Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study

Abstract

BackgroundUterine 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.ObjectivesTo 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.MethodsA total of 39 reproductive-age women (age 18–50 years, day 3 serum follicle-stimulating hormone <10 \U/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.ResultsOf 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.ConclusionEGCG 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.

Role of Transforming Growth Factor β in Uterine Fibroid Biology

“…If the development of UFs is considered as a TGF-β-dependent proliferation process, the treatment should be sought among antiproliferative and antifibrotic therapies. The available clinical studies demonstrated that some substances like cabergoline [ 47 ], epigallocatechin gallate [ 48 ], or vitamin D [ 49 , 50 ], might be useful in the pharmacological treatment of UFs [ 51 ].…”

Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials

“…19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52 Among the 34 studies, 28 were studies with the primary objective of efficacy assessment and six were studies for safety assessment. The subjects were healthy (10 studies), obese (seven studies), cancer patients (five studies) or other (12 studies).…”

Green Tea Extract Inhibition of Human Leiomyoma Cell Proliferation Is Mediated via Catechol-<b><i>O</i></b>-Methyltransferase

“…In a randomized controlled clinical pilot study, we have recently demonstrated the effectiveness of EGCG treatment on symptomatic uterine fibroids [40]. We have also shown previously that EGCG could effectively inhibit the proliferation of HuLM cells in vitro [27] and in vivo in a nude mouse model of uterine fibroids [28].…”