|
| Efficacy | Safety | Recommendations |
|
| Loperamide | | |
Combined data from four RCTs showed that loperamide compared with placebo reduced the risk of
(i) diarrhoea at 24 hours and at 48 hours.
(ii) Loperamide also reduced the duration of diarrhoea (6 trials), and the number of stools at 24 hours (4 trials). | (i) In the considered studies, serious adverse events, defined as lethargy or death, were reported in 8 out of 972 children allocated to loperamide compared with none of 764 children allocated to placebo.
(ii) All serious adverse events were reported in children less than 3 years of age.
(iii) Loperamide may exert life-threatening effects and, for this reason, it should not be used for the management of acute diarrhoea in infants and young children. | Loperamide should not be used in the management of acute diarrhoea in children. |
| Racecadotril | | |
(i) In three relatively small RCTs with some methodological problems, two conducted in hospitalised children, in developed and developing countries, racecadotril was effective in reducing the volume and frequency of stool output and in reducing the duration of diarrhoea (particularly in children with rotavirus diarrhoea).
(ii) There is evidence in favour of the use of racecadotril over placebo or no intervention to reduce the stool output in children with acute diarrhoea. | (i) Tolerability of racecadotril was good in these studies.
(ii) Racecadotril did not differ from placebo in terms of adverse events, none of which was severe.
(iii) The available evidence base does not take into account safety concerns that can be resolved either in studies involving large cohorts of children or in post-marketing surveillance evaluation, which is mandatory before therapy with racecadotril can be recommended. | (i) May be considered in the management of acute diarrhoea in children.
(ii) However, well-designed prospective studies of efficacy and safety should be carried out in outpatient children. |
| Diosmectite | | |
| (i) The results of one meta-analysis are promising, and the use of diosmectite may be considered in the management of acute diarrhoea as an adjunct to standard rehydration therapy. | | |
| (ii) These results should be interpreted with caution, because most of the included studies had important limitations. | Not discussed. | Diosmectite may be considered in the management of acute diarrhoea in children. |
| (iii) Cost-effectiveness analyses should be undertaken before routine pharmacological therapy with diosmectite is universally recommended. | | |
| (iv) It is important to delineate the groups (out-patient versus in-patient, older versus younger, viral versus other aetiology of diarrhoea) that derive the greatest clinical benefit from diosmectite therapy. | | |
| Probiotics | | |
| (i) Data from several meta-analyses consistently show a statistically significant effect and moderate clinical benefit of selected probiotic strains in the treatment of acute watery diarrhoea (primarily rotaviral), mainly in infants and young children. | (i) Safety issues with probiotics are related to bacterial translocation and sepsis and to the risk of antibiotic resistance. | (i) Probiotics may be an effective adjunct to the management of diarrhoea. However, because there is no evidence of efficacy for many preparations, we suggest the use of probiotic strains with proven efficacy and in appropriate doses for the management of children with acute gastroenteritis as an adjunct to rehydration therapy. |
| (ii) The beneficial effects of probiotics in acute diarrhoea in children seem to be moderate, strain-dependent and dose-dependent. | (ii) While bacterial translocation seems an exceptional event, antibiotic resistance may be a true problem in terms of safety. | (ii) The following probiotics showed benefit in meta-analyses of RCTs: Lactobacillus GG and Saccharomyces boulardii. |
| | | (iii) Evidence of lack of risk of antibiotic resistance transfer is required for probiotics proposed for clinical use. |
|
