Burkin 1967.
Study characteristics | ||
Methods |
Allocation: randomised, but no further details given Design: cross‐over with data extractable before cross‐over occurred |
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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 |
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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 |
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Outcomes |
Primary outcome: dizziness ‐ present or absent dichotomy Secondary outcomes: adverse events |
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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 | — |