treatments differently than
clinical trials and how well these results generalise to they were allowed by the study design [Linde et al.
the practice of acupuncture elsewhere. 2006, Melchart et al. 2005]. Some of the participating
Up until a few years ago in Germany there was a practitioners [24% - Melchart et al. 2005, 20% Linde et
general agreement that for physicians to join one al. 2006] thought that the number of treatments may
of the major acupuncture organisations and get not have been enough. These complex issues lead to
insurance reimbursement, a minimum of 130 hours two questions.
of acupuncture education was required. Over the last Were all the participating acupuncturists adequately
years this number was increased in some groups to trained? It is possible that some of the participating
350 hours [Stux G, personal communication], more physicians were not sufciently equipped to perform
recently called the a-level and b-level licenses [Streng the TCM acupuncture treatments they were asked
2007]. But the issue of the number of hours of basic to perform. Although some see them as having
training in acupuncture required by organisations been well trained [Baeker et al. 2007], others have
has been contentious. Understandably many would questioned this [Stux 2007]. An important number
Journal of Chinese Medicine Number 83 February 2007 Reections on the German Acupuncture studies 15

of participants wanted to apply more treatment but were and clinical effectiveness. Perhaps this is why some study
constrained by study design. Many in the non-physician authors concluded: Our observation raises the question
community, who use acupuncture as a complete system of of whether there is a single optimal point selection and
therapy rather than as just an adjunctive technique within whether deep needling with stimulation and deqi is
a medical practice, have questioned how well prepared superior to shallow needling [Scharf et al. 2006]. Besides
the participating practitioners really were [Stux 2007]. these questions, the issue of whether one can generalise
This leads to the second question. from studies where acupuncture was used primarily as
Can we generalise these results beyond the practice an adjunctive therapy in medical practice to the general
of acupuncture by physicians trained only to use practice of acupuncture still remains.
acupuncture as an adjunctive technique within general Some people reading these studies have noted that
medical practice? Can we proclaim that acupuncture does the lack of signicant difference between the real and
or does not work? I think not. It is necessary to state clearly sham arms of the trials implies that it does not matter
what was done; the nature of the acupuncture given, by where one inserts the needles and that thus the theories
whom and how the results relate to that alone and not of acupuncture are unnecessary [Ernst 2004]. This is an
attempt to make grandiose statements [Ernst 2004] about invalid conclusion. In order to answer questions about
acupuncture. I believe that all we can say is that when site specicity, or the relative role of the sites at which
physicians trained to use acupuncture techniques in their the needles are inserted, it is necessary to apply the same
medical practice compared such treatments to techniques techniques to both those sites and the control sites [Baecker
they were unfamiliar with (the sham - more on this below), et al. 2007, Birch 2003]. This was not done in these studies.
they could produce no difference in results between their Both the sites of needle insertion and types of needling
chosen treatments and sham treatments and that both varied.
forms of acupuncture were generally better than or Finally, there are questions concerning recruitment.
equal to the treatment they usually provide for the same Patients were generally recruited out of the practice
conditions. Although it is difcult to interpret this nding, of participating physicians. For a social or economic
it certainly does not sound the death knell of acupuncture comparison study this is a proper recruitment strategy,
as some would try to have us believe [Ernst 2004]. but for a sham study it makes it virtually impossible to
The next major issue with the study was the sham guarantee that all the strict requirements needed for sham
acupuncture. Sham interventions are usually used in studies were followed [Margolin et al. 1998]. Because
order to control for placebo effects so that the specic the therapist is not blind to treatment assignment, it is
effects of the therapy can be examined. However, as the important to keep the therapist out of all communications
study authors acknowledge [Linde et al. 2005, Scharf et with the patient except for those necessary for the correct
al. 2006], their sham (minimal acupuncture) is an active administration of the treatment. It is very difcult to
sham and is not a placebo treatment. I need to emphasise eliminate the possibility of unintended communication
this because many that see a sham controlled study when the therapist is involved in patient selection and
reexively interpret it as a placebo controlled study. Thus screening, treatment assignment, setting up the study
when, in this case, acupuncture did not outperform the with the patient and administering the treatments.
