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The '''German Acupuncture Trials''' ({{lang-de|GERAC-Studien<ref name=dmw1>{{cite journal|last=Wenzel|first=K.-W|title=Akupunktur: Was zeigen die GERAC-Studien?|journal='']''|year=2005|month=June|volume=130|issue=24|pages=1520–1520|doi=10.1055/s-2005-870855|url=https://www.thieme-connect.com/ejournals/abstract/10.1055/s-2005-870855#RLB-13-1|language=German}}</ref>}}) are a series of nationwide ] trials set up in 2001 and published in 2006, on behalf of several ].<ref name="spiegelacupuncture">{{cite web|last=Veronika Hackenbroch|title=Die eingebildete Heilung|url=http://www.spiegel.de/spiegel/print/d-32565481.html|publisher='']''|language=German|date=25.10.2004}}</ref> They consist 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"/> | The '''German Acupuncture Trials''' ({{lang-de|GERAC-Studien<ref name=dmw1>{{cite journal|last=Wenzel|first=K.-W|title=Akupunktur: Was zeigen die GERAC-Studien?|journal='']''|year=2005|month=June|volume=130|issue=24|pages=1520–1520|doi=10.1055/s-2005-870855|url=https://www.thieme-connect.com/ejournals/abstract/10.1055/s-2005-870855#RLB-13-1|language=German|quote=Der Aufbau der Studie hält wissenschaftlichen Kriterien sicherlich nicht stand}}</ref>}}) are a series of nationwide ] trials set up in 2001 and published in 2006, on behalf of several ].<ref name="spiegelacupuncture">{{cite web|last=Veronika Hackenbroch|title=Die eingebildete Heilung|url=http://www.spiegel.de/spiegel/print/d-32565481.html|publisher='']''|language=German|date=25.10.2004|quote=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.}}</ref> They consist 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"/> | ||
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 was reported to work 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 that there was no difference in efficiency of real 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|pages=92-94}}</ref> Subsequent assessment of the trials judged that since they did not include a well-designed placebo, they were unlikely to have emitted clinically significant findings.<ref name="Howick2011"/> | |||
As a result of the GERAC trials, the ] ruled in April 2006 that the costs of acupunctural treatment for chronic ] and knee ] will be covered by ] in Germany.<ref name="Karin Hertzer">{{cite web|last=Karin Hertzer|title=Akupunktur ist wirksam|url=http://www.focus.de/gesundheit/gesundleben/alternativmedizin/chinamedizin/akupunktur/aktuelle-studie_aid_19882.html|publisher='']''|language=German|date=12.08.2009}}</ref> | As a result of the GERAC trials, the ] ruled in April 2006 that the costs of acupunctural treatment for chronic ] and knee ] will be covered by ] in Germany.<ref name="Karin Hertzer">{{cite web|last=Karin Hertzer|title=Akupunktur ist wirksam|url=http://www.focus.de/gesundheit/gesundleben/alternativmedizin/chinamedizin/akupunktur/aktuelle-studie_aid_19882.html|publisher='']''|language=German|date=12.08.2009|quote=Der Gemeinsame Bundesausschuss der Ärzte und Krankenkassen entschied dann im April 2006, die Akupunktur als Kassenleistung gegen Rücken- und Knieschmerzen anzuerkennen.}}</ref> | ||
According to ], the total cost of the trials amounted to 7.5 million Euros.<ref>{{cite web|title=Akupunktur|url=http://www.puls.sf.tv/Nachrichten/Archiv/2003/03/10/Gesundheitsthemen/Akupunktur|date=10.03.2003 |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 eventually surpassed one million.<ref name="accupuncture-rponline">{{cite web|title=Frauen häufiger mit Akupunktur behandelt|url=http://www.rp-online.de/gesundheit/medizin-und-vorsorge/frauen-haeufiger-mit-akupunktur-behandelt-1.2973239|publisher='']''|accessdate=25 May 2013|language=German}}</ref> | According to ], the total cost of the trials amounted to 7.5 million Euros.<ref>{{cite web|title=Akupunktur|url=http://www.puls.sf.tv/Nachrichten/Archiv/2003/03/10/Gesundheitsthemen/Akupunktur|date=10.03.2003 |publisher=]|quote=. 7 gesetzliche Krankenkassen in Deutschland unterstützen die Studien mit 7.5 Millionen Euro.}}</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 eventually surpassed one million.<ref name="accupuncture-rponline">{{cite web|title=Frauen häufiger mit Akupunktur behandelt|url=http://www.rp-online.de/gesundheit/medizin-und-vorsorge/frauen-haeufiger-mit-akupunktur-behandelt-1.2973239|publisher='']''|accessdate=25 May 2013|language=German}}</ref> | ||
== |
== History == | ||
⚫ | ]]] | ||
