Five-Flavor Sophora flavescens Enteric-Coated Capsules for Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

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.