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

Tabibian 2013.

Methods Randomised clinical trial.
Participants Country: USA.
 Number randomised: 35.
 Post‐randomisation drop‐outs: 7 (20%).
 Revised sample size: 28.
 Mean age: 40 years.
Females: 14 (40%).
Separate data for the subgroup with ulcerative colitis: no.
Inclusion criteria:

  1. Diagnosis of primary sclerosing cholangitis based on serum alkaline phosphatase at least 1.5 times the upper limit of normal for at least 6 months and cholangiography demonstrating intrahepatic and/or extrahepatic biliary strictures, beading, or irregularity consistent with primary sclerosing cholangitis.


Exclusion criteria:

  1. Treatment with any investigational agents, such as UDCA or other antibiotics, within 3 months of the study.

  2. Prior history of allergic reactions to vancomycin and/or metronidazole.

  3. Evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites, or spontaneous hepatic encephalopathy.

  4. Anticipated need for liver transplant within 1 year as determined by Mayo Primary Sclerosing Cholangitis risk score.

  5. Findings highly suggestive of liver disease of an alternative or concomitant aetiology, such as chronic alcoholic liver disease, chronic hepatitis B or C infection, haemochromatosis, Wilson’s disease, alpha‐1 antitrypsin deficiency, non‐alcoholic steatohepatitis, primary biliary cirrhosis, or secondary sclerosing cholangitis.

  6. Pregnancy or lactation.

  7. Active illicit drug or alcohol abuse.

  8. Age younger than 18 years or older than 75 years.

  9. UDCA treatment in the previous 3 months.


Follow‐up: 3 months.
Interventions Participants were randomly assigned to 1 of 4 groups.
Group 1: vancomycin 125 or 250 mg orally 4 times a day for 12 weeks (n = 15).
Group 2: metronidazole 250 or 500 mg orally 3 times a day for 12 weeks (n = 13).
Outcomes Numbers of any types of adverse events.
Notes Reasons for post‐randomisation drop‐out:

  1. One participant stopped treatment indefinitely owing to migraine headaches and increased diarrhoea (low‐dose vancomycin group).

  2. One participant stopped treatment indefinitely owing to diarrhoea and increased fatigue (high‐dose vancomycin group).

  3. One participant stopped treatment indefinitely owing to persistent dyspepsia (low‐dose metronidazole group).

  4. One participant was severed because of non‐compliance (low‐dose metronidazole group).

  5. One participant stopped treatment indefinitely owing to nausea and flu (high‐dose metronidazole group).

  6. One participant stopped treatment indefinitely owing to dyspepsia and burning in the eyes (high‐dose metronidazole group).

  7. One participant stopped treatment indefinitely owing to dyspepsia, diarrhoea, and anorexia (high‐dose metronidazole group).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: This information was not available.
Allocation concealment (selection bias) Unclear risk Comment: This information was not available.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Drugs were packaged in identical gelatin capsules, and patients and investigators were blinded to the type and dose of the drug".
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Drugs were packaged in identical gelatin capsules, and patients and investigators were blinded to the type and dose of the drug".
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: Post‐randomisation drop‐outs may be related to the treatment that participants received.
Selective reporting (reporting bias) High risk Comment: No published protocol was available; mortality was not reported.
For‐profit bias Low risk Quote: "Funded by the PSC Partners Seeking a Cure 2009–2010 Research Grant".
Other bias Low risk Comment: no other bias.