In the late 1990s, German healthcare regulators began to voice their doubts over the therapeutical usage of acupuncture, mostly due to the lack of reliable evidence regarding its therapeutic efficacy.<ref>{{cite book|last=Ernst|first=Simon Singh & Edzard|title=Trick or treatment : the undeniable facts about alternative medicine|year=2008|publisher=W.W. Norton|location=New York|isbn=9780393066616|pages=81-82|edition=1st American ed.}}</ref> This resulted in a heated debate, which led to Paul Rheinberger, Director of the ], making the following statement: "The higher the quality of clinical studies performed on acupuncture, the lesser the amount of evidence supporting its efficacy."<ref>{{cite journal|last=Korzilius, Heike|title=Bundesausschuss: Streit um Akupunktur|journal='']''|date=28 July 2000|volume=97|issue=30|pages=A-2013-14|language=German|url=http://www.aerzteblatt.de/pdf/97/30/a2013.pdf|accessdate=26 November 2013}}</ref><ref>{{cite journal|last=Suess|first=Jochen|coauthors=Scharl, Anton|title=Lässt sich die Wirksamkeit der Akupunktur naturwissenschaftlich erklären?|journal=Die Hebamme|year=2004|month=December|language=German|volume=17|issue=4|pages=214–217|doi=10.1055/s-2004-860883|url=https://www.thieme-connect.com/ejournals/abstract/10.1055/s-2004-860883|accessdate=26 November 2013}}</ref> | 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.<ref>{{cite book|last=Ernst|first=Simon Singh & Edzard|title=Trick or treatment : the undeniable facts about alternative medicine|year=2008|publisher=W.W. Norton|location=New York|isbn=9780393066616|pages=81-82|edition=1st American ed.}}</ref> This resulted in a heated debate, which led to Paul Rheinberger, Director of the ], making the following statement: "The higher the quality of clinical studies performed on acupuncture, the lesser the amount of evidence supporting its efficacy."<ref>{{cite journal|last=Korzilius, Heike|title=Bundesausschuss: Streit um Akupunktur|journal='']''|date=28 July 2000|volume=97|issue=30|pages=A-2013-14|language=German|url=http://www.aerzteblatt.de/pdf/97/30/a2013.pdf|accessdate=26 November 2013|quote=„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.“}}</ref><ref>{{cite journal|last=Suess|first=Jochen|coauthors=Scharl, Anton|title=Lässt sich die Wirksamkeit der Akupunktur naturwissenschaftlich erklären?|journal=Die Hebamme|year=2004|month=December|language=German|volume=17|issue=4|pages=214–217|doi=10.1055/s-2004-860883|url=https://www.thieme-connect.com/ejournals/abstract/10.1055/s-2004-860883|accessdate=26 November 2013}}</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>{{cite journal|last=Cummings|first=M.|title=Modellvorhaben Akupunktur - a summary of the ART, ARC and GERAC trials|journal='']''|date=1 March 2009|volume=27|issue=1|pages=26–30|doi=10.1136/aim.2008.000281|url=http://aim.bmj.com/content/27/1/26.short}}</ref><ref>Gemeinsamer Bundesausschuss 2007, p. 2</ref><ref name="da1">{{cite journal|last=Endres, Heinz G.; Diener, Hans-Christoph; Maier, Christoph; Böwing, Gabriele; Trampisch, Hans-Joachim; Zenz, Michael|title=Akupunktur bei chronischen Kopfschmerzen|journal='']''|year=2007|volume=104|issue=3|pages=A-114 / B-105 / C-101|url=http://www.aerzteblatt.de/archiv/54176/|language=German}}</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>{{cite journal|last=Cummings|first=M.|title=Modellvorhaben Akupunktur - a summary of the ART, ARC and GERAC trials|journal='']''|date=1 March 2009|volume=27|issue=1|pages=26–30|doi=10.1136/aim.2008.000281|url=http://aim.bmj.com/content/27/1/26.short}}</ref><ref>Gemeinsamer Bundesausschuss 2007, p. 2</ref><ref name="da1">{{cite journal|last=Endres, Heinz G.; Diener, Hans-Christoph; Maier, Christoph; Böwing, Gabriele; Trampisch, Hans-Joachim; Zenz, Michael|title=Akupunktur bei chronischen Kopfschmerzen|journal='']''|year=2007|volume=104|issue=3|pages=A-114 / B-105 / C-101|url=http://www.aerzteblatt.de/archiv/54176/|language=German}}</ref> | ||
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...") Gemeinsamer Bundesausschuss 2007, p.5 |
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 ].<ref name="spiegelacupuncture"/><ref name="da1"/> | ||
== 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.<ref name="spiegelacupuncture">{{cite web|last=Veronika Hackenbroch|title=Die eingebildete Heilung|url=http://www.spiegel.de/spiegel/print/d-32565481.html|publisher='']''|language=German|date=25.10.2004}}</ref> The number of patients randomized was one of the largest ever for acupuncture trials.<ref name="spiegelacupuncture"/> | |||
{{Undue-section|date=November 2013}} | |||
