Maqbool 2010.
Methods | A 2‐armed, parallel‐group randomised controlled trial with 2 months duration of treatment and 2 months duration of follow‐up | |
Participants |
Location: Rawalpindi, Pakistan Setting: single‐centre study, Department of Otorhinolaryngology, Combined Military Hospital Rawalpindi, from July 2006 to December 2006 Sample size:
Participant baseline characteristics:
Inclusion criteria: patients aged over 18 years with tinnitus due to noise‐induced hearing loss with a confirmed history of exposure to noise and confirmed hearing loss at 3 or 4 kHz Exclusion criteria:
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Interventions |
Intervention group: betahistine hydrochloride tablets, 48 mg daily (16 mg 3 times a day), 2 months Comparator group: multivitamin tablets, 3 tablets daily (1 tablet 3 times a day), 2 months Use of additional interventions: none reported |
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Outcomes | Tinnitus loudness measured using a visual analogue scale (range 0 to 10) at 1 month and 2 months | |
Funding sources | No information provided | |
Declarations of interest | No information provided | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Methods of randomisation not reported |
Allocation concealment (selection bias) | Unclear risk | Methods of allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported whether participants and/or personnel were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported whether outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported whether participants dropped out or were lost to follow‐up. Not reported whether outcome data were missing. |
Selective reporting (reporting bias) | Low risk | There is no protocol available. The outcomes listed in the patients and methods section of the article are all reported in the results section of the article. |
Other bias | Unclear risk | Conflicts of interest and funding were not reported |