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[PMID]:28818391
[Au] Autor:Bertlich M; Ihler F; Weiss BG; Freytag S; Strupp M; Jakob M; Canis M
[Ad] Endereço:Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Göttingen, Robert-Koch-Strasse 40, 37075 Göttingen, Germany. Electronic address: Mattis.Bertlich@med.uni-goettingen.de.
[Ti] Título:Role of capillary pericytes and precapillary arterioles in the vascular mechanism of betahistine in a guinea pig inner ear model.
[So] Source:Life Sci;187:17-21, 2017 Oct 15.
[Is] ISSN:1879-0631
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:AIMS: Betahistine is a histamine analogue that is used for the treatment of Menière's disease. Animal studies showed that it increases local blood flow in the stria vascularis. In terms of its mode of action, recent studies have prompted discussion of whether betahistine actively affects cochlear microcirculation by dilations of pericytes or of precapillary arterioles or by mere downstream effects. Hence, we investigated the effects of betahistine on cochlear capillary pericytes and precapillary arterioles. MAIN METHODS: The stria vascularis was visualized in 12 guinea pigs by in vivo fluorescence microscopy. In these, 152 pericytes were stained and local diameter at sites of pericyte somas and downstream controls as well as intravascular blood flow were measured before and after betahistine application. Moreover, in two guinea pigs the precapillary arterioles were visualized by 2-photon-microscopy before and after betahistine application. KEY FINDINGS: There was no significant change in capillary diameter at sites of pericyte somas after betahistine application compared to controls, baseline or downstream controls, even though cochlear blood flow increased significantly. The two-photon measurements indicated an active dilation of precapillary arterioles. SIGNIFICANCE: Since we found no evidence that betahistine affects cochlear microcirculation by cochlear pericytes, its main mode of action is evidently active dilation of pre-capillary arterioles. These findings are in line with similar effects reported in the central nervous system and indicate an active effect on cochlear microcirculation.
[Mh] Termos MeSH primário: Arteríolas/efeitos dos fármacos
beta-Histina/farmacologia
Orelha Interna/efeitos dos fármacos
Pericitos/efeitos dos fármacos
[Mh] Termos MeSH secundário: Animais
Arteríolas/fisiologia
Orelha Interna/irrigação sanguínea
Cobaias
Agonistas dos Receptores Histamínicos/farmacologia
Microscopia de Fluorescência
Microscopia de Fluorescência por Excitação Multifotônica
Pericitos/fisiologia
Vasodilatadores/farmacologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Histamine Agonists); 0 (Vasodilator Agents); X32KK4201D (Betahistine)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170921
[Lr] Data última revisão:
170921
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170819
[St] Status:MEDLINE


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[PMID]:28358888
[Au] Autor:Parfenov VA; Golyk VA; Matsnev EI; Morozova SV; Melnikov OA; Antonenko LM; Sigaleva EE; Situkho MI; Asaulenko OI; Popovych VI; Zamergrad MV
[Ad] Endereço:Neurology Department, I.M. Sechenov First Moscow State Medical University, Moscow, Russia.
[Ti] Título:Effectiveness of betahistine (48 mg/day) in patients with vestibular vertigo during routine practice: The VIRTUOSO study.
