Adverse events in patients with ulcerative colitis treated with indigo naturalis

a Japanese nationwide survey

INDIGO survey Group

Research output: Contribution to journalArticle

Abstract

Background: Although indigo naturalis (IN) is effective for patients with active ulcerative colitis (UC), IN was associated with adverse events (AEs), including pulmonary arterial hypertension (PAH). Our aim was to evaluate the occurrence of IN-associated AEs and to evaluate any IN dose–effect on AEs. Methods: A nationwide survey, using questionnaires, was conducted by conducted by the research group funded by the Ministry of Health, Labour and Welfare of Japan, between June 2017 and September 2018. A first questionnaire determined the occurrence of AEs associated with the therapeutic use of IN or herbal medicines containing IN in patients with UC. A second survey identified the clinical characteristics of patients who developed IN-associated critical AEs, namely, liver dysfunction, PAH, and intussusception. Results: Across 337 participating institutions, 49,320 patients with UC were identified, with IN used in 877 (1.8%). AEs were reported in 91 patients (107 events), including liver dysfunction (n = 40), gastrointestinal symptoms (n = 21), headache (n = 13), and PAH (n = 11). No dose–effect relationship between IN and AEs was identified. Liver dysfunction tended to be mild and reversible. Ten cases of intussusception were reported, with 40% of these patients requiring surgical resection. IN-induced PAH was recovered in patients who discontinued to use IN. No IN-associated deaths were reported. Conclusions: IN-associated AEs were identified among patients with UC, with liver dysfunction often being reversible, while surgical resection was required in a high proportion of patients who developed intussusception. Both healthcare workers and patients should adequately recognize the potential for AEs with the use of IN.

Original languageEnglish
JournalJournal of Gastroenterology
DOIs
Publication statusPublished - 01-01-2019

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Indigo Carmine
Ulcerative Colitis
Pulmonary Hypertension
Intussusception
Liver Diseases
Surveys and Questionnaires
Herbal Medicine
Therapeutic Uses

All Science Journal Classification (ASJC) codes

  • Gastroenterology

Cite this

@article{15440c9c59ed43ba8285ac749cc5c7d4,
title = "Adverse events in patients with ulcerative colitis treated with indigo naturalis: a Japanese nationwide survey",
abstract = "Background: Although indigo naturalis (IN) is effective for patients with active ulcerative colitis (UC), IN was associated with adverse events (AEs), including pulmonary arterial hypertension (PAH). Our aim was to evaluate the occurrence of IN-associated AEs and to evaluate any IN dose–effect on AEs. Methods: A nationwide survey, using questionnaires, was conducted by conducted by the research group funded by the Ministry of Health, Labour and Welfare of Japan, between June 2017 and September 2018. A first questionnaire determined the occurrence of AEs associated with the therapeutic use of IN or herbal medicines containing IN in patients with UC. A second survey identified the clinical characteristics of patients who developed IN-associated critical AEs, namely, liver dysfunction, PAH, and intussusception. Results: Across 337 participating institutions, 49,320 patients with UC were identified, with IN used in 877 (1.8{\%}). AEs were reported in 91 patients (107 events), including liver dysfunction (n = 40), gastrointestinal symptoms (n = 21), headache (n = 13), and PAH (n = 11). No dose–effect relationship between IN and AEs was identified. Liver dysfunction tended to be mild and reversible. Ten cases of intussusception were reported, with 40{\%} of these patients requiring surgical resection. IN-induced PAH was recovered in patients who discontinued to use IN. No IN-associated deaths were reported. Conclusions: IN-associated AEs were identified among patients with UC, with liver dysfunction often being reversible, while surgical resection was required in a high proportion of patients who developed intussusception. Both healthcare workers and patients should adequately recognize the potential for AEs with the use of IN.",
author = "{INDIGO survey Group} and Makoto Naganuma and Shinya Sugimoto and Hideo Suzuki and Yuichi Matsuno and Toshimitsu Araki and Hirotaka Shimizu and Ryohei Hayashi and Tomohiro Fukuda and Nobuhiro Nakamoto and Hideki Iijima and Shiro Nakamura and Masaharu Kataoka and Yuichi Tamura and Koichiro Tatsumi and Toshifumi Hibi and Yasuo Suzuki and Takanori Kanai and Yusuke Yoshimatsu and Chu, {Po sung} and Motoi Uchino and Kenji Watanabe and Atsushi Hirano and Motohiro Esaki and Yoshitaka Ueno and Takayuki Yamamoto and Koji Sawada and Kosaku Kawashima and Shunji Ishihara and Shinichi Hashimoto and Junji Yokoyama and Shinya Ashizuka and Tatsuya Toyokawa and Hirotake Sakuraba and Kazuhiro Matsueda and Naoki Yoshimura and Naoki Ohmiya and Naoki Omiya and Shunichi Yanai and Takayuki Matsumoto and Hiroyuki Kobayashi and Sachiko Nakajima and Tsutomu Nishida and Yoshiaki Takeuchi and Kenji Ina and Takuji Kawamura",
year = "2019",
month = "1",
day = "1",
doi = "10.1007/s00535-019-01591-9",
language = "English",
journal = "Journal of Gastroenterology",
issn = "0944-1174",
publisher = "Springer Japan",

}

Adverse events in patients with ulcerative colitis treated with indigo naturalis : a Japanese nationwide survey. / INDIGO survey Group.

