Trial reportMenopause (New York, N.Y.)2012
A phase III, randomized, placebo-controlled, double-blind trial of flaxseed for the treatment of hot flashes: North Central Cancer Treatment Group N08C7.
Trial report in Menopause (New York, N.Y.), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00956813 (Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes), which is not on this map. Cited by 28 papers, 4 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.
Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes
Who cites it
28 citing papers in PubMed, 4 syntheses or guidelines pooled it, 75 citations in OpenAlex.
- Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review.BJOG : an international journal of obstetrics and gynaecology · 2020Pooled it
- Clinical practice guidelines on the evidence-based use of integrative therapies during and after breast cancer treatment.CA: a cancer journal for clinicians · 2017Guideline
- Efficacy of phytoestrogens for menopausal symptoms: a meta-analysis and systematic review.Climacteric : the journal of the International Menopause Society · 2015Pooled it
- Phytoestrogens for menopausal vasomotor symptoms.The Cochrane database of systematic reviews · 2013Pooled it
- Phase II evaluation of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016Trial
- Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms.Obstetrics and gynecology · 2015Trial
- 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
- Role of the ABCG2 transporter in the biodistribution of the food-borne uremic toxin p-cresyl sulfate.Scientific reports · 2026Article
- Natural supplements in breast cancer therapy: translational evidence, clinical safety, and emerging challenges.Frontiers in oncology · 2026Review
- Effects of Flaxseed on Perimenopausal Symptoms: Findings From a Single-Blind, Randomized, Placebo-Controlled Study.Cureus · 2024Article
- Bioinformatics and Chemoinformatics Analysis Explored the Role ofJournal of medical signals and sensors · 2024Article
- Clinical guidelines for managing menopausal symptoms in women with (a history of) breast cancer.Facts, views & vision in ObGyn · 2023Article
- Frequency of Phytoestrogen Consumption and Symptoms at Midlife among Bangladeshis in Bangladesh and London.Nutrients · 2023Article
- Article
- Amino-Acid-Conjugated Natural Compounds: Aims, Designs and Results.Molecules (Basel, Switzerland) · 2022Review
- Lignan exposure: a worldwide perspective.European journal of nutrition · 2022Review
- Dietary Flaxseed as a Strategy for Improving Human Health.Nutrients · 2019Review
- Exogenous reproductive hormone use in breast cancer survivors and previvors.Nature reviews. Clinical oncology · 2018Review
- Management of Potential Long-Term Toxicities in Breast Cancer Patients.Current breast cancer reports · 2016Article
- The pharmacological and hormonal therapy of hot flushes in breast cancer survivors.Breast cancer (Tokyo, Japan) · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 9 institutions in 2 countries.
Funding
Abstract
objectivePreliminary data suggest that flaxseed, a rich source of dietary lignans, may be a potentially effective treatment of hot flashes. A phase III, randomized, placebo, controlled trial was conducted to evaluate the efficacy of flaxseed in reducing hot flashes.
methodsPostmenopausal women with or without breast cancer were randomly assigned to a flaxseed bar (providing 410 mg of lignans) for 6 weeks versus a placebo bar. Participants completed daily, prospective, hot flash diaries during the baseline week, and then ate one study bar per day for 6 weeks while recording their daily hot flashes. The intraparticipant difference in hot flash activity between baseline and the last treatment week was the primary endpoint. Adverse effects were evaluated through a self-report and the Common Terminology Criteria assessment.
resultsA total of 188 women were enrolled in this trial. The mean hot flash score was reduced 4.9 in the flaxseed group and 3.5 in the placebo group (P = 0.29). In both groups, slightly more than a third of the women received a 50% reduction in their hot flash score. Only one adverse effect was significantly different between groups, grade 1 pruritus, which was more common in the placebo group (8% vs 1%). Both groups reported abdominal distension, flatulence, diarrhea, and nausea. Adherence and ability to detect treatment assignment did not differ between groups.
conclusionsThe results of this trial do not support the use of 410 mg of lignans for the reduction of hot flashes. The bars were fairly well tolerated, with both groups reporting gastrointestinal effects, probably due to the fiber content.
Indexed as
Identifiers
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.