All RCTs were designed as three-armed trials, with the three parallel groups in each trial receiving either verum (real) acupuncture treatment, sham acupuncture treatment, or guideline-based conventional treatment.<ref name="spiegelacupuncture">{{cite web|last=Veronika Hackenbroch|title=Die eingebildete Heilung|url=http://www.spiegel.de/spiegel/print/d-32565481.html|publisher='']''|language=German|date=25.10.2004|quote=Zu diesem Zweck wurden die Kranken nach dem Zufallsprinzip drei Gruppen zugeteilt: Die Schmerzpatienten der ersten Gruppe wurden nach einem chinesischen Originalverfahren gestochen, auf das sich Akupunkteure bundesweit geeinigt hatten; die Patienten der Kontrollgruppe hingegen erhielten - ohne davon zu wissen - nur die Scheinakupunktur. Eine weitere Kontrollgruppe wiederum bestand aus Patienten, die nach der schulmedizinischen Standardtherapie behandelt wurden.}}</ref> The number of patients randomized was one of the largest ever for acupuncture trials.<ref name="spiegelacupuncture"/><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> | |||
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> | |||
⚫ | Beginning in 2001, the trials were carried out by the following universities: ], the ], the ] and the ]. |
||
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.{{CN|date=November 2013}} | |||
⚫ | == Domestic consequences |
||
For sham acupuncture, needles were inserted only superficially (3 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> 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> | |||
=== Results === | |||
⚫ | ]]] | ||
⚫ | Beginning in 2001, the trials were carried out by the following universities: ], the ], the ] and the ]. The results are summarized below: | ||
;Low back pain trial | |||
1162 patients were randomized in this trial.<ref name="shenker"/> 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 name="ReferenceA">Gemeinsamer Bundesausschuss 2007, p. 304</ref><ref name="archinte.ama-assn.org">{{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 name="ReferenceA"/><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> 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 name="archinte.ama-assn.org"/><ref>Gemeinsamer Bundesausschuss 2007, p. 307</ref> This implied both real and sham acupuncture being ] more effective than standard therapy (]<0.001<ref name="archinte.ama-assn.org"/>); the efficacy of both types of acupuncture was actually noted to be almost twice that of standard therapy.<ref name="shenker">{{cite journal|last=Pyne|first=D.|coauthors=Shenker, N. G.|title=Demystifying acupuncture|journal='']''|date=29 April 2008|volume=47|issue=8|pages=1132–1136|doi=10.1093/rheumatology/ken161|url=http://rheumatology.oxfordjournals.org/content/47/8/1132.full|quote=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}}</ref> However, there was no statistical significant difference between the effectiveness of real and sham acupuncture (p=0.39<ref name="archinte.ama-assn.org"/>).<ref>Gemeinsamer Bundesausschuss 2007, pp. 309-310</ref> | |||
;Knee osteoarthritis trial | |||
A total of 1039 patients were randomized in this study.<ref name="ReferenceB">Gemeinsamer Bundesausschuss 2007, p. 396</ref><ref name="Scharf et al. 2006, p. 13">Scharf et al. 2006, p. 13</ref> Treatment in the standard therapy group consisted of ] or ] medication on an as-needed basis.<ref name="Scharf et al. 2006, p. 13"/><ref name="ReferenceC">Gemeinsamer Bundesausschuss 2007, p. 390</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 name="ReferenceC"/><ref name="Scharf et al. 2006, p. 14">Scharf et al. 2006, p. 14</ref> Patients in all three groups could attend six physiotherapy sessions.<ref name="ReferenceB"/><ref name="Scharf et al. 2006, p. 14"/> 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 name="Scharf et al. 2006, p. 14"/><ref>Gemeinsamer Bundesausschuss 2007, p. 391</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 name=mao1/> This amounts to significant superiority of acupuncture and sham acupuncture over standard treatment, but no statistical significant efficacy difference between real and sham acupuncture.<ref name=mao1/> | |||
;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.<ref>Gemeinsamer Bundesausschuss 2007, p. 473</ref> Primary outcome was defined as reduction in migraine days in week 21 to 25 after randomization.<ref>Gemeinsamer Bundesausschuss 2007, pp. 469-470</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>Gemeinsamer Bundesausschuss 2007, p. 469</ref><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> 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.<ref>Gemeinsamer Bundesausschuss 2007, p. 474</ref> | |||
;Tension-type headache trial | |||
The standard, guideline-based therapy arm for the RCT for chronic ] provided for ] medication.<ref>Gemeinsamer Bundesausschuss 2007, p. 431</ref><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> Since only few patients were willing to take this antidepressant, the standard therapy arm had to be aborted.<ref>Gemeinsamer Bundesausschuss 2007, p. 431</ref><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> In the two remaining arms (real against sham acupuncture), 405 patients were included altogether.<ref>Gemeinsamer Bundesausschuss 2007, p. 435</ref> Successful treatment was defined as a reduction in headache days per month of more than 50%;<ref>Gemeinsamer Bundesausschuss 2007, p. 433</ref> 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).<ref>Gemeinsamer Bundesausschuss 2007, p. 436</ref><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> | |||
