Duphar H108906NL 1990.
Study characteristics | ||
Methods |
Allocation: randomised, no further information Design: prospective, parallel‐group, single centre |
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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 |
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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Funding sources | Unpublished manufacturer data | |
Declarations of interest | Unpublished manufacturer data | |
Notes | Unpublished study | |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 | — |