Efficacy and Safety of N-Acetylcysteine in Prevention of Noise Induced Hearing Loss: A Randomized Clinical Trial

Details

• Personal Author:
  Balough B ; Dreisbach L ; Fausti S ; Hammill T ; Jackson R ; Kopke R ; Lonsbury-Martin B ; Rabinowitz P ; Sanderson A ; Slade MD ; Torre P III
• Description:
  Despite a robust hearing conservation program, military personnel continue to be at high risk for noise induced hearing loss (NIHL). For more than a decade, a number of laboratories have investigated the use of antioxidants as a safe and effective adjunct to hearing conservation programs. Of the antioxidants that have been investigated, N-acetylcysteine (NAC) has consistently reduced permanent NIHL in the laboratory, but its clinical efficacy is still controversial. This study provides a prospective, randomized, double-blinded, placebo-controlled clinical trial investigating the safety profile and the efficacy of NAC to prevent hearing loss in a military population after weapons training. Of the 566 total study subjects, 277 received NAC while 289 were given placebo. The null hypothesis for the rate of STS was not rejected based on the measured results. While no significant differences were found for the primary outcome, rate of threshold shifts, the right ear threshold shift rate difference did approach significance (p = 0.0562). No significant difference was found in the second primary outcome, percentage of subjects experiencing an adverse event between placebo and NAC groups (26.7% and 27.4%, respectively, p = 0.4465). Results for the secondary outcome, STS rate in the trigger hand ear, did show a significant difference (34.98% for placebo-treated, 27.14% for NAC-treated, p-value = 0.0288). Additionally, post-hoc analysis showed significant differences in threshold shift rates when handedness was taken into account. While the secondary outcomes and post-hoc analysis suggest that NAC treatment is superior to the placebo, the present study design failed to confirm this. The lack of significant differences in overall hearing loss between the treatment and placebo groups may be due to a number of factors, including suboptimal dosing, premature post-exposure audiograms, or differences in risk between ears or subjects. Based on secondary outcomes and post hoc analyses however, further studies seem warranted and are needed to clarify dose response and the factors that may have played a role in the observed results. [Description provided by NIOSH]
• Subjects:
  Antioxidants Hearing Hearing Loss Hearing Loss, Noise-Induced Noise Noise, Occupational Occupational Health Safety
• Keywords:
  Hearing Conservation Hearing Loss Prevention Military Personnel Noise Exposure Noise Induced Hearing Loss
• ISSN:
  0378-5955
• Document Type:
  Text
• Funding:
  Grant
• Genre:
  Journal Article
• Place as Subject:
  California ; Colorado ; Connecticut ; Oklahoma ; Oregon ; OSHA Region 1 ; OSHA Region 10 ; OSHA Region 6 ; OSHA Region 8 ; OSHA Region 9 ; Texas ; Washington
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  40-50
• Volume:
  323
• NIOSHTIC Number:
  nn:20063669
• Citation:
  Hear Res 2015 May; 323:40-50
• Contact Point Address:
  Richard Kopke, Hough Ear Institute, 3400 NW 56th St, Oklahoma City, OK 73112-4463, USA
• Email:
  rkopke@houghear.org
• CAS Registry Number:
  N-Acetyl-L-cysteine (CAS RN 616-91-1)
• Federal Fiscal Year:
  2015
• Performing Organization:
  University of Washington
• Peer Reviewed:
  True
• Start Date:
  20050701
• Source Full Name:
  Hearing Research
• End Date:
  20250630
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:aa25c585ebafc82f2e08d8076446a171bba6e2c921f0133758a445b58cb00a475412b7b9900c9cd6be809492f36a9bef6659b98f8e355d977eef9480f1697059
• Download URL:
  https://stacks.cdc.gov/view/cdc/222232/cdc_222232_DS1.pdf
• File Type:
  [PDF - 743.92 KB ]