Table 2.
Study primary outcomes compared between the groups
Group | Observation group (n = 50) | Control group (n = 50) | P-value | |||
---|---|---|---|---|---|---|
Before | After | Before | After | |||
FEV1/l, mean ± SD | 1.53 ±0.32 | 2.20 ±0.41* | 1.50 ±0.35 | 1.92 ±0.41* | 0.681 | |
FEV1/FVC (%), mean ± SD | 37.12 ±8.44 | 52.70 ±10.76* | 37.37 ±8.44 | 40.19 ±16.06* | 0.888 | |
TNF-α [μg/l] mean ± SD | 13.23 ±1.42 | 4.18 ±0.41* | 12.65 ±1.62 | 8.25 ±0.96* | 0.059 | |
IL-6 [μg/l] mean ± SD | 172.29 ±41.09 | 130.72 ±13.74* | 172.61 ±38.90 | 141.43 ±18.49* | 0.968 | |
FeNO [ppb] mean ± SD | 45.50 ±5.07 | 19.80 ±3.31* | 43.84 ±4.78 | 33.45 ±3.78* | 0.094 | |
EOS count (%), mean ± SD | 7.95 ±1.39 | 1.65 ±0.58* | 8.18 ±1.61 | 4.10 ±1.05* | 0.451 | |
Efficacy, n (%) | Markedly effective | – | 30 (60.00) | – | 21 (42.00) | 0.037 |
Effective | – | 17 (34.00) | – | 19 (38.00) | ||
Ineffective | – | 3 (6.00) | – | 10 (20.00) | ||
Adverse events, n (%) | Nausea | – | 2 (4.00) | – | 2 (4.00) | 0.749 |
Rash | – | 2 (4.00) | – | 1 (2.00) | ||
Headache | – | 1 (2.00) | – | 3 (6.00) |
Represents a significant change post-treatment compared to pre-treatment.