sham, it is seen as meaning it was no better than placebo. [Margolin et al. 1998] A second problem concerns how
This conclusion is not valid and cannot be drawn from strictly the inclusion-exclusion criteria were applied and
sham acupuncture studies unless particularly difcult monitored. In the original idea of the studies, patient
procedures are also followed [Birch et al. 2002, Birch treatments were to be paid for by the insurance companies
2004, 2006-a]. Any sham technique that is not inert if the patient was treated for one of the four conditions
needs to have been investigated in pilot studies so that studied and was enrolled into the relevant study. In fact
one can determine what it is capable of doing and to reimbursement would continue only for patients with
ensure that it is not (unbeknownst to the researchers) a one of these problems, provided they participated in the
highly active treatment [e.g. Wyon et al. 1995, see Birch studies. The Munich-Berlin group conducted a number
1997 and Medici et al. 2003, see Birch 2003a]. There is of lesser controlled studies to examine adverse effects
no evidence of pilot studies having been conducted in [Melchart et al. 2004], epidemiological factors [Linde et al.
these German studies [e.g. Haake et al. 2003, Melchart 2006, Melchart et al. 2006] and cost effectiveness [Witt et
et al. 2005]. Hence these studies potentially suffer from a al. 2006]. This allowed the research teams to include huge
double fault with regards to the two types of acupuncture numbers of patients in the various studies. Given how
treatment given: i. the acupuncture treatments that were patient recruitment was performed in these studies, can
provided may have fallen short on adequacy through the we be sure that physicians wanting to treat a patient with
variability and nature of the training of the participating another medical problem (such as menstrual pain or IBS)
physicians, and ii. these treatments were compared to did not enroll the patient into one of the studies because
sham acupuncture treatments of unknown physiological they also complained of one of the four symptoms, thereby
16 Reections on the German Acupuncture studies Journal of Chinese Medicine Number 83 February 2007

ensuring that their treatments would be paid for? This results be taken into account by scientists and health
is unlikely in the ART studies where participating care analysts in other countries? How will they be
physicians could refer patients into the larger lesser interpreted in systematic reviews and what effect will
controlled studies. But it is likely to be more of a they have on the conclusions and potential applications
problem for the GERAC studies where the studies of those systematic reviews [Birch 2007]? Have these
did not offer this out to the participating physicians. studies exposed problems with how acupuncture is
From the study descriptions, it appears that recruiting understood to work? If so will this trigger demands for
physicians applied the inclusion-exclusion criteria more studies investigating specic effects using sham
themselves to patients in their practices, without controlled trials or have they nally demonstrated
the presence of an independent observer which is the inherent difculty of conducting them [Birch
necessary to ensure proper application of inclusion- 2006-b]? Is it now time to acknowledge that placebo,
exclusion criteria [Birch, 2004, Margolin et al. 1998]. rather than being a nuisance variable in clinical trials,
Although there was periodic external monitoring, is a poorly constructed term that captures some of the
this cannot exclude inadvertent problems. ways that the body heals itself and thus maybe should
not be controlled for? Answers to these questions will
only emerge over time.
It is difcult to generalise the results of these studies
outside the practice of acupuncture as adjunctive Stephen Birch PhD, LicAc (US), MBAcC (UK) has been
practising acupuncture for 25 years. He is author of several
therapy in medical practice. books and teaches widely throughout Europe. He has been
engaged in research on acupuncture for almost 20 years
and has written numerous papers about clinical trials of
In summary, I believe that the design used in these acupuncture, especially the needs of sham and placebo
studies makes contradictory interpretations possible. controlled acupuncture trials. Stephen currently practises in
It looks as though some or all of these studies may Holland.
have suffered from problems with the training of
the acupuncturists, adequacy of treatments and
References of placebo treatments,
importantly, use of an unvalidated and untested placebo effects and placebo
Acupuncture. Acupuncture: controls in trials of medical
sham. These issues make interpretation of the real- NIH consensus procedures when sham is
sham comparisons difcult. It is difcult to generalise development panel on not inert. J Alt Complem Med,
acupuncture. JAMA 2006-a: 12, 3:303-310.
the results of these studies outside the practice 1998:280,17:1518-1524.
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Baecker M, Tao I, Dobos GJ. Acupuncture Council News.
practice. Further the strict requirements for a sham Acupuncture Quo Vadis? September: 2006-b:p. 19.
On the current discussion
acupuncture study were either not followed and/ Birch S. Comments on the
around its effectiveness and
or not well monitored or regulated; there are issues point specicity. Thieme G e r m a n a c u p u n c t u re
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that when physicians used acupuncture in these Birch S. Issues to consider in
determining an adequate Birch S, Felt RO. Understanding
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treatment in a clinical trial
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Ther Med 1997:5:8-12. Livingstone,1999.
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As a result of these studies, acupuncture is now Trinh K, Zaslawski C.
non-specific effects of
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