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


CONCLUSIONS
AST-120 is useful for the control of intractable anal fistulas in CD patients.
Fukuda
Yoshihiro
Y
Clinical Nutrition and Health Science and General Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
Takazoe
Masakazu
M
Sugita
Akira
A
Kosaka
Tadashi
T
Kinjo
Fukunori
F
Otani
Yoshimasa
Y
Fujii
Hisao
H
Koganei
Kazutaka
K
Makiyama
Kazuya
K
Nakamura
Toshio
T
Suda
Takeyasu
T
Yamamoto
Shojiro
S
Ashida
Toshifumi
T
Majima
Akira
A
Morita
Norikazu
N
Murakami
Kazunari
K
Oshitani
Nobuhide
N
Takahama
Kazuya
K
Tochihara
Masahiro
M
Tsujikawa
Tomoyuki
T
Watanabe
Makoto
M
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002244:Carbon / Q000627:therapeutic use*; D003424:Crohn Disease / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010087:Oxides / Q000627:therapeutic use*; D012003:Rectal Fistula / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome
D010087:Oxides; D002244:Carbon; C040896:AST 120