⚫ | == Domestic consequences== | ||
=== Media === | === Media === | ||
The trials resulted in increased coverage of acupuncture in the German ].<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=]|accessdate=26 November 2013|language=German}}</ref> According to the news broadcaster ], the GERAC trials are considered to be the world's largest set of clinical studies on acupuncture.<ref>{{cite web|last=William Vorsatz|title=Bestechendes Argument|url=http://www.deutschlandfunk.de/bestechendes-argument.709.de.html?dram:article_id=88197|language=German|publisher=]|date=13.11.2007}}</ref> The national daily newspaper '']'' remarked that the results of the studies are "promising".<ref>{{cite web|title=Studie belegt: Akupunktur hilft bei chronischen Schmerzen|language=German|quote=|url=http://www.welt.de/wissenschaft/article709480/Studie-belegt-Akupunktur-hilft-bei-chronischen-Schmerzen.html|publisher='']''|date=17.01.07}}</ref> News magazine '']'' stated that the results of GERAC couldn't be brushed aside by the ] anymore.<ref |
The trials resulted in increased coverage of acupuncture in the German ].<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=]|accessdate=26 November 2013|language=German|quote=Zuletzt war die Akupunktur in den Medien präsent, nachdem die von deutschen Krankenkassen in Auftrag gegebenen Studien „German Acupuncture Trials (Gerac)“ mit ersten Ergebnissen veröffentlicht wurden (siehe Hessel 2005).}}</ref> According to the news broadcaster ], the GERAC trials are considered to be the world's largest set of clinical studies on acupuncture.<ref>{{cite web|last=William Vorsatz|title=Bestechendes Argument|url=http://www.deutschlandfunk.de/bestechendes-argument.709.de.html?dram:article_id=88197|language=German|publisher=]|date=13.11.2007}}</ref> The national daily newspaper '']'' remarked that the results of the studies are "promising".<ref>{{cite web|title=Studie belegt: Akupunktur hilft bei chronischen Schmerzen|language=German|quote=|url=http://www.welt.de/wissenschaft/article709480/Studie-belegt-Akupunktur-hilft-bei-chronischen-Schmerzen.html|publisher='']''|date=17.01.07}}</ref> News magazine '']'' stated that the results of GERAC couldn't be brushed aside by the ] anymore.<ref>{{cite web|last=Hackenbroch, Veronika|title=Die eingebildete Heilung|url=http://www.spiegel.de/spiegel/print/d-32565481.html|publisher='']''|date=25.10.2004|quote=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.}}</ref> | ||
⚫ | === Decision of German healthcare regulators === | ||
As a result of the GERAC trials, the ] (''Gemeinsamer Bundesausschuss'') recognized acupunctural treatment as a therepautical option to be reimbursed by ] in Germany, specifically for the treatment of low back pain and knee pain.<ref name="Karin Hertzer"/> | |||
On April 18, 2006, the Committee explained its decision as follows: | |||
{{quotation|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.<ref>{{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=German|date=18.04.2006}}</ref> | |||
"''In conclusion, the Federal Committee is able to accept the results of these studies regarding the treatment of chronic ] and ] of the knee. Although the exact mechanism of acupuncture remains unclear and the choice of acupuncture points according to ] 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 ] of the ] 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 ] confirmed the inclusion of acupunctural treatment for specific conditions as part of ]: | |||
{{quotation|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.<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=03.07.2006}}</ref> | |||
⚫ | === German healthcare regulators === | ||
"''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 ]''"}} | |||
As a result of the GERAC trials, the ] (''Gemeinsamer Bundesausschuss'') recognized acupunctural treatment as a therepautical option to be reimbursed by ] in Germany, specifically for the treatment of low back pain and knee pain in 2006.<ref name="Karin Hertzer"/> During the 16th ] of the ] in July 2006, the German federal government announced that it will not object to the committee's decision. The German Health Minister ] confirmed the inclusion of acupunctural treatment for specific conditions as part of ] on July 3, 2006.<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=03.07.2006}}</ref> | |||
=== Usage of acupuncture === | === Usage of acupuncture === | ||
