OBJECTIVE: The effect of azelastine hydrochloride (AZ), an oral antiallergic drug, was evaluated in patients displaying otitis media with effusion (OME) accompanying allergic rhinitis. METHODS: A total of 53 patients diagnosed with OME accompanied by symptomatic perennial allergic rhinitis were randomized to receive in an open fashion 2 mg of AZ in combination with 750 mg of S-carboxymethyl cysteine (SCMC) per day, or 750 mg of SCMC only (controls) for 8 weeks. Efficacy was assessed according to the global improvement rating (GIR) of six nasal or four ear symptoms or signs. RESULTS: Patients treated with AZ and SCMC had superior improvements in their nasal symptom GIRs compared to controls overall across the 8 week trial, but not in their ear symptom GIRs. However, the clinical course of patients treated with AZ and SCMC tended to be better than that of patients treated with SCMC only, and the nasal and ear symptom GIRs were significantly correlated in the AZ-treated group. CONCLUSION: These data suggest that AZ may not provide direct efficacy on the ear symptoms in OME patients with allergic rhinitis, but that there might be a possibility of its indirect efficacy in the patients in part by relieving the allergic rhinitis.
RCT Entities:
OBJECTIVE: The effect of azelastine hydrochloride (AZ), an oral antiallergic drug, was evaluated in patients displaying otitis media with effusion (OME) accompanying allergic rhinitis. METHODS: A total of 53 patients diagnosed with OME accompanied by symptomatic perennial allergic rhinitis were randomized to receive in an open fashion 2 mg of AZ in combination with 750 mg of S-carboxymethyl cysteine (SCMC) per day, or 750 mg of SCMC only (controls) for 8 weeks. Efficacy was assessed according to the global improvement rating (GIR) of six nasal or four ear symptoms or signs. RESULTS:Patients treated with AZ and SCMC had superior improvements in their nasal symptom GIRs compared to controls overall across the 8 week trial, but not in their ear symptom GIRs. However, the clinical course of patients treated with AZ and SCMC tended to be better than that of patients treated with SCMC only, and the nasal and ear symptom GIRs were significantly correlated in the AZ-treated group. CONCLUSION: These data suggest that AZ may not provide direct efficacy on the ear symptoms in OME patients with allergic rhinitis, but that there might be a possibility of its indirect efficacy in the patients in part by relieving the allergic rhinitis.