Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010
Phase III, randomized, double-blind, placebo-controlled evaluation of pregabalin for alleviating hot flashes, N07C1.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 36 papers, 6 of them syntheses that pooled 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.
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
36 citing papers in PubMed, 6 syntheses or guidelines pooled it, 162 citations in OpenAlex.
- Movement disorders associated with antiseizure medications: A systematic review.Epilepsy & behavior : E&B · 2022Pooled it
- Comparing the reporting and conduct quality of exercise and pharmacological randomised controlled trials: a systematic review.BMJ open · 2021Pooled it
- Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review.BJOG : an international journal of obstetrics and gynaecology · 2020Pooled it
- Survivorship, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2017Guideline
- Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions.Breast cancer research and treatment · 2016Pooled it
- Non-hormonal interventions for hot flushes in women with a history of breast cancer.The Cochrane database of systematic reviews · 2010Pooled it
- Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Breast Cancer.Cancer medicine · 2025Trial
- North Central Cancer Treatment Group N10C2 (Alliance): a double-blind placebo-controlled study of magnesium supplements to reduce menopausal hot flashes.Menopause (New York, N.Y.) · 2015Trial
- Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010Trial
- Hormonal management after risk-reducing surgery in BRCA-mutated triple-negative breast cancer survivors.Journal of cancer research and clinical oncology · 2026Review
- Review
- Management of vasomotor symptoms in cancer patients.The oncologist · 2025Review
- Reproductive aging in biological females: mechanisms and immediate consequences.Frontiers in endocrinology · 2025Review
- Exploring the Efficacy of Melatonin in Alleviating Menopausal Symptoms in Breast Cancer Survivors: A Randomized, Double-Blind, Placebo-Controlled Study.Advanced biomedical research · 2025Article
- Article
- Clinical guidelines for managing menopausal symptoms in women with (a history of) breast cancer.Facts, views & vision in ObGyn · 2023Article
- Measuring symptoms and toxicities: a 35-year experience.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Review
- Treating menopause - MHT and beyond.Nature reviews. Endocrinology · 2022Review
- Contemporary Non-hormonal Therapies for the Management of Vasomotor Symptoms Associated with Menopause: A Literature Review.TouchREVIEWS in endocrinology · 2021Review
- Oxybutynin vs Placebo for Hot Flashes in Women With or Without Breast Cancer: A Randomized, Double-Blind Clinical Trial (ACCRU SC-1603).JNCI cancer spectrum · 2020Article
Corrections and comments
- Erratum issuedBaclueva, Ernie P [corrected to Balcueva, Ernie P]
Authors and funding
11 authors at 1 institution in 1 country.
Funding
Abstract
purposeHot flashes are a common problem for which effective and safe treatments are needed. The current trial was conducted on the basis of preliminary promising data that pregabalin decreased hot flashes. PATIENTS AND
methodsA double-blind, placebo-controlled, randomized trial design was used to compare pregabalin at target doses of 75 mg twice daily and 150 mg twice daily with a placebo. Hot flash frequencies and scores (frequency times mean severity) were recorded daily during a baseline week and for six treatment weeks. The primary end point for this study was the change-from-baseline hot flash score during treatment week 6 between the 150 mg twice daily target pregabalin treatment and placebo. Nonparametric Wilcoxon rank sum tests, two-sample t tests, and chi(2) tests were used to compare the primary and secondary hot flash efficacy end points between pregabalin treatments and placebo.
resultsHot flash score changes available for 163 patients during the sixth treatment week compared with a baseline week decreased by 50%, 65%, and 71% in the placebo, and target 75 mg twice daily and 150 mg twice daily pregabalin arms, respectively (P = .009 and P = .007, comparing respective pregabalin arms to the placebo arm). While some toxicities were significantly more common in the pregabalin arms, being more evident with the higher dose, pregabalin was generally well tolerated by most patients.
conclusionPregabalin decreases hot flashes and is reasonably well tolerated. A target dose of 75 mg twice daily is recommended. Its effects appear to be roughly comparable to what has been reported with gabapentin and with some newer antidepressants.
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What OpenQuestion holds
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.