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Indigo naturalis is effective even in treatment-refractory patients with ulcerative colitis: a post hoc analysis from the INDIGO study.

Abstract：

BACKGROUND:We recently reported the efficacy of indigo naturalis (IN) in patients with active ulcerative colitis (UC) in a randomized controlled trial (INDIGO study). However, few studies have been conducted to investigate whether IN is effective even in treatment-refractory cases, such as in those with steroid dependency and anti-TNF refractoriness. METHODS:In the INDIGO study, 86 patients with active UC were randomly assigned to an IN group (0.5-2.0 g daily) or placebo group. The rate of clinical response (CR), mucosal healing (MH), and change in fecal calprotectin (FCP) levels was compared between refractory [patients with steroid-dependent disease, previous use of anti-TNF-α, and concomitant use of immunomodulators (IM)] and non-refractory patients. We also analyzed factors predicting CR and MH at week 8. RESULTS:The rates of CR of IN group were significantly higher than placebo group, even in patients with steroid-dependent disease (p < 0.001), previous use of anti-TNF-α (p = 0.002), and concomitant use of IM (p = 0.013). The rates of MH in IN group were significantly higher than in placebo group in patients with steroid-dependent disease (p = 0.009). In the IN group, median FCP levels, at week 8, were significantly lower than baseline in patients with steroid-dependent disease and patients with the previous use of anti-TNF-α (p < 0.001, respectively). Multivariate analysis indicated that the previous use of anti-TNF-α was not a predictive factor for CR and MH at week 8. CONCLUSIONS:In a sub-analysis of data from a randomized placebo-controlled trial, we found that IN may be useful even in patients with steroid-dependent disease and patients with the previous use of anti-TNF-α.

journal_name

J Gastroenterol

journal_title

Journal of gastroenterology

authors

Naganuma M,Sugimoto S,Fukuda T,Mitsuyama K,Kobayashi T,Yoshimura N,Ohi H,Tanaka S,Andoh A,Ohmiya N,Saigusa K,Yamamoto T,Morohoshi Y,Ichikawa H,Matsuoka K,Hisamatsu T,Watanabe K,Mizuno S,Abe T,Suzuki Y,Kanai T,IN

doi

10.1007/s00535-019-01625-2

subject

Has Abstract

pub_date

2020-02-01 00:00:00

pages

169-180

issue

eissn

0944-1174

issn

1435-5922

pii

10.1007/s00535-019-01625-2

journal_volume

pub_type

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Indigo naturalis is effective even in treatment-refractory patients with ulcerative colitis: a post hoc analysis from the INDIGO study.