[So] Source:PLoS One;12(3):e0174114, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Vestibular vertigo is associated with substantially reduced quality of life. Betahistine is effective in improving vertigo-associated symptoms, with longer treatment periods leading to greater improvements; however, it is not known whether these effects persist after treatment cessation. METHODS: VIRTUOSO was a prospective, multinational, non-comparative, post-marketing observational programme investigating the effectiveness of betahistine (48 mg/day) and the course of vertigo after the discontinuation of treatment. Patients with vestibular vertigo who were prescribed 48 mg/day betahistine were enrolled in Russia and Ukraine. Treatment duration was up to 2 months, and patients were followed up for 2 months after discontinuation of betahistine. Efficacy endpoints included clinical response (assessed by change in vertigo severity), monthly attack frequency, and physician and patient grading of overall clinical response and improvement of vertigo-associated symptoms. RESULTS: Overall, 309 patients were enrolled and 305 completed the study. Clinical response was rated as good, very good or excellent in 74.1% of patients at end of treatment, with vertigo severity significantly decreased from baseline (p < 0.001). Monthly vertigo attack frequency decreased significantly during the 2 months of treatment (p < 0.001 from baseline) and further decreased during the 2-month follow-up (p < 0.001 from end of treatment). Overall, clinical response was graded as good or excellent by 94.4% of physicians and 95.4% of patients. Clinical improvement was considered either good or excellent by 82.6-90.5% of physicians and patients for nausea, vomiting and faintness. Only one adverse event was reported, with no serious adverse events. CONCLUSION: Our findings suggest that betahistine (48 mg/day) therapy is effective in treating vertigo in routine clinical settings. The observed effects persisted for 2 months after treatment cessation, suggesting that betahistine may facilitate lasting vestibular compensation.
[Mh] Termos MeSH primário: beta-Histina/uso terapêutico
Vertigem/tratamento farmacológico
Vestíbulo do Labirinto/efeitos dos fármacos
[Mh] Termos MeSH secundário: Adulto
Idoso
beta-Histina/administração & dosagem
beta-Histina/efeitos adversos
Esquema de Medicação
Feminino
Seres Humanos
Masculino
Meia-Idade
Estudos Prospectivos
Qualidade de Vida
Federação Russa
Ucrânia
Vestíbulo do Labirinto/patologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
X32KK4201D (Betahistine)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170828
[Lr] Data última revisão:
170828
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170331
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0174114


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[PMID]:27428039
[Au] Autor:Soni K; Bhatt C; Singh K; Bhuvaneshwari PC; Jha A; Patel P; Patel H; Srinivas NR
[Ad] Endereço:Zydus Research Centre, Bioanalytical Laboratory, Ahmedabad, India.
[Ti] Título:An LC-MS/MS assay for the quantitative determination of 2-pyridyl acetic acid, a major metabolite and key surrogate for betahistine, using low-volume human K EDTA plasma.
[So] Source:Biomed Chromatogr;31(2), 2017 Feb.
[Is] ISSN:1099-0801
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Betahistine is widely used for the treatment of vertigo. Owing to first-pass metabolism, 2-pyridyl acetic acid (2PAA, major metabolite of betahistine) was considered as surrogate for quantitation. A specific and sensitive LC-MS/MS method was developed and validated for quantitation of 2PAA using turbo-ion spray in a positive ion mode. A solid-phase extraction was employed for the extraction of 2PAA and 2PAA d (IS) from human plasma. Chromatographic separation of analytes was achieved using an ACE CN, 5 µm (50 × 4.6 mm) column with a gradient mobile phase comprising acetonitrile-methanol (90:10% v/v) and 0.7% v/v formic acid in 0.5 mm ammonium trifluoroacetate in purified water (100% v/v). The retention times of 1.15 and 1.17 min for 2PAA and internal standard, respectively, were achieved. Quantitation of 2PAA and internal standard was achieved by monitoring multiple reaction monitoring transition pairs (m/z 138.1 to m/z 92.0 and m/z 142.1 to m/z 96.1, respectively). The developed method was validated for various parameters. The calibration curves of 2PAA showed linearity from 5.0 to 1500 ng/mL, with a lower limit of quantitation of 5.0 ng/mL. The bias and precision for inter- and intra-batch assays were <10%. The developed method was used to support clinical sample analysis.
