Table 3.
Comparison of clinical symptom improvement rate between Ludangshen and placebo group
| Variables | FAS analysis | PPS analysis | |||||
|---|---|---|---|---|---|---|---|
| Ludangshen | Placebo | P value | Ludangshen | Placebo | P value | ||
| Fatigue (n) | 94 | 90 | 92 | 89 | |||
| Week 1 | 52 (55.3) | 29 (32.2) | 0.002 | 50 (54.3) | 29 (32.6) | 0.003 | |
| Week 2 | 81 (86.2) | 38 (42.2) | < 0.001 | 78 (84.8) | 37 (41.6) | < 0.001 | |
| Anorexia (n) | 68 | 70 | 67 | 68 | |||
| Week 1 | 49 (72.1) | 25 (35.7) | < 0.001 | 48 (71.6) | 25 (36.8) | < 0.001 | |
| Week 2 | 61 (89.7) | 38 (54.3) | < 0.001 | 60 (89.6) | 36 (52.9) | < 0.001 | |
| Distension (n) | 43 | 34 | 42 | 33 | |||
| Week 1 | 28 (65.1) | 14 (41.2) | 0.036 | 27 (64.3) | 14 (42.4) | 0.059 | |
| Week 2 | 38 (88.4) | 22 (64.7) | 0.013 | 38 (90.5) | 21 (63.6) | 0.01 | |
| Loose stools (n) | 48 | 52 | 48 | 50 | |||
| Week 1 | 32 (66.7) | 24 (46.2) | 0.039 | 32 (66.7) | 24 (48.0) | 0.062 | |
| Week 2 | 41 (85.4) | 32 (61.5) | 0.007 | 41 (85.4) | 30 (60.0) | 0.005 | |
| Shortness of breath (n) | 50 | 50 | 49 | 49 | |||
| Week 1 | 27 (54.0) | 21 (42.0) | 0.23 | 26 (53.1) | 21 (42.9) | 0.312 | |
| Week 2 | 44 (88.0) | 28 (56.0) | < 0.001 | 43 (87.8) | 28 (57.1) | 0.001 | |
FAS full analysis set, PPS per protocol set