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Table 4 Primary and secondary outcomes

From: A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment

  Intratympanic Dex Topical IGF-1 Pvalue
Primary outcome    
Proportion of patients showing hearing recovery at 8 weeks 53.6% (30/56) 66.7% (38/57) 0.109
  [95% CI: 39.7-67.0] [95% CI: 52.9-8.6]  
  Complete recovery 0.0% (0/56) 3.5% (2/57)  
  Marked recovery 16.1% (9/56) 24.6% (14/57)  
  Slight recovery 37.5% (21/56) 38.6% (22/57)  
  No recovery 46.4% (26/56) 33.3% (19/57)  
Secondary outcomes    
Proportion of patients showing hearing recovery at 12 weeks 55.4% (31/56) 70.7% (41/58) 0.066
  [95% CI: 41.5-68.7] [95% CI: 57.3-81.9]  
  Complete recovery 0.0% (0/56) 5.2% (3/58)  
  Marked recovery 21.4% (12/56) 31.0% (18/58)  
  Slight recovery 33.9% (19/56) 34.5% (20/58)  
  No recovery 44.6% (25/56) 29.3% (17/58)  
Proportion of patients showing hearing recovery at 16 weeks 54.7% (29/53) 67.9% (36/53) 0.116
  [95% CI: 40.4-68.4] [95% CI: 53.7-80.1]  
  Complete recovery 0.0% (0/53) 5.7% (3/53)  
  Marked recovery 22.6% (12/53) 24.5% (13/53)  
  Slight recovery 32.1% (17/53) 37.7% (20/53)  
  No recovery 45.3% (24/53) 32.1% (17/53)  
Adverse events    
  Serious 0.0% (0/58) 0.0% (0/59) >0.999
  Non-serious 43.1% (25/58) 35.0% (21/59) 0.452
  Tympanic membrane perforation 15.5% (9/58) 0.0% (0/59) 0.001*
  Otitis media 1.7% (1/58) 6.8% (4/59) 0.364
  Otitis externa 0.0% (0/58) 1.7% (1/59) >0.999
  Tinnitus 8.6% (5/58) 0.0% (0/59) 0.027*
  Nausea/Vomit 3.4% (2/58) 3.4% (2/59) >0.999
  Others 24.1% (14/58) 30.5% (18/59) 0.535
  1. Asterisks indicate statistical significance with Fisher’s exact test.