Lertkhachonsuk 2009.
Methods | Single‐centre RCT (Thailand). Study duration: 1994 to 2005. Follow‐up: 1 year. |
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Participants | Low‐risk GTN (FIGO stage 1). Number randomised: 49. Number evaluable: 45. |
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Interventions | Group 1: Act D IV 10 µg/kg/day (D1 to D5) repeated every two weeks. Group 2: MTX‐FA: MTX IM 1 mg/kg/day (days 1, 3, 5, 7) and MTX‐FA IM 0.1 mg/kg/day (days 2, 4, 6, 8), repeated every two weeks. |
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Outcomes | Efficacy: remission rate, number of cycles to remission, need for second‐line chemotherapy. Adverse effects: liver toxicity, neutropenia, skin pigmentation, alopecia and mucositis. |
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Notes | Risk scoring: FIGO. Two participants in each arm of treatment were lost to follow‐up and were excluded from the analysis in the reporting article. Six participants in the MTX‐FA group were switched to Act D due to rising levels of liver enzymes. The investigators excluded these participants from analyses of remission rates (i.e. not ITT analyses), however we have added these data back. ITT analysis gives a remission rate of 14/25 in the MTX group, not 14/19 as reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used table of random numbers. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Four lost to follow‐up, two in each group. Therefore 92% analysed : 20/22 (91%) of 5‐day Act D arm and 25/27 (92.6%) of the MTX‐FA arm. |
Selective reporting (reporting bias) | Unclear risk | Not ITT analysis. Six women in MTX‐FA who were switched to Act D due to hepatotoxicity were excluded from final analysis; therefore remission rate was reported as 14/19 instead of 14/25. |
Other bias | Low risk | No evidence of other bias. |