Na‐Bangchang 2004.
Methods | Randomized controlled trial Generation of allocation sequence: method not mentioned Allocation concealment: not mentioned Blinding: not mentioned Inclusion of all randomized participants: ITT or per protocol profile not included, but all 25 participants completed treatment Duration: 2000 to 2002 |
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Participants | Number randomized: 25 Inclusion criteria: age 18 to 69 years; bodyweight 43 to 63 kg; parasitologically confirmed second‐stage T. b. gambiense infection Exclusion criteria: pregnancy; lactating women; Glasgow coma scale < 8; chronic medical condition or critically ill Diagnosis and follow‐up methods: Miniature anion exchange centrifugation technique and double centrifuge for detection of trypanosomes, cerebrospinal fluid (CSF) WBC |
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Interventions | 1. Eflornithine, oral, 400 mg/kg/day (100 mg/kg every 6 h) for 14 days 2. Eflornithine, oral, 500 mg/kg/day (125 mg/kg every 6 h) for 14 days All participants pretreated with chloroquine and albendazole |
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Outcomes | 1. Cure rates
2. Death
3. Adverse events Pharmacokinetics analysis |
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Notes | Location: Daloa, Cote d'Ivoire Setting: research centre Source of funding: UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Patients were randomly allocated but method not specified |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not mentioned in report |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data from all 25 patients were analysed |