Duphar 77054 1983.
Study characteristics | ||
Methods |
Allocation: randomised, but no further detail Design: prospective, parallel‐group, single centre |
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Participants |
Number: 50 randomised Age: up to 70 Gender: 22 M, 14 F Setting: specialist centre Eligibility criteria: vertigo "likely to be of peripheral origin", "stable for 2 or 3 months"Exclusion criteria: other significant medical conditions (specified in report) Baseline characteristics: data provided in Table I and Table III of paper |
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Interventions | Betahistine 12 mg 3 times a day versus placebo for 12 weeks Intervention group: n = 19 Comparator group: n = 17 Use of additional interventions: none |
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Outcomes | Primary outcome: vertigo severity (4‐point ordinal scale)Secondary outcomes: adverse effects | |
Funding sources | Unpublished manufacturer data | |
Declarations of interest | Unpublished manufacturer data | |
Notes | Unpublished study | |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 | High risk | Envelopes provided to participants stating allocation; returned sealed envelope collection not reported; opacity not stated |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "Double blind", but no further information |
Incomplete outcome data (attrition bias) All outcomes | High risk | 50 randomised, 33 analysed; betahistine participants dropped out due to increased symptoms or high anxiety levels making assessment difficult; analysis is "as treated" Participants lost to follow‐up: 14 |
Selective reporting (reporting bias) | Unclear risk | No protocol available for inspection |
Other bias | Unclear risk | No exclusion of participants who had previously taken betahistine |