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Ondansetron in patients with tinnitus: randomized double-blind placebo-controlled study

  • Otology
  • Published:
European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

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.

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Acknowledgments

This project was funded by the Tehran University of Medical Sciences, grant number 89-01-48-1045. The trial was registered in IRCT.ir (ID: IRCT201105185867N4). This project was MD-MPH thesis of the first author.

Conflict of interest

The authors declare no conflict of interest.

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Authors and Affiliations

  1. Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran

    Shervin Taslimi, Hamed Vahidi, Ali Pourvaziri, Arezoo Yeke Fallah, Nasrin Yazdani, Negin Taslimi & Masoud Motesadi Zarandi

  2. Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran

    Shervin Taslimi & Mostafa Hosseini

  3. Department of Psychiatry, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran

    Amirhossein Modabbernia

  4. Otorhinolaryngology Research Center, Amir Aalam Hospital, North Saadi Ave, Tehran, Iran

    Shervin Taslimi

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  1. Shervin Taslimi
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  2. Hamed Vahidi
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Correspondence to Shervin Taslimi.

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Taslimi, S., Vahidi, H., Pourvaziri, A. et al. Ondansetron in patients with tinnitus: randomized double-blind placebo-controlled study. Eur Arch Otorhinolaryngol 270, 1635–1641 (2013). https://doi.org/10.1007/s00405-012-2179-0

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  • DOI: https://doi.org/10.1007/s00405-012-2179-0

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