Page 141 - 15Diarrhoeaandvomiting

Diarrhoea and vomiting caused by gastroenteritis in children under 5 years

dehydrated and had had diarrhoea for less than 3 days prior to inclusion in the studies). Data were
extracted and meta-analysis was performed for the following outcomes: diarrhoea continuing at
24 hours and at 48 hours, reduction in diarrhoea duration, diarrhoea counts for the first 24 hours
and adverse events.
In the four trials reporting diarrhoea at 24 hours, the prevalence of diarrhoea among the group
treated with loperamide was statistically significantly lower than in the control group (RR 0.66;
95% CI 0.57 to 0.78). When combining the data from the three trials defining the resolution of
diarrhoea as the last unformed stool, the findings were not statistically significantly different.
Data on the proportion of patients with diarrhoea at 48 hours were available in four studies.
The meta-analysis performed showed that the loperamide group had a statistically significantly
lower proportion of patients with diarrhoea when compared with the control group (RR 0.59;
95% CI 0.45 to 0.78). The mean duration of diarrhoea was obtained combining the data from
six trials. It was found that the group receiving loperamide had a statistically significantly shorter
duration of diarrhoea when compared with the control group (WMD −0.80 days; 95% CI −0.87
to −0.74 days). When restricting the analysis to those five studies administering a loperamide
dose of up to 0.25 ml/kg per day, the findings were not statistically significantly different. Four
studies were included in the meta-analysis for the number of stools at 24 hours. The group treated
with loperamide showed a statistically significantly lower mean number of stools than the control
group (count ratio = 0.84; 95% CI 0.77 to 0.92). Twelve RCTs reported information on serious
adverse events (defined as presence of ileus, lethargy or death). When pooling the data together,
it was found that eight participants out of 927 in the intervention group and none out of 764
in the control group underwent some serious adverse event. When abdominal distension and
sleepiness were also included among the adverse events, it was found that in total 21 children
out of 927 in the intervention group and four out of 764 in the placebo group suffered some kind
of adverse event. These last findings were statistically significant.

Evidence summary

There was evidence from a well-conducted systematic review [EL = 1+] for the effectiveness
of loperamide in the treatment of diarrhoea in children. Meta-analysis performed in the review
showed that children receiving loperamide experienced less stool output and had a reduction
of the duration of diarrhoea when compared with children that did not receive the drug. Serious
adverse events only occurred in the children receiving loperamide and these participants also
had statistically significantly more total adverse events than the children in the control groups.

GDG translation from evidence to recommendation
Diarrhoea is the predominant clinical symptom in gastroenteritis and a major cause of dehydration.
It also causes concern to parents who may understandably ask whether there is a treatment
available to alleviate it. Various antidiarrhoeal agents have been proposed and some have been
widely used. However, as they have been considered relatively ineffective, unnecessary and
potentially harmful, their use is avoided.
The GDG considered the evidence available regarding several adsorbent agents (kaolin, charcoal
and smectite), an antisecretory agent (racecadotril), BSS and an antimotility agent (loperamide),
and drew the following conclusions.
There was no evidence to support the use of kaolin. There was some evidence of possible benefit
from activated charcoal but this came from one small study. Young children would probably
find this agent unpalatable and adherence would be poor. There was evidence suggesting that
smectite was an effective antidiarrhoeal, seemingly without adverse effects, at least in the short
term. However, further research would be necessary to examine its potential clinical and health
economic benefits in the UK.
There was evidence that racecadotril had an antidiarrhoeal effect but further research is required
to examine the possible clinical and health economic benefits that might be associated with its
use in the UK.
Studies on BSS had yielded inconsistent results in children and it was thought that any possible
benefit was likely to be small.

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