Ricci 1987.
Study characteristics | ||
Methods |
Allocation: "randomisation list" Design: parallel‐group |
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Participants |
Number: 10 analysed Age: mean 36 Gender: 6 M, 4 F Setting: outpatients, Italy Eligibility criteria: Ménière's syndrome, investigator‐definedExclusion criteria: allergy to betahistine, ulcer, other medical conditions as defined Baseline characteristics: similar baseline characteristics |
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Interventions | Betahistine 8 mg 3 times a day versus placebo for variable duration (10 x mean duration of interval between attacks for each patient) Intervention group: n = 5 Comparator group: n = 5 Use of additional interventions: none |
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Outcomes | Primary outcome: narrative only (description of each patient's history)Secondary outcomes: none | |
Funding sources | Not stated | |
Declarations of interest | Not stated | |
Notes | Participants lost to follow‐up: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomisation list" |
Allocation concealment (selection bias) | Unclear risk | Method not stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, but no further information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double‐blind, but no further information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information |
Selective reporting (reporting bias) | High risk | Limited outcome data and no information on adverse events |
Other bias | Unclear risk | — |