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.