A clinical trial of nicergoline to prevent temporary threshold shift
Pana Klamkam1, Rongrat Pagcharoenpol1, Treewit Treesaranuwattana2
1Department of Otolaryngology Phramongkutklao Hospital, Royal Thai Amy Bangkok Thailand.
Objective:
To evaluate the effectiveness of nicergoline to prevent temporary threshold shift (TTS) in military personnel.
Study Design:
A randomized control trial.
Methods:
Two hundred and twenty-four participants were enrolled. Nicergoline 30 mg twice daily intake was prescribed to the study group (n = 119) for 3 weeks. The placebo was prescribed to the control group (n = 105) for 3 weeks, as well. Audiometric thresholds were measured at baseline and within 24 h after the participants attended a 1-day weapons firing practice. During the firing practice, all participants had to wear foam earplugs. The TTS was assessed by using a variety of published significant threshold shift (STS) definitions. Additionally, the effects of the treatment group on the magnitude of pre- to postexposure threshold shifts were estimated. Tinnitus and other adverse effects of the medication were recorded.
Results:
The incidence of STS was 65.4% from the study group and 75% from the control group. The negative STS (thresholds improved) was 68.6% from the study group and 44.7% from the control group. The positive STS (thresholds worsened) from the study group and the control group was 31.4% and 55.3%, respectively. The effect of treatment in participants receiving nicergoline demonstrated significant coefficients (change in dB) in both ears (p = .001). The mean different threshold of participants receiving nicergoline showed negative STS in all tested frequencies without statistical significance. However, the mean different threshold of participants receiving a placebo showed positive STS with statistical significance. Additionally, there were 16 ears detecting a warning sign of permanent hearing loss. These participants from the control group presented a longer duration of tinnitus (p = .042). Moreover, the serious adverse effects of nicergoline were considerably low.
Conclusion:
The study results suggest that nicergoline may attenuate noise-related TTS and tinnitus, and justify further investigation on the effectiveness of this drug as an otoprotectant.
Level Of Evidence:
2.
