Trial reportPsychosomatic medicine
Placebo improvement in pharmacologic treatment of menopausal hot flashes: time course, duration, and predictors.
Trial report in Psychosomatic medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Neurokinin 3 Receptor Antagonists Compared With Serotonin Norepinephrine Reuptake Inhibitors for Non-Hormonal Treatment of Menopausal Hot Flushes: A Systematic Qualitative Review.Advances in therapy · 2021Pooled it
- Efficacy and safety of fezolinetant for moderate to severe vasomotor symptoms associated with menopause among women in East Asia: a phase 3 randomized study (MOONLIGHT I).The Journal of international medical research · 2024Trial
- Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT.The Journal of clinical endocrinology and metabolism · 2023Trial
- Trial
- Effect of the neurokinin 3 receptor antagonist fezolinetant on patient-reported outcomes in postmenopausal women with vasomotor symptoms: results of a randomized, placebo-controlled, double-blind, dose-ranging study (VESTA).Menopause (New York, N.Y.) · 2020Trial
- Open-label placebos for menopausal hot flushes: a randomized controlled trial.Scientific reports · 2020Trial
- A multicenter, randomized study to select the minimum effective dose of estetrol (E4) in postmenopausal women (E4Relief): part 1. Vasomotor symptoms and overall safety.Menopause (New York, N.Y.) · 2020Trial
- Genetic predictors to acupuncture response for hot flashes: an exploratory study of breast cancer survivors.Menopause (New York, N.Y.) · 2020Trial
- Placebo treatment facilitates social trust and approach behavior.Proceedings of the National Academy of Sciences of the United States of America · 2018Trial
- Trial
- Development and application of a weighted change score to evaluate interventions for vasomotor symptoms in patients with breast cancer using regression trees: a cohort study.Breast cancer research and treatment · 2024Article
- Hormonal Therapies in Multiple Sclerosis: a Review of Clinical Data.Current neurology and neuroscience reports · 2024Review
- Clinically Meaningful Benefit in Women with Hypoactive Sexual Desire Disorder Treated with Flibanserin.Sexual medicine · 2022Article
- Lights on MsFLASH: a review of contributions.Menopause (New York, N.Y.) · 2020Review
- Efficacy ofFood & nutrition research · 2020Article
- Non-concealed placebo treatment for menopausal hot flushes: Study protocol of a randomized-controlled trial.Trials · 2019Article
- The Management of Menopausal Symptoms in Women Following Breast Cancer: An Overview.Drugs & aging · 2018Article
- Placebo Effects in Traumatic Brain Injury.Journal of neurotrauma · 2018Review
- Informed consent and clinical trials: where is the placebo effect?BMJ (Clinical research ed.) · 2017Article
- Expectancy after the first treatment and response to acupuncture for menopausal hot flashes.PloS one · 2017Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
objectivesTo characterize the time course, duration of improvement, and clinical predictors of placebo response in treatment of menopausal hot flashes.
methodsData were pooled from two trials conducted in the Menopausal Strategies: Finding Lasting Answers to Symptoms and Health network, providing a combined placebo group (n = 247) and a combined active treatment group (n = 297). Participants recorded hot flash frequency in diaries twice daily during treatment (Weeks 0-8) and subsequent follow-up (Weeks 9-11). The primary outcome variable was clinically significant improvement, defined as a 50% or greater decrease in hot flash frequency from baseline and calculated for each week in the study. Subgroups were defined a priori using standard clinical definitions for significant improvement and partial improvement. Clinical and demographic characteristics of the participants were evaluated as predictors of improvement.
resultsClinically significant improvement with placebo accrued each treatment week, with 33% significantly improved at Week 8. Of placebo responders who were improved at both Weeks 4 and 8, 77% remained clinically improved at Week 11 after treatment ended. Independent predictors of significant placebo improvement in the final multivariable model were African American race (odds ratio [OR] = 5.61, 95% confidence interval [CI] = 2.41-13.07, p < .001), current smokers (OR = 2.30, 95% CI = 1.05-5.06, p = .038), and hot flash severity in screening (OR = 1.45, 95% CI = 1.00-2.10, p = .047).
conclusionsClinically significant improvement with placebo accrued throughout treatment with a time course similar to improvement with active drug. A meaningful number of participants in the placebo group sustained a clinically significant response after stopping placebo pills. The results suggest that nonspecific effects are important components of treatment and warrant further studies to optimize their contributions in clinical care.
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