OBJECTIVE: Over the past 5 years, the interest in alternative therapies for menopause has increased dramatically due to the findings of the Women's Health Initiative (U.S. National Institutes of Health). Menoprogen, a traditional Chinese medicine formulation is an herbal remedy that has been used in China for the management of menopause-related symptoms. An observational pilot study was performed to assess the effects of Menoprogen in the management of menopausal symptoms in perimenopausal and postmenopausal women. DESIGN, SUBJECTS, AND SETTING: A multicenter prospective study was conducted at four clinical centers in China. Female subjects were eligible if they had menopausal diagnosis for at least 3 months and wished to use an alternative to hormone replacement therapy (HRT). INTERVENTION: Subjects received two capsules of Menoprogen (a combination product containing 0.2 g extracts of five herbs per capsule) orally, twice daily. MAIN OUTCOME MEASURES: The primary outcome measured was an improvement of Kupperman Menopausal Index (KMI) from baseline. Secondary outcomes measured included hormone levels and the status of the endometrial and vaginal cytology after completion of treatment. RESULTS: After treatment with Menoprogen, a significant reduction in the KMI was observed (mean of paired difference = -14.875; p < 0.01) as compared with baseline. Endogenous estrogen levels were significantly increased with Menoprogen (mean of paired difference = -3.145; p < 0.01). Progesterone levels increased with Menoprogen (mean of paired difference = -10.003; p < 0.01). Both follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels showed significant before-and-after treatment difference (mean of paired difference = 6.125 mIU/mL for FSH and 4.938 mIU/mL for LH; p < 0.01). No significant endometrial hyperplasia was observed post-treatment with Menoprogen. Most of the postmenopausal women exhibited a vaginal cell proliferation degree of 2-3, suggesting a possible estrogenic effect. CONCLUSIONS: The present pilot study found that Menoprogen reduced symptoms associated with perimenopausal and postmenopausal complaints. Therefore, the rationale for a randomized, placebo-controlled clinical trial is supported.
RCT Entities:
OBJECTIVE: Over the past 5 years, the interest in alternative therapies for menopause has increased dramatically due to the findings of the Women's Health Initiative (U.S. National Institutes of Health). Menoprogen, a traditional Chinese medicine formulation is an herbal remedy that has been used in China for the management of menopause-related symptoms. An observational pilot study was performed to assess the effects of Menoprogen in the management of menopausal symptoms in perimenopausal and postmenopausal women. DESIGN, SUBJECTS, AND SETTING: A multicenter prospective study was conducted at four clinical centers in China. Female subjects were eligible if they had menopausal diagnosis for at least 3 months and wished to use an alternative to hormone replacement therapy (HRT). INTERVENTION: Subjects received two capsules of Menoprogen (a combination product containing 0.2 g extracts of five herbs per capsule) orally, twice daily. MAIN OUTCOME MEASURES: The primary outcome measured was an improvement of Kupperman Menopausal Index (KMI) from baseline. Secondary outcomes measured included hormone levels and the status of the endometrial and vaginal cytology after completion of treatment. RESULTS: After treatment with Menoprogen, a significant reduction in the KMI was observed (mean of paired difference = -14.875; p < 0.01) as compared with baseline. Endogenous estrogen levels were significantly increased with Menoprogen (mean of paired difference = -3.145; p < 0.01). Progesterone levels increased with Menoprogen (mean of paired difference = -10.003; p < 0.01). Both follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels showed significant before-and-after treatment difference (mean of paired difference = 6.125 mIU/mL for FSH and 4.938 mIU/mL for LH; p < 0.01). No significant endometrial hyperplasia was observed post-treatment with Menoprogen. Most of the postmenopausal women exhibited a vaginal cell proliferation degree of 2-3, suggesting a possible estrogenic effect. CONCLUSIONS: The present pilot study found that Menoprogen reduced symptoms associated with perimenopausal and postmenopausal complaints. Therefore, the rationale for a randomized, placebo-controlled clinical trial is supported.
Authors: Yu Li; Hong Ma; Ye Lu; B J Tan; L Xu; Temitope O Lawal; Gail B Mahady; Daniel Liu Journal: Biomed Res Int Date: 2016-02-14 Impact factor: 3.411