Designing an acupuncture study: the nationwide, randomized, controlled, German acupuncture trials on migraine and tension-type headache.

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.