Nishad 2019.
Study characteristics | ||
Methods | A 4‐armed (Gingko biloba and placebo; caroverine and placebo), parallel‐group randomised controlled trial with 3 months duration of treatment and 4 weeks, 12 weeks and 6 months duration of follow‐up | |
Participants |
Location: India Setting: single‐centre study, Otolaryngology Department, India Sample size:
Participant baseline characteristics:
Inclusion criteria: age between 18 and 60 years, diagnosis of tinnitus, unilateral or bilateral, cochlear hearing defect, reflex audiometry confirming cochlear‐synaptic tinnitus and excluding middle ear tinnitus, written consent after explanation by consultant in charge Exclusion criteria: patients not willing to give written consent after receiving due instructions, reasonable doubts as to the patient’s co‐operation, severe secondary disorders (i.e. any acute/chronic illness), contra‐indication for caroverine therapy (e.g. severe hypertension), concomitant symptoms, pregnancy or plan for having children, hydrops cochlea or Ménière's disease, retrocochlear hearing defect, blast injury, status post psychiatrist therapy, status post operation of the middle ear, pulse‐synchronous tinnitus, excessive consumption of alcohol, drug or nicotine, known to intolerance to caroverine, concomitant medication, medicative tinnitus therapy within 1 week prior to enrolment, masticatory movements influencing subjective tinnitus sensation |
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Interventions |
Intervention group: Ginkgo biloba (60 mg of Ginkgo biloba extract) 12‐hourly for a period of 3 months Comparator group: placebo (60 mg of placebo) 12‐hourly for a period of 3 months Use of additional interventions: none reported |
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Outcomes | Primary outcome: change in tinnitus grading measured with unspecified non‐standard questionnaire at 4 weeks, 12 weeks and 6 months Secondary outcome: quality of life (method not described) and tinnitus matching (method not described) at 4 weeks, 12 weeks and 6 months | |
Funding sources | None specified | |
Declarations of interest | The authors declare that they have no conflict of interest | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | By using a computer‐generated block randomisation method participants were randomised into 4 groups. |
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 | Low risk | All participants seemed to complete the study, no dropout reported. |
Selective reporting (reporting bias) | High risk | Quality of life stated as primary outcome but no results were reported. Report mentions "tinnitus matching" improved but this was not pre‐defined as an outcome measure. |
Other bias | High risk | Lack of criteria for defining improvement, no statistical analyses, results do not justify conclusions. Audiological selection criteria complex and of uncertain significance in selecting stated aetiological group. No prospective protocol available. No funding sources reported. |