Intranasal phenylephrine-surfactant treatment is not beneficial in otitis media with effusion

Summary Background Otitis media is the most common reason for non-well-child visits to the primary care physician. Various treatments are in use to try to ameliorate the pain arising from Eustachian tube (ET) dysfunction. One such treatment is topical phenylephrine spray, despite clinical evidence disputing its use. Previous research by this laboratory has demonstrated the beneficial effect of topical surfactant treatment in reducing ET opening pressure, allowing the tube to open. This study is designed to test the effectiveness of topical phenylephrine, delivered with surfactant, in reducing days of effusion in OME, in an animal model. Methods OME was generated by injecting Klebsiella pneumoniae lipopolysaccharide into the right bullae of 28 gerbils. After frank OME resulted, the animals were divided into four groups. Group 1 received no treatment or propellant spray alone (placebo). Group 2 received intranasal surfactant spray once daily. Group 3 received intranasal surfactant-phenylephrine spray once daily. Group 4 received intranasal surfactant-phenylephrine spray twice daily. All animals were evaluated on a daily basis by both otomicroscopy and tympanometry, and treatment was ceased when the ear returned to normal appearance. Evaluations were continued for a total of 30 days. Chi-squared analysis with significance set at .05 was performed. Results In the untreated and placebo groups, middle ear effusion resolved at 16.25 days by otomicroscopy and 28.26 days by tympanometry. In Group 2 (surfactant alone), effusion resolved at 10.57 days and 15.71 days, respectively. In Group 3 (surfactant-phenylephrine once daily), effusion resolved at 15.67 days and 28.33 days. In Group 4 (surfactant-phenylephrine twice daily), effusion resolved at 18.67 days and 28.33 days. These results were statistically significant. Conclusions Intranasal phenylephrine-surfactant treatment is shown to be at least ineffective, and possibly detrimental, in the resolution of OME, in this animal model. The hypothesis is that surfactant potentiates the drying effect of phenylephrine at the ET by allowing it to get to the ET more easily; in addition, the drying effect of phenylephrine prevents full surfactant action. We believe that these results can be extrapolated to humans and that phenylephrine should be avoided in these cases.