Potasman 2002.
Methods | Design: RCT Study dates: unclear Malaria transmission pattern and local antimalarial drug resistance: not applicable Adverse event monitoring: "Two days after drug ingestion, a second EEG was performed, and a blood sample for mefloquine level was obtained...Travelers were given forms on which to record adverse effects that appeared within 48 hours after drug intake" |
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Participants | Number enrolled: 90 Inclusion criteria: not explicitly mentioned, included travellers from the Bnia Zion medical centre, Haifa, Israel Exclusion criteria: "Travelers younger than 18 years; with a history of epilepsy or depression, known allergy to mefloquine, cardiac conduction block; using beta‐blockers; or who were pregnant...Travelers with an abnormal baseline EEG (unifocal or repetitive bursts)" Country of recruitment: Israel Country of malaria exposure: not applicable Duration of follow up: 48 hours Type of participants: non‐travellers |
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Interventions | 1. Mefloquine (1 x Mephaquine 250 mg tablet, Mepha, Aesch, Switzerland) one dose 2. Mefloquine (1 x Larium 250 mg tablet, Roche, Basel, Switzerland) one dose 3. Placebo |
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Outcomes | 1. Adverse events; any 2. Adverse events; other (neuropsychiatric, abnormal EEG 48 hours after ingestion) |
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Notes | Funding sources: "Partially funded by Mepha Ltd, Aesch, Switzerland" | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Eligible travelers were randomly assigned to one of three groups" "Randomization and statistical tests were carried out using Statmate and InStat" |
Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned |
Blinding of participants and personnel (performance bias) Adverse effects/events | Unclear risk | "Participants were unaware of their group assignment until they completed their tests" Comment: methods used to blind participants not reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "EEG pairs (pre‐ and post‐mefloquine) were examined separately by two senior neurologists who were unaware of group allocation" |
Incomplete outcome data (attrition bias); efficacy | Unclear risk | N/A |
Incomplete outcome data (attrition bias); safety | Unclear risk | Comment: data were provided for all participants who were not excluded on the basis of abnormal baseline EEG |
Selective reporting (reporting bias); efficacy | Unclear risk | N/A |
Selective reporting (reporting bias); safety | Unclear risk | "Adverse effects, mainly gastrointestinal and neuropsychiatric were noted in 26 travellers" Comment: specific nature of each adverse effect is not noted per group |
Other bias | High risk | Partially funded by Mepha Ltd, Aesch, Switzerland. Comment: the role of the study sponsor was not clear |