Bile acids for viral hepatitis

Wendong Chen; Jian Ping Liu; Christian Gluud

doi:10.1002/14651858.CD003181.pub2

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Analysis 1.1

Comparison 1 Bile acids for acute hepatitis B, Outcome 1 Risk of having positive serum HBsAg at the end of treatment.

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Analysis 1.2

Comparison 1 Bile acids for acute hepatitis B, Outcome 2 Risk of having positive HBsAg at the end of follow‐up.

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Analysis 1.3

Comparison 1 Bile acids for acute hepatitis B, Outcome 3 Serum DNA (pg/ml) level at the end of treatment.

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Analysis 1.4

Comparison 1 Bile acids for acute hepatitis B, Outcome 4 Serum DNA (pg/ml) level at the end of follow‐up.

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Analysis 1.5

Comparison 1 Bile acids for acute hepatitis B, Outcome 5 Risk of abnormal serum ALT at the end of treatment.

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Analysis 1.6

Comparison 1 Bile acids for acute hepatitis B, Outcome 6 Risk of abnormal serum ALT at the end of follow‐up.

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Analysis 1.7

Comparison 1 Bile acids for acute hepatitis B, Outcome 7 Risk of abnormal serum GGT at the end of treatment.

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Analysis 1.8

Comparison 1 Bile acids for acute hepatitis B, Outcome 8 Risk of abnormal serum GGT at the end of follow‐up.

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Analysis 2.1

Comparison 2 Bile acids for chronic hepatitis B, Outcome 1 Risk of abnormal serum ALT at the end of treatment.

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Analysis 2.2

Comparison 2 Bile acids for chronic hepatitis B, Outcome 2 Serum ALT (IU/L) at the end of treatment.

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Analysis 3.1

Comparison 3 Bile acids for chronic hepatitis C, Outcome 1 Risk of having serum HCV RNA at the end of treatment.

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Analysis 3.2

Comparison 3 Bile acids for chronic hepatitis C, Outcome 2 Sensitivity analyses: Risk of having serum HCV RNA at the end of treatment ‐ Duration of treatment.

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Analysis 3.3

Comparison 3 Bile acids for chronic hepatitis C, Outcome 3 Risk of having serum HCV RNA at the end of follow‐up.

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Analysis 3.4

Comparison 3 Bile acids for chronic hepatitis C, Outcome 4 Sensitivity analyses: Risk of having serum HCV RNA at the end of follow‐up ‐ Duration of treatment.

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Analysis 3.5

Comparison 3 Bile acids for chronic hepatitis C, Outcome 5 Risk of cirrhosis at the end of treatment.

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Analysis 3.6

Comparison 3 Bile acids for chronic hepatitis C, Outcome 6 Risk of abnormal serum ALT at the end of treatment.

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Analysis 3.7

Comparison 3 Bile acids for chronic hepatitis C, Outcome 7 Sensitivity analyses: Risk of abnormal serum ALT at the end of treatment ‐ Duration of treatment.

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Analysis 3.8

Comparison 3 Bile acids for chronic hepatitis C, Outcome 8 Risk of abnormal serum ALT at the end of follow‐up.

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Analysis 3.9

Comparison 3 Bile acids for chronic hepatitis C, Outcome 9 Sensitivity analyses: Risk of abnormal serum ALT at the end of follow‐up ‐ Duration of treatment.

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Analysis 3.10

Comparison 3 Bile acids for chronic hepatitis C, Outcome 10 Serum ALT (IU/L) at the end of treatment.

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Analysis 3.11

Comparison 3 Bile acids for chronic hepatitis C, Outcome 11 Serum AST (IU/L) at the end of treatment.

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Analysis 3.12

Comparison 3 Bile acids for chronic hepatitis C, Outcome 12 Serum GGT (IU/L) at the end of treatment.

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Analysis 3.13

Comparison 3 Bile acids for chronic hepatitis C, Outcome 13 Portal and periportal inflammation scores at the end of treatment.

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Analysis 3.14

Comparison 3 Bile acids for chronic hepatitis C, Outcome 14 Knodell score at the end of treatment.

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Analysis 3.15

Comparison 3 Bile acids for chronic hepatitis C, Outcome 15 Adverse events caused by bile acid.

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Analysis 4.1

Comparison 4 Bile acids for chronic viral hepatitis among heart transplanted patients, Outcome 1 All cause mortality at the end of treatment.

