title: Randomised clinical trial: a herbal preparation of myrrh, chamomile and coffee charcoal compared with mesalazine in maintaining remission in ulcerative colitis--a double-blind, double-dummy study.
abstract: BACKGROUND
  The herbal treatment with myrrh, dry extract of chamomile flowers and coffee charcoal has anti-inflammatory and antidiarrhoeal potential and might benefit patients with UC. Aminosalicylates are used as standard treatment for maintaining remission in ulcerative colitis (UC).
  
  
  OBJECTIVE
  To compare the efficacy of the two treatments in maintaining remission in patients with ulcerative colitis.
  
  
  METHODS
  We performed a randomised, double-blind, double-dummy study over a 12-month period in patients with UC. Primary endpoint was non-inferiority of the herbal preparation as defined by mean Clinical Colitis Activity Index (CAI-Rachmilewitz). Secondary endpoints were relapse rates, safety profile, relapse-free times, endoscopic activity and faecal biomarkers.
  
  
  RESULTS
  A total of 96 patients (51 female) with inactive UC were included. Mean CAI demonstrated no significant difference between the two treatment groups in the intention-to-treat (P = 0.121) or per-protocol (P = 0.251) analysis. Relapse rates in total were 22/49 patients (45%) in the mesalazine treatment group and 25/47 patients (53%) in the herbal treatment group (P = 0.540). Safety profile and tolerability were good and no significant differences were shown in relapse-free time, endoscopy and faecal biomarkers.
  
  
  CONCLUSIONS
  The herbal preparation of myrrh, chamomile extract and coffee charcoal is well tolerated and shows a good safety profile. We found first evidence for a potential efficacy non-inferior to the gold standard therapy mesalazine, which merits further study of its clinical usefulness in maintenance therapy of patients with ulcerative colitis. EudraCT-Number 2007-007928-18.
authors.affiliation: Department for Integrative Gastroenterology, Kliniken Essen-Mitte, University of Duisburg-Essen, Essen, Germany. jost.langhorst@gmx.de
authors.forename: J
authors.initials: J
authors.lastname: Langhorst
authors.forename: I
authors.initials: I
authors.lastname: Varnhagen
authors.forename: S B
authors.initials: SB
authors.lastname: Schneider
authors.forename: U
authors.initials: U
authors.lastname: Albrecht
authors.forename: A
authors.initials: A
authors.lastname: Rueffer
authors.forename: R
authors.initials: R
authors.lastname: Stange
authors.forename: A
authors.initials: A
authors.lastname: Michalsen
authors.forename: G J
authors.initials: GJ
authors.lastname: Dobos
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D020843:Chamomile / Q000737:chemistry*; D002606:Charcoal / Q000737:chemistry*; D003069:Coffee; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use*; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use*; D028321:Plant Preparations / Q000627:therapeutic use*; D012074:Remission Induction; D013729:Terpenes / Q000737:chemistry*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003069:Coffee; D010936:Plant Extracts; D028321:Plant Preparations; D013729:Terpenes; D002606:Charcoal; D019804:Mesalamine; C014119:myrrh oil