Tormentil for active ulcerative colitis: an open-label, dose-escalating study.
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.
Huber
Roman
R
Department for Internal Medicine II, University Hospital Freiburg, Germany. roman.huber@uniklinik-freiburg.de
Ditfurth
Amelie V
AV
Amann
Frank
F
Güthlin
Corina
C
Rostock
Matthias
M
Trittler
Rainer
R
Kümmerer
Klaus
K
Merfort
Irmgard
I
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
D010936:Plant Extracts; D013634:Tannins; D002097:C-Reactive Protein