Evidence map›Paper›PMID 40132912›Full record

ArticleBMJ evidence-based medicine2025

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

Antje Frey Nascimento, Jens Gaab, Bojana Degen, Mareike Rytz, Anja Holder, Dilan Sezer, Sarah Buergler, Andrea H Meyer, Irving Kirsch, Joe Kossowsky and 1 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ evidence-based medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03547661 (Open-Label Placebo Treatment of Women With Premenstrual Syndrome), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03547661 nacompletednot on this map

Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial

TypeinterventionalSponsorJens GaabRan2018 to 2021Enrolled150ConditionsPremenstrual SyndromeArmsP-Dragees rosa Lichtenstein
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Antje Frey NascimentoDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland antje.freynascimento@unibas.ch.ORCID http://orcid.org/0000-0001-7907-0439
Jens GaabDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.
Bojana DegenDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.
Mareike RytzDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.
Anja HolderDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.
Dilan SezerDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.
Sarah BuerglerDivision of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland.
Andrea H MeyerDivision of Clinical Psychology & Epidemiology, University of Basel, Basel, Switzerland.
Irving KirschProgram in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Joe KossowskyDepartment of Anesthesiology, Critical Care & Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Cosima LocherDepartment of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

designRandomised controlled trial.

settingSwitzerland, 2018-2020.

participants150 women (18-45 years of age) with PMS or premenstrual dysphoric disorder.

interventionRandom 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 measuresPrimary 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.

resultsFrom 2 August 2018 to 3 December 2020, 150 women were randomly allocated to TAU (n=50), OLP- (n=50), and OLP+ (n=50), of whom 145 (96.7%) completed trial participation. Groups differed in symptom intensity (F(4)=4.419, p=0.002, r

conclusionsThe results of our clinical trial indicate that OLP provided with a treatment rationale is an effective, safe, and acceptable treatment for PMS.

trial registrationClinicalTrials.gov NCT03547661 (submitted 2 May 2018).

Indexed as

Evidence-Based PracticeMENTAL HEALTHPsychology, MedicalReproductive medicine

Identifiers

PMID40132912
PMCPMC12573394

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.