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The '''German acupuncture trials''' ({{langx|de|GERAC-Studien<ref name=dmw1>{{cite journal |doi=10.1055/s-2005-870855 |title=Akupunktur: Was zeigen die gerac-Studien? |trans-title=Acupuncture: What of the GERAC studies? |language=de |year=2005 |last1=Wenzel |first1=K.-W |journal=Deutsche Medizinische Wochenschrift |volume=130 |issue=24 |pages=1520|pmid=15942849 }}</ref>}}) were a series of nationwide ] trials set up in 2001 and published in 2006 on behalf of several ] because of a dispute as to the usefulness of acupuncture.<ref name="spiegelacupuncture">{{cite news |first=Veronika |last=Hackenbroch |title=Die eingebildete Heilung |trans-title=The Imaginary Healing |url=http://www.spiegel.de/spiegel/print/d-32565481.html |work=] |language=de |date=2004-10-25}}</ref> They consisted of one observational study on acupuncture side effects, and four ] (RCTs) investigating acupuncture treatment for ], knee ], ] prophylaxis, and ]. The trials are considered to be one of the largest clinical studies in the field of acupuncture.<ref name="spiegelacupuncture"/>
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⚫ ]
The '''German Acupuncture Trials''' ('''GERAC''') are a series of ] trials set up in 2001 and published in 2006, on behalf of six ].{{CN|date=November 2013}} They consist of one observational study on acupuncture side effects, and four ] (RCTs) - investigating acupuncture treatment for ], knee ], ] prophylaxis, and ].


As a result of the '''GERAC''' trials, the ] ruled in April 2006 that the costs of acupuncture treatment for chronic ] and knee ] would be covered by ] in Germany,<ref name=FJC /> though no coverage was offered for headache or migraine.<ref name="Hinrichs"/> However, because of the outcome of these trials, in the case of the other conditions, ] in Germany were not convinced that acupuncture had adequate benefits over usual care or ]s.<ref name="Stuart B. Porter"/> No significant differences between acupuncture and sham acupuncture were found in any trial.<ref name=Novella>{{cite web |first=Steven |last=Novella |title=Acupuncture Doesn't Work|website=Science-Based Medicine |date=June 19, 2013 |author-link=Steven Novella|url=http://www.sciencebasedmedicine.org/acupuncture-doesnt-work/ |quote=Referencing this study: "Verum (or true) acupuncture and sham acupuncture treatments are no different in decreasing pain levels."}}</ref>
The observational study revealed ] 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<ref>"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</ref>, but there was no significant difference in efficacy between real and ].


According to ], the total cost of the trials amounted to 7.5 million Euros.<ref>{{cite web |title=Akupunktur |trans-title=Acupuncture |url=http://www.puls.sf.tv/Nachrichten/Archiv/2003/03/10/Gesundheitsthemen/Akupunktur |date=2003-03-10 |publisher=]}}</ref> Several years after the committee's decision to incorporate acupunctural treatment into the ] was passed into law, the number of regular users of acupuncture in the country surpassed one million.<ref name="accupuncture-rponline">{{cite news |title=Frauen häufiger mit Akupunktur behandelt |trans-title=Women treated more often with acupuncture |date=2012-08-30 |url=http://www.rp-online.de/gesundheit/medizin-und-vorsorge/frauen-haeufiger-mit-akupunktur-behandelt-1.2973239 |work=] |access-date=2013-05-23 |language=de}}</ref>
==Background==
In 2000, the paramount decision-making body within the self-government of medical service providers and ] in Germany, known as the ] (''Gemeinsamer Bundesausschuss''), ruled that acupuncture treatment may not be covered by statutory health insurance companies except within the framework of field studies.<ref>Gemeinsamer Bundesausschuss 2007, p. 2</ref><ref>"... beschloss der Gemeinsame Bundesausschuss (B-BA) am 16. Oktober 2000, dass Akupunktur nur noch im Rahmen von Modellvorhaben ... von der Gesetzlichen Krankenkasse bezahlt werden kann." ("... on October 16th 2000, the Joint Federal Committee ruled that acupuncture may only be covered by statutory health insurance companies within the framework of field studies ..." As seen at: Endres et al. 2007, p. C101</ref>{{RS|date=November 2013}}


== History ==
Subsequently, the GERAC were set up at ]<ref>"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</ref> in 2001,<ref>"... 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</ref> as a field study on behalf of six health insurance companies.<ref>"Modellvorhaben der AOK, BKK, IKK, Bundesknappschaft, Bundesverband der Landwirtschaftlichen Krankenkassen und Seekasse" ("Field study of AOK, BKK, IKK, Bundesknappschaft, Bundesverband der Landwirtschaftlichen Krankenkassen, and Seekasse") As seen at: Endres et al. 2007, p. C101</ref>{{RS|date=November 2013}}


