Green Tea Extract, Vitamin D, and Vitamin B6 Combination for the Treatment of Uterine Leiomyoma in Reproductive-age Women: A Prospective, Single-arm Study

Background: Conservative uterine leiomyoma treatment options are limited. There is an unmet need for well-tolerated, non-invasive treatments that can be safely used long-term to reduce fibroid burden and symptoms. We investigated the efficacy of epigallocatechin gallate (EGCG) from green tea, in combination with vitamins D and B6, for fibroid reduction and improvement of symptoms. Methods: In this single-center study, we enrolled Korean, reproductive age women aged 18–50 years with confirmed uterine leiomyoma, with fibroids ≥3 cm in the longest dimension. Participants received EGCG 150 mg, vitamin D3 25 μg/1000 international units (IU), and vitamin B6 5 mg in tablet form for 16 weeks, and were instructed to take 2 tablets each morning. Participants completed a pictorial bleeding assessment chart (PBAC) during menstruation, and uterine fibroid symptom (UFS) severity and quality of life (QoL) assessments before and after treatment. The primary endpoint was the change in largest fibroid volume at 16 weeks. Outcomes were compared using a paired t-test or Wilcoxon’s signed rank test based on satisfaction of the normality assumption. Results: After 16 weeks, 31/33 patients (93.9%) showed a reduced fibroid volume. Mean fibroid volume was significantly reduced by 12.7% (675.57 vs. 590.00 mm3, respectively; p < 0.001). Significant volume reductions were observed across all age groups, with the greatest reduction observed in the 41–50-year age group (–16.0%). While there was no significant improvement in mean PBAC scores, UFS-severity and UFS-QoL scores improved in 72.7% and 81.8% of patients, respectively, with significant improvements in mean scores compared to baseline (p = 0.002 and p = 0.008, respectively). No adverse events were reported. Conclusions: The use of EGCG/vitamin D3/vitamin B6 represents an effective and well-tolerated non-hormonal and non-surgical treatment for reproductive age women with symptomatic uterine leiomyoma. Clinical Trial Registration: This study is registered on the Korean Clinical Research Information Service (CRIS) https://cris.nih.go.kr/cris/search/detailSearch.do?seq=30490&search_page=L (registration number: KCT0010798).