CLINICAL-TRIALS OF IMPROVED ORAL REHYDRATION SALT FORMULATIONS - A REVIEW

Reviewed are all the published clinical trials of glycine-based oral r ehydration salts (ORS), L-alanine-based ORS, L-glutamine-based ORS, ma ltodextrin-based ORS, and rice-based ORS, as well as the results of se veral recently completed, but unpublished, studies of these formulatio ns that were supported by WHO. All experimental ORS formulations conta ined the same concentrations of salts as citrate-based WHO-ORS; all tr ials were randomized comparisons with WHO-ORS, and all except those wi th rice-based ORS were double-blind studies. The rate of stool loss an d, less frequently, the duration of diarrhoea were used as indicators of clinical performance to compare ORS formulations. The following con clusions were reached concerning the efficacy and use of modified ORS formulations. Rice-based ORS (50 g/l) is superior to WHO-ORS for patie nts with cholera, and for such patients it can be recommended in any s ituation 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 fol lowing initial rehydration, as has been consistently recommended by WH O. 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-coo ked rice in the recommended formulation for WHO-ORS. Maltodextrin-base d ORS formulations (50 g/l) and WHO-ORS appear to be equally effective for treating children with acute non-cholera diarrhoea; there is no r eason to advise a change from glucose to maltodextrin in the recommend ed formulation for WHO-ORS. Amino-acid-containing ORS formulations are not recommended for either non-cholera or cholera diarrhoea, since th ey are more costly and have no clinical advantage over WHO-ORS for chi ldren with acute non-cholera diarrhoea or over rice-based ORS for pers ons with cholera.