Methods	Single centre RCT. Study duration: 1994 to 2005. Follow-up: 1 year.
Participants	Low-risk GTN (FIGO stage 1). Number randomised: 49. Number evaluable: 45.
Interventions	Group 1: DACT IV 10 μg/kg/day (D1 to D5) repeated every two weeks Group 2: methotrexate-folinic acid (MTX-FA): MTX IM 1mg/kg/day (days 1, 3, 5, 7) and FA IM 0.1mg/kg/day (days 2, 4, 6, 8), repeated every two weeks
Outcomes	Efficacy: remission rate, number of cycles to remission, need for second-line chemotherapy Adverse effects: liver toxicity, neutropenia, skin pigmentation, alopecia and mucositis
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 DACT 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
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 DACT 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 DACT 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.