Summary of findings 7. Physical barriers versus placebo for treating people with burning mouth syndrome.
| Physical barriers 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: physical barriers (tongue protector) 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 | Physical barriers | |||||
| Symptom relief: short‐term (≤ 3 months) ‐ Mean VAS pain score (Scale 0‐10: lower better) | 5.6 | 1.10 lower (2.14 to 0.06 lower) | ‐ | 50 (1 RCT) | ⊕⊝⊝⊝ very low1 | Single study assessing tongue protectors No data were available to estimate long‐term symptom relief |
| Change in quality of life (QoL): short‐term (≤ 3 months) ‐ Mean OHIP‐49 score (Scale 0‐196: lower better) | 53.72 | 9.20 lower (26.90 lower to 8.50 higher) | ‐ | 50 (1 RCT) | ⊕⊝⊝⊝ very low2 | Single study assessing tongue protectors No data were available to estimate long‐term change in QoL, or its surrogate markers: anxiety or depression |
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Change in QoL ‐ anxiety: short‐term (≤ 3 months) ‐ Mean HAD anxiety score (Scale 0‐21: lower better) |
11.04 | 0.16 higher (3.19 lower to 3.51 higher) | ‐ | ⊕⊝⊝⊝ very low3 | ||
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Change in QoL ‐ depression: short‐term (≤ 3 months) ‐ Mean HAD depression score (Scale 0‐21: lower better) |
8.92 | 0.64 lower (3.98 lower to 2.70 higher) | ‐ | ⊕⊝⊝⊝ very low4 | ||
| 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 | The single study narratively reported that no adverse events occurred from the use of tongue protectors | 50 (1 RCT) | ⊕⊕⊝⊝ low5 | |||
| *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; HAD: Hospital Anxiety and Depression scale; OHIP‐49: Oral Health Impact Profile‐49; OIS: optimal information size; RCT: randomised controlled trial; 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 twice due to serious concerns of risk of bias, relating to blinding and potential confounding influence of participants in receipt of anxiolytics; downgraded once due to imprecision: OIS not met. 2Assumed placebo risk based on mean placebo group quality of life score at short‐term (≤ 3 months) follow‐up; downgraded twice due to serious concerns of risk of bias, relating to blinding and potential confounding influence of participants in receipt of anxiolytics; downgraded twice due to imprecision: OIS not met, and 95% CI includes no effect. 3Assumed placebo risk based on mean placebo group anxiety score at short‐term (≤ 3 months) follow‐up; downgraded twice due to serious concerns of risk of bias, relating to blinding and potential confounding influence of participants in receipt of anxiolytics; downgraded twice due to imprecision: OIS not met, and 95% CI includes no effect; downgraded once due to indirectness: use of surrogate measure. 4Assumed placebo risk based on mean placebo group depression score at short‐term (≤ 3 months) follow‐up; downgraded twice due to serious concerns of risk of bias, relating to blinding and potential confounding influence of participants in receipt of anxiolytics; downgraded twice due to imprecision: OIS not met, and 95% CI includes no effect; downgraded once due to indirectness: use of surrogate measure. 5Downgraded twice due to serious concerns of risk of bias, relating to blinding and potential confounding influence of participants in receipt of anxiolytics; downgraded once due to imprecision: OIS not met.