Objective: The aim of this study is to investigate the effectiveness and safety of a Chinese herbal formula, Er-Xian decoction (EXD), in the treatment of menopausal symptoms among Hong Kong perimenopausal women.
Methods: A randomized, double-blind, controlled trial was conducted for 12 weeks among 108 Hong Kong perimenopausal women who reported Menopause Rating Scale (MRS) total scores of 28 or higher. Posttreatment follow-up was performed 3 months after the intervention. The primary outcome measure was the frequency and severity of hot flushes. The secondary outcome measures included the MRS, the Menopause-Specific Quality of Life questionnaire, and serum hormone levels.
Results: Among 108 participants, 101 participants finished the study. EXD significantly reduced the mean (SD) frequency of hot flushes from 5.8 (5.0) to 2.2 (3.0) in the treatment group and from 5.0 (3.8) to 2.4 (2.5) in the placebo group (P = 0.04). The mean (SD) hot flush score was also reduced from 19.6 (6.6) to 4.9 (7.8) in the treatment group and from 16.6 (5.4) to 7.0 (6.4) in the placebo group (P = 0.02). The superiority of EXD to placebo was also observed with greater improvement in the total scores for the MRS (P = 0.03) and the Menopause-Specific Quality of Life questionnaire (P < 0.01). There were no differences in serum hormone levels between the EXD group and the placebo group. There were no serious adverse events, and the safety indices of whole blood counts, renal function, and liver function were within the normal range before and after treatment.
Conclusions: The Chinese herbal formula EXD is superior to placebo in reducing the frequency and severity of hot flushes and in improving menopausal symptoms in Hong Kong perimenopausal women. It is well tolerated, with no serious adverse events noted during the study period.
From the 1School of Chinese Medicine and2Department of Obstetricsand Gynecology, Li Ka Shing Faculty of Medicine, The Universityof Hong Kong, Pukfulam, Hong Kong SAR; and 3Department ofClinical Oncology, Queen Elizabeth Hospital, Hospital Authority, Hong Kong SAR.
Received August 13, 2012; revised and accepted November 6, 2012.
Funding/support: This study was supported by the Liu Hao Tsing. Foundation (research) and HKU Small Project Funding (“A pilot study on the effects of a Chinese herbal formula on menopause”; project code 200907176133).
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Financial disclosure/conflicts of interest: None reported.
Address correspondence to: Yao Tong, PhD, School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, G/F, 10 Sassoon Road, Pukfulam, Hong Kong SAR. E-mail: email@example.com