Objective:To further understand and compare the effectiveness of pattern differentiation treatment and fixed prescription treatment in perimenopausal syndrome.Methods:The study will be conducted in the Hong Kong Feder...Objective:To further understand and compare the effectiveness of pattern differentiation treatment and fixed prescription treatment in perimenopausal syndrome.Methods:The study will be conducted in the Hong Kong Federation of Trade Unions Workers'Medical Clinics,Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre(Hong Kong,China).One hundred Chinese women,aged 45-55 years,will be recruited.The participants will be randomized into 2 groups.The intervention group will be administered medication,based on pattern differentiation,by qualified traditional Chinese medicine(TCM)practitioners.After each evaluation,TCM practitioners will evaluate and revise the prescription,based on the participants'patterns.The control group will be given the standard formula,i.e.,the Erxian decoction,which contains 6 herbs.The treatment period and the follow-up period will be 8 weeks each.The primary assessment outcome measure will be the Kupperman Index,and the secondary outcome measure will be the Menopause-specific Quality of Life Questionnaire score.Conclusion:Pattern-differentiated treatment is the basic principle of TCM to understand and treat diseases.The study will show the pattern-differentiated treatment is effectiveness than the fixed prescription.展开更多
Background It is now recognized that Cimicifuga foetida extract is effective in alleviating menopausal symptoms. But the durations reported were usually short. This paper compares the clinical effects of different reg...Background It is now recognized that Cimicifuga foetida extract is effective in alleviating menopausal symptoms. But the durations reported were usually short. This paper compares the clinical effects of different regimens of three-month course on climacteric symptoms in Chinese women, so as to evaluate the efficacy and safety of Cimicifuga foefida extract. Methods This was a prospective, randomized trial. Ninety-six early menopausal women were recruited and randomly assigned into 3 groups to take different kinds of medicine for 3 months; participants were given Cimicifuga foefida extract daily in group A (n=32), given estradiol valerate and progesterone capsule cycle sequentially in group B (n=32), and given estradiol valerate and medroxyprogesterone acetate cycle sequentially in group C (n=32). The questionnaires of Kupperman menopause index, Menopause-Specific Quality of Life, and Hospital Anxiety and Depression Scale were finished before and after the treatment. The status of vaginal bleeding and breast tenderness was recorded every day. Results Eighty-nine participants (89/96, 92.7%) completed the treatment. Kupperman menopause index decreased after taking the medicine for 3 months in each group (with all P〈0.001), but the score after the treatment was higher in group A than in the other 2 groups. Except for the score of sexual domain in group A (P=0.103), the scores of all domains of the Menopause-Specific Quality of Life decreased significantly after the treatment in all groups (with all P〈-0.01). Score of anxity decreased significantly in group A (P=0.0l 5) and B (P=0.003). Incidence of breast tenderness was 12.9% (4/31) in groupA, 36.7% (11/30) in group B, and 14.3% (4/28) in group C. Incidence of vaginal bleeding was 6.5% (2/31)in group A, 26.7% (8/30) in group B, and 82.1% (23/28)in group C. Conclusions Cimicifuga foeticla extract is effective and safe in the treatment of menopausal syndrome. It is worth extending its use in the treatment of climacteric complaints, especially among those having contradiction for hormone replacement therapy.展开更多
Objective: To evaluate the efficacy and safety of Heyan Kuntai Capsule(和颜坤泰胶囊, HYKT) and hormone therapy(HT) on perimenopausal syndromes(PMSs). Methods: From 2005 to 2008, 390 women with PMSs were recrui...Objective: To evaluate the efficacy and safety of Heyan Kuntai Capsule(和颜坤泰胶囊, HYKT) and hormone therapy(HT) on perimenopausal syndromes(PMSs). Methods: 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). Conclusions: HYKT could effectively relieve PMSs and improve patient quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.展开更多
基金funded by Chinese Medicine Research Practical Training Program of Hong Kong Hospital Authority Chinese Medicine Department(Hong Kong,China)。
文摘Objective:To further understand and compare the effectiveness of pattern differentiation treatment and fixed prescription treatment in perimenopausal syndrome.Methods:The study will be conducted in the Hong Kong Federation of Trade Unions Workers'Medical Clinics,Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre(Hong Kong,China).One hundred Chinese women,aged 45-55 years,will be recruited.The participants will be randomized into 2 groups.The intervention group will be administered medication,based on pattern differentiation,by qualified traditional Chinese medicine(TCM)practitioners.After each evaluation,TCM practitioners will evaluate and revise the prescription,based on the participants'patterns.The control group will be given the standard formula,i.e.,the Erxian decoction,which contains 6 herbs.The treatment period and the follow-up period will be 8 weeks each.The primary assessment outcome measure will be the Kupperman Index,and the secondary outcome measure will be the Menopause-specific Quality of Life Questionnaire score.Conclusion:Pattern-differentiated treatment is the basic principle of TCM to understand and treat diseases.The study will show the pattern-differentiated treatment is effectiveness than the fixed prescription.
文摘Background It is now recognized that Cimicifuga foetida extract is effective in alleviating menopausal symptoms. But the durations reported were usually short. This paper compares the clinical effects of different regimens of three-month course on climacteric symptoms in Chinese women, so as to evaluate the efficacy and safety of Cimicifuga foefida extract. Methods This was a prospective, randomized trial. Ninety-six early menopausal women were recruited and randomly assigned into 3 groups to take different kinds of medicine for 3 months; participants were given Cimicifuga foefida extract daily in group A (n=32), given estradiol valerate and progesterone capsule cycle sequentially in group B (n=32), and given estradiol valerate and medroxyprogesterone acetate cycle sequentially in group C (n=32). The questionnaires of Kupperman menopause index, Menopause-Specific Quality of Life, and Hospital Anxiety and Depression Scale were finished before and after the treatment. The status of vaginal bleeding and breast tenderness was recorded every day. Results Eighty-nine participants (89/96, 92.7%) completed the treatment. Kupperman menopause index decreased after taking the medicine for 3 months in each group (with all P〈0.001), but the score after the treatment was higher in group A than in the other 2 groups. Except for the score of sexual domain in group A (P=0.103), the scores of all domains of the Menopause-Specific Quality of Life decreased significantly after the treatment in all groups (with all P〈-0.01). Score of anxity decreased significantly in group A (P=0.0l 5) and B (P=0.003). Incidence of breast tenderness was 12.9% (4/31) in groupA, 36.7% (11/30) in group B, and 14.3% (4/28) in group C. Incidence of vaginal bleeding was 6.5% (2/31)in group A, 26.7% (8/30) in group B, and 82.1% (23/28)in group C. Conclusions Cimicifuga foeticla extract is effective and safe in the treatment of menopausal syndrome. It is worth extending its use in the treatment of climacteric complaints, especially among those having contradiction for hormone replacement therapy.
基金Supported by the"Tenth-Five"National Medical Science and Technique Foundation,China(No.2004BA720A08)
文摘Objective: To evaluate the efficacy and safety of Heyan Kuntai Capsule(和颜坤泰胶囊, HYKT) and hormone therapy(HT) on perimenopausal syndromes(PMSs). Methods: 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). Conclusions: HYKT could effectively relieve PMSs and improve patient quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.