title: Ondansetron in patients with tinnitus: randomized double-blind placebo-controlled study.
abstract: The aim of this study was to assess the effect of ondansetron on symptoms of patients with subjective tinnitus accompanied by sensorineural hearing loss or normal hearing. Sixty patients with a chief complaint of tinnitus (with duration of more than 3 months) were equally randomized to ondansetron or placebo for 4 weeks. The dose of ondansetron was gradually increased from 4 mg/day (one tablet) to 16 mg/day (4 tablets) during 12 days and then continued up to 4 weeks. The exact number of tablets was prescribed in the placebo group. Patients underwent audiologic examinations and filled questionnaires at baseline and after 4 weeks of treatment. Our primary outcomes were changes in Tinnitus Handicap Inventory questionnaire (THI), Tinnitus Severity Index (TSI) and visual analog scale (VAS) scores. Our secondary outcomes were the changes in depression and anxiety based on Hospital Anxiety and Depression (HADS) questionnaire, side effects, tinnitus loudness matching, tinnitus pitch matching, pure tone audiometry and speech recognition threshold (SRT). In the ondansetron and placebo groups, 27 and 26 patients completed the study, respectively. The changes in VAS (P = 0.934), THI (P = 0.776), anxiety (P = 0.313) and depression (P = 0.163) scores were not different between the groups. TSI score decreased significantly in the ondansetron compared with the placebo group (P = 0.004). Changes in tinnitus loudness matching (P = 0.75) and pitch matching (P = 0.56) did not differ between the two groups. Ondansetron, but not placebo, decreased the SRT threshold (right, P < 0.001; left, P = 0.043) and mean PTA (right, P = 0.006; left, P < 0.001). In conclusion, ondansetron reduces the severity of tinnitus hypothetically through cochlear amplification.
authors.affiliation: Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran. taslimi@razi.tums.ac.ir
authors.forename: Shervin
authors.initials: S
authors.lastname: Taslimi
authors.forename: Hamed
authors.initials: H
authors.lastname: Vahidi
authors.forename: Ali
authors.initials: A
authors.lastname: Pourvaziri
authors.forename: Amirhossein
authors.initials: A
authors.lastname: Modabbernia
authors.forename: Arezoo Yeke
authors.initials: AY
authors.lastname: Fallah
authors.forename: Nasrin
authors.initials: N
authors.lastname: Yazdani
authors.forename: Negin
authors.initials: N
authors.lastname: Taslimi
authors.forename: Mostafa
authors.initials: M
authors.lastname: Hosseini
authors.forename: Masoud Motesadi
authors.initials: MM
authors.lastname: Zarandi
mesh_terms: D000328:Adult; D000368:Aged; D001007:Anxiety / Q000188:drug therapy / Q000523:psychology; D003863:Depression / Q000188:drug therapy / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006319:Hearing Loss, Sensorineural / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D018733:Nicotinic Antagonists / Q000627:therapeutic use*; D017294:Ondansetron / Q000627:therapeutic use*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D014012:Tinnitus / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D018733:Nicotinic Antagonists; D017294:Ondansetron