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. 2018 Dec 28;2018(12):CD013093. doi: 10.1002/14651858.CD013093.pub2

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:
  • Number randomised: 35 in betahistine group and 35 in multivitamin group

  • Number completed: not reported


Participant baseline characteristics:
  • Age (mean (SD) years): 48 (14) in betahistine group versus 49 (12) in multivitamin group

  • Gender (male/female, n): 35/0 in betahistine group versus 35/0 in multivitamin group

  • Tinnitus loudness (dB (SD)): 6 (2) in betahistine group versus 6 (2) in multivitamin group


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:
  • Tinnitus due to other causes

  • Diabetes

  • Hypertension

  • Peptic ulcer disease

  • Alcoholics

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
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