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

Duphar H108906NL 1990.

Study characteristics
Methods Allocation: randomised, no further information
Design: prospective, parallel‐group, single centre
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
Interventions Betahistine 16 mg 3 times a day for 8 weeks
Intervention group:
n = 50
Comparator group:
n = 50
Use of additional interventions: none
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Funding sources Unpublished manufacturer data
Declarations of interest Unpublished manufacturer data
Notes Unpublished study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