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. |
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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 |
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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 |
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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 |