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. 2016 Jun 21;2016(6):CD010696. doi: 10.1002/14651858.CD010696.pub2

Okamoto 1968.

Study characteristics
Methods Allocation: random number allocation from a table by independent person not connected with the trial
Design: parallel‐group
Participants Number: 40 randomised
Age: teens to 70s
Gender: 13 M, 23 F
Setting: specialist unit, Japan
Eligibility criteria: Ménière's disease (clinically defined)
Exclusion criteria: vertigo due to other causes, e.g. central disorders
Baseline characteristics: similar pre‐trial symptom scores
Interventions Betahistine 18 mg twice a day versus placebo over 2 weeks
Intervention group:
n = 18
Comparator group:
n = 18
Use of additional interventions: none
Outcomes Primary outcome: vertigo (3‐point ordinal scale)
Secondary outcomes: none
Funding sources Not stated
Declarations of interest Not stated
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number allocation from a table by independent person not connected with the trial (James 2001)
Allocation concealment (selection bias) Low risk Independently allocated identical bottles (James 2001)
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Double‐blind, but no further information
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Double‐blind, but no further information
Incomplete outcome data (attrition bias)
All outcomes High risk 2 (out of 20 randomised) patients withdrew from each group, not due to adverse effects (James 2001)
Participants lost to follow‐up: 4
Selective reporting (reporting bias) Low risk Appropriate outcomes reported
Other bias Unclear risk