Clinical investigation on the beneficial effects of the Chinese medicinal herb Gushen Pian on sensorineural deafness and tinnitus.

The objective is to study the therapeutic effects of Gushen Pian on sensorineural deafness according to the Phase II clinical trial protocol, as approved for novel traditional Chinese medicines by Ministry of Health of PRC. This is a double blind study in which 120 patients were allocated randomly into treatment and control groups and an open treatment group (40 cases in each group). Patients in the treatment groups were administrated with Gushen Pian and controls received placebo. Routine examination of blood and urine, hepatic and renal function tests and pure tone audiometry were performed before and after treatment. Clinical symptoms and therapeutic outcomes were compared and evaluated. For double-blind treatment group, the total effective rate of deafness was 42.2% and total relieved rate of deafness was 4.6%; for double-blind control group, the total effective rate of deafness was 18.7% and total relieved rate of deafness was 0%; for simple treatment group, the total effective rate of deafness was 58.7% and total relieved rate of deafness was 6.3%. For double-blind treatment group, the total effective rate of tinnitus was 89.2% and total relieved rate of tinnitus was 59.5%; for double-blind control group, the total effective rate of tinnitus was 30.8% and total relieved rate of tinnitus was 5.1%; for simple treatment group, the total effective rate of tinnitus was 74.3% and total relieved rate of tinnitus was 57.1%. The double-blind treatment showed statistically significant differences from control group. The medication could effectively alleviate aural fullness, dizziness, lassitude of loins and knees, dysphoria with feverish sensation in chest, insomnia, and fatigue, etc. No adverse effect was reported during treatment; no abnormal results were reported in blood, urine, faces, heart function, liver function and kidney function examination. Gushen Pian had beneficial effect on deafness and tinnitus and could effectively alleviate aural fullness, insomnia, etc., without any adverse effects.

RCT Entities:   Population Interventions Outcomes