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Analysis 4.2

Comparison 4 Bile acids for chronic viral hepatitis among heart transplanted patients, Outcome 2 Risk of abnormal serum ALT at the end of treatment.

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Analysis 4.3

Comparison 4 Bile acids for chronic viral hepatitis among heart transplanted patients, Outcome 3 Improvement of total Knodell score at the end of treatment.

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Analysis 4.4

Comparison 4 Bile acids for chronic viral hepatitis among heart transplanted patients, Outcome 4 Number of graft rejection at the end of treatment.

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Comparison 1. Bile acids for acute hepatitis B

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Risk of having positive serum HBsAg at the end of treatment Show forest plot	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.17, 0.92]

1.1 UDCA versus placebo	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.17, 0.92]
2 Risk of having positive HBsAg at the end of follow‐up Show forest plot	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.23 [0.05, 1.00]

2.1 UDCA versus placebo	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.23 [0.05, 1.00]
3 Serum DNA (pg/ml) level at the end of treatment Show forest plot	1	59	Mean Difference (IV, Fixed, 95% CI)	‐574.05 [‐1148.71, 0.61]

3.1 UDCA versus placebo	1	59	Mean Difference (IV, Fixed, 95% CI)	‐574.05 [‐1148.71, 0.61]
4 Serum DNA (pg/ml) level at the end of follow‐up Show forest plot	1	59	Mean Difference (IV, Fixed, 95% CI)	‐954.73 [‐1813.71, ‐95.75]

4.1 UDCA versus placebo	1	59	Mean Difference (IV, Fixed, 95% CI)	‐954.73 [‐1813.71, ‐95.75]
5 Risk of abnormal serum ALT at the end of treatment Show forest plot	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.12, 1.02]

5.1 UDCA versus placebo	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.12, 1.02]
6 Risk of abnormal serum ALT at the end of follow‐up Show forest plot	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.06, 1.21]

6.1 UDCA versus placebo	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.06, 1.21]
7 Risk of abnormal serum GGT at the end of treatment Show forest plot	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.11, 0.90]

7.1 UDCA versus placebo	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.11, 0.90]
8 Risk of abnormal serum GGT at the end of follow‐up Show forest plot	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.06, 1.21]

8.1 UDCA versus placebo	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.06, 1.21]

Comparison 1. Bile acids for acute hepatitis B

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Comparison 2. Bile acids for chronic hepatitis B

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Risk of abnormal serum ALT at the end of treatment Show forest plot	1	112	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.45, 0.94]

1.1 UDCA versus no intervention	1	112	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.45, 0.94]
2 Serum ALT (IU/L) at the end of treatment Show forest plot	1	112	Mean Difference (IV, Fixed, 95% CI)	‐14.94 [‐21.20, ‐8.68]

2.1 UDCA versus no intervention	1	112	Mean Difference (IV, Fixed, 95% CI)	‐14.94 [‐21.20, ‐8.68]

Comparison 2. Bile acids for chronic hepatitis B

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Comparison 3. Bile acids for chronic hepatitis C

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Risk of having serum HCV RNA at the end of treatment Show forest plot	13	837	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.91, 1.07]

1.1 UDCA versus placebo or no intervention	2	106	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.84, 1.21]
1.2 UDCA plus interferon versus interferon	11	731	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.90, 1.08]
2 Sensitivity analyses: Risk of having serum HCV RNA at the end of treatment ‐ Duration of treatment Show forest plot	13	837	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.91, 1.07]

2.1 Short treatment duration (less than 12 months)	8	444	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.83, 1.04]
2.2 Long treatment duration (12 months or more)	5	393	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.92, 1.19]
3 Risk of having serum HCV RNA at the end of follow‐up Show forest plot	10	676	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.87, 1.00]

3.1 UDCA plus interferon versus interferon	10	676	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.87, 1.00]
4 Sensitivity analyses: Risk of having serum HCV RNA at the end of follow‐up ‐ Duration of treatment Show forest plot	10	676	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.87, 1.00]

4.1 Short treatment duration (less than 12 months)	5	283	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.87, 1.12]
4.2 Long treatment duration (12 months or more)	5	393	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.83, 0.99]
5 Risk of cirrhosis at the end of treatment Show forest plot	1	103	Risk Ratio (M‐H, Fixed, 95% CI)	1.79 [0.93, 3.47]

5.1 UDCA plus interferon versus interferon	1	103	Risk Ratio (M‐H, Fixed, 95% CI)	1.79 [0.93, 3.47]
6 Risk of abnormal serum ALT at the end of treatment Show forest plot	21	1582	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.77, 0.90]

