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.
Highlights
After menopause, because of the rapid decline in oestrogen, women are prone to a significantly increased risk of developing psychological and emotional symptoms such as fatigue, excitation, insomnia, poor concentration, depression, memory loss, headache, anxiety, and sleep disturbances
We conducted a clinical trial of an extract containing Rubus coreanus Miquel and Astragalus membranaceus Bunge to evaluate its ability to improve the postmenopausal syndrome
A comparison of the 12-week and baseline values for the RCAM and placebo groups showed a significant difference in AST and ALT levels at visit 5, but the values were within the normal range (0–35 IU/L) (Table 2)
Summary
Because of the rapid decline in oestrogen, women are prone to a significantly increased risk of developing psychological and emotional symptoms such as fatigue, excitation, insomnia, poor concentration, depression, memory loss, headache, anxiety, and sleep disturbances. Long-term administration of synthetic oestrogen increases the risk of breast and uterine cancer [2,3,4]. Ere is a growing controversy among scholars and throughout society that long-term synthetic oestrogen replacement therapy causes breast cancer. Ere has been a steady need for safe drugs or health-promoting foods that are effective in improving menopause symptoms in women and do not increase the risk of breast or uterine cancer. In this context, we conducted a clinical trial of an extract containing Rubus coreanus Miquel and Astragalus membranaceus Bunge to evaluate its ability to improve the postmenopausal syndrome
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