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.
RCT Entities:
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.