Oosterveld 1989.
Study characteristics | ||
Methods |
Allocation: randomised, but no further information Design: cross‐over with data extractable before cross‐over |
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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 |
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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 |
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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 | — |