Page 140 - 15Diarrhoeaandvomiting

Other therapies

with 150 mg/kg BSS (n = 83) and 16.2 ml/kg (SD 27.0 ml/kg) in children receiving placebo
(n = 84). The mean total volume of vomitus was statistically significantly reduced in the group
receiving 150 mg/kg BSS compared with the control group (WMD −7.5 ml/kg; 95% CI −14.5
to −0.5 ml/kg). No statistically significant difference in the mean total volume of vomitus was
found between the group receiving 100 mg/kg BSS and the placebo group (WMD −4.6 ml/kg;
95% CI −11.7 to 2.5 ml/kg). The mean total intake of rehydration solutions was 239 ml/kg
(SD 177 ml/kg) in children treated with 100 mg/kg BSS (n = 85), 236 ml/kg (SD 152 ml/kg) in
children treated with 150 mg/kg BSS (n = 83) and 314 ml/kg (SD 234 ml/kg) in children receiving
placebo (n = 84). The mean total intake of rehydration solutions was statistically significantly
reduced in each of the two intervention groups compared with the control group (100 mg/kg
BSS WMD −75 ml/kg; 95% CI −138 to −12 ml/kg, and 150 mg/kg BSS WMD −78 ml/kg; 95% CI
−138 to −18 ml/kg). The mean length of hospital stay was 3.3 days (SD 1.5 days) in children
treated with 100 mg/kg BSS (n = 85), 4.1 days (SD 2.1 days) in children treated with 150 mg/kg
BSS (n = 83) and 3.4 days (SD 1.5 days) in children receiving placebo (n = 84). The mean length
of hospital stay was statistically significantly reduced in each of the two intervention groups
compared with the control group (100 mg/kg BSS WMD −8.0 days; 95% CI −1.4 to −0.3 days,
and 150 mg/kg BSS WMD −0.7 days; 95% CI −1.3 to −0.2 days). The effects of administering
BSS 100 mg/kg compared with BSS 150 mg/kg were also reported. No statistically significant
differences were observed between the treatment groups for the duration of diarrhoea, total stool
output, total volume of vomitus, total intake of rehydration or duration of hospitalisation. No
adverse reactions were observed.

Evidence summary
Three RCTs with EL = 1+ were identified for the effectiveness of BSS in the treatment of diarrhoea.
Meta-analysis could not be performed because of the variability of the outcomes. Data from
two RCTs with small sample sizes showed that children with acute diarrhoea and receiving BSS
with ORS solution had a significantly reduced duration of diarrhoea, duration of hospital stay
and need for fluid therapy. However, results from the third RCT, which had a large sample size,
did not show a statistically significant reduction in the duration of diarrhoea, in the incidence of
persistent diarrhoea or in the total intake of ORS solution in the group of children treated with BSS
compared with the placebo group. In this trial, a statistically significant reduction in the duration
of diarrhoea was seen only for the subgroup of children who were positive for rotavirus. Two trials
showed a reduction in the stool output and one trial showed a statistically significant reduction in
vomiting in patients receiving a higher dose of BSS. No evidence of benefit was found between
the administration per day of 100 mg/kg versus 150 mg/kg of BSS in the treatment of diarrhoea in
children for this outcome or any other outcome investigated. No adverse events were identified
although two incidents of ‘black tongue’ during treatment were reported in one trial.

8.2.3 Antimotility agents
Evidence overview

One relevant systematic review of trials comparing loperamide with placebo for diarrhoea in
children was identified. 174 [EL = 1+]

8.2.3.1 Loperamide

This well-conducted systematic review 174 included 13 RCTs published between 1980 and 1999.
Four of the 13 studies were conducted in European countries, two in South Africa, two in Mexico,
one in Costa Rica, one in India, one in Saudi Arabia and two in North Africa (Egypt and Libya).
Across the 13 trials, data from 1788 children was collected, 975 were assigned to the intervention
group (loperamide) and 813 to the control group. The methodology and conduction of the 13
RCTS was heterogeneous: method of randomisation and allocation concealment were only
reported in six and seven studies, respectively, nine trials were double-blinded and two trials did
not report inclusion of more than 90% of all randomised participants. Definitions for diarrhoeal
resolution, rehydration protocols administered and doses of the study medication varied across
the studies. Children recruited in the trials presented with different grades of dehydration and
duration of diarrhoea prior to enrolment. However, in most of the trials, participants were mildly

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