Community-based randomized controlled trial of reduced osmolarity oral rehydration solution in acute childhood diarrhea

Objective. The standard oral rehydration solution (ORS) recommended by WHO and UNICEF does not reduce the volume or frequency of stools or the length of the episode. Hospital-based studies from developing and developed countr ies and intestinal perfusion studies suggest a beneficial effect on water a nd sodium absorption with reduced osmolarity ORS as compared with standard ORS. We conducted a community-based study comparing the efficacy of reduced osmolarity ORS (224 mmol/l) with standard ORS (311 mmol/l) in acute childh ood diarrhea in a West African community. Methods. Infants and toddlers age 0 to 30 months having 738 episodes of dia rrhea identified by weekly household visits were randomly assigned to treat ment with either standard ORS (n = 376) or reduced osmolarity ORS (n = 362) . The children were followed by daily home visits to assess ORS intake and clinical characteristics. Duration of diarrhea was compared by proportional hazards regression analysis, the hazard ratio being interpreted as the rel ative recovery rate between the children receiving the two types of ORS. Be cause earlier reports have suggested that weaning status might be an import ant modifier for the performance of reduced osmolarity ORS, the effect was assessed overall and as an interaction between type of ORS and weaning stat us and age. Maternal satisfaction was assessed in a paired analysis among m others whose children participated at least twice in the study. Results. In the overall analysis reduced osmolarity ORS was as efficacious as standard ORS as assessed by duration of diarrheal episode and total numb er of stool evacuations on Days 1 and 2. Non-breast-fed toddlers (i.e. chil dren ages 12 to 30 months) treated with reduced osmolarity ORS had signific antly shorter diarrheal episodes [1.14 days vs. 1.78 days with standard ORS ; hazard ratio, 1.50; 95% confidence interval (CI), 1.07 to 2.09] and lower total number of stool evacuations on Days 1 and 2 (3.9 stool evacuations u s. 5.0 stool evacuations with standard ORS; ratio of geometric means, 0.77; 95% CI 0.60 to 1.01). No significant difference was found for breast-fed t oddlers or for infants. There was no statistically significant difference i n the ORS intake between the two treatment groups. The odds ratio for the m other preferring reduced osmolarity ORS to standard ORS was 1.92 (95% CI 0. 97 to 3.85). Conclusions. Reduced osmolarity ORS was as efficacious as standard ORS. Non -breast-fed children treated with reduced osmolarity ORS had significantly shorter diarrheal episodes and a tendency toward lower stool frequency. The se findings may be of importance, especially in developing countries where early weaning is common.