[Mh] Termos MeSH primário: Acetatos/sangue
beta-Histina/sangue
Piridinas/sangue
Espectrometria de Massas em Tandem/métodos
Vasodilatadores/sangue
[Mh] Termos MeSH secundário: Acetatos/metabolismo
beta-Histina/metabolismo
Cromatografia Líquida de Alta Pressão/métodos
Ácido Edético/sangue
Seres Humanos
Limite de Detecção
Piridinas/metabolismo
Tamanho da Amostra
Extração em Fase Sólida/métodos
Vasodilatadores/metabolismo
[Pt] Tipo de publicação:JOURNAL ARTICLE; VALIDATION STUDIES
[Nm] Nome de substância:
0 (2-pyridylacetic acid); 0 (Acetates); 0 (Pyridines); 0 (Vasodilator Agents); 9G34HU7RV0 (Edetic Acid); X32KK4201D (Betahistine)
[Em] Mês de entrada:1701
[Cu] Atualização por classe:170131
[Lr] Data última revisão:
170131
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160719
[St] Status:MEDLINE
[do] DOI:10.1002/bmc.3790


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[PMID]:28008227
[Au] Autor:El-Nabarawi MA; Ali AA; Aboud HM; Hassan AH; Godah AH
[Ad] Endereço:Department of Pharmaceutics, Faculty of Pharmacy, Cairo University, Cairo.
[Ti] Título:Transbuccal delivery of betahistine dihydrochloride from mucoadhesive tablets with a unidirectional drug flow: in vitro, ex vivo and in vivo evaluation.
[So] Source:Drug Des Devel Ther;10:4031-4045, 2016.
[Is] ISSN:1177-8881
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: Betahistine dihydrochloride (BH.2HCl), an anti-vertigo histamine analog used in the treatment of Ménière's disease, undergoes extensive first-pass metabolism and suffers from short biological half-life. The aim of the present work was to develop and estimate controlled release mucoadhesive buccal tablets of BH.2HCl with a unidirectional drug flow to overcome this encumbrance. METHODS: A direct compression method was adopted for preparation of the tablets using mucoadhesive polymers like guar gum, hydroxypropyl methyl cellulose K4M, sodium carboxymethyl cellulose and their combinations. The tablets were coated from all surfaces except one surface with a solution of 5% (w/v) cellulose acetate and 1% (w/v) dibutyl phthalate. Different permeation enhancers like 2% sodium deoxycholate, 2% sodium cholate hydrate (SCH) and 5% menthol were tested. Swelling index, ex vivo residence time, mucoadhesion strength, in vivo testing of mucoadhesion time, in vitro dissolution and ex vivo permeation were carried out. Furthermore, compatibility and accelerated stability studies were performed for the drug excipients. Finally, drug bioavailability of the BH.2HCl-optimized buccal mucoadhesive formulation was compared with that of the orally administered Betaserc 24 mg tablet in six healthy male volunteers. RESULTS: Formulation F10, which contained a combination of 35% guar gum and 5% sodium carboxymethyl cellulose, exhibited long adhesion time, high adhesion strength and diminished irritation to volunteers and showed zero-order release kinetics. SCH produced a significant enhancement in permeation of BH.2HCl across buccal mucosa. BH.2HCl-optimized buccal mucoadhesive formulation showed percentage relative bioavailability of 177%. CONCLUSION: The developed mucoadhesive tablets represent a promising alternative for the buccal delivery of BH.2HCl.
[Mh] Termos MeSH primário: beta-Histina/química
beta-Histina/farmacologia
Celulose/análogos & derivados
Ácido Desoxicólico/farmacologia
Sistemas de Liberação de Medicamentos/métodos
Galactanos/administração & dosagem
Mananas/administração & dosagem
Mucosa Bucal/química
Gomas Vegetais/administração & dosagem
[Mh] Termos MeSH secundário: Administração Bucal
beta-Histina/administração & dosagem
Disponibilidade Biológica
Celulose/química
Ácido Desoxicólico/química
Excipientes
Galactanos/química
Seres Humanos
Mananas/química
Gomas Vegetais/química
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Excipients); 0 (Galactans); 0 (Mannans); 0 (Plant Gums); 005990WHZZ (Deoxycholic Acid); 3J2P07GVB6 (acetylcellulose); 9004-34-6 (Cellulose); E89I1637KE (guar gum); X32KK4201D (Betahistine)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170515
[Lr] Data última revisão:
170515
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161224
[St] Status:MEDLINE
[do] DOI:10.2147/DDDT.S120613


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[PMID]:27824413
[Au] Autor:Pommer P
[Ti] Título:Betahistin reduziert Schwindelsymptome..
