Document Detail


Oral spherical adsorptive carbon for the treatment of intractable anal fistulas in Crohn's disease: a multicenter, randomized, double-blind, placebo-controlled trial.
MedLine Citation:
PMID:  18616656     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: Anal fistulas are common in individuals with Crohn's disease (CD). We sought to evaluate the efficacy of oral spherical adsorptive carbon (AST-120) (Kremezin; Kureha Corporation, Tokyo, Japan) for the treatment of intractable anal fistulas in patients with CD. METHODS: In this multicenter, randomized, double-blind, placebo-controlled trial, patients with CD and at least one active anal fistula under treatment were assigned to receive either AST-120 or placebo for 8 wk. Improvement was defined as a reduction of 50% or more from baseline in the number of draining fistulas observed at both 4 and 8 wk. Remission was defined by closure of all draining fistulas at both 4 and 8 wk. The Perianal Disease Activity Index (PDAI) and Crohn's Disease Activity Index (CDAI) were also assessed. RESULTS: In total, 62 patients were randomized, of whom 57 received AST-120 (N = 27) or placebo (N = 30). The improvement rate in the AST-120 group (37.0%) was significantly greater than that in the placebo group (10.0%) (P= 0.025). The corresponding remission rates were 29.6% and 6.7%, respectively (P= 0.035). PDAI significantly improved at both 4 and 8 wk with AST-120, compared to placebo (P= 0.004 and P= 0.005, respectively). CDAI was also significantly improved at both 4 and 8 wk in the AST-120 group, compared to the placebo group (P= 0.007 and P= 0.001, respectively). AST-120 treatment was well tolerated and no life-threatening adverse events were observed. CONCLUSION: AST-120 is useful for the control of intractable anal fistulas in CD patients.
Authors:
Yoshihiro Fukuda; Masakazu Takazoe; Akira Sugita; Tadashi Kosaka; Fukunori Kinjo; Yoshimasa Otani; Hisao Fujii; Kazutaka Koganei; Kazuya Makiyama; Toshio Nakamura; Takeyasu Suda; Shojiro Yamamoto; Toshifumi Ashida; Akira Majima; Norikazu Morita; Kazunari Murakami; Nobuhide Oshitani; Kazuya Takahama; Masahiro Tochihara; Tomoyuki Tsujikawa; Makoto Watanabe
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2008-07-04
Journal Detail:
Title:  The American journal of gastroenterology     Volume:  103     ISSN:  1572-0241     ISO Abbreviation:  Am. J. Gastroenterol.     Publication Date:  2008 Jul 
Date Detail:
Created Date:  2008-08-11     Completed Date:  2008-09-03     Revised Date:  2009-07-21    
Medline Journal Info:
Nlm Unique ID:  0421030     Medline TA:  Am J Gastroenterol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1721-9     Citation Subset:  IM    
Affiliation:
Clinical Nutrition and Health Science and General Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Carbon / therapeutic use*
Crohn Disease / complications*
Double-Blind Method
Female
Humans
Male
Middle Aged
Oxides / therapeutic use*
Rectal Fistula / drug therapy*,  etiology
Treatment Outcome
Chemical
Reg. No./Substance:
0/Oxides; 7440-44-0/Carbon; 90597-58-3/AST 120
Comments/Corrections
Comment In:
Inflamm Bowel Dis. 2009 Aug;15(8):1276-7   [PMID:  19107776 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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