OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: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.
RCT Entities:
OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.