[So] Source:Dtsch Med Wochenschr;141(22):1607, 2016 Oct.
[Is] ISSN:1439-4413
[Cp] País de publicação:Germany
[La] Idioma:ger
[Mh] Termos MeSH primário: beta-Histina/uso terapêutico
Ensaios Clínicos Controlados Aleatórios como Assunto
Vertigem/tratamento farmacológico
Vertigem/epidemiologia
[Mh] Termos MeSH secundário: Vertigem Posicional Paroxística Benigna/tratamento farmacológico
beta-Histina/efeitos adversos
Seres Humanos
Prevalência
Resultado do Tratamento
Vasodilatadores/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Vasodilator Agents); X32KK4201D (Betahistine)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170817
[Lr] Data última revisão:
170817
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161109
[St] Status:MEDLINE


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[PMID]:27494687
[Au] Autor:Tang KT; Chao YH; Chen DY; Lim YP; Chen YM; Li YR; Yang DH; Lin CC
[Ad] Endereço:Ph.D. Program in Translational Medicine, National Chung Hsing University, Taichung, Taiwan; Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital, Taichung, Taiwan.
[Ti] Título:Betahistine attenuates murine collagen-induced arthritis by suppressing both inflammatory and Th17 cell responses.
[So] Source:Int Immunopharmacol;39:236-245, 2016 Oct.
[Is] ISSN:1878-1705
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:The objective of this study was to evaluate the potential therapeutic effects of betahistine dihydrochloride (betahistine) in a collagen-induced arthritis (CIA) mouse model. CIA was induced in DBA/1 male mice by primary immunization with 100µl of emulsion containing 2mg/ml chicken type II collagen (CII) mixed with complete Freund's adjuvant (CFA) in an 1:1 ratio, and booster immunization with 100µl of emulsion containing 2mg/ml CII mixed with incomplete Freund's adjuvant (IFA) in an 1:1 ratio. Immunization was performed subcutaneously at the base of the tail. After being boosted on day 21, betahistine (1 and 5mg/kg) was orally administered daily for 2weeks. The severity of CIA was determined by arthritic scores and assessment of histopathological joint destruction. Expression of cytokines in the paw and anti-CII antibodies in the serum was evaluated by ELISA. The proliferative response against CII in the lymph node cells was measured by (3)H-thymidine incorporation assay. The frequencies of different CII specific CD4(+) T cell subsets in the lymph node were determined by flow-cytometric analysis. Betahistine treatment attenuated the severity of arthritis and reduced the levels of pro-inflammatory cytokines, including TNF-α, IL-6, IL-23 and IL-17A, in the paw tissues of CIA mice. Lymph node cells from betahistine-treated mice showed a decrease in proliferation, as well as a lower frequency of Th17 cells. In vitro, betahistine suppressed CD4(+) T cell differentiation into Th17 cells. These results indicate that betahistine is effective in suppressing both inflammatory and Th17 responses in mouse CIA and that it may have therapeutic value as an adjunct treatment for rheumatoid arthritis.
[Mh] Termos MeSH primário: Anti-Inflamatórios/uso terapêutico
Artrite Experimental/tratamento farmacológico
Artrite Reumatoide/tratamento farmacológico
beta-Histina/uso terapêutico
Subpopulações de Linfócitos T/efeitos dos fármacos
Células Th17/efeitos dos fármacos
[Mh] Termos MeSH secundário: Animais
Anticorpos/sangue
Diferenciação Celular/efeitos dos fármacos
Proliferação Celular/efeitos dos fármacos
Células Cultivadas
Colágeno Tipo II/imunologia
Citocinas/sangue
Seres Humanos
Masculino
Camundongos
Camundongos Endogâmicos DBA
Subpopulações de Linfócitos T/imunologia
Células Th17/imunologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents); 0 (Antibodies); 0 (Collagen Type II); 0 (Cytokines); X32KK4201D (Betahistine)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170813
[Lr] Data última revisão:
170813
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160806
[St] Status:MEDLINE


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[PMID]:27416687
[Au] Autor:Holy R; Prazenica P; Stolarikova E; Dosel P; Fundova P; Kovar D; Astl J
[Ti] Título:Hyperbaric oxygen therapy in tinnitus with normal hearing in association with combined treatment.
