Antibiotics for Acute Otitis Media in Children: Effective Pain Relief but Increased Side Effects, suggests study

Acute otitis media is one of the most common childhood infections: up to 85% of children in high-income countries experience at least one episode by age 15. Although the majority of cases resolve without complications, over 85% of children with AOM are treated with antibiotics, despite increasing antibiotic resistance and the risk of adverse effects. This meta-analysis was done to review whether there existed short-term benefits of antibiotic therapy for the alleviation of pain and possible side effects associated with use.

The authors of this meta-analysis searched four databases: CENTRAL, MEDLINE, Embase, and CINAHL. Further, they accessed two trials registry sites. They then chose RCTs that enrolled children aged between 1 month to 15 years who were diagnosed with AOM and then put on antibiotic therapy against placebo or expectant observation. Thirteen RCTs assessed antibiotics compared with placebo, and six trials evaluated immediate antibiotic treatment versus expectant management. Pain outcomes are reported at various times following the event (24 hours, 2-3 days, 4-7 days, and 10-12 days), as well as secondary outcomes related to side effects: rash, diarrhea, and vomiting.

. Antibiotics vs. Placebo:

• Meta-analysis demonstrated that a statistically significant reduction in pain was associated with antibiotics at 2-3 days, based on summary data from seven trials including 2,320 children.

• In addition, at 10-12 days, meta-analysis was also significant for reductions in pain (RR 0.33, 95% CI 0.17-0.66), based on summary data from one trial including 278 children.

• Antibiotics had a negligible effect on pain at 24 hours (RR 0.89, 95% CI 0.78-1.01) or at 4-7 days (RR 0.76, 95% CI 0.50-1.14).

• The incidence of side effects from antibiotics such as diarrhea and vomiting was significantly higher (RR 1.38, 95% CI 1.16-1.63), with eight trials and 2,107 children reporting adverse effects.

• Immediate antibiotic use decreased pain at 2-3 days (RR 0.53, 95% CI 0.35-0.79) but no other effects at 4-7 days or 10-12 days were significant.

• Side effects were reported more in the antibiotic treated group at RR 1.87, 95% CI 1.39-2.51 by three trials with 946 children in total. Antibiotics relieved pain at 2-3 days in children with AOM; the NNT was 20 at this stage to relieve pain. The NNT to relieve pain at 10-12 days was seven. The authors reported no significant pain relief at either 24 hours or 4-7 days.

• Antibiotics were associated with increased risks for adverse gastrointestinal effects, with a number needed to harm of 14 compared with placebo and a number needed to harm of 10 compared with expectant management.

Results of this study suggest that though antibiotics may offer a degree of comfort to children with AOM, they do enhance the risk of side effects. Thus, in high-income settings where most AOMs resolve uneventfully, expectant management using appropriate pain control and careful monitoring would be safer. Parents and caregivers should be informed of the advantages and risks of antibiotics; and shared decision-making should be facilitated in the management of AOM in children. Future studies should be targeted at drug prescription with respect to the use of antibiotics in low- and middle-income countries, particularly where the complications of untreated AOM are more prevalent.

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