After the committee's decision to incorporate |
After the committee's decision to incorporate acupuncuture into the ] 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.<ref name="accupuncture-rponline"/> | ||
== International reception == | == International reception == | ||
Line 48: | Line 88: | ||
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> | 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> | ||
], 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>{{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}} |
], 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> | ||
*{{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> | |||
On June 8, 2005, the '']'' (''German Medical Weekly'') published an article which criticized the trials for "not meeting scientific criteria".<ref name=dmw1/> | On June 8, 2005, the '']'' (''German Medical Weekly'') published an article which criticized the trials for "not meeting scientific criteria".<ref name=dmw1/> | ||
Line 60: | Line 102: | ||
==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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The German Acupuncture Trials (Template:Lang-de) are a series of nationwide acupuncture trials set up in 2001 and published in 2006, on behalf of several German statutory health insurance companies. They consist of one observational study on acupuncture side effects, and four randomized controlled trials (RCTs) - investigating acupuncture treatment for low back pain, knee osteoarthritis, migraine prophylaxis, and tension-type headache. The trials are considered to be one of the largest clinical studies in the field of acupuncture.
The observational study revealed adverse events occurring in 7.5% of all acupuncture patients. While the trial for tension-type headache had to be aborted, the other three RCTs had the same results: acupuncture was reported to work as well as or even better than conventional therapy, but that there was no difference in efficiency of real and sham acupuncture. Subsequent assessment of the trials judged that since they did not include a well-designed placebo, they were unlikely to have emitted clinically significant findings.
As a result of the GERAC trials, the German Federal Joint Committee ruled in April 2006 that the costs of acupunctural treatment for chronic back pain and knee osteoarthritis will be covered by public health insurers in Germany.
According to Schweizer Fernsehen, the total cost of the trials amounted to 7.5 million Euros. Several years after the Committee's decision to incorporate acupunctural treatment into the healthcare of Germany was passed into law, the number of regular users of acupuncture in the country eventually surpassed one million.
History
In the late 1990s, German healthcare regulators began to voice their doubts over the therapeutical usage of acupuncture, mostly due to the lack of reliable evidence regarding its therapeutic efficacy. This resulted in a heated debate, which led to Paul Rheinberger, Director of the Federal Committee of Physicians and Health Insurers, making the following statement: "The higher the quality of clinical studies performed on acupuncture, the lesser the amount of evidence supporting its efficacy."
In October 2000, the Federal Committee of Physicians and Health Insurers decided that acupunctural treatment may not be reimbursed by statutory health insurance companies except within the framework of experimental field studies.
Subsequently, the GERAC were set up at Bochum University in 2001, as a field study on behalf of six German statutory health insurance organizations.
Overview
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All RCTs were designed as three-armed trials, with the three parallel groups in each trial receiving either verum (real) acupuncture treatment, sham acupuncture treatment, or guideline-based conventional treatment. The number of patients randomized was one of the largest ever for acupuncture trials.
Only registered physicians with an additional license for acupuncture and at least two years of clinical experience in acupuncture treatment qualified as performing acupuncturists. In order to acquaint them with the study-specific standards of acupuncture, sham acupuncture and conventional therapy, the performing physicians received a one-day training.
The acupuncture point selection was partially predetermined. Needles were to be manipulated until arrival of de-qi sensation, 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. Thus, only the patients (not the performing acupuncturists) could be blinded. Type and quantity of needles were the same in real and sham acupuncture. Assessment regarding the therapy's efficacy was undertaken by blinded interviewers.
