2. GRADE profile: Diuretic versus no treatment/placebo for Ménière's disease.
| Certainty assessment | Number of participants | Effect | Certainty | Comment | ||||||||
| № of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Diuretic | Placebo/no treatment | Relative (95% CI) | Absolute (95% CI) | ||
| Improvement in vertigo frequency (follow‐up: range 6 months to ≤ 12 months; assessed with: self‐rated improvement in either frequency or severity of vertigo) | ||||||||||||
| 1 | randomised trials | very seriousa | not serious | seriousb,c | seriousd | none | 27/35 (77.1%) | 16/35 (45.7%) | RR 1.69 (1.13 to 2.53) | 315 more per 1000 (from 59 more to 699 more) | ⊕⊝⊝⊝ Very low | |
| Change in vertigo frequency (follow‐up: range 3 months to ≤ 6 months; assessed with: number of episodes during a 4 week‐period) | ||||||||||||
| 1 | randomised trials | very seriouse | not serious | seriousf | seriousd,g | none | 110 | 110 | — | MD 2.44 episodes per 4 weeks lower (4.98 lower to 0.1 higher) | ⊕⊝⊝⊝ Very low | |
| Change in disease‐specific health‐related quality of life (follow‐up: range 3 months to < 6 months; assessed with: Korean DHI; scale from: 0 to 100) | ||||||||||||
| 1 | randomised trials | very seriouse | not serious | seriousf | seriousd | none | 110 | 110 | — | MD 2.94 points higher (3.86 lower to 9.74 higher) | ⊕⊝⊝⊝ Very low | |
| Change in hearing: continuous data only (follow‐up: range 3 months to < 6 months; assessed with: PTA change in hearing threshold) | ||||||||||||
| 1 | randomised trials | very seriouse | not serious | seriousf | seriousd | none | 110 | 110 | — | MD 0.94 dB HL lower (3.84 lower to 1.96 higher) | ⊕⊝⊝⊝ Very low | |
| Change in hearing: dichotomous data only (follow‐up: range 6 months to ≤ 12 months; assessed with: ≥ 10dB improvement with PTA on the "better hearing side") | ||||||||||||
| 1 | randomised trials | very seriousa | not serious | seriousb,h | seriousd | none | 23/36 (63.9%) | 13/36 (36.1%) | RR 1.77 (1.07 to 2.91) | 278 more per 1000 (from 25 more to 690 more) | ⊕⊝⊝⊝ Very low | |
| Change in tinnitus (follow‐up: range 3 months to < 6 months; assessed with: Korean THI; scale from: 0 to 100) | ||||||||||||
| 1 | randomised trials | very seriouse | not serious | seriousf | seriousd | none | 110 | 110 | — | MD 1.89 points higher (4.96 lower to 8.74 higher) | ⊕⊝⊝⊝ Very low | |
CI: confidence interval; DHI: Dizziness Handicap Inventory; MD: mean difference; PTA: pure tone average; RR: risk ratio
aHigh risk of bias for five domains in this study, and unclear risk of bias for the remaining two domains.
bThe criteria used for the diagnosis of Ménière's disease were poorly defined, therefore the population may not be appropriate.
cThis outcome was reported as an improvement in either the frequency or severity of attacks, not only frequency.
dOptimal information size was not reached (taken as < 300 events for dichotomous outcomes or < 400 participants for continuous outcomes, as a rule of thumb).
eHigh risk of performance and detection bias. Unclear risk of bias for multiple domains.
fAll participants were also taking betahistine for the duration of the trial.
gConfidence interval ranges from a trivial effect to potential benefit.
hThe study assessed the "better hearing side", which may not be appropriate (likely to be the ear without Ménière's disease).