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A Randomized Controlled Trial

Jeffrey P. Harris, MD, PhD; Michael H. Weisman, MD; Jennifer M. Derebery, MD; Mark A. Espeland, PhD; Bruce J. Gantz, MD; A. Julianna Gulya, MD; Paul E. Hammerschlag, MD; Maureen Hannley, PhD; Gordon B. Hughes, MD; Richard Moscicki, MD; Ralph A. Nelson, MD; John K. Niparko, MD; Steven D. Rauch, MD; Steven A. Telian, MD; Patrick E. Brookhouser, MD

JAMA. 2003;290:1875-1883.

Context  A number of therapies have been proposed for the long-term management of corticosteroid-responsive, rapidly progressive, bilateral sensorineural hearing loss (autoimmune inner ear disease [AIED]). Methotrexate has emerged as the benchmark agent but has not been rigorously evaluated for hearing improvement in patients with AIED.

Objective  To assess the efficacy of long-term methotrexate in maintaining hearing improvements achieved with glucocorticoid (prednisone) therapy in patients with AIED.

Design, Setting, and Participants  A randomized, double-blind, placebo-controlled trial conducted from February 3, 1998, to November 5, 2001, of 67 patients with rapidly progressive, bilateral sensorineural hearing loss at 10 tertiary care centers in the United States.

Intervention  Randomization to either oral methotrexate (15 to 20 mg/wk; n = 33) or placebo (n = 34), in combination with an 18-week prednisone taper. Follow-up examinations, including audiometric evaluation, were performed at 4, 8, 12, 24, 36, 48, and 52 weeks, or until hearing loss was documented.

Main Outcome Measure  Maintenance of hearing improvement achieved from prednisone treatment.

Results  Sixty-seven patients (57.8%) enrolled in the prednisone challenge experienced hearing improvement. Twenty-five patients (37%) experienced hearing improvements in both ears. Of the individuals who reached study end points, 24 (80%) of 30 end points were because of measured hearing loss in the methotrexate group and 29 (93.5%) of 31 end points were because of measured hearing loss in the placebo group (P = .15). Methotrexate was no more effective than placebo in maintaining the hearing improvement achieved with prednisone treatment (hazard ratio, 1.31; 95% confidence interval, 0.79-2.17; P = .30).

Conclusion  Methotrexate does not appear to be effective in maintaining the hearing improvement achieved with prednisone therapy in patients with AIED.

Author Affiliations: Division of Otolaryngology–Head & Neck Surgery, University of California, San Diego (Dr Harris); Division of Rheumatology, Cedars-Sinai Medical Center, Los Angeles, Calif (Dr Weisman); House Ear Institute, Los Angeles, Calif (Drs Derebery and Nelson); Department of Public Health Sciences, Wake Forest University, Winston-Salem, NC (Dr Espeland); Department of Otolaryngology–Head & Neck Surgery, University of Iowa, Iowa City (Dr Gantz); National Institute on Deafness and Other Communication Disorders, Bethesda, Md (Dr Gulya); Department of Otolaryngology–Head & Neck Surgery, New York University, New York (Dr Hammerschlag); Research Development, American Academy of Otolaryngology–Head & Neck Surgery, Alexandria, Va (Dr Hannley); Otolaryngology and Communicative Disorders, The Cleveland Clinic, Cleveland, Ohio (Dr Hughes); Department of Allergy and Immunology, Massachusetts General Hospital, Boston (Dr Moscicki); Department of Otolaryngology, Johns Hopkins University, Baltimore, Md (Dr Niparko); Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston (Dr Rauch); Department of Otolaryngology–Head & Neck Surgery, University of Michigan, Ann Arbor (Dr Telian); and Boystown National Research Hospital, Omaha, Neb (Dr Brookhouser).

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