Legent 1988.
| Study characteristics | ||
| Methods |
Allocation: randomised, but no further information Design: parallel‐group |
|
| 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 |
|
| 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 |
|
| 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 | — |