Treatment of symptomatic Uterine fibroids with green tea extract: A pilot randomized controlled clinical study

Eman Roshdy, Veera Rajaratnam, Sarbani Maitra, Mohamed Sabry, Abdou S. Ait Allah, Ayman Al-Hendy

Research output: Contribution to journalArticle

32 Citations (Scopus)

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 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.

Original languageEnglish (US)
Pages (from-to)477-486
Number of pages10
JournalInternational Journal of Women's Health
Volume5
Issue number1
DOIs
StatePublished - Aug 6 2013

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Leiomyoma
Tea
Quality of Life
Placebos
Therapeutics
Ultrasonography
Endometrial Hyperplasia
Clinical Studies
Follicle Stimulating Hormone
Women's Health
Anemia
Randomized Controlled Trials
Public Health
epigallocatechin gallate
Pathology
Students
Safety
Serum

Keywords

  • EGCG
  • Green tea
  • Leiomyoma
  • Pilot clinical study
  • Quality of life
  • Uterine fibroid

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology
  • Maternity and Midwifery

Cite this

Treatment of symptomatic Uterine fibroids with green tea extract : A pilot randomized controlled clinical study. / Roshdy, Eman; Rajaratnam, Veera; Maitra, Sarbani; Sabry, Mohamed; Ait Allah, Abdou S.; Al-Hendy, Ayman.

In: International Journal of Women's Health, Vol. 5, No. 1, 06.08.2013, p. 477-486.

Research output: Contribution to journalArticle

Roshdy, Eman ; Rajaratnam, Veera ; Maitra, Sarbani ; Sabry, Mohamed ; Ait Allah, Abdou S. ; Al-Hendy, Ayman. / Treatment of symptomatic Uterine fibroids with green tea extract : A pilot randomized controlled clinical study. In: International Journal of Women's Health. 2013 ; Vol. 5, No. 1. pp. 477-486.
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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 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.",
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T2 - A pilot randomized controlled clinical study

AU - Roshdy, Eman

AU - Rajaratnam, Veera

AU - Maitra, Sarbani

AU - Sabry, Mohamed

AU - Ait Allah, Abdou S.

AU - Al-Hendy, Ayman

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N2 - 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.

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