[So] Source:Undersea Hyperb Med;43(3):201-5, 2016 May-Jun.
[Is] ISSN:1066-2936
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Tinnitus is a phantom perception of sound in the absence of overt acoustic stimulation. The focus of our attention is a combined therapy of tinnitus. In this prospective study (2013-2014) we evaluated the data of normal-hearing patients with tinnitus treated with various treatment modalities. In Group 1 we evaluated the data of 84 patients/124 ears after six weeks of treatment with betahistine dihydrochloride (72 mg). In Group 2, we evaluated the data of 36 patients/ 55 ears unimproved from Group 1 who were then treated for six weeks with hyperbaric oxygen (HBO2) therapy combined with gingko biloba extract (120 mg). In Group 1, tinnitus disappeared in 9.7%, alleviated in 18.5% and improved overall in 28.2%. Average intensity of tinnitus before/after treatment was 37 decibels (dB)/33 dB. Tinnitus intensities after treatment are statistically significantly lower (p = 0.001) than the values before treatment. In Group 2 tinnitus disappeared in 5.4%, 36.4% achieved alleviation, and 41.8% showed overall improvement. The average intensity of tinnitus before/after treatment was 41dB/ 38dB. The values of tinnitus intensity after combined therapy are statistically significantly lower (p = 0.046). We have shown that both methods treatment of tinnitus are statistically significant. HBO2therapy was recommended for the general public.
[Mh] Termos MeSH primário: beta-Histina/uso terapêutico
Audição
Oxigenação Hiperbárica
Extratos Vegetais/uso terapêutico
Zumbido/terapia
Vasodilatadores/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Idoso
Terapia Combinada/métodos
Feminino
Ginkgo biloba
Seres Humanos
Masculino
Meia-Idade
Estudos Prospectivos
Índice de Gravidade de Doença
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Plant Extracts); 0 (Vasodilator Agents); X32KK4201D (Betahistine)
[Em] Mês de entrada:1607
[Cu] Atualização por classe:160715
[Lr] Data última revisão:
160715
[Sb] Subgrupo de revista:IM; S
[Da] Data de entrada para processamento:160716
[St] Status:MEDLINE


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Registro de Ensaios Clínicos
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[PMID]:27362705
[Au] Autor:Kitahara T; Okamoto H; Fukushima M; Sakagami M; Ito T; Yamashita A; Ota I; Yamanaka T
[Ad] Endereço:Department of Otolaryngology, Nara Medical University, Kashihara-city, Nara, Japan.
[Ti] Título:A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere's Disease-A Pilot Study.
[So] Source:PLoS One;11(6):e0158309, 2016.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:UNLABELLED: Meniere's disease, a common inner ear condition, has an incidence of 15-50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere's patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control) traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I < II = III = IV). Hearing was improved in 7.1% of patients in Group-I, 35.7% in Group-II, 34.9% in Group-III, and 31.7% in Group-IV (statistically I < II = III = IV). Plasma vasopressin concentrations decreased more in Groups-II, -III, and -IV than in Groups-I (statistically I < II = III = IV), although patients' stress/psychological factors had not changed. Physicians have focused on stress management for Meniere's disease. However, avoidance of stress is unrealistic for patients who live in demanding social environments. Our findings in this pilot study suggest that interventions to decrease vasopressin secretion by abundant water intake, tympanic ventilation tubes and sleeping in darkness is feasible in treating Meniere's disease, even though these therapies did not alter reported mental/physical stress levels. TRIAL REGISTRATION: ClinicalTrials.gov NCT01099046.
