January 22, 2014
Dosing Schedule Matters in Using Xylitol to Help Prevent Recurring Acute Otitis Media

Boston—Past research has confirmed that a gum or syrup made from xylitol, a naturally occurring sugar alcohol, can reduce recurrence of acute otitis media (AOM) in children when administered five times a day. The preventative measure has not often been employed, however, because of the inconvenient dosing schedule, according to a recent study.

That study, led by researchers from several Boston-area universities and medical centers, tested whether a dosing schedule more doable for most parents—5 g three times a day—was equally effective. Their report was published recently in the journal Pediatrics.

Results indicated that the more convenient dosing was ineffective in reducing the occurrence of clinically diagnosed AOM among otitis-prone children from 6 months to 5-years-old. Study authors noted, however, that their study subjects had more of a history of recurring AOM than some of the previous research.

For the study, 326 children were enrolled, with 160 receiving xylitol and 166 receiving placebo. The researchers found that, in the primary analysis of time to first clinically diagnosed AOM episode, the hazard ratio for xylitol versus placebo recipients was 0.88 (95% confidence interval [CI] 0.61 to 1.3). In terms of secondary analyses, the incidence of AOM was 0.53 episodes per 90 days in the xylitol group versus 0.59 in the placebo group (difference 0.06; 95% CI –0.25 to 0.13). Total antibiotic use turned out to be 6.8 days per 90 days in the xylitol group versus 6.4 in the placebo group.

Study authors pointed out that the lack of effectiveness was not explained by nonadherence to treatment, “as the hazard ratio for those taking nearly all assigned xylitol compared with those taking none was 0.93 (95% CI 0.56 to 1.57).”

Background in the study noted that the clinical use of xylitol to prevent AOM was first described by Finnish researchers in 1996. In that randomized controlled trial, children who chewed gum containing 1.7 g of xylitol five times daily had significantly fewer episodes of AOM and less antibiotic use than controls. The same researchers reported in 1998 that, in children too young to chew gum, xylitol given as an oral solution in a dose of 2 g five times daily reduced the incidence of AOM by 30% over a 12-week study period. The study underscores that dosage of xylitol, as with all sugar alcohols, is limited by osmotic diarrhea.

“Despite these findings, xylitol has not entered widespread use, presumably because consistent five times daily treatment is infeasible for most families,” the Boston-led authors write. “The Finnish investigators who performed the original studies of xylitol for AOM prevention attempted two strategies aimed at more convenient use: five times daily dosing given only during episodes of upper respiratory illness and daily xylitol solution dosed at 3.2 g three times daily, both of which proved ineffective.”

Authors of the recent trial state that, since xylitol resulted in only an additional 3.6% of children remaining AOM-free throughout their study participation, “We feel this result excludes a benefit sufficiently large for most parents and clinicians to accept the burdens of 3 times daily prophylactic treatment.”

U.S. Pharmacist Social Connect