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The German Acupuncture Trials (GERAC-Studien) 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.

The observational study revealed adverse events occurring in 7.5% of all acupuncture patients. While the trial for tension-type headache had to be aborted, the other three RCTs had the same results: acupuncture worked as well as or even better than conventional therapy. 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 Committee's decision to incorporate acupunctural 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 the late 1990s, German healthcare regulators began to voice their doubts over the therapeutical usage of acupuncture, mostly due to the lack of reliable evidence regarding its therapeutic efficacy. This resulted in a heated debate, which led to Paul Rheinberger, Director of the Federal Committee of Physicians and Health Insurers, making the following statement: "The higher the quality of clinical studies performed on acupuncture, the lesser the amount of evidence supporting its efficacy."

In October 2000, the Federal Committee of Physicians and Health Insurers 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. These organizations are:


 * Allgemeine Ortskrankenkasse (AOK)
 * Betriebskrankenkasse (BKK)
 * Bundesknappschaft
 * Innungskrankenkasse (IKK)
 * Landwirtschaftliche Krankenkasse (LKK)
 * See-Krankenkasse

Overview
All RCTs were designed as three-armed trials, with the three parallel groups in each trial receiving either verum (real) acupuncture treatment, sham acupuncture treatment, or guideline-based conventional treatment. 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 de-qi 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 blinded. Type and quantity of needles were the same in real and sham acupuncture. Assessment regarding the therapy's efficacy was undertaken by blinded interviewers.

Results


Beginning in 2001, the trials were carried out by the following universities: Heidelberg University, the University of Marburg, the University of Mainz and the Ruhr University Bochum. The results are summarized below:


 * Low back pain trial

1162 patients were randomized in this trial. Primary outcome was defined as 33% improvement or better on three pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire, or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire, 6 months after randomization. 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 ).

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 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.
 * Knee osteoarthritis trial

In this trial, a total of 960 patients was randomized; immediately after randomization, however, 125 patients (almost all of them from the standard group) withdrew from the study. Primary outcome was defined as reduction in migraine days in week 21 to 25 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.
 * Migraine prophylaxis trial

The standard, guideline-based therapy arm for the RCT for chronic tension type headache provided for amitryptiline medication. Since only few patients were willing to take this antidepressant, the standard therapy arm had to be aborted. In the two remaining arms (real against sham acupuncture), 405 patients were included 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=0.181).
 * Tension-type headache trial

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.
 * Observational study

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

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
After the committee's decision to incorporate acupuncuture into the healthcare of Germany was passed into law, health insurers reported that the number of users of acupuncture in the country increased, finding favour especially among women; in 2012 there were around one million estimated users.

Media
ABC News reported that the study "highlights the superiority of acupuncture", but also introduces uncertainty about the specific mechanisms of treatment. Heinz Endres, one of the authors of the study, told the Canadian Broadcasting Corporation that "acupuncture has not yet been recommended as a routine therapy", but "we think this will change with our study". The BBC pointed out that the study "echoes the findings of two studies published last year in the British Medical Journal, which found a short course of acupuncture could benefit patients with low back pain". Nigel Hawkes, health editor of The Times, wrote that the trials "suggest that both acupuncture and sham acupuncture act as powerful versions of the placebo effect."

Academic community
In September 2007, NHS Choices commented on the news surrounding the study and said that "this trial seems to support the role of acupuncture as an effective alternative therapy for chronic lower back pain" but that "it will be important to try to tease apart the real treatment effects from those that occur through the placebo effect". The guidance within the UK National Health Service is that "there is little or no scientific evidence that acupuncture works for many of the conditions for which it is often used", and its use is only supported for lower back pain.

It has been pointed out that the GERAC study could not find any advantage of needling specific acupuncture points in contrast to random points. Edzard Ernst, a professor of complementary 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 that they "[failed] 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".