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In September 2007, a post on the [[NHS Choices]] web site 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".<ref name="nhsa">{{cite web|title=Acupuncture may ease back pain|url=http://www.nhs.uk/news/2007/September/Pages/Acupuncturemaybeeffectiveforbackpain.aspx|publisher=[[NHS Choices]]|date=26 September 2007|accessdate=November 2013}}</ref> {{asof|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.<ref name=nice>{{cite web|url=http://www.nhs.uk/Conditions/Acupuncture/Pages/Introduction.aspx?url=Pages%2fWhat-is-it.aspx|title=Acupuncture|publisher=NHS Choices|date=22 May 2012|accessdate=November 2013}}</ref>
In September 2007, a post on the [[NHS Choices]] web site 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".<ref name="nhsa">{{cite web|title=Acupuncture may ease back pain|url=http://www.nhs.uk/news/2007/September/Pages/Acupuncturemaybeeffectiveforbackpain.aspx|publisher=[[NHS Choices]]|date=26 September 2007|accessdate=November 2013}}</ref> {{asof|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.<ref name=nice>{{cite web|url=http://www.nhs.uk/Conditions/Acupuncture/Pages/Introduction.aspx?url=Pages%2fWhat-is-it.aspx|title=Acupuncture|publisher=NHS Choices|date=22 May 2012|accessdate=November 2013}}</ref>


The trials found no significant differences between acupuncture and sham acupuncture.<ref name="Howick2011">{{cite book|author=Jeremy H. Howick|title=The Philosophy of Evidence-based Medicine|url=http://books.google.com/books?id=O8djbHBva5IC&pg=PA92|date=23 February 2011|publisher=John Wiley & Sons|isbn=978-1-4443-4266-6|page=92}}</ref>
It has been pointed out that the GERAC study couldn't find any advantage of needling specific acupuncture points in contrast to random points.<ref>{{cite journal|last=Cummings|first=M.|title=Modellvorhaben Akupunktur - a summary of the ART, ARC and GERAC trials|journal=''[[Acupuncture in Medicine]]''|date=1 March 2009|volume=27|issue=1|pages=26–30|doi=10.1136/aim.2008.000281|quote=These programmes of research do not confirm the hypothesis that needling at specific points is essential to achieve satisfactory clinical effects of acupuncture.}}</ref><ref name="Howick2011">{{cite book|author=Jeremy H. Howick|title=The Philosophy of Evidence-based Medicine|url=http://books.google.com/books?id=O8djbHBva5IC&pg=PA92|date=23 February 2011|publisher=John Wiley & Sons|isbn=978-1-4443-4266-6|page=92}}</ref>

[[Edzard Ernst]], a researcher 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 said that they "[failed] to conclusively answer the question whether acupuncture helps patients through a specific or a nonspecific effect".<ref>
[[Edzard Ernst]], a researcher 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".<ref>
*{{cite journal|doi=10.1111/j.1365-2796.2005.01584.x|title=Acupuncture - a critical analysis|year=2006|last1=Ernst|first1=E.|journal=Journal of Internal Medicine|volume=259|issue=2|pages=125–37|pmid=16420542}}
*{{cite journal|doi=10.1111/j.1365-2796.2005.01584.x|title=Acupuncture - a critical analysis|year=2006|last1=Ernst|first1=E.|journal=Journal of Internal Medicine|volume=259|issue=2|pages=125–37|pmid=16420542}}
*{{cite journal|doi=10.1007/s00482-005-0404-0|title=Die GERAC-Gonarthrose-Studie|year=2005|journal=Der Schmerz|volume=19|issue=4|pages=330–1; author reply 331–2|pmid=16145742|last1=Wettig|first1=D}}</ref>
*{{cite journal|doi=10.1007/s00482-005-0404-0|title=Die GERAC-Gonarthrose-Studie|year=2005|journal=Der Schmerz|volume=19|issue=4|pages=330–1; author reply 331–2|pmid=16145742|last1=Wettig|first1=D}}</ref>

Revision as of 06:55, 24 November 2013

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

In October 2000, Germany's Federal Committee of Physicians and Health Insurers (Gemeinsamer Bundesausschuss) decided that acupunctural treatment may not be reimbursed by statutory health insurance companies except within the framework of experimental field studies.[8][9][10]

Subsequently, the GERAC were set up at Bochum University[11] in 2001,[12] as a field study on behalf of six German statutory health insurance organizations.[2][10] These organizations are:

Overview

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.[14] The number of patients randomized was one of the largest ever for acupuncture trials.[15]

Only registered physicians with an additional license for acupuncture and at least two years of clinical experience in acupuncture treatment qualified as performing acupuncturists.[16] 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.[17]

