Pharmacological interventions for primary sclerosing cholangitis

Francesca Saffioti; Kurinchi Selvan Gurusamy; Neil Hawkins; Clare D Toon; Emmanuel Tsochatzis; Brian R Davidson; Douglas Thorburn

doi:10.1002/14651858.CD011343.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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$Based on an alpha error of 2.5%, power of 90% (beta error of 10%), relative risk reduction (RRR) of 20%, control group proportion observed in the trials (Pc), and heterogeneity observed in the analyses, only a small fraction of the diversity‐adjusted required information size (DARIS) has been reached (required information size = 348; DARIS = 14,509 for mortality at maximal follow‐up; required information size = 348; DARIS = 35,846 for liver transplantation; required information size = 348; DARIS = 29,191 for cholangiocarcinoma), and trial sequential monitoring boundaries were not drawn. The Z‐curves (blue lines) do not cross conventional boundaries (dotted green lines). This indicates high risk of random errors for all outcomes included in this review.$

Figure 4

Based on an alpha error of 2.5%, power of 90% (beta error of 10%), relative risk reduction (RRR) of 20%, control group proportion observed in the trials (Pc), and heterogeneity observed in the analyses, only a small fraction of the diversity‐adjusted required information size (DARIS) has been reached (required information size = 348; DARIS = 14,509 for mortality at maximal follow‐up; required information size = 348; DARIS = 35,846 for liver transplantation; required information size = 348; DARIS = 29,191 for cholangiocarcinoma), and trial sequential monitoring boundaries were not drawn. The Z‐curves (blue lines) do not cross conventional boundaries (dotted green lines). This indicates high risk of random errors for all outcomes included in this review.

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Figure 5

Network plot for mortality at maximal follow‐up. The size of the node (circle) provides a measure of the number of trials in which the particular treatment was included in one of the arms. The thickness of the line provides a measure of the number of direct comparisons between two nodes (treatments).

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Analysis 1.1

Comparison 1 Pharmacological treatments for primary sclerosing cholangitis: not stratified by ursodeoxycholic acid dose, Outcome 1 Mortality at maximal follow‐up.

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Analysis 1.2

Comparison 1 Pharmacological treatments for primary sclerosing cholangitis: not stratified by ursodeoxycholic acid dose, Outcome 2 Serious adverse events proportion.

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Analysis 1.3

Comparison 1 Pharmacological treatments for primary sclerosing cholangitis: not stratified by ursodeoxycholic acid dose, Outcome 3 Serious adverse events number.

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Analysis 1.4

Comparison 1 Pharmacological treatments for primary sclerosing cholangitis: not stratified by ursodeoxycholic acid dose, Outcome 4 Adverse events proportion.

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Analysis 1.5

Comparison 1 Pharmacological treatments for primary sclerosing cholangitis: not stratified by ursodeoxycholic acid dose, Outcome 5 Adverse events number.

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Analysis 1.6

Comparison 1 Pharmacological treatments for primary sclerosing cholangitis: not stratified by ursodeoxycholic acid dose, Outcome 6 Quality of life.

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Analysis 1.7

Comparison 1 Pharmacological treatments for primary sclerosing cholangitis: not stratified by ursodeoxycholic acid dose, Outcome 7 Liver transplantation.

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Analysis 1.8

Comparison 1 Pharmacological treatments for primary sclerosing cholangitis: not stratified by ursodeoxycholic acid dose, Outcome 8 Cholangiocarcinoma.

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Analysis 2.1

Comparison 2 Pharmacological treatments for primary sclerosing cholangitis: stratified by ursodeoxycholic acid dose, Outcome 1 Mortality at maximal follow‐up.

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Analysis 2.2

Comparison 2 Pharmacological treatments for primary sclerosing cholangitis: stratified by ursodeoxycholic acid dose, Outcome 2 Serious adverse events proportion.

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Analysis 2.3

Comparison 2 Pharmacological treatments for primary sclerosing cholangitis: stratified by ursodeoxycholic acid dose, Outcome 3 Serious adverse events number.

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Analysis 2.4

Comparison 2 Pharmacological treatments for primary sclerosing cholangitis: stratified by ursodeoxycholic acid dose, Outcome 4 Adverse events proportion.

