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The efficacy of betahistine dihydrochloride in the treatment of primary tinnitus: a randomized clinical trial study
  • Gustavo Leão Castilho,
  • Norimar Hernandes Dias,
  • Regina Helena Garcia Martins
Gustavo Leão Castilho
Universidade Estadual Paulista Julio de Mesquita Filho

Corresponding Author:[email protected]

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Norimar Hernandes Dias
Universidade Estadual Paulista Julio de Mesquita Filho
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Regina Helena Garcia Martins
Botucatu Medical School, UNESP-Univ Estadual Paulista
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Abstract Objective: To determine whether Betahistine dihydrochloride is effective in treating primary tinnitus in adults. Design: Intention-to-treat, randomized, triple-blinding, monocentric clinical trial Setting: Botucatu Medical School – State University of São Paulo (Unesp) in Brazil. Participants: 62 adults with primary tinnitus for at least six months (both sexes), and a Tinnitus Handicap Inventory score above 18 were randomized in two equal study groups: betahistine (24 mg of oral betahistine 12/12hs for 90 days), control group (a matched placebo). Main outcomes measures: Primary outcome measure - change in Tinnitus Handicap Inventory score; secondary outcome - Clinical Global Impression Improvement and participants’ perceived improvement after the intervention. Results: Participants had a median age (interquartile range) of 54 (48 to 60) years, with a balanced number of men and women. There was no significant difference in Tinnitus Handicap Inventory change before and after treatment between the study group and control (median difference of -2 points; 95% CI, -8 to 6 points); the Tinnitus Handicap Inventory after intervention was a median (interquartile range) of 4 (-4 to 14) lower in the betahistine group, and a median (interquartile range) of 2 (-6 to 10) lower in the placebo group. The secondary endpoint, covariate adjustment, and per-protocol analysis provided similar results, and side effects were without difference between both groups. Conclusion: Betahistine was ineffective when compared to the placebo in the treatment of the primary tinnitus .
05 Jul 2022Submitted to Clinical Otolaryngology
14 Jul 2022Submission Checks Completed
14 Jul 2022Assigned to Editor
26 Jul 2022Reviewer(s) Assigned
30 Aug 2022Review(s) Completed, Editorial Evaluation Pending
04 Sep 2022Editorial Decision: Revise Minor
06 Sep 20221st Revision Received
09 Sep 2022Assigned to Editor
09 Sep 2022Submission Checks Completed
11 Sep 2022Reviewer(s) Assigned
14 Sep 2022Review(s) Completed, Editorial Evaluation Pending
17 Sep 2022Editorial Decision: Revise Minor
18 Sep 20222nd Revision Received
26 Sep 2022Assigned to Editor
26 Sep 2022Submission Checks Completed
18 Oct 2022Review(s) Completed, Editorial Evaluation Pending
23 Oct 2022Editorial Decision: Accept