Results
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:
- Low back pain trial
1162 patients were randomized in this trial. 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. Treatment given in the standard therapy group consisted of a combination of physical therapy and NSAID medication. 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. This implied both real and sham acupuncture being significantly more effective than standard therapy (p<0.001); the efficacy of both types of acupuncture was actually noted to be almost twice that of standard therapy. However, there was no statistical significant difference between the effectiveness of real and sham acupuncture (p=0.39).
- Knee osteoarthritis trial
A total of 1039 patients were randomized in this study. Treatment in the standard therapy group consisted of diclofenac or rofecoxib medication on an as-needed basis. Patients in the acupuncture and sham acupuncture groups were also allowed additional medication with diclofenac (as needed), but limited to a small amount (i.e., a total of 1g between week 2 and 23). Patients in all three groups could attend six physiotherapy sessions. 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. 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. This amounts to significant superiority of acupuncture and sham acupuncture over standard treatment, but no statistical significant efficacy difference between real and sham acupuncture.
- Migraine prophylaxis trial
In this trial, a total of 960 patients was randomized; immediately after randomization, however, 125 patients (almost all of them from the standard group) withdrew from the study. Primary outcome was defined as reduction in migraine days in week 21 to 25 after randomization. Treatment for the standard group consisted of medication according to the 2005 therapy guidelines issued by the German Neurological Association, usually comprising a beta-blocker. 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.
- Tension-type headache trial
The standard, guideline-based therapy arm for the RCT for chronic tension type headache provided for amitryptiline medication. Since only few patients were willing to take this antidepressant, the standard therapy arm had to be aborted. In the two remaining arms (real against sham acupuncture), 405 patients were included altogether. 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=0.181).
- Observational study
12,617 physicians took part in the observational study, reporting on adverse events during or after acupuncture therapies they performed between 2001 and 2005. This resulted in data of roughly 2.6 million patients, out of which a random sample of 190,924 was reviewed in terms of frequency of adverse events and serious adverse events. Adverse events were reported in 7.5% of the cases, including 45 serious adverse events. 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. Underreporting of adverse events had to be assumed.
Domestic consequences
Media
The trials resulted in increased coverage of acupuncture in the German media. According to the news broadcaster Deutschlandfunk, the GERAC trials are considered to be the world's largest set of clinical studies on acupuncture. The national daily newspaper Die Welt remarked that the results of the studies are "promising". News magazine Der Spiegel stated that the results of GERAC couldn't be brushed aside by the Federal Joint Committee anymore.
Decision of German healthcare regulators
As a result of the GERAC trials, the German Federal Joint Committee (Gemeinsamer Bundesausschuss) recognized acupunctural treatment as a therepautical option to be reimbursed by public health insurance in Germany, specifically for the treatment of low back pain and knee pain.
On April 18, 2006, the Committee explained its decision as follows:
Im Ergebnis hat der Gemeinsame Bundesausschuss in seinen Beratungen die in den Studien zu chronischen Rückenschmerzen und zur Gonarthrose erzielten Verbesserungen nachvollziehen können. Dass der genaue Wirkungsmechanismusder Akupunktur nach wie vor unbekannt ist und die spezifische Punktauswahl nach den Regeln der TCM in den Studien nicht als ausschlaggebend für den Therapieerfolg erhärtet werden konnte, führt nicht zwangsläufig zur Verneinung des Nutzennachweises. Ausschlaggebend für die Anerkennungist der geführte Nachweis, dass die Akupunkturbehandlung bei den genannten Indikationen der Standardtherapie überlegen ist. "In conclusion, the Federal Committee is able to accept the results of these studies regarding the treatment of chronic back pain and osteoarthritis of the knee. Although the exact mechanism of acupuncture remains unclear and the choice of acupuncture points according to TCM did not affect therapeutic outcome, the deciding factor is that acupuncutral treatment has been superior to convential therapy for the conditions listed above."
