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Needles being inserted into a patient's forearm.

The German Acupuncture Trials (German: GERAC-Studien[1]) are a series of nationwide acupuncture trials set up in 2001 and published in 2006, on behalf of six German statutory health insurance companies.[2] 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.[2]

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 worked as well as or even better than conventional therapy.[3] Although there was no significant difference in efficacy between real and sham acupuncture for treatment of lower back pain, the efficacy of both types of acupuncture was noted to be almost twice that of standard therapy.[4]

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.[5]

According to Schweizer Fernsehen, the total cost of the trials amounted to 7.5 million Euros.[6] 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.[7]

History

[edit]

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.[8] 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."[9][10]

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.[11][12][13]

Subsequently, the GERAC were set up at Bochum University[14] in 2001,[15] as a field study on behalf of six German statutory health insurance organizations.[2][13] These organizations are:

Overview

[edit]

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.[17] The number of patients randomized was one of the largest ever for acupuncture trials.[18]

Only registered physicians with an additional license for acupuncture and at least two years of clinical experience in acupuncture treatment qualified as performing acupuncturists.[19] 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.[20]

The acupuncture point selection was partially predetermined.[21] Needles were to be manipulated until arrival of de-qi sensation,[22] which according to Traditional Chinese medicine indicates successful activation of an acupoint.

For sham acupuncture, needles were inserted only superficially (3 mm at most), and at bogus points; there also was no subsequent manipulation.[23] Thus, only the patients (not the performing acupuncturists) could be blinded.[24] Type and quantity of needles were the same in real and sham acupuncture.[25] Assessment regarding the therapy's efficacy was undertaken by blinded interviewers.[26]

Results

[edit]
The Ruhr University Bochum

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 results are summarized below:

Rates of improvement among patients treated with acupuncture, sham acupuncture, and standard therapy
Treatment Low back pain Knee osteoarthritis Migraine Tension headache
Acupuncture 47.6%[4] 53.1%[27] 47%[28] 33%[29]
Sham acupuncture 44.2%[4] 51.0%[27] 39%[30] 27%[29]
Standard therapy 27.4%[4] 29.1%[27] 40%[28] N.A.[31]
Note: The treatment outcome of standard therapy for tension headache could not be determined because a large number of patients who were prescribed with Amitriptyline did not comply to take it.[31]
Low back pain trial

1162 patients were randomized in this trial.[4] Primary outcome was defined as 33% improvement or better on three pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire, or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire, 6 months after randomization.[32][33] Treatment given in the standard therapy group consisted of a combination of physical therapy and NSAID medication.[32][34] Primary outcome was met by 47.6% of patients in the real acupuncture group, 44.2% of patients in the sham acupuncture group, and 27.4% of patients in the conventional therapy group.[33][35] This implied both real and sham acupuncture being significantly more effective than standard therapy (p<0.001[33]); however, there was no statistical significant difference between the effectiveness of real and sham acupuncture (p=0.39[33]).[36]

Knee osteoarthritis trial

A total of 1039 patients were randomized in this study.[37][38] Treatment in the standard therapy group consisted of diclofenac or rofecoxib medication on an as-needed basis.[38][39] 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).[39][40] Patients in all three groups could attend six physiotherapy sessions.[37][40] Treatment success was defined as an improvement of at least 36% from baseline WOMAC scores at 13 and 26 weeks after the start of therapy.[40][41] In the end, observed success rates were 53.1% for the acupuncture group, 51.0% for the sham acupuncture group, and 29.1% for the standard therapy group.[27] This amounts to significant superiority of acupuncture and sham acupuncture over standard treatment, but no statistical significant efficacy difference between real and sham acupuncture.[27]

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.[42] Primary outcome was defined as reduction in migraine days in week 21 to 25 after randomization.[43] 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.[44][45] Regarding the outcome, an average reduction in migraine days of 2.3 days in the real acupuncture group, 1.5 days in the sham acupuncture group, and 2.1 days in the standard therapy group were observed; this implies no statistically significant difference between the groups.[46]

