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The German Acupuncture Trials (GERAC) are a series of acupuncture trials set up in 2001 and published in 2006, on behalf of six 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 observational study revealed adverse events occurring in 7.5% of all acupuncture patients. While the trial for tension-type headache had to be aborted, the other three RCTs had the same results: acupuncture worked as well as or even better than conventional therapy, but there was no significant difference in efficacy between real and sham acupuncture.

Background

In 2000, the paramount decision-making body within the self-government of medical service providers and statutory health insurance companies in Germany, known as the Joint Federal Committee (Gemeinsamer Bundesausschuss), ruled that acupuncture treatment may not be covered by statutory health insurance companies except within the framework of field studies.

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

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. 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.

In later years, Edzard Ernst 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".

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); 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 up to 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 (at p=0.48).

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. 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. 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%).

Tension-type headache trial

The standard, guideline-based therapy arm for the RCT for chronic tension type headache provided for amitryptiline medication. Although first-line, this usage of amitryptiline was not mentioned in the drug's package insert in Germany at that time. Subsequently, only four patients were willing to try this treatment, and the standard therapy arm had to be aborted.

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).

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.

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.

References

1. Gemeinsamer Bundesausschuss 2007, p. 2
2. "... 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
3. "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
4. "... 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
5. "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
6. "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
7. "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
8. "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
9. "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
10. "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
11. "... 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
12. "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
13. "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
14. "Nadelart und -zahl ... waren deshalb gleich." ("Needle type and numbers ... therefore were the same.") As seen at: Endres et al. 2007, p. C103
15. "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
16. • 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.
17. Gemeinsamer Bundesausschuss 2007, p. 307
18. Gemeinsamer Bundesausschuss 2007, p. 304
19. 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.
20. "... 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
21. 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.
22. 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.
23. Scharf et al. 2006, p. 13
24. Scharf et al. 2006, p. 13
25. Scharf et al. 2006, p. 14
26. Scharf et al. 2006, p. 14
27. Scharf et al. 2006, p. 14
28. Scharf et al. 2006, p. 16
29. Scharf et al. 2006, p. 16
30. Diener, Hans-Christoph; Kronfeld, Kai; Boewing, Gabriele; Lungenhausen, Margitta; Maier, Christoph; Molsberger, Albrecht; Tegenthoff, Martin; Trampisch, Hans-Joachim; Zenz, Michael; Meinert, Rolf (2006). "Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial". The Lancet Neurology. 5 (4): 310–316.
31. "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
32. Diener, Hans-Christoph; Kronfeld, Kai; Boewing, Gabriele; Lungenhausen, Margitta; Maier, Christoph; Molsberger, Albrecht; Tegenthoff, Martin; Trampisch, Hans-Joachim; Zenz, Michael; Meinert, Rolf (2006). "Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial". The Lancet Neurology. 5 (4): 310–316.
33. "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
34. "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
35. "... 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
36. 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.
37. "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
38. "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
39. "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
40. "... 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
41. "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
42. "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
43. Gemeinsamer Bundesausschuss 2007, p. 2
44. "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

• 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.

External links

• GERAC homepage

• Clinical trials
• Acupuncture