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. 2010 Aug 8;2010(8):CD006784. doi: 10.1002/14651858.CD006784.pub4

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
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
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)
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 All outcomes High risk "...two patients in the control group were voluntarily withdrawn from the study".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)