Legent 1988.
Study characteristics | ||
Methods |
Allocation: randomised, but no further information Design: parallel‐group |
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Participants |
Number: 81 Age: not specified Gender: not specified Setting: ENT departments, France Eligibility criteria: progressive episodic vertigo with or without cochlear symptomsExclusion criteria: central vertigo, BPPV, tumours, CNS disease, iatrogenic, ear disease, pregnancy, psychiatric disease, asthma, gastrointestinal disease Baseline characteristics: betahistine group slightly lower intensity and longer duration of attack scores; raw data not given |
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Interventions | Betahistine 16 mg 3 times a day for 3 months versus placebo n = 59 in total in analysis, but unclear how many in each group (intervention/comparator) Use of additional interventions: none |
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Outcomes | Primary outcome: proportion of patients with "good results"Secondary outcomes: intensity (5‐point scale), duration and frequency of attacks, global patient/doctor rating | |
Funding sources | One co‐author affiliated to manufacturer | |
Declarations of interest | One co‐author affiliated to manufacturer | |
Notes | Groups "similar at baseline" clinically but data not given | |
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 | Participants lost to follow‐up: 22. Numbers lost in each treatment arm unclear. |
Selective reporting (reporting bias) | High risk | Raw data for outcomes missing, e.g. patient and investigator satisfaction |
Other bias | Unclear risk | — |