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The use of antibiotics in the initial treatment of acute otitis media is currently being questioned. Homeopathy has been used historically to treat this illness, but there have been no methodologically rigorous trials to determine whether there is a positive treatment effect.A randomized double blind placebo control pilot study was conducted in a private pediatric practice in Seattle, WA. Seventy-five children ages 18 months to 6 years with middle ear effusion and ear pain and/or fever for no more than 36 h were entered into the study. Children received either an individualized homeopathic medicine or a placebo administered orally three times daily for 5 days, or until symptoms subsided, whichever occurred first. Outcome measures included the number of treatment failures after 5 days, 2 weeks and 6 weeks. Diary symptom scores during the first 3 days and middle ear effusion at 2 and 6 weeks after treatment were also evaluated.There were fewer treatment failures in the group receiving homeopathy after 5 days, 2 weeks and 6 weeks, with differences of 11.4, 18.4 and 19.9%, respectively, but these differences were not statistically significant. Diary scores showed a significant decrease in symptoms at 24 and 64 h after treatment in favor of homeopathy (P < 0.05). Sample size calculations indicate that 243 children in each of 2 groups would be needed for significant results, based on 5-day failure rates.These results suggest that a positive treatment effect of homeopathy when compared with placebo in acute otitis media cannot be excluded and that a larger study is justified.