A randomized, double-blind, controlled trial of a Chinese herbal formula (Er-Xian decoction) for menopausal symptoms in Hong Kong perimenopausal women.

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.

A pilot study on the effects of a Chinese herbal preparation on menopausal symptoms.

This study was conducted to determine whether a particular Chinese medicinal preparation is effective in alleviating menopausal symptoms. Chinese women with menopausal symptoms were recruited to receive treatment for 3 months followed by 3 months without treatment. The severity of menopausal symptoms and serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol levels were assessed at baseline, 3 and 6 months. Data from 97 women with a mean age of 52.3 years were analyzed. Sixty women (62%) were postmenopausal. The serum FSH level (interquartile range) was 58.0 (39.5-72.4) IU/l at baseline and rose significantly 3 months after treatment. The difference remained significant in the postmenopausal group while there was no significant difference in the perimenopausal women. The changes in serum LH and estradiol levels remained unchanged. The baseline menopausal symptom score was 8.9 +/- 6.0. The menopausal symptom score improved markedly after treatment and remained at the same level at 6 months. All individual menopausal symptoms improved significantly after 3 months of treatment except dry eye. Most of these symptoms remained significantly improved at 6 months compared with the pre-treatment assessment. We observed that the Chinese medicinal preparation used in this study is effective in improving menopausal symptoms in healthy Chinese women. Further randomized controlled trial will be needed to confirm this observation.