Treatment in a Randomized Multicenter Trial of Acupuncture for Migraine (ART Migraine)

Abstract

Background: This paper aims to describe the characteristics ofphysicians and interventions of a large, multicenter randomizedtrial of acupuncture for migraine (ART Migraine) in order to enableacupuncturists to assess the study interventions. Patients andMethods: 302 patients suffering from migraine were randomized to12 sessions of semi-standardized acupuncture (6 predefined basicpoints, recommendations for optional individual choice of additionalpoints given), standardized minimal acupuncture (superficialneedling of at least 5 of 10 predefined, distant non-acupuncturepoints) or a waiting list. 30 physicians trained and experienced inacupuncture from 18 centers in Germany participated in the trial.Results: The median duration of acupuncture training of trial physicianswas 500 h (range 140-1350). Physicians had acupuncture experiencefor 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. Compliancewith treatment instructions varied considerably among centers inthe acupuncture group. In contrast, compliance with the minimalacupuncture protocol was very good. 6 of the 30 physicians statedthat they would have treated patients somewhat differently outsidethe trial, 1 completely differently. The trial found a significant effectof those treated with acupuncture compared to those on the waitinglist for treatment, but minimal acupuncture was as effective asacupuncture. Conclusions: The treatment protocols for acupunctureand minimal acupuncture in ART Migraine appeared an adequatecompromise in the specific situation and for the predefined purposes.However, a relevant minority of participating physicians wouldhave treated patients differently outside the trial.