Del Giorno 2010.

Methods	Design: parallel‐group Number randomly assigned: 120 Number dropped out: eight because they did not take more than 80% of drug and 12 for personal reasons (not given per group) Number analysed: 100 Intention‐to‐treat analysis: no Power calculation: yes, 80% power, beta 10%, 38 participants per group Duration: follow‐up at four, eight and 12 months Timing: December 2005 to December 2008 Location: University of Sao Paolo, Brazil Funding: not stated
Participants	Inclusion criteria: 45 to 65 years of age with menopausal symptoms; > 12 months amenorrhoea; FSH > 30 mIU/mL; oestradiol < 30 pg/mL Exclusion criteria: diabetes mellitus; CVD; hypersensitivity to drugs used in the study; oestrogen‐dependent cancer; liver failure; nephropathy; systemic lupus erythematosus; porphyia; altered cervicovaginal cytology; osteoporosis; endometrial thickness > 6 mm; uterine volume > 200 cm3; BI‐RADS category 3, 4 or 5 mammograms; hormone treatment with sex steroids or phytoestrogens in past six months Mean age, years: 56 in phytoestrogen group; 55 in placebo group Recruitment: from outpatient clinic
Interventions	Trifolium pratense (red clover) 40 mg Placebo
Outcomes	Vasomotor symptom score (Kupperman): sexual satisfaction (as measured by GRISS questionnaire)
Notes	Vasomotor symptoms not further defined
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Computer program"
Allocation concealment (selection bias)	Low risk	"Sample blinding codes" not disclosed during study
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Stated as "double‐blind"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Stated as "double‐blind"
Incomplete outcome data (attrition bias) All outcomes	High risk	High dropout; appears that women were allocated to groups after dropouts were excluded
Selective reporting (reporting bias)	High risk	Insufficient information on outcomes assessed