Tension-type headache trial

The standard, guideline-based therapy arm for the RCT for chronic tension type headache provided for amitryptiline medication.[47][48] Since only few patients were willing to take this antidepressant, the standard therapy arm had to be aborted.[49][50] In the two remaining arms (real against sham acupuncture), 405 patients were included altogether.[51] Successful treatment was defined as a reduction in headache days per month of more than 50%;[52] this primary goal was achieved in 33% and 27% of patients in the real and sham acupuncture group, respectively, representing no significant difference (at p=0.181).[53][54]

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.[55] This resulted in data of roughly 2.6 million patients,[56] out of which a random sample of 190,924 was reviewed in terms of frequency of adverse events and serious adverse events.[57] Adverse events were reported in 7.5% of the cases, including 45 serious adverse events.[58] The three most frequent adverse events were bruising at the puncture site, temporary worsening of the original symptoms intended to be treated, and vasovagal response.[59] Underreporting of adverse events had to be assumed.[60]

Publication

[edit]

From 2006 onwards, the trials were published in the following medical journals:

Domestic consequences

[edit]

Media

[edit]

The trials received coverage from most of the major media outlets in Germany. According to the news broadcaster Deutschlandfunk, the GERAC trials are considered to be the world's largest set of clinical studies on acupuncture.[65] The national daily newspaper Die Welt remarked that the results of the studies are "promising".[66] As explained by the news magazine Der Spiegel, the Federal Committee of Physicians and Health Insurers decided in 2000 that the costs of acupunctural treatment is to be reimbursed under the condition that treatment is administered for the purpose of scientific evaluation of its effectiveness. Based on this evaluation, the Federal Committee will soon have to decide if acupuncture is to be recognized by public health insurers as a regular form of therapy (Kassenleistung).[67]

Decision of German healthcare regulators

[edit]

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.[5]

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.[68] "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.[69] "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

[edit]

After the committee's decision to incorporate acupuncuture 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.[7]

International reception

[edit]

Media

[edit]

ABC News reported that the study "highlights the superiority of acupuncture", but also introduces uncertainty about the specific mechanisms of treatment.[70] 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".[71] 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".[72] 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."[73]

Academic community

[edit]

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".[74] 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.[75]

It has been pointed out that the GERAC study could not find any advantage of needling specific acupuncture points in contrast to random points.[76][77]

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".[78]

On June 8, 2005, the Deutsche Medizinische Wochenschrift (German Medical Weekly) published an article which criticized the trials for "not meeting scientific criteria".[1]

See also

[edit]

