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. 2017 Mar 28;2017(3):CD011343. doi: 10.1002/14651858.CD011343.pub2

Rahimpour 2016.

Methods Randomised clinical trial.
Participants Country: Iran.
 Number randomised: 29.
 Post‐randomisation drop‐outs: 0 (0%).
 Revised sample size: 29.
 Average age: 36 years.
 Females: 12 (41.4%).
 Separate data for the subgroup with ulcerative colitis: no.
Inclusion criteria:
  1. Age older than 18 years and younger than 66 years.

  2. Diagnosed primary sclerosing cholangitis (chronic liver disease described by advanced course of cholestasis, inflammation with intrahepatic and extrahepatic bile duct fibrosis) with cholestasis longer than 3 months, magnetic resonance cholangiopancreatography (MRCP), and pathological confirmation.


Exclusion criteria:
  1. Symptoms of decompensated cirrhosis including ascites, hepatic encephalopathy, and variceal bleeding.

  2. Concomitant usage of corticosteroids, immunosuppressives, and other antibiotics within 3 months before the study.

  3. History of allergy to vancomycin.

  4. Considered as on the waiting list for liver transplantation.

  5. Renal failure with creatinine higher than 1.5 mg/dL.

  6. Thrombocytopenia.

  7. Different or concomitant cause of liver disease other than primary sclerosing cholangitis.

  8. Pregnancy and lactation.

  9. Drug or alcohol abuse.


Follow‐up: 12 weeks after 12 weeks of treatment.
Interventions Participants were randomly assigned to 2 groups.
 Group 1: vancomycin 125 mg QDS (n = 18).
 Group 2: placebo (n = 11).
Outcomes
  1. Mortality.

  2. Adverse events.

  3. Malignancy.

  4. Liver cirrhosis.

  5. Decompensated liver disease.

  6. Liver transplantation.

Notes Trial authors provided additional information on outcomes in February 2017.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "An independent investigator who was blinded to the treatment group made random allocation cards by using computer‐generated random numbers".
Allocation concealment (selection bias) Low risk Quote: "Another investigator who was also blinded was responsible for the patients’ enrolments and data collection".
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "We used the triple blinding method which meant that patients, investigators who were responsible for the patients’ enrolment and the analyzer of the data at the end of the study were unaware of identities to reduce the chance of bias occurrence in the study".
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "We used the triple blinding method which meant that patients, investigators who were responsible for the patients’ enrolment and the analyzer of the data at the end of the study were unaware of identities to reduce the chance of bias occurrence in the study".
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: No post‐randomisation drop‐outs were reported.
Selective reporting (reporting bias) Low risk Comment: No published protocol was available; mortality and morbidity were reported.
For‐profit bias Low risk Quote: "This study was supported by a grant from the Tehran University of Medical Sciences".
Other bias Low risk Comment: no other bias.