Halbreich 1997.
| Methods | Crossover trial 2X2 cycles | |
| Participants | Country: USA Site: Not stated Recruitment: Women recruited by advertisement in local newspapers and posted notices. Over 60 screened by structured telephone interview, 32 women interviewed, Twenty seven eligible for study; fifteen entered single blind phase. 11 were randomised, 8 completed. Refer to Table of bias for details of attrition. Inclusion: Age 24 to 45 years, regular menstrual cycles (25 to 34 days), not meeting criteria for DSM‐IV major diagnoses for at least 6 months, meeting DSM‐IV criteria for PMDD and criteria for dysphoric PMS. Physically healthy and not taking any medications. Confirmed PMDD symptoms during late luteal phase and no symptoms during mid follicular phase. |
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| Interventions | Screening: Two screening cycles Placebo run in : Single blind drug run‐in Intervention: 100mg sertraline orally for 2 cycles versus placebo orally for 2 cycles luteal phase only Timing of administration: Intervention administered fourteen days before expected onset of menses or for full cycle, unclear as to which day commenced Summary measures: Data from both arms pooled |
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| Outcomes | Clinical Global Impression ‐ Improvement Scale (CGI‐I) Hamilton Rating Scale for Depression (HAM‐D)modified Daily Rating Form (DRF) | |
| Notes | Not included in analysis due to cross‐over design. No pre‐crossover data reported Only responders to drug randomised Symptoms rated daily Funded by Pfizer |
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| 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 | Double blind, no details |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 11 were randomised, 8 completed (72%) 2 withdrawals due to side effects and one due to pregnancy: all dropped out during placebo phase |
| Selective reporting (reporting bias) | Unclear risk | Adverse events data not collected prospectively |
| Other bias | Unclear risk | Only responders to drug randomised. Review includes only first phase data from crossover trial |