[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Dexamethasone 1
Dexamethosone 2
Placebo
Included criteria: Unilateral Meniere disease, AAO-OH. 2 or more episodes of vertigo per month for 2 months before the study lead-in period and 2 or more episodes of definitive vertigo during the last 4-week lead in-periode: Meniere disease 20 years.
Excluded criteria: Exclusion criteria included infection in the ear, sinuses, or upper respiratory system; history of immunodeficiency disease or active or recent (G1 month before screening) middle ear disease; abnormality of the tympanic membrane in the affected ear that would preclude intratympanic injection; history of endo- lymphatic sac surgery; previous use of gentamicin in the affected ear; and use of systemic or intratympanic steroids within 1 month before screening.
Pretreatment: No apparent differences at baseline
Intervention Characteristics
Dexamethasone 1
Dexamethosone 2
Placebo
Anfaldshyppighed, SD
Alvorlige bivirkninger, n
Sværhedsgraden af tinnitus, THI, SD
Sponsorship source: Supported in full by Otonomy, Inc.
Country: USA
Setting: 15 centers in the United States.
Authors name: Paul R. Lambert
Institution: Otonomy, Inc.,
Email: clebel@otonomy.com
Address: Otonomy, Inc., 6275 Nancy Ridge Dr., Suite 100, San Diego, CA 92121, U.S.A.;
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Dexamethasone
Placebo
Included criteria: Key patient inclusion criteria were the following: ages 18 to85 years diagnosed with definite unilateral Me ́nie`re’s disease(2); patient recorded at least two definitive (a score of 2 – 4 fromthe vertigo severity scale) vertigo episodes during the 4-weeklead-in period and completed at least 22 of 28 diary entriesduring screening; patient agreed to maintain their current treat-ments for Me ́nie`re’s disease; women of childbearing potentialhad a negative pregnancy test before randomization and tookadequate contraceptive precautions for the duration ofthe study.
Excluded criteria: Patients were excluded from the study if they had any of thefollowing: infection in the sinuses or upper respiratory system;middle ear disease or a significant abnormality of the tympanicmembrane affecting the IT injection; a history of immunode-ficiency disease; previous use of IT gentamicin; previousendolymphatic sac surgery; tympanostomy tubes with evidenceof perforation or lack of closure; vertiginous migraine; dropattacks; systemic or IT steroids (within 1 month previous);experience of an adverse reaction to IT injection of steroids; orwomen who were pregnant or lactating.
Pretreatment: Baseline demographics weregenerally balanced across both groups.
Intervention Characteristics
Dexamethasone
Placebo
Anfaldshyppighed, SD
Alvorlige bivirkninger, n
Livskvalitet, SF-36, SD
Activity of daily living, DHI, SD
Tone audometri, SD
Sponsorship source: The trial and analyses were financially supported by Otonomy, Inc.
Country: USA
Setting: Fifty-two academic and community otolaryngologycenters.
Comments: clinicaltrials.gov Identifier NCT01412177
Authors name: Paul R. Lambert
Institution: Medical University of South Carolina
Email: lambertp@musc.edu
Address: Paul R. Lambert,M.D., Medical University of South Carolina, Charleston, SC 29425
Wrong intervention
Wrong intervention
Wrong study design
only abstract
only abstract
Wrong intervention
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Judgement Comment: Randomly assigned, unclear how
Quote: "generated permuted block randomization algorithm. OTO-104"
Quote: "Intervention Following the 4-week lead-in <b>period, eligible patients were randomly assigned to receive either 12 mg OTO-104 or placebo on Day 1 using a 1:1 allocation ratio based on a computer-</b> generated permuted block randomization algorithm."
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: Nothing mentioned
Judgement Comment: Nothing mentioned
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: Personnel was kept blinded
Quote: "The administering physicians were trained not to use video monitors or discuss the appearance of the injected materials that would unblind the study staff or patients."
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: Outcome assessors were blinded
Judgement Comment: The administering physicians were trained not to use video monitors or discuss the appearance of the injected materials that would unblind the study staff or patients.The physicians are not a part of the study staff??
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: No other apparent sources of bias
Judgement Comment: No other apparent sources of bias
Reporting bias due to selective outcome reporting
Judgement Comment: No other apparent sources of bias
Judgement Comment: Matches study protocol
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