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Betahistine for tinnitus.
Inge Wegner1, Deborah A Hall, Adriana Leni Smit
1Department of Otorhinolaryngology & Head and Neck Surgery, University Medical Center Utrecht, Utrecht, Netherlands.
The Cochrane Database of Systematic Reviews
|March 26, 2019
Summary
Betahistine does not appear to effectively treat subjective idiopathic tinnitus, showing no significant difference compared to placebo. While generally well-tolerated, further high-quality research is needed to confirm its efficacy for tinnitus management.
Area of Science:
- Otolaryngology
- Pharmacology
- Clinical Trials
Background:
- Tinnitus, the perception of sound without an external source, affects millions and poses a significant healthcare burden.
- Current management strategies for tinnitus include behavioral therapies, sound enrichment, and medications for co-morbid symptoms, but no drug is specifically approved.
- Betahistine is frequently prescribed for tinnitus in England despite a lack of regulatory approval.
Purpose of the Study:
- To evaluate the efficacy and safety of betahistine in individuals experiencing subjective idiopathic tinnitus through a systematic review of randomized controlled trials.
Main Methods:
- A comprehensive search of multiple databases (Cochrane ENT Register, MEDLINE, Embase, etc.) was conducted up to July 2018.
- Included were randomized controlled trials (RCTs) of patients with subjective idiopathic tinnitus, comparing betahistine to placebo, no intervention, or education.
- Primary outcomes were tinnitus loudness and adverse effects; secondary outcomes included symptom severity, mood, quality of life, and other adverse events.
Main Results:
- Five RCTs with 303-305 participants were reviewed, with unclear risk of bias across studies.
- No significant difference in tinnitus loudness was found between betahistine and placebo (mean difference -0.16, 95% CI -1.01 to 0.70; very low-quality evidence).
- No significant difference in tinnitus symptom severity was observed (mean difference 0.02, 95% CI -1.05 to 1.09; moderate-quality evidence), and other secondary outcomes were not consistently reported.
Conclusions:
- There is insufficient evidence to support the use of betahistine for subjective idiopathic tinnitus compared to placebo.
- Betahistine appears to be well-tolerated, with adverse effect profiles similar to placebo.
- Future research should employ rigorous methodology, including high-quality randomization and blinding, and utilize validated patient-centered outcome measures.
