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A randomized double-blind placebo-controlled trial of a Chinese herbal medicine preparation (Jiawei Qing’e Fang) for hot flashes and quality of life in perimenopausal women

Xia, Ye MSc1; Zhao, Yingqiang MD2; Ren, Ming MD1; Zhang, Junhua MD1; Wang, Yuefei PhD1,3; Chang, Yanxu PhD1,3; Fu, Shufei MD1; Fan, Guanwei MD1,3; Zhu, Yan PhD1,3; Huang, Yuhong MD2; Gao, Xiumei MD, PhD1,3

Menopause: The Journal of The North American Menopause Society: February 2012 - Volume 19 - Issue 2 - p 234–244
doi: 10.1097/gme.0b013e3182273177
Original Articles
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Objective This study aimed to evaluate the effectiveness and safety of a Chinese herbal medicine preparation, Jiawei Qing’e Fang (JQF), on menopausal symptoms in perimenopausal women.

Methods A randomized double-blind placebo-controlled trial was performed over 12 weeks in 72 perimenopausal women who reported 14 or more hot flashes per week. The participants were randomly allocated to receive JQF or placebo for 8 weeks. Posttreatment follow-up was performed 4 weeks after intervention. The primary outcome was the Menopause-Specific Quality of Life. Secondary outcomes included hot flash and plasma lipids.

Results There was greater improvement in hot flash score in the JQF group compared with the placebo group, and the difference between the two groups was statistically significant (P = 0.048). There were between-group differences in vasomotor (P = 0.011) and physical (P = 0.034) domains. The triglyceride (TG) level in the JQF group showed a significant reduction (P = 0.036) in women with a baseline TG greater than 150 mg/dL (1.7 mmol/L).

Conclusions The Chinese herbal medicine preparation JQF was found to be superior to placebo in reducing hot flashes and improving menopausal symptoms in the vasomotor and physical aspects and might have a potential benefit in reducing TG levels. The herbal medicine preparation was well tolerated, with no serious adverse events noted during the study period.

Phytoestrogen-rich traditional Chinese herbal formula Jiawei Qing’e Fang was better than placebo in reducing hot flashes and improving menopausal symptoms and might have a potential benefit in reducing triglyceride levels.

From the 1Institute of Traditional Chinese Medicine Research, Tianjin University of Traditional Chinese Medicine, Tianjin, China; 2Second Affiliated Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, China; and 3Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin, China.

Received March 30, 2011; revised and accepted May 31, 2011.

Funding/support: This study was supported by the National Science & Technology Pillar Program (2009ZX09311-002; 2008ZX09312-001), by the International Cooperative Project of the Science and Technology Ministry (2008DFB30070), and by the Program for Changjiang Scholars and Innovative Research Team (PCSIRT) in Tianjin.

Financial disclosure/conflicts of interest: None reported.

Address correspondence to: Xiumei Gao, MD, PhD, Institute of Traditional Chinese Medicine Research, Tianjin University of Traditional Chinese Medicine, 88 Yuquan Street, Nankai District, Tianjin, China. E-mail: gaoxiumei@tjutcm.edu.cn

©2012The North American Menopause Society