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. 2022 Jan 12;2022:9633048. doi: 10.1155/2022/9633048

Table 2.

Characteristics of included randomized trials of FSEC for ulcerative colitis.

Study ID Year Gender (male/female) Sample size Age (mean or range, years) Course of disease (mean or range) Duration of treatment (days) Intervention vs. control Intervention details Controls Outcomes
ZhiYJ2017 2017 42/38 I:40 I:38.8 ± 3.9 I: 6 months–8 years 42 FSEC + mesalazine vs. compound glutamine enteric capsules + mesalazine FSEC: 3 times/day, 1.6 g/time Compound glutamine enteric capsules: 3 times/day, 3 pills/time (1), (5), (6), (7)
C:40 C:39.4 ± 4.2 C: 2 months–9 years Mesalazine: 4 times/day, 1 g/time Mesalazine: 4 times/day, 1 g/time

JiaoYW2019 2019 I:21/22 I:43 I:57 ± 12 I: 6.8 ± 2.3 years 56 FSEC + mesalazine vs. mesalazine FSEC: 3 times/day, 1.6 g/time Mesalazine: 4 times/day, 1 g/time (1)
C:20/23 C:43 C:59 ± 12 C: 7.2 ± 2.5 years Mesalazine: 4 times/day, 1 g/time

ZhaoJ2017 2017 74/46 I:60 20–60 (42.56 ± 3.26) 1–15 (7.01 ± 1.24) years 64 FSEC vs. mesalazine FSEC: 3 times/day, 1.6 g/time Mesalazine: 4 times/day, 1 g/time (1), (5)
C:60

LiuHY2012 2012 I:8/16 I:24 26–64 (48.14 ± 8.72) 19–62 (46.49 ± 10.02) years 56 FSEC + mesalazine placebo vs. mesalazine + FSEC placebo FSEC: 3 times/day, 1.6 g/time; Mesalazine: 4 times/day, 1 g/time (2), (3), (4), (5)
C:6/13 C:19 Mesalazine placebo: 4 times/day, 1 g/time FSEC placebo: 3 times/day, 1.6 g/time

TangJS2011 2011 17/23 I: 20 34 years on average 6 months–10 years 56 FSEC + SASP vs. SASP FSEC: 3 times/day, 1.6 g/time; SASP: 4 times/day, 1 g/time (1)
C: 20 SASP: 4 times/day, 1 g/time

TongZQ2011-1 2011 I: 59/61 I: 120 I: 42.88 ± 11.77 NR 56 FSEC + mesalazine placebo vs. mesalazine + FSEC placebo FSEC: 3 times/day, 1.6 g/time; Mesalazine:4 times/day, 1 g/time (1), (2), (4), (5)
C: 23/17 C: 40 C: 42.70 ± 10.42 Mesalazine placebo: 4 times/day, 1 g/time FSEC placebo: 3 times/day, 1.6 g/time

LiangL2010 2010 I: 18/12 I: 30 I: 18–65 (43.28 ± 12.33) 14 days–20 years 56 FSEC + mesalazine placebo vs. mesalazine + FSEC placebo FSEC: 3 times/day, 1.6 g/time; Mesalazine:4 times/day, 1 g/time (1), (3)
C: 6/4 C: 10 C: 18–65 (42.78 ± 12.36) Mesalazine placebo: 4 times/day, 1 g/time FSEC placebo: 3 times/day, 1.6 g/time

TongZQ2011-2 2011 I: 20/22 I: 42 I: 38.7 ± 10.8 NR 56 FSEC vs. mesalazine FSEC: 3 times/day, 2.4 g/time Mesalazine:4 times/day, 1 g/time (1), (2), (3), (5)
C: 21/21 C: 42 C: 41.2 ± 12.3
I: 24/18 I: 42 I: 40.7 ± 10.2 NR 56 FSEC vs. mesalazine FSEC: 3 times/day, 1.6 g/time Mesalazine:4 times/day, 1 g/time
C: 21/21 C: 42 C: 41.2 ± 12.3

LuC2010 2010 I: 126/114 I: 240 I: 43.63 ± 12.02 NR 56 FSEC + mesalazine placebo vs. mesalazine + FSEC placebo FSEC: 3 times/day, 1.6 g/time; Mesalazine:4 times/day, 1 g/time (1), (2), (3), (5)
C: 38/42 C: 80 C: 44.51 ± 12.02 Mesalazine placebo: 4 times/day, 1 g/time FSEC placebo: 3 times/day, 1.6 g/time

TongZQ2009 2009 I: 10/13 I: 23 I: 44.39 ± 12.99 NR 56 FSEC vs. SASP FSEC: 3 times/day, 1.6 g/time SASP: 4 times/day, 0.75 g/time (1), (2) ,(3), (5)
C: 13/11 C: 24 C: 38.25 ± 13.19

WangCH2009 2009 I: NR I: 8 18–65 NR 56 FSEC vs. SASP FSEC: 3 times/day, 1.6 g/time SASP: 4 times/day, 0.75 g/time (1), (2), (3), (5)
C: NR C: 8

FanH2009 2009 I: NR I: 16 18–65 NR 56 FSEC vs. mesalazine FSEC: 3 times/day, 1.6 g/time Mesalazine: 4 times/day, 1 g/time (1)
C: NR C: 8

ZhaoJ2009 2009 I: 5/17 I: 22 I: 25–64 (32.51 ± 12.46) I: 1.5–25 years 56 FSEC vs. SASP FSEC: 3 times/day, 1.6 g/time SASP: 4 times/day, 1 g/time (1), (2)
C: 6/6 C: 12 C: 24–62 (31.73 ± 11.58) C: 2–28 years

ZhuangX2009 2009 I: NR I: 22 NR NR 56 FSEC vs. mesalazine FSEC: 3 times/day, 1.6 g/time Mesalazine: 4 times/day, 1 g/time (1)
C: NR C: 18

FanH2008 2008 I: 6/5 I: 11 I: 25–59 I: 1.5–25 years 56 FSEC vs. mesalazine FSEC: 3 times/day, 1.6 g/time Mesalazine: 4 times/day, 1 g/time (1), (2), (3)
C: 3/4 C: 7 C: 24–58 C: 1.5–28 years

I, intervention group; C, control group; FSEC, five-flavor Sophora flavescens enteric-coated capsule; SASP, sulfasalazine; DAI, disease activity index; TCM, traditional Chinese medicine; NR, not reported. (1) Clinical effective rate, (2) colonoscopy curative effect, (3) effective rate of TCM syndromes, (4) DAI, (5) adverse effects, (6) IL-8, (7) IL-10.