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

Duphar 77054 1983.

Study characteristics
Methods Allocation: randomised, but no further detail
Design: prospective, parallel‐group, single centre
Participants Number: 50 randomised
Age: up to 70
Gender: 22 M, 14 F
Setting: specialist centre
Eligibility criteria: vertigo "likely to be of peripheral origin", "stable for 2 or 3 months"Exclusion criteria: other significant medical conditions (specified in report)
Baseline characteristics: data provided in Table I and Table III of paper
Interventions Betahistine 12 mg 3 times a day versus placebo for 12 weeks
Intervention group:
n = 19
Comparator group:
n = 17
Use of additional interventions: none
Outcomes Primary outcome: vertigo severity (4‐point ordinal scale)Secondary outcomes: adverse effects
Funding sources Unpublished manufacturer data
Declarations of interest Unpublished manufacturer data
Notes Unpublished study
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 High risk Envelopes provided to participants stating allocation; returned sealed envelope collection not reported; opacity not stated
Blinding of outcome assessment (detection bias)
All outcomes High risk "Double blind", but no further information
Incomplete outcome data (attrition bias)
All outcomes High risk 50 randomised, 33 analysed; betahistine participants dropped out due to increased symptoms or high anxiety levels making assessment difficult; analysis is "as treated"
Participants lost to follow‐up: 14
Selective reporting (reporting bias) Unclear risk No protocol available for inspection
Other bias Unclear risk No exclusion of participants who had previously taken betahistine