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

Beach 1999.

Methods Design: parallel group randomized trial
Duration of study: started January 1996
Duration of follow‐up: 35 days
Participants Country: Haiti
Setting: school
Number included in study: 965
Age: 5–11 years
Sex: 407 girls, 446 boys
Inclusion criteria: aged 5–11 years; anthropometric measurements before and 4 months after treatment; stool specimens before and 5 weeks after treatment; random assignment to a treatment group; and height, weight, and age within limits of the anthropometric database
Exclusion criteria: haematocrit levels < 22%
Lost at follow‐up: 112 (11.6%)
Number positive for A lumbricoides: 249
Number included in review: 249
Interventions Treatment strategy: screening and treat all included participants

  • Group 1: albendazole 400 mg single dose (n = 62)

  • Group 2: ivermectin 200–400 μg/kg (mean 282.7 μg/kg) (n = 52)

  • Group 3: albendazole 400 mg single dose + ivermectin 200–400 μg/kg (n = 73)

  • Group 4: placebo (vitamin C 250 mg) (n = 62)
Outcomes Outcomes included:Ascaris prevalence pre‐ and post‐treatment, prevalence reduction, pre‐ and post‐treatment AM and GM epg, ERR
Outcomes not included in review: efficacy of anthelmintic treatment for Trichuris, hookworm,and W bancrofti microfilariae; nutritional and anthropometric measures; data after 4 months of treatment
Notes Diagnostic technique: modified Stoll method
Funding support: United States Agency for International Development; Merck Inc. donated the ivermectin and SmithKline Beecham donated the albendazole.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "All eligible students were assigned, using a random number table, to four treatment groups."
Allocation concealment (selection bias) Unclear risk Details not reported.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Details not reported for parasitological cure outcome.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Laboratory personnel, measurement teams, and personnel evaluating students for adverse reactions were blinded to the treatment status of the children."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 112 (11.6%) participants 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.