During the 16th legislative session of the Bundestag in July 2006, the German federal government announced that it will not object to the committee's decision. In a statement issued on July 3, 2006, the German Health Minister Ulla Schmidt confirmed the inclusion of acupunctural treatment for specific conditions as part of healthcare in Germany:
Die Anerkennung der Akupunktur durch den Gemeinsamen Bundesausschuss ist zu begrüßen. Sie erweitert den Leistungskatalog der gesetzlichen Krankenkassen um eine wirksame und schonende Behandlungsmethode für Patientinnen und Patienten mit chronischen Schmerzen der Lendenwirbelsäule und des Kniegelenks. Die Modellvorhaben der gesetzlichen Krankenkassen haben nämlich gezeigt, dass die Akupunktur bei diesen beiden Indikationen deutlich besser wirkt als die übliche Standardbehandlung mit Medikamenten oder Krankengymnastik. "I welcome the Federal Committee's decision to accept acupuncture as an effective treatment option for patients with chronic back pain and osteoarthritis of the knee. The proposed trials undertaken by statutory health insurers have shown that acupunctural treatment for these conditions is more effective than medication or physiotherapy"
Usage of acupuncture
After the committee's decision to incorporate 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.
International reception
Media
ABC News reported that the study "highlights the superiority of acupuncture", but also introduces uncertainty about the specific mechanisms of treatment. Heinz Endres, one of the authors of the study, told the Canadian Broadcasting Corporation that "acupuncture has not yet been recommended as a routine therapy", but "we think this will change with our study". The BBC pointed out that the study "echoes the findings of two studies published last year in the British Medical Journal, which found a short course of acupuncture could benefit patients with low back pain". Nigel Hawkes, health editor of The Times, wrote that the trials "suggest that both acupuncture and sham acupuncture act as powerful versions of the placebo effect."
Academic community
In September 2007, NHS Choices commented on the news surrounding the study and said that "this trial seems to support the role of acupuncture as an effective alternative therapy for chronic lower back pain" but that "it will be important to try to tease apart the real treatment effects from those that occur through the placebo effect". As of 2012 The guidance within the UK National Health Service is that "there is little or no scientific evidence that acupuncture works for many of the conditions for which it is often used", and its use is only supported for lower back pain.
The trials found no significant differences between acupuncture and sham acupuncture.
Edzard Ernst, a professor of complementary medicine at the University of Exeter, noted that the studies had attracted criticism for not taking into account the risk of patient de-blinding, and that they " to conclusively answer the question whether acupuncture helps patients through a specific or a nonspecific effect".
On June 8, 2005, the Deutsche Medizinische Wochenschrift (German Medical Weekly) published an article which criticized the trials for "not meeting scientific criteria".
See also
References
- ^ 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.
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(help) Cite error: The named reference "spiegelacupuncture" was defined multiple times with different content (see the help page). - "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
- ^ Jeremy H. Howick (23 February 2011). The Philosophy of Evidence-based Medicine. John Wiley & Sons. pp. 92–94. ISBN 978-1-4443-4266-6. Cite error: The named reference "Howick2011" was defined multiple times with different content (see the help page).
- ^ 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.
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(help) - "Akupunktur". Schweizer Fernsehen. 10.03.2003.
. 7 gesetzliche Krankenkassen in Deutschland unterstützen die Studien mit 7.5 Millionen Euro.
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(help) - ^ "Frauen häufiger mit Akupunktur behandelt" (in German). Rheinische Post. Retrieved 25 May 2013.
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(help) - Ernst, Simon Singh & Edzard (2008). Trick or treatment : the undeniable facts about alternative medicine (1st American ed. ed.). New York: W.W. Norton. pp. 81–82. ISBN 9780393066616.
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has extra text (help) - 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."
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(help) - Suess, Jochen (2004). "Lässt sich die Wirksamkeit der Akupunktur naturwissenschaftlich erklären?". Die Hebamme (in German). 17 (4): 214–217. doi:10.1055/s-2004-860883. Retrieved 26 November 2013.
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ignored (help) - 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.
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(help) - Gemeinsamer Bundesausschuss 2007, p. 2
- ^ 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.
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(help)CS1 maint: multiple names: authors list (link) - "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
- "... 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
- "Eine weitere Stärke ist eine sehr hohe Power aufgrund der bislang größten Zahl an Patienten, die jemals in Akupunkturstudien randomisiert worden sind." - "Another strength is a very big power due to the largest sample size of patients ever to be randomized in an acupuncture trial." As seen at: Endres et al. 2007, p. C107
- "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
- "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
- "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
- "... 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
- "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
- "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
- "Nadelart und -zahl ... waren deshalb gleich." ("Needle type and numbers ... therefore were the same.") As seen at: Endres et al. 2007, p. C103
- "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
- ^ 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
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ignored (|author=
suggested) (help) - ^ Gemeinsamer Bundesausschuss 2007, p. 304
- ^ 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.
