Demonstration of the effectiveness of zinc in diarrhoea of children living in Switzerland
Crisinel, Pierre ; Verga, Marie-Elise ; Kouame, Konan ; Pittet, Anne ; Rey-Bellet, Céline ; Fontaine, Olivier ; Di Paolo, Ermindo ; Gehri, Mario
In: European Journal of Pediatrics, 2015, vol. 174, no. 8, p. 1061-1067
Ajouter à la liste personnelle- Summary
- We designed a double-blinded randomized clinical trial of zinc (10 or 20mg of zinc sulphate for 2-5month-old or 6-59month-old children, respectively, during 10days) vs. placebo in otherwise healthy children aged 2months to 5years who presented with acute diarrhoea (i.e. ≥3 stools/day for less than 72h). Eighty-seven patients (median age 14months; range 3.1-58.3) were analysed in an intention-to-treat approach. Forty-two patients took zinc and 45 placebo. There was no difference in the duration nor in the frequency of diarrhoea, but only 5% of the zinc group still had diarrhoea at 120h of treatment compared to 20% in the placebo group (P = 0.05). Thirty-one patients (13 zinc and 18 placebo) were available for per-protocol analyses. The median (IQR) duration of diarrhoea in zinc-treated patients was 47.5h (18.3-72) and differed significantly from the placebo group (median 76.3; IQR 52.8-137) (P = 0.03). The frequency of diarrhoea was also lower in the zinc group (P = 0.02). Conclusion: zinc treatment decreases the frequency and severity of diarrhoea in children aged 2months to 5years living in Switzerland. However, the intention-to-treat analysis reveals compliance issues that question the proper duration of treatment and the choice of optimal pharmaceutical formulation. What is known • The effectiveness of zinc in childhood diarrhoea has been demonstrated in developing countries. It helps to decrease the duration and severity of diarrhoea. There is currently no sufficient data to justify its use in developed countries, where there is, theoretically, no zinc deficiency. What is new • We demonstrated the effectiveness of zinc in diarrhoea of children living in a developed country. This confirms the result of two studies (Passariello 2011, and Dalgic 2011) that also reported the positive impact of zinc in diarrhoea of children living in Italy and in Turkey. However, our population is wider in terms of age (2-60 months compared to 3-36 months for Passariello's study and 1-28 months for Dalgic's study) and is not limited to a specific aetiology or to a certain degree of severity of the diarrhoea. Furthermore, it's the first study that uses a placebo for the control group. The main limitation of our study is the differences in the intention-to-treat and the per-protocol analyses that reveal big compliance problems. These could be dealt by changing the dosage form of the zinc formula and/or by diminishing the treatment duration.