OBJECTIVE: To assess the longitudinal curative effect and improvement of subjective symptoms by using intratympanic injection of Budesonide(BUD) for otitis media witheffusion (OME) patients older than 12 years and adults. STUDY DESIGN: A single-blind, randomized, parallel-controlled prospective study. SETTING: Hospital, outpatient. PATIENTS: Ninety patients (112 ears) who were diagnosed as having OME were recruited and then randomized to BUD, dexamethasone (DEX), and sodium chloride (NS) groups, the latter two served as controls. INTERVENTIONS: The randomly allocated patients received intratympanic injection of BUD (0.5 mg/1 ml), DEX (2 mg/1 ml), or 0.9% NS solution (1 ml) once a week. MAIN OUTCOME MEASURES: Survival analysis was applied to compare the longitudinal curative effects among the 3 groups. Meanwhile, the 6 main subjective symptoms were scored by 10-point visual scale, and physician's evaluations were preformed during treatment and follow-up. RESULTS: After adjustment for course of disease, volume, and characters of effusion, the relative risk (RR) of BUD is 0.139 (95% CI, 0.054-0.358) when compared with NS. Survival curve demonstrated that the rank of longitudinal therapeutic efficacy was BUD, DEX, and NS (p < 0.05). Both BUD and DEX showed improvements in subjective symptoms and quality of life compared with NS (p < 0.05). In the aspect of improving the symptom of stuffy ear, BUD showed advantage over both DEX and NS. During and after treatment, no serious complications or sequelae were observed. CONCLUSION: Intratympanic injection with BUD for OME patients showed advantages in improving long-term therapeutic efficacy, it was a safe and effective intervention for adolescents and adults with OME.
RCT Entities:
OBJECTIVE: To assess the longitudinal curative effect and improvement of subjective symptoms by using intratympanic injection of Budesonide(BUD) for otitis media with effusion (OME) patients older than 12 years and adults. STUDY DESIGN: A single-blind, randomized, parallel-controlled prospective study. SETTING: Hospital, outpatient. PATIENTS: Ninety patients (112 ears) who were diagnosed as having OME were recruited and then randomized to BUD, dexamethasone (DEX), and sodium chloride (NS) groups, the latter two served as controls. INTERVENTIONS: The randomly allocated patients received intratympanic injection of BUD (0.5 mg/1 ml), DEX (2 mg/1 ml), or 0.9% NS solution (1 ml) once a week. MAIN OUTCOME MEASURES: Survival analysis was applied to compare the longitudinal curative effects among the 3 groups. Meanwhile, the 6 main subjective symptoms were scored by 10-point visual scale, and physician's evaluations were preformed during treatment and follow-up. RESULTS: After adjustment for course of disease, volume, and characters of effusion, the relative risk (RR) of BUD is 0.139 (95% CI, 0.054-0.358) when compared with NS. Survival curve demonstrated that the rank of longitudinal therapeutic efficacy was BUD, DEX, and NS (p < 0.05). Both BUD and DEX showed improvements in subjective symptoms and quality of life compared with NS (p < 0.05). In the aspect of improving the symptom of stuffy ear, BUD showed advantage over both DEX and NS. During and after treatment, no serious complications or sequelae were observed. CONCLUSION: Intratympanic injection with BUD for OME patients showed advantages in improving long-term therapeutic efficacy, it was a safe and effective intervention for adolescents and adults with OME.