German acupuncture trials

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Needles being inserted into a patient's forearm.

The German acupuncture trials (German: GERAC-Studien[1]) were a series of nationwide acupuncture trials set up in 2001 and published in 2006 on behalf of several German statutory health insurance companies due to a dispute as to the usefulness of acupuncture.[2] 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.[2]

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.[3] This decision was made in part on the results of the trials and in part for socio-political reasons.[4] However, because of the trial's conclusions, some insurance corporations in Germany no longer reimbursed acupuncture.[5]

No significant differences between acupuncture and sham acupuncture were found in any trial.[5][6] 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.[6]

According to Schweizer Fernsehen, the total cost of the trials amounted to 7.5 million Euros.[7] 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.[8]

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.[9] 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."[10][11]

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.[12][13][14] In 2001 the GERAC were set up at Bochum University[12] as a field study on behalf of six German statutory health insurance organizations.[2][14]

Overview and results

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 for low back pain,[15][12] knee osteoarthritis,[12][16] migraine prophylaxis,[12] and tension-type headache.[12] Apart from that, an observational study on adverse events of acupuncture was done.[14]

The 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.[2] The number of patients randomized was one of the largest ever for acupuncture trials.[2][14] For each indication, around 1000 test subjects were included.[17][18] The trials were conducted using sham acupuncture.[4] The trial design was criticised as being faulty.[4]

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".[19]

No significant differences between acupuncture and sham acupuncture were found in any trial.[6] 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.[5] 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'".[5] The review said that the "sham acupuncture used in Germany may not be standardized and may not be suitable for acupuncture clinical trial research".[5] 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 "[failed] to conclusively answer the question whether acupuncture helps patients through a specific or a nonspecific effect".[20] In 2005, the Deutsche Medizinische Wochenschrift (German Medical Weekly) published an article which criticized the trials for "not meeting scientific criteria".[1]

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.[3] On April 18, 2006, the Committee had made their decision.[21] This decision was made in part on the results of the trials and in part for socio-political reasons.[4] 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.[22] However, 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.[5]

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.[8]

Reception

The trials resulted in increased coverage of acupuncture in the German media.[23] According to the news broadcaster Deutschlandfunk, the GERAC trials were considered to be the world's largest set of clinical studies on acupuncture.[24] An article in Die Welt said that the results of the studies were "promising".[25] Der Spiegel said that the results of GERAC couldn't be brushed aside by the Federal Joint Committee.[2]

ABC News reported that the study "highlights the superiority of acupuncture", but also introduces uncertainty about the specific mechanisms of treatment.[26] 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".[27] 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".[28] 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."[29]

See also

References

  1. ↑ 1.0 1.1 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. 
  2. ↑ 2.0 2.1 2.2 2.3 2.4 2.5 Hackenbroch, Veronika (2004-10-25). "Die eingebildete Heilung" [The Imaginary Healing]. Der Spiegel (in German). 
  3. ↑ 3.0 3.1 Hertzer, Karin (2009-08-12). "Akupunktur ist wirksam" [Acupuncture is effective]. Focus (in German). 
  4. ↑ 4.0 4.1 4.2 4.3 Birch, S. (2007). "Reflections on the German Acupuncture studies". Journal of Chinese Medicine (83): 12–17. 
  5. ↑ 5.0 5.1 5.2 5.3 5.4 5.5 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. 
  6. ↑ 6.0 6.1 6.2 Howick, Jeremy H. (2011). The Philosophy of Evidence-based Medicine. John Wiley & Sons. pp. 92–4. ISBN 9781444342666. 
  7. ↑ "Akupunktur" [Acupuncture]. Schweizer Fernsehen. 2003-03-10. 
  8. ↑ 8.0 8.1 "Frauen häufiger mit Akupunktur behandelt" [Women treated more often with acupuncture]. Rheinische Post (in German). 2012-08-30. Retrieved 2013-05-23. 
  9. ↑ 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. 
  10. ↑ Korzilius, Heike (2000). "Bundesausschuss: Streit um Akupunktur". Deutsches Ärzteblatt (in German) 97 (30): A–2013–4. Retrieved 2013-11-26. 
  11. ↑ 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. 
  12. ↑ 12.0 12.1 12.2 12.3 12.4 12.5 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. 
  13. ↑ 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. 
  14. ↑ 14.0 14.1 14.2 14.3 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. 
  15. ↑ Pyne, D.; Shenker, N. G. (2008). "Demystifying acupuncture". Rheumatology 47 (8): 1132–6. doi:10.1093/rheumatology/ken161. PMID 18460551. 
  16. ↑ 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. 
  17. ↑ Thieme Almanac 2007: Acupuncture and Chinese Medicine. Georg Thieme. 2007. p. 30. 
  18. ↑ Hessel, W. (2005). "Die Gerac-Akupunkturstudien". Skeptiker (1). 
  19. ↑ "Acupuncture may ease back pain". NHS Choices. 2007-09-26. Retrieved November 2013. 
  20. ↑ 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. 
  21. ↑ "Tragende Gründe zum Beschluss des Gemeinsamen Bundesau sschusses zur Akupunktur" (in German). Federal Joint Committee (Germany). 2006-04-18. 
  22. ↑ "Akupunktur wird Leistung der gesetzlichen Krankenkassen". Federal Ministry of Health (Germany). 2006-07-03. 
  23. ↑ "Akupunktur bei Migräne - nicht besser als ein Placebo?" (in German). de:Gesellschaft zur wissenschaftlichen Untersuchung von Parawissenschaften. Retrieved 2013-11-26. 
  24. ↑ Vorsatz, William (2007-11-13). "Bestechendes Argument" (in German). Deutschlandfunk. 
  25. ↑ "Studie belegt: Akupunktur hilft bei chronischen Schmerzen" (in German). Die Welt. 2007-01-17. 
  26. ↑ Williams, Carla (2007-09-24). "Fake or not, acupuncture helps back pain". ABC News. Retrieved 2013-11-25. 
  27. ↑ "Acupuncture more effective than conventional treatments for back pain: Study". Canadian Broadcasting Corporation. 2007-09-27. 
  28. ↑ "Needles 'are best for back pain'". BBC. 2007-09-25. Retrieved 2013-11-25. 
  29. ↑ Hawkes, Nigel (2007-09-25). "Sticking needles in a bad back 'eases pain better than drugs'". The Times. Retrieved 2013-11-25. 

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