German Acupuncture Trials
The German Acupuncture Trials (German: GERAC-Studien) are a series of nationwide acupuncture trials set up in 2001 and published in 2006, on behalf of several 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 was reported to work as well as or even better than conventional therapy,[n 1] but that there was no difference in efficiency of true acupuncture and sham. Subsequent assessment of the trials judged that since the sham acupuncture was not a well-designed placebo, they were unlikely to have emitted clinically significant findings.
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.
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.
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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.
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. 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, the University of Marburg, the University of Mainz and the Ruhr University Bochum. The trials were for the following conditions:
- Low back pain trial – 1162 patients were randomized in this trial. The treatment given in the standard therapy group consisted of a combination of physical therapy and NSAID medication. In the outcome, true acupuncture and sham were significantly more effective than standard therapy; however, there was no statistical significant difference between the effectiveness of true and sham acupuncture.[n 2]
- 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 six physiotherapy sessions. The observed success rates amounted to significant superiority of acupuncture and sham acupuncture over standard treatment, but no statistical significant efficacy difference between true and sham acupuncture.[n 3]
- Migraine prophylaxis 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 efficacy, no statistically significant difference between the groups was observed.
- Tension-type headache trial – The standard, guideline-based therapy arm for the RCT for chronic tension type headache provided for amitriptyline medication. Since only a 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. No significant difference in efficacy was observed between true acupuncture and sham.
- 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.
The trials resulted in increased coverage of acupuncture in the German media. According to the news broadcaster Deutschlandfunk, the GERAC trials were considered to be the world's largest set of clinical studies on acupuncture. An article in Die Welt said that the results of the studies were "promising". Der Spiegel said that the results of GERAC couldn't be brushed aside by the Federal Joint Committee anymore.
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. 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. 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 acupuncture 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. In 2006, German researchers published the results of one of the first, largest controlled randomized clinical trials which indicated that there was no difference between acupoints and non-acupoints. As a result of the trial's conclusions, some insurance corporations in Germany no longer reimbursed acupuncture. It also had an adverse impact on acupuncture in the international community.
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 stated 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."
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". As of 2012[update] 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.
The trials found no significant differences between acupuncture and sham acupuncture.
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".
- "The decision was determined by the findings of the studies that acupuncture therapy in these cases showed significant advantages compared to 'standard therapy'. Whether the specific selection of acupuncture points according to Traditional Chinese Medicine (TCM) had any influence on these findings remained unclear but did not lead to a negative vote of the G-BA."
- In the GERAC back pain study, 1162 patients with chronic low back pain were randomized. The studies found the effectiveness of acupuncture to be almost twice that of standard therapy with 6-month response rates being 47.6, 44.2 and 27.4% for true acupuncture, sham and standard groups, respectively
- The GERAC trials were being conducted to compare acupuncture to sham acupuncture and guideline-oriented standard therapy. Unlike ARTs though, GERAC found very little difference between acupuncture and sham acupuncture. In results published in Scharf et al. 2006, the success rates (defined as a 36% improvement in WOMAC scores at 13 and 26 weeks) were 53.1% for acupuncture, 51.0% for sham acupuncture, and 29.1% for standard therapy. Both acupuncture and sham acupuncture were significantly better than standard therapy.
- Wenzel, K.-W (2005). "Akupunktur: Was zeigen die gerac-Studien?" [Acupuncture: What of the GERAC studies?]. Deutsche Medizinische Wochenschrift (in German) 130 (24): 1520. doi:10.1055/s-2005-870855.
- Hackenbroch, Veronika (2004-10-25). "Die eingebildete Heilung" [The Imaginary Healing]. Der Spiegel (in German).
- Gemeinsamen Bundesausschusses 2007, p. 2
- Howick, Jeremy H. (2011). The Philosophy of Evidence-based Medicine. John Wiley & Sons. pp. 92-4. ISBN 9781444342666.
- Hertzer, Karin (2009-08-12). "Akupunktur ist wirksam" [Acupuncture is effective]. Focus (in German).
- "Akupunktur" [Acupuncture]. Schweizer Fernsehen. 2003-03-10.
- "Frauen häufiger mit Akupunktur behandelt" [Women treated more often with acupuncture]. Rheinische Post (in German). 2012-08-30. Retrieved 2013-05-23.
- Singh, Simon; Ernst, Edzard (2008). Trick Or Treatment: The Undeniable Facts about Alternative Medicine (1st American ed.). New York: W.W. Norton. pp. 81–2. ISBN 9780393066616.
- Korzilius, Heike (2000). "Bundesausschuss: Streit um Akupunktur". Deutsches Ärzteblatt (in German) 97 (30): A–2013–4. Retrieved 2013-11-26.
