Okamoto 1968.
| Study characteristics | ||
| Methods |
Allocation: random number allocation from a table by independent person not connected with the trial Design: parallel‐group |
|
| Participants |
Number: 40 randomised Age: teens to 70s Gender: 13 M, 23 F Setting: specialist unit, Japan Eligibility criteria: Ménière's disease (clinically defined) Exclusion criteria: vertigo due to other causes, e.g. central disorders Baseline characteristics: similar pre‐trial symptom scores |
|
| Interventions | Betahistine 18 mg twice a day versus placebo over 2 weeks Intervention group: n = 18 Comparator group: n = 18 Use of additional interventions: none |
|
| Outcomes | Primary outcome: vertigo (3‐point ordinal scale) Secondary outcomes: none | |
| Funding sources | Not stated | |
| Declarations of interest | Not stated | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number allocation from a table by independent person not connected with the trial (James 2001) |
| Allocation concealment (selection bias) | Low risk | Independently allocated identical bottles (James 2001) |
| 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 | High risk | 2 (out of 20 randomised) patients withdrew from each group, not due to adverse effects (James 2001) Participants lost to follow‐up: 4 |
| Selective reporting (reporting bias) | Low risk | Appropriate outcomes reported |
| Other bias | Unclear risk | — |