Rodriguez 1989.
Methods | Randomized controlled trial
Generation of allocation sequence: unclear
Allocation concealment: no
Blinding: nil
Inclusion of all randomized participants: adequate, 100% Duration: 1 year and 7 months, from January 1987 to July 1988 |
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Participants | Number of participants enrolled: 125
Number of participants analysed: 123
Loss to follow up: nil
Inclusion criteria: children, aged 2 months to 59 months; passage of 3 or more watery stools in the previous 24 hours; history of diarrhoea up to 5 days before admission; and polymorphonuclear leucocytes and blood in stool samples Exclusion criteria: received in the previous 48 hours any antimicrobials, antidiarrhoeals or any other drug capable of modifying the course of the disease; who had amoeba in stools; any severe concomitant disease; any intolerance to the drug; any known allergy to the study drugs |
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Interventions | (1) Furazolidone (7.5 mg/kg/day, in 4 equally divided doses) (2) Cotrimoxazole (Trimethoprim (8 mg/kg/day) + sulphamethoxazole (40 mg/kg/day)) in 2 equally divided doses (3) Control group (no antimicrobials) | |
Outcomes | (1) Cure/treatment success (in initial culture positive cases it is defined as both clinical cure, absence of diarrhoea and alleviation of all signs and symptoms by day 3 plus a bacteriological cure, a negative stool culture; in initial culture negative patients only clinical cure on day 3) (2) Adverse events | |
Notes | Location: Mexico Setting: out‐patient study Follow‐up period: 6 days Antibiotic sensitivity pattern of Shigella isolates: not reported Funding source(s): Norwich Eaton Pharmaceuticals, Inc. (a Proctor and Gamble company) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | "...randomised into three groups" but the method not mentioned. Neither the author nor the journal could be contacted for clarifications. |
Allocation concealment? | Unclear risk | Not mentioned |
Blinding? All outcomes | High risk | "Single blind"; not mentioned which group was blinded; blinding of the dosage schedules of the trial drugs in the 3 arms not done |
Incomplete outcome data addressed? All outcomes | High risk | "...two patients in the control group were voluntarily withdrawn from the study". They were not included in the analysis. 98% follow up. |
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? | High risk | Baseline imbalance, patients in furazolidone group had fewer days with diarrhoea (P value < 0.02) |