Vitamin D and green tea extracts for the treatment of uterine fibroids in late reproductive life: a pilot, prospective, daily-diary based study

Abstract

Objective

The beneficial effects of Vitamin D (VD) and Epigallocatechin gallate (EGCG), a polyphenol of green tea, on the growth of uterine fibroids (UF) were previously described in vitro and in vivo. We have decided to investigate their simultaneous administration in women with UFs in late reproductive life.

Methods

>40 years old n = 16 premenopausal women with intramural (IM) or subserosal (SS) UF of ≥3 cm or several UFs of different sizes, even smaller but with a total diameter ≥3 cm but <10 cm, without further concomitant organic causes of abnormal uterine bleeding, treated with EGCG 300 mg, Vitamin B6 10 mg and VD 50 µg/day for 90 days. Women completed a diary on a daily basis to obtain information about bleeding and pelvic pain.

Results

We have observed a significant reduction in UF’s mean size both at patient’s (−17.8%, p = .03) and at single UF’s level (−37.3%, p = .015). The effect was more evident in women with predominant IM (p = .016) in comparison to SS UFs. No significant changes were observed for uterine and ovarian volume and endometrial thickness during treatment. We reported a significant decrease in menstrual flow length of 0.9 day (p = .04) with no modification in cycle length, menstrual flow intensity and menstrual pain intensity. The satisfaction with treatment was in general very high, with no adverse effects reported.

Conclusion

The concomitant administration of VD and EGCG represents a promising treatment of UF in women of late reproductive life for which hormonal manipulation is not foreseen.

维生素D和绿茶提取物治疗育龄晚期子宫肌瘤：一项先导性、前瞻性每天记录的研究 摘要

目的：维生素D（VD）和绿茶提取物（epigallocatechin gallate, EGCG）对子宫肌瘤（uterine fibroids, UF）生长的有益影响已有体外和体内研究。我们现在研究同时服用这些药物对育龄晚期UFs的治疗效果。

方法：16名40岁以上的绝经前女性, ≥3 cm的壁内（intramural, IM）或浆膜下（subserosal, SS）UF, 或多发性子宫肌瘤, 总直径≥3 cm但<10 cm, 无其他器质性异常子宫出血原因, 用EGCG 300 mg、维生素B6 10 mg和VD 50µg/天治疗90天。她们每天完成一份记录, 以获取有关出血和骨盆疼痛的信息。

结果：我们观察到, 在患者水平（-17.8%, p = 0.03）和单个UF水平（-37.3%, p = 0.015）下, UF的平均大小均显著减小。与SS UFs相比, 这种效应在IM UFs女性中更为明显（p = 0.016）。治疗期间, 未观察到子宫和卵巢体积以及子宫内膜厚度的显著变化。我们发现月经周期长度、经期出血量和痛经程度没有改变, 月经周期长度显著缩短0.9天（p = 0.04）。总体上, 患者对治疗的满意度非常高, 未报告任何不良反应。

结论：对于育龄晚期UF, 激素治疗是有风险的, 而同时给予VD和EGCG是一种很有前景的治疗方法。

Keywords:

• Uterine fibroid
• leiomyomas
• myomas
• vitamin D
• green tea
• epigallocatechin

Disclosure statement

Fabio Facchinetti was invited by Lo.Li. Pharma to sponsored symposia within International Congresses. Other authors: nothing to declare. There was no funding for this trial except Farmares provided Delphys^® tablets.