Table 3.
Within-Group Differences at Weeks 28 and 52 for Various Secondary Outcomes
Outcome and Group | Baseline Mean (SD), 95% CI | End of Treatment, Mean Change (SD), 95% CI | End of Follow-Up, Mean (SD), 95% CI |
---|---|---|---|
SGRQ total score: Ginseng | 30.19 (11.04), 28.00 to 32.38 | –2.07 (8.02), –3.66 to –0.48, p=0.01 | –0.79 (9.73), –2.83 to 1.25, p=0.44 |
SGRQ total score: Placebo | 29.99 (11.45), 27.72 to 32.26 | –2.98 (8.06), –4.58 to –1.38, p<0.001 | –2.60 (8.86), –4.48 to –0.73, p=0.007 |
CAT total score: Ginseng | 14.77 (5.17), 13.74 to 15.80 | –1.26 (4.59), –2.17 to –0.35, p=0.007 | –0.63 (5.30) –1.74 to 0.48, p=0.28 |
CAT total score: Placebo | 14.37 (5.32), 13.31 to 15.43 | –1.54 (4.55), –2.44 to –0.64, p=0.001 | –0.73 (4.71), –1.17 to 0.27, p=0.15 |
SF-36 (mental score): Ginseng | 45.67 (6.31), 44.42 to 46.92 | 0.16 (4.19), –0.67 to 0.99, p=0.71 | NA |
SF-36 (mental score): Placebo | 46.05 (5.77), 44.93 to 47.22 | 0.05 (5.11), –0.97 to 1.06, p=0.92 | NA |
SF-36 (physical score): Ginseng | 50.19 (7.06), 48.79 to 51.59 | 1.08 (5.75), –0.06 to 2.22, p=0.06 | NA |
SF-36 (physical score): Placebo | 51.0 (7.06), 49.60 to 52.40 | 0.92 (7.32), –0.53 to 2.38, p=0.21 | NA |
FEV1, liters: Ginseng | 1.20 (0.40), 1.12 to 1.28 | –0.04 (0.13), –0.06 to –0.01, p=0.008 | –0.18 (0.36) –0.25 to –0.11, p<0.001 |
FEV1, liters: Placebo | 1.29 (0.47), 1.20 to 1.39 | –0.08 (0.13), –0.10 to 0.05, p<0.001 | –0.22 (0.43), –0.30 to –0.13, p<0.001 |
FEV1, %: Ginseng | 47.17 (14.63), 44.27 to 50.07 | –1.34 (5.34), –2.40 to –0.28, p=0.014 | –2.10 (6.01) –3.38 to –0.83, p=0.001 |
FEV1, %: Placebo | 49.82 (16.28), 46.59 to 53.05 | –2.69 (4.97), –3.68 to –1.70, p<0.001 | –2.01 (6.88), –3.49 to –0.54, p=0.008 |
FVC, liters: Ginseng | 2.52 (0.60), 2.40 to 2.64 | 0.01 (0.34), –0.06 to 0.07, p=0.85 | –0.25 (0.82) –0.41 to –0.08, p=0.003 |
FVC, liters: Placebo | 2.60 (0.62), 2.48 to 2.72 | –0.03 (0.28), –0.08 to 0.03, p=0.37 | –0.32 (0.92), –0.50 to –1.4, p=0.001 |
FVC, %: Ginseng | 76.55 (14.33), 73.71 to 79.39 | 0.44 (10.13), –1.57 to 2.45, p=0.67 | 1.35 (11.54) –1.09 to 3.80, p=0.28 |
FVC, %: Placebo | 78.06 (15.65), 74.96 to 81.16 | –0.55 (8.81), –2.30 to 1.20, p=0.53 | 1.30 (10.3) –0.92 to 3.50, p=0.25 |
6MWT meters: Ginseng | 432.97 (80.58), 416.98 to 448.96 | 3.17 (52.21), –7.19 to 13.53, p=0.55 | –3.34 (61.90) –16.31 to 9.62, p=0.61 |
6MWT meters: Placebo | 419.53 (87.63), 402.14 to 436.92 | 10.36 (61.14), –1.77 to 22.49, p=0.09 | 6.19 (68.04) –8.22 to 20.61, p=0.40 |
Notes: Lung function values are post-bronchodilator. Results are presented using intention-to-treat between baseline and end of treatment; intention-to-treat was dispensed with at end of follow up. Paired t-tests were used for testing within-group difference.
Abbreviations: 6MWT, 6-minute Walking Test; CAT, COPD Assessment Test; CI, confidence interval; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; NA, not applicable; SD, standard deviation; SGRQ, St Georges Respiratory Questionnaire; SF-36, Short Form 36 Health Survey.