Yarandi 2008.
Methods | Single‐centre RCT (Iran). Study duration: 09/2003 to 09/2006. Follow‐up: 1 year. |
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Participants | Low‐risk GTN. Number eligible:131. Number evaluable:131. Participants randomised into two groups: group 1 = 81 and group 2 = 50 (randomisation ratio of 1.5 MTX:1 Act D applied). Reasons given for this were economic limitations. Excluded patients with choriocarcinoma. |
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Interventions | Group 1: MTX, IM, 30 mg/m² repeated every week. Group 2: Act D, IV, 1.25 mg/m² repeated every 2 weeks. |
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Outcomes | Efficacy: remission rate, number of cycles to remission, duration of treatment, need for second‐line chemotherapy. Adverse effects: nausea. |
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Notes | Risk scoring: FIGO 2000. Six women ( 4 in group 1 and 2 in group 2) did not complete their first‐line chemotherapy, but were considered in the ITT analysis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not described. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 100% of randomised participants were analysed. |
Selective reporting (reporting bias) | Low risk | All pre‐specified and expected outcomes were reported. Analysis was by ITT. |
Other bias | Unclear risk | See 'Risk of bias' comment for Gilani 2005. |