Efficacy of Ginger as Antiemetic in Children With Acute Gastroenteritis

A Randomised Controlled Trial

Rita Nocerino; Gaetano Cecere; Maria Micillo; Giulio De Marco; Pasqualina Ferri; Mariateresa Russo; Giorgio Bedogni; Roberto Berni Canani

Disclosures

Aliment Pharmacol Ther. 2021;54(1):24-31. 

In This Article

Results

Flow Diagram

The trial was performed between March 2016 and April 2017. The flow diagram of the trial is depicted in Figure 1. A total of 168 children were assessed for eligibility and 18 were excluded, 11 because they did not meet the inclusion criteria, and 7 because their parents declined to participate in the study. The remaining 150 children were randomised in a 1:1 ratio to ginger (n = 75) and to placebo (n = 75). Five children in the ginger arm and 4 in the placebo arm abandoned the study shortly after randomisation, leaving 70 children in the ginger arm and 71 children in the placebo arm.

Figure 1.

Flow of the children through the study

Baseline Data

Table 2 shows that the children randomised to placebo and ginger had similar baseline features. All children were from families of middle socioeconomic status and lived in the city area of Naples. The vaccination status was similar in the two groups and no child had received anti-Rotavirus or anti-Influenza vaccination (data not shown).

Primary Outcome

The primary outcome, that is, the occurrence of ≥1 episode of vomiting after the first dose of treatment, is reported in Table 3.

Assuming under ITT that all children lost to follow-up had reached the primary outcome, the ARR was −20% (−33% to −7%, P = 0.003, N = 150). Under the worst-case scenario ITT analysis, that is, assuming that the 4 children lost in the placebo arm had not vomiting and the 5 children lost in the ginger arm had vomiting, the ARR was −0.15 (95% CI −0.29 to −0.006, P = 0. 038, N = 150) for ginger versus placebo. Ignoring children lost to follow-up, that is, performing a per-protocol analysis, the ARR was −22% (−35% to −8%, P = 0.002, N = 141).

Secondary Outcomes

Table 4 gives the incidence of vomiting at 24 h and 48 h from the first dose of treatment (per-protocol analysis, binomial regression). The ARR in the incidence of vomiting for the ginger versus the placebo arm was −22% (P = 0.005) at day 1 and −19% (P = 0.04) at day 2.

Table 5 gives the number of episodes of vomiting at 24 h and 48 h after the first dose of treatment (per-protocol analysis, negative binomial regression). The difference in the number of episodes of vomiting for the ginger versus the placebo arm was −0.54 (P = 0.08) at day 1 and −0.64 (P = 0.003) at day 2.

Other Outcomes

The other outcomes were analysed using per-protocol analysis and are reported as descriptive statistics only. The median (IQR) volume of ORS assumed by the children in the 4 h after the first dose of treatment was 30 (15; 40) ml/kg in the ginger arm and 10 (5; 25) ml/kg in the placebo arm. The number of children refusing ORS was 17 (24%) in the ginger arm and 37 (52%) in the placebo arm. The number of children with diarrhea after 24 h, 48 h and 72 h from the first dose of treatment was 38 (54%), 30 (43%) and 7 (10%) in the ginger arm, and 36 (51%), 30 (42%), 13 (18%) in the placebo arm. Intravenous fluid rehydration or hospitalisation were not required for any child. The number of children not attending school 24 h, 48 h and 72 h after the first dose of treatment was 39 (56%), 31 (44%) and 20 (29%) in the ginger arm, and 57 (80%), 40 (56%) and 21 (30%) in the placebo arm.

Compliance

The intervention was well accepted by the children as confirmed by an adherence rate of 100%.

Adverse Effects

There were no reported adverse effects attributable placebo or ginger.

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