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 | 104◊ | (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 |