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. 2022 Nov 16;2022(11):CD013514. doi: 10.1002/14651858.CD013514.pub2

Yarmohammadi 2007.

Study characteristics
Methods A 2‐armed (Ginkgo biloba and placebo), parallel‐group randomised controlled trial with 2 weeks duration of treatment and 2 weeks duration of follow‐up
Participants Location: Teheran, Iran
Setting: single‐centre study, otolaryngology clinic
Sample size:
  • Number randomised: 30 in Ginkgo biloba group and 30 in placebo group

  • Number completed: 30 in Ginkgo biloba group and 30 in placebo group


Participant baseline characteristics:
  • Age (mean (SD) years): 51.2 (SD 1.9) in Ginkgo biloba group versus 51.5 (SD 1.7) years in placebo group

  • Gender (male/female, n): 14/16 in Ginkgo biloba group versus 12/18 in placebo group

  • Other characteristics: baseline tinnitus symptom severity was not reported. Mean tinnitus duration was 51.2 (SD 9.1) months in the intervention group and 56.9 (SD 7.9) months in the placebo group. Tinnitus was unilateral in 56.7% of participants in the intervention group and 66.7% participants in the placebo group and bilateral in the rest of the participants. All participants had normal hearing.


Inclusion criteria: patients diagnosed with tinnitus and with no reduction of hearing who had a normal MRI were included in the study
Exclusion criteria: none
Interventions Intervention group: Ginkgo T.D. tablets (Tolid Darou Pharmaceutical Company), 40 mg, twice daily for 2 weeks
Comparator group: placebo tablets, 40 mg, twice daily for 2 weeks
Use of additional interventions: none reported
Outcomes Primary outcome: improvement in severity of tinnitus measured with undefined questionnaire at 2 weeks
Secondary outcomes: none
Funding sources Quote: "The authors would like to thank Tolid Darou Pharmaceutical Company for providing the medication and the placebo."
Declarations of interest No information provided
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: “The ginkgo T.D. tablets and the placebos were placed in an equal number of paper bags—30 bags containing ginkgo T.D. and 30 bags containing the placebo, labelling the bags with numbers. The doctor randomly administered the contents of the bags to the patients.”
Allocation concealment (selection bias) Unclear risk Bags with tablets but concealment methods not described (doctor randomly administered the contents of the bags to the patients).
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "In this study, the doctor and patients were unaware of the type of medication, with only the second co‐researcher in charge of numbering and packaging the bags being aware."
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Information not reported in the manuscript.
Incomplete outcome data (attrition bias)
All outcomes Low risk Data for all participants reported.
Selective reporting (reporting bias) High risk Questionnaire for tinnitus severity was not described; authors interpreted the result as no change, improvement and exacerbation but it is unclear what the criteria were for such classification.
Other bias Unclear risk No prospective protocol available. No declarations of interest reported. 

AD: Alzheimer's disease; CT: computerised tomography; MRI: magnetic resonance imaging; SD: standard deviation; SKT: Short Cognitive Performance Test (Syndrom‐Kurztest); THI: Tinnitus Handicap Inventory; VaD: vascular dementia