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Analysis 2.5

Comparison 2 Pharmacological treatments for primary sclerosing cholangitis: stratified by ursodeoxycholic acid dose, Outcome 5 Adverse events number.

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Analysis 2.6

Comparison 2 Pharmacological treatments for primary sclerosing cholangitis: stratified by ursodeoxycholic acid dose, Outcome 6 Quality of life.

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Analysis 2.7

Comparison 2 Pharmacological treatments for primary sclerosing cholangitis: stratified by ursodeoxycholic acid dose, Outcome 7 Liver transplantation.

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Analysis 2.8

Comparison 2 Pharmacological treatments for primary sclerosing cholangitis: stratified by ursodeoxycholic acid dose, Outcome 8 Cholangiocarcinoma.

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Summary of findings for the main comparison. Ursodeoxycholic acid versus placebo for primary sclerosing cholangitis

Ursodeoxycholic acid versus placebo for primary sclerosing cholangitis
Patient or population: people with primary sclerosing cholangitis Settings: secondary or tertiary care Intervention: ursodeoxycholic acid Comparison: placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (trials)	Quality of the evidence (GRADE)
	Assumed risk	Corresponding risk
	Placebo	Ursodeoxycholic acid
Mortality Follow‐up: 60 months	72 per 1000	105 per 1000 (47 to 220)	OR 1.51 (0.63 to 3.63)	348 (2 trials)	⊕⊝⊝⊝ very low^1,2,3
Serious adverse events	No trials reported the number of participants with serious adverse events or numbers of serious adverse events.
Proportion of people with adverse events Follow‐up: 60 months	337 per 1000	358 per 1000 (237 to 498)	OR 1.22 (0.68 to 2.17)	198 (1 trial)	⊕⊝⊝⊝ very low^1,2,3
Number of adverse events	No trials reported the number of adverse events.
Health‐related quality of life Follow‐up: 5 years Scale: SF‐36 General Health Scale (Limits: 0 to 100; higher = better)	Mean in the placebo group was 61.10.	Mean in the ursodeoxycholic acid group was 1.30 higher (5.61 lower or 8.21 higher).	‐	198 (1 trial)	⊕⊝⊝⊝ very low^1,2,3
Liver transplantation Follow‐up: 60 months	123 per 1000	120 per 1000 (68 to 202)	OR 0.97 (0.52 to 1.81)	348 (2 trials)	⊕⊝⊝⊝ very low^1,2,3,4
Any malignancy	No trials reported this outcome.
Cholangiocarcinoma Follow‐up: 60 months	43 per 1000	57 per 1000 (21 to 142)	OR 1.34 (0.48 to 3.68)	348 (2 trials)	⊕⊝⊝⊝ very low^1,2,3
Colorectal cancer	No trials reported this outcome.
Cholecystectomy	No trials reported this outcome.
The basis for the assumed risk* is the mean control group proportion. The corresponding risk (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; OR: odds ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Downgraded one level for risk of bias: the trial(s) were at high risk of bias. ² Downgraded one level for imprecision: the sample size was small. ³ Downgraded one level for imprecision: the confidence intervals were wide and overlapped a clinically significant reduction or increase (25% reduction or increase) and no effect. ⁴ Downgraded two levels for inconsistency: I² was high and overlap of confidence intervals was poor.

Summary of findings for the main comparison. Ursodeoxycholic acid versus placebo for primary sclerosing cholangitis

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Table 1. Characteristics table (according to comparisons)

