A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus
Autor(a) principal: | |
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Data de Publicação: | 2023 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1111/coa.13999 http://hdl.handle.net/11449/247878 |
Resumo: | Objectives: 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. |
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Repositório Institucional da UNESP |
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A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitusbetahistine dihydrochlorideclinical trialtinnitustreatmentObjectives: 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.Ophthalmology Otorhinolaryngology and Head and Neck Surgery Department Universidade Estadual Paulista Julio de Mesquita Filho Botucatu Medical SchoolOphthalmology Otorhinolaryngology and Head and Neck Surgery Department Universidade Estadual Paulista Julio de Mesquita Filho Botucatu Medical SchoolUniversidade Estadual Paulista (UNESP)Castilho, Gustavo Leão [UNESP]Dias, Norimar Hernanes [UNESP]Martins, Regina Helena Garcia [UNESP]2023-07-29T13:28:21Z2023-07-29T13:28:21Z2023-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article50-57http://dx.doi.org/10.1111/coa.13999Clinical Otolaryngology, v. 48, n. 1, p. 50-57, 2023.1749-44861749-4478http://hdl.handle.net/11449/24787810.1111/coa.139992-s2.0-85141815407Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengClinical Otolaryngologyinfo:eu-repo/semantics/openAccess2023-07-29T13:28:21Zoai:repositorio.unesp.br:11449/247878Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462023-07-29T13:28:21Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus |
title |
A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus |
spellingShingle |
A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus Castilho, Gustavo Leão [UNESP] betahistine dihydrochloride clinical trial tinnitus treatment |
title_short |
A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus |
title_full |
A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus |
title_fullStr |
A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus |
title_full_unstemmed |
A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus |
title_sort |
A triple blind, placebo controlled, randomised controlled trial of betahistine dihydrochloride in the treatment of primary tinnitus |
author |
Castilho, Gustavo Leão [UNESP] |
author_facet |
Castilho, Gustavo Leão [UNESP] Dias, Norimar Hernanes [UNESP] Martins, Regina Helena Garcia [UNESP] |
author_role |
author |
author2 |
Dias, Norimar Hernanes [UNESP] Martins, Regina Helena Garcia [UNESP] |
author2_role |
author author |
dc.contributor.none.fl_str_mv |
Universidade Estadual Paulista (UNESP) |
dc.contributor.author.fl_str_mv |
Castilho, Gustavo Leão [UNESP] Dias, Norimar Hernanes [UNESP] Martins, Regina Helena Garcia [UNESP] |
dc.subject.por.fl_str_mv |
betahistine dihydrochloride clinical trial tinnitus treatment |
topic |
betahistine dihydrochloride clinical trial tinnitus treatment |
description |
Objectives: 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. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023-07-29T13:28:21Z 2023-07-29T13:28:21Z 2023-01-01 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.1111/coa.13999 Clinical Otolaryngology, v. 48, n. 1, p. 50-57, 2023. 1749-4486 1749-4478 http://hdl.handle.net/11449/247878 10.1111/coa.13999 2-s2.0-85141815407 |
url |
http://dx.doi.org/10.1111/coa.13999 http://hdl.handle.net/11449/247878 |
identifier_str_mv |
Clinical Otolaryngology, v. 48, n. 1, p. 50-57, 2023. 1749-4486 1749-4478 10.1111/coa.13999 2-s2.0-85141815407 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Clinical Otolaryngology |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
50-57 |
dc.source.none.fl_str_mv |
Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
|
_version_ |
1792961692111470592 |