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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) 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.

In 2005, the Deutsche Medizinische Wochenschrift (German Medical Weekly) journal found that the trials were "not meeting scientific criteria". The trials showed there was no difference in efficiency of real and sham acupuncture. Subsequent assessment of the trials judged that since they did not include 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.

Background

The Ruhr University Bochum

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 were Allgemeine Ortskrankenkasse (AOK), Betriebskrankenkasse (BKK), Bundesknappschaft, Innungskrankenkasse (IKK), Landwirtschaftliche Krankenkasse (LKK), and See-Krankenkasse.

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.

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.

Domestic consequences

Media

The trials resulted in increased coverage of acupuncture in the German media. 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". News magazine Der Spiegel stated that the results of GERAC couldn't be brushed aside by the Federal Joint Committee anymore.

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 in 2006. 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. The German Health Minister Ulla Schmidt confirmed the inclusion of acupunctural treatment for specific conditions as part of healthcare in Germany on July 3, 2006.

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.

International reception

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". As of 2012 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 " 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".

See also

References

  1. ^ Veronika Hackenbroch (25.10.2004). "Die eingebildete Heilung" (in German). Der Spiegel. {{cite web}}: Check date values in: |date= (help); Italic or bold markup not allowed in: |publisher= (help)
  2. ^ Cite error: The named reference dmw1 was invoked but never defined (see the help page).
  3. ^ Jeremy H. Howick (23 February 2011). The Philosophy of Evidence-based Medicine. John Wiley & Sons. pp. 92–94. ISBN 978-1-4443-4266-6. Cite error: The named reference "Howick2011" was defined multiple times with different content (see the help page).
  4. ^ Karin Hertzer (12.08.2009). "Akupunktur ist wirksam" (in German). Focus (German magazine). {{cite web}}: Check date values in: |date= (help); Italic or bold markup not allowed in: |publisher= (help)
  5. "Akupunktur". Schweizer Fernsehen. 10.03.2003. {{cite web}}: Check date values in: |date= (help)
  6. ^ "Frauen häufiger mit Akupunktur behandelt" (in German). Rheinische Post. Retrieved 25 May 2013. {{cite web}}: Italic or bold markup not allowed in: |publisher= (help)
  7. Ernst, Simon Singh & Edzard (2008). Trick or treatment : the undeniable facts about alternative medicine (1st American ed. ed.). New York: W.W. Norton. pp. 81–82. ISBN 9780393066616. {{cite book}}: |edition= has extra text (help)
  8. Korzilius, Heike (28 July 2000). "Bundesausschuss: Streit um Akupunktur" (PDF). Deutsches Ärzteblatt (in German). 97 (30): A-2013-14. Retrieved 26 November 2013. {{cite journal}}: Italic or bold markup not allowed in: |journal= (help)
  9. Suess, Jochen (2004). "Lässt sich die Wirksamkeit der Akupunktur naturwissenschaftlich erklären?". Die Hebamme (in German). 17 (4): 214–217. doi:10.1055/s-2004-860883. Retrieved 26 November 2013. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  10. Cummings, M. (1 March 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. {{cite journal}}: Italic or bold markup not allowed in: |journal= (help)
  11. Gemeinsamer Bundesausschuss 2007, p. 2
  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}}: Italic or bold markup not allowed in: |journal= (help)CS1 maint: multiple names: authors list (link)
  13. "Die wissenschaftliche Gesamtverantwortung für die GERAC-Studien oblag der Abteilung für Medizinische Informatik, Biometrie und Epidemiologie der Ruhr-Universität Bochum..." ("Scientific responsibility for the GERAC studies fell to the department of medicial computing, biometrics and epidemiology at Ruhr University Bochum...") Gemeinsamer Bundesausschuss 2007, p.5.
  14. ^ "Egal wo: Reinstechen hilft gegen Schmerzen" (in German). Berufsverband Deutscher Internisten. 26.10.2004. {{cite web}}: Check date values in: |date= (help)
  15. "Akupunktur bei Migräne - nicht besser als ein Placebo?" (in German). de:Gesellschaft zur wissenschaftlichen Untersuchung von Parawissenschaften. Retrieved 26 November 2013.
  16. William Vorsatz (13.11.2007). "Bestechendes Argument" (in German). Deutschlandfunk. {{cite web}}: Check date values in: |date= (help)
  17. "Studie belegt: Akupunktur hilft bei chronischen Schmerzen" (in German). Die Welt. 17.01.07. {{cite web}}: Check date values in: |date= (help); Italic or bold markup not allowed in: |publisher= (help)
  18. "Akupunktur wird Leistung der gesetzlichen Krankenkassen". Federal Ministry of Health (Germany). 03.07.2006. {{cite web}}: Check date values in: |date= (help)
  19. ^ Attention: This template ({{cite pmid}}) is deprecated. To cite the publication identified by PMID 24024341, please use {{cite journal}} with |pmid= 24024341 instead.
  20. CARLA WILLIAMS (Sept. 24, 2007). "Fake or Not, Acupuncture Helps Back Pain". ABC News. Retrieved 25 November 2013. {{cite web}}: Check date values in: |date= (help)
  21. "http://www.cbc.ca/news/technology/acupuncture-more-effective-than-conventional-treatments-for-back-pain-study-1.646658". Canadian Broadcasting Corporation. Sep 24, 2007. {{cite web}}: External link in |title= (help)
  22. "Needles 'are best for back pain'". BBC. 25 September 2007. Retrieved 25 November 2013.
  23. Nigel Hawkes (September 25, 2007). "Sticking needles in a bad back 'eases pain better than drugs'". The Times. Retrieved 25 November 2013. {{cite web}}: Italic or bold markup not allowed in: |publisher= (help)
  24. "Acupuncture may ease back pain". NHS Choices. 26 September 2007. Retrieved November 2013. {{cite web}}: Check date values in: |accessdate= (help)
  25. "Acupuncture". NHS Choices. 22 May 2012. Retrieved November 2013. {{cite web}}: Check date values in: |accessdate= (help)
  26. 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.

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