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

Menkes 1992.

Methods Randomised, double‐blind, placebo‐controlled, crossover trial 2x3 cycles
Participants Country: New Zealand
Site: No details
Recruitment: Community sample of volunteers ‐ 23 women screened. After two cycles of screening 21 women had PMS confirmed by psychiatric interview and agreed to be randomised. 21 randomised, 16 completed. Mean age 37.8±4.7 years. 23 women met provisional criteria, Daily Symptom Scores and ratings of PAF
Inclusion: Age 18 to 48 years. Confirmation of PMS by psychiatric evaluation
Exclusion: Taking regular psychotropics, diuretics, or using hormonal contraception. Any appreciable menstrual irregularity, psychiatric or substance use disorder
Interventions Screening: Three cycles of screening
Placebo run‐in: None
Intervention: Crossover trial of 20mg fluoxetine PO every day for 3 cycles versus placebo PO every day for 3 cycles with 12 day washout period between arms
Timing of administration: Medication commenced on twelfth day of menstrual cycle and continued through three cycles stopping at the onset of menses
Summary measures: Mean data over three months of treatment presented in paper
Outcomes Premenstrual Assessment Form
Side effects
Notes No data extracted as unable to distinguish first and second arm of study
Same patient group as excluded study, Menkes 1992
Daily symptom rating
Fluoxetine provided by Eli‐Lilly
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 (patient and rater)
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Five women excluded from analysis (23%), two for protocol violation and three due to adverse effects ‐ no details as to which arm of the crossover this occurred in
Selective reporting (reporting bias) Unclear risk Tolerability assessed at end of each treatment phase, not prospectively. Adverse events not reported by treatment arm
Other bias Unclear risk Crossover trial with 12‐day washout period