Open-label placebo treatment of women with premenstrual syndrome: study protocol of a randomised controlled trial

Antje Frey Nascimento, Jens Gaab, Irving Kirsch, Joe Kossowsky, Andrea Meyer, Cosima Locher, Antje Frey Nascimento, Jens Gaab, Irving Kirsch, Joe Kossowsky, Andrea Meyer, Cosima Locher

Abstract

Introduction: Recent evidence suggests that for certain clinical conditions, placebos can improve clinical outcomes even without deception. These so-called open-label placebos (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.

Methods and analysis: 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 and dissemination: 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).

Keywords: PMS symptom diary; open-label placebos; premenstrual syndrome; randomised controlled trial; treatment rationale.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Study design and flow of participants. IC, informed consent; OLP, open-label placebo; PMS, premenstrual syndrome; TAU, treatment as usual.
Figure 2
Figure 2
Overview of study groups. OLP, open-label placebo; TAU, treatment as usual.

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Source: PubMed

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