4. GRADE profile: Corticosteroids versus no treatment/placebo for Ménière's disease.
| Certainty assessment | Number of participants | Effect | Certainty | Importance | ||||||||
| № of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Corticosteroids | Placebo/no treatment | Relative (95% CI) | Absolute (95% CI) | ||
| Improvement in vertigo (follow‐up: range > 12 months; assessed with: AAO‐HNS class A, B or C) | ||||||||||||
| 1 | randomised trials | very seriousa | not serious | seriousb | seriousc,d | none | 8/8 (100.0%) | 8/8 (100.0%) | RR 1.00 (0.80 to 1.25) | 0 fewer per 1000 (from 200 fewer to 250 more) | ⊕⊝⊝⊝ Very low | |
| Improvement in vertigo: sensitivity analysis for complete/substantial improvement (follow‐up: range > 12 months; assessed with: AAO‐HNS class A or B) | ||||||||||||
| 1 | randomised trials | very seriousa | not serious | seriousb | seriousc | none | 8/8 (100.0%) | 1.0% | Peto OR 42.52 (6.37 to 283.65) | 290 more per 1000 (from 50 more to 731 more) | ⊕⊝⊝⊝ Very low | |
| 10.0% | 725 more per 1000 (from 314 more to 869 more) | |||||||||||
| Change in vertigo frequency (follow‐up: range 3 months to < 6 months; assessed with: number of episodes per day) | ||||||||||||
| 1 | randomised trials | very seriousa | not serious | seriousb | seriousc | none | 8 | 8 | — | MD 0.44 episodes per day fewer (0.7 fewer to 0.18 fewer) | ⊕⊝⊝⊝ Very low | |
| Disease‐specific health‐related quality of life (follow‐up: range > 12 months; assessed with: number of people in whom the FLS improved) | ||||||||||||
| 1 | randomised trials | very seriousa | not serious | seriousb | seriousc | none | 7/8 (87.5%) | 1.0% | Peto OR 28.03 (4.14 to 189.82) | 211 more per 1000 (from 00 more to 647 more) | ⊕⊝⊝⊝ Very low | |
| 10.0% | 657 more per 1000 (from 215 more to 855 more) | |||||||||||
| Other adverse effects ‐ steroid‐related side effects | ||||||||||||
| 1 | randomised trials | very seriousa | not serious | seriousb | very seriousc,d | none | 1/8 (12.5%) | 1.0% | Peto OR 7.39 (0.15 to 372.38) | 59 more per 1000 (from 8 fewer to 780 more) | ⊕⊝⊝⊝ Very low | |
| 10.0% | 351 more per 1000 (from 84 fewer to 876 more) | |||||||||||
CI: confidence interval; FLS: Functional Level Scale; MD: mean difference; OR: odds ratio; RR: risk ratio
aHigh risk of performance and detection bias. Potential for selective reporting.
bCriteria for diagnosis of Ménière's disease are not fully described. All participants received background interventions of diphenidol and acetazolamide.
cOptimal information size was not reached (taken as < 300 events for dichotomous outcomes or < 400 participants for continuous outcomes, as a rule of thumb).
dConfidence interval ranges from potential harm to potential benefit.