Evidence mapPaperPMID 33208855Full record

Trial reportScientific reports2020

Open-label placebos for menopausal hot flushes: a randomized controlled trial.

Yiqi Pan, Ramona Meister, Bernd Löwe, Ted J Kaptchuk, Kai J Buhling, Yvonne Nestoriuc

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05051995 (Combined N-of-1 Trials to Assess Open-Label Placebo Treatment for Antidepressant Discontinuation Symptoms), which is not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
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.

NCT05051995 nacompletednot on this mapstarted 2022, after this paper: background citation

Combined N-of-1 Trials to Assess Open-Label Placebo Treatment for Antidepressant Discontinuation Symptoms

TypeinterventionalSponsorUniversitätsklinikum Hamburg-EppendorfRan2022 to 2024Enrolled25ConditionsDepressive Symptoms, Expectations, AntidepressantsArmsOpen-label placebo, No-treatment
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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.

Yiqi PanDepartment of Clinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces, Hamburg, Germany. y.pan@uke.de.
Ramona MeisterDepartment of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
Bernd LöweDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
Ted J KaptchukProgram in Placebo Studies and the Therapeutic Encounter (PiPS), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA.
Kai J BuhlingDepartment of Gynecological Endocrinology, Clinic of Gynecology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
Yvonne NestoriucDepartment of Clinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces, Hamburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study investigated the efficacy of an open-label placebo (OLP) treatment for menopausal hot flushes. Women with at least five moderate or severe hot flushes per day were allocated to receive four weeks of OLP for twice a day or no-treatment. Intention-to-treat analyses included n = 100 women. In comparison to no-treatment, OLP reduced the log-transformed hot flush composite score (frequency × intensity) (mean difference in change: - 0.32, 95% CI [- 0.43; - 0.21], p < 0.001, Cohen's d = 0.86), hot flush frequency (- 1.12 [- 1.81; - 0.43], p = 0.02, Cohen's d = 0.51), and improved overall menopause-related quality of life (- 2.53 [- 4.17; - 0.89], p = 0.02, Cohen's d = 0.49). Twelve (24%) (vs. three [6%]) patients had 50% lesser hot flushes. Problem rating of hot flushes and subdomains of quality of life did not improve. After four weeks, the OLP group was further divided via randomization to continue or discontinue the treatment. Benefits were maintained at week 8 (log-transformed score: - 0.04 [- 0.06; 0.14], p = 0.45). There was no difference between taking placebos for 8 or 4 weeks (log-transformed score: 0.04 [- 0.17; 0.25], p = 0.73). Results indicate that open-label placebos may be an effective, safe alternative for menopausal hot flushes.

Indexed as

MenopauseQuality of LifeAdultAgedDouble-Blind MethodFemaleHot FlashesHumansMiddle AgedPlacebo EffectPlacebosPlacebos

Identifiers

PMID33208855
PMCPMC7674475

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.