A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus

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dc.contributor.authorCastilho, Gustavo Leão [UNESP]
dc.contributor.authorDias, Norimar Hernanes [UNESP]
dc.contributor.authorMartins, Regina Helena Garcia [UNESP]
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)
dc.date.accessioned2023-07-29T13:28:21Z
dc.date.available2023-07-29T13:28:21Z
dc.date.issued2023-01-01
dc.description.abstractObjectives: To evaluate the effectiveness of betahistine in the treatment of primary tinnitus. Design: To evaluate the effectiveness of betahistine in the treatment of primary tinnitus. Setting: Universidade estadual Paulista Julio de Mesquita Filho, Botucatu Medical School, São paulo, Brazil. Participants: Adult patients with primary tinnitus who had not undergone treatment for tinnitus in the last 6 months were included. Patients with profound sensorineural deafness, hearing aid users and patients with metabolic, neurological, psychiatric or decompensated cardiovascular diseases were excluded. Study groups: in the betahistine group, patients received betahistine 24 mg every 12 h for 90 days; in the control group, patients received placebo tablets every 12 h for 90 days. Mean Outcome Measures: Primary outcome measure: Tinnitus Handicap Inventory (THI). Secondary outcome measures: Clinical Global Impression Improvement (CGI-I) and a question of ‘Yes’ or ‘No’ to participants about their perception of improvement in symptoms. Results: Of 284 participants initially identified, 62 were randomised (betahistine group n = 31; control group n = 31). Median age (IQR) 54 (48–60) years, with a balanced number of men and women. There was no difference in THI outcome between the study groups (median difference, −2 points; 95% CI, −8 to 6 points); the THI after the intervention was a median (IQR) 4 (−4 to 14) lower points in the betahistine group, and a median (IQR) 2 (−6 to 10) in the control group. There was no statistical difference in secondary outcome measures. Adverse events were mild and there was no statistical difference between groups. Conclusions: Betahistine dihydrochloride was ineffective in the treatment of primary tinnitus in adults.en
dc.description.affiliationOphthalmology Otorhinolaryngology and Head and Neck Surgery Department Universidade Estadual Paulista Julio de Mesquita Filho Botucatu Medical School
dc.description.affiliationUnespOphthalmology Otorhinolaryngology and Head and Neck Surgery Department Universidade Estadual Paulista Julio de Mesquita Filho Botucatu Medical School
dc.format.extent50-57
dc.identifierhttp://dx.doi.org/10.1111/coa.13999
dc.identifier.citationClinical Otolaryngology, v. 48, n. 1, p. 50-57, 2023.
dc.identifier.doi10.1111/coa.13999
dc.identifier.issn1749-4486
dc.identifier.issn1749-4478
dc.identifier.scopus2-s2.0-85141815407
dc.identifier.urihttp://hdl.handle.net/11449/247878
dc.language.isoeng
dc.relation.ispartofClinical Otolaryngology
dc.sourceScopus
dc.subjectbetahistine dihydrochloride
dc.subjectclinical trial
dc.subjecttinnitus
dc.subjecttreatment
dc.titleA triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitusen
dc.typeArtigo
unesp.author.orcid0000-0003-3327-0050[1]
unesp.author.orcid0000-0003-4743-7894[2]
unesp.author.orcid0000-0003-0772-1962[3]

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