Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study
Authors Roshdy E, Rajaratnam V, Maitra S, Sabry M, Ait Allah AS, Al-Hendy A
Received 1 December 2012
Accepted for publication 15 February 2013
Published 7 August 2013 Volume 2013:5 Pages 477—486
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 3
Eman Roshdy,1,* Veera Rajaratnam,2,* Sarbani Maitra,2 Mohamed Sabry,3,4 Abdou S Ait Allah,3,4 Ayman Al-Hendy2
1Department of Public Health and Community Medicine, Sohag University, Sohag, Egypt; 2Department of Obstetrics and Gynecology, Meharry Medical College, Nashville, TN, USA; 3Department of Obstetrics and Gynecology, Sohag University, Sohag, Egypt; 4Ibn Sina IVF Center, Ibn Sina Hospital, Sohag, Egypt
*These authors contributed equally to this work
Background: Uterine fibroids (UFs, also known as leiomyoma) affect 70% of reproductive-age women. Imposing a major burden on health-related quality-of-life (HRQL) of premenopausal women, UF is a public health concern. There are no effective medicinal treatment options currently available for women with symptomatic UF.
Objectives: To evaluate the efficacy and safety of green tea extract (epigallocatechin gallate [EGCG]) on UF burden and quality of life in women with symptomatic UF, in a double-blinded, placebo-controlled randomized clinical trial.
Methods: A total of 39 reproductive-age women (age 18–50 years, day 3 serum follicle-stimulating hormone < 10 mIU/mL) with symptomatic UF were recruited for this study. All subjects had at least one fibroid lesion 2 cm3 or larger, as confirmed by transvaginal ultrasonography. The subjects were randomized to oral daily treatment with either 800 mg of green tea extract (45% EGCG) or placebo (800 mg of brown rice) for 4 months, and UF volumes were measured at the end, also by transvaginal ultrasonography. The fibroid-specific symptom severity and HRQL of these UF patients were scored at each monthly visit, using the symptom severity and quality-of-life questionnaires. Student's t-test was used to evaluate statistical significance of treatment effect between the two groups.
Results: Of the final 39 women recruited for the study, 33 were compliant and completed all five visits of the study. In the placebo group (n = 11), fibroid volume increased (24.3%) over the study period; however, patients randomized to green tea extract (n = 22, 800 mg/day) treatment showed significant reduction (32.6%, P = 0.0001) in total UF volume. In addition, EGCG treatment significantly reduced fibroid-specific symptom severity (32.4%, P = 0.0001) and induced significant improvement in HRQL (18.53%, P = 0.01) compared to the placebo group. Anemia also significantly improved by 0.7 g/dL (P = 0.02) in the EGCG treatment group, while average blood loss significantly decreased from 71 mL/month to 45 mL/month (P = 0.001). No adverse effects, endometrial hyperplasia, or other endometrial pathology were observed in either group.
Conclusion: EGCG shows promise as a safe and effective therapeutic agent for women with symptomatic UFs. Such a simple, inexpensive, and orally administered therapy can improve women's health globally.
Keywords: EGCG, leiomyoma, uterine fibroid, green tea, quality of life, pilot clinical study
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.Download Article [PDF] View Full Text [HTML][Machine readable]