OBJECTIVETo observe the clinical efficacy of Qingqiao Capsule (QQC) in treating patients with secretory otitis media (SOM).

METHODSA total of 90 patients were randomly assigned into the treated group (n = 45) and the control group (n = 45). Patients in the treated group were administrated with QQC, 5 capsules each time, 3 times a day for totally 10-14 days, and those in the control group were given per os cefaclor capsules 0.5 g each time for adult, 3 times a day, or 20 mg/(kg.d) for children, for 10-14 days. The therapeutic efficacy of treatment on the patients was observed and compared after treatment and followed up for 3-6 months.

RESULTS(1) The clinical efficacy in the treated group was superior to that in the control group with significant statistical difference (P < 0.01); (2) Comparison of the efficacies in patients of three different TCM syndrome types (the external pathogenic wind invasion caused auditory orifice stuffiness type, the Gan-Dan damp-heat steaming up auditory orifice type and the Pi-deficiency dysfunction induced dirty dampness blocking ear type) showed no statistically significant difference (P > 0.05); (3) The vanishing rate and time needed of the main symptoms and signs in the treated group were superior to those in the control group on ear muffle, tinnitus, hearing impairment, hydrotypanum, pure tone threshold and abnormal tongue figure, and the difference was statistically significant (P < 0.05 or P < 0.01), only those of earache, otopiesis and abnormal pulse figure were insignificantly different between the two groups (P > 0.05).

CONCLUSIONQQC is an effective Chinese composite medicine on patients with SOM, and shows no obvious adverse reaction.