title: Tormentil for active ulcerative colitis: an open-label, dose-escalating study.
abstract: BACKGROUND
  Tormentil extracts (TE) have antioxidative properties and are used as a complementary therapy for chronic inflammatory bowel disease. In individual patients with ulcerative colitis (UC) positive effects have been observed.
  
  
  OBJECTIVE
  To assess the safety, pharmacology, and clinical effects of different doses of TE in patients with active UC.
  
  
  METHODS
  Sixteen patients with active UC [clinical activity index (CAI) >/=5] received TE in escalating doses of 1200, 1800, 2400 and 3000 mg/d for 3 weeks each. Each treatment phase was followed by a 4-week washout phase. The outcome parameters were side effects, CAI, C-reactive protein, and tannin levels in patient sera.
  
  
  RESULTS
  Mild upper abdominal discomfort was experienced by 6 patients (38%), but did not require discontinuation of the medication. During therapy with 2400 mg TE per day, median CAI and C-reactive protein improved from 8 (6 to 10.75) and 8 (3 to 17.75) mg/L at baseline to 4.5 (1.75 to 6) and 3 (3 to 6) mg/L, respectively. During therapy, the CAI decreased in all patients, whereas it increased during the washout phase. Neither undegraded nor metabolized tannins could be detected by liquid-mass spectrometry (LC-MS) in patient sera.
  
  
  CONCLUSIONS
  TE appeared safe up to 3000 mg/d. Tannins from TE are not systemically absorbed. The efficacy in patients with UC should be further evaluated.
authors: Department for Internal Medicine II, University Hospital Freiburg, Germany. roman.huber@uniklinik-freiburg.de
authors: Roman
authors: R
authors: Huber
authors: Amelie V
authors: AV
authors: Ditfurth
authors: Frank
authors: F
authors: Amann
authors: Corina
authors: C
authors: Güthlin
authors: Matthias
authors: M
authors: Rostock
authors: Rainer
authors: R
authors: Trittler
authors: Klaus
authors: K
authors: Kümmerer
authors: Irmgard
authors: I
authors: Merfort
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002097:C-Reactive Protein / Q000187:drug effects / Q000378:metabolism; D002853:Chromatography, Liquid; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D013058:Mass Spectrometry; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D010946:Plants, Medicinal; D031987:Potentilla / Q000737:chemistry*; D027343:Rhizome; D012720:Severity of Illness Index; D013634:Tannins / Q000097:blood
chemical_list: D010936:Plant Extracts; D013634:Tannins; D002097:C-Reactive Protein