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

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
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
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):
  1. United States Agency for International Development (USAID);

  2. International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B);

  3. Leo Pharmaceutical Products, Copenhagen and M/S Opsonin Chemical industries Ltd., Bangladesh provided the study drugs.

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