Clinical trials of improved oral rehydration salt formulations: a review

Abstract

Reviewed are all the published clinical trials of glycine-based oral rehydration salts (ORS), L-alanine-based ORS, L-glutamine-based ORS, maltodextrin-based ORS, and rice-based ORS, as well as the results of several recently completed, but unpublished, studies of these formulations that were supported by WHO. All experimental ORS formulations contained the same concentrations of salts as citrate-based WHO-ORS; all trials were randomized comparisons with WHO-ORS, and all except those with rice-based ORS were double-blind studies. The rate of stool loss and, less frequently, the duration of diarrhoea were used as indicators of clinical performance to compare ORS formulations. The following conclusions were reached concerning the efficacy and use of modified ORS formulations. Rice-based ORS (50 g/l) is superior to WHO-ORS for patients with cholera, and for such patients it can be recommended in any situation where its preparation and use are practical. Rice-based (50 g/l) and WHO-ORS solutions are equally effective for treating children with acute non-cholera diarrhoea, when feeding is resumed promptly following initial rehydration, as has been consistently recommended by WHO. Since rice-based ORS is not superior to WHO-ORS for such children, there is no apparent reason to advise a change from glucose to pre-cooked rice in the recommended formulation for WHO-ORS. Maltodextrin-based ORS formulations (50 g/l) and WHO-ORS appear to be equally effective for treating children with acute non-cholera diarrhoea; there is no reason to advise a change from glucose to maltodextrin in the recommended formulation for WHO-ORS. Amino-acid-containing ORS formulations are not recommended for either non-cholera or cholera diarrhoea, since they are more costly and have no clinical advantage over WHO-ORS for children with acute non-cholera diarrhoea or over rice-based ORS for persons with cholera.