Marti 1996.
Methods | RCT. Lenght of follow‐up: 3 weeks. |
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Participants | Number randomized: 417 participants. Inclusion criteria: schoolchildren aged 9 to 22 years old. Inclusion criteria: any individual with demonstrated first or third‐stage larvae of S. stercoralis on stool sample was included in the trial. Exclusion criteria: consent not given; fever or other signs of acute illness; severe neurologic disorders; severe liver disorders; and pregnancy. Baseline signs and symptoms such as cough, abdominal distention, diffuse itching, urticaria, and larva migrans were recorded. |
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Interventions | Ivermectin 200 /kg single dose (N = 208) versus albendazole 400 mg/day for 3 days (N = 209). | |
Outcomes | Drug efficacy: negative stool samples (3 and 21 days). Symptoms of strongyloidiasis and adverse effects of the two drugs according to the literature were detailed beforehand. The list was translated from English into Kiswahili and back to English to ensure correct interpretation of the findings. The interviews were carried out in Kiswahili by a medical assistant of the Ministry of Health. Special symptoms were recorded on a separate sheet, where the findings of a thorough clinical examination were also recorded. | |
Notes | Kato‐Katz smear and Baermann. Place: Zanzibar. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A randomized list for the sequential allocation of the drugs was prepared in advance. |
Allocation concealment (selection bias) | High risk | We do not know how allocation was concealed. Probably not done. |
Blinding of participants and personnel (performance bias) Cure overall | Low risk | No blinding of participants and personnel but we don't believe this will introduce bias. |
Blinding of participants and personnel (performance bias) Adverse events overall | High risk | No blinding, and the outcome is likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Cure overall | Low risk | No blinding, but we judge that the outcome measurement is unlikely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Adverse events overall | High risk | No blinding, and the outcome measurement is likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 116/ 417 (28%) lost during follow‐up period (56/208 (27%):45 incomplete questionnaire or treatment and 11 incomplete follow‐up in the ivermectin arm and 60/209 (29%): 39 incomplete questionnaire or treatment and 21 incomplete follow‐up in the albendazole arm). Per‐protocol analysis. |
Selective reporting (reporting bias) | Low risk | No protocol provided, but given the outcomes nominated in the methods section, all pre‐specified outcomes were reported. |
Other bias | Low risk | No additional biases were identified. |