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

Otto 2008.

Study characteristics
Methods Allocation: computer‐generated randomisation
Design: parallel‐group
Participants 26 with vertigo as part of "vertebrobasilar ischaemia" (see below, clinical diagnosis)
Number: 26 randomised, 22 analysed
Age: 31 to 70
Gender: (M:F) 7:19
Setting: ENT clinic, Germany
Eligibility criteria: vertigo with at least 2 of impaired hearing, impaired vision, tinnitus, headache ("vertebrobasilar ischaemia" according to authors), 2 weeks off anti‐vertigo drugsExclusion criteria: other causes of vertigo, other medical conditions (specified)
Baseline characteristics: baseline female predominance in placebo group
Interventions Betahistine 12 mg 3 times a day versus placebo for 4 weeks
Intervention group:
n = 13
Comparator group:
n = 13
Use of additional interventions: none, but study also included a third group treated with fixed combination of cinnarizine and dimenhydrinate, which was the main intervention of interest to the study authors
Outcomes Primary outcome: vertigo scores (4‐point scale)Secondary outcomes: overall efficacy rated by both patients and investigator on a 5‐point scale
Funding sources Not stated
Declarations of interest 1 co‐author affiliated to manufacturer
Notes Study was designed to compare betahistine and placebo with a third comparator group (fixed proprietary combination of dimenhydrinate and cinnarizine). Only the betahistine/placebo comparison is included in this review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation
Allocation concealment (selection bias) Unclear risk Method not stated
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 15% lost to follow‐up in each group
Participants lost to follow‐up: 4
Selective reporting (reporting bias) High risk Study was designed for a different purpose (assessment of the effect of a different drug)
Other bias Unclear risk