[Summary text]
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Overall
Included criteria: All patients were adults over 18 years old age, affected by a stage 2, or greater, unilateral definite Menière’s disease, according to the AAO-NHS criteria 2. They were included if they experienced at least two episodes of rotatory vertigo in the preceding two months (vertigo lasting at least 20 minutes, with a free interval of 12 hours), with or without associated tinnitus, and/or a sensation of fullness in the ear. Moreover, the impact of vertigo on the patient’s daily life had to be at level 3 at least on the functionality level according to AAO- HNS criteria.
Excluded criteria: Patients having undergone surgical treatment or chemical labyrinthectomy for Menière’s disease were excluded
Pretreatment: No other apparent differences at baseline
Intervention Characteristics
Intervention 1
Control
Anfaldshyppighed, mean SEM
Activities of daily life, mean SEM
Number of vertigo attackts, n (improvement in 2nd phase, 2nd period)
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Quote: "Randomization was performed by blocks of four. Each center received a block of four devices (2 Meniett® and 2 Placebo). If necessary, according to the rate of inclusion in a given center, more blocks of four devices were attributed to the center."
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Quote: "The boxes were randomly numerated and the physician did not know their content, and had to distribute them to the patients. The placebo was identical in all aspects to the active device, but did not generate pressure pulses."
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Quote: "The boxes were randomly numerated and the physician did not know their content, and had to distribute them to the patients. The placebo was identical in all aspects to the active device, but did not generate pressure pulses. The"
Judgement Comment: Mentioned as double-blinded
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Detection bias due to knowledge of the allocated interventions by outcome assessors
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Judgement Comment: Nothing mentioned
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Attrition bias due to amount, nature or handling of incomplete outcome data
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Judgement Comment: No dropouts
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Reporting bias due to selective outcome reporting
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Judgement Comment: No apparent sources of bias
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Bias due to problems not covered elsewhere in the table
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015
Judgement Comment: No apparent sources of bias
For more information see: Van Sonsbeek et al "positive pressure therapy for Meniere" cochrane library 2015