References

[edit]
  1. ^ a b Wenzel, K.-W (June 2005). "Akupunktur: Was zeigen die GERAC-Studien?". Deutsche Medizinische Wochenschrift (in German). 130 (24): 1520. doi:10.1055/s-2005-870855. PMID 15942849. Der Aufbau der Studie hält wissenschaftlichen Kriterien sicherlich nicht stand{{cite journal}}: CS1 maint: date and year (link)
  2. ^ a b c Veronika Hackenbroch (25.10.2004). "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 web}}: Check date values in: |date= (help)
  3. ^ "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." As seen at: Gemeinsamer Bundesausschuss 2007, p. 2
  4. ^ a b c d e Pyne, D.; Shenker, N. G. (29 April 2008). "Demystifying acupuncture". Rheumatology (journal). 47 (8): 1132–1136. doi:10.1093/rheumatology/ken161. PMID 18460551. 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
  5. ^ a b Karin Hertzer (12.08.2009). "Akupunktur ist wirksam". Focus (German magazine) (in German). Der Gemeinsame Bundesausschuss der Ärzte und Krankenkassen entschied dann im April 2006, die Akupunktur als Kassenleistung gegen Rücken- und Knieschmerzen anzuerkennen. {{cite web}}: Check date values in: |date= (help)
  6. ^ "Akupunktur". Schweizer Fernsehen. 10.03.2003. . 7 gesetzliche Krankenkassen in Deutschland unterstützen die Studien mit 7.5 Millionen Euro. {{cite web}}: Check date values in: |date= (help)
  7. ^ a b "Frauen häufiger mit Akupunktur behandelt". Rheinische Post (in German). Retrieved 25 May 2013.
  8. ^ Ernst, Simon Singh & Edzard (2008). Trick or treatment : the undeniable facts about alternative medicine (1st American ed.). New York: W.W. Norton. pp. 81–82. ISBN 9780393066616.
  9. ^ 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."
  10. ^ Suess, Jochen; Scharl, Anton (2004). "Lässt sich die Wirksamkeit der Akupunktur naturwissenschaftlich erklären?". Die Hebamme (in German). 17 (4): 214–217. doi:10.1055/s-2004-860883. S2CID 178540792. Retrieved 26 November 2013. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: date and year (link)
  11. ^ 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. PMID 19369191. S2CID 6879017.
  12. ^ Gemeinsamer Bundesausschuss 2007, p. 2
  13. ^ a b 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}}: CS1 maint: multiple names: authors list (link)
  14. ^ "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...") As seen at: Gemeinsamer Bundesausschuss 2007, p.5
  15. ^ "... wurden an der Universität Bochum Anfang 2001 die German Acupuncture Trials (GERAC) ins Leben gerufen, ..." ("... the German Acupuncture Trials (GERAC) were brought into being at Bochum University at the beginning of 2001 ...") As seen at: Endres et al. 2007, p. C101
  16. ^ a b c d e f "Egal wo: Reinstechen hilft gegen Schmerzen" (in German). Berufsverband Deutscher Internisten. 26.10.2004. {{cite web}}: Check date values in: |date= (help)
  17. ^ "Entsprechend den Vorgaben des G-BA waren beide dreiarmigen Kopfschmerzstudien für einen Wirksamkeitsvergleich zwischen Verumakupunktur, Shamakupunktur und leitlinienorientierter Standardtherapie konzipiert." ("In accordance with the Joint Federal Committee's specifications, both three-armed headache trials were designed for an efficacy comparison between verum acupuncture, sham acupuncture, and guideline-oriented conventional therapy.") As seen at: Endres et al. 2007, p. C102
  18. ^ "Eine weitere Stärke ist eine sehr hohe Power aufgrund der bislang größten Zahl an Patienten, die jemals in Akupunkturstudien randomisiert worden sind." - "Another strength [of the study] 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
  19. ^ "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
  20. ^ "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
  21. ^ "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
  22. ^ "... und die Nadel wurde manuell stimuliert bis zum Eintreten eines elektrisierenden Gefühls am Akupunkturpunkt ("De Qi"-Gefühl), ..." ("... and the needle was manually stimulated until arrival of an electrifying sensation at the acupuncture point ("De Qi" sensation) ...") As seen at: Endres et al. 2007, p. C103
  23. ^ "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
