Brinkhaus B, Becker-Witt C, Jena S, Linde K, Streng A, Wagenpfeil S, Irnich D, Hummelsberger J, Melchart D, Willich S N
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Klinikum Charit , Humboldt-Universität zu Berlin, Berlin, Germany.
Forsch Komplementarmed Klass Naturheilkd. 2003 Aug;10(4):185-91. doi: 10.1159/000073474.
We report on the study design and protocols of two randomized controlled trials (Acupuncture Randomized Trials = ART) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee, respectively.
To investigate whether acupuncture is more efficacious than (a) no treatment or (b) minimal acupuncture in the treatment of low back pain and osteoarthritis.
Two randomized, controlled, multicenter trials with three treatment arms and a total follow-up time of 52 weeks.
30 practitioners and outpatient units in Germany specialized in acupuncture treatment.
300 patients will be included in each study. In the low back pain trial, patients will be included according to clinical diagnosis. In the osteoarthritis pain trial, patients will be included according to the American College of Rheumatology criteria.
Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) minimal acupuncture at non-acupuncture points (75 patients), or (3) no treatment for two months followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks.
The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters: pain intensity as measured by a visual analogue scale (VAS; 0-100 mm) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score (WOMAC) in the osteoarthritis trial.
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.
我们报告两项随机对照试验（针灸随机试验 = ART）的研究设计和方案，这两项试验分别研究针灸治疗慢性腰痛和膝关节骨关节炎的疗效。
研究针灸在治疗腰痛和骨关节炎方面是否比（a）不治疗或（b）微量针灸更有效。
两项随机、对照、多中心试验，有三个治疗组，总随访时间为52周。
德国30个专门从事针灸治疗的从业者和门诊单位。
每项研究将纳入300名患者。在腰痛试验中，患者将根据临床诊断纳入。在骨关节炎疼痛试验中，患者将根据美国风湿病学会标准纳入。
患者被随机分配接受以下治疗之一：（1）半标准化针灸（150名患者），（2）在非穴位进行微量针灸（75名患者），或（3）两个月不治疗，随后进行半标准化针灸（75名患者，等待名单对照）。针灸治疗每位患者在8周内进行12次疗程。
主要结局指标是以下参数在基线和8周治疗期结束时的差异：腰痛试验中通过视觉模拟量表（VAS；0 - 100毫米）测量的疼痛强度，以及骨关节炎试验中通过西安大略和麦克马斯特大学骨关节炎评分（WOMAC）测量的疼痛强度。
这两项研究的结果（2004年可得）将为医疗保健提供者和政策制定者提供所需信息，以便对针灸疗法进行科学合理的评估。
