High dose betahistine (48 mg three times per day, tid) is superior to low dose betahistine (8 mg tid) in reducing the frequency of vertigo attacks in patients diagnosed with definite unilateral MD.
ID
Bron
Verkorte titel
Aandoening
Menière's disease, betahistine, randomised controlled trial
Ondersteuning
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
Address: Albert Schweitzerlaan 31, P.O. Box 9014 7300 DS Apeldoorn
Telephone: 055-58181810
Email: j.van.suijlen@gelre.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Complete control of vertigo or reduction in vertigo attack frequence related to the dose of betahistine.
Achtergrond van het onderzoek
The effect of betahistine on vertigo attacks in patients with Meniere’s Disease (MD) has been investigated in several placebo-controlled randomized cross-over and parallel designed trials. Generally the authors concluded betahistine reduced vertigo attack frequency. A Cochrane review investigating this matter stated that due to the lack of high quality studies its clinical efficacy remains inconclusive. However, recent publications claim the existence of a dose-related effect of betahistine which needs to be further elucidated. As betahistine is registered as the only long-term treatment for MD patients in the Netherlands, performing a placebo-controlled trial would be unethical. Therefore, performing a dose-finding study is essential to clarify if a high dose betahistine (48 mg three times per day, tid) is superior to low dose betahistine (8 mg tid) in reducing the frequency of vertigo attacks in patients diagnosed MD.
Doel van het onderzoek
High dose betahistine (48 mg three times per day, tid) is superior to low dose betahistine (8 mg tid) in reducing the frequency of vertigo attacks in patients diagnosed with definite unilateral MD.
Onderzoeksproduct en/of interventie
Betahistine 48 mg three times per day or betahistine 8 mg three times per day.
Publiek
Babette van Esch
Albert Schweitzerlaan 31
Apeldoorn 7334 DZ
The Netherlands
+31 55 844 6343
B.van.esch@gelre.nl
Wetenschappelijk
Babette van Esch
Albert Schweitzerlaan 31
Apeldoorn 7334 DZ
The Netherlands
+31 55 844 6343
B.van.esch@gelre.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5263 |
| NTR-old | NTR5379 |
| Ander register | : GELRE.ADC.BETMEN.2015. |