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Table 4 Study characteristics for Review Question C

From: Quality of life in primary sclerosing cholangitis: a systematic review

Study ID

Study design

Country

Sample size

Gender (%male)

Age (mean)

% IBD

Disease stage/severity

Intervention group

Comparator group

Follow-up (weeks)

Outcome measure(s)

Fickert 2017

RCT

Austria, Belgium, Denmark, Finland, Germany, UK Hungary, Spain Lithuania, Norway Netherlands, Sweden

161

68%

42

64%

Mean ALP = 445 U/L

norUrsodeoxycholic acid (0.5 g/1 g/1.5 g)

Placebo

16

(1) Short health scale†

Hommes 2008

RCT

Netherlands

10

20%

45

NR

Mean ALP = 526 U/L

Infliximab

Placebo

52

(1) Medical outcomes study 36-item short form survey†

Mayo 2019

RCT

France, Netherlands, USA, UK

62

61%

43

66%

Mean ALP = 364 U/L

Aldafermin (1 mg/3 mg)

Placebo

62

(1) 5-D itch scale

(2) Numerical rating scale for itch

Olsson 2005

RCT

Sweden, Norway, Denmark

219

70%

43

85%

Mean ALP = 729 U/L

Asymptomatic = 45%

Ursodeoxycholic acid

Placebo

260

(1) Medical outcomes study 36-item short form survey†

Ponsioen 2018

RCT

Belgium, France, Finland, Italy, Netherlands, Norway, Sweden, UK

65

69%

40

78%

Mean ALP = 306 U/L

Balloon dilation

Stent dilation

104â—Š

(1) Medical outcomes study 36-item short form survey†

(2) Amsterdam cholestatic complaints score

Rahimpour 2016

RCT

Iran

29

59%

36

75%

Mean ALP = 1015 U/L

PSC Mayo Risk score = − 0.15

Vancomycin

Placebo

12

(1) Fatigue impact scale

(2) Visual analogue scale for itch

Tabibian 2013

RCT

USA

35

60%

40

71%

Mean ALP = 383 U/L

PSC Mayo Risk score = 0.01

Vancomycin (125 mg/250 mg)

Metronizadole

(50 mg/500 mg)

12

(1) Fatigue impact scale

(2) Visual analogue scale for itch

ter Borg 2004

RCT

Netherlands

11

82%

47

NR

Mean ALP = 164 U/L*

Fluoxetine

Placebo

10

(1) Medical outcomes study 36-item short form survey†

(2) Fatigue impact scale

(3) Multidimensional fatigue inventory

(4) Visual analogue scale for fatigue

(5) Visual analogue scale for itch

Pavlides 2014

Retrospective cohort

UK

40

78%

NR

100%

NR

Restorative proctocolectomy with ileal pouch anal anastomosis

No surgery

574

(1) Medical outcomes study 36-item short form survey†

(2) Female sexual satisfaction index

(3) International index of erectile function

  1. NR not reported
  2. †Multi-dimensional quality of life questionnaire. ††Mean of medians. ◊Quality of life outcomes reported at 12 weeks only. *Value for whole sample including 22 people with PBC