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

Burkin 1967.

Study characteristics
Methods Allocation: randomised, but no further details given
Design: cross‐over with data extractable before cross‐over occurred
Participants Number: 22 analysed
Age: 37 to 58
Gender: 50% female
Setting: ENT department
Eligibility criteria: investigator's clinical diagnosis of Ménière's disease
Exclusion criteria: not specified
Baseline characteristics: not given
Interventions Betahistine 4 mg 4 times a day versus placebo over 2 weeks before cross‐over
Intervention group:
n = 11
Comparator group:
n = 11
Use of additional interventions: none
Outcomes Primary outcome: dizziness ‐ present or absent dichotomy
Secondary outcomes: adverse events
Funding sources Not specified
Declarations of interest Not given
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomised"; no further information
Allocation concealment (selection bias) Unclear risk Method not stated
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Double‐blind; "neither patient nor investigator knew which group" but no further details
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Double‐blind
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No information
Participants lost to follow‐up: not specified
Selective reporting (reporting bias) Low risk Appropriate outcomes
Other bias Unclear risk