Study name	Number of people in intervention group	Number of people in control group	Risk of bias							Overall risk of bias
Study name	Number of people in intervention group	Number of people in control group	Random sequence generation	Allocation concealment	Blinding of participants and personnel	Blinding of outcome assessment	Incomplete outcome data	Selective reporting	Vested interest bias	Overall risk of bias
Colchicine vs placebo
Olsson 1995	44	40	Unclear	Unclear	Low	Low	Unclear	High	Unclear	High
Cyclosporin vs placebo
Sandborn 1993	16	10	Unclear	Unclear	Low	Low	High	High	High	High
Infliximab vs placebo
Hommes 2008	4	3	Unclear	Unclear	Low	Low	High	High	High	High
Methotrexate vs placebo
Knox 1994	11	10	Unclear	Unclear	Low	Low	High	High	High	High
Rasmussen 1998	5 (crossed over after 1 year)	8 (crossed over after 1 year)	Unclear	Unclear	Unclear	Unclear	Unclear	High	Unclear	High
NorUrsodeoxycholic acid vs placebo
Trauner 2016	Not stated	Not stated	Unclear	Unclear	Unclear	Unclear	Unclear	High	High	High
Penicillamine vs placebo
LaRusso 1988	39	31	Unclear	Unclear	Low	Low	Unclear	Low	High	High
Steroids vs placebo
Allison 1986	6	5	Unclear	Low	Low	Low	High	High	Low	High
UDCA (high) vs placebo
Lindor 2009	76	74	Low	Low	Low	Low	Low	High	High	High
UDCA (moderate) vs placebo
Bansi 1996	11	11	Unclear	Unclear	Unclear	Unclear	High	High	Unclear	High
Mitchell 2001	13	13	Unclear	Unclear	Low	Low	Low	High	Unclear	High
Olsson 2005	97	101	Unclear	Low	Low	Low	High	Low	High	High
UDCA (low) vs placebo
Beuers 1992	6	8	Low	Unclear	Low	Low	Unclear	High	High	High
Lindor 1997	51	51	Low	Unclear	Low	Low	High	High	High	High
Lo 1992	7	7	Unclear	Unclear	Unclear	Unclear	High	High	Unclear	High
Stiehl 1989	6	6	Unclear	Unclear	Unclear	Unclear	High	High	Unclear	High
UDCA (low) vs UDCA (moderate) vs UDCA (high)
Cullen 2008	11	11 (UDCA (moderate)) and 9 (UDCA (high))	Low	Low	Low	Low	High	High	High	High
UDCA (low) vs colchicine vs placebo
De Maria 1996	20	19 (colchicine) and 20 (placebo)	Unclear	Unclear	High	Unclear	Unclear	High	Unclear	High
UDCA (low) plus metronidazole vs UDCA (low)
Farkkila 2004	37	34	Low	Low	Low	Low	High	High	High	High
UDCA (low) plus mycophenolate vs UDCA (low)
Sterling 2004	6	10	Unclear	Unclear	High	High	Unclear	High	High	High
Vancomycin vs metronidazole
Tabibian 2013	16	13	Unclear	Unclear	Low	Low	High	High	Low	High
Vancomycin vs placebo
Rahimpour 2016	18	11	Low	Low	Low	Low	Low	High	Low	High

Table 1. Characteristics table (according to comparisons)

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Comparison 1. Pharmacological treatments for primary sclerosing cholangitis: not stratified by ursodeoxycholic acid dose

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality at maximal follow‐up Show forest plot	6		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Colchicine vs placebo	1	84	Odds Ratio (M‐H, Fixed, 95% CI)	0.44 [0.04, 5.07]
1.2 Penicillamine vs placebo	1	70	Odds Ratio (M‐H, Fixed, 95% CI)	1.18 [0.39, 3.58]
1.3 Steroids vs placebo	1	11	Odds Ratio (M‐H, Fixed, 95% CI)	3.0 [0.10, 90.96]
1.4 Ursodeoxycholic acid vs placebo	2	348	Odds Ratio (M‐H, Fixed, 95% CI)	1.51 [0.63, 3.63]
1.5 Vancomycin vs placebo	1	29	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Serious adverse events proportion Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.1 Infliximab vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 Steroids vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 Vancomycin vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Serious adverse events number Show forest plot	3		rate ratio (Fixed, 95% CI)	Totals not selected

3.1 Infliximab vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Penicillamine vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 Steroids vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Adverse events proportion Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 Steroids vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Ursodeoxycholic acid vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 Vancomycin vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Adverse events number Show forest plot	5		rate ratio (Fixed, 95% CI)	Totals not selected

