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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Jul 11;7:CD007102. doi: 10.1002/14651858.CD007102.pub3
Methods Single centre RCT.
Study duration: 2001 to 2003.
Participants Low-risk GTN.
Number randomised: 46.
Number evaluable:46.
Randomisation ratio of 1.5 MTX:1 DACT applied due to economic limitations
Interventions Group1: MTX, IM, 30mg/m2 repeated every week.
Group2: ACT, IV, 1.25mg/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: WHO/FIGO 2000.
Non-response defined as < 10% decrease in hCG over 3 weeks, more than 20% rise in hCG over 2 consecutive weeks or the appearance of new metastatic disease
Remission defined as hCG < 5 IU/L. One additional cycle was given after remission
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation not reported.
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 100% of participants analysed.
Selective reporting (reporting bias) Low risk All pre-specified outcomes reported. Toxicity not reported in detail but said to be ‘minimal’ in both groups
Other bias Unclear risk This trial has the same authors, location and protocol as Yarandi 2008, with consecutive enrolment dates, yet the later Yarandi 2008 study does not refer to Gilani 2005. It is not clear why. Attempts to clarify this with Dr Yarandi have been unsuccessful