Department of Public Health and Community Medicine, Sohag University, Sohag, Egypt.
Int J Womens Health. 2013 Aug 7;5:477-86. doi: 10.2147/IJWH.S41021. eCollection 2013.
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.
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.
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.
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.
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.
子宫肌瘤（UFs，也称为平滑肌瘤）影响 70%的育龄妇女。UF 严重影响绝经前妇女的健康相关生活质量（HRQL），是一个公共卫生问题。目前，对于有症状的 UF 妇女，尚无有效的药物治疗选择。
在一项双盲、安慰剂对照的随机临床试验中，评估绿茶提取物（表没食子儿茶素没食子酸酯 [EGCG]）对有症状 UF 妇女 UF 负担和生活质量的疗效和安全性。
本研究共招募了 39 名育龄妇女（年龄 18-50 岁，第 3 天血清卵泡刺激素<10 mIU/mL），患有有症状 UF。所有受试者均通过经阴道超声检查证实至少有一个 2 cm(3) 或更大的肌瘤病变。这些受试者被随机分为每日口服 800mg 绿茶提取物（45% EGCG）或安慰剂（800mg 糙米）治疗 4 个月，并在结束时通过经阴道超声测量 UF 体积。在每月的就诊时，使用症状严重程度和生活质量问卷对这些 UF 患者的肌瘤特异性症状严重程度和 HRQL 进行评分。使用学生 t 检验评估两组之间治疗效果的统计学意义。
在最终纳入研究的 39 名妇女中，有 33 名符合条件并完成了研究的所有五次就诊。在安慰剂组（n=11）中，肌瘤体积在研究期间增加（24.3%）；然而，接受绿茶提取物（n=22，每天 800mg）治疗的患者的总 UF 体积显示出显著减少（32.6%，P=0.0001）。此外，与安慰剂组相比，EGCG 治疗还显著降低了肌瘤特异性症状严重程度（32.4%，P=0.0001）并改善了 HRQL（18.53%，P=0.01）。EGCG 治疗组的贫血也显著改善了 0.7g/dL（P=0.02），平均每月出血量从 71mL 减少到 45mL（P=0.001）。两组均未观察到不良反应、子宫内膜增生或其他子宫内膜病理学变化。
EGCG 作为一种安全有效的治疗有症状 UF 妇女的药物具有广阔前景。这种简单、廉价、口服的治疗方法可以改善全球妇女的健康。
