The efficacy and safety of ipidacrine in patients with idiopathic neuropathy of the facial nerve (PELICAN study)

Abstract

Idiopathic facial nerve neuropathy (FNN), or Bell's palsy, is characterized by a manifest neurological defect and a pronounced decrease in the quality of life of patients.Objective: to evaluate the efficacy and safety of ipidacrine in patients with FNN in an open-label observational study.Patients and methods. The study included 35 patients with FNN, who were divided into two groups. Treatment in the main group (n=20) included the basic regimen (glucocorticoids, B vitamins, pentoxifylline, glycine, a complex of non-pharmacological therapies), as well as the anticholinesterase drug ipidacrine (Ipigrix). Treatment of patients in the control group (n=15) was limited to the basic regimen. The followup was six months. The treatment effectiveness was assessed with the House-Brackmann scale, FaCE (Facial Clinimetric Evaluation), SAQ (The Synkinesis Assessment Questionnaire), electroneuromyography (ENMG), and determining the number of patients with indications for botulinum therapy.Results and discussion. After six months of treatment, more significant restoration of facial nerve function was observed in the main group, according to the House-Brackmann scale (1.4±0.5), FaCE (90±9.8), and ENMG results, compared to the control group (HouseBrackmann – 1.9±0.7 points, FaCE – 78±11.8 points; p<0.05). There were no intergroup differences in the SAQ scores (main group – 42.1±16.1 points, control group – 48.6±12.9 points; p=0.203) and the number of patients with indications for botulinum therapy. Predictors of the synkinesis were pronounced damage to the branches of n. facialis at the disease onset according to the clinical examination (4 and 5 points on the House-Brackmann scale), I degree of severity according to ENMG, pain >75 mm on the visual analog scale, poor recovery of facial nerve function in the first month of treatment (3 and 4 points on the House–Brackmann scale).Conclusion. The use of ipidacrine in the complex treatment of patients with FNN improves the efficiency of restoration of the function of the facial nerve after 6 months without increasing the risk of pathological synkinesis.