TABLE 3.
Efficacy outcomes assessment after treatment.
| Outcomes | TCM group | Control group | Difference (95% CI) | p | ||
|---|---|---|---|---|---|---|
| No. of patients | Mean change from baseline a | No. of patients | Mean change from baseline a | |||
| Annual numbers of AEs | 35 | −0.37 ± 1.96 | 32 | 1.19 ± 2.66 | −1.56 (−2.69, −0.43) | 0.01 |
| Pulmonary function | ||||||
| FEV1(L)-at week 26 | 35 | −0.06 ± 0.22 | 32 | −0.10 ± 0.20 | 0.05 (−0.06, 0.15) | 0.38 |
| FVC(L)-at week 26 | 35 | −0.10 ± 0.27 | 32 | −0.11 ± 0.24 | 0.01 (−0.11, 0.13) | 0.86 |
| DLCO%-at week 26 | 35 | 4.40 ± 9.89 | 32 | −0.88 ± 8.66 | 5.29 (0.76, 9.81) | 0.02 |
| Clinical symptoms and signs | ||||||
| Cough score | ||||||
| At week 13 | 35 | −0.14 ± 0.65 | 32 | 0.03 ± 0.54 | −0.18 (−0.47, 0.12) | 0.24 |
| At week 26 | 35 | −0.26 ± 0.78 | 32 | 0.13 ± 0.61 | −0.38 (−0.73, −0.04) | 0.03 |
| Expectoration score | ||||||
| At week 13 | 35 | 0.00 ± 0.91 | 32 | 0.19 ± 0.64 | −0.19 (−0.58, 0.2) | 0.34 |
| At week 26 | 35 | 0.00 ± 0.94 | 32 | 0.25 ± 0.72 | −0.25 (−0.66, 0.16) | 0.23 |
| Chest tightness score | ||||||
| At week 13 | 35 | −0.23 ± 0.77 | 32 | −0.03 ± 0.54 | −0.20 (−0.52, 0.13) | 0.23 |
| At week 26 | 35 | −0.20 ± 1.11 | 32 | −0.13 ± 0.66 | −0.08 (−0.53, 0.38) | 0.74 |
| Shortness of breath score | ||||||
| At week 13 | 35 | −0.06 ± 0.64 | 32 | −0.06 ± 0.62 | 0.01 (−0.30, 0.31) | 0.97 |
| At week 26 | 35 | −0.26 ± 0.78 | 32 | −0.03 ± 0.70 | −0.23 (−0.59, 0.14) | 0.22 |
| Fatigue score | ||||||
| At week 13 | 35 | −0.26 ± 0.70 | 32 | −0.13 ± 0.71 | −0.13 (−0.48, 0.21) | 0.45 |
| At week 26 | 35 | −0.37 ± 0.97 | 32 | −0.16 ± 0.68 | −0.22 (−0.63, 0.20) | 0.30 |
| Cyanosis score | ||||||
| At week 13 | 35 | −0.17 ± 0.51 | 32 | −0.03 ± 0.54 | −0.14 (−0.40, 0.12) | 0.28 |
| At week 26 | 35 | −0.29 ± 0.57 | 32 | −0.13 ± 0.55 | −0.16 (−0.44, 0.12) | 0.25 |
| mMRC score | ||||||
| At week 13 | 35 | −0.31 ± 0.80 | 32 | −0.16 ± 0.72 | −0.16 (−0.53, 0.21) | 0.40 |
| At week 26 | 35 | −0.43 ± 1.07 | 32 | −0.22 ± 0.79 | −0.21 (−0.67, 0.25) | 0.37 |
| HRQoL | ||||||
| CAT total score | ||||||
| At week 13 | 35 | −1.17 ± 6.90 | 32 | 0.28 ± 5.62 | −1.45 (−4.54, 1.63) | 0.35 |
| At week 26 | 35 | −1.60 ± 7.50 | 32 | 0.19 ± 6.87 | −1.79 (−5.31, 1.73) | 0.31 |
| SF-36 total score | ||||||
| At week 13 | 35 | 5.91 ± 12.31 | 32 | 6.35 ± 13.36 | −0.44 (−6.70, 5.82) | 0.89 |
| At week 26 | 35 | 6.62 ± 16.50 | 32 | 6.12 ± 13.91 | 0.50 (-6.98, 7.98) | 0.89 |
| SGRQ total score | ||||||
| At week 13 | 35 | −5.02 ± 15.44 | 32 | −1.29 ± 11.76 | −3.73 (−1078, 3.01) | 0.27 |
| At week 26 | 35 | −5.66 ± 18.04 | 32 | −0.86 ± 10.69 | −4.80 (−12.13, 2.52) | 0.20 |
| 6MWD (m) | ||||||
| At week 13 | 35 | 14.11 ± 34.26 | 32 | −8.91 ± 39.28 | 23.02 (5.07, 40.97) | 0.01 |
| At week 26 | 35 | 24.46 ± 63.07 | 32 | −5.97 ± 48.18 | 30.43 (2.85, 58.00) | 0.03 |
| All-cause mortality | No. of patients | No. of patients with events (%) | No. of patients | No. of patients with event (%) | Hazard Ratio (95% CI) | |
| 35 | 3 (8.6) | 32 | 7 (21.9) | 0.39 (0.10, 1.52) | 0.13 | |
a
mean ± SD.
Data presented as between-time mean (95% CI) differences by groups.
6MWT, 6-min walk test; AE, acute exacerbation; CAT, COPD assessment test; DLco%, diffusing capacity percentage of the predicted value; FEV1, forced expiratory volume in one second percentage; FVC, forced vital capacity; HRQoL, health-related quality of life; mMRC, modified medical research council; SF-36, 36-item short-form health survey; SGRQ, St. George’s respiratory questionnaire.