Rejali 2004.
Study characteristics | ||
Methods | A 2‐armed (Gingko biloba and placebo), parallel‐group randomised controlled trial with 12 weeks duration of treatment and 12 weeks duration of follow‐up | |
Participants |
Location: Airdrie, UK Setting: single‐centre study, Department of Otolaryngology, Monklands Hospital Sample size:
Participant baseline characteristics:
Inclusion criteria: adult patients recruited from general otolaryngology outpatient clinics with tinnitus as their only or main presenting complaint Exclusion criteria: patients with active middle or external ear disease, known hypersensitivity to Ginkgo biloba and pregnant patients, and patients already on Ginkgo biloba, warfarin or with bleeding diatheses were excluded from the study |
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Interventions |
Intervention group: Ginkgo biloba tablets, 120 mg once a day, 12 weeks Comparator group: placebo tablets, 1 tablet a day, 12 weeks Use of additional interventions: none reported |
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Outcomes |
Primary outcome: change in tinnitus symptom severity measured with THI at 12 weeks Secondary outcomes: change in handicap caused by otolaryngological disease measured with Glasgow Health Status Inventory (GHSI) at 12 weeks; change in hearing determined by averaging air conduction thresholds for both ears at 0.5 kHz, 1 kHz, 2 kHz and 4 kHz at 12 weeks; adverse effects |
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Funding sources | Quote: "We acknowledge Lamberts Healthcare for the supply of G. biloba and placebo medication." | |
Declarations of interest | No information provided | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was carried out by an independent third party using a card from bag system. |
Allocation concealment (selection bias) | Low risk | Randomisation was carried out by an independent third party using a card from bag system. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The study was double‐blind. The patients received either 120 mg once daily sustained release formulation of Ginkgo biloba or placebo (all tablets provided by Lambert’s Health Care, TunbridgeWells, UK) for 12 weeks. |
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 | Small dropout (3 participants: 1 in intervention and 2 in placebo group); reasons for dropout explained. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Unclear risk | No prospective protocol available. No declarations of interest reported. Baseline tinnitus severity higher in the control group. |