Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland
Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.
BMJ Open. 2020 Feb 17;10(2):e032868. doi: 10.1136/bmjopen-2019-032868.
Recent evidence suggests that for certain clinical conditions, placebos can improve clinical outcomes even without deception. These so-called (OLPs) bear the advantage of a significant lower risk of adverse events and comply with ethical principles. Although premenstrual syndrome (PMS) seems to be considerably susceptible to placebo effects, no study has examined open-OLP responses on PMS.
To test the efficacy of OLPs in women suffering from PMS, a clinical randomised controlled trial including two OLP study groups (with and without treatment rationale) was designed to investigate on the effect on PMS. PMS symptoms are monitored on a daily basis via a symptom diary, adverse events are monitored intermittently. The study started in spring 2018 and patients will be included until a maximum of 150 participants are randomised. Besides the primary outcome PMS symptom intensity and interference, an array of further variables is assessed. Multilevel modelling will be used for data analyses.
Ethics approval was obtained from the Ethics Committee Northwest and Central Switzerland. Results of the main analysis and of secondary analyses will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: (1) ClinicalTrials.gov (NCT03547661); (2) Swiss national registration (SNCTP000002809).
最近的证据表明，对于某些临床情况，即使没有欺骗，安慰剂也可以改善临床结果。这些所谓的开放性安慰剂（OLP）具有显著降低不良事件风险的优势，并且符合伦理原则。虽然经前综合征（PMS）似乎对安慰剂效应非常敏感，但尚无研究检查过 PMS 对开放性安慰剂的反应。
为了测试安慰剂对患有 PMS 的女性的疗效，设计了一项临床随机对照试验，包括两个 OLP 研究组（有和没有治疗原理），以研究对 PMS 的影响。通过症状日记每天监测 PMS 症状，间歇性监测不良事件。该研究于 2018 年春季开始，直到最多 150 名参与者被随机分组，患者才会被纳入。除了主要结局 PMS 症状强度和干扰外，还评估了一系列其他变量。将使用多层次模型进行数据分析。
西北和瑞士中部伦理委员会已批准该研究。主要分析和次要分析的结果将提交给同行评议的期刊发表。试验注册号：（1）ClinicalTrials.gov（NCT03547661）；（2）瑞士国家注册（SNCTP000002809）。