In: Journal of Gastroenterology, 01.01.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Adverse events in patients with ulcerative colitis treated with indigo naturalis

T2 - a Japanese nationwide survey

AU - INDIGO survey Group

AU - Naganuma, Makoto

AU - Sugimoto, Shinya

AU - Suzuki, Hideo

AU - Matsuno, Yuichi

AU - Araki, Toshimitsu

AU - Shimizu, Hirotaka

AU - Hayashi, Ryohei

AU - Fukuda, Tomohiro

AU - Nakamoto, Nobuhiro

AU - Iijima, Hideki

AU - Nakamura, Shiro

AU - Kataoka, Masaharu

AU - Tamura, Yuichi

AU - Tatsumi, Koichiro

AU - Hibi, Toshifumi

AU - Suzuki, Yasuo

AU - Kanai, Takanori

AU - Yoshimatsu, Yusuke

AU - Chu, Po sung

AU - Uchino, Motoi

AU - Watanabe, Kenji

AU - Hirano, Atsushi

AU - Esaki, Motohiro

AU - Ueno, Yoshitaka

AU - Yamamoto, Takayuki

AU - Sawada, Koji

AU - Kawashima, Kosaku

AU - Ishihara, Shunji

AU - Hashimoto, Shinichi

AU - Yokoyama, Junji

AU - Ashizuka, Shinya

AU - Toyokawa, Tatsuya

AU - Sakuraba, Hirotake

AU - Matsueda, Kazuhiro

AU - Yoshimura, Naoki

AU - Ohmiya, Naoki

AU - Omiya, Naoki

AU - Yanai, Shunichi

AU - Matsumoto, Takayuki

AU - Kobayashi, Hiroyuki

AU - Nakajima, Sachiko

AU - Nishida, Tsutomu

AU - Takeuchi, Yoshiaki

AU - Ina, Kenji

AU - Kawamura, Takuji

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Although indigo naturalis (IN) is effective for patients with active ulcerative colitis (UC), IN was associated with adverse events (AEs), including pulmonary arterial hypertension (PAH). Our aim was to evaluate the occurrence of IN-associated AEs and to evaluate any IN dose–effect on AEs. Methods: A nationwide survey, using questionnaires, was conducted by conducted by the research group funded by the Ministry of Health, Labour and Welfare of Japan, between June 2017 and September 2018. A first questionnaire determined the occurrence of AEs associated with the therapeutic use of IN or herbal medicines containing IN in patients with UC. A second survey identified the clinical characteristics of patients who developed IN-associated critical AEs, namely, liver dysfunction, PAH, and intussusception. Results: Across 337 participating institutions, 49,320 patients with UC were identified, with IN used in 877 (1.8%). AEs were reported in 91 patients (107 events), including liver dysfunction (n = 40), gastrointestinal symptoms (n = 21), headache (n = 13), and PAH (n = 11). No dose–effect relationship between IN and AEs was identified. Liver dysfunction tended to be mild and reversible. Ten cases of intussusception were reported, with 40% of these patients requiring surgical resection. IN-induced PAH was recovered in patients who discontinued to use IN. No IN-associated deaths were reported. Conclusions: IN-associated AEs were identified among patients with UC, with liver dysfunction often being reversible, while surgical resection was required in a high proportion of patients who developed intussusception. Both healthcare workers and patients should adequately recognize the potential for AEs with the use of IN.

AB - Background: Although indigo naturalis (IN) is effective for patients with active ulcerative colitis (UC), IN was associated with adverse events (AEs), including pulmonary arterial hypertension (PAH). Our aim was to evaluate the occurrence of IN-associated AEs and to evaluate any IN dose–effect on AEs. Methods: A nationwide survey, using questionnaires, was conducted by conducted by the research group funded by the Ministry of Health, Labour and Welfare of Japan, between June 2017 and September 2018. A first questionnaire determined the occurrence of AEs associated with the therapeutic use of IN or herbal medicines containing IN in patients with UC. A second survey identified the clinical characteristics of patients who developed IN-associated critical AEs, namely, liver dysfunction, PAH, and intussusception. Results: Across 337 participating institutions, 49,320 patients with UC were identified, with IN used in 877 (1.8%). AEs were reported in 91 patients (107 events), including liver dysfunction (n = 40), gastrointestinal symptoms (n = 21), headache (n = 13), and PAH (n = 11). No dose–effect relationship between IN and AEs was identified. Liver dysfunction tended to be mild and reversible. Ten cases of intussusception were reported, with 40% of these patients requiring surgical resection. IN-induced PAH was recovered in patients who discontinued to use IN. No IN-associated deaths were reported. Conclusions: IN-associated AEs were identified among patients with UC, with liver dysfunction often being reversible, while surgical resection was required in a high proportion of patients who developed intussusception. Both healthcare workers and patients should adequately recognize the potential for AEs with the use of IN.

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U2 - 10.1007/s00535-019-01591-9

DO - 10.1007/s00535-019-01591-9

M3 - Article

JO - Journal of Gastroenterology

JF - Journal of Gastroenterology

SN - 0944-1174

ER -