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 | — |