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Treatment of Otitis Media With Effusion

Kenny H. Chan, MD; Ellen M. Mandel, MD; Howard E. Rockette, PhD; Charles D. Bluestone, MD; Lee W. Bass, MD; Mark M. Blatter, MD; Jane M. Breck, MD; Keith S. Reisinger, MD; Jerome H. Wolfson, MD; Frederick P. Wucher, MD; Patricia Fall, CPNP; Ha-Kyung Kim, PhD

Arch Otolaryngol Head Neck Surg. 1988;114(2):142-146.

Abstract
• A double-blind randomized clinical trial was conducted at two sites comparing amoxicillin-clavulanate potassium (Augmentin) and amoxicillin trihydrate for the treatment of otitis media with effusion ("secretory otitis media"). One hundred eight subjects were randomly assigned to receive a ten-day course of either drug regimen. Clinical response was assessed at ten days and four weeks after entry. For those without middle ear effusion at four weeks, recurrence rates were measured at 8, 12, and 16 weeks after entry. At ten days following entry, 29 (51.8%) of 56 subjects in the amoxicillin-clavulanate-treated group were effusion free compared with 16 (32.0%) of 50 subjects in the amoxicillin-treated group (P=.06). At four weeks following entry, 26 (50.0%) of 50 subjects in the amoxicillin-clavulanate-treated group were effusion free compared with 23 (51.1%) of 45 subjects in the group given amoxicillin. By the 16-week visit, eight (36.4%) of 22 subjects in the amoxicillin-clavulanate-treated group who were effusion free at four weeks had recurrence of effusion, compared with 12 (63.2%) of 19 subjects in the amoxicillin-treated group. This study suggests that there was a favorable clinical response immediately following treatment in the amoxicillin-clavulanate-treated subjects as compared with those treated with amoxicillin, but this benefit was not sustained at the four-week end point.

(Arch Otolaryngol Head Neck Surg 1988;114:142-146)

Author Affiliations
From the Departments of Pediatric Otolaryngology (Drs Chan, Bluestone, Kim, and Ms Fall) and Pediatrics (Drs Bass, Blatter, Breck, Mandel, Reisinger, Wolfson, and Wucher), University of Pittsburgh School of Medicine and the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (Dr Rockette).

Footnotes
Accepted for publication Aug 31, 1987.

Reprint requests to Children's Hospital of Pittsburgh, One Children's Place, 3705 Fifth Ave at DeSoto Street, Pittsburgh, PA 15213 (Dr Chan).

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