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Betahistine for tinnitus (Protocol)

Hall, Deborah A.; Wegner, Inge; Smit, Adriana Leni; McFerran, Don; Stegeman, Inge

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Deborah A. Hall

Inge Wegner

Adriana Leni Smit

Don McFerran

Inge Stegeman


Background: Tinnitus describes 'ringing', 'whooshing' or 'hissing' sounds that are heard in the absence of any corresponding external sound. Between 5% and 43% of people experience this symptom and for some it has a significant negative impact on their quality of life. Tinnitus can be managed through education and advice, prescription devices that improve hearing, over-the-counter devices that generate background sounds, psychological therapy and relaxation therapy. Drug therapies are used to manage complaints associated with tinnitus such as sleep difficulties, anxiety or depression. No drug therapies exist that manage the tinnitus itself. Nonetheless, betahistine is often prescribed for tinnitus. The purpose of this review is to evaluate the evidence from high-quality clinical trials to work out the effect of betahistine on people's tinnitus. We particularly wanted to look at the effect of betahistine on tinnitus loudness and the side effects of betahistine.
Study characteristics: Our review identified five randomised controlled trials with a total of 303 to 305 participants who suffered from tinnitus. These studies compared participants receiving betahistine to those receiving a placebo. Four study designs allocated participants into parallel groups. In one study, participants consented to take all study medications in a pre-defined sequence. The outcomes that we evaluated included tinnitus loudness and intrusiveness, tinnitus symptoms and side effects.
Key results: The included studies did not show differences in tinnitus loudness, severity of tinnitus symptoms or side effects between participants receiving betahistine and participants receiving a placebo. No significant side effects were reported. We had planned to evaluate changes in tinnitus intrusiveness, depression and anxiety and quality of life, but these were not measured. The evidence suggests that betahistine is generally well tolerated with a similar risk of side effects to placebo.
Quality of the evidence: The quality of the evidence ranged from moderate to very low. The risk of bias in all of the included studies was unclear. The results were drawn from one or two studies only. In some studies, the participants that were included did not fully represent the entire population of people with tinnitus and so we cannot draw general conclusions.


Hall, D. A., Wegner, . I., Smit, A. L., McFerran, D., & Stegeman, I. (2018). Betahistine for tinnitus (Protocol). Cochrane Database of Systematic Reviews, 2018(8), Article CD013093.

Journal Article Type Article
Acceptance Date Apr 17, 2018
Online Publication Date Aug 28, 2018
Publication Date Aug 28, 2018
Deposit Date Jan 4, 2019
Publicly Available Date Aug 29, 2019
Publisher Cochrane Collaboration
Peer Reviewed Peer Reviewed
Volume 2018
Issue 8
Article Number CD013093
Public URL
Publisher URL


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