5.1 Cyclosporin vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 Penicillamine vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
5.3 Steroids vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
5.4 Ursodeoxycholic acid plus metronidazole vs ursodeoxycholic acid	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
5.5 Vancomycin vs metronidazole	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Quality of life Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6.1 Ursodeoxycholic acid vs placebo	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Liver transplantation Show forest plot	7		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 Colchicine vs placebo	1	84	Odds Ratio (M‐H, Fixed, 95% CI)	0.59 [0.09, 3.71]
7.2 Penicillamine vs placebo	1	70	Odds Ratio (M‐H, Fixed, 95% CI)	1.14 [0.32, 4.01]
7.3 Steroids vs placebo	1	11	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.4 Ursodeoxycholic acid vs placebo	2	348	Odds Ratio (M‐H, Fixed, 95% CI)	0.97 [0.52, 1.81]
7.5 Vancomycin vs placebo	1	29	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.6 Ursodeoxycholic acid plus metronidazole vs ursodeoxycholic acid	1	71	Odds Ratio (M‐H, Fixed, 95% CI)	0.29 [0.03, 2.90]
8 Cholangiocarcinoma Show forest plot	4		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 Cyclosporin vs placebo	1	26	Odds Ratio (M‐H, Fixed, 95% CI)	0.19 [0.01, 5.20]
8.2 Ursodeoxycholic acid vs placebo	2	348	Odds Ratio (M‐H, Fixed, 95% CI)	1.34 [0.48, 3.68]
8.3 Vancomycin vs placebo	1	29	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Pharmacological treatments for primary sclerosing cholangitis: not stratified by ursodeoxycholic acid dose

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Comparison 2. Pharmacological treatments for primary sclerosing cholangitis: stratified by ursodeoxycholic acid dose

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality at maximal follow‐up Show forest plot	6		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 Colchicine vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Penicillamine vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.3 Steroids vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.4 Ursodeoxycholic acid (high) vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.5 Ursodeoxycholic acid (moderate) vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.6 Vancomycin vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Serious adverse events proportion Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.1 Infliximab vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 Steroids vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 Vancomycin vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Serious adverse events number Show forest plot	4		rate ratio (Fixed, 95% CI)	Totals not selected

3.1 Infliximab vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Penicillamine vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 Steroids vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
3.4 Ursodeoxycholic acid (high) vs ursodeoxycholic acid (moderate)	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
3.5 Ursodeoxycholic acid (high) vs ursodeoxycholic acid (low)	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
3.6 Ursodeoxycholic acid (moderate) vs ursodeoxycholic acid (low)	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Adverse events proportion Show forest plot	3		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 Steroids vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Ursodeoxycholic acid (moderate) vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 Vancomycin vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Adverse events number Show forest plot	6		rate ratio (Fixed, 95% CI)	Totals not selected

5.1 Cyclosporin vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 Penicillamine vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
5.3 Steroids vs placebo	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
5.4 Ursodeoxycholic acid (high) vs ursodeoxycholic acid (low)	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
5.5 Ursodeoxycholic acid (high) vs ursodeoxycholic acid (moderate)	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
5.6 Ursodeoxycholic acid (low) plus metronidazole vs ursodeoxycholic acid (low)	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
5.7 Ursodeoxycholic acid (moderate) vs ursodeoxycholic acid (low)	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
5.8 Vancomycin vs metronidazole	1		rate ratio (Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Quality of life Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6.1 Ursodeoxycholic acid (moderate) vs placebo	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Liver transplantation Show forest plot	8		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

7.1 Colchicine vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.2 Penicillamine vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.3 Steroids vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.4 Ursodeoxycholic acid (high) vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.5 Ursodeoxycholic acid (moderate) vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.6 Vancomycin vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.7 Ursodeoxycholic acid (moderate) vs ursodeoxycholic acid (low)	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.8 Ursodeoxycholic acid (high) vs ursodeoxycholic acid (low)	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.9 Ursodeoxycholic acid (high) vs ursodeoxycholic acid (moderate)	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.10 Ursodeoxycholic acid (low) plus metronidazole vs ursodeoxycholic acid (low)	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 Cholangiocarcinoma Show forest plot	4		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

8.1 Cyclosporin vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8.2 Ursodeoxycholic acid (high) vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8.3 Ursodeoxycholic acid (moderate) vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8.4 Vancomycin vs placebo	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 2. Pharmacological treatments for primary sclerosing cholangitis: stratified by ursodeoxycholic acid dose

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