In the late 1990s, German healthcare regulators began to voice their doubts over the therapeutical usage of acupuncture, mostly because of the lack of reliable evidence regarding its therapeutic efficacy.<ref>{{cite book |first1=Simon |last1=Singh |first2=Edzard |last2=Ernst |title=Trick Or Treatment: The Undeniable Facts about Alternative Medicine |year=2008 |publisher=W.W. Norton |location=New York |isbn=9780393066616 |pages=81–2 |edition=1st American |url=https://books.google.com/books?id=5m6CKTEr3I0C&pg=PA81}}</ref> This resulted in a heated debate, which led to Paul Rheinberger, Director of the ], saying: "The higher the quality of clinical studies performed on acupuncture, the lesser the amount of evidence supporting its efficacy."<ref>{{cite journal |last=Korzilius |first=Heike |title=Bundesausschuss: Streit um Akupunktur |journal=] |year=2000 |volume=97 |issue=30 |pages=A-2013–4 |language=de |url=http://www.aerzteblatt.de/pdf/97/30/a2013.pdf |access-date=2013-11-26}}</ref><ref>{{cite journal |doi=10.1055/s-2004-860883 |title=Lässt sich die Wirksamkeit der Akupunktur naturwissenschaftlich erklären? |year=2004 |last1=Suess |first1=Jochen |last2=Scharl |first2=Anton |journal=Die Hebamme |volume=17 |issue=4 |pages=214–7}}</ref>
==Overall RCT set-up==
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.<ref>"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</ref> The number of patients randomized was one of the largest ever for acupuncture trials.<ref>"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 ] 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</ref>


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.<ref name="GemeinsamerBundesausschuss" /><ref name="da1">{{cite journal |last1=Endres |first1=Heinz G. |last2=Diener |first2=Hans-Christoph |last3=Maier |first3=Christoph |last4=Böwing |first4=Gabriele |last5=Trampisch |first5=Hans-Joachim |last6=Zenz |first6=Michael |display-authors= 4 |title=Akupunktur bei chronischen Kopfschmerzen |trans-title=Acupuncture for chronic headache |journal=] |year=2007 |volume=104 |issue=3 |pages=A-114, B-105, C-101 |url=http://www.aerzteblatt.de/archiv/54176/ |language=de}}</ref> In 2001 the GERAC were set up at ]<ref name="GemeinsamerBundesausschuss" /> as a field study on behalf of six ].<ref name="spiegelacupuncture"/><ref name="da1"/>
Only registered physicians with an additional license for acupuncture and at least two years of clinical experience in acupuncture treatment qualified as performing acupuncturists.<ref>"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</ref> 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.<ref>"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</ref>


== Overview and results ==
The acupuncture point selection was partially predetermined.<ref>"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</ref> Needles were to be manipulated until arrival of ] sensation,<ref>"... 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</ref> which according to ] indicates successful activation of an acupoint.


]]]
For sham acupuncture, needles were inserted only superficially (3&nbsp;mm at most), and at bogus points; there also was no subsequent manipulation.<ref>"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</ref> Thus, only the patients (not the performing acupuncturists) could be ].<ref>"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</ref> Type and quantity of needles were the same in real and sham acupuncture.<ref>"Nadelart und -zahl ... waren deshalb gleich." ("Needle type and numbers ... therefore were the same.") As seen at: Endres et al. 2007, p. C103</ref>


