Skip to main content
. 2013 Jun 7;2013(6):CD001396. doi: 10.1002/14651858.CD001396.pub3

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
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
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
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