Effectiveness of continuous vs. intermittent amoxicillin to prevent episodes of otitis media.

The effectiveness of continuous compared with intermittent amoxicillin prophylaxis administered to subjects with a history of recurrent otitis media enrolled during the winter respiratory infection season was assessed in a prospective single blinded clinical trial. Patients with three or more chart-documented episodes of otitis media (OM) in the preceding 6 months were enrolled and randomly assigned to each treatment group. Patients in the continuous group received amoxicillin twice a day every day for up to 4 months. During the same period patients in the intermittent group received amoxicillin twice a day only when they developed respiratory symptoms of congestion, runny nose or cough. Among the 30 patients receiving continuous amoxicillin who were followed for at least 3 months, 22 (73%) had no OM episodes and 8 (28%) had one OM episode. Among the 25 patients receiving intermittent amoxicillin for at least 3 months, 13 (52%) had no OM episodes, 8 (32%) had 1 episode and 4 (16%) had 2 episodes. Significantly fewer patients had fewer than 2 OM episodes on continuous compared with intermittent amoxicillin (P less than 0.04). The incidence density was 0.46 episode/120 days at risk in the continuous treatment group compared with 1.10 episodes/120 days at risk for intermittent treatment (P less than 0.03). Among patients 12 months or older the incidence density of OM episodes per 120 days was 3.5 times higher in the intermittent amoxicillin group (0.80) compared with the continuous amoxicillin group (0.23) (P = 0.05). The incidence densities of the continuous vs. intermittent therapy groups did not differ significantly for patients younger than 12 months of age. The findings suggest that continuous amoxicillin prophylaxis may be more effective than intermittent treatment in preventing OM episodes in patients 12 months or older with a history of recurrent otitis media.

Management of chronic middle ear effusion with prednisone combined with trimethoprim-sulfamethoxazole.

Fifty-three patients were enrolled and evaluable in a randomized, double-blinded controlled clinical trial comparing prednisone for 7 days plus trimethoprim-sulfamethoxazole (TMP/SMZ) for 30 days vs. TMP/SMZ alone in treating chronic middle ear effusion (MEE). Clearing of the effusion in both ears or in one when only one was involved was called complete resolution; clearing in one of two affected ears was called partial resolution. The outcomes 2 weeks after initiation of therapy of 26 patients initially treated with prednisone plus TMP/SMZ were complete resolution in 20, partial resolution in three, and unchanged in three. The outcomes in 27 patients initially treated with TMP/SMZ alone were complete resolution in eight, partial resolution in three, unchanged in 13 and development of acute otitis media in three (P less than 0.01 for complete resolution). Two weeks after initiation of therapy, patients with a MEE that failed to clear were crossed over to the alternative regimen. Overall 29 of 41 patients (71%) who received oral prednisone plus TMP/SMZ initially or after the crossover had complete resolution of their middle ear effusion at 2 weeks after starting prednisone and TMP/SMZ. Five of 35 (14%) patients treated with prednisone plus TMP/SMZ and one of six (17%) patients treated with TMP/SMZ alone who had complete resolution at 4 weeks required subsequent referrals for tympanostomy tubes. A course of prednisone for 7 days plus TMP/SMZ for 30 days with monthly follow-up should be considered in children with MEE persisting beyond 6-8 weeks before referral for tympanostomy tube placement.