Melchart D, Linde K, Streng A, Reitmayr S, Hoppe A, Brinkhaus B, Becker-Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Willich S N, Weidenhammer W
Zentrum für naturheilkundliche Forschung, II. Medizinische Klinik und Poliklinik, TU München, Germany.
Forsch Komplementarmed Klass Naturheilkd. 2003 Aug;10(4):179-84. doi: 10.1159/000073473.
We report the design and essentials of the protocols of two Acupuncture Randomized Trials (ART) investigating whether acupuncture is more efficacious than no treatment and minimal acupuncture in the interval treatment of migraine and tension-type headache.
Randomized controlled multicenter trials with three treatment arms and a total observation period of 28 weeks.
30 practitioners and outpatient units in Germany specialized in acupuncture treatment.
Per study 300 patients with migraine and episodic or chronic tension-type headache, respectively (diagnosis according to the criteria of the International Headache Society).
Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) standardized minimal acupuncture (75 patients), or (3) no interval treatment for 12 weeks followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks.
Main outcome measure in the migraine trial is the difference between the number of days with headache of moderate or severe intensity during the 4 weeks before randomization and weeks 9 to 12 after randomization. In the study on tension-type headache the main outcome measure is similar to that described above, but for the number of headache days regardless of intensity.
The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.
我们报告两项针刺随机试验（ART）方案的设计及要点，这两项试验旨在探究在偏头痛和紧张型头痛的间歇期治疗中，针刺疗法是否比不治疗及微量针刺疗法更有效。
具有三个治疗组的随机对照多中心试验，总观察期为28周。
德国30个专门从事针刺治疗的医疗机构及从业者。
每项研究分别纳入300例偏头痛患者以及发作性或慢性紧张型头痛患者（根据国际头痛协会标准进行诊断）。
患者被随机分配接受以下治疗之一：（1）半标准化针刺治疗（150例患者）；（2）标准化微量针刺治疗（75例患者）；或（3）12周不进行间歇期治疗，随后接受半标准化针刺治疗（75例患者，作为等待名单对照）。针刺治疗每位患者在8周内进行12次疗程。
偏头痛试验的主要观察指标是随机分组前4周与随机分组后第9至12周中度或重度头痛天数的差值。紧张型头痛研究中的主要观察指标与上述相似，但为不考虑强度的头痛天数。
这两项研究（2004年可得结果）将为医疗保健提供者和政策制定者提供对针刺疗法进行科学合理评估所需的信息。
