Efficacy of open-label placebos for premenstrual syndrome: a randomised controlled trial

BMJ Evidence-based Medicine, 30(5), 295-304

DOI 10.1136/bmjebm-2024-112875

Abstract

Objective

To investigate the efficacy and safety of open-label placebos (OLP) in premenstrual syndrome (PMS).

Design

Randomised controlled trial.

Setting

Switzerland, 2018-2020.

Participants

150 women (18-45 years of age) with PMS or premenstrual dysphoric disorder.

Intervention

Random assignment (1:1:1) to treatment as usual (TAU), OLP without treatment rationale (OLP-), or OLP with treatment rationale (OLP+). OLP consisted of two placebo pills per day for 6 weeks.

Main outcome measures

Primary outcomes were PMS symptom intensity and interference between groups across three menstrual cycles (MC1-MC3); adverse events (ie, safety) were measured at weeks 3 and 6 after the start of the intervention. Secondary outcomes were psychological and somatic subscales of PMS symptom intensity, and adherence.

Results

From 2 August 2018 to 3 December 2020,

Topics

premenstrual syndrome treatment options, open-label placebo for PMS, non-hormonal PMS management, premenstrual dysphoric disorder placebo response, PMS symptom intensity reduction, placebo effect in menstrual disorders, treatment as usual for premenstrual syndrome, randomized controlled trial PMS, PMDD treatment without hormones, menstrual cycle symptom management

Cite this article

Frey Nascimento, A., Gaab, J., Degen, B., Rytz M, Holder, A., Sezer, D., Buergler, S., Meyer, A. H., Kirsch, I., Kossowsky, J., & Locher, C. (2025). Efficacy of open-label placebos for premenstrual syndrome: a randomised controlled trial. *BMJ evidence-based medicine*, bmjebm-2024-112875. https://doi.org/10.1136/bmjebm-2024-112875

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