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Archives of Gynecology and Obstetrics

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01-06-2016 | Gynecologic Endocrinology and Reproductive Medicine

Comparison of the symptomatic response in Indian menopausal women with different estrogen preparations for the treatment of menopausal symptoms: a randomized controlled trial

Authors: Sunita Malik, Deepika Pannu, Shashi Prateek, Renuka Sinha, Harsha Gaikwad

Published in: Archives of Gynecology and Obstetrics | Issue 6/2016

Abstract

Purpose

To compare symptomatic response in Indian women using different estrogen preparations for treatment of menopausal symptoms.

Methodology

A 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’s t test 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.

Results

Both 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.

Conclusion

Low 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 registry

The trial was registered under Clinical trial registry of India prospectively (number: CTRI/2012/04/002566).

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Title: Comparison of the symptomatic response in Indian menopausal women with different estrogen preparations for the treatment of menopausal symptoms: a randomized controlled trial
Authors: Sunita Malik
Deepika Pannu
Shashi Prateek
Renuka Sinha
Harsha Gaikwad
Publication date: 01-06-2016
Publisher: Springer Berlin Heidelberg
Published in: Archives of Gynecology and Obstetrics / Issue 6/2016
Print ISSN: 0932-0067
Electronic ISSN: 1432-0711
DOI: https://doi.org/10.1007/s00404-016-4034-9

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Comparison of the symptomatic response in Indian menopausal women with different estrogen preparations for the treatment of menopausal symptoms: a randomized controlled trial

Abstract

Purpose

Methodology

Results

Conclusion

Trial registry

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Springer Medicine

Abstract

Purpose

Methodology

Results

Conclusion

Trial registry

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