Arrendondo 1997.
| Methods | Randomised, double‐blind, placebo‐controlled, parallel two‐arm trial | |
| Participants | Country: USA Site: No details Recruitment: 72 women no other details Refer to table of bias for details of attrition Inclusion: Meeting defined criteria for PMS using Penn Daily Symptom Report (DSR) for two cycles. Regular menstrual cycles (22‐35 days), general good health Exclusion: No current major psychiatric diagnoses as assessed by Structured Clinical Interview (SCID) No explicit exclusion criteria noted |
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| Interventions | Screening: Screening for two cycles Placebo run‐in: None Interventions: Placebo (n=35) versus sertraline 50mg administered orally (n=37) Duration: Treatment administered for three cycles Timing of administration: No details of when in the cycle this was first administered Summary measures: Data presented as individual treatment cycles. Review has used mean data across all three cycles |
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| Outcomes | Penn Daily Self Rating Symptoms (DSR). Depression and food craving scores. Depression score reported in current review | |
| Notes | Only available as abstract Daily recording of symptoms Measured depression and food cravings No details of ITT or power calculation No details of funding source |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | States randomised. Method not reported |
| Allocation concealment (selection bias) | Unclear risk | Method not reported |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | States double blind. No further details |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 72 women randomised, number analysed not reported |
| Selective reporting (reporting bias) | Unclear risk | Adverse effects not reported |
| Other bias | Unclear risk | Few details available as not published in full text |