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German acupuncture trials

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Needles being inserted into a patient's forearm.

The German acupuncture trials (Template:Lang-de) were a series of nationwide acupuncture trials set up in 2001 and published in 2006 on behalf of several German statutory health insurance companies. They consisted 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.

No significant differences between acupuncture and sham acupuncture were found in any trial. A 2011 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 would be covered by public health insurers in Germany. Because of the trial's conclusions, some insurance corporations in Germany no longer reimbursed acupuncture.

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 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, saying: "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. In 2001 the GERAC were set up at Bochum University as a field study on behalf of six German statutory health insurance organizations.

Trial set-up

The Ruhr University Bochum

Beginning in 2001, the trials were carried out by Heidelberg University, the University of Marburg, the University of Mainz and the Ruhr University Bochum.

There were separate trials for four indications: low back pain, knee osteoarthritis, migraine prophylaxis, and tension-type headache. Apart from that, an observational study on adverse events of acupuncture was started.

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 involved acupuncturists were all medical doctors with a both a formal qualification and at least two years experience in acupuncture.

Conventional treatment included pain killers, injections, and physical therapy.

In the real acupuncture group, a semi-standardized acupuncture approach was used, i.e. part of the acupuncture points were predetermined and part of them could be freely selected by the acupuncturist. In regards of the technique, deep needling with stimulation and activation of de-qi sensation was stipulated.

In the sham control group, random points instead of acupuncture points were chosen. Needles were only superficially inserted and there was no subsequent stimulation or de-qi activation.

The number of patients randomized was one of the largest ever for acupuncture trials. For each indication, around 1000 test subjects were included.

In the observational study, 12,617 physicians reported on adverse events during or after acupuncture therapies they performed between 2001 and 2005, resulting in data on 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.

Results and analysis

No significant differences between acupuncture and sham acupuncture were found in any trial.

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 The guidance within the UK National Health Service is that acupuncture is supported for treatment of low back pain, and that "there is some evidence that acupuncture works for a small number of other conditions, including migraine and post-operative nausea. However, there is little or no scientific evidence that acupuncture works for many of the conditions for which it is often used".

A 2013 Chinese review stated that the results of controlled clinical trials of sham acupuncture in Germany had an adverse impact on acupuncture in the international community. The same review found there was "not enough evidence to support the statements that 'acupuncture and sham acupuncture have no difference in treatment effect' and 'acupuncture is just a placebo effect'". The review said that the "sham acupuncture used in Germany may not be standardized and may not be suitable for acupuncture clinical trial research".

In 2005, the Deutsche Medizinische Wochenschrift (German Medical Weekly) published an article which criticized the trials for "not meeting scientific criteria".

In 2006, 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 " to conclusively answer the question whether acupuncture helps patients through a specific or a nonspecific effect".

Domestic consequences

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 their decision was based on the acceptance of the results of the trials as the deciding factor. During the 16th legislative session of the Bundestag in July 2006, the German federal government announced that it would 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. Since no difference in efficacy of verum and sham acupuncture was found in the trials, some insurance corporations in Germany chose to stop reimbursement 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.

Reception

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.

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."

See also

References

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  2. ^ Howick, Jeremy H. (2011). The Philosophy of Evidence-based Medicine. John Wiley & Sons. pp. 92–4. ISBN 9781444342666.
  3. ^ He, W.; Tong, Y.; Zhao, Y.; Zhang, L.; Ben, H.; Qin, Q.; Huang, F.; Rong, P. (2013). "Review of controlled clinical trials on acupuncture versus sham acupuncture in Germany". Journal of traditional Chinese medicine. 33 (3): 403–7. PMID 24024341. {{cite journal}}: Unknown parameter |displayauthors= ignored (|display-authors= suggested) (help)
  4. ^ Hertzer, Karin (2009-08-12). "Akupunktur ist wirksam". Focus (in German). {{cite news}}: Unknown parameter |trans_title= ignored (|trans-title= suggested) (help)
  5. "Akupunktur". Schweizer Fernsehen. 2003-03-10. {{cite web}}: Unknown parameter |trans_title= ignored (|trans-title= suggested) (help)
  6. ^ "Frauen häufiger mit Akupunktur behandelt". Rheinische Post (in German). 2012-08-30. Retrieved 2013-05-23. {{cite news}}: Unknown parameter |trans_title= ignored (|trans-title= suggested) (help)
  7. 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.
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  10. ^ 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 (PDF) (in German). pp. 1–527. Retrieved 2013-11-30. {{cite book}}: Unknown parameter |trans_title= ignored (|trans-title= suggested) (help)
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  12. ^ Endres, Heinz G.; Diener, Hans-Christoph; Maier, Christoph; Böwing, Gabriele; Trampisch, Hans-Joachim; Zenz, Michael (2007). "Akupunktur bei chronischen Kopfschmerzen". Deutsches Ärzteblatt (in German). 104 (3): A-114, B-105, C-101. {{cite journal}}: Unknown parameter |displayauthors= ignored (|display-authors= suggested) (help); Unknown parameter |trans_title= ignored (|trans-title= suggested) (help)
  13. Pyne, D.; Shenker, N. G. (2008). "Demystifying acupuncture". Rheumatology. 47 (8): 1132–6. doi:10.1093/rheumatology/ken161. PMID 18460551.
  14. Scharf, Hanns-Peter; Mansmann, Ulrich; Streitberger, Konrad; Witte, Steffen; Krämer, Jürgen; Maier, Christoph; Trampisch, Hans-Joachim; Victor, Norbert (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. {{cite journal}}: Unknown parameter |displayauthors= ignored (|display-authors= suggested) (help)
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