The acupuncture point selection was partially predetermined.[18] Needles were to be manipulated until arrival of de-qi sensation,[19] 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.[20] Thus, only the patients (not the performing acupuncturists) could be blinded.[21] Type and quantity of needles were the same in real and sham acupuncture.[22]

The Ruhr University Bochum

Assessment regarding the therapy's efficacy was undertaken by blinded interviewers.[23] Beginning in 2001, the trials were carried out by the following universities:

Results

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.[24][25] Treatment given in the standard therapy group consisted of a combination of physical therapy and NSAID medication.[26] 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.[27][28] This implied both real and sham acupuncture being significantly more effective than standard therapy (p<0.001[29]); however, there was no statistical significant difference between the effectiveness of real and sham acupuncture (p=0.39[30]).[31]

Knee osteoarthritis trial

A total of 1039 patients were randomized in this study.[32] Treatment in the standard therapy group consisted of diclofenac or rofecoxib medication on an as-needed basis.[33] 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).[34] Patients in all three groups could attend up to six physiotherapy sessions.[35] 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.[36] 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.[37] This amounts to significant superiority of acupuncture and sham acupuncture over standard treatment, but no statistical significant efficacy difference between real and sham acupuncture (at p=0.48).[38]

Migraine prophylaxis trial

In this trial, a total of 960 patients was randomized; immediately after randomization, however, 125 patients (106 from the standard group) withdrew from the study. Primary outcome was defined as reduction in migraine days 26 weeks after randomization.[39] 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.[40] 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. There also was no statistical difference in the numbers of responders in each group (responding being defined by a reduction in migraine days of at least 50%).[41]

Tension-type headache trial

The standard, guideline-based therapy arm for the RCT for chronic tension type headache provided for amitryptiline medication.[42] Although first-line, this usage of amitryptiline was not mentioned in the drug's package insert in Germany at that time.[43] Subsequently, only four patients were willing to try this treatment, and the standard therapy arm had to be aborted.[44] In the two remaining arms (real against sham acupuncture), 409 patients were randomized altogether. Successful treatment was defined as a reduction in headache days per month of more than 50%; 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=0.18).[45]

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.[46] This resulted in data of roughly 2.6 million patients,[47] out of which a random sample of 190,924 was reviewed in terms of frequency of adverse events and serious adverse events.[48] Adverse events were reported in 7.5% of the cases, including 45 serious adverse events.[49] 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.[50] Underreporting of adverse events had to be assumed.[51]

Publication

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

Domestic consequences

Media

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.[56] The national daily newspaper Die Welt remarked that the results of the studies are "promising".[57] 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).[58]

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.[59]

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.[60] "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.[61] "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

Several years after the Commitee's decision to incoporate acupuncutral 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]

Reception

In September 2007, a post on the NHS Choices web site 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".[62] 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.[63]

It has been pointed out that the GERAC study couldn't find any advantage of needling specific acupuncture points in contrast to random points.[64][65]

Edzard Ernst, a researcher 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".[66]

