PMID- 23384404
OWN - NLM
STAT- MEDLINE
DCOM- 20130723
LR  - 20221129
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 37
IP  - 6
DP  - 2013 Mar
TI  - Randomised clinical trial: vancomycin or metronidazole in patients with primary 
      sclerosing cholangitis - a pilot study.
PG  - 604-12
LID - 10.1111/apt.12232 [doi]
AB  - BACKGROUND: Emerging data suggest that oral antibiotics may have therapeutic 
      effects in primary sclerosing cholangitis (PSC), but published studies are 
      limited. AIMS: To investigate the safety and efficacy of oral vancomycin and 
      metronidazole in patients with PSC. METHODS: Thirty-five patients with PSC were 
      randomised in a double-blind manner into four groups: vancomycin 125 mg or 250 mg 
      four times/day, or metronidazole 250 mg or 500 mg three times/day for 12 weeks. 
      The primary endpoint was decrease in alkaline phosphatase (ALK) at 12 weeks. 
      Secondary end points included serum bilirubin and Mayo PSC risk score; pruritus; 
      and adverse effects (AEs). Nonparametric tests were used for analysis. RESULTS: 
      The primary endpoint was reached in the low-dose (-43% change in ALK, P = 0.03) 
      and high-dose (-40%, P = 0.02) vancomycin groups, with two patients in the former 
      experiencing ALK normalisation. Bilirubin decreased significantly in the low-dose 
      metronidazole group (-20%, P = 0.03) and trended towards significance in the 
      low-dose vancomycin group (-33%, P = 0.06). Mayo PSC risk score decreased 
      significantly in the low-dose vancomycin (-0.55, P = 0.02) and low-dose 
      metronidazole group (-0.16, P = 0.03). Pruritus decreased significantly in the 
      high-dose metronidazole group (-3.4, P = 0.03). AEs led to medication 
      discontinuation in six patients, four of whom were receiving metronidazole. 
      CONCLUSIONS: Both vancomycin and metronidazole demonstrated efficacy; however, 
      only patients in the vancomycin groups reached the primary endpoint, and with 
      less adverse effects. Larger, longer-term studies are needed to further examine 
      the safety and efficacy of antibiotics as a potential treatment for patients with 
      primary sclerosing cholangitis (clinicaltrials.gov NCT01085760).
CI  - (c) 2013 Blackwell Publishing Ltd.
FAU - Tabibian, J H
AU  - Tabibian JH
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
FAU - Weeding, E
AU  - Weeding E
FAU - Jorgensen, R A
AU  - Jorgensen RA
FAU - Petz, J L
AU  - Petz JL
FAU - Keach, J C
AU  - Keach JC
FAU - Talwalkar, J A
AU  - Talwalkar JA
FAU - Lindor, K D
AU  - Lindor KD
LA  - eng
SI  - ClinicalTrials.gov/NCT01085760
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130205
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Biomarkers)
RN  - 140QMO216E (Metronidazole)
RN  - 6Q205EH1VU (Vancomycin)
RN  - RFM9X3LJ49 (Bilirubin)
SB  - IM
CIN - Aliment Pharmacol Ther. 2013 May;37(9):915. PMID: 23551156
MH  - Adult
MH  - Aged
MH  - Anti-Bacterial Agents/adverse effects/*therapeutic use
MH  - Bilirubin
MH  - Biomarkers
MH  - Cholangitis, Sclerosing/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Metronidazole/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Pilot Projects
MH  - Vancomycin/adverse effects/*therapeutic use
MH  - Young Adult
EDAT- 2013/02/07 06:00
MHDA- 2013/07/24 06:00
CRDT- 2013/02/07 06:00
PHST- 2012/11/17 00:00 [received]
PHST- 2012/12/24 00:00 [revised]
PHST- 2013/01/10 00:00 [revised]
PHST- 2013/01/14 00:00 [accepted]
PHST- 2013/02/07 06:00 [entrez]
PHST- 2013/02/07 06:00 [pubmed]
PHST- 2013/07/24 06:00 [medline]
AID - 10.1111/apt.12232 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2013 Mar;37(6):604-12. doi: 10.1111/apt.12232. Epub 2013 
      Feb 5.