Milan R Amin1, Stratos Achlatis1, Shirley Gherson1,2, Yixin Fang3,4, Binhuan Wang4, Hayley Born5, Ryan C Branski1, Aaron M Johnson1. 1. 1 NYU Voice Center, Department of Otolaryngology-Head and Neck Surgery, New York University School of Medicine, New York, New York, USA. 2. 2 Rusk Institute of Rehabilitation, New York University School of Medicine, New York, New York, USA. 3. 3 Department of Mathematical Sciences, New Jersey Institute of Technology, Newark, New Jersey, USA. 4. 4 Department of Population Heath, Division of Biostatistics, New York University School of Medicine, New York, New York, USA. 5. 5 Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati School of Medicine, Cincinnati, Ohio, USA.
Abstract
OBJECTIVES: (1) To determine the short-term effectiveness of oral steroids in women with benign vocal fold lesions and (2) to determine the effectiveness of adjuvant oral steroids in women undergoing voice therapy for benign vocal fold lesions. STUDY DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING:Tertiary voice care center. SUBJECTS AND METHODS: Thirty-six patients undergoing voice therapy for the treatment of phonotraumatic vocal fold lesions randomly received either a 4-day course of oral steroids or a placebo prior to initiating voice therapy. Voice Handicap Index-10 (VHI-10) scores, video and audioperceptual analyses, acoustic and aerodynamic analyses at baseline, and patient perception of improvement after a short course of steroids or a placebo and at the conclusion of voice therapy were collected. RESULTS:Thirty patients completed the study, of whom 27 (only female) were analyzed. The primary outcome measure, VHI-10, did not improve after the 4-day course of steroids or placebo. Secondary measures similarly showed no improvement with steroids relative to placebo. Voice therapy demonstrated a positive effect on both VHI-10 and patient-perceived improvement of voice in all subjects. CONCLUSION: A short course of oral steroids did not benefit women with phonotraumatic vocal fold lesions. In addition, steroids had little beneficial effect when used adjunctively with voice therapy in this patient cohort.
RCT Entities:
OBJECTIVES: (1) To determine the short-term effectiveness of oral steroids in women with benign vocal fold lesions and (2) to determine the effectiveness of adjuvant oral steroids in women undergoing voice therapy for benign vocal fold lesions. STUDY DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Tertiary voice care center. SUBJECTS AND METHODS: Thirty-six patients undergoing voice therapy for the treatment of phonotraumatic vocal fold lesions randomly received either a 4-day course of oral steroids or a placebo prior to initiating voice therapy. Voice Handicap Index-10 (VHI-10) scores, video and audioperceptual analyses, acoustic and aerodynamic analyses at baseline, and patient perception of improvement after a short course of steroids or a placebo and at the conclusion of voice therapy were collected. RESULTS: Thirty patients completed the study, of whom 27 (only female) were analyzed. The primary outcome measure, VHI-10, did not improve after the 4-day course of steroids or placebo. Secondary measures similarly showed no improvement with steroids relative to placebo. Voice therapy demonstrated a positive effect on both VHI-10 and patient-perceived improvement of voice in all subjects. CONCLUSION: A short course of oral steroids did not benefit women with phonotraumatic vocal fold lesions. In addition, steroids had little beneficial effect when used adjunctively with voice therapy in this patient cohort.
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