Stone 1991.

Methods	Randomised, double‐blind, placebo‐controlled 2‐arm parallel trial
Participants	Country: USA Site: Based in PMS clinic Recruitment: Women enrolled via self‐referral from newspaper advertisements. 152 completed two cycles of daily symptom rating (42 did not meet criteria of LLPDD). 110 women underwent further psychiatric evaluation. 71 of these were eligible to participate and 25 of these elected to participate and were randomised. The 46 who declined were unwilling to take medication or to be involved in a placebo controlled study. 25 entered first cycle, 5 were eliminated from the study and the remaining 20 were randomised. Mean age 36 years (27 to 45). Mean age fluoxetine 36.6 years, mean age placebo group 35.4 years. Inclusion: Met criteria of DSM‐III‐R diagnosis of LLPDD, physically healthy, and normal gynaecological examination. 30% increase in symptoms during the luteal phase of two cycles in at least five of the ten symptom categories listed in DSM‐III‐R. Average score of premenstrual week had to show 30% increase in severity over average score of postmenstrual week. At least one of the five positive symptoms had to be 'affective'. Exclusion: No current major psychiatric disorder, pregnant, be receiving anti‐depressants, anxiolytics, diuretics, hormones, neuroleptics or have irregular menstrual cycles.
Interventions	Screening: Two screening cycles Placebo run in: Single blind placebo for first cycle Intervention: 20mg fluoxetine (n=10) every day for 2 cycles versus placebo (n=10) taken daily for two cycles Timing of administration: Medication taken in the morning. No details as to what stage of the menstrual cycle medication commenced Summary measures: Mean final scores
Outcomes	Daily Assessment Form (DAF); Global Assessment Scale (GAS); Adverse events
Notes	Daily symptom rating Funded by Eli‐Lilly
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method not stated
Allocation concealment (selection bias)	Unclear risk	Method not stated
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	Low risk	20 women randomised, all analysed
Selective reporting (reporting bias)	Unclear risk	Adverse effects data collected retrospectively at clinic visits
Other bias	Unclear risk	Placebo responders excluded