Comparing Watchful Waiting Approach vs. Antibiotic Therapy in Children with Nonsevere Acute Otitis Media: A Randomized Clinical Trial

Abstract

Objective. To compare both approaches for the treatment of nonsevere acute otitis media (AOM) in Iran. Methods. This randomized clinical trial was performed at a pediatric infectious diseases clinic in Buali tertiary hospital in Sari, north of Iran, from 2016 to 2018. All participants in this study were previously healthy children with AOM diagnosis, who were 6 months to 6 years old. The patients were randomly assigned into two groups: the intervention (80 mg/kg/day amoxicillin for 7-10 days) and the control group (watchful waiting approach). AOM recovery and adverse drug reactions were evaluated after 72 hours, and the patients were followed for the frequency of AOM and middle ear effusion 1 and 3 months’ postintervention. Results. A total of 396 children have participated in this study. AOM recovery was significantly different in the two groups (73% vs. 44% in the intervention and control groups, respectively). Recurrence of AOM and middle ear effusion (MEE) persistence, one month following the intervention, have not shown any significant differences between the two groups. However, the AOM recurrence between 1 and 3 months was more frequent in the control group. The frequency of diarrhea was also higher in the intervention group compared to the control but no significant difference was found between the two groups regarding vomiting and skin rash. Conclusion. The faster recovery from AOM is achieved when an antibiotic treatment regimen is applied, although the risk of potential side effects should be considered.

Antibiotic treatment to prevent pediatric acute otitis media infectious complications: A meta-analysis

“…Six studies included results for AM as a serious complication of AOM (2 RCTs and 4 observational studies), observing a total of 269 episodes of AM following 1,623,458 treated AOM episodes and 187 episodes of AM following 531,258 untreated AOM episodes [22, 24,25,42,47,53]. An additional 5 studies reported no AM, out of 630 controls and 610 treated AOM cases [37,39,46,51,52]. Antibiotics showed a protective effect for acute AM (RR 0.48, 95% CI 0.40-0.59), with an NNT of 5,368 (Fig 2A).…”

“…For observational studies, the control groups included no antibiotic prescription/treatment and delayed treatment. Out of the 5 studies with delayed antibiotic therapy as the control group, 1 used a watchful waiting period of 72 hours [43] and 4 used 48 hours [15,41,45,46]. Co-interventions were allowed or encouraged in 18 studies, consisting of symptomatic treatment with analgesics, antipyretics, antihistamines, and decongestants.…”

“…Seven studies reported pneumococcal vaccination rates, ranging 1.4-100% [46,47]. Breastfeeding was reported by 8 studies.…”

“…Five studies reported the percentage of children who had siblings, ranging from 20 to 69% [14,44]. Eleven studies reported smoke exposure, ranging 16-39% [46,48]. Lastly, 12 studies reported attendance at school or daycare, ranging 15-88% [39,48].…”

Watchful Waiting Strategy in the Treatment of Acute Otitis Media in Children

“…Such studies suggest that for certain children with non-severe AOM, a watchful waiting approach might be a viable alternative to immediate antibiotic therapy (5,6). Only one Iranian study on this issue revealed that faster recovery from AOM is achieved when antibiotics are prescribed, although the potential risk of side effects should be considered (7).…”