Brooks 2004.
Methods | Randomised, double‐blinded, placebo controlled trial conducted in a rural hospital in Matlab, Bangladesh for 2 years (August 1999 to August 2001) on the effect of zinc supplementation in addition to standard therapy in children suffering from severe pneumonia on time taken to recover and discharge from hospital | |
Participants | Infants (2 to 23 months of age) hospitalised for severe pneumonia i.e. presence of cough, RR > 50/min, crepitations on chest auscultation and either chest indrawing or lethargy or inability to feed or cyanosis. Children with concurrent diarrhoea, were receiving zinc supplements, or who had severe malnutrition were excluded. The participants had low baseline serum zinc levels. 270 children participated in the trial. The participant population lived in economically poor conditions and possibly suffered from malnutrition | |
Interventions | Zinc acetate syrup (10 mg zinc per 5 ml of syrup), 20 mg of elemental zinc was given daily by mouth in 2 divided doses to the participants until discharge. The control group received placebo | |
Outcomes | The outcomes reported were mean duration of chest indrawing, RR > 50/min, hypoxia (oxygen saturation < 95% on air), to cessation of severe pneumonia and discharge from hospital | |
Notes | Children were treated with intravenous ampicillin + gentamicin | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "We pre allocated group assignments by fixed randomisation using permuted
blocks of variable length" Comment: probably done |
Allocation concealment (selection bias) | Unclear risk | Quote: "A health worker not involved with the patients care gave all doses" Comment: no clear method of allocation concealment stated |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "zinc and placebo syrups were identical in appearance, colour, odour, and taste." "A health worker not involved with the patients care gave all doses" Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition and exclusion was 2.59%. Reasons for attrition were stated |
Selective reporting (reporting bias) | Low risk | All outcomes have been measured and reported as predefined in the methodology of the study |
Other bias | Low risk | The study appears to be free of other sources of bias |