Double blind, randomised controlled clinical trial of hypo-osmolar oral rehydration salt solution in dehydrating acute diarrhoea in severely malnourished (marasmic) children

Abstract

Aims-To compare the clinical eYcacy of hypo-osmolar oral rehydration salt (ORS) solution (224 mmol/l) and standard ORS solution (311 mmol/l) in severely malnourished (marasmic) children having less than 60% Harvard standard weight for age with dehydrating acute watery diarrhoea. Methods-In a double blind, randomised, controlled trial, 64 children aged 6-48 months were randomly assigned standard (n = 32) or hypo-osmolar ORS (n = 32). Results-Stool output (52.3 v 96.6 g/kg/ day), duration of diarrhoea (41.5 v 66.4 hours), intake of ORS (111.5 v 168.9 ml/kg/ day), and fluid intake (214.6 v 278.3 ml/kg/ day) were significantly less in the hypoosmolar group than in the standard ORS group. Percentage of weight gain on recovery in the hypo-osmolar group was also significantly less (4.3 v 5.4% of admission weight) than in the standard ORS group. A total of 29 (91%) children in the standard ORS group and 32 (100%) children in the hypo-osmolar group recovered within five days of initiation of therapy. Mean serum sodium and potassium concentrations on recovery were within the normal range in both groups. Conclusion-Our findings suggest that hypo-osmolar ORS has beneficial eVects on the clinical course of dehydrating acute watery diarrhoea in severely malnourished (marasmic) children. Furthermore, children did not become hyponatraemic after receiving hypo-osmolar ORS. (Arch Dis Child 2001;84:237-240)

Oral rehydration of malnourished children with diarrhoea and dehydration: A systematic review

“…Two of these compared old WHO ORS formulations with hypo-osmolar formulations (Alam et al 2000 and Dutta et al 2001). Alam et al (2000) only reported baseline chemistry 18 ; however Dutta et al (2001) found no significant differences in sodium at baseline and recovery, with sodium levels remaining within normal limits at recovery for both formulations of ORS 23 . Two studies (Alam et al 2003 19 and Kumar et al 2015 22 ) compared ReSoMal with old WHO ORS: the first (Alam et al 2003) compared ReSoMal with Old WHO ORS and found that 1/64 (2%) in the ORS group developed severe hyponatraemia (Na≤120mmol/L) compared to 3/62 (5%) children receiving ReSoMal, with one of these three experiencing hyponatraemic seizures (serum sodium 108mmol/L).…”

“…One study (Alam et al 2009) 20 found that there was no significant difference in time to rehydration (time to attain 80% of weight for length or height) between groups. Two studies evaluating old WHO ORS versus hypo-osmolar ORS (Alam et al 2000 18 and Dutta et al 2001 23 ) found that there was a faster recovery (passage of 2 consecutive formed stools or no diarrhoea for 12 hours) in the group receiving hypo-osmolar ORS compared to old WHO ORS (36 vs. 53 hours, p=0.001). Alam et al (2000) reported average time to rehydration (though how this was assessed was not defined) of 10.95 hours in hypo-osmolar group versus 11.7 hours in old WHO-ORS group (p=0.32).…”

“…After screening and evaluation, six studies were identified that investigated ORS in children with SAM complicated by dehydration, incorporating a total of 686 children. All six of these studies were conducted in Asia, four of which were conducted at the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B) 18– 21 and two in India (New Delhi 22 and Calcutta 23 ). One study included children with and without SAM 18 , but reported independently on outcomes for children with SAM.…”

“…Four studies had a low risk of bias 19– 22 and two had low-moderate risk of bias 18, 23 due to lack of pre-determined outcomes in the methods.…”

“…All of the studies reported on stool output, either by measuring weight of stools or nappies (Alam et al 2003, 2009, 2015 and Dutta 2015) 19– 21, 23 or recording frequency (Alam et al 2000 and Kumar et al 2015) 18, 22 . Of the two studies comparing standard with hypo-osmolar ORS, both found that the stool output was significantly less in the group receiving hypo-osmolar ORS (Alam et al 2000 found that daily stool frequency was 4.27 compared with 5.86 episodes, p<0.05, and Dutta et al (2001) found that stool output was 52.3 versus 96.6 g/Kg/day, p=0.0001).…”