Cohen 2002.

Methods	Randomised, double‐blind, placebo‐controlled, 3‐arm parallel study Study flow: 1276 women screened for study, 260 randomised: 86 to fluoxetine 10mg (77 completed), 86 to fluoxetine 20mg (66 completed); 88 to placebo (75 completed)
Participants	Country:USA Site: Multi‐centre (19 investigators at 20 sites) Mean age placebo group 35.6±4.9 years, fluoxetine 10mg group 37.2±5.1 years, fluoxetine 20mg group 35.1±5.3 years Inclusion: PMDD: 18 to 45 years, regular menstrual cycles (23 to 35 days). Two consecutive cycles in which scores averaged 3.0 or more each for five of the eleven DRSP items during the luteal phase, and their scores averaged 2.5 or less for each of the same items during the follicular week; and if they showed 50% or more increase from follicular to luteal scores for these items; and if at least twice during the defined luteal period, they had scores of 4 or more on any of the three functional items Exclusion: Having Axis 1 disorder other than PMDD, History of Axis 1 pathology occurring within the past six months (exception of specific phobias), women using hormonal contraception
Interventions	Screening: Two screening cycles Placebo run in: One cycle single blind placebo run‐in Interventions: 1. Fluoxetine 10mg administered orally daily during the luteal phase for three cycles (n=86) versus placebo administered orally daily during the luteal phase for three cycles (n=88) followed by one cycle single blind placebo run‐out 2. Fluoxetine 20mg administered orally daily during the luteal phase for three cycles (n=86) versus placebo administered orally daily during the luteal phase for three cycles (n=88) followed by one cycle single blind placebo run‐out Duration: Three cycles of treatment Timing of administration: Medication administered 14 days before the expected date of the next menses and until the first day of active bleeding Summary measures: For change scores no details as to whether this is an average over treatment or endpoint score. For absolute scores data presented for baseline and three cycles of treatment. Review authors calculated average over the three cycles presented
Outcomes	Hand‐held electronic diary used to record Daily Record of Severity of Problems (DRSP) ‐ self‐rated Rating Scale for Premenstrual Tension Clinician rated Adverse events Arizona Sexual Experience Scale
Notes	Daily recording of symptoms luteal score calculated using scores from the five most symptomatic days occurring from six days before menses to the first day of menses Funded by Eli‐Lilly
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"computer generated randomisation code that was stratified by investigative site"
Allocation concealment (selection bias)	Unclear risk	Method not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	States double blind, with placebo "identical in appearance"
Incomplete outcome data (attrition bias) All outcomes	Low risk	84% of women randomised (218/260) completed study; 97% (252/260) included in primary analysis Reasons for dropouts as follows: fluoxetine 10 mg: 9 of 86 dropped out (2 adverse events, 2 patient decision, 5 protocol requirement), fluoxetine 20 mg: 22 of 86 dropped out (4 adverse events, 2 lack of efficacy, 5 patient decision, 1 physician decision, 3 protocol requirement, 7 loss to follow‐up). Placebo: 13 of 88 dropped out (1 adverse event, 3 lack of efficacy, 3 patient decision, 1 physician decision, 2 protocol requirement, 3 lost to follow up)
Selective reporting (reporting bias)	Unclear risk	States "The incidence of treatment‐emergent adverse events during placebo or fluoxetine therapy was compared using Fisher exact test". Adverse events not a clearly pre stated outcome and does not state whether adverse event data collected prospectively
Other bias	Unclear risk	Exclusion of placebo responders