[Mh] Termos MeSH primário: beta-Histina/uso terapêutico
Perda Auditiva/epidemiologia
Doença de Meniere/terapia
Ventilação da Orelha Média/métodos
Vasopressinas/sangue
Vertigem/epidemiologia
[Mh] Termos MeSH secundário: Adulto
Idoso
Gerenciamento Clínico
Ingestão de Líquidos
Feminino
Seguimentos
Perda Auditiva/terapia
Seres Humanos
Masculino
Doença de Meniere/metabolismo
Meia-Idade
Projetos Piloto
Sono
Resultado do Tratamento
Vertigem/etiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
11000-17-2 (Vasopressins); X32KK4201D (Betahistine)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170726
[Lr] Data última revisão:
170726
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160701
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0158309


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[PMID]:27327415
[Au] Autor:Murdin L; Hussain K; Schilder AG
[Ad] Endereço:Ear Institute, Faculty of Brain Sciences, University College London, London, UK.
[Ti] Título:Betahistine for symptoms of vertigo.
[So] Source:Cochrane Database Syst Rev;(6):CD010696, 2016 Jun 21.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Vertigo is a symptom in which individuals experience a false sensation of movement. This type of dizziness is thought to originate in the inner ear labyrinth or its neural connections. It is a commonly experienced symptom and can cause significant problems with carrying out normal activities. Betahistine is a drug that may work by improving blood flow to the inner ear. This review examines whether betahistine is more effective than a placebo at treating symptoms of vertigo from different causes. OBJECTIVES: To assess the effects of betahistine in patients with symptoms of vertigo from different causes. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 8); PubMed; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. We also contacted manufacturers and researchers in the field. The date of the search was 21 September 2015. SELECTION CRITERIA: We included randomised controlled trials of betahistine versus placebo in patients of any age with vertigo from any neurotological diagnosis in any settings. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Our primary outcome was the proportion of patients with reduction in vertigo symptoms (considering together the intensity, frequency and duration those symptoms). MAIN RESULTS: We included 17 studies, with a total of 1025 participants; 12 studies were published (567 patients) and five were unpublished (458 patients). Sixteen studies including 953 people compared betahistine with placebo. All studies with analysable data lasted three months or less. The majority were at high risk of bias, but in some the risk of bias was unclear. One study, at high risk of bias, included 72 people with benign paroxysmal positional vertigo (BPPV) and compared betahistine with placebo; all patients also had particle repositioning manoeuvres. The studies varied considerably in terms of types of participants, their diagnoses, the dose of betahistine and the length of time it was taken for, the study methods and the way any improvement in vertigo symptoms was measured. Using the GRADE system, we judged the quality of evidence overall to be low for two outcomes (proportion of patients with improvement and proportion with adverse events).Pooled data showed that the proportion of patients reporting an overall reduction in their vertigo symptoms was higher in the group treated with betahistine than the placebo group: risk ratio (RR) 1.30, 95% confidence interval (CI) 1.05 to 1.60; 606 participants; 11 studies). This result should be interpreted with caution as the test for statistical heterogeneity as measured by the I(2) value was high.Adverse effects (mostly gastrointestinal symptoms and headache) were common but medically serious events in the study were rare and isolated: there was no difference in the frequency of adverse effects between the betahistine and placebo groups, where the rates were 16% and 15% respectively (weighted values, RR 1.03, 95% CI 0.76 to 1.40; 819 participants; 12 studies).Sixteen per cent of patients from both the betahistine and the placebo groups withdrew (dropped out) from the studies (RR 0.96, 95% CI 0.65 to 1.42; 481 participants; eight studies).Three studies looked at objective vestibular function tests as an outcome; the numbers of participants were small, techniques of measurement very diverse and reporting details sparse, so analysis of this outcome was inconclusive.We looked for information on generic quality of life and falls, but none of the studies reported on these outcomes. AUTHORS' CONCLUSIONS: Low quality evidence suggests that in patients suffering from vertigo from different causes there may be a positive effect of betahistine in terms of reduction in vertigo symptoms. Betahistine is generally well tolerated with a low risk of adverse events. Future research into the management of vertigo symptoms needs to use more rigorous methodology and include outcomes that matter to patients and their families.
