Roshdy 2013.

Study characteristics
Methods	RCT, parallel, double‐blind in Egypt
Participants	Participants: 39 Egyptian women, 22 in the intervention group and 17 in the control group Inclusion criteria: age ≥18 years, women in pre‐menopause with follicle‐stimulating hormone level < 10 mIU/L, had reported at least moderately severe leiomyoma‐related symptoms (a score of ≥ 25 on the UF quality‐of‐life symptom severity subscale), had a total uterine volume of ≥ 160 mL by vaginal and abdominal ultrasound and at least 1 UF/leiomyoma that was ≥ 2 cm3, not pregnant or breastfeeding, with untreated abnormal pap smear, with no major morbidity of severe anaemia, elevated liver enzymes > 1.5 times the upper limit of normal, or active substance abuse and no use of such medication (oral or systemic corticosteroids, hormones i.e. oestrogen, progestin, oral contraceptives, herbal or botanical supplements with possible hormonal or GTE effects, or GnRH analogues or Depo‐Provera) in the previous 6 months Recruitment: from November 2010‐August 2011
Interventions	Treatment group: 2 capsules (400 mg each)/d with 95% polyphenols and 45% GTE = total 800 mg/d Control group: placebo (brown rice) Duration: 4 months
Outcomes	Primary outcome Mean change in uterine leiomyoma burden Secondary outcomes Health‐related QoL assessed with 2 different questionnaires. Scale 1: the fibroid‐specific symptom severity (SS) scale ranges from 5‐40, where high values are indicative of greater symptom severity. Scale 2: the HRQoL questionnaire, which measures perceived impact of leiomyoma on activities of daily living, general concern and worry, energy, mood, sense of self‐control, self‐consciousness and sexual functioning of the participants. The scale ranges from 29‐145 where higher scores indicate better QoL. Safety monitoring: monthly haemoglobin levels, liver‐ and kidney‐function tests and pregnancy testing
Green tea in exposure categories	N/A
Notes	Funding: Grant support: grant 1 ‐ R01 HD04 228‐01 from the National Institute of Child Health and Human Development, National Institutes of Health; RCMI grant 2 ‐ G12 RR003032
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The study pharmacist at Sohag Faculty of Medicine carried out the randomization process (by sequential digital assignment coding) and dispensed green tea extract or placebo capsules to participants, based on the assignment code randomly picked by each participant prior to treatment." Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote: "based on the assignment code randomly picked by each participant prior to treatment" Comment: probably done
Blinding of participants and personnel (performance bias) Uterine leiomyoma burden	Low risk	Quote: "The study staff and the participants were blinded to the treatment assignment throughout the whole study. The placebo capsules were identical to the EGCG capsules in appearance and weight" Comment: probably done
Blinding of outcome assessment (detection bias) Uterine leiomyoma burden	Low risk	Quote: "The study staff and the participants were blinded to the treatment assignment throughout the whole study. The placebo capsules were identical to the EGCG capsules in appearance and weight" Comment: probably done
Incomplete outcome data (attrition bias) Uterine leiomyoma burden	Unclear risk	Comment: number of participants included in analysis not stated
Selective reporting (reporting bias)	Low risk	The study protocol is available (ClinicalTrials.gov identifier (NCT number): NCT01311869) and the published reports include all expected outcomes
Other bias	Unclear risk	High rate of dropout in the placebo group (35%). In the protocol, treatment duration was reported to be 6 months. In the study, treatment duration was 4 months.