Steiner 2008.
| Methods | Randomised, double‐blind, placebo‐controlled study. 103 randomised, 99 analysed | |
| Participants | Country: Canada Site: 4 health centres Recruitment: via outpatient clinic Inclusion: aged 18‐45 presenting with PMDD meeting DSM IV criteria, with regular menstrual periods, reliable non hormonal contraception, at least one of four core symptoms prominent (irritability, depressed mood, tension or affective lability), baseline Clinical Global Impressions Severity of Illness Scale score over 3. Exclusion criteria: taking oral contraception, breastfeeding, pregnant or planning pregnancy, any Axis I disorder, suicidal risk, SSRI use for premenstrual symptoms, on medication that could affect PMDD symptoms, clinically significant abnormality on screening blood tests, baseline score of over 10 on Montgomery Asberg Depression Rating Scale. |
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| Interventions | Screening: 2 cycles Placebo run in: none Intervention: Paroxetine 10 mg or 20 mg versus placebo Timing of administration: luteal Summary measures: change from baseline |
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| Outcomes | Total symptoms (clinician‐rated PMTS‐O), VAS irritability scale, premenstrual tension scale, response rate using CGI‐S score (1 or 2), response rate (at least 50% reduction in each of VAS mood items), Sheehan disability Scale (SDs not reported) | |
| Notes | Funded by Glaxo. Primary author emailed to request data for total symptoms, but no reply received | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated |
| Allocation concealment (selection bias) | Unclear risk | Method not described |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Described as double‐blinded ‐ no further details |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Last‐observation‐carried‐forward analysis used for 99/103 women (96%) |
| Selective reporting (reporting bias) | High risk | Does not state how adverse effects data collected. Data were collected on total symptoms and response rate but reported in published article as p values only, and findings for these total symptoms are marked as "not available" on the sponsor's web site. Findings for severe adverse events (not a review outcome) differ on published and unpublished reports |
| Other bias | Unclear risk | 30% (30/99) of participants had protocol violations. Groups well balanced for demographic characteristics |