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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.