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- Title
Indigo naturalis is effective even in treatment-refractory patients with ulcerative colitis: a post hoc analysis from the INDIGO study.
- Authors
Naganuma, Makoto; Sugimoto, Shinya; Fukuda, Tomohiro; Mitsuyama, Keiichi; Kobayashi, Taku; Yoshimura, Naoki; Ohi, Hidehisa; Tanaka, Shinji; Andoh, Akira; Ohmiya, Naoki; Saigusa, Keiichiro; Yamamoto, Takayuki; Morohoshi, Yuichi; Ichikawa, Hitoshi; Matsuoka, Katsuyoshi; Hisamatsu, Tadakazu; Watanabe, Kenji; Mizuno, Shinta; Abe, Takayuki; Suzuki, Yasuo
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
ULCERATIVE colitis; RANDOMIZED controlled trials; STEROID drugs; WOUND healing; RESEARCH; HERBAL medicine; RESEARCH methodology; MEDICAL cooperation; EVALUATION research; TREATMENT effectiveness; FECES; SEVERITY of illness index; COMPARATIVE studies; IMMUNOLOGICAL adjuvants; REOPERATION; INTESTINAL mucosa; STATISTICAL sampling; CHINESE medicine; THERAPEUTICS
- Publication
Journal of Gastroenterology, 2020, Vol 55, Issue 2, p169
- ISSN
0944-1174
- Publication type
journal article
- DOI
10.1007/s00535-019-01625-2