Pragmatic open-label clinical trial investigating the treatment effects of Ginkgo biloba extract EGb 761 on patients with vertigo and dizziness of various aetiologies
Abstract
Introduction: Ginkgo extract EGb 761 demonstrated favourable therapeutic effects in peripheral and central vestibular syndromes. This pragmatic study explored whether administration of EGb 761 in patients with vertigo and dizziness of various aetiologies results in improvement of symptom intensity, posture, gait and ocular motor function, and whether specific patient subgroups benefit most from this treatment.
Methods: This pragmatic open-label, multicentre clinical trial involved 179 patients with various vertigo and dizziness syndromes taking 240 mg of EGb 761 daily for 12 weeks. Patient-reported outcomes were assessed at 6 and 12 weeks using the Dizziness Handicap Inventory (DHI), the short form of the Vertigo Symptom Scale (VSS-SF) and a 11-point box scale to measure vertigo severity. A moderate treatment response was defined as an improvement of at least 30% from the baseline score. The Romberg test and Unterberger stepping test were carried out to clinically grade posture and gait instability. Spontaneous nystagmus detection was performed with and without fixation suppression. Subgroups were analysed using analysis of covariance models to explore potential effect modifiers.
Results: A total of 174 patients (mean age: 52.2 years; 77.6% female) were enrolled. Compared to baseline, mean scores on the DHI, the VSS-SF and the 11-point box scale for vertigo severity showed statistically significant improvement (p < 0.0001) both after 6 and 12 weeks. After 12 weeks,…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 761 participants or records.
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