Olivier Meeus1, Dirk De Ridder, Paul Van de Heyning. 1. University Department of Otorhinolaryngology and Head and Neck Surgery, Antwerp University Hospital (UZA), University of Antwerp, Antwerp, Belgium. oliviermeeus@uza.be
Abstract
HYPOTHESIS: Present study investigates the combination of Deanxit and clonazepam (Rivotril) intake for relief of tinnitus complaints, respecting a double-blind placebo-controlled approach for Deanxit in a crossover setup. BACKGROUND: Although several pharmacologic treatments--including antidepressants, prostaglandins, and aminobutyric acid (GABA)-active drugs--were already presented as promising in tinnitus treatment, no drug has yet been approved by the Food and Drug Administration and European Medicine Agency for the treatment of tinnitus. METHODS: Patients were randomly assigned to patient group A or patient group B in a double-blind way. Patient group A first received 3 weeks of Deanxit, followed by 1 week of washout and 3 weeks of placebo. Treatment was given in opposite order to subjects from Patient group B.All patients received a daily treatment consisting of clonazepam 1 mg once daily, starting on Day 1. RESULTS:Significant tinnitus reduction was seen after intake of the combination clonazepam-Deanxit, whereas no differences in tinnitus could be demonstrated after the administration of clonazepam-placebo. This was true for all patients according to the following parameters: time patients are annoyed by the tinnitus (p = 0.026) and the visual analogue scale for tinnitus annoyance (p = 0.024). CONCLUSION: Although tinnitus reduction was recorded as modest, this article provides valuable data demonstrating a placebo-controlled tinnitus reduction after clonazepam and Deanxit intake.
RCT Entities:
HYPOTHESIS: Present study investigates the combination of Deanxit and clonazepam (Rivotril) intake for relief of tinnitus complaints, respecting a double-blind placebo-controlled approach for Deanxit in a crossover setup. BACKGROUND: Although several pharmacologic treatments--including antidepressants, prostaglandins, and aminobutyric acid (GABA)-active drugs--were already presented as promising in tinnitus treatment, no drug has yet been approved by the Food and Drug Administration and European Medicine Agency for the treatment of tinnitus. METHODS:Patients were randomly assigned to patient group A or patient group B in a double-blind way. Patient group A first received 3 weeks of Deanxit, followed by 1 week of washout and 3 weeks of placebo. Treatment was given in opposite order to subjects from Patient group B.All patients received a daily treatment consisting of clonazepam 1 mg once daily, starting on Day 1. RESULTS: Significant tinnitus reduction was seen after intake of the combination clonazepam-Deanxit, whereas no differences in tinnitus could be demonstrated after the administration of clonazepam-placebo. This was true for all patients according to the following parameters: time patients are annoyed by the tinnitus (p = 0.026) and the visual analogue scale for tinnitus annoyance (p = 0.024). CONCLUSION: Although tinnitus reduction was recorded as modest, this article provides valuable data demonstrating a placebo-controlled tinnitus reduction after clonazepam and Deanxit intake.