Jermain 1999.

Methods	Randomised, double‐blind, crossover trial
Participants	Country: USA Site: Research centre in large multi‐speciality clinic Recruitment: Women recruited via advertisements and from referral from affiliated psychiatric and gynaecological clinics.189 women screened, of these 57 had increases in COPE score to be randomised.57 randomised, 40 completed. Refer to Table of bias for details of attrition.Mean age Sertraline first arm 35±7 (25‐47) years, Placebo first arm 38±5 (23‐48) years Inclusion: women aged 19 to 49 years with regular menstrual cycles (23 to 35 days) meeting DSM ‐IV criteria for PMDD. Pre treatment luteal phase score (using COPE) >41 and double follicular phase score for two consecutive menstrual cycles. Follicular phase score < 40 and follicular to luteal phase increase to increase by 30% for at least five pre menstrual symptoms Exclusion: Current Axis 1 disorder, pregnant, significant medical or gynaecologic disorders, taking psychotropic drugs or hormonal medications including the oral contraceptive
Interventions	Screening: Two cycles Placebo run in: None Intervention: Two cycles treatment with 50mg sertraline luteal phase only increasing to 100mg for non‐improvers versus placebo followed by crossover for two cycles. No washout Timing of administration: Drug was commenced fourteen days before the expected onset of menses and discontinued when menses began Summary data: Data was summarised for luteal phase as a sum of the last seven days of the cycle and averaged over two cycles in the paper. No details of average drug received
Outcomes	Calendar of Premenstrual Experiences (COPE) patient rated daily assessment; Beck Depression Inventory (BDI) patient rated; Adverse events
Notes	Some data such as adverse events and BDI was not extractable from the first arm of the crossover Funded by Pfizer
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	States randomised. 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 further details
Incomplete outcome data (attrition bias) All outcomes	High risk	40 completed study out of 57 women randomised completed study (70%) Seventeen women withdrew or data not available. Five withdrew while taking placebo (two due to adverse events) and nine withdrew while taking sertraline (5 due to adverse events)
Selective reporting (reporting bias)	Unclear risk	Adverse events data collected by retrospectively by open‐ended enquiry at follow‐up visits
Other bias	Unclear risk	Crossover study with no washout period (though used in luteal phase only)