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Volume 154, Issue 4, Pages 935-947 (March 2018)
Efficacy of Indigo Naturalis in a Multicenter Randomized Controlled Trial of Patients With Ulcerative Colitis Makoto Naganuma, Shinya Sugimoto, Keiichi Mitsuyama, Taku Kobayashi, Naoki Yoshimura, Hidehisa Ohi, Shinji Tanaka, Akira Andoh, Naoki Ohmiya, Keiichiro Saigusa, Takayuki Yamamoto, Yuichi Morohoshi, Hitoshi Ichikawa, Katsuyoshi Matsuoka, Tadakazu Hisamatsu, Kenji Watanabe, Shinta Mizuno, Wataru Suda, Masahira Hattori, Shinji Fukuda, Akiyoshi Hirayama, Takayuki Abe, Mamoru Watanabe, Toshifumi Hibi, Yasuo Suzuki, Takanori Kanai Makoto Naganuma, Shinya Sugimoto, Shinta Mizuno, Yoshihiro Nakazato, Tomohiro Fukuda, Toshiaki Teratani, Haruhiko Ogata, Yasushi Iwao, Takanori Kanai, Hiroshi Yamasaki, Keiichi Mitsuyama, Taku Kobayashi, Takahiko Toyonaga, Masaru Nakano, Toshifumi Hibi, Naoki Yoshimura, Yoichi Sameshima, Hidehisa Ohi, Ryohei Hayashi, Yoshitaka Ueno, Shinji Tanaka, Shigeki Bamba, Akira Andoh, Katsuyoshi Matsuoka, Mamoru Watanabe, Keiichiro Saigusa, Atsushi Nakazawa, Yuichi Morohoshi, Yuji Koike, Jin Imai, Hitoshi Ichikawa, Takahiro Shimoyama, Takayuki Yamamoto, Ken Takeuchi, Yasuo Suzuki, Mitsuo Nagasaka, Naoki Ohmiya, Atsuo Kitano, Shinya Ashizuka, Haruhiko Inatsu, Kei Onodera, Hiroshi Nakase, Kazuya Kitamura, Kentaro Ikeya, Hiroyuki Hanai, Chikako Watanabe, Ryota Hokari, Fumihito Hirai, Yuji Naito, Namiko Hoshi, Fukunori Kinjo, Yo Ishiguro, Makoto Sasaki, Takayuki Matsumoto, Kenji Watanabe, Tadakazu Hisamatsu, Fumiya Sano, Rachel Roberts, Takayuki Abe, Wataru Suda, Masahira Hattori, Shinji Fukuda, Akiyoshi Hirayama Makoto Naganuma, Shinya Sugimoto, Keiichi Mitsuyama, Taku Kobayashi, Naoki Yoshimura, Hidehisa Ohi, Shinji Tanaka, Akira Andoh, Naoki Ohmiya, Keiichiro Saigusa, Takayuki Yamamoto, Yuichi Morohoshi, Hitoshi Ichikawa, Katsuyoshi Matsuoka, Tadakazu Hisamatsu, Kenji Watanabe, Shinta Mizuno, Wataru Suda, Masahira Hattori, Shinji Fukuda, Akiyoshi Hirayama, Takayuki Abe, Mamoru Watanabe, Toshifumi Hibi, Yasuo Suzuki, Takanori Kanai Makoto Naganuma, Shinya Sugimoto, Shinta Mizuno, Yoshihiro Nakazato, Tomohiro Fukuda, Toshiaki Teratani, Haruhiko Ogata, Yasushi Iwao, Takanori Kanai, Hiroshi Yamasaki, Keiichi Mitsuyama, Taku Kobayashi, Takahiko Toyonaga, Masaru Nakano, Toshifumi Hibi, Naoki Yoshimura, Yoichi Sameshima, Hidehisa Ohi, Ryohei Hayashi, Yoshitaka Ueno, Shinji Tanaka, Shigeki Bamba, Akira Andoh, Katsuyoshi Matsuoka, Mamoru Watanabe, Keiichiro Saigusa, Atsushi Nakazawa, Yuichi Morohoshi, Yuji Koike, Jin Imai, Hitoshi Ichikawa, Takahiro Shimoyama, Takayuki Yamamoto, Ken Takeuchi, Yasuo Suzuki, Mitsuo Nagasaka, Naoki Ohmiya, Atsuo Kitano, Shinya Ashizuka, Haruhiko Inatsu, Kei Onodera, Hiroshi Nakase, Kazuya Kitamura, Kentaro Ikeya, Hiroyuki Hanai, Chikako Watanabe, Ryota Hokari, Fumihito Hirai, Yuji Naito, Namiko Hoshi, Fukunori Kinjo, Yo Ishiguro, Makoto Sasaki, Takayuki Matsumoto, Kenji Watanabe, Tadakazu Hisamatsu, Fumiya Sano, Rachel Roberts, Takayuki Abe, Wataru Suda, Masahira Hattori, Shinji Fukuda, Akiyoshi Hirayama Gastroenterology Volume 154, Issue 4, Pages (March 2018) DOI: /j.gastro Copyright © 2018 AGA Institute Terms and Conditions
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Gastroenterology 2018 154, 935-947DOI: (10.1053/j.gastro.2017.11.024)
Copyright © 2018 AGA Institute Terms and Conditions
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Figure 1 Proportions of patients who achieved a clinical response, clinical remission, and mucosal healing at week 8 among patients who received IN and the placebo (ITT principle). Asterisks (*) indicate a significant difference between each treatment group and the placebo group at each visit (Fisher’s exact test, ∗P < .05; ∗∗P< .01; ∗∗∗P< .001). Gastroenterology , DOI: ( /j.gastro ) Copyright © 2018 AGA Institute Terms and Conditions
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Figure 2 Changes in the partial Mayo (A) and Modified Truelove and Witts Severity Index (MTWSI) scores (B) compared with the baseline scores (ITT principle). Changes in the total Mayo score at week 8 or in the partial Mayo score and MTWSI at each visit (weeks 2, 4, and 8) compared with the baseline scores are indicated by mean values ± SD. Asterisks (*) indicate a significant difference between each treatment group and the placebo group at each visit (t test, ∗P < .05; ∗∗P< .01; ∗∗∗P< .001). Gastroenterology , DOI: ( /j.gastro ) Copyright © 2018 AGA Institute Terms and Conditions
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Figure 3 (A) Redundancy analysis of microbiota from healthy volunteers and patients before and after treatment using a weighted UniFrac analysis. (B) Comparison of the abundance of 6 phyla of fecal bacteria in healthy controls (n = 104) and patients before (n = 30) and after treatment (n = 25). (C) Comparison of the abundance of 6 genera of fecal bacteria in healthy controls (n = 104) and patients before (n = 30) and after treatment (n = 25). The average OTU abundance is shown for each group. OTU, operational taxonomic unit. *P < .05, **P < .01, ***P < .001. Gastroenterology , DOI: ( /j.gastro ) Copyright © 2018 AGA Institute Terms and Conditions
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