  24. ^ "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
  25. ^ "Nadelart und -zahl ... waren deshalb gleich." ("Needle type and numbers ... therefore were the same.") As seen at: Endres et al. 2007, p. C103
  26. ^ "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
  27. ^ a b c d e Mao, Jun J.; Kapur, Rahul (2010 Mar). "Acupuncture in Primary Care". Primary Care: Clinics in Office Practice. 37 (1): 105–117. doi:10.1016/j.pop.2009.09.010. PMC 2830903. PMID 20189001. 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 by Scharf et al. in 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. {{cite journal}}: Check date values in: |date= (help); Unknown parameter |month= ignored (help)CS1 maint: date and year (link)
  28. ^ a b Taylor, Frederick R.; Tepper, Stewart J.; Bigal, Marcelo E. (13 October 2006). "Abstracts and Citations". Headache: The Journal of Head and Face Pain. 46 (9): 1464–1473. doi:10.1111/j.1526-4610.2006.00594.x. The proportion of responders, defined as patients with a reduction of migraine days by at least 50%, 26 weeks after randomization, was 47% in the verum group, 39% in the sham acupuncture group, and 40% in the standard group (P= .133).
  29. ^ a b Linde, Klaus; Allais, Gianni; Brinkhaus, Benno; Manheimer, Eric; Vickers, Andrew; White, Adrian R. (2009 Jan 21). Linde, Klaus (ed.). "Acupuncture for tension-type headache". The Cochrane Database of Systematic Reviews (1): CD007587. doi:10.1002/14651858.CD007587. PMC 3099266. PMID 19160338. The meta-analyses on response, headache days per 4 weeks and intensity are heavily influenced by the large, rigorous trial by Endres 2007. For headache frequency (response and headache days per 4 weeks), this trial found statistically significant benefits over sham acupuncture. Interestingly, for the predefined outcome measure of this trial, the difference was not statistically significant (P = 0.18). The predefined outcome measure was the proportion of patients with at least 50% reduction at 6 months, but patients with protocol violations were counted as non-responders. For example, patients who changed from one analgesic to another were reclassified as non-responders. Thus, only 33% in the true acupuncture and 27% in the sham group were counted as responders, while the commonly used response criterion without reclassification yielded responder proportions of 66% and 55%, respectively. {{cite journal}}: Check date values in: |date= (help)
  30. ^ "Acupuncture 'like migraine pill'". BBC. 2 March 2006. Retrieved 26 November 2013. The researchers then returned to the patients between 23 and 26 weeks later and checked on whether they had been "migraine free" for 50% of days. It was found 47% of those receiving traditional acupuncture, 39% of those given sham acupuncture and 40% of those in the drug treatment group had been migraine-free for at least 50% of the time.
  31. ^ a b Linde, Klaus; Allais, Gianni; Brinkhaus, Benno; Manheimer, Eric; Vickers, Andrew; White, Adrian R. (2009 Jan 21). Linde, Klaus (ed.). "Acupuncture for tension-type headache". The Cochrane Database of Systematic Reviews (1): CD007587. doi:10.1002/14651858.CD007587. PMC 3099266. PMID 19160338. The trial by Endres 2007 was originally designed to include a third arm of patients randomized to amitriptyline, the currently most widely accepted therapy (Diener 2004). However, as patients were unwilling to participate in a trial with the possibility of being randomized to amitriptyline, this arm was dropped after 1 year of very poor accrual. {{cite journal}}: Check date values in: |date= (help)
  32. ^ a b Gemeinsamer Bundesausschuss 2007, p. 304
  33. ^ a b c d Haake, Michael; Müller, Hans-Helge; Schade-Brittinger, Carmen; Basler, Heinz D.; Schäfer, Helmut; Maier, Christoph; Endres, Heinz G.; Trampisch, Hans J.; Molsberger, Albrecht (2007). "German Acupuncture Trials (GERAC) for Chronic Low Back Pain: Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups". Archives of Internal Medicine. 167 (17): 1892–1898. doi:10.1001/archinte.167.17.1892. PMID 17893311.
