Abstract
Objectives: To determine the effects of long-term, lowdose difluoromethylornithine (DFMO) on audiometric thresholds and distortion product otoacoustic emission (DPOAE) levels in humans. Design: A prospective, randomized, placebo-controlled phase 2 clinical trial of DFMO in participants with a prior adenomatous colonic polyp. Setting: Academic tertiary care referral center. Participants: One hundred twenty-three volunteer subjects with colorectal polyps and normal hearing for the frequencies 250 through 2000 Hz. Interventions: Subjects were randomized to receive placebo or oral DFMO at daily dosages between 0.075 and 0.4 g/m 2 of body surface area for 12 months. Outcome Measures: Pure-tone audiometric thresholds for the frequencies 250,500, 1000, 2000, 3000, 4000, 6000, and 8000 Hz and DPOAE levels were measured at baseline and 1, 3, 6, 9, and 12 months after starting treatment with DFMO or placebo and 3 months after cessation of treatment if there was a suggestion of possible changes at the 12-month measurement. Results: At these low dosages, there was little evidence for shifts in auditory pure-tone thresholds, and there were no statistically significant shifts in DPOAE levels. For auditory pure-tone thresholds, there was a subtle, approximately 2- to 3-dB hearing level decrease in hearing sensitivity for the 2 higher DFMO dosages, but only at the 2 lowest frequencies, 250 and 500 Hz. Conclusions: Administration of low-dose DFMO for 12 months did not produce hearing loss, in contrast to prior studies that used higher dosages.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 553-558 |
| Number of pages | 6 |
| Journal | Archives of Otolaryngology - Head and Neck Surgery |
| Volume | 127 |
| Issue number | 5 |
| State | Published - May 2001 |
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ASJC Scopus subject areas
- Otorhinolaryngology
Cite this
Effects of difluoromethylornithine chemoprevention on audiometry thresholds and otoacoustic emissions. / Doyle, Karen J.; McLaren, Christine E.; Shanks, Janet E.; Galus, Cheryl M.; Meyshens, Frank L.
In: Archives of Otolaryngology - Head and Neck Surgery, Vol. 127, No. 5, 05.2001, p. 553-558.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Effects of difluoromethylornithine chemoprevention on audiometry thresholds and otoacoustic emissions
AU - Doyle, Karen J.
AU - McLaren, Christine E.
AU - Shanks, Janet E.
AU - Galus, Cheryl M.
AU - Meyshens, Frank L.
PY - 2001/5
Y1 - 2001/5
N2 - Objectives: To determine the effects of long-term, lowdose difluoromethylornithine (DFMO) on audiometric thresholds and distortion product otoacoustic emission (DPOAE) levels in humans. Design: A prospective, randomized, placebo-controlled phase 2 clinical trial of DFMO in participants with a prior adenomatous colonic polyp. Setting: Academic tertiary care referral center. Participants: One hundred twenty-three volunteer subjects with colorectal polyps and normal hearing for the frequencies 250 through 2000 Hz. Interventions: Subjects were randomized to receive placebo or oral DFMO at daily dosages between 0.075 and 0.4 g/m 2 of body surface area for 12 months. Outcome Measures: Pure-tone audiometric thresholds for the frequencies 250,500, 1000, 2000, 3000, 4000, 6000, and 8000 Hz and DPOAE levels were measured at baseline and 1, 3, 6, 9, and 12 months after starting treatment with DFMO or placebo and 3 months after cessation of treatment if there was a suggestion of possible changes at the 12-month measurement. Results: At these low dosages, there was little evidence for shifts in auditory pure-tone thresholds, and there were no statistically significant shifts in DPOAE levels. For auditory pure-tone thresholds, there was a subtle, approximately 2- to 3-dB hearing level decrease in hearing sensitivity for the 2 higher DFMO dosages, but only at the 2 lowest frequencies, 250 and 500 Hz. Conclusions: Administration of low-dose DFMO for 12 months did not produce hearing loss, in contrast to prior studies that used higher dosages.
AB - Objectives: To determine the effects of long-term, lowdose difluoromethylornithine (DFMO) on audiometric thresholds and distortion product otoacoustic emission (DPOAE) levels in humans. Design: A prospective, randomized, placebo-controlled phase 2 clinical trial of DFMO in participants with a prior adenomatous colonic polyp. Setting: Academic tertiary care referral center. Participants: One hundred twenty-three volunteer subjects with colorectal polyps and normal hearing for the frequencies 250 through 2000 Hz. Interventions: Subjects were randomized to receive placebo or oral DFMO at daily dosages between 0.075 and 0.4 g/m 2 of body surface area for 12 months. Outcome Measures: Pure-tone audiometric thresholds for the frequencies 250,500, 1000, 2000, 3000, 4000, 6000, and 8000 Hz and DPOAE levels were measured at baseline and 1, 3, 6, 9, and 12 months after starting treatment with DFMO or placebo and 3 months after cessation of treatment if there was a suggestion of possible changes at the 12-month measurement. Results: At these low dosages, there was little evidence for shifts in auditory pure-tone thresholds, and there were no statistically significant shifts in DPOAE levels. For auditory pure-tone thresholds, there was a subtle, approximately 2- to 3-dB hearing level decrease in hearing sensitivity for the 2 higher DFMO dosages, but only at the 2 lowest frequencies, 250 and 500 Hz. Conclusions: Administration of low-dose DFMO for 12 months did not produce hearing loss, in contrast to prior studies that used higher dosages.
UR - http://www.scopus.com/inward/record.url?scp=0035036630&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0035036630&partnerID=8YFLogxK
M3 - Article
C2 - 11346432
AN - SCOPUS:0035036630
VL - 127
SP - 553
EP - 558
JO - JAMA Otolaryngology - Head and Neck Surgery
JF - JAMA Otolaryngology - Head and Neck Surgery
SN - 2168-6181
IS - 5
ER -