Tormentil for active ulcerative colitis: an open-label, dose-escalating study
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Tormentil for active ulcerative colitis: an open-label, dose-escalating study. / Huber, Roman; Ditfurth, Amelie V; Amann, Frank; Güthlin, Corina; Rostock, Matthias; Trittler, Rainer; Kümmerer, Klaus; Merfort, Irmgard.
in: Journal of clinical gastroenterology, Jahrgang 41, Nr. 9, 10.2007, S. 834-8.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Tormentil for active ulcerative colitis: an open-label, dose-escalating study
AU - Huber, Roman
AU - Ditfurth, Amelie V
AU - Amann, Frank
AU - Güthlin, Corina
AU - Rostock, Matthias
AU - Trittler, Rainer
AU - Kümmerer, Klaus
AU - Merfort, Irmgard
PY - 2007/10
Y1 - 2007/10
N2 - 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.GOALS: To assess the safety, pharmacology, and clinical effects of different doses of TE in patients with active UC.STUDY: 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.
AB - 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.GOALS: To assess the safety, pharmacology, and clinical effects of different doses of TE in patients with active UC.STUDY: 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.
KW - Adolescent
KW - Adult
KW - Aged
KW - C-Reactive Protein/drug effects
KW - Chromatography, Liquid
KW - Colitis, Ulcerative/drug therapy
KW - Dose-Response Relationship, Drug
KW - Female
KW - Humans
KW - Male
KW - Mass Spectrometry
KW - Middle Aged
KW - Phytotherapy
KW - Plant Extracts/administration & dosage
KW - Plants, Medicinal
KW - Potentilla/chemistry
KW - Rhizome
KW - Severity of Illness Index
KW - Tannins/blood
U2 - 10.1097/MCG.0b013e31804b2173
DO - 10.1097/MCG.0b013e31804b2173
M3 - SCORING: Journal article
C2 - 17881930
VL - 41
SP - 834
EP - 838
JO - J CLIN GASTROENTEROL
JF - J CLIN GASTROENTEROL
SN - 0192-0790
IS - 9
ER -