Loperamide in acute diarrhoea in childhood: results of a double blind, placebo controlled clinical trial

Abstract

Fifty-three young children with acute diarrhoea were included in a hospital-based, double-blind trial of loperamide at two dose levels (0.4 and 0.8 mg/kg/day), given with standard oral rehydration therapy versus placebo plus oral rehydration therapy. The differences in the overall recovery rate were significant (P less than 0.05), the fastest being in the group given 0.8 mg/kg and slowest in the placebo group. Comparison between weights on admission and weights by day 3 showed that more children in the loperamide groups gained weight than in the placebo group (P less than 0.05). No serious side effects of loperamide were observed. The drug was withdrawn in one child because of excessive lethargy and sleep. The results indicate that loperamide in the doses employed is safe and may be a useful adjunct to oral rehydration in certain children.

Loperamide Therapy for Acute Diarrhea in Children: Systematic Review and Meta-Analysis

“…While four out of 13 studies defined diarrhea resolution as the time to the last unformed stool [16,17,26,31], four studies defined diarrhea resolution as change in stool consistency [22], <15 g of stool/kg/d [24], two or fewer liquid/soft stools/d [18], or return to normal bowel habits [21], and five studies did not report their criteria for diarrhea resolution [19,20,23,25,27]. …”

“…Only four studies specifically mentioned that some of their patients received intravenous fluid rehydration in addition to oral rehydration therapy [17–19,27]; two studies did not report the hydration method used [16,22]. Early refeeding was reported in four studies [23,24,26,31]; restriction to only oral rehydration therapy in the first 24 h was reported in two studies [20,25]; and six studies did not report on feeding practices [16–19,22,27]. …”

“…Generation of the allocation sequence was reported in only six out of 13 studies (Table 2) [17,19,21,25,26,31]. Allocation concealment was reported in seven studies [17,19–21,25,26,31].…”

“…Allocation concealment was reported in seven studies [17,19–21,25,26,31]. Although nine trials were double-blind [16,17,19–21,25–27,31], four were open [18,22–24].…”

“…Although nine trials were double-blind [16,17,19–21,25–27,31], four were open [18,22–24]. Most (11/13) trials reported inclusion of more than 90% of all randomized participants in their analysis [17–26,31]. Only six studies met all four indicators of methodological quality that we used [17,19,21,25,26,31], and of those, only four provided outcome data that could be combined [17,19,21,31].…”