Beginning in 2001, the trials were carried out by ], the ], the ] and the ] for ],<ref name="GemeinsamerBundesausschuss" /><ref name="shenker">{{cite journal |last1=Pyne |first1=D. |last2=Shenker |first2=N. G. |title=Demystifying acupuncture |journal=Rheumatology |volume=47 |issue=8 |pages=1132–6 |year=2008 |pmid=18460551 |doi=10.1093/rheumatology/ken161 |doi-access=free }}</ref> ],<ref name="GemeinsamerBundesausschuss" /><ref name="Scharf et al. 2006">{{cite journal |last1=Scharf |first1=Hanns-Peter |last2=Mansmann |first2=Ulrich |last3=Streitberger |first3=Konrad |last4=Witte |first4=Steffen |last5=Krämer |first5=Jürgen |last6=Maier |first6=Christoph |last7=Trampisch |first7=Hans-Joachim |last8=Victor |first8=Norbert |title=Acupuncture and knee osteoarthritis: a three-armed randomized trial |journal=Annals of Internal Medicine |volume=145 |issue=1 |pages=12–20 |year=2006 |pmid=16818924 |doi=10.7326/0003-4819-145-1-200607040-00005 |s2cid=53090249 }}</ref> ] prophylaxis,<ref name="GemeinsamerBundesausschuss" /> and ].<ref name="GemeinsamerBundesausschuss">{{cite book |url=http://www.g-ba.de/downloads/40-268-487/2007-09-27-Abschluss-Akupunktur.pdf |title=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 |trans-title=Summary report of the subcommittee 'Medical treatment' of the Federal Joint Committee on the assessment pursuant to § 135 SGB V, Section 1 of the body acupuncture with needles without electrical stimulation for chronic headache, chronic lumbar pain, chronic pain associated with osteoarthritis |author=Gemeinsamer Bundesausschuss |date=2007-09-27 |access-date=2013-11-30 |language=de|pages=1–527}}</ref> Apart from that, an observational study on ] of acupuncture was done.<ref name="da1"/>
Assessment regarding the therapy's efficacy was undertaken by blinded interviewers.<ref>"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</ref>


The RCTs were designed as three-armed trials, with the three parallel groups in each trial receiving either verum (real) acupuncture treatment, sham acupuncture treatment, or guideline-based conventional treatment.<ref name="spiegelacupuncture"/> The number of patients randomized was one of the largest ever for acupuncture trials.<ref name="spiegelacupuncture"/><ref name="da1"/> For each indication, around 1000 test subjects were included.<ref>{{cite journal|url=http://www.gwup.org/infos/themen-nach-gebiet/769-die-gerac-akupunkturstudien?catid=77%3Akomplementaer-und-alternativmedizin-cam |title=Die Gerac-Akupunkturstudien |author=Hessel, W. |journal=Skeptiker |issue=1 |year=2005}}</ref> The trials were conducted using sham acupuncture.<ref name=Novella/> No significant differences between acupuncture and sham acupuncture were found in any trial.<ref name=Novella/>
In later years, ] noted that the studies had attracted criticism for not controlling the risk of patient de-blinding, and said that they " 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=10.1007/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>


In 2005, the '']'' (''German Medical Weekly'') published an article which criticized the trials for "not meeting scientific criteria".<ref name=dmw1/> In 2006, ], a professor of complementary medicine at the ], 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".<ref name="Ernst-2006">{{cite journal |last1=Ernst |first1=E. |title=Acupuncture - a critical analysis |journal=Journal of Internal Medicine |volume=259 |issue=2 |pages=125–37 |year=2006 |pmid=16420542 |doi=10.1111/j.1365-2796.2005.01584.x |doi-access= }}</ref> In September 2007, ] 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|url=http://www.nhs.uk/news/2007/September/Pages/Acupuncturemaybeeffectiveforbackpain.aspx|title=Acupuncture may ease back pain|date=2007-09-26|publisher=]|access-date=January 2, 2019}}</ref> Highlighting the results of the placebo group, researchers refused to accept a ] therapy as ].<ref name="Hinrichs">{{cite book |author1=TJ Hinrichs |author2=Linda L. Barnes |page=314 |title=Chinese Medicine and Healing: An Illustrated History |edition=1 |editor1=TJ Hinrichs |editor2=Linda L. Barnes |publisher=] |year=2013 |isbn=978-0674047372}}</ref>
==Low back pain trial==
1162 patients were randomized in this trial.<ref>Gemeinsamer Bundesausschuss 2007, p. 307</ref>{{RS|date=November 2013}} Primary outcome was defined as 33% improvement or better on three pain-related items on the Von Korff Chronic ] questionnaire, or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire, 6 months after randomization.<ref>Gemeinsamer Bundesausschuss 2007, p. 304</ref><ref>{{cite journal|url=http://archinte.ama-assn.org/cgi/content/abstract/167/17/1892 |last1= Haake|first1=Michael|last2=Müller|first2=Hans-Helge |last3=Schade-Brittinger|first3=Carmen |last4=Basler|first4=Heinz D. |last5=Schäfer|first5=Helmut |last6=Maier|first6=Christoph |last7=Endres|first7=Heinz G.|last8=Trampisch|first8=Hans J. |last9=Molsberger|first9=Albrecht |title=German Acupuncture Trials (GERAC) for Chronic Low Back Pain: Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups|journal=Archives of Internal Medicine|volume=167|issue=17|pages=1892–1898|year=2007 |doi=10.1001/archinte.167.17.1892 |pmid=17893311}}</ref> Treatment given in the standard therapy group consisted of a combination of ] and ] medication.<ref>"... 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</ref>


