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. 2016 Jun 9;2016(6):CD007102. doi: 10.1002/14651858.CD007102.pub4

Yarandi 2008.

Methods Single‐centre RCT (Iran).
Study duration: 09/2003 to 09/2006.
Follow‐up: 1 year.
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.
Interventions Group 1: MTX, IM, 30 mg/m² repeated every week.
Group 2: Act D, IV, 1.25 mg/m² repeated every 2 weeks.
Outcomes Efficacy: remission rate, number of cycles to remission, duration of treatment, need for second‐line chemotherapy.
Adverse effects: nausea.
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.
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.