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A randomized, double-blind, multiple-dose escalation study of a Chinese herbal medicine preparation (Dang Gui Buxue Tang) for moderate to severe menopausal symptoms and quality of life in postmenopausal women.
Menopause. 2013 Feb; 20(2):223-31.M

Abstract

OBJECTIVE

This study is a phase II clinical trial that aims to investigate the dose-response relationship of a Chinese herbal medicine preparation, Dang Gui Buxue Tang (DBT), with short-term menopausal symptoms and quality of life in local postmenopausal women.

METHODS

A randomized, double-blind, multiple-dose escalation trial was performed in 60 postmenopausal women experiencing severe hot flashes and night sweats. The participants were randomized to receive DBT preparations at 1.5, 3.0, or 6.0 g/day for 12 weeks. The primary outcomes were vasomotor symptoms, Greene Climacteric Scale (GCS) score, and Menopause-Specific Quality of Life (MENQOL) score. Secondary outcomes included serum hormones and lipids.

RESULTS

There were between-group differences in psychological/psychosocial (P = 0.015, GCS; P = 0.013, MENQOL) and somatic/physical (P = 0.019, GCS; P = 0.037, MENQOL) domains, and improvement was significantly greatest (P < 0.05) in the 6.0 g/day dose group. The frequency and severity of hot flashes and night sweats were significantly reduced in the 3.0 g/day (14.5%-21.2%, P < 0.05, hot flashes; 28.6%-39.6%, P < 0.05, night sweats) and 6.0 g/day (34.9%-37.4.0%, P < 0.01, hot flashes; 10.1%-12.8%, P < 0.01, night sweats) dose groups. The female hormones follicle-stimulating hormone, luteinizing hormone, and 17β-estradiol, as well as the lipids total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol, were not significantly different within groups and between groups.

CONCLUSIONS

DBT preparations at 6.0 g/day significantly improve physical and psychological scores and significantly reduce vasomotor symptoms from baseline. The treatment was well tolerated, with no serious adverse events noted during the 12-week intervention period. The changes do not affect hormones and lipid profiles.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22990757

Citation

Wang, Chi Chiu, et al. "A Randomized, Double-blind, Multiple-dose Escalation Study of a Chinese Herbal Medicine Preparation (Dang Gui Buxue Tang) for Moderate to Severe Menopausal Symptoms and Quality of Life in Postmenopausal Women." Menopause (New York, N.Y.), vol. 20, no. 2, 2013, pp. 223-31.
Wang CC, Cheng KF, Lo WM, et al. A randomized, double-blind, multiple-dose escalation study of a Chinese herbal medicine preparation (Dang Gui Buxue Tang) for moderate to severe menopausal symptoms and quality of life in postmenopausal women. Menopause. 2013;20(2):223-31.
Wang, C. C., Cheng, K. F., Lo, W. M., Law, C., Li, L., Leung, P. C., Chung, T. K., & Haines, C. J. (2013). A randomized, double-blind, multiple-dose escalation study of a Chinese herbal medicine preparation (Dang Gui Buxue Tang) for moderate to severe menopausal symptoms and quality of life in postmenopausal women. Menopause (New York, N.Y.), 20(2), 223-31. https://doi.org/10.1097/gme.0b013e318267f64e
Wang CC, et al. A Randomized, Double-blind, Multiple-dose Escalation Study of a Chinese Herbal Medicine Preparation (Dang Gui Buxue Tang) for Moderate to Severe Menopausal Symptoms and Quality of Life in Postmenopausal Women. Menopause. 2013;20(2):223-31. PubMed PMID: 22990757.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, multiple-dose escalation study of a Chinese herbal medicine preparation (Dang Gui Buxue Tang) for moderate to severe menopausal symptoms and quality of life in postmenopausal women. AU - Wang,Chi Chiu, AU - Cheng,King Fai, AU - Lo,Wing Man, AU - Law,Cindy, AU - Li,Lu, AU - Leung,Ping Chung, AU - Chung,Tony Kwok Hung, AU - Haines,Christopher John, PY - 2012/9/20/entrez PY - 2012/9/20/pubmed PY - 2013/7/17/medline SP - 223 EP - 31 JF - Menopause (New York, N.Y.) JO - Menopause VL - 20 IS - 2 N2 - OBJECTIVE: This study is a phase II clinical trial that aims to investigate the dose-response relationship of a Chinese herbal medicine preparation, Dang Gui Buxue Tang (DBT), with short-term menopausal symptoms and quality of life in local postmenopausal women. METHODS: A randomized, double-blind, multiple-dose escalation trial was performed in 60 postmenopausal women experiencing severe hot flashes and night sweats. The participants were randomized to receive DBT preparations at 1.5, 3.0, or 6.0 g/day for 12 weeks. The primary outcomes were vasomotor symptoms, Greene Climacteric Scale (GCS) score, and Menopause-Specific Quality of Life (MENQOL) score. Secondary outcomes included serum hormones and lipids. RESULTS: There were between-group differences in psychological/psychosocial (P = 0.015, GCS; P = 0.013, MENQOL) and somatic/physical (P = 0.019, GCS; P = 0.037, MENQOL) domains, and improvement was significantly greatest (P < 0.05) in the 6.0 g/day dose group. The frequency and severity of hot flashes and night sweats were significantly reduced in the 3.0 g/day (14.5%-21.2%, P < 0.05, hot flashes; 28.6%-39.6%, P < 0.05, night sweats) and 6.0 g/day (34.9%-37.4.0%, P < 0.01, hot flashes; 10.1%-12.8%, P < 0.01, night sweats) dose groups. The female hormones follicle-stimulating hormone, luteinizing hormone, and 17β-estradiol, as well as the lipids total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol, were not significantly different within groups and between groups. CONCLUSIONS: DBT preparations at 6.0 g/day significantly improve physical and psychological scores and significantly reduce vasomotor symptoms from baseline. The treatment was well tolerated, with no serious adverse events noted during the 12-week intervention period. The changes do not affect hormones and lipid profiles. SN - 1530-0374 UR - https://www.unboundmedicine.com/medline/citation/22990757/A_randomized_double_blind_multiple_dose_escalation_study_of_a_Chinese_herbal_medicine_preparation__Dang_Gui_Buxue_Tang__for_moderate_to_severe_menopausal_symptoms_and_quality_of_life_in_postmenopausal_women_ L2 - https://doi.org/10.1097/gme.0b013e318267f64e DB - PRIME DP - Unbound Medicine ER -