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

References

  1. ^ a b Wenzel, K.-W (2005). "Akupunktur: Was zeigen die GERAC-Studien?". Deutsche Medizinische Wochenschrift (in German). 130 (24): 1520–1520. doi:10.1055/s-2005-870855. Der Aufbau der Studie hält wissenschaftlichen Kriterien sicherlich nicht stand {{cite journal}}: Italic or bold markup not allowed in: |journal= (help); Unknown parameter |month= ignored (help)
  2. ^ a b c Veronika Hackenbroch (25.10.2004). "Die eingebildete Heilung" (in German). Der Spiegel. 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); Italic or bold markup not allowed in: |publisher= (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 Pyne, D. (29 April 2008). "Demystifying acupuncture". Rheumatology (journal). 47 (8): 1132–1136. doi:10.1093/rheumatology/ken161. 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 {{cite journal}}: Italic or bold markup not allowed in: |journal= (help); Unknown parameter |coauthors= ignored (|author= suggested) (help)
  5. ^ Karin Hertzer (12.08.2009). "Akupunktur ist wirksam" (in German). Focus (German magazine). 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); Italic or bold markup not allowed in: |publisher= (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" (in German). Rheinische Post. Retrieved 25 May 2013. {{cite web}}: Italic or bold markup not allowed in: |publisher= (help)
  8. ^ 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)
  9. ^ Gemeinsamer Bundesausschuss 2007, p. 2
  10. ^ 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}}: Italic or bold markup not allowed in: |journal= (help)CS1 maint: multiple names: authors list (link)
  11. ^ "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
  12. ^ "... 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
  13. ^ 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)
  14. ^ "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
  15. ^ "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
  16. ^ "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
  17. ^ "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
  18. ^ "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
  19. ^ "... 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
  20. ^ "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
  21. ^ "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
  22. ^ "Nadelart und -zahl ... waren deshalb gleich." ("Needle type and numbers ... therefore were the same.") As seen at: Endres et al. 2007, p. C103
  23. ^ "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
  24. ^ Gemeinsamer Bundesausschuss 2007, p. 304
  25. ^ 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.
  26. ^ "... 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
  27. ^ Gemeinsamer Bundesausschuss 2007, p. 307
  28. ^ 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.
  29. ^ 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.
  30. ^ 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.
  31. ^ Gemeinsamer Bundesausschuss 2007, pp. 309-310
  32. ^ Scharf et al. 2006, p. 13
  33. ^ Scharf et al. 2006, p. 13
  34. ^ Scharf et al. 2006, p. 14
  35. ^ Scharf et al. 2006, p. 14
  36. ^ Scharf et al. 2006, p. 14
  37. ^ Scharf et al. 2006, p. 16
  38. ^ Scharf et al. 2006, p. 16
  39. ^ Diener, Hans-Christoph; Kronfeld, Kai; Boewing, Gabriele; Lungenhausen, Margitta; Maier, Christoph; Molsberger, Albrecht; Tegenthoff, Martin; Trampisch, Hans-Joachim; Zenz, Michael; Meinert, Rolf (2006). "Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial". The Lancet Neurology. 5 (4): 310–316.
  40. ^ "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
  41. ^ Diener, Hans-Christoph; Kronfeld, Kai; Boewing, Gabriele; Lungenhausen, Margitta; Maier, Christoph; Molsberger, Albrecht; Tegenthoff, Martin; Trampisch, Hans-Joachim; Zenz, Michael; Meinert, Rolf (2006). "Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial". The Lancet Neurology. 5 (4): 310–316.
  42. ^ "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
  43. ^ "Da in den Beipackzetteln der Hinweis auf die Wirksamkeit bei Spannungskopfschmerzen fehlt,..." ("Since efficacy in treating tension type headache is not mentioned in the package insert ...") As seen at: Endres et al. 2007, p. C102
  44. ^ "... 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
  45. ^ 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.
  46. ^ "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
  47. ^ "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
  48. ^ "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
  49. ^ "... 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
  50. ^ "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
  51. ^ "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
  52. ^ Scharf, HP (2006 Jul 4). "Acupuncture and knee osteoarthritis: a three-armed randomized trial". Annals of Internal Medicine. 145 (1): 12–20. PMID 16818924. {{cite journal}}: Check date values in: |date= (help); Italic or bold markup not allowed in: |journal= (help); Unknown parameter |coauthors= ignored (|author= suggested) (help)
  53. ^ 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. PMID 17893311. {{cite journal}}: Check date values in: |date= (help); Italic or bold markup not allowed in: |journal= (help); Unknown parameter |coauthors= ignored (|author= suggested) (help)
  54. ^ Endres, Heinz G. (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. {{cite journal}}: Italic or bold markup not allowed in: |journal= (help); Unknown parameter |coauthors= ignored (|author= suggested) (help)
  55. ^ Diener, HC (2006 Apr). "Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial". The Lancet Neurology. 5 (4): 310–6. PMID 16545747. {{cite journal}}: Check date values in: |date= (help); Italic or bold markup not allowed in: |journal= (help); Unknown parameter |coauthors= ignored (|author= suggested) (help)
  56. ^ William Vorsatz (13.11.2007). "Bestechendes Argument" (in German). Deutschlandfunk. {{cite web}}: Check date values in: |date= (help)
  57. ^ "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)
  58. ^ 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); Italic or bold markup not allowed in: |publisher= (help)
  59. ^ Karin Hertzer (12.08.2009). "Akupunktur ist wirksam" (in German). Focus (German magazine). 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); Italic or bold markup not allowed in: |publisher= (help)
  60. ^ "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)
  61. ^ "Akupunktur wird Leistung der gesetzlichen Krankenkassen". Federal Ministry of Health (Germany). 03.07.2006. {{cite web}}: Check date values in: |date= (help)
  62. ^ "Acupuncture may ease back pain". NHS Choices. 26 September 2007. Retrieved November 2013. {{cite web}}: Check date values in: |accessdate= (help)
  63. ^ "Acupuncture". NHS Choices. 22 May 2012. Retrieved November 2013. {{cite web}}: Check date values in: |accessdate= (help)
  64. ^ 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. These programmes of research do not confirm the hypothesis that needling at specific points is essential to achieve satisfactory clinical effects of acupuncture. {{cite journal}}: Italic or bold markup not allowed in: |journal= (help)
  65. ^ Jeremy H. Howick (23 February 2011). The Philosophy of Evidence-based Medicine. John Wiley & Sons. p. 92. ISBN 978-1-4443-4266-6.
  66. ^
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