A clinical trial of nicergoline to prevent temporary threshold shift
Abstract 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...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-04-01
|
| Series: | Laryngoscope Investigative Otolaryngology |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/lio2.746 |
| _version_ | 1811329720123392000 |
|---|---|
| author | Pana Klamkam Rongrat Pagcharoenpol Treewit Treesaranuwattana Pichayen Silpsrikul Pariyanan Jaruchinda Piyalarp Wasuwat Picha Suwannahitatorn |
| author_facet | Pana Klamkam Rongrat Pagcharoenpol Treewit Treesaranuwattana Pichayen Silpsrikul Pariyanan Jaruchinda Piyalarp Wasuwat Picha Suwannahitatorn |
| author_sort | Pana Klamkam |
| collection | DOAJ |
| description | Abstract 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 |
| first_indexed | 2024-04-13T15:48:52Z |
| format | Article |
| id | doaj.art-a5bded78046e454aba75f8af595c27b8 |
| institution | Directory Open Access Journal |
| issn | 2378-8038 |
| language | English |
| last_indexed | 2024-04-13T15:48:52Z |
| publishDate | 2022-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | Laryngoscope Investigative Otolaryngology |
| spelling | doaj.art-a5bded78046e454aba75f8af595c27b82022-12-22T02:40:53ZengWileyLaryngoscope Investigative Otolaryngology2378-80382022-04-017251552210.1002/lio2.746A clinical trial of nicergoline to prevent temporary threshold shiftPana Klamkam0Rongrat Pagcharoenpol1Treewit Treesaranuwattana2Pichayen Silpsrikul3Pariyanan Jaruchinda4Piyalarp Wasuwat5Picha Suwannahitatorn6Department of Otolaryngology Phramongkutklao Hospital, Royal Thai Amy Bangkok ThailandDepartment of Otolaryngology Phramongkutklao Hospital, Royal Thai Amy Bangkok ThailandDepartment of Otolaryngology Queen Sirikit Naval Hospital Sattahip Chonburi ThailandMedical Battalion, Support Regiment, Marines Division Royal Thai Navy Sattahip Chonburi ThailandDepartment of Otolaryngology Phramongkutklao Hospital, Royal Thai Amy Bangkok ThailandDepartment of Otolaryngology Phramongkutklao Hospital, Royal Thai Amy Bangkok ThailandDepartment of Parasitology Phramongkutklao College of Medicine Bangkok ThailandAbstract 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 2https://doi.org/10.1002/lio2.746nicergolinesignificant threshold shifttemporary threshold shifttinnitus |
| spellingShingle | Pana Klamkam Rongrat Pagcharoenpol Treewit Treesaranuwattana Pichayen Silpsrikul Pariyanan Jaruchinda Piyalarp Wasuwat Picha Suwannahitatorn A clinical trial of nicergoline to prevent temporary threshold shift Laryngoscope Investigative Otolaryngology nicergoline significant threshold shift temporary threshold shift tinnitus |
| title | A clinical trial of nicergoline to prevent temporary threshold shift |
| title_full | A clinical trial of nicergoline to prevent temporary threshold shift |
| title_fullStr | A clinical trial of nicergoline to prevent temporary threshold shift |
| title_full_unstemmed | A clinical trial of nicergoline to prevent temporary threshold shift |
| title_short | A clinical trial of nicergoline to prevent temporary threshold shift |
| title_sort | clinical trial of nicergoline to prevent temporary threshold shift |
| topic | nicergoline significant threshold shift temporary threshold shift tinnitus |
| url | https://doi.org/10.1002/lio2.746 |
| work_keys_str_mv | AT panaklamkam aclinicaltrialofnicergolinetopreventtemporarythresholdshift AT rongratpagcharoenpol aclinicaltrialofnicergolinetopreventtemporarythresholdshift AT treewittreesaranuwattana aclinicaltrialofnicergolinetopreventtemporarythresholdshift AT pichayensilpsrikul aclinicaltrialofnicergolinetopreventtemporarythresholdshift AT pariyananjaruchinda aclinicaltrialofnicergolinetopreventtemporarythresholdshift AT piyalarpwasuwat aclinicaltrialofnicergolinetopreventtemporarythresholdshift AT pichasuwannahitatorn aclinicaltrialofnicergolinetopreventtemporarythresholdshift AT panaklamkam clinicaltrialofnicergolinetopreventtemporarythresholdshift AT rongratpagcharoenpol clinicaltrialofnicergolinetopreventtemporarythresholdshift AT treewittreesaranuwattana clinicaltrialofnicergolinetopreventtemporarythresholdshift AT pichayensilpsrikul clinicaltrialofnicergolinetopreventtemporarythresholdshift AT pariyananjaruchinda clinicaltrialofnicergolinetopreventtemporarythresholdshift AT piyalarpwasuwat clinicaltrialofnicergolinetopreventtemporarythresholdshift AT pichasuwannahitatorn clinicaltrialofnicergolinetopreventtemporarythresholdshift |