Efficacy of Rubus coreanus Miq. and Astragalus membranaceus Bunge Extract for Postmenopausal Syndrome: A Randomised, Double-Blind, Placebo Comparative Clinical Trial

Abstract

Objectives: The most effective way to improve menopausal symptoms is to supplement deficient oestrogen; however, long-term administration of synthetic oestrogen increases the risk for breast and uterine cancers. Here, we report results from a clinical trial of Rubus coreanus Miq. and Astragalus membranaceus Bunge as agents for improving the menopause syndrome.

Methods: This study was a single-centre, double-blinded, parallel-group, placebo-controlled study. The efficacy of an extract of R. coreanus Miq. and A. membranaceus Bunge was investigated. Participants were females with postmenopausal syndrome in the menopausal or menopausal transition period. The primary endpoint of validation was improvement in the Kupperman index (KI) score of women. The secondary end point was change in the Menopause Rating Scale (MRS) and lipid profile. The participants were randomly allocated at a 1 : 1 ratio into R. coreanus Miq. and A. membranaceus Bunge extract (RCAM) or placebo groups and were administered 2000 mg of the extract or placebo, respectively, daily for 12 weeks. Outcomes were measured at visits 2 (day 0) and 5 (week 12).

Results: The RCAM group demonstrated decreased KI score and MRS compared with the placebo group after 12 weeks. In the safety evaluation, laboratory tests and vital signs demonstrated no clinically significant changes in subjects, and there was no difference in adverse reactions between the groups. The R. coreanus Miq. and A. membranaceus Bunge extract was effective in reducing postmenopausal symptoms in women. Moreover, the extract was found to be safe.

Conclusions: For females with menopausal symptoms in the menopausal transitional and postmenopausal periods, ingestion of the R. coreanus Miq. and A. membranaceus Bunge extract for 12 weeks was effective, as demonstrated by a decrease in KI score and MRS relative to that in the placebo group, and significantly improved the menopausal symptoms.

Figure 1

The study flow chart. The intervention: the Rubus coreanus Miq. and Astragalus membranaceus Bunge extract and placebo (RCAM: Rubus coreanus Miq. and Astragalus membranaceus Bunge).

Figure 2

(a) The RCAM tablet and placebo. (b, c, d) Fingerprinting analysis of RCAM. (b) Chromatogram of ellagic acid and formononetin. (c) Chromatogram of standard mixture. (d) The content of each standard compound in RCAM.