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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.

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, but that 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.

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

Overview

This section may lend undue weight to certain ideas, incidents, or controversies. Please help to create a more balanced presentation. Discuss and resolve this issue before removing this message. (November 2013)

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.

The acupuncture point selection was partially predetermined. Needles were to be manipulated until arrival of de-qi sensation.

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. Type and quantity of needles were the same in real and sham acupuncture. Assessment regarding the therapy's efficacy was undertaken by blinded interviewers.

Individual 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. 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.
• 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.
• 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.
• Tension-type headache trial – The standard, guideline-based therapy arm for the RCT for chronic tension type headache provided for amitryptiline 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.
• 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.

Domestic consequences

Media

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 as follows:

Im Ergebnis hat der Gemeinsame Bundesausschuss in seinen Beratungen die in den Studien zu chronischen Rückenschmerzen und zur Gonarthrose erzielten Verbesserungen nachvollziehen können. Dass der genaue Wirkungsmechanismusder Akupunktur nach wie vor unbekannt ist und die spezifische Punktauswahl nach den Regeln der TCM in den Studien nicht als ausschlaggebend für den Therapieerfolg erhärtet werden konnte, führt nicht zwangsläufig zur Verneinung des Nutzennachweises. Ausschlaggebend für die Anerkennungist der geführte Nachweis, dass die Akupunkturbehandlung bei den genannten Indikationen der Standardtherapie überlegen ist. "In conclusion, the Federal Committee is able to accept the results of these studies regarding the treatment of chronic back pain and osteoarthritis of the knee. Although the exact mechanism of acupuncture remains unclear and the choice of acupuncture points according to TCM did not affect therapeutic outcome, the deciding factor is that acupuncutral treatment has been superior to convential therapy for the conditions listed above."

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. In a statement issued 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:

Die Anerkennung der Akupunktur durch den Gemeinsamen Bundesausschuss ist zu begrüßen. Sie erweitert den Leistungskatalog der gesetzlichen Krankenkassen um eine wirksame und schonende Behandlungsmethode für Patientinnen und Patienten mit chronischen Schmerzen der Lendenwirbelsäule und des Kniegelenks. Die Modellvorhaben der gesetzlichen Krankenkassen haben nämlich gezeigt, dass die Akupunktur bei diesen beiden Indikationen deutlich besser wirkt als die übliche Standardbehandlung mit Medikamenten oder Krankengymnastik. "I welcome the Federal Committee's decision to accept acupuncture as an effective treatment option for patients with chronic back pain and osteoarthritis of the knee. The proposed trials undertaken by statutory health insurers have shown that acupunctural treatment for these conditions is more effective than medication or physiotherapy"

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

• British Doctors Study
• Heart Protection Study
• Scandinavian Simvastatin Survival Study

