German Acupuncture Trials

The German Acupuncture Trials () are a series of nationwide acupuncture trials set up in 2001 and published in 2006, on behalf of six German statutory health insurance companies. They consist of one observational study on acupuncture side effects, and four randomized controlled trials (RCTs) - investigating acupuncture treatment for low back pain, knee osteoarthritis, migraine prophylaxis, and tension-type headache. The trials are considered to be one of the largest clinical studies in the field of acupuncture. Although there was no significant difference in efficacy between real and sham acupuncture for treatment of lower back pain, the efficacy of both types of acupuncture was noted to be almost twice that of standard therapy.
As a result of the GERAC trials, the German Federal Joint Committee ruled in April 2006 that the costs of acupunctural treatment for chronic back pain and knee osteoarthritis will be covered by public health insurers in Germany.
According to Schweizer Fernsehen, the total cost of the trials amounted to 7.5 million Euros. Several years after the Commitee's decision to incoporate acupuncutral treatment into the healthcare of Germany was passed into law, the number of regular users of acupuncture in the country eventually surpassed one million.
History
In October 2000, Germany's Federal Committee of Physicians and Health Insurers (Gemeinsamer Bundesausschuss) decided that acupunctural treatment may not be reimbursed by statutory health insurance companies except within the framework of experimental field studies.
Subsequently, the GERAC were set up at Bochum University in 2001, as a field study on behalf of six German statutory health insurance organizations. (AOK)
* Betriebskrankenkasse The number of patients randomized was one of the largest ever for acupuncture trials.
Only registered physicians with an additional license for acupuncture and at least two years of clinical experience in acupuncture treatment qualified as performing acupuncturists. In order to acquaint them with the study-specific standards of acupuncture, sham acupuncture and conventional therapy, the performing physicians received a one-day training.
The acupuncture point selection was partially predetermined. Needles were to be manipulated until arrival of sensation, which according to Traditional Chinese medicine indicates successful activation of an acupoint.
For sham acupuncture, needles were inserted only superficially (3 mm at most), and at bogus points; there also was no subsequent manipulation. Thus, only the patients (not the performing acupuncturists) could be . Type and quantity of needles were the same in real and sham acupuncture.
Assessment regarding the therapy's efficacy was undertaken by blinded interviewers. Beginning in 2001, the trials were carried out by the following universities:
* Heidelberg University
* University of Marburg
* University of Mainz
* Ruhr University Bochum
Results
;Low back pain trial
1162 patients were randomized in this trial. Treatment given in the standard therapy group consisted of a combination of physical therapy and NSAID medication. Primary outcome was met by 47.6% of patients in the real acupuncture group, 44.2% of patients in the sham acupuncture group, and 27.4% of patients in the conventional therapy group. This implied both real and sham acupuncture being significantly more effective than standard therapy (p<0.001); however, there was no statistical significant difference between the effectiveness of real and sham acupuncture (p=0.39).
;Knee osteoarthritis trial
A total of 1039 patients were randomized in this study. Treatment in the standard therapy group consisted of diclofenac or rofecoxib medication on an as-needed basis. Patients in the acupuncture and sham acupuncture groups were also allowed additional medication with diclofenac (as needed), but limited to a small amount (i.e., a total of 1g between week 2 and 23). Patients in all three groups could attend up to six physiotherapy sessions. Treatment success was defined as an improvement of at least 36% from baseline WOMAC scores at 13 and 26 weeks after the start of therapy. In the end, observed success rates were 53.1% for the acupuncture group, 51.0% for the sham acupuncture group, and 29.1% for the standard therapy group. This amounts to significant superiority of acupuncture and sham acupuncture over standard treatment, but no statistical significant efficacy difference between real and sham acupuncture (at p=0.48).
