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

Oosterveld 1989.

Study characteristics
Methods Allocation: randomised, but no further information
Design: cross‐over with data extractable before cross‐over
Participants Number: 114 randomised
Age: < 65 years old
Gender: 46 F, 36 M
Setting: 18 ENT practices in the Netherlands
Eligibility criteria: episodic vertigo, at least 2 episodes of vertigo in the last month
Exclusion criteria: vertigo secondary to middle/inner ear infection, Parkinson's, brain tumour, head trauma, epilepsy, multiple sclerosis or ocular diseases
Baseline characteristics: baseline duration is longer in the placebo group
Interventions Betahistine 16 mg 3 times a day for 10 weeks (5 weeks prior to cross‐over)
Intervention group:
n = 38 analysed
Comparator group:
n = 44 analysed
Use of additional interventions: none
Outcomes Primary outcome: frequency, duration, severity of attacks (4‐point scale)Secondary outcomes: global rating by patient, unwanted signs and symptoms
Funding sources Not reported
Declarations of interest Not reported. Pharmaceutical company assisted with preparation of report.
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, 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 32 missing/excluded; unclear from which groups some of them originate
Participants lost to follow‐up: 32
Selective reporting (reporting bias) Low risk Appropriate outcomes reported
Other bias Unclear risk