== Domestic consequences ==
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.<ref>Gemeinsamer Bundesausschuss 2007, p. 307</ref><ref>{{cite journal|url=http://archinte.ama-assn.org/cgi/content/abstract/167/17/1892 |last1= Haake|first1=Michael|last2=Müller|first2=Hans-Helge |last3=Schade-Brittinger|first3=Carmen |last4=Basler|first4=Heinz D. |last5=Schäfer|first5=Helmut |last6=Maier|first6=Christoph |last7=Endres|first7=Heinz G.|last8=Trampisch|first8=Hans J. |last9=Molsberger|first9=Albrecht |title=German Acupuncture Trials (GERAC) for Chronic Low Back Pain: Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups|journal=Archives of Internal Medicine|volume=167|issue=17|pages=1892–1898|year=2007 |doi=10.1001/archinte.167.17.1892 |pmid=17893311}}</ref> This implied both real and sham acupuncture being ] more effective than standard therapy (]<0.001<ref>{{cite journal|url=http://archinte.ama-assn.org/cgi/content/abstract/167/17/1892 |last1= Haake|first1=Michael|last2=Müller|first2=Hans-Helge |last3=Schade-Brittinger|first3=Carmen |last4=Basler|first4=Heinz D. |last5=Schäfer|first5=Helmut |last6=Maier|first6=Christoph |last7=Endres|first7=Heinz G.|last8=Trampisch|first8=Hans J. |last9=Molsberger|first9=Albrecht |title=German Acupuncture Trials (GERAC) for Chronic Low Back Pain: Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups|journal=Archives of Internal Medicine|volume=167|issue=17|pages=1892–1898|year=2007 |doi=10.1001/archinte.167.17.1892 |pmid=17893311}}</ref>); however, there was no statistical significant difference between the effectiveness of real and sham acupuncture (p=0.39<ref>{{cite journal|url=http://archinte.ama-assn.org/cgi/content/abstract/167/17/1892 |last1= Haake|first1=Michael|last2=Müller|first2=Hans-Helge |last3=Schade-Brittinger|first3=Carmen |last4=Basler|first4=Heinz D. |last5=Schäfer|first5=Helmut |last6=Maier|first6=Christoph |last7=Endres|first7=Heinz G.|last8=Trampisch|first8=Hans J. |last9=Molsberger|first9=Albrecht |title=German Acupuncture Trials (GERAC) for Chronic Low Back Pain: Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups|journal=Archives of Internal Medicine|volume=167|issue=17|pages=1892–1898|year=2007 |doi=10.1001/archinte.167.17.1892 |pmid=17893311}}</ref>).<ref>Gemeinsamer Bundesausschuss 2007, pp. 309-310</ref>


As a result of the GERAC trials, in April 2006 the ], which sets ], determined that acupuncture for the treatment of low back pain and knee pain would be reimbursed by ]<ref name=FJC>{{cite web|title=Tragende Gründe zum Beschluss des Gemeinsamen Bundesau sschusses zur Akupunktur|url=http://www.g-ba.de/downloads/40-268-71/2006-04-18_Akupunktur-TGr.pdf|publisher=]|language=de|date=2006-04-18}}</ref> but coverage was not offered for headache or migraine.<ref name="Hinrichs"/> In July 2006, the German Health Minister ] confirmed the decision.<ref>{{cite web|title=Akupunktur wird Leistung der gesetzlichen Krankenkassen|url=http://www.bmg.bund.de/ministerium/presse/pressemitteilungen/2006-03/akupunktur-wird-leistung-der-gesetzlichen-krankenkassen.html|publisher=]|date=2006-07-03}}</ref> However, because of the outcome of these trials, in the case of the other conditions, ] in Germany were not convinced that acupuncture had adequate benefits over usual care or sham treatments.<ref name="Stuart B. Porter">{{cite book |author=Stuart B. Porter |pages=408 |title=Tidy's Physiotherapy |edition=15 |editor=Stuart B. Porter |publisher=] |year=2013 |isbn=978-0702043444}}</ref>
==Knee osteoarthritis trial==
A total of 1039 patients were randomized in this study.<ref>Scharf et al. 2006, p. 13</ref> Treatment in the standard therapy group consisted of ] or ] medication on an as-needed basis.<ref>Scharf et al. 2006, p. 13</ref> 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).<ref>Scharf et al. 2006, p. 14</ref> Patients in all three groups could attend up to six physiotherapy sessions.<ref>Scharf et al. 2006, p. 14</ref>


