German Acupuncture Trials

The GERAC studies ( German Acupuncture Trials, 2002-2007), the world's largest prospective, randomized study on the efficacy of acupuncture compared to a guideline- based standard therapy for the economically relevant indications of chronic back pain, chronic pain associated with osteoarthritis, chronic tension-type headache and chronic migraine. A placebo effect could not be detected. In another part of the study possible adverse effects (side effects) were recorded at over ten million acupuncture treatments. The GERAC studies were the basis for the introduction of acupuncture as German cash performance for the clinical picture of chronic low back pain and chronic knee pain in osteoarthritis of the knee.

Methodology

A governing body at the Ruhr- University Bochum ( H.-J. Trampisch (statistics, Bochum), J. Kraemer (orthopedics, Bochum ), HC Diener ( Neurology, Essen), J. Michaelis (Statistics, Mainz ), ( USA) A. Molsberger ( research group acupuncture, Dusseldorf ), H. Schaefer (statistics, Marburg), N. Victor (statistics, Heidelberg ), M. Zenz (pain, Bochum) ) coordinated the Germany -wide studies. Six universities with a total of 100 scientists were responsible for the sub-studies: Migraine University of Essen and University of Mainz, tension headache, Ruhr- University Bochum, University of Heidelberg osteoarthritis, low back pain University of Marburg. On the design, management and implementation of the study, the scientific society research group acupuncture played a pivotal role. 500 doctors, who had received at least 140 hours of acupuncture training at various German acupuncture societies and had at least two years of clinical experience with acupuncture have been specially trained for GERAC and resulted in their practices by the Prüftherapien. The GERAC studies were obtained from a consortium of major German statutory cash financed ( including the AOK, BKK, IKK ).

The three-arm trials compared to more than 3500 randomized patients, the efficacy of acupuncture in Chinese acupuncture points (verum, lat real ) with a non-Chinese acupuncture points ( sham, Eng. Pretense for ) and a conventional ( pharmacological, physiotherapy, etc.) therapy. Moxibustion and electrical stimulation of acupuncture points were not allowed in the GERAC studies. Total carried over 35,000 acupuncture treatments. The patients were compared to the type of acupuncture (verum or sham ) blinded.

Main results

The main results were collected six months after starting treatment.

• In chronic Gonarthroseschmerz about 11 acupuncture treatments are superior within 6 weeks of a six -month standard conventional therapy with daily medication of pain and anti-inflammatory agents by about a factor of three.

• In chronic low back pain about 12 acupuncture treatments are superior to 1.7 -fold within 6 weeks of standard conventional therapy; the acupuncture patients were compared with a significantly less medication.

• In the prophylaxis of chronic migraine about 11 acupuncture treatments within 6 weeks are at least as effective as the daily intake of beta-blockers for 6 months.

• For tension headaches, acupuncture reduced the number of headache days per month, at least 50%. The comparison with the standard therapy had to be canceled because too few patients were willing to take amitriptyline for months.

• Acupuncture is a safe medical procedure comparable. Unwanted severe effects (side effects ) of acupuncture are negligible.

Could be detected for any of the indications an effect over placebo.

Importance for the German health care system

Based on these results, the Federal Joint Committee decided that acupuncture is covered by health insurance since January 1, 2007 for back pain and chronic joint pain. The unaccounted difference between an acupuncture of Chinese and non-Chinese points has an impact on the content of training of medical education and training for acupuncture. " A medical acupuncture training acupuncture - training and continuing education seminars, which focused mainly on only a historically-based selection of Chinese acupuncture points, can be explained by these study results, however, no longer legitimate ," said A. Molsberger, GERAC governing body.

Scientific and medical political resonance

In Germany and internationally GERAC studies experienced a positive response. This was mainly due to the high study quality ( standards of Good Clinical Practice were exceeded ), the large number of cases, the review of the Verblindungserfolges, the Guideline oriented standard therapy, which exceeds the generally accepted power in the German Statutory Health Insurance Physicians area, and the individualized acupuncture, taking into account the Chinese diagnosis. The similar positive effects of verum and sham acupuncture points were the placebo research a new impetus and led to a discussion about the specificity of acupuncture points. The 2009 update of the international Cochrane reviews to tension headaches and migraines, whose résumé were significantly influenced by the results of the GERAC studies come to the conclusion that acupuncture " a valuable non-pharmacological treatment option in patients with frequent episodic tension-type headache is " and that the "Acupuncture at least as effective, and possibly more effective as a prophylactic drug therapy, and this at lower adverse effects in migraine ."

Criticism

Critical less the design or the blinding but rather the cultural and experiential as well as related training and background of the therapist must be seen. So the criticism includes the following points:

• Not the documentation of the points used for the sham acupuncture. This allows the comparable effect of Scheinakupuktur for example, explained by the fact that there may indeed no standard points, but spare points which lie on the same meridian, were used. Recall that the same interconnect, though not stimulated at the optimum points, change neither the reduced penetration depth nor the lack of needle stimulation, which causes a toning, somewhat.

• The inadequate training of the therapist. In contrast to the information required here at least 140 hours for the A-diploma, the WHO recommends a period of training for a TCM additional training of at least 800 hours, including 675 hours theory and 185 hours supervised clinical practice. The correct acupuncture, in terms of Chinese medicine, also requires the provision of a diagnosis according to traditional Chinese medicine, including the integration of very subjective and therefore not as quick -to-learn standard methods such as the pulse diagnosis.