;Migraine prophylaxis trial
In this trial, a total of 960 patients was randomized; immediately after randomization, however, 125 patients (106 from the standard group) withdrew from the study. Primary outcome was defined as reduction in migraine days 26 weeks after randomization. Treatment for the standard group consisted of medication according to the 2005 therapy guidelines issued by the German Neurological Association, usually comprising a beta-blocker. Regarding the outcome, an average reduction in migraine days of 2.3 days in the real acupuncture group, 1.5 days in the sham acupuncture group, and 2.1 days in the standard therapy group were observed; this implies no statistically significant difference between the groups. There also was no statistical difference in the numbers of responders in each group (responding being defined by a reduction in migraine days of at least 50%).
;Tension-type headache trial
The standard, guideline-based therapy arm for the RCT for chronic tension type headache provided for amitryptiline medication. Although first-line, this usage of amitryptiline was not mentioned in the drug's package insert in Germany at that time. Subsequently, only four patients were willing to try this treatment, and the standard therapy arm had to be aborted. In the two remaining arms (real against sham acupuncture), 409 patients were randomized altogether. Successful treatment was defined as a reduction in headache days per month of more than 50%; this primary goal was achieved in 33% and 27% of patients in the real and sham acupuncture group, respectively, representing no significant difference (at p=0.18).
;Observational study
12,617 physicians took part in the observational study, reporting on adverse events during or after acupuncture therapies they performed between 2001 and 2005. This resulted in data of roughly 2.6 million patients, out of which a random sample of 190,924 was reviewed in terms of frequency of adverse events and serious adverse events. Adverse events were reported in 7.5% of the cases, including 45 serious adverse events. The three most frequent adverse events were bruising at the puncture site, temporary worsening of the original symptoms intended to be treated, and vasovagal response. Underreporting of adverse events had to be assumed.
Publication
From 2006 onwards, the trials were published in the following medical journals:
* Annals of Internal Medicine
* Archives of Internal Medicine
* The Journal of Headache and Pain
* The Lancet Neurology
Domestic consequences
Media
The trials received coverage from most of the major media outlets in Germany. According to the news broadcaster Deutschlandfunk, the GERAC trials are considered to be the world's largest set of clinical studies on acupuncture. The national daily newspaper Die Welt remarked that the results of the studies are "promising". As explained by the news magazine Der Spiegel, the Federal Committee of Physicians and Health Insurers decided in 2000 that the costs of acupunctural treatment is to be reimbursed under the condition that treatment is administered for the purpose of scientific evaluation of its effectiveness. Based on this evaluation, the Federal Committee will soon have to decide if acupuncture is to be recognized by public health insurers as a regular form of therapy (Kassenleistung).
Decision of German healthcare regulators
As a result of the GERAC trials, the German Federal Joint Committee (Gemeinsamer Bundesausschuss) recognized acupunctural treatment as a therepautical option to be reimbursed by public health insurance in Germany, specifically for the treatment of low back pain and knee pain.
On April 18, 2006, the Committee explained its decision as follows:
During the 16th legislative session of the Bundestag in July 2006, the German federal government announced that it will not object to the committee's decision. In a statement issued on July 3, 2006, the German Health Minister Ulla Schmidt confirmed the inclusion of acupunctural treatment for specific conditions as part of healthcare in Germany:
Usage of acupuncture
Several years after the Commitee's decision to incoporate acupuncutral treatment into the healthcare of Germany was passed into law, the number of regular users of acupuncture in the country eventually surpassed one million.
International reception
Assesement by Britain's National Health Service
In September 2007, Britain's National Health Service (NHS) reviewed the study and concluded that "this trial seems to support the role of acupuncture as an effective alternative therapy for chronic lower back pain".
Academic community
Within the academic community, the trials have received criticism for failing to uncover the specific mechanism of acupuncture. In addition, the trials found no significant differences between acupuncture and sham acupuncture.
Edzard Ernst, a researcher of complmentary medicine at the University of Exeter, noted that the studies had attracted criticism for not taking into account the risk of patient de-blinding, and said that they " to conclusively answer the question whether acupuncture helps patients through a specific or a nonspecific effect".
On June 8, 2005, the Deutsche Medizinische Wochenschrift (German Medical Weekly) published an article which criticized the trials for "not meeting scientific criteria".<ref name=dmw1/>

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