In 2012, health insurers reported that after the committee's decision to incorporate acupuncture into the healthcare of Germany was passed into law, the number of users of acupuncture in the country had increased by about 20%, finding favour especially among women; in 2012 there were around one million estimated users.<ref name="accupuncture-rponline"/>
Treatment success was defined as an improvement of at least 36% from baseline ] scores at 13 and 26 weeks after the start of therapy.<ref>Scharf et al. 2006, p. 14</ref> 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.<ref>Scharf et al. 2006, p. 16</ref> 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).<ref>Scharf et al. 2006, p. 16</ref>


== Media reception ==
==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.<ref>{{cite journal|url=http://www.sciencedirect.com/science/article/pii/S1474442206703829|last1=Diener|first1=Hans-Christoph|last2=Kronfeld|first2=Kai |last3=Boewing|first3=Gabriele |last4=Lungenhausen|first4=Margitta |last5=Maier|first5=Christoph |last6=Molsberger|first6=Albrecht|last7=Tegenthoff|first7=Martin |last8=Trampisch|first8=Hans-Joachim|last9=Zenz|first9=Michael|last10=Meinert|first10=Rolf |title=Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial |journal=The Lancet Neurology|volume=5|issue=4|pages=310–316|year=2006}}</ref> Treatment for the standard group consisted of medication according to the 2005 therapy guidelines issued by the German Neurological Association, usually comprising a ].<ref>"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</ref>


The trials resulted in increased coverage of acupuncture in the German media.<ref>{{cite web|title=Akupunktur bei Migräne - nicht besser als ein Placebo?|url=http://www.gwup.org/infos/nachrichten/536-akupunktur-bei-migraene-nicht-besser-als-ein-placebo|publisher=]|access-date=2013-11-26|language=de}}</ref> According to the news broadcaster ], the GERAC trials were considered to be the world's largest set of clinical studies on acupuncture.<ref>{{cite web|first=William |last=Vorsatz|title=Bestechendes Argument|url=http://www.deutschlandfunk.de/bestechendes-argument.709.de.html?dram:article_id=88197|language=de|publisher=]|date=2007-11-13}}</ref> An article in '']'' said that the results of the studies were "promising".<ref>{{cite news|title=Studie belegt: Akupunktur hilft bei chronischen Schmerzen|language=de|url=https://www.welt.de/wissenschaft/article709480/Studie-belegt-Akupunktur-hilft-bei-chronischen-Schmerzen.html|newspaper=]|date=2007-01-17}}</ref> '']'' said that the results of GERAC couldn't be brushed aside by the ].<ref name="spiegelacupuncture"/>
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%).<ref>{{cite journal|url=http://www.sciencedirect.com/science/article/pii/S1474442206703829|last1=Diener|first1=Hans-Christoph|last2=Kronfeld|first2=Kai |last3=Boewing|first3=Gabriele |last4=Lungenhausen|first4=Margitta |last5=Maier|first5=Christoph |last6=Molsberger|first6=Albrecht|last7=Tegenthoff|first7=Martin |last8=Trampisch|first8=Hans-Joachim|last9=Zenz|first9=Michael|last10=Meinert|first10=Rolf |title=Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial |journal=The Lancet Neurology|volume=5|issue=4|pages=310–316|year=2006}}</ref>


] reported that the study "highlights the superiority of acupuncture", but also introduces uncertainty about the specific mechanisms of treatment.<ref>{{cite web|last=Williams |first= Carla|title=Fake or not, acupuncture helps back pain|url=https://abcnews.go.com/Health/PainManagement/story?id=3644234&page=1&singlePage=true|work=]|access-date=2013-11-25|date=2007-09-24}}</ref> Heinz Endres, one of the authors of the study, told the ] that "acupuncture has not yet been recommended as a routine therapy", but "we think this will change with our study".<ref>{{cite web|title=Acupuncture more effective than conventional treatments for back pain: Study|url=http://www.cbc.ca/news/technology/acupuncture-more-effective-than-conventional-treatments-for-back-pain-study-1.646658|publisher=]|date=2007-09-27}}</ref> The ] stated that the study "echoes the findings of two studies published last year in the '']'', which found a short course of acupuncture could benefit patients with low back pain".<ref>{{cite web|title=Needles 'are best for back pain'|url=http://news.bbc.co.uk/2/hi/7011738.stm|publisher=]|access-date=2013-11-25|date=2007-09-25}}</ref> Nigel Hawkes, health editor of '']'', wrote that the trials "suggest that both acupuncture and sham acupuncture act as powerful versions of the ]."<ref>{{cite news|first=Nigel |last=Hawkes|title=Sticking needles in a bad back 'eases pain better than drugs'|url=http://www.thetimes.co.uk/tto/health/article1962379.ece|newspaper=]|access-date=2013-11-25|date=2007-09-25}}</ref>
==Tension-type headache trial==
The standard, guideline-based therapy arm for the RCT for chronic ] provided for ] medication.<ref>"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</ref> Although first-line, this usage of amitryptiline was not mentioned in the drug's package insert in Germany at that time.<ref>"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</ref> Subsequently, only four patients were willing to try this treatment, and the standard therapy arm had to be aborted.<ref>"... war nur bei vier Patienten die Bereitschaft zur Einnahme vorhanden. Deshalb musste der Standardtherapiearm ... abgebrochen werden." ("... only four patients were willing to take . Therefore the standard therapy arm had to be aborted ...") As seen at: Endres et al. 2007, p. C102</ref>


