Page 157 - 15Diarrhoeaandvomiting

Diarrhoea and vomiting caused by gastroenteritis in children under 5 years

only one had adequate allocation concealment, two were not blinded and three did not apply
an intention-to-treat analysis. Meta-analyses were performed for duration of diarrhoea and
for number of stools on day 3 and on day 4. Other outcomes measured were resolution of
diarrhoea on days 2 and 8, presence of diarrhoea at several time intervals, hospitalisation and
vomiting. [EL = 1+]

The meta-analysis performed (four RCTs, n = 473) showed that children receiving the probiotic
had a statistically significantly shorter duration of the diarrhoeic episode (WMD −1.08 days;
95% CI −1.3 to −0.83 days) (Figure 8.12).
Data from three RCTs (n = 331) were combined in a meta-analysis. This showed that children
receiving the probiotic had statistically significantly fewer stools on day 3 when compared with
the control group (WMD −1.3; 95% CI −1.9 to −0.6). The results of two RCTs (n = 218) were
pooled and also showed a statistically significant reduction in the number of stools on day 4 in
those children receiving the probiotic compared with placebo (WMD −1.1; 95% CI −1.6 to −0.6).
One RCT (n = 130) measured the proportion of children without diarrhoea on day 2 and on day 8
from the start of the study. It found that statistically significantly more children in the intervention
group experienced cessation of diarrhoea on both study days, when compared with the control
group (RR 4; 95% CI 1.8 to 9.1, and RR 1.9; 95% CI 1.4 to 2.8, respectively). The proportion
of children with diarrhoea on days 3 and 6 was reported in one study (n = 101), which found
that the children in the intervention group were more likely to be diarrhoea-free by day 3 and
by day 6 when compared with the children in the control group (RR 0.71; 95% CI 0.56 to 0.90,
and RR 0.49; 95% CI 0.24 to 0.99, respectively). Another study (n = 88) found no statistically
significant difference between the two groups for the presence of diarrhoea on day 4. The same
study (n = 88) measured the proportion of children with diarrhoea on days 6 and 7, as well as the
proportion of children with diarrhoea lasting more than a week. It found that the children in the
intervention group were statistically significantly more likely to be diarrhoea-free on days 6 and
7 when compared with the control group (RR 0.49; 95% CI 0.24 to 0.99, and RR 0.39; 95% CI
0.20 to 0.75, respectively). In addition, the number of children with diarrhoea lasting more than
a week was statistically significantly higher in the control group (RR 0.25; 95% CI 0.08 to 0.83).
One RCT (n = 200) found that children who were treated with Saccharomyces boulardii had
a statistically significantly shorter stay in hospital than those children who did not receive the
probiotic (WMD −1 day; 95% CI −1.4 to −0.62 days) but that there was no statistically significant
difference between the two groups for the duration of vomiting. Adverse events associated with
the administration of Saccharomyces boulardii were not reported in any of the trials included in
the review.

Evidence summary
There was evidence from a well-conducted systematic review [EL = 1+] for the clinical benefit
of Saccharomyces boulardii in the management of acute diarrhoea in children. Meta-analysis
performed showed that the administration of the probiotic shortened the duration of diarrhoea
by 1 day and resulted in fewer stools on days 3 and 4, but the authors reported methodological
limitations in the included trials.

Figure 8.12 Comparison of the effect of Saccharomyces boulardii versus placebo on the duration of diarrhoea

132