Linde Klaus, Streng Andrea, Hoppe Andrea, Brinkhaus Benno, Witt Claudia M, Hammes Michael, Irnich Dominik, Hummelsberger Josef, Willich Stefan N, Melchart Dieter
Centre for Complementary Medicine Research, Department of Internal Medicine II, Technical University of Munich, Germany.
Forsch Komplementmed. 2006 Apr;13(2):101-8. doi: 10.1159/000091999. Epub 2006 Apr 19.
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.
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.
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.
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.
本文旨在描述一项大型多中心偏头痛针灸随机试验（ART偏头痛试验）中医师的特点及干预措施，以便针灸师能够评估该研究的干预措施。
302例偏头痛患者被随机分为三组，分别接受12次半标准化针灸治疗（6个预定义基本穴位，并给出额外穴位个体化选择建议）、标准化最小针灸治疗（在10个预定义的远端非穴位中至少浅刺5个）或进入等候名单。来自德国18个中心的30名接受过针灸培训且经验丰富的医师参与了该试验。
参与试验的医师针灸培训时间中位数为500小时（范围140 - 1350小时）。医师有10年（1至25年）的针灸经验，在参与试验前一年已用针灸治疗过200例（60至1000例以上）患者。6个基本穴位在76% - 93%的治疗疗程中被针刺。针灸组各中心对治疗指导的依从性差异很大。相比之下，对最小针灸方案的依从性非常好。30名医师中有6名表示，他们在试验外治疗患者的方式会有所不同，1名则完全不同。试验发现，与等候名单上的患者相比，接受针灸治疗的患者有显著疗效，但最小针灸与针灸效果相同。
ART偏头痛试验中的针灸和最小针灸治疗方案在特定情况下及针对预定义目的而言似乎是一种适当的折衷方案。然而，相当一部分参与试验的医师在试验外会采用不同的方式治疗患者。
