JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Oral spherical adsorptive carbon for the treatment of intractable anal fistulas in Crohn's disease: a multicenter, randomized, double-blind, placebo-controlled trial

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
American Journal of Gastroenterology 2008, 103 (7): 1721-9
18616656

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.

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