Summary of findings 2. Diuretic compared to placebo/no treatment for Ménière’s disease.
| Diuretic compared to placebo/no treatment for Ménière’s disease | ||||||
| Patient or population: Ménière’s disease Setting: outpatients Intervention: diuretic (isosorbide or amiloride/hydrochlorothiazide combination) Comparison: placebo/no treatment | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo/no treatment | Risk with diuretic | |||||
| Improvement in vertigo frequency Assessed with: self‐rated improvement in either frequency or severity of vertigo Follow‐up: range 6 months to ≤ 12 months |
Study population | RR 1.69 (1.13 to 2.53) | 70 (1 RCT) | ⊕⊝⊝⊝ very low1,2,3,4 | The evidence is very uncertain about the effect of diuretics on improvement in vertigo frequency at 6 to ≤ 12 months. | |
| 457 participants per 1000 would report that their vertigo had improved | 773 participants per 1000 would report that their vertigo had improved (from 517 to 1000) | |||||
| Change in vertigo frequency Assessed with: number of episodes during a 4 week‐period Follow‐up: range 3 months to ≤ 6 months |
The mean change in vertigo frequency was ‐1.4 episodes per 4 weeks | MD 2.44 episodes per 4 weeks lower (4.98 lower to 0.1 higher) | ‐ | 220 (1 RCT) | ⊕⊝⊝⊝ very low4,5,6,7 | The evidence is very uncertain about the effect of diuretics on the change in vertigo frequency at 6 to ≤ 12 months. |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
1High risk of bias for five domains in this study and unclear risk of bias for the remaining two domains.
2The criteria used for the diagnosis of Ménière's disease were poorly defined, therefore the population may not be appropriate.
3This outcome was reported as an improvement in either frequency or severity of attacks, not only frequency.
4Optimal information size was not reached (taken as < 300 events for dichotomous outcomes or < 400 participants for continuous outcomes, as a rule of thumb).
5High risk of performance and detection bias. Unclear risk of bias for multiple domains.
6All participants were also taking betahistine for the duration of the trial.
7Confidence interval ranges from a trivial effect to potential benefit.