Objective: To assess the results of drug therapy in patients with severe idiopathic sudden sensorineural hearing loss (ISSHL) with total frequency hearing loss.
Methods: A prospective randomized, single blind, multi-center clinical trial was designed. The untreated patients with ISSHL were included, who had severe hearing loss (pure tone audiometry showed patients had total frequency hearing loss, and their mean auditory threshold of 500, 1000, 2000, 4000 Hz was beyond 81 dB HL), age between 18 to 65 years old, and within 14 days of the onset . The patients were divided into one of the four drug groups [batroxobin, batroxobin + ginkgo biloba leaves extract (EGb), batroxobin + EGb + glucocorticoids, EGb + glucocorticoids] according to the random table, and receive treatment.
Results: Totally 276 patients with unilateral severe ISSHL were included from 33 hospitals, from August 2007 to October 2011. Among them, male patients accounted for 135 (48.91%), female 141 (51.09%); the average age was (41.7 ± 13.3)years. Forty cases were recovered (14.49%), 78 cases had marked effective (28.26%), 76 cases were effective (27.54%), 82 cases were in-effective (29.71%), and the total effective rate was 70.29%. Among four drug groups, the separate effective rate were 73.33%, 61.43%, 78.31% and 67.95% respectively, no significant difference was found between groups (χ(2) = 9.97,P = 0.62). Among the four groups, the separate cure rate for hearing loss were 11.11%, 12.86%, 16.87% and 15.38%, the glucocorticoid groups were significantly better than those not used. Among severe sudden deafness patients, 92.39% cases accompanied with tinnitus, 44.93% with dizziness (or vertigo), 50.36% with ear stuffy. There had no significant difference between the four groups with accompanied symptoms (all P > 0.05).
Conclusions: It is value to give active treatment to sever sudden deafness patients because of an effective rate of 70%. However, the doctors and patients should be mind of a cure rate of only 14%. Steroids are recommended bacause it may play a role in the improvement rate.