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

Fischer 1985.

Study characteristics
Methods Allocation: randomised, but no further information
Design: parallel‐group
Participants Number: 83 randomised
Age: 18 to 65
Gender: 43 F, 30 M
Setting: Netherlands
Eligibility criteria: episodic vertigo for at least 1 month prior to the beginning of the study and during this period for at least 2 episodes of dizzinessExclusion criteria: middle ear infections, cervical vertigo, head injury, cerebrovascular disease, epilepsy, Parkinson's, MS, pregnancy, patients on antihistamines, phenothiazines, vasodilators, barbiturates, tranquillisers
Baseline characteristics: baseline disease duration longer in betahistine group
Interventions Betahistine 16 mg 3 times a day versus placebo for 3 months
Intervention group:
n = 36
Comparator group:
n = 37
Use of additional interventions: none
Outcomes Primary outcome: vertigo intensity (4‐point ordinal scale), frequency and duration of attacks
Secondary outcomes: patient and physician global assessment
Funding sources One co‐author affiliated to manufacturer; statistical advice obtained from manufacturer
Declarations of interest As for funding sources
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 10 lost after randomisation and not included in analysis
Selective reporting (reporting bias) Low risk Appropriate outcomes reported
Other bias Unclear risk