OBJECTIVE: Many complementary or alternative medicines are being used for the treatment of menopausal symptoms but most have not been properly tested for efficacy or for safety. This study examined the effect of a Chinese herbal preparation (Dang Gui Buxue Tang) on menopausal symptoms in Hong Kong Chinese women. METHODS: A 6-month randomized, double-blind, placebo-controlled study of the effect of Dang Gui Buxue Tang (a 1 : 5 combination of Dang Gui (Angelicae sinensis) and Huang Qi (Astragalus membranaceus)) on acute menopausal symptoms. A total of 103 symptomatic women were enrolled. Three failed to meet inclusion criteria, leaving 50 subjects for inclusion in each group. RESULTS: Overall, mild hot flushes were reported more frequently than either moderate or severe flushes. In analysis by severity of flushes, there was a significant reduction in the number of mild hot flushes per month in the treatment group but not in the placebo group (from 18.9 +/- 23.5 at baseline to 8.6 +/- 17.1 at 6 months in the treatment group (p < 0.01) and from 26.0 +/- 43.5 to 12.4 +/- 17.6 in the placebo group (p = 0.062)). For moderate flushes, there was a significant reduction in the placebo group compared with the treatment group (from 18.9 +/- 28.7 at baseline to 11.1 +/- 29.9 at 6 months in the placebo group (p < 0.05) and from 10.5 +/- 22.3 to 6.0 +/- 16.0 in the treatment group (p = 0.107)). There was no significant change in either treatment or placebo groups in the reporting of severe hot flushes. Episodes of night sweats decreased significantly in the placebo but not in the treatment group (from 6.8 +/- 10.0 at baseline to 1.9 +/- 5.7 at 6 months in the placebo group (p < 0.05) and from 5.4 +/- 8.9 to 3.2 +/- 8.5 in the treatment group (p = 0.471)). In the vasomotor domain of the Menopause Specific Quality of Life, there was a significant reduction in scoring in the placebo group (from 2.8 +/- 1.6 to 1.7 +/- 1.3, p < 0.01) but not in the treatment group (from 2.8 +/- 2.1 to 2.3 +/- 1.6, p = 0.247). CONCLUSIONS: This study found overall no significant difference between Dang Gui Buxue Tang and placebo in the treatment of vasomotor symptoms in Hong Kong Chinese women. The frequency of mild, moderate and severe hot flushes decreased in both treatment and placebo groups, but Dang Gui Buxue Tang was statistically superior to placebo only in the treatment of mild hot flushes. There were no serious adverse events attributable to treatment during the study period.
RCT Entities:
OBJECTIVE: Many complementary or alternative medicines are being used for the treatment of menopausal symptoms but most have not been properly tested for efficacy or for safety. This study examined the effect of a Chinese herbal preparation (Dang Gui Buxue Tang) on menopausal symptoms in Hong Kong Chinese women. METHODS: A 6-month randomized, double-blind, placebo-controlled study of the effect of Dang Gui Buxue Tang (a 1 : 5 combination of Dang Gui (Angelicae sinensis) and Huang Qi (Astragalus membranaceus)) on acute menopausal symptoms. A total of 103 symptomatic women were enrolled. Three failed to meet inclusion criteria, leaving 50 subjects for inclusion in each group. RESULTS: Overall, mild hot flushes were reported more frequently than either moderate or severe flushes. In analysis by severity of flushes, there was a significant reduction in the number of mild hot flushes per month in the treatment group but not in the placebo group (from 18.9 +/- 23.5 at baseline to 8.6 +/- 17.1 at 6 months in the treatment group (p < 0.01) and from 26.0 +/- 43.5 to 12.4 +/- 17.6 in the placebo group (p = 0.062)). For moderate flushes, there was a significant reduction in the placebo group compared with the treatment group (from 18.9 +/- 28.7 at baseline to 11.1 +/- 29.9 at 6 months in the placebo group (p < 0.05) and from 10.5 +/- 22.3 to 6.0 +/- 16.0 in the treatment group (p = 0.107)). There was no significant change in either treatment or placebo groups in the reporting of severe hot flushes. Episodes of night sweats decreased significantly in the placebo but not in the treatment group (from 6.8 +/- 10.0 at baseline to 1.9 +/- 5.7 at 6 months in the placebo group (p < 0.05) and from 5.4 +/- 8.9 to 3.2 +/- 8.5 in the treatment group (p = 0.471)). In the vasomotor domain of the Menopause Specific Quality of Life, there was a significant reduction in scoring in the placebo group (from 2.8 +/- 1.6 to 1.7 +/- 1.3, p < 0.01) but not in the treatment group (from 2.8 +/- 2.1 to 2.3 +/- 1.6, p = 0.247). CONCLUSIONS: This study found overall no significant difference between Dang Gui Buxue Tang and placebo in the treatment of vasomotor symptoms in Hong Kong Chinese women. The frequency of mild, moderate and severe hot flushes decreased in both treatment and placebo groups, but Dang Gui Buxue Tang was statistically superior to placebo only in the treatment of mild hot flushes. There were no serious adverse events attributable to treatment during the study period.
Authors: Lian-Wei Xu; Man Jia; Roland Salchow; Michael Kentsch; Xue-Jun Cui; Hong-Yong Deng; Zhuo-Jun Sun; Lan Kluwe Journal: Evid Based Complement Alternat Med Date: 2013-01-13 Impact factor: 2.629