针治疗偏头痛患者:一项随机对照试验
Klaus Linde1, Andrea Streng, Susanne Jürgens
1Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universität München, Munich, Germany. Klaus.Linde@lrz.tu-muenchen.de
JAMA
|May 5, 2005
概括
针在减少偏头痛方面并没有比假针更有效. 然而,针和假针在控制偏头痛症状方面显著优于等待名单对照组.
科学领域:
- 神经学 神经学
- 综合医学是一个整体的医学.
- 临床试验 临床试验
背景情况:
- 针经常用于偏头痛预防,但支持其有效性的强有力的证据仍然有限.
- 偏头痛代表了一种影响生活质量的重要神经系统疾病.
研究的目的:
- 为了评估针与假针的有效性和对偏头痛管理的无针对照.
- 提供基于证据的见解,了解针在治疗慢性偏头痛中的作用.
主要方法:
- 在德国18个门诊中心,对302名偏头痛患者进行了三组随机对照试验.
- 参与者接受了针,假针或被列入等待名单,治疗时间长达8周.
- 在干预期之前和之后,使用患者日记监测头痛的频率和强度.
主要成果:
- 针和假针在中度至重度头痛天数中显示出相似的减少 (两者减少了2.2天).
- 这两种积极干预措施都比等候名单对照显著更有效 (减少了1.4天).
- 响应者 (头痛日减少≥50%) 在针方面为51%,在假针方面为53%,在等待名单方面为15%.
结论:
- 针在减少偏头痛的频率或严重程度方面并不比假针更有效.
- 针和假针都显示出与没有治疗相比,具有显著的治疗益处.
- 这些发现表明,潜在的非特异性效应或安慰剂反应有助于针在偏头痛治疗中的感知益处.
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相关概念视频
Randomized Experiments
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
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Simple randomization
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Blinding
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