References

1. ^ Hackenbroch, Veronika (October 25, 2004). "Die eingebildete Heilung". Der Spiegel (in German). Der Schwindel war Teil der Gerac-Studien ("German acupuncture trials"): der bislang größten wissenschaftlichen Akupunkturstudien, die im Auftrag mehrerer Krankenkassen klären sollten, ob die fernöstliche Nadelstecherei tatsächlich wirkt. {{cite news}}: Unknown parameter |trans_title= ignored (|trans-title= suggested) (help) Cite error: The named reference "spiegelacupuncture" was defined multiple times with different content (see the help page).
2. Gemeinsamer Bundesausschuss 2007, p. 2: "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."
3. ^ Howick, Jeremy H. (23 February 2011). The Philosophy of Evidence-based Medicine. John Wiley & Sons. pp. 92–4. ISBN 978-1-4443-4266-6. Cite error: The named reference "Howick2011" was defined multiple times with different content (see the help page).
4. ^ Hertzer, Karin (August 12, 2009). "Akupunktur ist wirksam". Focus (in German). Der Gemeinsame Bundesausschuss der Ärzte und Krankenkassen entschied dann im April 2006, die Akupunktur als Kassenleistung gegen Rücken- und Knieschmerzen anzuerkennen. {{cite news}}: Unknown parameter |trans_title= ignored (|trans-title= suggested) (help)
5. "Akupunktur". Schweizer Fernsehen. March 10, 2003. . 7 gesetzliche Krankenkassen in Deutschland unterstützen die Studien mit 7.5 Millionen Euro. {{cite web}}: Unknown parameter |trans_title= ignored (|trans-title= suggested) (help)
6. ^ "Frauen häufiger mit Akupunktur behandelt". Rheinische Post (in German). Autust 30, 2012. Retrieved 25 May 2013. {{cite news}}: Check date values in: |date= (help); 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 978-0-393-06661-6.
8. Korzilius, Heike (28 July 2000). "Bundesausschuss: Streit um Akupunktur" (PDF). Deutsches Ärzteblatt (in German). 97 (30): A-2013-14. Retrieved 26 November 2013. „Überraschend war, dass es unglaublich viele wissenschaftliche Veröffentlichungen gibt, darunter auch 100 randomisierte kontrollierte Studien", sagt Dr. med. Paul Rheinberger, Geschäftsführer des Arbeitsausschusses. „Je qualitativ hochwertiger die Studien jedoch waren, desto weniger Hinweise gab es zur Wirksamkeit der Akupunktur."
9. 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.
10. 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.
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}}: Unknown parameter |trans_title= ignored (|trans-title= suggested) (help)
13. Gemeinsamer Bundesausschuss 2007, p. 5: "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..."
14. "Eine weitere Stärke ist eine sehr hohe Power aufgrund der bislang größten Zahl an Patienten, die jemals in Akupunkturstudien randomisiert worden sind." - "Another strength is a very big power due to the largest sample size of patients ever to be randomized in an acupuncture trial." As seen at: Endres et al. 2007, p. C107
15. "Kohortenstudie: Studienteilnehmer - An der Kohortenstudie konnten alle niedergelassenen Ärzte mit mindestens einem A-Diplom für Akupunktur (140 Stunden Weiterbildung) teilnehmen ... Randomisiert kontrollierte Studien: Studienteilnehmer und Randomisierung - Die Mindestanforderungen an die Ärzte entsprechen denen der Kohortenstudie. Zusätzlich musste eine mindestens zweijährige Berufserfahrung in Akupunktur nachgewiesen werden." ("Cohort study: Participants - All registered physicians in own practice with at least an A-license (140 hours of advanced training) in acupuncture were allowed to participate in the cohort study ... Randomized controlled studies: Participants and Randomization - The minimum requirements for the doctors were in accordance with the cohort study's. Additionally, a minimum of two years of professional experience in acupuncture had to be substantiated.") As seen at: Endres et al. 2007, p. C102
16. "In eintägigen Schulungsveranstaltungen wurden alle Ärzte in die Durchführung der teilstandardisierten Verum- und Shamakupunktur sowie der leitlinienorientierten Standardtherapie eingeführt." ("In one-day training events, all physicians were familiarized with the implementation of semi-standardized verum acupuncture and sham acupuncture, and guideline-based conventional treatment.") As seen at: Endres et al. 2007, p. C102
