Table 6.
GRADE evidence profile.
| TABLE 6a | GRADE evidence profile of clinical efficacy and safety. | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Outcomes (Trials) | Quality assessment | No. of patients | Risk ratios (95% CI) | Quality | |||||
| Risk of bias | Inconsistency | Indirectness | Imprecision | Reporting bias | Astragalus-Containing TCM | PBC | |||
| ORR (32) | Seriousa | No | No | No | No | 666/1,235 (53.9%) | 524/1,219 (43%) | RR 1.24 (1.15 to 1.34) | ⊕⊕⊕O |
| Moderate | |||||||||
| DCR (32) | Seriousa | No | No | No | Serious | 1,021/1,187 (86%) | 893/1,171 (76.3%) | RR 1.10 (1.06 to 1.14) | ⊕⊕OO |
| Low | |||||||||
| Half-year survival rate (5) | Very Seriousd | Seriousg | No | No | No | 152/160 (95%) | 132/155 (85.2%) | RR 1.14 (0.89 to 1.45) | ⊕OOO |
| Very Low | |||||||||
| 1-year survival rate (8) | Seriousc | Nof | No | No | No | 173/254 (68.1%) | 127/258 (49.2%) | RR 1.41 (1.09 to 1.82) | ⊕⊕⊕O |
| Moderate | |||||||||
| 2-year survival rate (3) | Very Seriousd | No | No | Seriouse | No | 43/121 (35.5%) | 13/117 (11.1%) | RR 3.13 (1.80 to 5.46) | ⊕OOO |
| Very Low | |||||||||
| 3-year survival rate (1) | Very Seriousd | No | No | Seriouse | No | 0/58 (0%) | 0/54 (0%) | Not pooled | ⊕OOO |
| Very Low | |||||||||
| QOL, according to the number of KPS improved patients (14) | Seriousc | No | No | No | No | 233/426 (54.7%) | 108/413 (26.2%) | RR 2.03 (1.70 to 2.43) | ⊕⊕⊕O |
| Moderate | |||||||||
| Neutropenia (21) | Seriousa | Nof | No | No | Serious | 269/698 (38.5%) | 416/696 (59.8%) | RR 0.65 (0.54 to 0.79) | ⊕⊕OO |
| Low | |||||||||
| Anemia (13) | Seriousa | Nof | No | No | Serious | 135/379 (35.6%) | 195/375 (52%) | RR 0.68 (0.52 to 0.89) | ⊕⊕OO |
| Low | |||||||||
| Thrombocytopenia (21) | Seriousa | Nof | No | No | Serious | 155/602 (25.7%) | 237/595 (39.8%) | RR 0.65 (0.51 to 0.82) | ⊕⊕OO |
| Low | |||||||||
| Nausea and vomiting (20) | Seriousa | Nof | No | No | Serious | 263/647 (40.6%) | 377/646 (58.4%) | RR 0.73 (0.64 to 0.82) | ⊕⊕OO |
| Low | |||||||||
| Diarrhea (10) | Seriousc | No | No | No | Serious | 62/307 (20.2%) | 111/301 (36.9%) | RR 0.58 (0.45 to 0.75) | ⊕⊕OO |
| Low | |||||||||
| Hepatic dysfunction (14) | Seriousa | No | No | No | No | 45/442 (10.2%) | 86/446 (19.3%) | RR 0.55 (0.40 to 0.77) | ⊕⊕⊕O |
| Moderate | |||||||||
| Renal dysfunction (10) | Seriousa | No | No | No | No | 14/324 (4.3%) | 34/323 (10.5%) | RR 0.48 (0.26 to 0.88) | ⊕⊕⊕O |
| Moderate | |||||||||
| Neurotoxicity (12) | Seriousa | No | No | No | Serious | 123/389 (31.6%) | 162/379 (42.7%) | RR 0.78 (0.65 to 0.92) | ⊕⊕OO |
| Low | |||||||||
| Alopecia (4) | Very Seriousd | No | No | Seriouse | No | 50/145 (34.5%) | 61/138 (44.2%) | RR 0.77 (0.61 to 0.97) | ⊕OOO |
| Very Low | |||||||||
| Stomatitis (6) | Seriousa | No | No | No | No | 45/174 (25.9%) | 62/174 (35.6%) | RR 0.73 (0.53 to 1.00) | ⊕⊕⊕O |
| Moderate | |||||||||
ORR, objective response rate; DCR, disease control rate; QOL, quality of life; NK cells, natural killer cells; CI, confidence interval.
Most trials had unclear risk, and with high risk, but the result had good robustness. The evidence was rated down by only one level.
Most trials had unclear risk and with high risk, and the result had poor robustness. The evidence was rated down by two levels.
Most trials had unclear risk and the trials were no high risk, but the result had good robustness. The evidence was rated down by only one level.
Most trials had unclear risk and the trials were no high risk, but the result had poor robustness. The evidence was rated down by two levels.
The sample size for each outcome was fewer than 300 cases. Therefore, the evidence was rated down by one level.
Heterogeneity presented in them, and the results had good robustness. Not rated down.
Heterogeneity presented in them, and the result had poor robustness. The evidence was rated down by one level.