- Suess, Jochen; Scharl, Anton (2004). "Lässt sich die Wirksamkeit der Akupunktur naturwissenschaftlich erklären?". Die Hebamme 17 (4): 214–7. doi:10.1055/s-2004-860883.
- Gemeinsamer Bundesausschuss (2007-09-27). Zusammenfassender Bericht des Unterausschusses 'Ärztliche Behandlung' des Gemeinsamen Bundesausschusses über die Bewertung gemäß §135 Abs.1 SGB V der Körperakupunktur mit Nadeln ohne elektrische Stimulation bei chronischen Kopfschmerzen, chronischen LWS-Schmerzen, chronischen Schmerzen bei Osteoarthritis [Summary report of the subcommittee 'Medical treatment' of the Federal Joint Committee on the assessment pursuant to § 135 SGB V, Section 1 of the body acupuncture with needles without electrical stimulation for chronic headache, chronic lumbar pain, chronic pain associated with osteoarthritis] (in German). pp. 1–527. Retrieved 2013-11-30.
- Cummings, M. (2009). "Modellvorhaben Akupunktur - a summary of the ART, ARC and GERAC trials". Acupuncture in Medicine 27 (1): 26–30. doi:10.1136/aim.2008.000281. PMID 19369191.
- Endres, Heinz G.; Diener, Hans-Christoph; Maier, Christoph; Böwing, Gabriele et al. (2007). "Akupunktur bei chronischen Kopfschmerzen" [Acupuncture for chronic headache]. Deutsches Ärzteblatt (in German) 104 (3): A–114, B–105, C–101.
- Pyne, D.; Shenker, N. G. (2008). "Demystifying acupuncture". Rheumatology 47 (8): 1132–6. doi:10.1093/rheumatology/ken161. PMID 18460551.
- Gemeinsamen Bundesausschusses 2007, pp. 309-10
- Scharf, Hanns-Peter; Mansmann, Ulrich; Streitberger, Konrad; Witte, Steffen et al. (2006). "Acupuncture and knee osteoarthritis: A three-armed randomized trial". Annals of Internal Medicine 145 (1): 12–20. doi:10.7326/0003-4819-145-1-200607040-00005. PMID 16818924.
- Mao, Jun J.; Kapur, Rahul (2010). "Acupuncture in Primary Care". Primary Care: Clinics in Office Practice 37 (1): 105–17. doi:10.1016/j.pop.2009.09.010. PMC 2830903. PMID 20189001.
- Gemeinsamen Bundesausschusses 2007, p. 474
- Gemeinsamen Bundesausschusses 2007, p. 436
- "Akupunktur bei Migräne - nicht besser als ein Placebo?" (in German). de:Gesellschaft zur wissenschaftlichen Untersuchung von Parawissenschaften. Retrieved 2013-11-26.
- Vorsatz, William (2007-11-13). "Bestechendes Argument" (in German). Deutschlandfunk.
- "Studie belegt: Akupunktur hilft bei chronischen Schmerzen" (in German). Die Welt. 2007-01-17.
- "Tragende Gründe zum Beschluss des Gemeinsamen Bundesau sschusses zur Akupunktur" (in German). Federal Joint Committee (Germany). 2006-04-18.
- "Akupunktur wird Leistung der gesetzlichen Krankenkassen". Federal Ministry of Health (Germany). 2006-07-03.
- He, W.; Tong, Y.; Zhao, Y.; Zhang, L. et al. (2013). "Review of controlled clinical trials on acupuncture versus sham acupuncture in Germany". Journal of traditional Chinese medicine 33 (3): 403–7. PMID 24024341.
- Williams, Carla (2007-09-24). "Fake or not, acupuncture helps back pain". ABC News. Retrieved 2013-11-25.
- "Acupuncture more effective than conventional treatments for back pain: Study". Canadian Broadcasting Corporation. 2007-09-27.
- "Needles 'are best for back pain'". BBC. 2007-09-25. Retrieved 2013-11-25.
- Hawkes, Nigel (2007-09-25). "Sticking needles in a bad back 'eases pain better than drugs'". The Times. Retrieved 2013-11-25.
- "Acupuncture may ease back pain". NHS Choices. 2007-09-26. Retrieved 2013-11.
- "Acupuncture". NHS Choices. 2012-05-22. Retrieved 2013-11.
- Ernst, E. (2006). "Acupuncture - a critical analysis". Journal of Internal Medicine 259 (2): 125–37. doi:10.1111/j.1365-2796.2005.01584.x. PMID 16420542.