Oral Spherical Adsorptive Carbon for the Treatment of Intractable Anal Fistulas in Crohn's Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Fukuda, Yoshihiro; Takazoe, Masakazu; Sugita, Akira; Kosaka, Toshio; Kinjo, Fukunori; Otani, Yoshimasa; Fujii, Hisao; Koganei, Kazutaka; Makiyama, Kazuya; Nakamura, Toshio; Suda, Takeyasu; Yamamoto, Shojiro; Ashida, Toshifumi; Majima, Akira; Morita, Norikazu; Murakami, Kazunari; Oshitani, Nobuhide; Takahama, Kazuya; Tochihara, Masahiro; Tsujikawa, Tomoyuki; Watanabe, Makoto

doi:10.1111/j.1572-0241.2008.01860.x

Cited by 22 publications

(34 citation statements)

References 15 publications

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“…Characteristics of individual RCTs, including the magnitude of the placebo response in each trial, are provided in Table 1. Three trials included only patients with perianal fistulizing disease with fistula closure as the primary endpoint, 17,18,28 three trials recruited patients with fistulizing disease exclusively, but at any location, 20,22,26 again reporting fistula closure as the primary endpoint, and seven trials reported fistula closure as a secondary endpoint within a mixed population of patients with either luminal or fistulizing CD. 16,19,21,[23][24][25]27 Six trials were at low risk of bias.…”

Section: Resultsmentioning

confidence: 99%

“…Of these 44 RCTs, 31 were excluded for the reasons listed, leaving 13 eligible trials, [16][17][18][19][20][21][22][23][24][25][26][27][28] containing 579 individuals with fistulizing CD who were randomized to receive placebo. Agreement between reviewers for assessment of trial eligibility was good (kappa statistic = 0.90).…”

Section: Resultsmentioning

confidence: 99%

“…There were seven RCTs that reported the proportion of placebo patients receiving concomitant therapy at trial entry with 5-ASAs, glucocorticosteroids, or immunosuppressants, 16-18, 20, 22, 26, 28 and six that reported use of concomitant antibiotics. 17,18,20,22,26,28 We used a threshold of ≥30% of the placebo arm using these drugs to distinguish between individual trials for all of these analyses. There were no significant differences observed between placebo response rates according to use of 5-ASAs, glucocorticosteroids, immunosuppressants, or antibiotics, although the placebo response rates in trials where ≥30% of the placebo arm were using glucorticosteroids were generally higher (16.8% vs. 10.0%, Cochran Q = 3.87, P = 0.05) ( Table 3).…”

Section: Active Therapymentioning

confidence: 99%

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Placebo Response Rate in Clinical Trials of Fistulizing Crohn's Disease: Systematic Review and Meta-analysis

Ford

Luthra

Hanauer

et al. 2014

Clinical Gastroenterology and Hepatology

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Active Therapymentioning

confidence: 99%

See 1 more Smart Citation

Placebo Response Rate in Clinical Trials of Fistulizing Crohn's Disease: Systematic Review and Meta-analysis

Ford

Luthra

Hanauer

et al. 2014

Clinical Gastroenterology and Hepatology

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“…Sixty-two patients were randomized, 57 of whom received AST-120 (n = 27) or placebo (n = 30) [37] . The improvement rate in the AST-120 group (37.0%) was significantly higher than that in the placebo group (10.0%; p = 0.025).…”

Section: Other Medical Therapiesmentioning

confidence: 99%

Fistula Treatment: The Unresolved Challenge

Michetti¹

2009

Dig Dis

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Fistulas are common complications in Crohn’s disease, as their cumulative prevalence reaches up to two thirds of the patients in the long term. Fistulas worsen the overall patient prognosis, with permanent sphincter and perineal tissue destruction as well as professional and personal disabilities. The importance of healing these fistulas has been less well appreciated than mucosal healing for luminal disease. Management should not be left to any specialty alone, but requires an optimal combination of surgery, infection control, and immunosuppression. Outcome of therapy beyond fistula drainage is unclear and the means of assessing healing over a long time period is poorly characterized. Recent studies suggested that a substantial proportion of patients can achieve fistula healing with surgical and medical therapies. However, studies that measure the benefit of integrated approaches, of early intervention and of precise healing assessment are still missing. Such information is particularly needed in this subset of sick patients that undergo substantial physical and emotional distress because of pain, discharge, incontinence, perineal and genital disfigurement. The advent of adequate pelvic imaging, improved surgical outcomes, and potent biological therapies make it timely to develop best-management strategies and appropriateness of care criteria.

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“…A summary of different studies on medical therapy options in fistulizing CD is shown in table 1 [10,12,13,15,[17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] . Vavricka …”

Section: Medical Therapiesmentioning

confidence: 99%

Fistula Treatment: The Unresolved Challenge

Vavricka

Rogler²

2010

Dig Dis

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In population-based studies, up to 50% of patients with Crohn’s disease suffer from fistulas. Fistulas pose a considerable morbidity including permanent sphincter and perineal tissue destruction as well as professional and personal disabilities. Treatment options have progressed in recent years and fistula closure and fibrosis of the fistula track is achieved in some patients. Depending on severity of symptoms and fistula location, different medical and surgical therapies can be chosen. Internal fistulas such as ileoileal or ileocecal fistulas are either asymptomatic and do not require intervention or they are symptomatic and need surgery alone. They always carry a risk of abscess formation. Symptomatic perianal fistulizing disease can be treated with antibiotics (i.e. metronidazole and ciprofloxacin) for three months and/or immunosuppressant therapy (6-mercaptopurine or azathioprine). More complex cases require therapy with anti-TNF agents. Only few and preliminary data exist on cyclosporine A, tacrolimus or methotrexate in fistulizing Crohn’s disease. Therefore, these therapies should mainly be used as second-line therapies. Surgery is reserved for the treatment of perianal sepsis in the presence of abscesses and refractory disease or complications of fistulas, or used in combination with pharmacological approaches. The surgical interventions in perianal disease consist of surgical drainage with or without seton placement, transient ileostomy, or in severe cases, proctectomy. The classification of fistulas in patients with Crohn’s disease remains poorly defined and largely investigator dependent. The unresolved challenges in fistula treatment warrant randomized controlled trials for existing and future treatment strategies as well as a better classification system to compare available studies.

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Oral Spherical Adsorptive Carbon for the Treatment of Intractable Anal Fistulas in Crohn's Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Abstract: AST-120 is useful for the control of intractable anal fistulas in CD patients.

Cited by 22 publications

References 15 publications

Placebo Response Rate in Clinical Trials of Fistulizing Crohn's Disease: Systematic Review and Meta-analysis

Placebo Response Rate in Clinical Trials of Fistulizing Crohn's Disease: Systematic Review and Meta-analysis

Fistula Treatment: The Unresolved Challenge

Fistula Treatment: The Unresolved Challenge

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