Clinical Evaluation of Tsumura-Saireito in Otitis Media with Effusion.

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Abstract
To evaluate the clinical efficacy of Tsumura-Saireito, an open trial study was performed on 45 ears of 33 patients with otitis media with effusion. After 4 weeks of application, marked effects were observed in 2 ears (4.4%), moderate effects in 13 (28.9%) and slight effects in 22 (48.9%), while no effects were seen in 8 ears (17.8%). On the pure tone audiogram, 59.0% of the ears showed improvement, and 47.3% on the tympanogram. Clinical findings of the eardrum were also improved in 26.6% of the ears. Only one patient complained of mild abdominal pain as a side effect. Clinical efficacy was improved according to application duration. Younger cases showed better efficacy compared with older cases. These findings indicate that Tsumura-Saireito is effective in otitis media with effusion.

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