Fischer 1985.
Study characteristics | ||
Methods |
Allocation: randomised, but no further information Design: parallel‐group |
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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 |
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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 |
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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 | — |