Miner 2002.

Methods	Randomised, double‐blind, placebo‐controlled, 3‐arm parallel‐group study (luteal phase weekly dose (LPWD) x one versus LPWD x2 versus placebo)
Participants	Country: Australia, Europe and Mexico Site: Multi‐centre in 30 centres. No details as to what or where these centres were Recruitment: Mean age LPWDX1 37.4±5.8 years, LPWDX2 36.1±5.2 years and placebo 37.4±5.4 years.Not stated where women were recruited from. Refer to table of bias for details of attrition Inclusion: Women aged 18‐45 years, regular menstrual cycles(23‐35 days) were eligible. Meeting PMDD criteria in two screening cycles. Luteal scores average >/3.0 for each of the 5 DRSP symptoms corresponding to the items in DSM‐IV criterion A, with 1>/ symptom corresponding to a DSM IV mood item; if follicular phase scores averaged <2.5 for each of these 5 DRSP symptoms; if mean scores for these 5 DRSP symptoms increased by >/50% from the follicular to the luteal phase; and if scores on the three functional DRSP items were >/4 on >/2 occasions during the luteal phase. Exclusion: Axis 1 psychiatric disorder within previous 6 months (with exception of phobias). Women using hormonal contraceptives or who had used them in previous 3 months. Placebo responders in the single blind placebo run‐in
Interventions	Screening: Two cycles screening Placebo run‐in: Single blind placebo run‐in Intervention: 3 cycles of treatment or placebo followed by another single blind placebo run out. LPWD X 1 versus LPWD x2 Fluoxetine 90mg PO (n=86) versus Group 3 PLC placebo administered two times during luteal phase at 14 and 7 days before expected menses (n=85) Timing of administration: administered at 14 and 7 days before expected menses Summary measures: Mean data presented
Outcomes	Self‐completed electronic diary using the Daily Record of Severity of problems Scale (DRSP) for recording daily PMDD symptoms.Mood, physical and social functioning subtotals. Two clinician rated and one patient rated scale. Rating Scale for PreMenstrual Tension (PMTS‐ C) CGI Severity score
Notes	Study was supported by a grant from Forest Laboratories, New York Symptoms rated daily
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation schedule
Allocation concealment (selection bias)	Unclear risk	Method not reported
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Double blind (patient and other not stated)
Incomplete outcome data (attrition bias) All outcomes	Low risk	257 women randomised, 247 analysed by ITT (96%). (Dropouts: LPWDx1: 3 dropouts of whom 2 were for adverse events; LPWDX2: 2 dropouts, both for adverse events; placebo arm: 5 dropouts, one for adverse events)
Selective reporting (reporting bias)	Unclear risk	Does not state how adverse events data were collected
Other bias	Unclear risk	Placebo responders excluded