Controlled trial of hypo-osmalar versus World Health Organization oral rehydration solution.
OBJECTIVE
To compare the safety and efficacy of a hyposmolar oral rehydration solution (H-ORS) (245 mmol/liter) with the World Health Organization oral rehydration solution (WHO ORS) in cholera and acute non-cholera diarrhea.


METHODS
Controlled clinical trial.


METHODS
Diarrhea training and treatment unit.


METHODS
Thirty-five culture proven cholera and 135 acute non-cholera diarrheal patients randomly received H-ORS or WHO-ORS. Intake and output were measured every 4 hours.


RESULTS
Analysis of the total cases revealed rehydration phase (p=0.048, 95% CI 0.64-0.99) and overall (p=0.046, 95% CI 0.70-0.99) frequency of stools to be significantly less in the H-ORS group. In the severely malnourished, the rehydration phase (p=0.032, 95% CI 0.55-97), maintenance phase (p=0.035, 95% CI 0.51-0.97) and overall (p=0.011; 0.95% CI 0.55-0.93) stool frequency were significantly decreased in the H-ORS group. The amount of ORS consumed in the maintenance phase of the cholera cases was significantly (p=0.04, 95% CI 0.44-0.98) less in the H-ORS group. All other parameters, despite showing a decreasing trend, were statistically comparable in the cholera, non-cholera and total cases. The amount of intravenous fluid needed was significantly more in the noncholera and total cases on H-ORS. In the non-breastfed cases, under two years of age, the total duration of diarrhea was significantly decreased (p=0.03; 95% CI 11.07-11.45) but the need for intravenous fluids significantly increased (p=0.02; 95% CI 109.8-112.1) in the H-ORS group. The proportion of children vomiting, the weight gain, urine passed in 24 hours, serum sodium, caloric intake and failure rate were comparable.


CONCLUSIONS
H-ORS is as safe and effective as the WHO-ORS and may have some additional benefits in malnourished children.
Alam
S
S
Diarrhea Training and Treatment Unit, Department of Pediatrics and Department of Microbiology, JNMC, AMU, Aligarh, India.
Afzal
K
K
Maheshwari
M
M
Shukla
I
I
D000284:Administration, Oral; D002675:Child, Preschool; D002771:Cholera / Q000175:diagnosis / Q000628:therapy*; D016001:Confidence Intervals; D003967:Diarrhea / Q000382:microbiology* / Q000628:therapy*; D005260:Female; D005440:Fluid Therapy / Q000379:methods; D005500:Follow-Up Studies; D006801:Humans; D007038:Hypotonic Solutions; D007194:India; D007223:Infant; D008297:Male; D009994:Osmolar Concentration; D011336:Probability; D015532:Rehydration Solutions / Q000008:administration & dosage* / Q000592:standards*; D016896:Treatment Outcome; D014944:World Health Organization
D007038:Hypotonic Solutions; D015532:Rehydration Solutions