Methods | Single centre RCT. Study duration: 2001 to 2003. |
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Participants | Low-risk GTN. Number randomised: 46. Number evaluable:46. Randomisation ratio of 1.5 MTX:1 DACT applied due to economic limitations |
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Interventions | Group1: MTX, IM, 30mg/m2 repeated every week. Group2: ACT, IV, 1.25mg/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: 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 |
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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 |