Table 3.
Primary and secondary endpoint results after 4 weeks of follow-up in the PPS, n (%)
| Items | Wenxin Keli group (n = 536) | Placebo group (n = 535) | Rate difference, % (95% CI) | P |
|---|---|---|---|---|
| Primary endpoints | ||||
| SER | 200 (37.3) | 48 (9.0) | ||
| ER | 245 (45.7) | 162 (30.3) | ||
| TER | 445 (83.0) | 210 (39.3) | 40.2 (31.9–49.4) | <0.001 |
| Secondary endpoints | ||||
| Palpitation | ||||
| SER | 115 (21.5) | 43 (8.0) | ||
| ER | 297 (55.4) | 158 (29.5) | ||
| TER | 412 (76.9) | 201 (37.5) | 24.3 (17.9–31.4) | <0.001 |
| Chest discomfort | ||||
| SER | 95 (17.7) | 49 (9.2) | ||
| ER | 290 (54.1) | 140 (26.2) | ||
| TER | 385 (71.8) | 189 (35.3) | 26.6 (19.7–34.3) | <0.001 |
| Insomnia | ||||
| SER | 69 (12.9) | 26 (4.9) | ||
| ER | 254 (47.4) | 112 (20.9) | ||
| TER | 323 (60.3) | 138 (25.8) | 26.5 (19.1–35.0) | <0.001 |
| Fatigue | ||||
| SER | 72 (13.4) | 28 (5.2) | ||
| ER | 262 (48.9) | 135 (25.2) | ||
| TER | 334 (62.3) | 163 (30.4) | 26.4 (18.9–35.1) | <0.001 |
PPS: Per-protocol set; CI: Confidence interval; SER: Significantly effective response; ER: Effective response; TER: Total effective response; Rate difference: Rate of TER in Wenxin Keli group - Rate of TER in placebo group; P: Wenxin Keli group vs. Placebo group.