Fucci 1992.
Study characteristics | ||
Methods | A 2‐armed (Gingko biloba and placebo), parallel‐group randomised controlled trial with 6 months duration of treatment and 3 and 6 months duration of follow‐up | |
Participants |
Location: Philadelphia, USA Setting: Department of Otorhinolaryngology, Temple University Medical School, Philadelphia, USA Sample size:
Participant baseline characteristics:
Inclusion criteria: participants with tinnitus Exclusion criteria: not reported |
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Interventions |
Intervention group: Ginkgo biloba extract (EGb, bioflavonoid) for 6 months Comparator group: placebo for 6 months Use of additional interventions: none reported |
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Outcomes |
Primary outcomes: tinnitus loudness and annoyance measured with numerical rating scales (1 to 10) at 3 and 6 months Secondary outcomes: pure tone air and bone conduction thresholds, speech discrimination scores, speech reception thresholds, impedance audiometry, tinnitus loudness matching levels, tinnitus minimum masking levels and tinnitus pitch matching frequencies at 3 and 6 months |
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Funding sources | No information provided | |
Declarations of interest | No information provided | |
Notes | Only conference abstract was available for the study. Author was contacted but did not provide additional data. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Author confirmed that study was randomised but did not provide further details. Methods not described. Author disclosed that there was a potential bias in the selection of participants. |
Allocation concealment (selection bias) | Unclear risk | Only brief abstract available. Information not provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Only brief abstract available. Information not provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Only brief abstract available. Information not provided. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only brief abstract available. No information provided regarding number of participants who completed the study and completeness of outcome measures. |
Selective reporting (reporting bias) | High risk | Only brief abstract available. Not clear if all outcomes were reported. No data for secondary outcomes reported. |
Other bias | High risk | Author expressed concerns regarding quality of the study; no additional details provided. No prospective protocol available. No funding sources and declarations of interest reported. |