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. 2015 Jul 23;2015(7):CD000371. doi: 10.1002/14651858.CD000371.pub6

Stephenson 1993

Methods RCT
Length of follow‐up: 3.6 months (subgroup) and 8.2 months (main trial)
Participants Infected children (all children in the school were known to be infected)
Number analysed for primary outcome: 284
Age range/ mean age: 7 to 13 years
Inclusion criteria: all school children (unscreened) in grades 1 to 5 in Mvindeni Primary School
Subgroup (53 analysed) of 60 boys chosen because haemoglobin > 80 g/L, willing to cooperate in physical tests and appetite tests, pre‐pubertal, infected with at least 1 of helminths (screened), hookworm < 20,000 eggs/g; hookworm or Trichuris count > 1000 eggs/g or Ascaris > 4000 eggs/g
Exclusion criteria: Severe anaemia (haemoglobin < 75 g/L)
Interventions Multiple doses vs placebo

  1. Albendazole (single dose) plus placebo: 600 mg (3 x 200 mg) SmithKline Beecham at outset, identical placebo at 3.6 months;

  2. Albendazole (multiple doses): single dose 600 mg repeated at 3.6 months;

  3. Placebo: identical placebo.
Outcomes

  1. Mean weight post‐treatment;

  2. Mean change in weight post‐treatment;

  3. Mean height post‐treatment;

  4. Mean change in height post‐treatment;

  5. Mean MUAC;

  6. Mean change in MUAC;

  7. Mean triceps skinfold thickness;

  8. Mean change in triceps skinfold thickness;

  9. Mean subscapular skinfold thickness;

  10. Mean change in subscapular skinfold thickness;

  11. Mean haemoglobin post‐treatment;

  12. Mean change in haemoglobin post treatment;

  13. Harvard step test.


Not included in review: prevalence, eggs/g: geometric and arithmetic mean; converted to percentage of median for age and sex using NCHS references; % weight‐for‐age, % height for age; % weight‐for‐height; % arm circumference for age; % triceps for age; % subscapular for age; appetite (self‐rating and snack consumed intake in kJ)
Notes Location: Kwale, Kenya
Community category: 1
Source of funding: supported in part by Thrasher Research Fund and SmithKline Beecham, Ltd. 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "at random within sex by descending hookworm egg count".
Allocation concealment (selection bias) Unclear risk No details reported
Blinding (performance bias and detection bias) All outcomes Low risk Participants blinded, tablets identical for treatment and placebo; "Both examinations were conducted by the same team, each doing the same procedures, and were done in a blind fashion".
Incomplete outcome data (attrition bias) All outcomes Low risk 86% (284/328) of randomized participants were evaluated, reasons for losses to follow‐up not reported. Inclusion of all randomized participants (number evaluable/number randomized): 86% (284/328).
Selective reporting (reporting bias) Low risk Pre‐specified outcomes reported
Other bias Low risk No obvious other source of bias