Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness

Change from baseline in dizziness handicap inventory (DHI) after 2±1 months Vertigoheel® treatment.

The DHI, ranging from 0 to 100 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.

Change from baseline in quality of life (QoL) assessed by EQ-5D-5L after 2±1 months Vertigoheel® treatment.

The EQ-5D index was used as described by Ludwig et al. (PharmacoEconomics, 2018, 36:663-74), ranging from -0.661 to 1.000, with higher scores indicating better quality of life. QoL was assessed at two time points: baseline and 2 months.

Change from baseline in body sway assessed by static posturography after 2±1 months Vertigoheel® treatment.

Posturography was assessed as described by Brandt et al. (J Neurol 2012, 259:182-4) with an artificial neural network analysis. Category three of the method for "peripheral vestibular deficit" was evaluated for patients with bilateral vestibulopathy, and category five for "phobic postural vertigo" was evaluated for patients with functional dizziness. Posturography was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. Positive values indicate more swaying and negative values indicate less swaying. The higher the value, the more swaying (worse regulation of stand). The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change).

Change from baseline in depressive symptoms of functional dizziness patients assessed by PHQ-9 questionnaires after 2±1 months Vertigoheel® treatment.

The PHQ-9, ranging from 0 to 27 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.

Change from baseline in anxiety symptoms of functional dizziness patients assessed by GAD-7 questionnaires after 2±1 months Vertigoheel® treatment. The GAD-7, ranging from 0 to 21 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.

Change from baseline in vestibular function of bilateral vestibulopathy patients assessed by video head impulse test (vHIT) after 2 ± 1 months Vertigoheel ® treatment.

The vHIT was performed as described by MacDougall et al. (Neurology, 2009, 73(14):1134-41) to evaluate the function of the vestibulo-ocular reflex (VOR) in the high frequency range for the horizontal semicircular canals.

Based on previous HIT data from healthy, asymptomatic subjects, a normal VOR velocity gain was defined as 0.68 or greater (MacDougall et al.2009).

Vestibular function was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change).

Change from baseline in vestibular function of bilateral vestibulopathy patients assessed by caloric testing after 2 ± 1 months of Vertigoheel® treatment.

Caloric testing was performed as described by Strupp et al. (J Vestib Res. 2017;27(4):177-89) to evaluate the function of the vestibulo-ocular reflex (VOR) in the low-frequency range of the horizontal semicircular canal on each side.

Bilaterally reduced angular VOR function is a diagnostic criterion for bilateral vestibulopathy (BVP). Reduced caloric response, i.e., a sum of both responses per ear <6◦/sec, can be considered a safe criterion for BVP.

Vestibular function was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change).