  34. ^ "... bestand die leitlinienorientierte Standardtherapie aus einer Kombination von physikalischer Therapie und unterstützender Einnahme nichtsteroidaler Antirheumatika." ("... guideline-oriented standard therapy consisted of a combination of physical therapy and additional taking of non-steroidal anti-inflammatories.") As seen at: Endres et al. 2007, p. C111
  35. ^ Gemeinsamer Bundesausschuss 2007, p. 307
  36. ^ Gemeinsamer Bundesausschuss 2007, pp. 309-310
  37. ^ a b Gemeinsamer Bundesausschuss 2007, p. 396
  38. ^ a b Scharf et al. 2006, p. 13
  39. ^ a b Gemeinsamer Bundesausschuss 2007, p. 390
  40. ^ a b c Scharf et al. 2006, p. 14
  41. ^ Gemeinsamer Bundesausschuss 2007, p. 391
  42. ^ Gemeinsamer Bundesausschuss 2007, p. 473
  43. ^ Gemeinsamer Bundesausschuss 2007, pp. 469-470
  44. ^ Gemeinsamer Bundesausschuss 2007, p. 469
  45. ^ "Die sechsmonatige, medikamentöse Standardtherapie bei Migräne befolgte aktuelle Leitlinien (... Diener H, Limmroth V, Fritsche G et al.: Therapie der Migräneattacke und Migräneprophylaxe. Leitlinie der Deutschen Gesellschaft für Neurologie und der Deutschen Migräne- und Kopfschmerzgesellschaft...). Sie bestand meist aus der Gabe eines β-Blockers." ("The six-months medicamentous standard therapy adhered to current guidelines (... Diener H, Limmroth V, Fritsche G et al.: Therapy in migraine attacks and migraine prophylaxis. Guidelines of the German Neurological Associationen and the German Association for Migraine and Headache...). In the majority of cases, it consisted of beta-blocker prescription." As seen at. Endres et al. 2007, p. C103
  46. ^ Gemeinsamer Bundesausschuss 2007, p. 474
  47. ^ Gemeinsamer Bundesausschuss 2007, p. 431
  48. ^ "Die Standardtherapie diente der Anfallsprophylaxe. Beim chronischen Spannungskopfschmerz ist hierzu Amitryptilin ... Mittel der ersten Wahl." ("Standard therapy focused on attack prevention. In this regard, amitryptiline ... constitutes first-line treatment for chronic tension type headache.") As seen at: Endres et al. 2007, p. C102
  49. ^ Gemeinsamer Bundesausschuss 2007, p. 431
  50. ^ "... war nur bei vier Patienten die Bereitschaft zur Einnahme vorhanden. Deshalb musste der Standardtherapiearm ... abgebrochen werden." ("... only four patients were willing to take [this medication]. Therefore the standard therapy arm had to be aborted ...") As seen at: Endres et al. 2007, p. C102
  51. ^ Gemeinsamer Bundesausschuss 2007, p. 435
  52. ^ Gemeinsamer Bundesausschuss 2007, p. 433
  53. ^ Gemeinsamer Bundesausschuss 2007, p. 436
  54. ^ Endres, Heinz G.; Böwing, Gabriele; Diener, Hans-Christoph; Lange, Stefan; Maier, Christoph; Molsberger, Albrecht; Zenz, Michael; Vickers, Andrew J.; Tegenthoff, Martin (2007). "Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial". The Journal of Headache and Pain. 8 (5): 306–314. doi:10.1007/s10194-007-0416-5. PMC 3476149. PMID 17955168.
  55. ^ "Im Sommer 2005 nahmen am Modellvorhaben der Krankenkassen 12617 Ärzte ... teil. ("In the summer of 2005, 12617 physicians ... participated in the health insurance companies' field study.") As seen at: Endres et al. 2007, p. C103
  56. ^ "Von 2001 bis 2005 trafen in Bochum 2,9 Millionen Faxmeldeformulare von rund 2,6 Millionen Patienten ein,..." ("2.9 million faxed forms representing 2.6 million patients were collected in Bochum between 2001 and 2005,...") As seen at: Endres et al. 2007, p. C103
  57. ^ "In der ersten großen Stichprobe zur Erfassung von UEs und SUEs (190924 Patienten)..." ("In a first big random sample (190924 patients)...") As seen at: Endres et al. 2007, p. C104
  58. ^ "... haben die Ärzte in 7,5 Prozent aller Patienten ein unerwünschtes Ereignis dokumentiert ... Gemeldet wurden 45 SUE, ..." ("... the physicians documented an adverse event in 7.5% of all patients ... 45 SAE were registered, ...") As seen at: Endres et al. 2007, p. C104
  59. ^ "Die drei am häufigsten genannten UE waren das Hämatom an der Einstichstelle, die temporäre Symptomverschlechterung und eine vasovagale Kreislaufreaktion." ("The three most frequently reported AE were hematoma at the puncture site, temporary worsening of symptoms, and vasovagal circulatory reaction.") As seen at: Endres et al. 2007, p. C104
