Publication:

Comparison of the safety and efficacy of caroverine and betahistine in patients of subjective tinnitus

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.