Table 3.

Meta-analysis of clinical events and biochemical parameter changes in the included studies

Outcome title	No of studies	No of participants	Statistical method	Effect size	P-value
Mortality	9	269	Risk ratio (M–H, fixed, 95% CI)	0.41 (0.07, 2.29)	0.31
Pruritus	4	131	Risk ratio (M–H, fixed, 95% CI)	1.60 (0.90, 2.85)	0.11
Adverse events			Risk ratio
1. Permanent discontinuation of treatment	2	83	(M–H, fixed, 95% CI)	0.14 (0.02, 1.08)	0.06
2. Not necessitating permanent discontinuation of treatment	9	269		0.29 (0.08, 1.08)	0.06
Mayo risk score	2	60	Mean difference (IV, fixed, 95% CI)	0.60 (0.25, 0.95)	0.0008
Alkaline phosphatase			Mean difference
1. Trial duration ≤24 months	6	171	(IV, random, 95% CI)	−255.57 (−301.38, −209.77)	<0.0001
2. Trial duration >24 months	3	76		−191.35 (−263.62, −119.08)	<0.0001
Gamma-glutamyltransferase			Mean difference
1. Change from baseline	3	57	(IV, fixed, 95% CI)	−15.47 (−32.11, 1.18)	0.07
2. Final measurement values	4	137		−66.41 (−84.93, −47.88)	<0.0001
Alanine aminotransferase			Mean difference
1. Trial duration ≤24 months	3	75	(IV, fixed, 95% CI)	−14.89 (−21.07, −8.71)	<0.0001
2. Trial duration >24 months	1	37		−9.40 (−12.02, −6.78)	<0.0001
Immunoglobulin M			Mean difference
1. Trial duration ≤24 months	5	162	(IV, fixed, 95% CI)	−82.22 (−108.76, −55.68)	<0.0001
2. Trial duration >24 months	1	37		−264.70 (−310.15, −219.25)	<0.0001
Triglycerides	4	115	Mean difference (IV, fixed, 95% CI)	−26.84 (−36.51, −17.17)	<0.0001
Total cholesterol	4	115	Mean difference (IV, fixed, 95% CI)	−21.58 (−30.81, −12.34)	<0.0001
Serum bilirubin	4	97	Mean difference (IV, fixed, 95% CI)	−0.20 (−0.33, −0.07)	0.002
Albumin	2	63	Mean difference (IV, fixed, 95% CI)	−0.09 (−0.27, 0.10)	0.35
AST	2	39	Mean difference (IV, fixed, 95% CI)	4.53 (−2.54, 11.60)	0.21

Abbreviations: AST, aspartate aminotransferase; M–H, Mantel–Haenszel; CI, confidence interval; IV, inverse-variance.