Comparison of the symptomatic response in Indian menopausal women with different estrogen preparations for the treatment of menopausal symptoms: a randomized controlled trial
Comparison of the symptomatic response in Indian menopausal women with different estrogen preparations for the treatment of menopausal symptoms: a randomized controlled trial
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DOI：
10.1007/s00404-016-4034-9
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发表时间：
2016-02
影响因子：
2.6
通讯作者：
S. Malik;D. Pannu;S. Prateek;R. Sinha;Harsha S Gaikwad
中科院分区：
文献类型：
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作者：
S. Malik;D. Pannu;S. Prateek;R. Sinha;Harsha S Gaikwad
目的比较使用不同雌激素制剂治疗更年期症状的印度妇女的症状反应。方法在印度新德里VMMC和SJH进行了一项随机、单盲、四臂平行分配研究。200名印度更年期妇女被分成四组，即戊酸雌二醇组(E2V)、结合马雌激素组(CEE)、异黄酮组和安慰剂组。分类变量的统计意义用卡方检验、Fisher‘s精确检验来确定。在定量变量参数检验的情况下，采用学生t检验。对于非正态分布的定量变量，采用Kruskal-Wallis检验和Wilcoxon Mann-Whitney检验。结果E2V组和CEE组均能有效降低潮热的严重程度和次数。治疗24周后，E2V组平均潮热评分下降91.9%，CEE组下降89.2%，异黄酮组下降60.42%。而安慰剂导致平均潮热评分下降47.9%。治疗24周后，E2V组、CEE组和异黄酮组的阴道健康指数均有显著提高。结论小剂量CEE和E2V在24周以上对血管舒缩/阴道症状的控制效果相同。然而，补充成本更低、生物相同的激素似乎更合理，即微粉化的戊酸雌二醇酯，同样有效。试验登记该试验前瞻性地在印度临床试验注册登记(编号：CTRI/2012/04/002566)。
PurposeTo compare symptomatic response in Indian women using different estrogen preparations for treatment of menopausal symptoms.MethodologyA randomized, single blind, four arm, parallel assignment study was conducted in VMMC and SJH, New Delhi, India. 200 Indian menopausal women were recruited and assigned into four treatment groups viz., estradiol valerate (E2V), conjugated equine estrogen (CEE), isoflavones and Placebo group. The statistical significance of categorical variables was determined by Chi-square, Fisher’s exact test. In case of quantitative variable parametric test Student’sttest was used. In case of quantitative variables where data are not normally distributed, Kruskal–wallis test and Wilcoxon Mann–Whitney test were used. Symptomatic response in vasomotor/vaginal symptoms was assessed in all groups.ResultsBoth E2V and CEE groups were effective in reducing severity and frequency of hot flashes. 91.9 % decrease was observed in mean hot flash score in the E2V group after 24 weeks of treatment, 89.2 % in the CEE group, 60.42 % decrease in the isoflavones group. While placebo led to 47.9 % decrease in mean hot flash score. After 24 weeks of therapy there was significant increase in vaginal health index in the E2V and CEE and the isoflavones group. No serious side effect was reported in any of the groups.ConclusionLow doses of both CEE and E2V were equally effective for management of vasomotor/vaginal symptoms when administered over 24 weeks. However, it seems more reasonable to replenish with less costly and bio-identical hormone, i.e. micronized estradiol valerate which is equally effective.Trial registryThe trial was registered under Clinical trial registry of India prospectively (number: CTRI/2012/04/002566).