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. 2016 Jun 21;2016(6):CD010696. doi: 10.1002/14651858.CD010696.pub2

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