Duphar H108906NL 1990.
| Study characteristics | ||
| Methods |
Allocation: randomised, no further information Design: prospective, parallel‐group, single centre |
|
| Participants |
Number: 100 randomised Age: mean 56 (SD 12) in intervention group, mean 53 (SD 16) in placebo group Gender: 50 F, 24 M Setting: neurology department, Netherlands Eligibility criteria: vertigo 3 times a month or chronic Exclusion criteria: other specified medical conditions and medications. Previous trial with betahistine. Baseline characteristics: data not given |
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| Interventions | Betahistine 16 mg 3 times a day for 8 weeks Intervention group: n = 50 Comparator group: n = 50 Use of additional interventions: none |
|
| Outcomes | Primary outcome: duration of episodes in seconds, frequency of episodes per monthSecondary outcomes: patient and investigator global opinion | |
| Funding sources | Unpublished manufacturer data | |
| Declarations of interest | Unpublished manufacturer data | |
| Notes | Unpublished study | |
| 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"; no further information |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "double blind"; no further information |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 11 dropouts in betahistine group and 15 in placebo group; reasons unclear. Analysis was "as treated". Participants lost to follow‐up: 26. |
| Selective reporting (reporting bias) | High risk | Dropout data collected but not reported |
| Other bias | Unclear risk | — |