J Y Park1, K H Kim1. 1. a Department of Obstetrics and Gynecology , Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine , Seoul , South Korea.
Abstract
OBJECTIVES: The purpose of this clinical trial was to evaluate the effectiveness of a natural extract from Schisandra chinensis for relief of various menopausal symptoms. METHODS: A randomized, double-blind, placebo-controlled clinical trial was conducted from January 1, 2014 until January 13, 2015. We recruited women between the ages of 40 and 70 years who complained of menopausal symptoms measured by the Kupperman Index (KI). Patients were randomly assigned to treatment with either an extract from Schisandra chinensis (BMO-30) or placebo. They received the treatment for 6 weeks and were followed for 12 weeks. The primary endpoint was the mean interval change in KI score from baseline to week 12. Secondary measures included laboratory studies and the Menopause Rating Scale (MRS) score for sexual and bladder problems. RESULTS:Forty-one patients were considered eligible for enrolment, and 36 completed the study. After screening and randomization, patients were categorized into the placebo group (n = 18) and the BMO-30 group (n = 18). Total KI scores were significantly lower in the BMO-30 group than in the placebo group when evaluated with respect to group and time (p = 0.042). CONCLUSIONS:BMO-30 from Schisandra chinensis can be a safe and effective complementary medicine for menopausal symptoms, especially for hot flushes, sweating, and heart palpitations.
RCT Entities:
OBJECTIVES: The purpose of this clinical trial was to evaluate the effectiveness of a natural extract from Schisandra chinensis for relief of various menopausal symptoms. METHODS: A randomized, double-blind, placebo-controlled clinical trial was conducted from January 1, 2014 until January 13, 2015. We recruited women between the ages of 40 and 70 years who complained of menopausal symptoms measured by the Kupperman Index (KI). Patients were randomly assigned to treatment with either an extract from Schisandra chinensis (BMO-30) or placebo. They received the treatment for 6 weeks and were followed for 12 weeks. The primary endpoint was the mean interval change in KI score from baseline to week 12. Secondary measures included laboratory studies and the Menopause Rating Scale (MRS) score for sexual and bladder problems. RESULTS: Forty-one patients were considered eligible for enrolment, and 36 completed the study. After screening and randomization, patients were categorized into the placebo group (n = 18) and the BMO-30 group (n = 18). Total KI scores were significantly lower in the BMO-30 group than in the placebo group when evaluated with respect to group and time (p = 0.042). CONCLUSIONS: BMO-30 from Schisandra chinensis can be a safe and effective complementary medicine for menopausal symptoms, especially for hot flushes, sweating, and heart palpitations.
Entities:
Keywords:
Menopausal symptoms; Schisandra chinensis; herbal medicine; hot flushes; quality of life