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.

Acupuncture for tinnitus: a systematic review and meta-analysis of randomized controlled trials

“…TSI can also assess the magnitude of perceived annoyance and may be more adequate than THI in reflecting the difference between treatment groups. 25 The adequate reliability and validity of VAS, THI and TSI scores have been demonstrated. 17,18,25 VAS and THI are the most commonly accepted and widely used instruments to measure tinnitus.…”

“…25 The adequate reliability and validity of VAS, THI and TSI scores have been demonstrated. 17,18,25 VAS and THI are the most commonly accepted and widely used instruments to measure tinnitus. 18 Third, a standardized protocol was registered in the PROSPERO database before starting this review, rendering the potential reporting bias of this review as low.…”

A Systematic Review of Eligibility and Outcomes in Tinnitus Trials

“…and E.F.) for 3 inclusion criteria: ≥2 independent patient groups treated differently, randomization of patients, and reporting of tinnitus outcomes (if the study examined symptoms other than tinnitus, tinnitus results were reported separately). This yielded 147 studies ( Figure 1) for inclusion in data abstraction and analysis 5–151 …”

Evidence and evidence gaps in tinnitus therapy

“…Furthermore, the antiemetic drug of ondansetron was examined that is expected to be effective against tinnitus and to even improve the hearing threshold, as reported by an ENT team from Teheran [59]. In a randomized, double-blind, and placebo-controlled study, 30 patients with tinnitus persisting for more than 3 months, with and without hearing loss were treated with ondansetron and compared to a placebo group of the same size.…”