Cekkayan 1996.
Study characteristics | ||
Methods | A 3‐armed (betahistine, Gingko biloba and placebo), parallel‐group randomised controlled trial with 3 months duration of treatment and 3 months duration of follow‐up | |
Participants |
Location: Malatya, Turkey Setting: single‐centre study, Department of Otorhinolaryngology, Inönü University, from September 1993 to April 1994 Sample size:
Participant baseline characteristics:
Inclusion criteria: patients with subjective tinnitus Exclusion criteria: none |
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Interventions |
Intervention group: Ginkgo biloba tablets (9.6 mg ginkgo glycoside/tablet; Tebokan Fort tbl./Rökan/Tebonin), 1 tablet 3 times a day, 3 months Comparator group: placebo capsules, 1 capsule 3 times a day, 3 months Use of additional interventions: none reported |
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Outcomes | Primary outcome: change in tinnitus severity scale (range of 0 to 4) at 3 months Secondary outcome: adverse effects at 3 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 | The authors stated that participants were randomly allocated to groups but did not provide any details on methods Quote: "Randomised groups were created (...)" |
Allocation concealment (selection bias) | Unclear risk | Information not reported in the manuscript. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Information not reported in the manuscript. |
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 | Data on changes in tinnitus severity categories are reported only for 8 out of 13 participants (Table 3) but dropout and reasons are not mentioned. It seems that data for 5 participants in the placebo group are missing. |
Selective reporting (reporting bias) | High risk | Routine and audiological examinations were performed every 15 days, however those data are not reported. Only data regarding tinnitus severity categories are reported at 3 months. |
Other bias | Unclear risk | No prospective protocol available. No funding sources and declarations of interest reported. Statistical tests not reported ‐ not clear whether they were appropriate. |