Table 1 Trial details
From: Rofecoxib for dysmenorrhoea: meta-analysis using individual patient data
Trial ID | Study drug and dose, number of women | Design | Observations after 8 hrs | Quality score | Validity score |
|---|---|---|---|---|---|
38 | 49 women Rofecoxib 25 mg Rofecoxib 50 mg Ibuprofen 400 mg Placebo | Single oral dose, parallel 3 menstrual cycles | 12, 24 | 5/5 | ≥13/16 |
55 | 60 women Rofecoxib 50 mg then 25 mg as required Naproxen sodium 550 mg every 12 hrs Placebo | Oral. Multiple dose study with single dose efficacy data, multiple dose adverse events Cross-over, 1 of 6 drug sequences 3 menstrual cycles | 12 hour obervations after a single dose in a three-day study | 5/5 | ≥13/16 |
56 | 122 women Rofecoxib 50 mg as required Rofecoxib 50 mg then 25 mg as required Naproxen sodium 550 mg every 12 hrs Placebo | Oral. Multiple dose study with single dose efficacy data, multiple dose adverse events Cross-over, 1 of 4 drug sequences 4 menstrual cycles | 12 hour obervations after a single dose in a three-day study | 5/5 | ≥13/16 |