Uterine fibroids (UFs also referred to as uterine leiomyoma) are quite common, benign estrogen-dependent tumors of the uterine wall,1 affecting as much as 50% of girls aged 35-49 years.2 UFs trigger a number of medical issues, similar to acute and power pelvic ache, extreme vaginal bleeding, dyspareunia, and iron-deficiency anemia, in addition to miscarriage and infertility.3 The affect of those critical medical issues on girls’s well being is large.1 Being extra prevalent in African-American girls, uterine leiomyoma is a serious health-disparity concern additional diminishing high quality of life, particularly for girls of shade, who’re affected by this illness.4 Presently, there is no such thing as a efficient long-term medicinal remedy for this frequent debilitating illness. Gonadotropin-releasing hormone (GnRH) analogues are efficient short-term medical remedy choices, however FDA-approved solely as preoperative adjuvant remedy (3 months or much less) due to the chance of irreversible bone loss and osteoporosis and different main unwanted side effects.1 The present administration choices vary from hysterectomy (elimination of the uterus), myomectomy, uterine artery embolization, or image-guided centered ultrasound thermal remedy, to statement (in gentle circumstances).3,5,6 Surgical procedure, often within the type of hysterectomy, is the standard remedy choice for girls with symptomatic UFs. This radical choice creates a serious dilemma for girls with symptomatic UFs who haven’t accomplished their households or are but to begin one. Issues with fibroids have to be seen as a public well being concern due to their main burden on girls’s reproductive well being, typically, and on minority girls’s well being, particularly. We and others are exploring potential noninvasive remedy choices for uterine leiomyoma, similar to localized gene remedy, antiprogesterones, vitamin D, and inexperienced tea-extract dietary supplements.5-11
Inexperienced tea is a pure product, generally utilized by girls for a number of functions. Epigallocatechin gallate (EGCG), the most important catechin in inexperienced tea, displays a number of helpful organic results, together with anti-inflammatory, antiproliferative, and antioxidant results. A examine carried out by the US Division of Agriculture reported that inexperienced tea has potent anticancer results in opposition to a variety of human most cancers cells.12 Inexperienced tea’s polyphenols are thought of accountable for these optimistic results, and most notably EGCG has been proven to inhibit key pathways of tumor progress.13,14 A number of human medical research used EGCG for prolonged intervals of time wherein EGCG was very properly tolerated with nearly no reportable unwanted side effects. Wolfram14 used 300 mg/day oral EGCG in sufferers with cardiac illness, and reported improved endothelial operate and elevated brachial artery flow-mediated dilation that paralleled adjustments in EGCG plasma focus. In one other examine, Ahn et al investigated the medical efficacy of inexperienced tea extracts (EGCG) delivered within the type of a capsule in sufferers with human papilloma virus-infected cervical lesions. Sufferers with cervical lesions (power cervicitis, gentle dysplasia, reasonable dysplasia, and extreme dysplasia) have been divided into completely different teams receiving oral EGCG (200 mg/day for 8-12 weeks) with or and not using a native ointment containing EGCG and have been in contrast with untreated sufferers as management. Of their examine, 60% of sufferers (six of ten) present process EGCG capsule remedy confirmed a response in comparison with a ten% response charge (4 of 39) in untreated controls (P < 0.05). The effectiveness of inexperienced tea extracts in a capsule type for the remedy of cervical lesions means that oral consumption of inexperienced tea extracts is usually a potential systemic remedy routine.15
Quite a few research have described favorable results of oral EGCG remedy when utilized in chubby and overweight people for prolonged durations. Chow et al16 reported on human use of EGCG in 30 wholesome volunteers randomly assigned to one of many following doses of polyphenol E (a decaffeinated inexperienced tea catechin combination): 400, 800, or 1200 mg/day (ten topics per dose group). Solely transient gentle nausea was famous in 3% of the examine individuals, and solely on the highest examine agent dose (1200 mg EGCG/day) and in fasting state. Luo et al reported on the consumption of 500-1000 mg/day of oral EGCG for 3 months, which resulted in marked decreases in a number of oxidative biomarkers in comparison with placebo.17 Doses of 800 mg have been properly tolerated, with no reported unwanted side effects.16,17 Latest research from our laboratory demonstrated the power of EGCG to inhibit proliferation and to induce apoptosis in human leiomyoma cells in animal and in vitro fashions. These preclinical knowledge in a mouse mannequin with preexisting fibroid lesions demonstrated that EGCG at a dose of 1.25 mg/kg/day added to consuming water was in a position to induce a extremely vital (as much as 80%) shrinkage of fibroid lesions in comparison with untreated controls.11,18 The remedy was properly tolerated, with no detected unwanted side effects. Such day by day doses of EGCG have additionally been administered safely to human topics in prior medical trials. This shrinkage of fibroids is partially attributed to potent inhibitory results of EGCG on catechol-O- methyltransferase (COMT), an enzyme that now we have just lately linked to the pathogenesis of UFs.19 We have now just lately demonstrated elevated COMT ranges in UFs in comparison with adjoining myometrium, and described the vital position of COMT in fibroid pathogenesis. Curiously, current experiences demonstrated that EGCG has potent anti-COMT exercise,20-22 and one among these experiences has additionally proven that inexperienced tea-extract consumption is related to weight reduction because of EGCG-induced thermogenesis. EGCG is understood to be able to inhibiting COMT – the enzyme that degrades norepinephrine – thus ensuing within the accumulation of norepinephrine that stimulates thermogenesis. The inhibition of COMT by EGCG was uncompetitive with respect to S- adenosylmethionine, suggesting that there is no such thing as a direct interplay between EGCG and the S-adenosylmethionine-binding website on COMT, but there was clear inhibition of COMT exercise with rising EGCG focus. Our preliminary knowledge utilizing human leiomyoma cells confirmed that EGCG additionally inhibited COMT gene expression in a dose-dependent method.23
Armed with our preclinical findings, on this pilot double-blinded placebo-controlled medical trial, we got down to consider the efficacy and security of oral inexperienced tea extract (EGCG) in girls with symptomatic UFs. The first purpose of this examine was to check the speculation that oral inexperienced tea extract, at 800 mg (45% EGCG) day by day for 4 months, may scale back UF measurement. Secondary goals have been to evaluate the impact of inexperienced tea extract (EGCG) on leiomyoma-specific symptom severity (SS) and well being associated quality-of-life (HRQL) amongst girls with symptomatic leiomyoma, using the validated UF symptom quality-of-life questionnaire (UFS-QOL).24
Briefly, this pilot double-blinded placebo-controlled medical trial was designed to judge the efficacy and security of oral inexperienced tea extract (EGCG) remedy in reproductive-age girls with symptomatic UFs.
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