title: Designing an acupuncture study: the nationwide, randomized, controlled, German acupuncture trials on migraine and tension-type headache.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Forschungsgruppe Akupunktur und Chinesische Medizin, Duesseldorf, Germany. a.molsberger@facm.de
authors.forename: Albrecht F
authors.initials: AF
authors.lastname: Molsberger
authors.forename: Gabriele
authors.initials: G
authors.lastname: Boewing
authors.forename: Hans Christoph
authors.initials: HC
authors.lastname: Diener
authors.forename: Heinz G
authors.initials: HG
authors.lastname: Endres
authors.forename: Nils
authors.initials: N
authors.lastname: Kraehmer
authors.forename: Kai
authors.initials: K
authors.lastname: Kronfeld
authors.forename: Michael
authors.initials: M
authors.lastname: Zenz
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D015670:Acupuncture Therapy / Q000379:methods; D019091:Critical Pathways / Q000458:organization & administration; D005858:Germany; D008881:Migraine Disorders / Q000628:therapy; D015337:Multicenter Studies as Topic / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012107:Research Design; D018781:Tension-Type Headache / Q000628:therapy