ABSTRACT
Background: Owing to lack of any established treatment and handicap assessment methods, subjective tinnitus can be a debilitating disorder. This study was carried out to compare the safety and efficacy of caroverine and betahistine in patients of subjective tinnitus. Methods: A total of 60 patients of subjective tinnitus were randomized into two groups and followed-up for 12 weeks using tinnitus handicap inventory (THI) questionnaire. One group received 8 mg betahistine tablet TDS for a month whereas the other group was given supervised intravenous (IV) infusion of 160 mg of caroverine dihydrochloride. Data for the safety were also recorded. Results: Both the drugs showed significant improvement in severity of symptoms at 1 week, 4 weeks and 12 weeks individually as assessed by the THI scores. The response to caroverine was significant up to 4 weeks, but it was not significant at 12 weeks; whereas the response to betahistine was significant up to 12 weeks. A total of 28 adverse drug reactions (ADRs) were reported (53.6% with caroverine, 46.4% with betahistine). 24 ADRs were mild and 4 were moderate in intensity. There was no serious adverse event. Conclusions: Both the drugs are safe and efficacious in reducing the handicap of subjective tinnitus. A single IV infusion of caroverine may suffice for 4-6 weeks, so it may be repeated after 6 weeks to maintain the relief.