Effects of Isoflavone Supplementation on the Response to Medroxyprogesterone in Premenopausal Women with Nonatypical Endometrial Hyperplasia: A Randomized, Double-Blind, Placebo-Controlled Trial

Objective. The purpose of this study was to evaluate the impact of isoflavone supplementation compared with placebo on endometrial histology and serum estradiol levels in premenopausal women with nonatypical endometrial hyperplasia. Materials and Methods. The present double-blindplacebo-controlled c...

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Published in:	International journal of clinical practice (Esher) Vol. 2022; no. 1; p. 1263544
Main Authors:	Vahedpour, Zahra, Boroumand, Homa, Tabatabaee Anaraki, Shirin, Tabasi, Zohre, Motedayyen, Hossein, Akbari, Hossein, Raygan, Fariba, Ostadmohammadi, Vahidreza
Format:	Journal Article
Language:	English
Published:	India Hindawi 2022 John Wiley & Sons, Inc Wiley
Subjects:	17β-Estradiol Acetic acid Adult Analysis of covariance Biopsy Blood pressure Body mass index Cancer therapies Chi-square test Clinical trials Diabetes Dietary Supplements Double-Blind Method Drug-Related Side Effects and Adverse Reactions Endometrial cancer Endometrial Hyperplasia - chemically induced Endometrial Hyperplasia - drug therapy Endometrial Hyperplasia - epidemiology Endometrium Estradiol - adverse effects Estrogens Female Gynecology Histology Humans Hyperplasia Iran Isoflavones Isoflavones - adverse effects Medroxyprogesterone Medroxyprogesterone acetate Middle Aged Pharmaceutical industry Placebos Sample size Side effects Iran
ISSN:	1368-5031, 1742-1241, 1742-1241
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Abstract	Objective. The purpose of this study was to evaluate the impact of isoflavone supplementation compared with placebo on endometrial histology and serum estradiol levels in premenopausal women with nonatypical endometrial hyperplasia. Materials and Methods. The present double-blindplacebo-controlled clinical trial was conducted on 100 women with nonatypical endometrial hyperplasia in the age range of 30 to 45 years. Participants were randomly assigned to receive 50 mg of isoflavone (n = 50) or placebos (n = 50) daily for three months. Both groups received the standard treatment of nonatypical endometrial hyperplasia. Endometrial biopsy and blood samples were taken at the baseline and three months after the intervention. The incidence of drug side effects was assessed as well. Results. After three months, 88.4% of isoflavone-administered subjects had a significant histological improvement compared to 68.9% subjects in the placebo group (P=0.02). There were no significant differences between the two groups in the changes of serum estradiol levels and the incidence of drug side effects. Conclusion. The findings of the present study demonstrated that the coadministration of 50 mg of isoflavones and medroxyprogesterone acetate increases the treatment efficacy in women with nonatypical endometrial hyperplasia. Clinical Trial Registration. This trial was registered on the Iranian website for clinical trial registration (https://www.irct.ir/trial/53553).
AbstractList	Objective. The purpose of this study was to evaluate the impact of isoflavone supplementation compared with placebo on endometrial histology and serum estradiol levels in premenopausal women with nonatypical endometrial hyperplasia. Materials and Methods. The present double-blindplacebo-controlled clinical trial was conducted on 100 women with nonatypical endometrial hyperplasia in the age range of 30 to 45 years. Participants were randomly assigned to receive 50 mg of isoflavone (n = 50) or placebos (n = 50) daily for three months. Both groups received the standard treatment of nonatypical endometrial hyperplasia. Endometrial biopsy and blood samples were taken at the baseline and three months after the intervention. The incidence of drug side effects was assessed as well. Results. After three months, 88.4% of isoflavone-administered subjects had a significant histological improvement compared to 68.9% subjects in the placebo group (P=0.02). There were no significant differences between the two groups in the changes of serum estradiol levels and the incidence of drug side effects. Conclusion. The findings of the present study demonstrated that the coadministration of 50 mg of isoflavones and medroxyprogesterone acetate increases the treatment efficacy in women with nonatypical endometrial hyperplasia. Clinical Trial Registration. This trial was registered on the Iranian website for clinical trial registration (https://www.irct.ir/trial/53553). The purpose of this study was to evaluate the impact of isoflavone supplementation compared with placebo on endometrial histology and serum estradiol levels in premenopausal women with nonatypical endometrial hyperplasia.ObjectiveThe purpose of this study was to evaluate the impact of isoflavone supplementation compared with placebo on endometrial histology and serum estradiol levels in premenopausal women with nonatypical endometrial hyperplasia.The present double-blindplacebo-controlled clinical trial was conducted on 100 women with nonatypical endometrial hyperplasia in the age range of 30 to 45 years. Participants were randomly assigned to receive 50 mg of isoflavone (n = 50) or placebos (n = 50) daily for three months. Both groups received the standard treatment of nonatypical endometrial hyperplasia. Endometrial biopsy and blood samples were taken at the baseline and three months after the intervention. The incidence of drug side effects was assessed as well.Materials and MethodsThe present double-blindplacebo-controlled clinical trial was conducted on 100 women with nonatypical endometrial hyperplasia