[Mh] Termos MeSH primário: beta-Histina/uso terapêutico
Vertigem/tratamento farmacológico
[Mh] Termos MeSH secundário: Vertigem Posicional Paroxística Benigna/tratamento farmacológico
beta-Histina/efeitos adversos
Seres Humanos
Ensaios Clínicos Controlados Aleatórios como Assunto
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Nm] Nome de substância:
X32KK4201D (Betahistine)
[Em] Mês de entrada:1608
[Cu] Atualização por classe:170922
[Lr] Data última revisão:
170922
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160622
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD010696.pub2


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[PMID]:27178513
[Au] Autor:Albu S; Nagy A; Doros C; Marceanu L; Cozma S; Musat G; Trabalzini F
[Ad] Endereço:II-nd Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca Cluj-Napoca, Romania; RoNeuro Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania. Electronic address: silviualbu63@gmail.com.
[Ti] Título:Treatment of Meniere's disease with intratympanic dexamethazone plus high dosage of betahistine.
[So] Source:Am J Otolaryngol;37(3):225-30, 2016 May-Jun.
[Is] ISSN:1532-818X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: The aim of the present study was to assess if the combined therapy of intratympanic dexamethasone (ITD) and high dosage of betahistine (HDBH) is able to provide increased vertigo control compared to ITD alone in patients suffering from definite unilateral Meniere's disease (MD). MATERIALS AND METHODS: Consecutive MD patients were enrolled and randomly divided in two groups, each comprising 33 cases. Group A received a combination of ITD and identical-appearing placebo pills while Group B received a combination of ITD and HDBH. ITD protocol consisted of three consecutive daily injections. HDBH comprised 144mg/day (48mg tid). The main outcome measures were: 1) vertigo class, pure tone average (PTA), speech discrimination score (SDS) and Functional Level Score (FLS) according to the American Academy of Otolaryngology-Head and Neck Surgery criteria; 2) complete and substantial vertigo control according to the Kaplan-Meier survival method. RESULTS: Sixty two patients completed the 24-month follow-up. A complete vertigo control was achieved in 14 patients (44%) from Group A and in 22 patients (73.3%) from Group B, statistically significant (p=0.01). Complete vertigo relief is also significant according to the Kaplan-Meier method: p=0.027, log rank test. Substantial vertigo control was obtained in 21 patients (65.6%) in Group A and 27 patients (90%) in Group B. The difference is statistically significant, p=0.02. The difference is significant according to the Kaplan-Meier method: p=0.035, log rank test. No significant differences between hearing levels and tinnitus scores were demonstrated between the groups. CONCLUSIONS: Our preliminary results demonstrate that complete and substantial vertigo control is significantly higher in patients treated with a combination of HDBH and ITD.
[Mh] Termos MeSH primário: Anti-Inflamatórios/uso terapêutico
beta-Histina/uso terapêutico
Dexametasona/uso terapêutico
Agonistas dos Receptores Histamínicos/uso terapêutico
Doença de Meniere/dietoterapia
Vertigem/prevenção & controle
[Mh] Termos MeSH secundário: Adulto
Quimioterapia Combinada
Feminino
Seres Humanos
Injeção Intratimpânica
Masculino
Doença de Meniere/complicações
Estudos Prospectivos
Resultado do Tratamento
Vertigem/etiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents); 0 (Histamine Agonists); 7S5I7G3JQL (Dexamethasone); X32KK4201D (Betahistine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171002
[Lr] Data última revisão:
171002
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160515
[St] Status:MEDLINE



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