Pragmatic open-label clinical trial investigating the treatment effects of Ginkgo biloba extract EGb 761 on patients with vertigo and dizziness of various aetiologies.

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, two-thirds of patients (between 60.9% and 66.7%) showed a clinically relevant improvement in these patient-reported outcomes. The proportion of patients with a normal postural control in the Romberg test increased from 48.3% at baseline to 85.2% after 12 weeks. Meanwhile, the proportion of patients with abnormal results in the Unterberger stepping test decreased from 33.5% at baseline to 10.1% at week 12. Patients with episodic vertigo/dizziness, and those whose symptoms had lasted up to 6 months, improved more than those with continuous vertigo/dizziness and symptoms lasting more than 6 months. Conclusion: After 12 weeks, patient-reported and functional outcomes had significantly improved in patients with vertigo/dizziness. However, within the setting of this pragmatic study, it is not possible to discriminate between the effects of treatment, self-healing, or the natural course of the disease. Clinical Trial Registration: https://eudract.ema.europa.eu/, identifier EUdraCT 2016-000316-15.