Trial reportMenopause (New York, N.Y.)2011
The TU-025 keishibukuryogan clinical trial for hot flash management in postmenopausal women: results and lessons for future research.
Trial report in Menopause (New York, N.Y.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 4 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- Nutritional interventions in treating menopause-related sleep disturbances: a systematic review.Nutrition reviews · 2024Pooled it
- Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review.BJOG : an international journal of obstetrics and gynaecology · 2020Pooled it
- Chinese herbal formulae for the treatment of menopausal hot flushes: A systematic review and meta-analysis.PloS one · 2019Pooled it
- Chinese herbal medicine for menopausal symptoms.The Cochrane database of systematic reviews · 2016Pooled it
- Trial
- Sequential therapy of dienogest following relugolix for adenomyosis and impact on symptoms and serum CA125 levels: a case series.BMC women's health · 2025Article
- Traditional clinical symptoms and signs: Kampo pattern diagnosis in modern gastrointestinal disease.Frontiers in pharmacology · 2024Article
- Beneficial effect of Gyejibokryeong-hwan on climacteric syndrome with blood stasis pattern: A randomized, double-blinded, placebo-controlled clinical pilot trial.Integrative medicine research · 2023Article
- Climacteric symptoms in postoperative patients among endometrial cancer, cervical cancer, and ovarian cancer: a cross-sectional study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Article
- Article
- Live-Imaging Analysis of Target Vessels and Nitric Oxide Production Associated with Gosha-Jinki-Gan and Keishi-Bukuryo-Gan: Two Herbal Preparations with Clinically Proven Blood Flow-Improving Effects but with Different Traditional Clinical Indicative Patterns.Evidence-based complementary and alternative medicine : eCAM · 2022Article
- The Multiple Pharmacologic Functions and Mechanisms of Action of Guizhi Fuling Formulation.Evidence-based complementary and alternative medicine : eCAM · 2022Review
- Clinical studies of traditional Japanese herbal medicines (Kampo): Need for evidence by the modern scientific methodology.Integrative medicine research · 2021Review
- A Review on the Mechanism and Application of Keishibukuryogan.Frontiers in nutrition · 2021Review
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: The KOSMOS Study.Evidence-based complementary and alternative medicine : eCAM · 2021Article
- Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial.Evidence-based complementary and alternative medicine : eCAM · 2020Article
- Effect of the Mixed Herbal Medicines Extract (Fennel, Chamomile, and Saffron) on Menopause Syndrome: a Randomized Controlled Clinical Trial.Journal of caring sciences · 2019Article
- A Classic Herbal Formula Guizhi Fuling Wan for Menopausal Hot Flushes: From Experimental Findings to Clinical Applications.Biomedicines · 2019Review
- Perception of cold and heat pattern identification in diseases: a survey of Korean medicine doctors.Integrative medicine research · 2017Article
- The coordination of plural logics of action and its consequences: Evidence from plural medical systems.PloS one · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
Abstract
objectiveThe aim of this study was to assess the efficacy of TU-025, keishibukuryogan, a Japanese prescription herbal medicine used for hot flash management, in American women.
methodsThis randomized, double-blind, placebo-controlled, phase II trial enrolled 178 postmenopausal women aged 45 to 58 years with a Mayo hot flash score greater than 28 per week who met other inclusion criteria. After a 1-week placebo run-in period, participants were randomly assigned placebo, or 7.5 g/day, or 12.5 g/day groups, for 12 weeks. Primary and secondary outcomes were measured using the Mayo Clinic Hot Flash Diary, the Greene Climacteric Index, and the Pittsburgh Sleep Quality Index.
resultsAt 3 months, hot flash scores, climacteric symptoms, and sleep quality improved by 34% in the placebo group, 40% in the 7.5 g/day group, and 38% in the 12.5 g/day group. (P < 0.001). However, the differences in changes between groups were not statistically significant (P = 0.990). Diarrhea unexpectedly developed in 20% of participants receiving active medication.
conclusionsFor American women, unlike the clinical experience for Japanese women, TU-025 did not significantly reduce the frequency and severity of hot flash symptoms, improve climacteric symptoms, or benefit sleep quality. This study identified several potentially significant methodological factors to be considered in future scientific assessments of traditional Asian medicines.
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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 OpenQuestion graph.