Summary of findings for the main comparison. Positive pressure therapy versus placebo for Ménière's disease or syndrome.
| Positive pressure therapy versus placebo for Ménière's disease or syndrome | ||||||
| Patient or population: patients with Ménière's disease or syndrome Settings: ENT departments Intervention: positive pressure therapy versus placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Positive pressure therapy | |||||
| Proportion of days with vertigo in 4 weeks: vertigo scores > 2 Follow‐up: mean 4 weeks | The mean proportion of days with vertigo in 4 weeks (vertigo scores > 2) in the control groups was 0.11 | The mean proportion of days with vertigo in 4 weeks (vertigo scores > 2) in the intervention groups was 0.01 lower (0.08 lower to 0.06 higher) | 62 (1 study) | ⊕⊕⊕⊝ moderate1,2,3,4,5,6 | ||
| Cumulative vertigo scores after 4 months Follow‐up: mean 4 months | The mean cumulative vertigo score after 4 months in the control groups was 19.23 | The mean cumulative vertigo score after 4 months in the intervention groups was 3.68 lower (14.24 lower to 6.88 higher) | 68 (1 study) | ⊕⊕⊕⊝ moderate1,7 | ||
| Vertigo days in 4 months: vertigo scores > 2 Follow‐up: mean 4 months | The mean vertigo days in 4 months (vertigo scores > 2) in the control groups was 5.52 | The mean vertigo days in 4 months (vertigo scores > 2) in the intervention groups was 1.55 lower (5.4 lower to 2.3 higher) | 68 (1 study) | ⊕⊕⊕⊝ moderate1,7 | ||
| Vertigo frequency in the 8 weeks before and after 4 weeks of treatment Follow‐up: mean 12 weeks | The mean vertigo frequency in the 8 weeks before and after 4 weeks of treatment in the control groups was 4.0 | The mean vertigo frequency in the 8 weeks before and after 4 weeks of treatment in the intervention groups was 2.10 lower (5.25 lower to 1.05 higher) | 40 (1 study) | ⊕⊕⊕⊝ moderate1,2,8,9 | ||
| VAS scores for vertigo after 8 weeks of treatment Follow‐up: mean 12 weeks | The mean VAS score for vertigo after 8 weeks of treatment in the control groups was 46.6 | The mean VAS score for vertigo after 8 weeks of treatment in the intervention groups was 21.1 lower (35.47 to 6.73 lower) | 40 (1 study) | ⊕⊕⊕⊝ moderate1,2,8,9 | ||
|
Loss or gain of hearing in 4 months (dB) Follow‐up: mean 4 months |
The mean hearing threshold at 0.25 kHz to 1 kHz in 4 months in the control groups was 44.4 | The mean loss or gain of hearing in 4 months in the intervention groups was 7.38 higher (2.51 to 12.25 higher) | 123 (2 studies) | ⊕⊕⊕⊝ moderate1,2,3,4,5,6,7 | ||
|
Cumulative activity score Follow‐up: mean 4 months |
The mean activity score after 4 months in the control group was 20.23 |
The mean cumulative activity score in the intervention groups was 7.18 lower (17.68 lower to 3.32 higher) | 68 (1 study) | ⊕⊕⊕⊝ moderate1,7 | ||
|
Change in functional profile in the 8 weeks before and after 4 weeks of treatment Follow‐up: mean 12 weeks |
The mean change in functional profile in the 8 weeks before and after 4 weeks of treatment in the control group was 3.5 | The mean change in functional profile in the 8 weeks before and after 4 weeks of treatment in the intervention group was 1.10 lower (1.81 to 0.39 lower) | 40 (1 study) |
⊕⊕⊕⊝ moderate1,2,8,9 | ||
| Sick days in 4 months | The mean sick days in 4 months in the control groups was 1.73 | The mean sick days in 4 months in the intervention groups was 1.03 lower (3.59 lower to 1.53 higher) | 125 (2 studies) | ⊕⊕⊕⊝ moderate1,2,3,4,5,6,7 | ||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; 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. | ||||||
1Per‐protocol analysis while claiming an intention‐to‐treat analysis. 2No description of reasons for drop‐out or treatment failure. 3Overestimation of the effect of the placebo device (and underestimation of the effect of the Meniett device), because most treatment failures dropped out of the placebo group. 4The decrease in days with vertigo is not significantly different in the treatment group compared to the placebo group in any of the follow‐up months. 5Additional low‐sodium diet. 6A high proportion of participants used diuretics (80% in the placebo group and 73% in the active treatment group). 7Additional use of betahistine. 8Unclear statistics. 9Use of frequencies before insertion of the ventilation tube and after treatment, while claiming to rule out the effect of the ventilation tube.