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 |
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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 |
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Outcomes | Premenstrual Assessment Form Side effects |
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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 |
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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 (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 |