Efficacy and safety of Xileisan combined with mesalazine for ulcerative colitis: A meta-analysis and trial sequential analysis

Table 1 Basic characteristics of the included studies

Ref.	Sample size	Age (years)	Male	Disease duration (years)	Intervention	Treatment duration (weeks)
Cai et al[13], 2022	38	30.2	44.7	3.0	XLS 1.0 g/d, mesalazine 3.0 g/d	8
	38	30.2	50.0	3.0	Mesalazine 3.0 g/d	8
Ding et al[14], 2019	27		62.3		XLS 1.0 g/d, mesalazine 4.0 g/d	4
	26		62.3		Mesalazine 4.0 g/d	4
Ge et al[15], 2011	30				XLS 1.0 g/d, mesalazine 4.0 g/d	4
	30				Mesalazine 4.0 g/d	4
Li et al[16], 2017	50	72.8	56.0		XLS 1.0 g/d, mesalazine 3.0 g/d	8
	50	60.8	58.0		Mesalazine 3.0 g/d	8
Liu et al[17], 2015	30	38.9	46.7		XLS 2.0 g/d, mesalazine 1.0 g/d	8
	26	37.4	42.3		Mesalazine 1.0 g/d	8
Ni et al[18], 2011	30	53.6	80.0		XLS 1.0 g/d, mesalazine 1.25-1.75 g/d	4
	30	50.8	73.3		Mesalazine 1.25-1.75 g/d	4
Wang et al[19], 2016	58	25.6	55.1	3.6	XLS 1.0 g/d, mesalazine 4.0 g/d	3
	58	26.5	60.3	3.2	Mesalazine 4.0 g/d	3
Xu et al[20], 2010	42	38.4	69.0	5.1	XLS 2.0 g/d, mesalazine 4.0 g/d	4
	42		59.5	6.5	Mesalazine 4.0 g/d	4
Yao et al[21], 2022	30	50.2	50.0		XLS 1.0 g/d, mesalazine 3.0 g/d	4
	30	49.7	53.3		Mesalazine 3.0 g/d	4
Zhang et al[22], 2013	35	35.3	62.9		XLS 1.0 g/d, mesalazine 4.0 g/d	2
	35	35.8	60.0		Mesalazine 4.0 g/d	2
Zhang et al[23], 2016	45	37.3	51.1		XLS 1.0 g/d, mesalazine 3.0 g/d	3
	45	36.2	55.6		Mesalazine 3.0 g/d	3
Zhu et al[24], 2013	58		45.5		XLS 1.0 g/d, mesalazine 3.0 g/d	4
	52		45.5		Mesalazine 3.0 g/d	4
Zhu et al[25], 2009	28				XLS 1.0 g/d, mesalazine 4.0 g/d	4
	27				Mesalazine 4.0 g/d	4

XLS: Xileisan.

Table 2 The results of meta-analysis and trial sequential analysis for safety endpoints

Outcome	Experimental	Control	I2	RR (95%CI)	P value	TSA
Total adverse events	21/226	19/224	0	1.10 (0.61-1.97)	0.75	No
Gastrointestinal adverse events	11/168	10/166	0	1.08 (0.50-2.36)	0.84	No
Abdominal distension	3/73	3/72	0	0.99 (0.23-4.22)	0.99	No
Erythra	3/130	3/128	0	0.98 (0.27-3.57)	0.98	No
Relapse	12/116	29/115	50	0.41 (0.22-0.76)	0.005	Yes

TSA: Trial sequential analysis; RR: Risk ratio.

Table 3 The results of subgroup analysis for Xileisan dosage, mesalazine dosage, and treatment duration

Subject	Subgroup	I2	RR (95%CI)	P value
XLS dosage	1.0 g/d	0	1.23 (1.15-1.30)	< 0.00001
	2.0 g/d	0	1.16 (1.03-1.31)	0.01
Mesalazine dosage	1.0-2.0 g/d	0	1.15 (1.01-1.32)	0.04
	3.0 g/d	3	1.20 (1.11-1.30)	< 0.00001
	4.0 g/d	0	1.26 (1.15-1.37)	< 0.00001
Treatment duration	2 weeks	0	1.17 (1.00-1.38)	0.05
	3 weeks	0	1.26 (1.12-1.42)	0.0002
	4 weeks	0	1.23 (1.14-1.34)	< 0.00001
	8 weeks	33	1.16 (1.05-1.29)	0.003

XLS: Xileisan; RR: Risk ratio.