Abstract and Introduction
Background: Ginger is a spice with a long history of use as a traditional remedy for nausea and vomiting. No data on the efficacy of ginger are presently available for children with vomiting associated with acute gastroenteritis (AGE).
Aim: To test whether ginger can reduce vomiting in children with AGE.
Methods: Double-blind, randomised placebo-controlled trial in outpatients aged 1 to 10 years with AGE-associated vomiting randomised to ginger or placebo. The primary outcome was the occurrence of ≥1 episode of vomiting after the first dose of treatment. Severity of vomiting and safety were also assessed.
Results: Seventy-five children were randomised to the ginger arm and 75 to the placebo arm. Five children in the ginger arm and 4 in the placebo arm refused to participate in the study shortly after randomisation, leaving 70 children in the ginger arm and 71 in the placebo arm (N = 141). At intention-to-treat analysis (N = 150), assuming that all children lost to follow-up had reached the primary outcome, the incidence of the main outcome was 67% (95% CI 56 to 77) in the ginger group and 87% (95% CI 79 to 94) in the placebo group, corresponding to the absolute risk reduction for the ginger versus the placebo group of −20% (95% CI −33% to −7%, P = 0.003), with a number needed to treat of 5 (95% CI 3 to 15).
Conclusion: Oral administration of ginger is effective and safe at improving vomiting in children with AGE.
Trial registration: The trial was registered on https://clinicaltrials.gov/ with the identifier NCT02701491.
Vomiting is a common symptom in childhood and has many causes, ranging from self-limited to life-threatening conditions. Vomiting is the presenting symptom in up to 75% of children with acute gastroenteritis (AGE), where it contributes to fluid loss, failure of oral rehydration therapy, and emergency admission to the hospital.[2,3] Nearly 80% of Italian pediatricians prescribe antiemetic drugs to children with AGE, mostly off-label.[4–6] The antiemetic drugs most frequently prescribed in Europe and Italy are domperidone, a dopamine receptor antagonist, and ondansetron, a 5-HT3 antagonist. Current evidence shows that ondansetron but not domperidone is effective for the treatment of AGE-associated vomiting in the emergency setting.[2,7]
Ginger (Zingiber officinale) is a spice with a long history of use as traditional remedy for nausea and vomiting. The active phenolic compounds of ginger, that is, gingerols, zingiberene and shogaols, have also anti-inflammatory and anti-oxidant properties. The antiemetic action of ginger has been investigated in various conditions including motion sickness, pregnancy, post-anesthesia, post-surgery, and chemotherapy-induced nausea and vomiting.[9–25] Given at doses up to 2 g/day, ginger is effective at controlling vomiting without side effects. Besides its general anti-inflammatory action,[26,27] potential mechanisms of action of ginger include the inhibition of 5-HT3 and muscarinic acetylcholine (M3) receptors, and the modulation of esophageal and gastrointestinal motility.[17,26,28]
The pharmacological properties of ginger have been investigated mostly in adults, and no data are available on its effects in children. However, many ginger-based food supplements are increasingly available on the market and are used for the prevention and treatment of vomiting in children without any proof of efficacy. Therefore, the present randomised trial was designed to test whether ginger can reduce AGE-associated vomiting in children.
Aliment Pharmacol Ther. 2021;54(1):24-31. © 2021 Blackwell Publishing