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. 2018 Dec 28;2018(12):CD013093. doi: 10.1002/14651858.CD013093.pub2

Summary of findings 2. Betahistine versus placebo (with concurrent medication).

Betahistine compared with placebo for tinnitus (with concurrent medication)
Patient or population: patients with subjective idiopathic tinnitus
Settings: departments of otorhinolaryngology in hospitals worldwide
Intervention: betahistine
Comparison: placebo (vitamin B6)
Outcomes Treatment effects Relative effect
 (95% CI) No of participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
Placebo (vitamin B6) Betahistine
Change in tinnitus loudness match (range 0 to 5)
Follow‐up: 1 week
The mean tinnitus loudness match was 2.5 in the control group The mean tinnitus loudness match in the intervention group was 0.1 lower ‐0.10 (‐0.50 to 0.30) 60 (1) ⊕⊕⊕⊝
 moderate1  
Significant adverse effects (yes or no)
Follow‐up: 1 week
Study population RR 3.10 (0.13 to 73.14) 59 (1) ⊕⊕⊝⊝
 low2  
34 per 1000 0 per 1000
Tinnitus symptom severity Not measured
Depressive symptoms Not measured
Symptoms of generalised anxiety Not measured
Other adverse effects (yes or no)
Follow‐up: 1 week
Study population RR 0.44 (0.13 to 1.55) 59 (1) ⊕⊕⊕⊝
 moderate1  
103 per 1000 233 per 1000
CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence
 High‐quality: Further research is very unlikely to change our confidence in the estimate of effect.
 Moderate‐quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low‐quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low‐quality: We are very uncertain about the estimate.

1Downgraded one level due to an unclear overall risk of bias.

2Downgraded one level due to an unclear overall risk of bias; downgraded one level due to imprecision.