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对月经前综合征的开放式安慰剂的有效性:一项随机对照试验

Antje Frey Nascimento¹, Jens Gaab², Bojana Degen²

¹Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland antje.freynascimento@unibas.ch.

BMJ evidence-based medicine

|March 25, 2025

概括

与治疗逻辑相关的开放标签安慰剂 (OLP) 与通常治疗相比,有效地减少了月经前综合征 (PMS) 症状和干扰. 这种安全可接受的干预措施为PMS管理提供了新的治疗选择.

科学领域:

妇科妇科医生妇科
精神病学是一个精神病学.
临床药理学临床药理学

背景情况:

月经前综合征 (PMS) 显著影响女性的生活质量.
现有的PMS治疗方法存在局限性,需要新的治疗方法.
开放式安慰剂 (OLP) 是一种潜在的非药物干预.

研究的目的:

评估OLP在管理PMS症状中的有效性和安全性.
为了比较OLP与没有治疗的治疗逻辑与通常的治疗 (TAU).

主要方法:

在瑞士进行了一项随机对照试验,涉及150名被诊断患有PMS或月经前失调障碍的妇女.
参与者被分配到TAU,没有理由的OLP (OLP-),或有理由的OLP (OLP+),每天服用两个安慰剂药丸六周.
主要结局包括PMS症状强度和三个月经周期的干扰,通过不良事件评估安全性.

主要成果:

与TAU和OLP-.相比,具有治疗理由的OLP (OLP+) 显著降低了PMS症状强度和干扰,而不是TAU和OLP-.
在OLP和TAU之间没有观察到症状强度或干扰的显著差异.
在OLP干预中报告了高坚持率 (93.18%),只有四个非严重的不良事件被记录.

结论:

提供明确治疗理由的开放标签安慰剂 (OLP) 在缓解PMS症状方面表现出有效性.
OLP代表了一个安全,有效和可接受的治疗选择为月经前综合征.
这些发现支持使用OLP作为PMS可行的治疗策略.

关键词:

基于证据的实践.心理健康心理健康心理学,医学心理学,医学生殖医学是一种生殖医学.

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