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. 2019 Dec 19;2019(12):CD009359. doi: 10.1002/14651858.CD009359.pub2

Sreenivas 2017.

Methods RCT
Length of follow‐up: not reported
Participants Number: 117
Participants were hospitalized but those with severe dehydration were excluded
Inclusion criteria:
Patients aged between 3 months and 5 years with acute watery diarrhoea with duration fewer than 7 days were selected for the trial.
Exclusion criteria:
Subjects were excluded if they had persistent vomiting > 3 episodes/h, severe dehydration, or any serious concomitant illness including HIV seropositive status and severe malnutrition, blood in stool, received an antibiotic or any antidiarrhoeal drug within the preceding 48 hours.
Missing data: 4 participants
Interventions Group 1: 55 received racecadotril additional to oral rehydration
Group 2: 62 received oral rehydration only
Racecadotril was given at a dose of 1.5 mg/kg/day 8 hourly. A uniform dose of 20 mg of elemental zinc was given to all children in both the groups. All the subjects were given breastfeeding, milk and soft food in accordance with WHO recommendations that diet be maintained during treatment of diarrhoea to prevent nutritional disturbance.
Outcomes
  • Stool frequency during first 48 hours

  • Total volume of ORS consumed until the cure of diarrhoea

  • Time taken for a cure

  • Tolerability

Notes Location: India
No funding received
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Simple random sampling was used to randomize the subjects into 2 groups by computer‐generated numbers
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The loss to follow‐up was balanced across the 2 groups, with 2/55 lost from the intervention and 2/62 from the control group. Total attrition was less than 20%.
Selective reporting (reporting bias) Unclear risk Registration of the protocol was not mentioned in the article and the trial protocol was not available.
Other bias Low risk No funding from the pharmaceutical industry

Abbreviations: RCT: randomized controlled trial.