== See also ==
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).<ref>{{cite journal|url=http://www.springerlink.com/content/f664451676xw7q06/ |last1=Endres|first1=Heinz G.|last2=Böwing|first2=Gabriele|last3=Diener|first3=Hans-Christoph|last4=Lange|first4=Stefan|last5=Maier|first5=Christoph|last6=Molsberger|first6=Albrecht|last7=Zenz|first7=Michael|last8=Vickers|first8=Andrew J.|last9=Tegenthoff|first9=Martin|title=Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial|journal=The Journal of Headache and Pain|volume=8|issue=5|pages=306–314|year=2007}}</ref>


* ]
==Observational study==
* ]
12,617 physicians took part in the observational study, reporting on ] during or after acupuncture therapies they performed between 2001 and 2005.<ref>"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</ref> This resulted in data of roughly 2.6 million patients,<ref>"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</ref> out of which a random sample of 190,924 was reviewed in terms of frequency of adverse events and ]s.<ref>"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</ref>
* ]

Adverse events were reported in 7.5% of the cases, including 45 serious adverse events.<ref>"... 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</ref> The three most frequent adverse events were bruising at the puncture site, temporary worsening of the original symptoms intended to be treated, and ].<ref>"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</ref> Underreporting of adverse events had to be assumed.<ref>"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</ref>

==Consequences==
As a result of the GERAC trials, the Joint Federal Committee (''Gemeinsamer Bundesausschuss'') decided to include acupuncture into the catalogue of services covered by the German statutory health insurances, for the treatment of low back pain and knee pain.<ref>Gemeinsamer Bundesausschuss 2007, p. 2</ref><ref>"Dieser Überlegenheitsnachweis war die Grundlage für den Gemeinsamen Bundesausschuss, Akupunktur gegen Lendenwirbelsäulen- und Knieschmerzen in den vertragsärztlichen Leistungskatalog zu Lasten der der GKV aufzunehmen." ("The documented evidence of superiority served as rationale for the Joint Federal Committee to include acupuncture into the catalogue of benefits covered by the statutory health insurances, for the treatment of low back pain and knee pain.") As seen at: Endres et al. 2007, p. C115</ref>{{RS|date=November 2013}}


==References== ==References==
{{reflist|2}} {{reflist|2}}
*{{cite journal|last1=Endres|first1=Heinz G.|last2=Diener|first2=Hans-Christoph|last3=Maier|first3=Christoph|last4=Böwing|first4=Gabriele|last5=Trampisch|first5=Hans-Joachim|last6=Zenz|first6=Michael|title=Akupunktur bei chronischen Kopfschmerzen|journal=Deutsches Ärzteblatt|volume=104|issue=3|pages=C101-C108|year=2007}}
*{{cite journal|last1=Endres|first1=Heinz G.|last2=Victor|first2=Norbert|last3=Haake|first3=Michael|last4=Witte|first4=Steffen|last5=Streitberger|first5=Konrad|last6=Zenz|first6=Michael|title=Akupunktur bei chronischen Knie- und Rückenschmerzen|journal=Deutsches Ärzteblatt|volume=104|issue=3|pages=C109-C116|year=2007}}
*{{cite web|url=http://www.g-ba.de/downloads/40-268-487/2007-09-27-Abschluss-Akupunktur.pdf |title=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 |author=Gemeinsamer Bundesausschuss |date=27 September 2007 |accessdate=5 November 2013 |language=German}}
*{{cite journal|url=http://www.annals.org/content/145/1/12.full.pdf+html|last1=Scharf|first1=Hanns-Peter |last2=Mansmann|first2=Ulrich |last3=Streitberger|first3=Konrad |last4=Witte|first4=Steffen |last5=Krämer|first5=Jürgen |last6=Maier|first6=Christoph |last7=Trampisch|first7=Hans-Joachim |last8=Victor|first8=Norbert |title=Acupuncture and Knee Osteoarthritis: A Three-Armed Randomized Trial|journal=Annals of Internal Medicine |volume=145|issue=1|pages=12–20|year=2006}}


