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New findings:
Amoxicillin may not prevent repeat episodes of acute otitis media

Chewing gum containing the food additive xylitol, however, might lower the risk for recurrent AOM.

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June 1996

WASHINGTON, D.C. — Contrary to other findings, amoxicillin prophylaxis may not decrease a child's risk of recurrent acute otitis media (AOM), but the food additive xylitol may, according to studies detailed here recently.

To test the value of amoxicillin prophylaxis in preventing repeat episodes of AOM, Robert Roark, MS, PA-C, and Stephen Berman, MD, conducted a blind, three-year study of 194 children from 3 months to 6 years.

The children were assigned randomly to receive placebo or one of two amoxicillin regimens: 20 mg/kg/d in one daily dose or in two divided doses. Investigators further divided each arm into groups that would receive placebo or amoxicillin for fewer than three months or more than three months.

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Inclusion criteria

Study children had three documented AOM episodes within the past six months. Participants also could not have ventilating tubes, immunodeficiencies or penicillin allergy. One hundred fifty-eight children were evaluated.

Investigators followed patients monthly and saw them as needed for upper respiratory infections. Failure, defined as two new AOM episodes, terminated patient participation in the study.

Of the children who received placebo or amoxicillin for fewer than three months, 22 of 31 children (71%) in the placebo group were free of otitis at the end of follow-up, compared with 20 of 31 children (65%) who received amoxicillin once daily and 18 of 29 (62%) who received amoxicillin twice daily.

Of these who received placebo or amoxicillin for more than three months, 15 of 28 (54%) who received placebo were otitis-free at the end of follow-up, compared with 15 of 24 (63%) who received amoxicillin once daily and nine of 15 (62%) in the twice daily group.

None of the groups showed statistically significant differences in the incidence of otitis media (OM).

Previous studies have shown that amoxicillin prophylaxis is effective at preventing recurrent AOM, but Roark claimed that these studies did not compare amoxicillin with placebo. In addition, they showed only small increases in efficacy when using amoxicillin instead of another agent. Roark and Berman did not look at the drug-susceptibilities of middle-ear isolates, and Roark said it is possible that drug-resistant organisms influenced their findings.

Still, the results suggest that the routine use of amoxicillin prophylaxis should be discouraged, said Roark, who is assistant professor of pediatrics at the University of Colorado School of Medicine, Denver. Instead, pediatricians should treat individual episodes of AOM.

Increasing drug resistance among bacteria also argues against routine amoxicillin prophylaxis to prevent the disease, Roark said. Moreover, data suggest that children receiving amoxicillin have an increased rate of colonization with penicillin-resistant pneumococci.

Chewing gum containing xylitol could be one answer to emerging drug-resistance among pneumococci. Finnish researchers randomly assigned 306 children in day care to receive chewing gum containing xylitol or sucrose. Children received chewing gum five times a day for two months. Children who received the sucrose-containing gum served as the control group.

The children were between 1.7 and 5 years old. Over the two months, 31 of 149 (20.8%) of children who received sucrose gum had at least one AOM episode, compared with 19 of 157 children (12.1%) who received xylitol gum, a statistically significant difference.

Twenty-nine children in the xylitol group (18.5%) had at least one period of antibiotic therapy, compared with 43 children (28.9%) in the sucrose group.

"Our finding is very promising, especially now that pneumococci are becoming resistant to various antimicrobial agents," said investigator Matti Uhari, MD, who is associate professor of pediatrics at the University of Oulu.

The investigators had demonstrated in the laboratory that xylitol inhibits the growth of Streptococcus pneumoniae, and theorized that xylitol could prevent human carriage of S. pneumoniae. They plan to study xylitol use in preventing AOM among children who cannot chew gum.

Xylitol is known to prevent dental caries, possibly by inhibiting the growth of Streptococcus mutans. "We would recommend the use of xylitol chewing gum since it is good for teeth and may even prevent acute otitis media attacks," said Uhari.

Editor's note: Most studies have shown that amoxicillin prophylaxis does prevent otitis in children who have had frequent recurrences. The reasons for the results in this study are unclear. Perhaps, an increase in pneumococcal resistance played a factor. —P. Brunell

For more information, see:

  • Roark R and Berman S. Amoxicillin prophylaxis for recurrent otitis media. Arch Pediatr Adolesc Med. 1996;150:19, Abstract 26. Presented at the 36th annual meeting of the Pediatric Academic Societies, May 6-10, Washington, D.C.
  • Kontiokari T, Uhari M, et al. Xylitol in preventing acute otitis media. Abstract 1040. Presented at the 36th annual meeting of the Pediatric Academic Societies, May 6-10, Washington, D.C.

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Copyright 1996, SLACK Incorporated. Revised 30 May 1996.