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

For the INDIGO Study Group

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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.

Original languageEnglish
JournalJournal of Gastroenterology
DOIs
Publication statusAccepted/In press - 01-01-2019

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Indigo Carmine
Ulcerative Colitis
Steroids
Placebos
Leukocyte L1 Antigen Complex
Therapeutics
Immunologic Factors
Randomized Controlled Trials
Multivariate Analysis

All Science Journal Classification (ASJC) codes

  • Gastroenterology

Cite this

@article{9b019e9909d14c7fb4701aac803b8d5f,
title = "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.",
author = "{For the INDIGO Study Group} and Makoto Naganuma and Shinya Sugimoto and Tomohiro Fukuda and Keiichi Mitsuyama and Taku Kobayashi and Naoki Yoshimura and Hidehisa Ohi and Shinji Tanaka and Akira Andoh and Naoki Ohmiya and Keiichiro Saigusa and Takayuki Yamamoto and Yuichi Morohoshi and Hitoshi Ichikawa and Katsuyoshi Matsuoka and Tadakazu Hisamatsu and Kenji Watanabe and Shinta Mizuno and Takayuki Abe and Yasuo Suzuki and Takanori Kanai and Makoto Naganuma and Yoshihiro Nakazato and Toshiaki Teratani and Haruhiko Ogata and Yasushi Iwao and Hiroshi Yamasaki and Takahiko Toyonaga and Masaru Nakano and Toshifumi Hibi and Yoichi Sameshima and Ryohei Hayashi and Yoshitaka Ueno and Shigeki Bamba and Mamoru Watanabe and Atsushi Nakazawa and Yuji Koike and Jin Imai and Takahiro Shimoyama and Ken Takeuchi and Mitsuo Nagasaka and Atsuo Kitano and Shinya Ashizuka and Haruhiko Inatsu and Kei Onodera and Hiroshi Nakase and Kazuya Kitamura and Kentaro Ikeya and Hiroyuki Hanai and Chikako Watanabe",
year = "2019",
month = "1",
day = "1",
doi = "10.1007/s00535-019-01625-2",
language = "English",
journal = "Journal of Gastroenterology",
issn = "0944-1174",
publisher = "Springer Japan",

}

TY - JOUR

T1 - Indigo naturalis is effective even in treatment-refractory patients with ulcerative colitis

T2 - a post hoc analysis from the INDIGO study

AU - For the INDIGO Study Group

AU - Naganuma, Makoto

AU - Sugimoto, Shinya

AU - Fukuda, Tomohiro

AU - Mitsuyama, Keiichi

AU - Kobayashi, Taku

AU - Yoshimura, Naoki

AU - Ohi, Hidehisa

AU - Tanaka, Shinji

AU - Andoh, Akira

AU - Ohmiya, Naoki

AU - Saigusa, Keiichiro

AU - Yamamoto, Takayuki

AU - Morohoshi, Yuichi

AU - Ichikawa, Hitoshi

AU - Matsuoka, Katsuyoshi

AU - Hisamatsu, Tadakazu

AU - Watanabe, Kenji

AU - Mizuno, Shinta

AU - Abe, Takayuki

AU - Suzuki, Yasuo

AU - Kanai, Takanori

AU - Naganuma, Makoto

AU - Nakazato, Yoshihiro

AU - Teratani, Toshiaki

AU - Ogata, Haruhiko

AU - Iwao, Yasushi

AU - Yamasaki, Hiroshi

AU - Toyonaga, Takahiko

AU - Nakano, Masaru

AU - Hibi, Toshifumi

AU - Sameshima, Yoichi

AU - Hayashi, Ryohei

AU - Ueno, Yoshitaka

AU - Bamba, Shigeki

AU - Watanabe, Mamoru

AU - Nakazawa, Atsushi

AU - Koike, Yuji

AU - Imai, Jin

AU - Shimoyama, Takahiro

AU - Takeuchi, Ken

AU - Nagasaka, Mitsuo

AU - Kitano, Atsuo

AU - Ashizuka, Shinya

AU - Inatsu, Haruhiko

AU - Onodera, Kei

AU - Nakase, Hiroshi

AU - Kitamura, Kazuya

AU - Ikeya, Kentaro

AU - Hanai, Hiroyuki

AU - Watanabe, Chikako

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

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UR - http://www.scopus.com/inward/citedby.url?scp=85073819029&partnerID=8YFLogxK

U2 - 10.1007/s00535-019-01625-2

DO - 10.1007/s00535-019-01625-2

M3 - Article

C2 - 31529220

AN - SCOPUS:85073819029

JO - Journal of Gastroenterology

JF - Journal of Gastroenterology

SN - 0944-1174

ER -