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学科主题临床医学
Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: A randomized, double blind, parallel-controlled study versus tibolone
Bai, Wenpei; Zepelin, Hans-Heinrich Henneicke-Von; Wang, Shuyu; Zheng, Shurong; Liu, Jianli; Zhang, Zhonglan; Geng, Li; Hu, Lina; Jiao, Chunfeng; Liske, Eckehard
刊名MATURITAS
2007-09-20
DOI10.1016/j.maturitas.2007.04.009
58期:1页:31-41
收录类别SCI
文章类型Review
WOS标题词Science & Technology
类目[WOS]Geriatrics & Gerontology ; Obstetrics & Gynecology
研究领域[WOS]Geriatrics & Gerontology ; Obstetrics & Gynecology
关键词[WOS]CIMICIFUGA-RACEMOSA ; CLIMACTERIC COMPLAINTS ; HORMONE-THERAPY ; POSTMENOPAUSAL WOMEN ; BREAST-CANCER ; HOT FLASHES ; TRIAL ; PLACEBO ; SAFETY ; ESTROGENS
英文摘要

Objective: To investigate the efficacy-safety balance of the isopropanolic extract of Actaea (=Cimicifuga) racemosa (iCR, Remifemin (R)) in comparison with tibolone in Chinese women with climacteric complaints.

Method: The randomized, double-blind, controlled 3-month study in 5 centers of 3 cities in China enrolled 244 menopausal patients aged 40-60 years and with a Kupperman Menopause Index (KMI) >= 15. The participants were assigned to either iCR corresponding to 40 mg crude drug/day (N = 122) or tibolone 2.5 mg/day (N = 122) orally. The primary endpoint was the combination of the Mann-Whitney values (MWV) of the KMI and the frequency of adverse events (benefit-risk balance) at end of treatment (MWV > 0.5 shows superiority; MWV > 0.36 shows non-inferiority).

Results: KMI decreased from 24.7 +/not superset of 6.1 to 11.2 +/not superset of 6.2 and 7.7 +/not superset of 5.8 (iCR) and to 11.2 +/not superset of 7.2 and 7.5 +/not superset of 6.8 (tibolone) at 4 and 12 weeks. This remarkable and clinically relevant improvement was similar in both treatment groups (MWV = 0.47; 95% CI = 0.39-0.54; Pnon-inferiority = 0.002) showing statistical significant non-inferiority of iCR to tibolone. The KMI-responder rate was similar in both groups (84% and 85%). The safety evaluation showed for both groups a good safety and tolerability profile, however, there is a significant lower incidence of adverse events (p<0.0001) in favor of the herbal treatment. None of the postmenopausal iCR patients experienced vaginal bleeding in contrast to tibolone (17 cases). Breast and abdominal pain as well as leukorrhea was mostly observed in the tibolone group (p = 0.015, p = 0.008,p = 0.002). No serious adverse event was observed in the iCR-group, however, two occurred in the tibolone-group. The benefit-risk balance for iCR was significantly (P=0.01) superior to fibolone (MWV = 0.56; 95% confidence interval [0.51-0.62]).

Conclusion: The efficacy of iCR (medicinal product Remifemin (R)) is as good as tibolone for the treatment of climacteric complaints, even for moderate to severe symptoms, whereby iCR is clearly superior regarding the safety profile. This iCR containing medicinal product is an excellent option for treatment of climacteric complaints which has now for the first time been verified in Asian women. (c) 2007 Elsevier Ireland Ltd. All rights reserved.

语种英语
WOS记录号WOS:000249728400004
引用统计
被引频次:57[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/58718
专题北京大学第一临床医学院_妇产科
作者单位1.Clin Res & Int Med Dept, Salzgitter, Germany
2.Jiangsu Prov Peoples Hosp, Dept Gynecol, Nanjing, Peoples R China
3.Biometr Dept, Excel Pharma Studies, Beijing, Peoples R China
4.Peking Univ, First Hosp, Dept Gynecol, Beijing 100871, Peoples R China
5.Gen Hosp PLA, Dept Gynecol, Beijing, Peoples R China
6.Peking Univ, Third Hosp, Dept Gynecol, Beijing 100871, Peoples R China
7.Sichuan Univ, W China Second Hosp, Dept Gynecol, Chengdu 610064, Peoples R China
推荐引用方式
GB/T 7714
Bai, Wenpei,Zepelin, Hans-Heinrich Henneicke-Von,Wang, Shuyu,et al. Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: A randomized, double blind, parallel-controlled study versus tibolone[J]. MATURITAS,2007,58(1):31-41.
APA Bai, Wenpei.,Zepelin, Hans-Heinrich Henneicke-Von.,Wang, Shuyu.,Zheng, Shurong.,Liu, Jianli.,...&Liske, Eckehard.(2007).Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: A randomized, double blind, parallel-controlled study versus tibolone.MATURITAS,58(1),31-41.
MLA Bai, Wenpei,et al."Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: A randomized, double blind, parallel-controlled study versus tibolone".MATURITAS 58.1(2007):31-41.
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