Evidence map›Paper›PMID 32071176›Full record

ArticleBMJ open2020

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. 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 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.2field-weighted citation impact, top 13% of its field
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

22 citing papers in PubMed, 41 citations in OpenAlex.

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  14. Prevalence of premenstrual syndrome and related factors among nurses.Journal of the Turkish German Gynecological Association · 2024
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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

6 authors at 3 institutions in 3 countries.

Antje Frey NascimentoDivision of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland antje.freynascimento@unibas.ch.ORCID 0000-0001-7907-0439
Jens GaabDivision of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.
Irving KirschProgram in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Joe KossowskyDivision of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.
Andrea MeyerDivision of Clinical Psychology and Epidemiology, Department of Psychology, University of Basel, Basel, Switzerland.
Cosima LocherDivision of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.ORCID 0000-0002-9660-0590
University of Basel · CHBeth Israel Deaconess Medical Center · USBoston Children's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRecent evidence suggests that for certain clinical conditions, placebos can improve clinical outcomes even without deception. These so-called 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).

Indexed as

Randomized Controlled Trials as TopicAdolescentAdultFemaleHumansMiddle AgedPlacebosPremenstrual SyndromeSample SizeSurveys and QuestionnairesSwitzerlandTreatment OutcomeYoung AdultPlacebosopen-label placebosPMS symptom diarypremenstrual syndromerandomised controlled trialtreatment rationale

Identifiers

PMID32071176
PMCPMC7045079
OpenAlexW3008212853

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 OpenQuestion graph.