Effect of Combined Antioxidant Therapy on Oxidative Stress Markers and Inflammatory Cytokines in Patients With Tinnitus

The main objective of our study is to evaluate the effect of combinated antioxidants therapy with Adepsique® (amitriptyline, perphenazine, and diazepam) on patients with tinnitus chronic symptoms, evaluating the levels of inflammatory cytokines and oxidative stress in blood.The researchers intend to include 58 patients, divided into two intervention groups, who will be randomly assigned a pill with antioxidants or placebo, and the patient must eat one pill per day for 3 months.In the study, the clinical characteristics of tinnitus, inflammatory cytokines and oxidative stress markers will be evaluated, before, during and after the intervention with antioxidant therapy. Subsequently, the clinical and sample results will be evaluated to compare the effects between them.

Inclusion Criteria:Male or female with subjective chronic tinnitus (unilateral or bilateral)Patients with normal audiometry or identification of hearing loss up to a medium degree (20-70 dB)Patients with evidence of endotic tinnitusPatients who have or do not have social medical securityFemales of childbearing age with a negative pregnancy test and use of oral contraceptivesPatients under pharmacological management with a period of stable medication (≥3 months) for chronic degenerative diseases and under good metabolic control through primary interventionExclusion Criteria:Presence of tinnitus secondary to head trauma, acoustic trauma, or sudden hearing lossHistory or presence of Ménière's disease, otosclerosis, acute or chronic otitis mediaActive gastrointestinal haemorrhagic diseaseHistory or presence of cancer (any type) or submission to radio and/or chemotherapyAutoimmune disease (any)History of severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vascular disease)Benign prostatic hyperplasiaBlood dyscrasias and/or bleeding diathesisThyroid disease (any)Temporomandibular joint dysfunctionNeurodegenerative processesHepatic and renal failureClosed or open angle glaucomaIntake of any medication belonging to the following families (Anticoagulants, Benzodiazepines, ASA diuretics, Aminoglycosides, Chemotherapeutics, Acetylsalicylic Acid, Quinine)Intake of antioxidants in the last 6 monthsHypersensitivity to vitamins that constitute the antioxidant intervention, or any medication belonging to the Adepsique formulationPregnancy, lactationHistory of disease due to COVID-19 infection in the last 6 monthsDiet rich in antioxidants that exceeds the concentrations of the daily nutritional recommendations of the Dietary Reference IntakeParticipation in another clinical trialDrug abuse, smoking (daily consumption during the last month of 5 to 10 cigarettes) and/or alcoholism