Wood 1992.
Methods | Randomised, placebo‐controlled, crossover trial 2X3 cycles | |
Participants | Country: USA Site: Women recruited from a PMS clinic Recruitment: Women were between the age of 33‐42 years. 8 women randomised, 8 completed Inclusion: Regular menstrual cycles (26‐32 days), ovulating, onset of premenstrual symptoms during the second half of the menstrual cycle with resolution within the first four days after the onset of menstruation Exclusion: Past or present psychiatric disorder, family history of depression in a first degree relative, significant medical or gynaecological disorders |
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Interventions | Screening: Screening for two to three cycles Placebo run‐in: No Intervention: 20mg fluoxetine every day for 3 cycles then crossover to placebo taken daily for 3 cycles Timing of administration: No details as to when in the cycle medication commenced Summary measures: Data pooled, unable to separate first‐arm data |
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Outcomes | Calendar premenstrual Experiences, Profile of Mood States, Beck Depression Inventory, STATE‐TRAIT Anxiety Inventory | |
Notes | Daily symptom rating Funding by National Institute of child health and human development |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, crossover design. "The order in which the subjects received the study drugs was determined according to a preselected randomized list based on the sequential assignment of subject numbers" |
Allocation concealment (selection bias) | Unclear risk | Method not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double blind, no details |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 8/8 women randomised were analysed |
Selective reporting (reporting bias) | Unclear risk | Data on adverse events extracted from symptom questionnaire, not solicited separately |
Other bias | Unclear risk | Crossover study, no washout period mentioned |