6.1 UDCA versus placebo or no intervention	3	239	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.69, 0.88]
6.2 UDCA plus interferon versus interferon	15	1007	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.73, 0.91]
6.3 TUDCA plus interferon versus interferon	2	166	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.70, 1.24]
6.4 UDCA plus glycyrrhizin versus glycyrrhizin	1	170	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.75, 1.24]
7 Sensitivity analyses: Risk of abnormal serum ALT at the end of treatment ‐ Duration of treatment Show forest plot	21	1582	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.77, 0.90]

7.1 Short treatment duration (less than 12 months)	16	1189	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.76, 0.92]
7.2 Long treatment duration (12 months or more)	5	393	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.69, 0.99]
8 Risk of abnormal serum ALT at the end of follow‐up Show forest plot	13	929	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.85, 0.97]

8.1 UDCA plus interferon versus interferon	12	869	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.84, 0.97]
8.2 TUDCA plus interferon versus interferon	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.68, 1.47]
9 Sensitivity analyses: Risk of abnormal serum ALT at the end of follow‐up ‐ Duration of treatment Show forest plot	13	929	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.85, 0.97]

9.1 Short treatment duration (less than 12 months)	7	495	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.84, 1.00]
9.2 Long treatment duration (12 months or more)	6	434	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.80, 1.00]
10 Serum ALT (IU/L) at the end of treatment Show forest plot	5	386	Mean Difference (IV, Fixed, 95% CI)	‐1.29 [‐3.16, 0.59]

10.1 UDCA versus placebo or no intervention	2	162	Mean Difference (IV, Fixed, 95% CI)	‐26.78 [‐39.65, ‐13.92]
10.2 TUDCA versus placebo or no intervention	3	224	Mean Difference (IV, Fixed, 95% CI)	‐0.73 [‐2.63, 1.16]
11 Serum AST (IU/L) at the end of treatment Show forest plot	2	146	Mean Difference (IV, Fixed, 95% CI)	‐25.16 [‐34.02, ‐16.30]

11.1 UDCA versus placebo or no intervention	1	61	Mean Difference (IV, Fixed, 95% CI)	‐20.70 [‐32.08, ‐9.32]
11.2 TUDCA versus placebo or no intervention	1	85	Mean Difference (IV, Fixed, 95% CI)	‐32.0 [‐46.10, ‐17.90]
12 Serum GGT (IU/L) at the end of treatment Show forest plot	5	302	Mean Difference (IV, Fixed, 95% CI)	‐14.09 [‐17.34, ‐10.84]

12.1 UDCA versus placebo or no intervention	3	184	Mean Difference (IV, Fixed, 95% CI)	‐13.14 [‐16.48, ‐9.80]
12.2 TUDCA versus placebo or no intervention	2	118	Mean Difference (IV, Fixed, 95% CI)	‐31.23 [‐45.45, ‐17.01]
13 Portal and periportal inflammation scores at the end of treatment Show forest plot	3	167	Mean Difference (IV, Fixed, 95% CI)	0.20 [0.15, 0.24]

13.1 UDCA plus interferon versus interferon	3	167	Mean Difference (IV, Fixed, 95% CI)	0.20 [0.15, 0.24]
14 Knodell score at the end of treatment Show forest plot	2	133	Mean Difference (IV, Fixed, 95% CI)	0.20 [0.08, 0.31]

14.1 UDCA plus interferon versus interferon	2	133	Mean Difference (IV, Fixed, 95% CI)	0.20 [0.08, 0.31]
15 Adverse events caused by bile acid Show forest plot	3	254	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.56, 2.46]

15.1 UDCA plus interferon versus interferon	2	179	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.49, 2.28]
15.2 UDCA versus no intervention	1	75	Risk Ratio (M‐H, Fixed, 95% CI)	2.75 [0.16, 48.61]

Comparison 3. Bile acids for chronic hepatitis C

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Comparison 4. Bile acids for chronic viral hepatitis among heart transplanted patients

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All cause mortality at the end of treatment Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	2.33 [0.67, 8.18]

2 Risk of abnormal serum ALT at the end of treatment Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.76, 1.22]

3 Improvement of total Knodell score at the end of treatment Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.46 [0.20, 1.05]

4 Number of graft rejection at the end of treatment Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	2.67 [0.78, 9.09]

Comparison 4. Bile acids for chronic viral hepatitis among heart transplanted patients

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