Evidence map›Paper›PMID 31420050›Full record

ArticleTrials2019

Non-concealed placebo treatment for menopausal hot flushes: Study protocol of a randomized-controlled trial.

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

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 30% 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.

NCT03838523 nacompletednot on this map

Non-concealed Placebo Treatment for Menopausal Hot Flushes

TypeinterventionalSponsorUniversitätsklinikum Hamburg-EppendorfRan2019 to 2020Enrolled100ConditionsHot FlashesArmsOpen Label Placebo
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

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
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

7 authors at 2 institutions in 2 countries.

Yiqi PanDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. y.pan@uke.de.ORCID http://orcid.org/0000-0002-5184-2860
Ramona MeisterDepartment of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
Bernd LöweDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
Anne WinkelmannDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
Ted J KaptchukProgram in Placebo Studies and the Therapeutic Encounter (PiPS), Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.
Kai J BuhlingClinic for Gynecology, Department of Gynecological Endocrinology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
Yvonne NestoriucDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
Universität Hamburg · DEBeth Israel Deaconess Medical Center · US

Funding

Foundation for the Science of the Therapeutic Encounter 1705-100
6 · The paper itself

Abstract

backgroundBeneficial effects of placebos are high in double-blind hot flush trials. Studies in various conditions suggest that honestly prescribed placebos may elicit symptom improvement.

objectiveTo determine whether open label placebo (OLP) treatment is efficacious in alleviating hot flushes among peri- and postmenopausal women. METHODS/

designIn this assessor-blinded, randomized-controlled trial, n = 100 women experiencing five or more daily hot flushes of at least moderate severity and bothersomeness are assigned 1:1 to a 4-week OLP treatment or no treatment. To explore the duration and maintenance of placebo effects, the OLP group is randomized a second time to either discontinue or continue the OLP treatment for another 4 weeks. All participants receive a briefing about placebo effects and study visits at baseline, post-treatment (4 weeks), and follow-up (8 weeks, OLP group only). Qualitative interviews about subjective experiences with the OLP treatment are conducted. Primary outcomes are differences between the OLP and the no-treatment group in the hot flush composite score (frequency × severity), and bothersomeness of hot flushes as assessed with the Hot Flush Rating Scale at post-treatment. Secondary outcomes include hot flush frequency, health-related quality of life, global improvement, and the number of responders at post-treatment. Data are analyzed by fitting (generalized) linear mixed models. An exploratory analysis of maintenance and duration is performed including follow-up data. DISCUSSION: This trial will contribute to the evaluation of OLP treatments in clinical practice and further our understanding about the magnitude of placebo effects in hot flush treatments.

trial registrationClinicaltrials.gov, NCT03838523 . Retrospectively registered on February 12th, 2019. The first patient was enrolled on October 10th, 2018.

Indexed as

Randomized Controlled Trials as TopicFemaleHot FlashesHumansMenopauseMiddle AgedOutcome Assessment, Health CarePlacebosPlacebosHot flashesHot flushesMenopauseNon-hormonal treatmentOpen-label placeboPlacebo effects

Identifiers

PMID31420050
PMCPMC6697911
OpenAlexW2968895498

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.