Table 3.
Summary of main findings of RCTs on compound Kushen injection for breast cancer.
| Outcomes | No. of participants (no. of RCTS) | Certainty of the evidence | Relative effect (95% CI) | Anticipated absolute effects | |
|---|---|---|---|---|---|
| Risk with control | Risk difference with intervention (95% CI) | ||||
| CKI plus chemotherapy versus chemotherapy | |||||
| ORR | 1694 (21) | ⊕⊕○○1,5 | RR 1.30, [1.18, 1.43] | 471 per 1000 | 141 more per 1000, (from 85 more to 203 more) |
| DCR | 1627 (20) | ⊕○○○1,2,5 | RR 1.21, [1.15, 1.28] | 698 per 1000 | 147 more per 1000, (from 105 more to 196 more) |
| KPS score improvement rate | 1172 (14) | ⊕⊕○○1,5 | RR 1.42, [1.26, 1.61] | 476 per 1000 | 200 more per 1000, (from 124 more to 291 more) |
| KPS score | 393 (6) | ⊕○○○1,4,5 | N/A | N/A | The KPS score improvement in the intervention groups was 12.81 higher (10.16 to 15.46 higher) |
| PFS | 94 (1) | ⊕○○○1,4,5 | N/A | N/A | The PFS in the intervention groups was 2.24 months higher (1.26 to 3.22 higher) |
| OS | 94 (1) | ⊕○○○1,4,5 | N/A | N/A | The OS in the intervention groups was 2.44 months higher (1.45 to 3.43 higher) |
| Leukocyte decrease | 1121 (15) | ⊕○○○1,2,5 | RR 0.60, [0.5, 0.71] | 572 per 1000 | 229 fewer per 1000, (from 286 fewer to 166 fewer) |
| Platelet decrease | 750 (9) | ⊕⊕○○1,5 | RR 0.41, [0.29, 0.58] | 397 per 1000 | 234 fewer per 1000, (from 282 fewer to 167 fewer) |
| Liver injury | 1215 (13) | ⊕⊕○○1,5 | RR 0.42, [0.31, 0.57] | 269 per 1000 | 156 fewer per 1000, (from 185 fewer to 116 fewer) |
| Renal injury | 879 (9) | ⊕⊕○○1,5 | RR 0.63, [0.46, 0.86] | 203 per 1000 | 83 fewer per 1000, (from 116 fewer to 37 fewer) |
| Nausea and vomiting | 1171 (14) | ⊕⊕○○1,5 | RR 0.68, [0.59, 0.79] | 578 per 1000 | 185 fewer per 1000, (from 237 fewer to 121 fewer) |
| Diarrhea | 210 (3) | ⊕○○○1,3,5 | RR 0.55, [0.35, 0.88] | 324 per 1000 | 146 fewer per 1000, (from 210 fewer to 39 fewer) |
| Alopecia | 584 (8) | ⊕○○○1,2,5 | RR 0.51, [0.39, 0.67] | 514 per 1000 | 252 fewer per 1000, (from 313 fewer to 170 fewer) |
| Oral mucositis | 441 (4) | ⊕⊕○○1,5 | RR 0.18, [0.07, 045] | 136 per 1000 | 111 fewer per 1000, (from 126 fewer to 75 fewer) |
| Decrease rate of CEA | 336 (3) | ⊕○○○1,3,5 | RR 1.19, [1.05, 1.35] | 468 per 1000 | 89 more per 1000, (from 23 more to 164 more) |
| Decrease rate of CA153 | 206 (2) | ⊕○○○1,3,5 | RR 1.15, [1.03, 1.27] | 821 per 1000 | 123 more per 1000, (from 25 more to 22 more) |
Note. (1) Risk of bias: methodological quality of these trials was graded as “high risk of bias” due to the design of comparison. The trials also had unclear risk of performance bias for not reporting blinding the outcome assessor. (2) Inconsistency: the significant heterogeneity with a large I2 value, an I2 >50% indicated the possibility of statistical heterogeneity among the studies. (3) Imprecision: for dichotomous outcomes, the total number of events is less than 300; or pooled results included no effects. (4) Imprecision: for continuous outcomes, the total population size is less than 400; or pooled results included no effects. (5) All the trials had high risk of performance bias for not blinding the participants. ∗The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio; MD: mean difference. N/A: not applicable. RCT: randomized controlled trial. No.: number. ⨁: very low quality of the evidence; ⨁⨁: low quality of the evidence; GRADE Working Group grades of evidence. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.