==External links== ==External links==
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Latest revision as of 01:24, 27 October 2024

Needles being inserted into a patient's forearm

The German acupuncture trials (German: GERAC-Studien) were a series of nationwide acupuncture trials set up in 2001 and published in 2006 on behalf of several German statutory health insurance companies because of a dispute as to the usefulness of acupuncture. They consisted of one observational study on acupuncture side effects, and four randomized controlled trials (RCTs) investigating acupuncture treatment for low back pain, knee osteoarthritis, migraine prophylaxis, and tension-type headache. The trials are considered to be one of the largest clinical studies in the field of acupuncture.

As a result of the GERAC trials, the German Federal Joint Committee ruled in April 2006 that the costs of acupuncture treatment for chronic back pain and knee osteoarthritis would be covered by public health insurers in Germany, though no coverage was offered for headache or migraine. However, because of the outcome of these trials, in the case of the other conditions, insurance corporations in Germany were not convinced that acupuncture had adequate benefits over usual care or sham treatments. No significant differences between acupuncture and sham acupuncture were found in any trial.

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 surpassed one million.

History

In the late 1990s, German healthcare regulators began to voice their doubts over the therapeutical usage of acupuncture, mostly because of 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, saying: "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. In 2001 the GERAC were set up at Bochum University as a field study on behalf of six German statutory health insurance organizations.

Overview and results

The Ruhr University Bochum

Beginning in 2001, the trials were carried out by Heidelberg University, the University of Marburg, the University of Mainz and the Ruhr University Bochum for low back pain, knee osteoarthritis, migraine prophylaxis, and tension-type headache. Apart from that, an observational study on adverse events of acupuncture was done.

The RCTs were designed as three-armed trials, with the three parallel groups in each trial receiving either verum (real) acupuncture treatment, sham acupuncture treatment, or guideline-based conventional treatment. The number of patients randomized was one of the largest ever for acupuncture trials. For each indication, around 1000 test subjects were included. The trials were conducted using sham acupuncture. No significant differences between acupuncture and sham acupuncture were found in any trial.

In 2005, the Deutsche Medizinische Wochenschrift (German Medical Weekly) published an article which criticized the trials for "not meeting scientific criteria". In 2006, Edzard Ernst, a professor of complementary medicine at the University of Exeter, noted that the studies had attracted criticism for not taking into account the risk of patient de-blinding, and that they " to conclusively answer the question whether acupuncture helps patients through a specific or a nonspecific effect". 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". Highlighting the results of the placebo group, researchers refused to accept a placebo therapy as efficient.

Domestic consequences

As a result of the GERAC trials, in April 2006 the German Federal Joint Committee, which sets health care reimbursement policy for Germany, determined that acupuncture for the treatment of low back pain and knee pain would be reimbursed by public health insurance but coverage was not offered for headache or migraine. In July 2006, the German Health Minister Ulla Schmidt confirmed the decision. However, because of the outcome of these trials, in the case of the other conditions, insurance corporations in Germany were not convinced that acupuncture had adequate benefits over usual care or sham treatments.

In 2012, health insurers reported that after the committee's decision to incorporate acupuncture into the healthcare of Germany was passed into law, the number of users of acupuncture in the country had increased by about 20%, finding favour especially among women; in 2012 there were around one million estimated users.

Media reception

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.

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 stated that the study "echoes the findings of two studies published last year in the British Medical Journal, which found a short course of acupuncture could benefit patients with low back pain". 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."

