Table 2.
Changes in primary and secondary indicators from baseline to after three months of treatment a
| Indicator |
BFHX (N = 64) b |
Placebo (N = 65) b |
Least Squares Means Differences (95% CI) |
P-valueb |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. of patientsc | Baseline | After 3 months of treatment | Change | No. of patientsc | Baseline | 3 months after treatment | Change | |||
| Primary indicator | ||||||||||
| Chest CT Indexes | ||||||||||
| Volume of total lung lesions (cm³) | 53 | 31.5 ± 120.5 | 14.3 ± 32.1 | -19.2 ± 96.4 | 51 | 15.1 ± 39.4 | 29.2 ± 75.4 | 15.1 ± 47.5 | -34.0 (-63.5 to -4.6) | 0.0243 |
| Volume of the ground-glass opacities (cm³) | 53 | 29.3 ± 115.4 | 13.2 ± 30.6 | -18.3 ± 92.0 | 51 | 14.2 ± 38.2 | 23.9 ± 71.4 | 10.5 ± 42.4 | -32.6 (-60.7 to -4.5) | 0.0444 |
| Volume of the consolidations (cm³) | 53 | 1.8 ± 34.4 | 1.1 ± 2.3 | -0.9 ± 4.7 | 51 | 1.0 ± 1.6 | 2.0 ± 4.1 | 1.1 ± 3.4 | -1.4 (-2.6 to -0.1) | 0.0188 |
| 6-Min Walk Distance (m) | 58 | 427.3 ± 73.6 | 475.6 ± 63.7 | 45.3 ± 62.4 | 60 | 435.0 ± 73.3 | 445.5 ± 69.1 | 10.1 ± 59.4 | 34.2 (11.7–56.8) | 0.0022 |
| Secondary indicator | ||||||||||
| Fatigue Assessment Inventory | 58 | 119.1 ± 26.2 | 85.5 ± 27.6 | -31.2 ± 27.0 | 60 | 112.9 ± 31.6 | 100.4 ± 25.7 | -12.5 ± 36.1 | -17.8 (-29.5 to -6.2) | 0.0019 |
| Total SGRQ | 58 | 16.0 ± 12.1 | 3.2 ± 2.9 | -12.0 ± 10.9 | 60 | 14.0 ± 10.1 | 4.5 ± 4.2 | -9.1 ± 8.6 | -2.4 (-5.8 to 1.0) | 0.1148 |
| Part 1 SGRQ | 58 | 4.0 ± 4.3 | 0.5 ± 0.9 | -3.2 ± 4.0 | 60 | 3.8 ± 4.0 | 0.5 ± 1.1 | -3.4 ± 4.1 | 0.3 (-1.2 to 1.7) | 0.8310 |
| Part 2 SGRQ | 58 | 9.3 ± 8.0 | 1.4 ± 2.4 | -7.5 ± 7.1 | 60 | 7.5 ± 6.5 | 2.3 ± 3.3 | -4.9 ± 4.9 | -2.2 (-4.4 to -0.1) | 0.0234 |
| Borg Dyspnea score | 58 | 2.1 ± 1.3 | 0.7 ± 1.2 | -1.3 ± 0.9 | 60 | 2.1 ± 1.2 | 0.9 ± 1.4 | -1.2 ± 1.3 | -0.1 (-0.5 to 0.2) | 0.4801 |
| Chinese medicine symptom complex score | 58 | 4.3 ± 2.5 | 1.1 ± 1.7 | -3.1 ± 2.6 | 60 | 4.5 ± 2.8 | 0.9 ± 1.2 | -3.4 ± 2.4 | 0.4 (-0.4 to 1.3) | 0.4723 |
‡ P-values were calculated for continuous outcomes with t-tests for the change from baseline to the last visit after three months of treatment; Fisher’ s exact test was performed for categorical outcomes.
a
Data are presented as the means ± standard deviations. The changes from baseline to the end of three months of treatment were arithmetic. N lrb% is the number of patients and percentage. The least squares mean difference was calculated by analysing the generalised linear regression model with site as a confounder.
b
Total patients are allocated to the intention-to-treat population.
c
No. of patients observed at end of three months of treatment.