Treatment in a randomized multicenter trial of acupuncture for migraine (ART migraine)

Background: This paper aims to describe the characteristics of physicians and interventions of a large, multicenter randomized trial of acupuncture for migraine ( ART Migraine) in order to enable acupuncturists to assess the study interventions. Patients and Methods: 302 patients suffering from migraine were randomized to 12 sessions of semi-standardized acupuncture ( 6 predefined basic points, recommendations for optional individual choice of additional points given), standardized minimal acupuncture ( superficial needling of at least 5 of 10 predefined, distant non-acupuncture points) or a waiting list. 30 physicians trained and experienced in acupuncture from 18 centers in Germany participated in the trial. Results: The median duration of acupuncture training of trial physicians was 500 h ( range 140 - 1350). Physicians had acupuncture experience for 10 (< 1 to 25) years and had treated 200 ( 60 to > 1000) patients with acupuncture in the year preceding trial participation. The 6 basic points were needled in 76 - 93% of sessions. Compliance with treatment instructions varied considerably among centers in the acupuncture group. In contrast, compliance with the minimal acupuncture protocol was very good. 6 of the 30 physicians stated that they would have treated patients somewhat differently outside the trial, 1 completely differently. The trial found a significant effect of those treated with acupuncture compared to those on the waiting list for treatment, but minimal acupuncture was as effective as acupuncture. Conclusions: The treatment protocols for acupuncture and minimal acupuncture in ART Migraine appeared an adequate compromise in the specific situation and for the predefined purposes. However, a relevant minority of participating physicians would have treated patients differently outside the trial.