BACKGROUND: This pilot registry study evaluated the efficacy of Pycnogenol® in relieving cochlear hypoperfusion and in improving related signs/symptoms over a 3 month follow-up. The registry included otherwise healthy subjects with cochlear hypoperfusion or inner ear ischemia associated with different mild-moderate problems such as hyperacusis, vertigo, tinnitus or hearing loss.METHODS: A total of 61 subjects with detectable cochlear arterial hypoperfusion and related signs and symptoms on one ear were included in the study. Thirty-two were supplemented with 100 mg Pycnogenol® per day in addition to standard management whereas 29 only used standard management and served as controls. The two registry groups were considered comparable at inclusion.RESULTS: No signs of infections of other lesions were visible at a full ear evaluation. There was no drop out in the 3 months of follow-up. No side effects were observed during the period of management and supplementation. Tolerability was very good. The Visual Analogue Scale scores for auditory and vestibular signs and symptoms ranging from 0 to 5 were comparable at inclusion. After 3 months, the Pycnogenol® group showed significantly lower scores for auditory and vestibular signs and symptoms compared to the control group (P<0.05). The improvements observed in the Pycnogenol® group were more pronounced. The specific signs and symptoms that showed significant improvement were spontaneous vertigo, positional vertigo, fluctuating hearing loss, tinnitus, unsteady gait, drop attacks, decreased hearing, hyperacusis, alterations of working/social life, and nausea. Over the 3-month period, the number of lost working days was significantly lower in the Pycnogenol® group compared to the control group (P<0.05). After 3 months, 60% of subjects using Pycnogenol® were asymptomatic (or with minor symptoms not requiring management) in comparison with 20% of control subjects (P<0.05). Symptomatic (on-demand) drugs, Antivert (meclizine HCl) and Phenergan (promethazine HCI) were used only by a total of 8 subjects in the Pycnogenol® group and by 16 patients in the control group during the study period (P<0.05). Furthermore, cochlear blood flow velocity in the labyrinthine artery within the cochlea was significantly higher in the Pycnogenol® group compared to controls (P<0.05). These findings indicate an improved perfusion of the cochlea in the Pycnogenol® group. Plasma oxidative stress, which was high in both groups at inclusion decreased significantly in the Pycnogenol® group (P<0.05) after 3 months compared to controls.CONCLUSIONS: This registry study showed that supplementation with Pycnogenol® can alleviate symptoms associated with cochlear hypoperfusion by enhancing microcirculation in the cochlea.
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Belcaro et al. (2024) studied this question.
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