Summary of findings for the main comparison. Antidepressants versus placebo for treating people with burning mouth syndrome.
| Antidepressants compared with placebo for treating burning mouth syndrome | ||||||
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Patient or population: people diagnosed with burning mouth syndrome Settings: secondary care Intervention: antidepressants (trazodone) Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Antidepressants | |||||
|
Symptom relief: short‐term (≤ 3 months) ‐ Mean VAS pain score (Scale 0‐10: lower better) |
4.66 | 1.26 higher (0.24 lower to 2.76 higher) | ‐ | 37 (1 RCT) | ⊕⊝⊝⊝ very low1 | Only trazodone was assessed by a single study No data were available to estimate long‐term symptom relief No data were available to estimate the effect of other antidepressants |
| Change in quality of life (QoL): short‐term (≤ 3 months) ‐ Mean Beck Depression Inventory score(Scale 0‐63: lower better) | This single study narratively reported that both intervention and placebo participants were less depressed at trial completion, but there was no evidence of a difference between groups | 37 (1 RCT) |
⊕⊝⊝⊝ very low2 | Single study assessing trazodone No data were available to estimate long‐term change in QoL |
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| Change in taste | No included studies reported change in taste | |||||
| Change in feeling of dryness | No included studies reported change in feeling of dryness | |||||
| Adverse effects | There was evidence of an increase in dizziness (RR 11.61, 95% CI 1.66 to 81.04) and drowsiness (RR 4.75, 95% CI 1.18 to 19.07) in people treated with antidepressants | 37 (1 RCT) | ⊕⊝⊝⊝ very low3 | Only trazodone was assessed by a single study No data were available to estimate the harms of other antidepressants |
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| *The basis for the assumed risk is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI) CI: confidence interval; OIS: optimal information size; RCT: randomised controlled trial; RR: risk ratio; VAS: visual analogue scale | ||||||
| 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 | ||||||
1Assumed placebo risk based on mean placebo group pain score at short‐term (≤ 3 months) follow‐up; downgraded once due to risk of bias: unclear risk of attrition and reporting biases; downgraded once due to indirectness: concerns relating to applicability, only 1 type of antidepressant assessed, effects of other antidepressants may differ; downgraded twice due to imprecision: OIS not met, and 95% CI includes no effect. 2Downgraded once due to unclear risk of attrition and reporting biases; downgraded twice due to indirectness: use of surrogate measure, and also concerns relating to applicability (only 1 type of antidepressant assessed, effects of other antidepressants may differ); downgraded once due to imprecision: OIS not met. 3Downgraded once due to risk of bias: unclear risk of attrition and reporting biases; downgraded once due to indirectness: concerns relating to applicability, only 1 type of antidepressant assessed, effects of other antidepressants may differ; downgraded twice due to imprecision: OIS not met, and narrative report did not permit estimation of effect or 95% CI.