  60. ^ "Da mit einem erheblichen Underreporting von SUEs gerechnet werden musste, ..." ("As considerable underreporting of AE had to be anticipated ...") As seen at: Endres et al. 2007, p. C102
  61. ^ Scharf, H. P.; Mansmann, U.; Streitberger, K.; Witte, S.; Krämer, J.; Maier, C.; Trampisch, H. J.; Victor, N. (2006 Jul 4). "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. S2CID 53090249. {{cite journal}}: Check date values in: |date= (help)
  62. ^ Haake, M (2007 Sep 24). "German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups". Archives of Internal Medicine. 167 (17): 1892–8. doi:10.1001/archinte.167.17.1892. PMID 17893311. {{cite journal}}: Check date values in: |date= (help); Unknown parameter |coauthors= ignored (|author= suggested) (help)
  63. ^ Endres, Heinz G.; Böwing, Gabriele; Diener, Hans-Christoph; Lange, Stefan; Maier, Christoph; Molsberger, Albrecht; Zenz, Michael; Vickers, Andrew J.; Tegenthoff, Martin (23 October 2007). "Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial". The Journal of Headache and Pain. 8 (5): 306–314. doi:10.1007/s10194-007-0416-5. PMC 3476149. PMID 17955168.
  64. ^ Diener, H. C.; Kronfeld, K.; Boewing, G.; Lungenhausen, M.; Maier, C.; Molsberger, A.; Tegenthoff, M.; Trampisch, H. J.; Zenz, M.; Meinert, R.; GERAC Migraine Study Group (2006 Apr). "Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial". The Lancet Neurology. 5 (4): 310–6. doi:10.1016/S1474-4422(06)70382-9. PMID 16545747. S2CID 20580335. {{cite journal}}: Check date values in: |date= (help)
  65. ^ William Vorsatz (13.11.2007). "Bestechendes Argument" (in German). Deutschlandfunk. {{cite web}}: Check date values in: |date= (help)
  66. ^ "Studie belegt: Akupunktur hilft bei chronischen Schmerzen". Die Welt (in German). 17.01.07. {{cite web}}: Check date values in: |date= (help)
  67. ^ Hackenbroch, Veronika (25.10.2004). "Die eingebildete Heilung". Der Spiegel. Die Studienergebnisse bestätigen andere, kleinere Studien und sind wegen ihrer wissenschaftlichen Qualität nicht mehr vom Tisch zu wischen. Sie werden auch nicht ohne Folgen bleiben: Vor vier Jahren hatte der gemeinsame Bundesausschuss der Ärzte und Krankenkassen die Erstattung der Akupunktur durch die gesetzlichen Krankenkassen nur noch unter der Bedingung erlaubt, dass das Verfahren gleichzeitig wissenschaftlich erforscht wird. Auf der Basis dieser Ergebnisse sollte dann die endgültige Entscheidung fallen, ob die Akupunktur in den Leistungskatalog der Krankenkassen aufgenommen wird. Spätestens im nächsten Sommer muss der Bundesausschuss seine Entscheidung fällen. {{cite web}}: Check date values in: |date= (help)
  68. ^ "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)
  69. ^ "Akupunktur wird Leistung der gesetzlichen Krankenkassen". Federal Ministry of Health (Germany). 03.07.2006. {{cite web}}: Check date values in: |date= (help)
  70. ^ 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)
  71. ^ "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)
  72. ^ "Needles 'are best for back pain'". BBC. 25 September 2007. Retrieved 25 November 2013.
  73. ^ Nigel Hawkes (September 25, 2007). "Sticking needles in a bad back 'eases pain better than drugs'". The Times. Retrieved 25 November 2013.
  74. ^ "Acupuncture may ease back pain". NHS Choices. 26 September 2007. Retrieved November 2013. {{cite web}}: Check date values in: |accessdate= (help)
  75. ^ "Acupuncture". NHS Choices. 22 May 2012. Retrieved November 2013. {{cite web}}: Check date values in: |accessdate= (help)
  76. ^ 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. PMID 19369191. S2CID 6879017. These programmes of research do not confirm the hypothesis that needling at specific points is essential to achieve satisfactory clinical effects of acupuncture.
  77. ^ Jeremy H. Howick (23 February 2011). The Philosophy of Evidence-based Medicine. John Wiley & Sons. p. 92. ISBN 978-1-4443-4266-6.
  78. ^
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Category:Clinical trials Category:Acupuncture

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