[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Overall
Included criteria: Patients of both genders, aged between 18 and 60 years, diagnosed with definite Ménière’s disease by an ENT, and with complaints of dizziness in the disease’s intercritical periods were enrolled in the study.
Excluded criteria: Patients diagnosed with bouts of the disease by the ENT physician immediately before the beginning of the study were excluded, as were subjects with rheumatic diseases, uncontrolled high blood pressure, heart disease, severe visual involvement or decompensated involvement despite contact lenses, orthopedic disorders resulting in motion limitation or use of lower limb prostheses, psychia-tric disorders, individuals submitted to stem cell transplant, patients unable to comprehend and obey simple verbal commands or stand independently in an orthostatic posi-tion, subjects who drank alcohol 24 hours before the tests, patients submitted to balance rehabilitation programs in the six months prior to the study, subjects who missed three consecutive body balance rehabilitation sessions, and those who failed to follow the orientations proposed by the authors of the study.
Pretreatment: No statistically significant differences were found between the groups in terms of age, gender, and duration, periodicity or time since onset of dizzy spells.
Intervention Characteristics
Intervention 1
Control
Disease severity, SD (Dizziness visual analogue scale)
ADL, SD
Stability limit, SD
CS/eyes closed, SD
Country: Brazil
Authors name: Adriana Pontin Garcia
Institution: Graduate Program on Human Communica on Disorders of the Federal University of São Paulo - Paulista Medical School (UNIFESP-EPM). (Professor in the Speech and Hearing Therapy Program at FMU).
Email: evista@aborlccf.org.br
Address: Av. Eng. Alberto de Zago s, no 897. São Paulo - SP. Brazil. CEP: 04675-085.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Overall
Included criteria: Members were eligible for participation if theyhad experienced symptoms of dizziness or imbalance over the past 12 months,had not had any severe vertigo attacks within the last 6 weeks, had consultedtheir GP to check there were no medical reasons why they should not take partin the trial, and could be contacted by post for the key stages of the trial.
Excluded criteria: Members were excluded if they reported having a vestibular disorder otherthan Me´nie`re disease.
Pretreatment:
Intervention Characteristics
Intervention 1
Control
Quality of life, n (number of patients getting better)
Disease severity, SD (VSS-SF)
ADL, SD
Sponsorship source: Projekt grant from Ménière's Society
Country: England
Authors name: Lucy Yardley
Institution: School of Psychology, University of Southhampton
Email: L.Yardley@soton.ac.uk
Address: School of Psychology, University of Southhampton. Highfield, Southhampton SO17, 1BJ, UK
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Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "The 44 patients diagnosed with unilateral or bilateral definite Ménière’s disease were divided into case and control groups according to a table with uniformly distributed random numbers produced by a computer program."
Judgement Comment: An independent research administratorallocated participants to the intervention arms using a computer randomizationprogram
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: Nothing mentioned
Judgement Comment: and sent each participant a letter informing them which interventiongroup they had been assigned to
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Quote: "Patients were informed of all treatment phases and of the occurrence of dizzy spells during the exercises, par- ticularly in the early sessions. They were also made aware of the importance of complying with the exercise regimen."
Judgement Comment: There is nothing mentioned on blinding
Judgement Comment: and sent each participant a letter informing them which interventiongroup they had been assigned to
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: Nothing mentioned on blinding
Judgement Comment: and sent each participant a letter informing them which interventiongroup they had been assigned to
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Reporting bias due to selective outcome reporting
Judgement Comment: No apparent sources of bias
Judgement Comment: No other apparent sources of bias
Bias due to problems not covered elsewhere in the table
Judgement Comment: No other apparent sources of bias
Judgement Comment: No other apparent sources of bias