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 | — |