Menière's disease, betahistine, randomised controlled trial
Conditions
Interventions
Betahistine 48 mg three times per day or betahistine 8 mg three times per day.
Sponsors
Prof. Dr. P.P.G. van Benthem (November 2015)
Functie/ Position: Hoogleraar Keel-, neus-, oorheelkunde │Opleiding/Education:
Studierichting/ Subject:
T: +31 55 844 8207 │ F: +31 55 581 8194 │E: p.van.benthem@gelre.nl
Prof. Dr. P.P.G. van Benthem (november 2015)
University Medical Centre Leiden
Head Otorhinolaryngolgy and Head- and Neck Surgery
P.O. Box 9600
2300 RC Leiden
Eligibility
Inclusion criteria
Inclusion criteria: 1. Unilateral MD (definite or probable) according to diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015. 2. Age > 18 years at the start of the trial. 3. ≥ 4 vertigo attacks over the last 6 months. 4. Willing to adhere to daily trial medication and the follow-up assessments.
Exclusion criteria
Exclusion criteria: 1.Bilateral MD. 2.Severe disability (e.g. neurological, orthopedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow-up. 3. Active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma). 4. Otitis media with effusion or perforation of the eardrum based on tympanogram results. 5. Contraindication for usage of betahistine e.g. known pheochromocytoma, bronchial asthma or allergy to this agent. 6. History of intratympanic injections with corticosteroids, gentamicin or ear surgery for treating MD. 7. Use of other antihistaminic agents or MAO inhibitors. 8. Women of child bearing age not using contraception, pregnant women or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete control of vertigo or reduction in vertigo attack frequence related to the dose of betahistine. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Frequency of co-interventions including: use of escape medication (metoclopramide) and intratympanic injections (dexamethason or gentamicin). 2. Change in pure tone audiometry scores. 3. Change in Functional Level Scale scores. 4. Change in Dizziness Handicap Index scores. 5. Change in Tinnitus Handicap Index scores. 6. Change in Multifrequency Tympanometry scores (Y width). 7. Frequency of adverse events. | — |
Contacts
Public ContactBabette van Esch
Apeldoorn Dizziness Center Gelre Hospital
Outcome results
None listed