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

Abstract

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 \U/mL) with symptomatic UF were recruited for this study. All subjects had at least one fibroid lesion 2 cm(3) 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; green tea; leiomyoma; pilot clinical study; quality of life; uterine fibroid.

Figure 1

Flowchart of participant recruitment and flow through randomized clinical epigallocatechin gallate (EGCG) treatment study. Only 39 of the 72 age eligible women consented during the enrollment phase. The ethical committee of the Faculty of Medicine, Sohag University approved the protocol. All consenting participants (n = 39) were confirmed by transvaginal ultrasonography to have uterine fibroids and randomized to treatment groups: 22 were randomized to receive green tea extract (EGCG, oral dose, 800 mg/day) and 17 to receive placebo capsules. The baseline characteristics of the two groups were well matched, with no significant difference (Table 1). After randomization and before any additional follow-up measures could be obtained, six patients dropped out of the placebo group. Compliance throughout the 4-month treatment period (visit 1 to visit 5) was high among the remaining patients in both treatment groups: EGCG (n = 22) and the placebo group (n = 11). Uterine fibroid volumes were measured again by transvaginal ultrasonography at the end of the 4-month treatment period (visit 5). * Signifies patients that dropped out after randomization. Abbreviation: UF, uterine fibroids.

Figure 2

Epigallocatechin gallate (EGCG) treatment decreases total uterine fibroid volume in patients. Fibroid volume decreased significantly with 4 months’ (visit 5 score t = 5.25; P < 0.0001) compared to the placebo group, for which mean fibroid volume increased by 24.25 (±38.09). A P-value of ≤0.05 was considered statistically significant and is indicated by the asterisk. The box plot shows the maximum and minimum values as well as the mean and the median. Mean values are indicated by the plus signs.

Figure 3

Epigallocatechin gallate (EGCG) treatment decreases symptom-severity (SS) score in patients with uterine fibroids. SS score dramatically decreased with 4 months’ (visit 5 [V5] score t = 5.22, P < 0.0001) compared to the placebo group, for which mean SS score was = 7.1 (±15.5). A P-value of ≤0.05 was considered statistically significant and is indicated by the asterisk. The box plot shows the maximum and minimum values as well as the mean and the median. Mean scores are indicated by plus signs.

Figure 4

Epigallocatechin gallate (EGCG) treatment increases health-related quality-of-life (HRQL) score in patients with uterine fibroids. HRQL score increased dramatically with 4 months’ (visit 5 [V5] score >visit 1 [V1] score) use of green tea extract (EGCG, oral dose, 800 mg/day). The mean increase in HRQL in the EGCG-treated group was 20.72 (±21.11) and significantly high (t = 1.25, P = 0.01) compared to the placebo group, for which the mean percentile increase in HRQL was only 2.19 (±17.42). A P-value of ≤0.05 was considered statistically significant and is indicated by the asterisk. The box plot shows the maximum and minimum values as well as the mean and the median. Mean scores are indicated by plus signs.

Figure 5

(A–D) Visit-to-visit quality-of-life improvement trends in response to epigallocatechin gallate (EGCG) treatment in patients with uterine fibroids. Oral dose (800 mg/day) of EGCG treatment dramatically increased health related quality-of-life (HRQL) score with every visit during the treatment period (visit 1 to visit 5, 4 months) while symptom severity scores decreased. The box plots show the 25th and 75th percentiles as well as the median, mean, and standard deviation (±standard deviation). Mean scores are indicated by plus signs.