Steiner 1995.

Methods	3‐arm parallel trial: 20 mg fluoxetine, 60 mg fluoxetine or placebo
Participants	Country: Canada Site: Multi‐centre ‐ 7 university affiliated clinics Recruitment: 405 women screened. 313 randomised to three conditions, 277 completed cycle 1 of phase 2 and were eligible for analysis. 60mg: 106 randomised 20mg: 102 randomised, placebo: 96 105 randomised. Refer to Table of bias for details of attrition. Mean age 36+/‐5 years Inclusion: Women ages 18 to 45 years meeting diagnostic criteria for LLPDD with at least one year history of 5+ symptoms attributable to the disorder that began premenstrually and remitted post‐menstrually. Severe enough to affect activities of daily living as assessed in screening cycles. Menstrual cycles ranging from 24 to 35 days. Exclusion: Pregnant or lactating, taking oral contraceptive, had irregular menstrual cycles, had an unstable medical condition, a seizure disorder with a seizure within the last year, a record of multiple adverse drug reactions, known allergies to inhibitors of the reuptake of serotonin or a history of fluoxetine use. Other major psychiatric syndrome, expressed suicide ideation or intent, had used psychoactive medication or investigational drugs within two months prior to the study or were taking any other medication to treat premenstrual symptoms.
Interventions	Screening: Two screening cycles Placebo run in: single‐blind placebo Intervention: 20mg fluoxetine taken orally every day for 6 cycles in the morning 60mg fluoxetine taken orally every day for 6 cycles in the morning Placebo taken orally every day for 6 cycles in the morning Timing of administration: Treatment began on day 1 of the third menstrual cycle Summary measures: Efficacy data used for all women completing at least one cycle of treatment
Outcomes	Observer and subject assessed VAS Prospective Record of the Impact and Severity of Menstrual Symptomology Side effects
Notes	Withdrawals are number withdrawn after 6 cycles Analysable data for 1st cycle only Funded by Eli‐Lilly
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	313 women randomised; 277 completed cycle 1 of phase 2 and were included in ITT analysis (88%). Only 180/313 completed protocol (58%) 33 withdrawals in fluoxetine (20mg): side effects (11), lack of efficacy (4), loss to follow up (2), personal reasons (9), protocol violation (7); 47 withdrawals in Fluoxetine 60mg group: side effects (35), lack of efficacy (2), loss to follow up (2), personal reasons (4), protocol violation (4); Placebo withdrawals = 53: side effects (8), lack of efficacy (27), loss to follow up (5), personal reasons (6), protocol violations (7)
Selective reporting (reporting bias)	Unclear risk	Adverse effects data apparently collected retrospectively
Other bias	Unclear risk	Placebo responders excluded