Betahistine Uses in Menière's Disease
Betahistine may be offered as maintenance therapy to reduce the frequency and severity of vertigo attacks in patients with definite or probable Menière's disease, though the highest quality evidence (the BEMED trial) showed no significant benefit over placebo. 1
Primary Indication
Maintenance therapy for Menière's disease: Betahistine is used to reduce symptoms or prevent attacks in patients with active Menière's disease symptoms, not as an abortive treatment for acute attacks. 1, 2
Definite Menière's disease requires 2 or more episodes of vertigo lasting 20 minutes to 12 hours AND fluctuating or nonfluctuating sensorineural hearing loss, tinnitus, or pressure in the affected ear. 2
Probable Menière's disease has the same symptoms but vertigo episodes may last up to 24 hours. 2
Dosing Protocol
Standard Dosing
- Initial dose: 16 mg three times daily (48 mg/day total). 3
- Maintenance dose: 24-48 mg daily in divided doses. 3
- Standard treatment duration: At least 3 months to evaluate efficacy, with reassessment if no improvement after 6-9 months. 4
High-Dose Therapy for Refractory Cases
- For severe disease unresponsive to standard dosing: 288-480 mg/day may be considered, though this is based on case series evidence. 5
- High-dose betahistine (144 mg/day was studied in the BEMED trial but showed no benefit over placebo). 1
- Doses up to 480 mg/day appear well-tolerated with only mild, self-limiting side effects. 5
Evidence Quality and Controversy
Critical caveat: The most rigorous evidence contradicts older studies. The BEMED trial (a well-designed double-blind RCT) found no significant difference between placebo, low-dose (48 mg/d), and high-dose (144 mg/d) betahistine in reducing vertigo attacks over 9 months. 1 This contrasts sharply with a 2016 Cochrane review that reported a 56% reduction in vertigo with betahistine versus placebo, though those studies were of lower quality. 1
The American Academy of Otolaryngology-Head and Neck Surgery acknowledges this uncertainty and cannot make a definitive statement on betahistine's efficacy, yet still offers it as an option given the balance of potential benefits and minimal harms. 1
Additional Benefits Beyond Vertigo
Hearing preservation: Betahistine may prevent or reverse hearing deterioration in Menière's disease, with mean hearing levels improving by 6.35 dB after 6 months of treatment. 3
Predictors of hearing benefit: Younger age (<47 years), better initial hearing level (<38 dB HL), and shorter disease duration (<1.4 years) predict better hearing outcomes. 3
Tinnitus and ear fullness: Statistically significant improvement in tinnitus (p=0.010) and ear fullness (p=0.036) compared to placebo. 6
Contraindications and Precautions
Absolute Contraindications
- Pheochromocytoma: Betahistine is absolutely contraindicated due to potential serious adverse effects. 2, 4, 7
Use with Caution
- Asthma: Risk of bronchospasm. 2, 4, 7
- History of peptic ulcer disease: Potential gastrointestinal effects. 2, 4, 7
- Combination with serotonergic drugs: Monitor for serotonin syndrome. 4, 7
Not Indicated For
Combination Therapy
Dual therapy with piracetam: Vertigo episodes occurred significantly less often with combined betahistine and piracetam (p=0.027, OR: 4.9). 8
Diuretics as alternative or adjunct: May be offered alongside or instead of betahistine for maintenance therapy. 1, 2
Monitoring Requirements
Document changes in: Vertigo frequency/severity, tinnitus, hearing loss, and quality of life. 2
Follow-up audiograms: Consider obtaining to monitor hearing function. 2
Reassess efficacy regularly: Particularly if no improvement after 6-9 months of treatment. 4
Monitor for side effects: Headache, balance disorders, and upper gastrointestinal symptoms are common. 4
Clinical Decision-Making Algorithm
Confirm diagnosis of definite or probable Menière's disease with appropriate vestibular and auditory testing. 2
Exclude contraindications: Screen for pheochromocytoma, asthma, and peptic ulcer disease. 2, 4, 7
Initiate standard dosing: Start with 16 mg three times daily (48 mg/day). 3
Trial duration: Continue for at least 3-6 months before assessing efficacy. 4, 3
For inadequate response: Consider increasing to maintenance dose of 24-48 mg daily or, in severe refractory cases, higher doses up to 288-480 mg/day. 3, 5
Better outcomes expected in: Younger patients, those with shorter disease duration, and better baseline hearing. 3
Consider combination therapy: Add piracetam if monotherapy insufficient. 8
If no benefit after 6-9 months: Discontinue and consider alternative therapies such as diuretics or vestibular rehabilitation. 2, 4
Important Clinical Pearls
Individual dose titration is essential: No correlation exists between dose and effectiveness in population studies, suggesting personalized dosing is necessary. 8
Patient preference matters: Given the equivocal high-quality evidence, shared decision-making is appropriate. 2
Not for acute attacks: Use vestibular suppressants for acute vertigo episodes, not betahistine. 2