- "... 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
- Gemeinsamer Bundesausschuss 2007, p. 307
- Gemeinsamer Bundesausschuss 2007, pp. 309-310
- ^ Gemeinsamer Bundesausschuss 2007, p. 396
- ^ Scharf et al. 2006, p. 13
- ^ Gemeinsamer Bundesausschuss 2007, p. 390
- ^ Scharf et al. 2006, p. 14
- Gemeinsamer Bundesausschuss 2007, p. 391
- ^ Cite error: The named reference
mao1
was invoked but never defined (see the help page). - Gemeinsamer Bundesausschuss 2007, p. 473
- Gemeinsamer Bundesausschuss 2007, pp. 469-470
- Gemeinsamer Bundesausschuss 2007, p. 469
- "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
- Gemeinsamer Bundesausschuss 2007, p. 474
- Gemeinsamer Bundesausschuss 2007, p. 431
- "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
- Gemeinsamer Bundesausschuss 2007, p. 431
- "... 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
- Gemeinsamer Bundesausschuss 2007, p. 435
- Gemeinsamer Bundesausschuss 2007, p. 433
- Gemeinsamer Bundesausschuss 2007, p. 436
- 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.
- "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
- "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
- "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
- "... 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
- "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
- "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
- "Akupunktur bei Migräne - nicht besser als ein Placebo?" (in German). de:Gesellschaft zur wissenschaftlichen Untersuchung von Parawissenschaften. Retrieved 26 November 2013.
Zuletzt war die Akupunktur in den Medien präsent, nachdem die von deutschen Krankenkassen in Auftrag gegebenen Studien „German Acupuncture Trials (Gerac)" mit ersten Ergebnissen veröffentlicht wurden (siehe Hessel 2005).
- William Vorsatz (13.11.2007). "Bestechendes Argument" (in German). Deutschlandfunk.
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(help) - "Studie belegt: Akupunktur hilft bei chronischen Schmerzen" (in German). Die Welt. 17.01.07.
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(help) - 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.
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(help) - "Tragende Gründe zum Beschluss des Gemeinsamen Bundesau sschusses zur Akupunktur" (PDF) (in German). Federal Joint Committee (Germany). 18.04.2006.
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(help) - "Akupunktur wird Leistung der gesetzlichen Krankenkassen". Federal Ministry of Health (Germany). 03.07.2006.
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(help) - CARLA WILLIAMS (Sept. 24, 2007). "Fake or Not, Acupuncture Helps Back Pain". ABC News. Retrieved 25 November 2013.
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(help) - "http://www.cbc.ca/news/technology/acupuncture-more-effective-than-conventional-treatments-for-back-pain-study-1.646658". Canadian Broadcasting Corporation. Sep 24, 2007.
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- "Needles 'are best for back pain'". BBC. 25 September 2007. Retrieved 25 November 2013.
- Nigel Hawkes (September 25, 2007). "Sticking needles in a bad back 'eases pain better than drugs'". The Times. Retrieved 25 November 2013.
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(help) - "Acupuncture may ease back pain". NHS Choices. 26 September 2007. Retrieved November 2013.
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(help) - "Acupuncture". NHS Choices. 22 May 2012. Retrieved November 2013.
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(help) -
- 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.
- Wettig, D (2005). "Die GERAC-Gonarthrose-Studie". Der Schmerz. 19 (4): 330–1, author reply 331–2. doi:10.1007/s00482-005-0404-0. PMID 16145742.
- Cite error: The named reference
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was invoked but never defined (see the help page).
- Endres, Heinz G.; Diener, Hans-Christoph; Maier, Christoph; Böwing, Gabriele; Trampisch, Hans-Joachim; Zenz, Michael (2007). "Akupunktur bei chronischen Kopfschmerzen". Deutsches Ärzteblatt. 104 (3): C101–C108.
- Endres, Heinz G.; Victor, Norbert; Haake, Michael; Witte, Steffen; Streitberger, Konrad; Zenz, Michael (2007). "Akupunktur bei chronischen Knie- und Rückenschmerzen". Deutsches Ärzteblatt. 104 (3): C109–C116.
- Gemeinsamer Bundesausschuss (27 September 2007). "Zusammenfassender Bericht des Unterausschusses "Ärztliche Behandlung" des Gemeinsamen Bundesausschusses über die Bewertung gemäß §135 Abs.1 SGB V der Körperakupunktur mit Nadeln ohne elektrische Stimulation bei chronischen Kopfschmerzen, chronischen LWS-Schmerzen, chronischen Schmerzen bei Osteoarthritis" (PDF) (in German). Retrieved 5 November 2013.
- 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.