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. 2013 Jun 7;2013(6):CD001396. doi: 10.1002/14651858.CD001396.pub3

Young 1998.

Methods Randomised double‐blind crossover trial
Participants Country: USA
Site: Walter Reed Army Medical Centre
Recruitment: 50 women screened, 31 selected. Following two screening cycles 17 women randomised, 11 completed. Three women failed to complete study due to medication side effects (2x sertraline and 1x placebo phase). One subject moved out of area and two discontinued for undetermined reasons. Women recruited from medical centre who had responded to advertisements in local military newspapers and gynaecology clinics.
Inclusion: Age between 18 and 45 years. Meeting DSM‐IV criteria. After screening cycles to have overall COPE score 30% greater during late luteal phase compared with follicular phase.
Exclusion: Any history of mental health treatment in previous 18 months, taking psychotropic medication. Diagnosis of active disease or pregnancy.
Interventions Screening: Two cycles screening with no medication
Placebo run in: None
Intervention: 50mg sertraline day 15 to menses for 2 cycles versus placebo with one cycle washout
Timing of administration: Commencing day 15 to the first day of menses
Summary measures: Data from both arms combined
Outcomes Calendar of Premenstrual Experiences (COPE) patient completed. Total scores and physical and behavioural subscores
Notes Unable to extract data as not distinguishable by arm of study. Authors not contacted
Independently funded
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method not reported
Allocation concealment (selection bias) Unclear risk Method not reported
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double blind (physicians assessing women were blinded to treatment)
Incomplete outcome data (attrition bias) 
 All outcomes High risk 11/17 included in efficacy analysis (65%)
Selective reporting (reporting bias) Unclear risk Adverse events not reported
Other bias Low risk No other potential source of bias identified