Morgenstern 1997.
Study characteristics | ||
Methods | A 2‐armed (Gingko biloba and placebo), parallel‐group randomised controlled trial with 12 weeks duration of treatment and 4, 8 and 12 weeks duration of follow‐up | |
Participants |
Location: Hamburg, Germany Setting: single‐centre study, St. Georg Hospital, Hamburg, Germany Sample size:
Participant baseline characteristics:
Inclusion criteria: over 18 years old and chronic subjective tinnitus, normal hearing at 3 neighbouring frequencies in the audiogram Exclusion criteria: objective tinnitus, middle ear pathology, reproducibility of the transient evoked otoacoustic emissions at the intake examination < 85%, latency extensions or pathological wave models of earlier brain stem auditory evoked potentials (BAEPs), severe organic diseases, alcohol or drug abuse, pregnancy |
|
Interventions |
Intervention group: Ginkgo biloba coated tablets (40 mg of Gingko special extract EGb 761, a dry extract made from gingko biloba leaves (35 to 67:1), set to 9.6 mg gingko flavone glycoside and 2.4 mg of terpene lactone), 1 tablet 3 x day (120 mg), 12 weeks Comparator group: placebo coated tablets, 1 tablet 3 x day, 12 weeks Use of additional interventions: none reported |
|
Outcomes |
Primary outcome: change in tinnitus loudness measured with audiometric methods in the ear with louder tinnitus at 4, 8 and 12 weeks Secondary outcomes: change in tinnitus intensity measured with a scale of Subjective Evaluation of Tinnitus Intensity (0 to 5), click‐evoked otoacoustic emissions (OAEs) at 4, 8 and 12 weeks |
|
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 | Information on methods of random sequence generation not reported in the manuscript. |
Allocation concealment (selection bias) | Unclear risk | Information not reported in the manuscript. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blinding stated, methods not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Information not reported in the manuscript. |
Incomplete outcome data (attrition bias) All outcomes | High risk | There are no data regarding the primary outcome measure for 14 patients in the intervention group and 12 in the control group at 12 weeks. Dropout is not explained. |
Selective reporting (reporting bias) | Unclear risk | No values for secondary outcome measures are reported. Only brief statements regarding whether those improved or not. |
Other bias | Unclear risk | This is an abbreviated version of the full study report, which is not available. No prospective protocol available. No funding sources and declarations of interest reported. |