in the age range of 30 to 45 years. Participants were randomly assigned to receive 50 mg of isoflavone (n = 50) or placebos (n = 50) daily for three months. Both groups received the standard treatment of nonatypical endometrial hyperplasia. Endometrial biopsy and blood samples were taken at the baseline and three months after the intervention. The incidence of drug side effects was assessed as well.After three months, 88.4% of isoflavone-administered subjects had a significant histological improvement compared to 68.9% subjects in the placebo group (P=0.02). There were no significant differences between the two groups in the changes of serum estradiol levels and the incidence of drug side effects.ResultsAfter three months, 88.4% of isoflavone-administered subjects had a significant histological improvement compared to 68.9% subjects in the placebo group (P=0.02). There were no significant differences between the two groups in the changes of serum estradiol levels and the incidence of drug side effects.The findings of the present study demonstrated that the coadministration of 50 mg of isoflavones and medroxyprogesterone acetate increases the treatment efficacy in women with nonatypical endometrial hyperplasia. Clinical Trial Registration. This trial was registered on the Iranian website for clinical trial registration (https://www.irct.ir/trial/53553).ConclusionThe findings of the present study demonstrated that the coadministration of 50 mg of isoflavones and medroxyprogesterone acetate increases the treatment efficacy in women with nonatypical endometrial hyperplasia. Clinical Trial Registration. This trial was registered on the Iranian website for clinical trial registration (https://www.irct.ir/trial/53553). The purpose of this study was to evaluate the impact of isoflavone supplementation compared with placebo on endometrial histology and serum estradiol levels in premenopausal women with nonatypical endometrial hyperplasia. The present double-blindplacebo-controlled clinical trial was conducted on 100 women with nonatypical endometrial hyperplasia in the age range of 30 to 45 years. Participants were randomly assigned to receive 50 mg of isoflavone ( = 50) or placebos ( = 50) daily for three months. Both groups received the standard treatment of nonatypical endometrial hyperplasia. Endometrial biopsy and blood samples were taken at the baseline and three months after the intervention. The incidence of drug side effects was assessed as well. After three months, 88.4% of isoflavone-administered subjects had a significant histological improvement compared to 68.9% subjects in the placebo group ( =0.02). There were no significant differences between the two groups in the changes of serum estradiol levels and the incidence of drug side effects. The findings of the present study demonstrated that the coadministration of 50 mg of isoflavones and medroxyprogesterone acetate increases the treatment efficacy in women with nonatypical endometrial hyperplasia. . This trial was registered on the Iranian website for clinical trial registration (https://www.irct.ir/trial/53553).
Author	Vahedpour, Zahra Motedayyen, Hossein Tabatabaee Anaraki, Shirin Akbari, Hossein Boroumand, Homa Ostadmohammadi, Vahidreza Tabasi, Zohre Raygan, Fariba
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Cites_doi	10.1039/c5ra06167a 10.1016/j.bpobgyn.2020.05.003 10.1248/bpb.25.48 10.1016/j.ultsonch.2016.06.035 10.1111/ijcp.14360 10.1111/j.1048-891x.2004.014220.x 10.1080/01635581003605979 10.3390/ijerph19073789 10.1007/s12325-021-01693-y 10.3390/ijms21082815 10.1016/j.fertnstert.2003.11.041 10.1097/01.gme.0000063567.84134.d1 10.1002/jcb.10539 10.1111/j.1753-4887.2009.00213.x 10.3390/nu12123853 10.1097/pas.0b013e318159a2a0 10.1016/j.jtcms.2016.12.008 10.1016/j.phymed.2010.03.024 10.1016/s0378-4274(03)00016-x 10.1089/jmf.2006.9.491 10.1111/ajo.13300 10.1080/13697137.2020.1863356 10.1080/07315724.2001.10719168 10.3945/ajcn.110.008359 10.1507/endocrj.ej15-0056 10.3390/healthcare7030088 10.1111/j.1349-7006.2001.tb01154.x 10.1002/jps.20987 10.1007/s00404-021-06380-5 10.1097/gme.0b013e3182804353
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Snippet	Objective. The purpose of this study was to evaluate the impact of isoflavone supplementation compared with placebo on endometrial histology and serum... Objective . The purpose of this study was to evaluate the impact of isoflavone supplementation compared with placebo on endometrial histology and serum... The purpose of this study was to evaluate the impact of isoflavone supplementation compared with placebo on endometrial histology and serum estradiol levels in...
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SubjectTerms	17β-Estradiol Acetic acid Adult Analysis of covariance Biopsy Blood pressure Body mass index Cancer therapies Chi-square test Clinical trials Diabetes Dietary Supplements Double-Blind Method Drug-Related Side Effects and Adverse Reactions Endometrial cancer Endometrial Hyperplasia - chemically induced Endometrial Hyperplasia - drug therapy Endometrial Hyperplasia - epidemiology Endometrium Estradiol - adverse effects Estrogens Female Gynecology Histology Humans Hyperplasia Iran Isoflavones Isoflavones - adverse effects Medroxyprogesterone Medroxyprogesterone acetate Middle Aged Pharmaceutical industry Placebos Sample size Side effects
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Title	Effects of Isoflavone Supplementation on the Response to Medroxyprogesterone in Premenopausal Women with Nonatypical Endometrial Hyperplasia: A Randomized, Double-Blind, Placebo-Controlled Trial
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Volume	2022
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