Alam 1994.
Methods | Randomized controlled trial
Generation of allocation sequence: block randomization technique
Allocation concealment: drugs were stored in bottles, identical in appearance
Blinding: participants and provider blinded
Inclusion of all randomized participants: inadequate, 89% Duration: not mentioned |
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Participants | Number of participants enrolled: 80 Number of participants analysed: 71 Loss to follow up: none Inclusion criteria: children of both sexes between 1 and 8 years of age; having bloody diarrhoea lasting less than 72 hours Exclusion criteria: taken drugs for shigellosis; with systemic illnesses; severe malnutrition; | |
Interventions | (1) Pivmecillinam (50 mg/kg/day, by mouth, in 4 divided doses, for 5 days) (2) Nalidixic acid (60 mg/kg/day, by mouth, in 4 divided doses, for 5 days) | |
Outcomes | (1) Treatment failure (diarrhoea at follow up) by day 5
(2) Bacteriological failure on day 5
(3) Temperature > 37.8 ºC (fever on day 5) Not included in this review: (4) Abdominal pain or tenderness on day 5 |
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Notes | Location: Bangladesh Setting: all patients hospitalized in the study ward for the study period Follow‐up period: 6 days Antibiotic sensitivity pattern of Shigella isolates: 71/71, 100%, were sensitive to pivmecillinam; 26/37, 45%, in the nalidixic group sensitive to nalidixic acid. Nalidixic acid sensitivity is not reported in the pivmecillinam group. Funding source(s):
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | "Block randomisation technique". Probably done. |
Allocation concealment? | Low risk | "...patients were randomly allocated to treatment groups". There is no clear mention that allocation was concealed. Probably done as drugs were stored in serially numbered bottles (see below). |
Blinding? All outcomes | Low risk | "Drugs were stored in bottles, identical in appearance, flavour and weight; labels on the bottles contained only the name of the study and the serial number of the patient who used the bottle." Participant and assessor blinding. |
Incomplete outcome data addressed? All outcomes | High risk | 80 entered the study; 71 had Shigella in culture; no data regarding participants with non‐Shigella dysentery (9) who were randomized according to the inclusion criteria. Outcomes reported only for all 71 (89%) with culture confirmed Shigella dysentery. |
Free of selective reporting? | Low risk | The study's prespecified outcomes which were of interest in this review, have been reported |
Free of other bias? | Low risk | The study appears to be free of other sources of bias |