Ozeren 1997.

Methods	Randomised, double‐blind, placebo‐controlled 2‐arm parallel trial
Participants	Country: Turkey Site: No details Recruitment: Self‐referred factory workers. 440 women screened. 35 met diagnostic criteria. 35 randomised and 30 completed. Mean age 30.6 ± 7.48 years for treatment group and 31.7 ± 7.42 years for placebo group Inclusion: Women aged 18‐45. Meeting criteria for PMS being a luteal phase score at least twice that of the follicular phase score, and the luteal phase score to be at least 42 and the follicular phase score to be less than 40. Diagnosis confirmed using DSM‐IV and DSM‐3‐R diagnostic criteria Exclusion: Those taking psychotropics, diuretics, antidepressants, anxiolytics, oral contraceptives, hormonal medications and those having major psychiatric disorders, pelvic pathology and irregular menstrual cycles
Interventions	Screening: Three screening cycles Placebo run‐in: None Intervention: 20mg fluoxetine (n=18) daily PO for 3 cycles versus placebo (n=17) PO for 3 cycles Timing of administration: Medication taken in the morning. No details as to when in the menstrual cycle medication was commenced Summary measures: Mean data presented
Outcomes	Calendar of Premenstrual Experiences
Notes	Daily symptom rating No details of ITT or power calculation No funding source stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method not reported
Allocation concealment (selection bias)	Unclear risk	Method not reported
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Double blind, no details as to whom was blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Five of 35 women (14%) excluded from efficacy analysis, two from the placebo group and three from the treatment group due to protocol violation or through intolerable adverse effects of fluoxetine
Selective reporting (reporting bias)	Unclear risk	Unclear whether data on adverse events collected prospectively. Adverse events data not clearly reported by comparison group
Other bias	Low risk	No potential for other bias identified