Freeman 1999.

Methods	Randomised, double‐blind placebo‐controlled, 3‐arm parallel trial. (sertraline versus desipramine versus placebo). Only sertraline and placebo reported in this review
Participants	Country: USA Site: Premenstrual Syndrome Program, University of Pennsylvania, Philadelphia Recruitment: 278 eligible women. 125 randomised to sertraline (n=66) or placebo (n=59) Inclusion: 18‐45 years, regular menstrual cycles (22‐35 days), ovulating, experiencing distressing premenstrual symptoms for at least six months, reporting moderate to severe impairment in work, family life or social activity on subject global ratings, meeting PMS criteria on DSR ratings, good health, no major psychiatric (DSM‐IV) diagnosis within past year. Exclusion: use of psychotropic drugs that could not be discontinued during the study period, all other prescription and non‐prescriptions drugs for PMS, pregnancy, lactation, hysterectomy, symptomatic endometriosis, irregular menstrual cycles, not using medically approved contraception, serious health problems, any major axis 1 psychiatric diagnosis, including major depression, current or within the past year, risk of suicide and alcohol or drug abuse within the past year.
Interventions	Placebo run‐in: None Intervention: 50mg ‐150mg sertraline administered orally continuously (average 105mg) for 3 cycles versus placebo administered orally for 3 cycles (a third study arm received desipramine) Timing of administration: Drug commenced on day 1 of the menstrual cycle Summary measures: Data for LOCF for all patients with treatment data and also for all completers
Outcomes	Daily Symptom Report Hamilton Scale for Depression Clinical Global Impression Scale
Notes	Daily symptom rating Drug provided by Pfizer Inc NY, Funding from National Institute of Child Health and Human Development
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised via computer‐generated number tables
Allocation concealment (selection bias)	Low risk	Allocation by a technician with no clinical contact
Blinding (performance bias and detection bias) All outcomes	Low risk	Double blind, medication prepared in pharmacy in identical capsules
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	97/125 of women randomised completed treatment (78%), but all women randomised were included in efficacy analysis by last‐observation‐carried‐forward. 13/66 dropped out of the sertraline group and 15/59 from the placebo group. Reasons for withdrawal not reported by treatment group, but text states that reasons for discontinuation did not differ significantly between the sertraline and placebo groups
Selective reporting (reporting bias)	Unclear risk	Adverse events recorded retrospectively at follow‐up visits
Other bias	Low risk	No other potential bias identified