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. 2020 Apr 14;2020(4):CD010599. doi: 10.1002/14651858.CD010599.pub2

Hadju 1997.

Methods Design: parallel group randomized trial
Duration of study: not reported
Duration of follow‐up: 90 days
Participants Country: Republic of Indonesia
Setting: school
Number included in study: 507
Age: ≤ 10 years
Sex: not reported
Inclusion criteria: primary school children attending to grades 1, 2, and 3
Exclusion criteria: children aged > 11 years old or with signs of puberty, with signs of severe protein energy malnutrition, with deformity or congenital abnormality
Lost at follow‐up: 177 (34.9%)
Number positive for A lumbricoides: 308
Number included in review: 198
Interventions Treatment strategy: screening and treat all participants
  • Group 1: placebo (n = 69)

  • Group 2: albendazole 400 mg single dose (n = 62)

  • Group 3: albendazole 400 mg twice (n = 67)

  • Group 4: pyrantel pamoate 10 mg/kg single dose (not included in review)

  • Group 5: pyrantel pamoate 10 mg/kg twice (not included in review)

Outcomes Outcomes included:Ascaris prevalence pre‐ and post‐treatment, cure rates, pre‐ and post‐treatment GM epg, ERR
Outcomes not included in review: anthropometric measures; efficacy of pyrantel pamoate for A lumbricoides
Notes Diagnostic technique: modified Kato‐Katz
Funding support: Directorate of Higher Education, Government of Indonesia; SmithKline Beecham Ltd. in the UK produced the placebo and albendazole.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "All eligible children were randomized to five treatments groups. Randomization was based on sex and eggs counts of Ascaris."
Allocation concealment (selection bias) Unclear risk Details not reported.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "The placebo table was similar to the albendazole tablet but pyrantel was different, Children and field workers were not informed of the actual name of both drugs. Each treatment was put in three different boxes label A, B, C. No one except the principal investigator was made aware of the labels."
Comment: no details if albendazole twice group received 2 days of placebo.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Details not reported.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 177 children lost at follow‐up and not included in analysis.
Selective reporting (reporting bias) High risk Adverse events not reported.
Other bias Low risk No other obvious source of bias.