Table 3.
Quality of life data from the Short Form-36 questionnaire on the intention-to-treat analysis
| Item |
Placebo arm
|
AN-PEP arm
|
||
|
At baseline
|
Final
|
At baseline
|
Final
|
|
| Number of patients | 21 | 19 | ||
| General health | ||||
| Median score (IQR) | 65 (50-72) | 70 (50-80)b | 50 (35-75) | 50 (40-80) |
| Pain | ||||
| Median score (IQR) | 80 (42-90) | 90 (50-80)b | 80 (45-90) | 67.5 (47.5-90.0)a |
| Vitality | ||||
| Median score (IQR) | 60 (45-65) | 60 (50-70) | 40 (30-60) | 55 (40-65)c |
| Mental health | ||||
| Median score (IQR) | 68 (52-72) | 68 (56-80) | 68 (40-72) | 64 (48-80) |
| Physical function | ||||
| Median score (IQR) | 95 (75-100) | 95 (75-100) | 95 (85-100) | 100 (90-100) |
| Social function | ||||
| Median score (IQR) | 75 (50-100) | 100 (62.5-100.0) | 50 (37-100) | 75 (50-100) |
| Physical limitations | ||||
| Median score (IQR) | 100 (50-100) | 100 (75-100) | 100 (25-100) | 75 (25-100) |
| Emotional limitations | ||||
| Median score (IQR) | 50 (0-100) | 100 (66-100)b | 66.7 (0-100) | 66.7 (0-100) |
a
vs placebo: P < 0.05.
b
Run-in vs treatment: P < 0.05.
c
Run-in vs treatment: P < 0.005.
AN-PEP: Aspergillus niger prolyl endopeptidase protease; IQR: Interquartile range.