Bibile 1961.
Methods | Randomized controlled trial
Generation of allocation sequence: previously prepared list of random numbers
Allocation concealment: no
Blinding: not blinded
Inclusion of all randomized participants: unclear Duration: not mentioned |
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Participants | Number of participants enrolled: unclear Number of participants analysed: 80 Loss to follow up: unclear Inclusion criteria: 3 or more unformed stools per day with blood and mucus; tenesmus; no previous treatment; macroscopic and microscopic appearance of the stool comparable with bacillary not amoebic dysentery Exclusion criteria: amoebic dysentery | |
Interventions | (1) Sulphadimidine (2 g immediately, followed by 1 g every 6 hours orally for 5 days)
(2) Sulpha methoxy pyridazine (1 g on first day and 0.5 g daily orally for a further 4 days)
(3)Tetracycline (250 mg orally every 6 hours for 5 days)
(4) "Strepto triad" (3 tablets three times daily, orally for 5 days; each tablet of streptotriad contains streptomycin 65 mg, sulphamerazine 65 mg, sulphadiazine 100 mg, and sulphathiazole 100 mg). This group was not included in the analysis (sulphonamides versus tetracycline) as it contains a non‐sulphonamide drug ‐ streptomycin. Other interventions: Injection pethidine given to one participant for severe tenesmus |
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Outcomes | (1) Number clinically cured by day 5 (2) Number bacteriologically cured (3) Mean duration of fever in days (4) Mean duration of abnormal stool in days | |
Notes | Location: Sri Lanka Setting: not reported Follow‐up period: 8 days Antibiotic sensitivity pattern of Shigella isolates: not reported Funding source(s): Supplies of drugs from:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | "...listed in a random order" |
Allocation concealment? | High risk | "...previously prepared list of random numbers". Probably not done. |
Blinding? All outcomes | High risk | Not mentioned; probably not done |
Incomplete outcome data addressed? All outcomes | Low risk | No missing outcome data |
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 |