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.


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.
Linde
Klaus
K
Centre for Complementary Medicine Research, Department of Internal Medicine II, Technical University of Munich, Germany. Klaus.Linde@lrz.tum.de
Streng
Andrea
A
Hoppe
Andrea
A
Brinkhaus
Benno
B
Witt
Claudia M
CM
Hammes
Michael
M
Irnich
Dominik
D
Hummelsberger
Josef
J
Willich
Stefan N
SN
Melchart
Dieter
D
D015669:Acupuncture Points; D015670:Acupuncture Therapy / Q000379:methods; D006801:Humans; D008881:Migraine Disorders / Q000628:therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome