초록
<P><B>Objective</B></P><P>To investigate the regular use of xylitol, compared with sorbitol, to prevent acute otitis media (AOM), upper respiratory tract infections (URTIs) and dental caries.</P><P><B>Design</B></P><P>Blinded randomised controlled trial with a 6-month study period.</P><P><B>Setting</B></P><P>Enrolment took place at 11 primary care practices in Ontario, Canada.</P><P><B>Patients</B></P><P>Children aged 1–5 years who did not use xylitol or sorbitol at enrolment.</P><P><B>Interventions</B></P><P>Children were randomly assigned to use a placebo syrup with sorbitol or xylitol syrup two times per day for 6 months.</P><P><B>Main outcome measures</B></P><P>Primary outcome was the number of clinician-diagnosed AOM episodes over 6 months. Secondary outcomes were caregiver-reported URTIs and dental caries.</P><P><B>Results</B></P><P>Among the 250 randomised children, the mean (SD) age was 38±14 months and there were 124 girls (50%). There were three clinician-diagnosed AOM episodes in the 125 placebo group participants and six in the 125 xylitol group participants (OR 2.04; 95% CI 0.43, 12.92; p=0.50). There was no difference in number of caregiver-reported URTI episodes (rate ratio (RR) 0.88; 95% CI 0.70, 1.11) between the placebo (4.2 per participant over 6 months; 95% CI 3.6, 5.0) and xylitol (3.7; 95% CI 3.2, 4.4) groups. Dental caries were reported for four participants in the placebo group and two in the xylitol group (OR 0.42; 95% CI 0.04, 3.05; p=0.42). In a post-hoc analysis of URTIs during the COVID-19 pandemic, the rate among the 59 participants receiving placebo was 2.3 per participant over 6 months (95% CI 1.8, 3.0) and for the 55 receiving xylitol, 1.3 over 6 months (95% CI 0.92, 1.82; RR 0.56; 95% CI 0.36, 0.87). The most common adverse event was diarrhoea (28% with placebo; 34% with xylitol).</P><P><B>Conclusions</B></P><P>Regular use of xylitol did not prevent AOM, URTIs or dental caries in a trial with limited statistical power. A post-hoc analysis indicated that URTIs were less common with xylitol exposure during the COVID-19 pandemic, but this finding could be spurious.</P><P><B>Trial registration number</B></P><P> NCT03055091.</P>