PMID- 16646722 OWN - NLM STAT- MEDLINE DCOM- 20060726 LR - 20240229 IS - 1075-5535 (Print) IS - 1075-5535 (Linking) VI - 12 IP - 3 DP - 2006 Apr TI - Designing an acupuncture study: the nationwide, randomized, controlled, German acupuncture trials on migraine and tension-type headache. PG - 237-45 AB - BACKGROUND: In the nationwide German Acupuncture Trials (GERAC) verum acupuncture, based on Traditional Chinese Medicine (TCM), was to be tested against sham acupuncture for the entities classified in the West as "migraine" (MIG) and "tension-type headache" (TTH). However, there were no generally accepted guidelines on how to perform a consistent verum or sham treatment. OBJECTIVE: To design broadly consensual verum and sham acupuncture treatment protocols for MIG and TTH for the GERAC. METHODOLOGY: Extensive literature study and consultation with acupuncture experts. Personal interviews, both free and structured, e-mail discussions, and phone conferences were used. RESULTS: Broadly consensual acupuncture protocols for MIG and TTH for verum and sham acupuncture were developed. They included semi-standardized point combinations with clearly described point selection rules based on TCM acupuncture diagnoses. A procedure was developed to help ensure homogenous treatment quality in a large multicenter trial. CONCLUSIONS: The GERAC study design allowed acupuncture to be tested in a naturalistic environment. The rigorous study design and the large number of physician investigators guaranteed a high external validity for the results. The results will help determine the significance of Chinese acupuncture in the context of Western medicine for the treatment of MIG and TTH. FAU - Molsberger, Albrecht F AU - Molsberger AF AD - Forschungsgruppe Akupunktur und Chinesische Medizin, Duesseldorf, Germany. a.molsberger@facm.de FAU - Boewing, Gabriele AU - Boewing G FAU - Diener, Hans Christoph AU - Diener HC FAU - Endres, Heinz G AU - Endres HG FAU - Kraehmer, Nils AU - Kraehmer N FAU - Kronfeld, Kai AU - Kronfeld K FAU - Zenz, Michael AU - Zenz M LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - J Altern Complement Med JT - Journal of alternative and complementary medicine (New York, N.Y.) JID - 9508124 SB - IM MH - Female MH - Humans MH - Male MH - *Acupuncture Therapy/methods MH - Critical Pathways/organization & administration MH - Germany MH - *Migraine Disorders/therapy MH - Multicenter Studies as Topic/methods MH - *Randomized Controlled Trials as Topic/methods/standards MH - Research Design MH - *Tension-Type Headache/therapy EDAT- 2006/05/02 09:00 MHDA- 2006/07/26 09:00 CRDT- 2006/05/02 09:00 PHST- 2006/05/02 09:00 [pubmed] PHST- 2006/07/26 09:00 [medline] PHST- 2006/05/02 09:00 [entrez] AID - 10.1089/acm.2006.12.237 [doi] PST - ppublish SO - J Altern Complement Med. 2006 Apr;12(3):237-45. doi: 10.1089/acm.2006.12.237.