A Multi-center, Randomized, Controlled and Open Clinical Trial of Heyan Kuntai Capsule () and Hormone Therapy in Perimenopausal Women / 中国结合医学杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of Heyan Kuntai Capsule (, HYKT) and hormone therapy (HT) on perimenopausal syndromes (PMSs).</p><p><b>METHODS</b>From 2005 to 2008, 390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years, estradiol (E2) below 30 ng/L, and follicle stimulating hormone (FSH) above 40 IU/L, etc. The patients were randomly assigned to HYKT group or HT group by random number table method, administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment, the patients were interviewed quarterly, Kupperman Menopausal Index (KMI) scores, hot flush scores, insomnia scores, Menopause-Specific Quality of Life (MENQOL) scores and adverse effects were used for evaluating drug efficacy and safety respectively. The last interview was made at the end of 12-month treatment RESULTS: After treatment, KMI scores of HYKT group and HT group were both significantly decreased compared with baseline (P <0.01) and there was no significant difference between groups (P >0.05), except that KMI of HYKT group was higher after 3-month treatment (P <0.05). After treatment, hot flush and insomnia scores were both improved significantly in two groups (P <0.01); and HT had a better performance than HYKT in improving hot flush (P <0.05). MENQOL were significantly improved in both groups after treatment (P <0.01); but there was no significant difference between two groups (P >0.05). The incidence of adverse event in the HYKT group was much lower than that in the HT group (P <0.01).</p><p><b>CONCLUSIONS</b>HYKT could effectively relieve PMSs and improve patients quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.</p>

Effects of kuntai capsule on quality of life, breast distending pain and vaginal bleeding in women at early stage of menopause / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To study the effects of Kuntai Capsule (KTC), a Chinese herbal preparation, on the quality of life (QOL), breast distending pain and vaginal bleeding in women at early stage of menopause.</p><p><b>METHODS</b>A total of 104 women at early stage of menopause, 54 had their uterus existed (Ue) and 50 in-existed (Ui), were enrolled, and they were randomized to the KTC group and the control group, with equal cases of Ue and Ui in each. The KTC group was treated with KTC 4 capsules twice a day; the control group treated with premarin 0.45 mg per day and for those of Ue 2 mg medroxyprogesterone additionally, with the remedies medicated orally for 1 year. All the testees were asked to record everyday their own condition of breast pain and vaginal bleeding and followed-up every 3 months to fulfill the Menopause Specific Quality of Life questionnaire. Ultrasonic examination on pelvis and breast as well as endocrine hormone assays of estradiol (E2) and follicle-stimulating hormone (FSH) were performed before and after the medication term.</p><p><b>RESULTS</b>Effects of treatment in the two groups were different insignificantly in terms of QOL. The women were benefited in vasomotor and physical domains from the 3rd month of medication, and the psychosocial domain was also improved (for Ui initiating from the 3rd month and for Ue from the 6th month). In the domain of sexual life, KTC showed its favorable effect only on Ue beginning from the 9th month, but not on Ui; while all subjects in the control group had their sexual life improved from the 3rd month. In domain of breast pain, the occurrence at various time points between the two groups was insignificantly different, only that the severity in Ue of the control group was more significant from the 1st to 3rd month than that in the KTC group. As for the domain of vaginal bleeding, the uterine membrane was basically normal in both groups either before or after medication, but the incidence and lasting days from the 1st to 3rd month in Ue of the KTC group were significantly lower than those of the control group. Levels of E2 and FSH were not significantly changed after medication in the KTC group, while in the control group, E2 significantly increased and FSH significantly decreased in the women of Ue (P <0.05).</p><p><b>CONCLUSION</b>KTC could evidently improve the QOL of women at the early stage of menopause, and is of high safety, with less adverse reaction of breast pain and vaginal bleeding, and shows few impact on sexual hormones.</p>