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Indigo naturalis is effective even in treatment-refractory patients with ulcerative colitis: a post hoc analysis from the INDIGO study |
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| 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 Kanai Takanori |
| Affiliation: | 1.Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan ;2.Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan ;3.Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan ;4.Department of Internal Medicine, Division of IBD, Tokyo Yamate Medical Center, Tokyo, Japan ;5.Department of Gastroenterology, Imamura Hospital, Kagoshima, Japan ;6.Department of Endoscopy and Medicine, Hiroshima University Hospital, Hiroshima, Japan ;7.Department of Medicine, Shiga University of Medical Science, Otsu, Japan ;8.Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan ;9.Department of Medicine, Tokyo Saiseikai Central Hospital, Tokyo, Japan ;10.IBD Center, Yokkaichi Hazu Medical Center, Yokkaichi, Japan ;11.Department of Medicine, Yokohama Municipal Citizen’s Hospital, Yokohama, Japan ;12.Department of Gastroenterology, Tokai University Hachioji Hospital, Hachioji, Japan ;13.Department of Gastroenterology, Toho University Sakura Medical Center, Sakura, Japan ;14.Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan ;15.The Third Department of Internal Medicine, Kyorin University School of Medicine, Mitaka, Japan ;16.Department of Intestinal Inflammation Research, Hyogo College of Medicine, Nishinomiya, Japan ;17.Department of Preventive Medicine and Public Health, Biostatistics Unit at Clinical and Translational Research Center, Keio University School of Medicine, Tokyo, Japan ;18.Inflammatory Bowel Disease Center, Toho University Sakura Medical Center, Sakura, Japan ; |
| 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. MethodsIn 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. ResultsThe 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. ConclusionsIn 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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