Table 1.
Characteristics of the randomized clinical trials of GuiZhi-ShaoYao-ZhiMu decoction for rheumatoid arthritis: GSZD+MTX versus MTX.
| Study | Number of patientsa | Female % | Age (years, mean ± SD or range) | RA duration (years) | MTX (mg/week) | GSZD (dose/day) | Other drugs | Study duration (weeks) | Effective rateb | Efficacy | Clinical manifestations, laboratory test indicators | AEs |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zhou et al.23 | A: 36 B: 33 |
A: 63.89 B: 66.67 |
A: 21–66 B: 23–64 |
A: 2.46 B: 2.52 |
7.5 | +1 | None | 6 | A: 88.89% B: 63.64% |
30% efficacy, 60% efficacy, 90% efficacy | No | No |
| Yuan24 | A: 44 B: 44 |
A: 40.91 B: 36.36 |
A: 20–68 B: 20–70 |
NR | 7.5 | +1 | None | 8 | A: 95.45% B: 75.00% |
ΔDAS28 > 0.6, ΔDAS28 > 1.2 | No | Yes |
| Zhang et al.25 | A: 45 B: 45 |
A: 51.11 B: 53.33 |
A: 37–79 B: 38–78 |
A: 6.11 B: 5.96 |
10 | +1 | None | 11 | A: 91.11% B: 73.33% |
35% efficacy, 75% efficacy | CRP, ESR, RF, DMS | No |
| Xi and Zhang26 | A: 80 B: 75 |
A: 37.5 B: 44.00 |
A: 44–85 B: 45–85 |
A: 12.4 B: 12.2 |
15 | +1 | None | 24 | A: 96.25% B: 84.00% |
60% efficacy, 90% efficacy | DMS, SJC, TJC | Yes |
| Xiao27 | A: 18 B: 18 |
A: 55.56 B: 61.11 |
A: 41 ± 5.1 B: 42 ± 4.6 |
A: 4.5 B: 4.6 |
7.5 | +1 | Dic | 12 | A: 94.44% B: 66.67% |
ACR20, ACR30 | ESR | No |
| Ji28 | A: 83 B: 83 |
A: 44.58 B: 38.55 |
A: 37–66 B: 36–68 |
A: 3.8 B: 3.6 |
7.5 | +1 | IBU | 8 | A: 96.38% B: 80.72% |
ACR20, ACR50 | CRP, ESR, RF | No |
| Cui29 | A: 53 B: 53 |
A: 60.38 B: 64.15 |
A: 36–78 B: 35–78 |
A: 3.61 B: 3.61 |
10 | +1 | IBU | 8 | A: 94.34% B: 81.13% |
35% efficacy, 85% efficacy | CRP, ESR, RF | No |
| Li et al.30 | A: 40 B: 39 |
A: 78.05 B: 73.17 |
A: 45–70 B: 43–69 |
A: 6.64 B: 6.18 |
7.5 | +1 | CLX | 12 | A: 95.00% B: 61.54% |
30% efficacy, 70% efficacy | CRP, ESR, RF | No |
| Yu and Zhang31 | A: 40 B: 41 |
A: 67.50 B: 60.98 |
A: 18–65 B: 20–69 |
A: 6.8 B: 5.4 |
10 | +1 | SSZ | 12 | A: 90.00% B: 70.73% |
ACR20, ACR50, ACR90, | CRP, ESR, DMS, SJC, TJC | Yes |
| Li et al.32 | A: 45 B: 45 |
A: 48.89 B: 46.67 |
A: 21–75 B: 21–76 |
NR | 7.5 | +1 | SSZ | 24 | A: 95.56% B: 77.78% |
ΔDAS28 > 0.6, ΔDAS28 > 1.2 | CRP, ESR, DMS | Yes |
| Huang et al.33 | A: 36 B: 27 |
A: 77.78 B: 85.19 |
A: 21–65 B: 22–64 |
A: 2.75 B: 2.65 |
10 | +1 | SSZ, CLX | 12 | A: 91.67% B: 66.67% |
ACR20, ACR50, ACR80 | CRP, ESR, RF, DMS, SJC, | Yes |
| Liang and Yang34 | A: 40 B: 38 |
A: 55.00 B: 57.89 |
A: 39–79 B: 40–80 |
A: 2.3 B: 2.1 |
10 | +1 | LEF, Dic | 8 | A: 95.00% B: 78.95% |
30% efficacy, 70% efficacy, 95% efficacy | CRP, ESR, RF, DMS, SJC | Yes |
| Dong35 | A: 30 B: 30 |
A: 43.33 B: 46.67 |
A: 52–79 B: 35–78 |
A: 6.10 B: 5.93 |
10 | +1 | SSZ, CLX | 12 | A: 96.67% B: 80.00% |
35% efficacy, 95% efficacy | CRP, ESR, RF, DMS, SJC, | Yes |
| Wu36 | A: 33 B: 30 |
A: 63.64 B: 66.67 |
A: 28–64 B: 31–67 |
A: 5.7 B: 5.5 |
10 | +1 | LEF, MePr | 24 | A: 100% B: 83.33% |
ACR20, ACR50, ACR70, | CRP, ESR, RF, DMS, SJC, TJC, | No |
a
A = GSZD group; B = control group.
b
Effective rate is defined as ACR20, 30% or 35% efficacy, ΔDAS28 >0.6.
ACR, American College of Rheumatology; AE, adverse event; CLX, celecoxib; CRP, C-reactive protein; ΔDAS28, a decrease of DAS28; DAS28, disease activity score 28; Dic, diclofenac sodium; DMS, duration of morning stiffness; ESR, erythrocyte sedimentation rate; GSZD, GuiZhi-ShaoYao-ZhiMu decoction; IBU, ibuprofen; LEF, leflunomide; MePr, methylprednisolone; MTX, methotrexate; NR, not reported; RF, rheumatoid factor; SJC, swollen joint count; SSZ, sulfasalazine; TJC, tender joint count.