17. "Die Akupunkturpunkte waren für die Prüfärzte teilstandardisiert vorgegeben." ("Acupuncture points were semi-standardizedly enjoined on the performing physicians.") As seen at: Endres et al. 2007, p. C102
18. Endres et al. 2007, p. C103
19. "Shamakupunktur war eine oberflächliche Akupunktur (bis maximal 3 mm), ohne Nadelstimulation, an falschen Punkten." ("Sham acupuncture consisted of a superficial acupuncture (to a maximum of 3 mm) without needle stimulation, at bogus points.") As seen at: Endres et al. 2007, p. C103
20. "Alle Patienten waren gegenüber der Akupunkturform verblindet." ("All patients were blinded regarding the type of acupuncture.") As seen at: Endres et al. 2007, p. C103
21. "Nadelart und -zahl ... waren deshalb gleich." ("Needle type and numbers ... therefore were the same.") As seen at: Endres et al. 2007, p. C103
22. "Auch den Interviewern war die Therapieform unbekannt, ..." ("The type of therapy also wasn't disclosed to the interviewers, ...") As seen at: Endres et al. 2007, p. C103
23. Pyne, D.; Shenker, N. G. (2008). "Demystifying acupuncture". Rheumatology. 47 (8): 1132–6. doi:10.1093/rheumatology/ken161. PMID 18460551.
24. Gemeinsamer Bundesausschuss 2007, p. 304
25. ^ Gemeinsamer Bundesausschuss 2007, p. 396
26. ^ 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.
27. ^ Gemeinsamer Bundesausschuss 2007, p. 390
28. Gemeinsamer Bundesausschuss 2007, p. 473
29. Gemeinsamer Bundesausschuss 2007, pp. 469–70
30. Gemeinsamer Bundesausschuss 2007, p. 469
31. ^ Gemeinsamer Bundesausschuss 2007, p. 431
32. Gemeinsamer Bundesausschuss 2007, p. 435
33. Endres et al. 2007, p. C103
34. Endres et al. 2007, p. C103
35. Endres et al. 2007, p. C104
36. "Akupunktur bei Migräne - nicht besser als ein Placebo?" (in German). de:Gesellschaft zur wissenschaftlichen Untersuchung von Parawissenschaften. Retrieved 26 November 2013.
37. William Vorsatz (13 November 2007). "Bestechendes Argument" (in German). Deutschlandfunk.
38. "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)
39. Hackenbroch, Veronika (25 October 2004). "Die eingebildete Heilung". Der Spiegel. {{cite web}}: Italic or bold markup not allowed in: |publisher= (help)
40. "Tragende Gründe zum Beschluss des Gemeinsamen Bundesau sschusses zur Akupunktur" (PDF) (in German). Federal Joint Committee (Germany). 18.04.2006. {{cite web}}: Check date values in: |date= (help)
41. "Akupunktur wird Leistung der gesetzlichen Krankenkassen". Federal Ministry of Health (Germany). 03.07.2006. {{cite web}}: Check date values in: |date= (help)
42. ^ Attention: This template ({{cite pmid}}) is deprecated. To cite the publication identified by PMID 24024341, please use {{cite journal}} with |pmid= 24024341 instead.
43. 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)
44. "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)
45. "Needles 'are best for back pain'". BBC. 25 September 2007. Retrieved 25 November 2013.
46. 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)
47. "Acupuncture may ease back pain". NHS Choices. 26 September 2007. Retrieved November 2013. {{cite web}}: Check date values in: |accessdate= (help)
48. "Acupuncture". NHS Choices. 22 May 2012. Retrieved November 2013. {{cite web}}: Check date values in: |accessdate= (help)
49. 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.
50. Cite error: The named reference dmw1 was invoked but never defined (see the help page).

• Endres, Heinz G.; Diener, Hans-Christoph; Maier, Christoph; Böwing, Gabriele; Trampisch, Hans-Joachim; Zenz, Michael (2007). "Akupunktur bei chronischen Kopfschmerzen". Deutsches Ärzteblatt. 104 (3): C101 – C108.
• Endres, Heinz G.; Victor, Norbert; Haake, Michael; Witte, Steffen; Streitberger, Konrad; Zenz, Michael (2007). "Akupunktur bei chronischen Knie- und Rückenschmerzen". Deutsches Ärzteblatt. 104 (3): C109 – C116.
• Gemeinsamer Bundesausschuss (27 September 2007). 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). Retrieved 5 November 2013. {{cite book}}: Invalid |ref=harv (help); Unknown parameter |trans_title= ignored (|trans-title= suggested) (help)

External links

• GERAC homepage

• Clinical trials
• Acupuncture