See also

References

  1. ^ Wenzel, K.-W (2005). "Akupunktur: Was zeigen die gerac-Studien?" [Acupuncture: What of the GERAC studies?]. Deutsche Medizinische Wochenschrift (in German). 130 (24): 1520. doi:10.1055/s-2005-870855. PMID 15942849.
  2. ^ Hackenbroch, Veronika (2004-10-25). "Die eingebildete Heilung" [The Imaginary Healing]. Der Spiegel (in German).
  3. ^ "Tragende Gründe zum Beschluss des Gemeinsamen Bundesau sschusses zur Akupunktur" (PDF) (in German). Federal Joint Committee (Germany). 2006-04-18.
  4. ^ TJ Hinrichs; Linda L. Barnes (2013). TJ Hinrichs; Linda L. Barnes (eds.). Chinese Medicine and Healing: An Illustrated History (1 ed.). Belknap Press. p. 314. ISBN 978-0674047372.
  5. ^ Stuart B. Porter (2013). Stuart B. Porter (ed.). Tidy's Physiotherapy (15 ed.). Churchill Livingstone. p. 408. ISBN 978-0702043444.
  6. ^ Novella, Steven (June 19, 2013). "Acupuncture Doesn't Work". Science-Based Medicine. Referencing this study: "Verum (or true) acupuncture and sham acupuncture treatments are no different in decreasing pain levels."
  7. "Akupunktur" [Acupuncture]. Schweizer Fernsehen. 2003-03-10.
  8. ^ "Frauen häufiger mit Akupunktur behandelt" [Women treated more often with acupuncture]. Rheinische Post (in German). 2012-08-30. Retrieved 2013-05-23.
  9. Singh, Simon; Ernst, Edzard (2008). Trick Or Treatment: The Undeniable Facts about Alternative Medicine (1st American ed.). New York: W.W. Norton. pp. 81–2. ISBN 9780393066616.
  10. Korzilius, Heike (2000). "Bundesausschuss: Streit um Akupunktur" (PDF). Deutsches Ärzteblatt (in German). 97 (30): A-2013–4. Retrieved 2013-11-26.
  11. Suess, Jochen; Scharl, Anton (2004). "Lässt sich die Wirksamkeit der Akupunktur naturwissenschaftlich erklären?". Die Hebamme. 17 (4): 214–7. doi:10.1055/s-2004-860883.
  12. ^ Gemeinsamer Bundesausschuss (2007-09-27). Zusammenfassender Bericht des Unterausschusses 'Ärztliche Behandlung' des Gemeinsamen Bundesausschusses über die Bewertung gemäß §135 Abs.1 SGB V der Körperakupunktur mit Nadeln ohne elektrische Stimulation bei chronischen Kopfschmerzen, chronischen LWS-Schmerzen, chronischen Schmerzen bei Osteoarthritis [Summary report of the subcommittee 'Medical treatment' of the Federal Joint Committee on the assessment pursuant to § 135 SGB V, Section 1 of the body acupuncture with needles without electrical stimulation for chronic headache, chronic lumbar pain, chronic pain associated with osteoarthritis] (PDF) (in German). pp. 1–527. Retrieved 2013-11-30.
  13. ^ Endres, Heinz G.; Diener, Hans-Christoph; Maier, Christoph; Böwing, Gabriele; et al. (2007). "Akupunktur bei chronischen Kopfschmerzen" [Acupuncture for chronic headache]. Deutsches Ärzteblatt (in German). 104 (3): A-114, B-105, C-101.
  14. Pyne, D.; Shenker, N. G. (2008). "Demystifying acupuncture". Rheumatology. 47 (8): 1132–6. doi:10.1093/rheumatology/ken161. PMID 18460551.
  15. 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. PMID 16818924. S2CID 53090249.
  16. Hessel, W. (2005). "Die Gerac-Akupunkturstudien". Skeptiker (1).
  17. 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.
  18. "Acupuncture may ease back pain". NHS Choices. 2007-09-26. Retrieved January 2, 2019.
  19. "Akupunktur wird Leistung der gesetzlichen Krankenkassen". Federal Ministry of Health (Germany). 2006-07-03.
  20. "Akupunktur bei Migräne - nicht besser als ein Placebo?" (in German). Gesellschaft zur wissenschaftlichen Untersuchung von Parawissenschaften. Retrieved 2013-11-26.
  21. Vorsatz, William (2007-11-13). "Bestechendes Argument" (in German). Deutschlandfunk.
  22. "Studie belegt: Akupunktur hilft bei chronischen Schmerzen". Die Welt (in German). 2007-01-17.
  23. Williams, Carla (2007-09-24). "Fake or not, acupuncture helps back pain". ABC News. Retrieved 2013-11-25.
  24. "Acupuncture more effective than conventional treatments for back pain: Study". Canadian Broadcasting Corporation. 2007-09-27.
  25. "Needles 'are best for back pain'". BBC. 2007-09-25. Retrieved 2013-11-25.
  26. Hawkes, Nigel (2007-09-25). "Sticking needles in a bad back 'eases pain better than drugs'". The Times. Retrieved 2013-11-25.

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