PMID- 31102012 OWN - NLM STAT- MEDLINE DCOM- 20200721 LR - 20210109 IS - 1435-5922 (Electronic) IS - 0944-1174 (Linking) VI - 54 IP - 10 DP - 2019 Oct TI - Adverse events in patients with ulcerative colitis treated with indigo naturalis: a Japanese nationwide survey. PG - 891-896 LID - 10.1007/s00535-019-01591-9 [doi] 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. FAU - Naganuma, Makoto AU - Naganuma M AUID- ORCID: 0000-0002-4244-3243 AD - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. nagamakoto@keio.jp. FAU - Sugimoto, Shinya AU - Sugimoto S AD - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. FAU - Suzuki, Hideo AU - Suzuki H AD - Department of Gastroenterology, Institute of Clinical Medicine, University of Tsukuba Graduate School, Ibaraki, Japan. FAU - Matsuno, Yuichi AU - Matsuno Y AD - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Araki, Toshimitsu AU - Araki T AD - Department of Gastrointestinal and Pediatric Surgery, Mie University Graduate School of Medicine, Tsu, Japan. FAU - Shimizu, Hirotaka AU - Shimizu H AD - Division of Gastroenterology, National Center for Child Health and Development, Tokyo, Japan. FAU - Hayashi, Ryohei AU - Hayashi R AD - Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan. FAU - Fukuda, Tomohiro AU - Fukuda T AD - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. FAU - Nakamoto, Nobuhiro AU - Nakamoto N AD - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. FAU - Iijima, Hideki AU - Iijima H AD - Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan. FAU - Nakamura, Shiro AU - Nakamura S AD - Department of Intestinal Inflammation Research, Hyogo College of Medicine, Nishinomiya, Japan. FAU - Kataoka, Masaharu AU - Kataoka M AD - Division of Cardiology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. FAU - Tamura, Yuichi AU - Tamura Y AD - Pulmonary Hypertension Center, International University of Health and Welfare Mita Hospital, Tokyo, Japan. FAU - Tatsumi, Koichiro AU - Tatsumi K AD - Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan. FAU - Hibi, Toshifumi AU - Hibi T AD - Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan. FAU - Suzuki, Yasuo AU - Suzuki Y AD - IBD Center, Toho University Sakura Medical Center, Sakura, Japan. FAU - Kanai, Takanori AU - Kanai T AD - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. takagast@keio.jp. CN - INDIGO survey Group LA - eng PT - Journal Article PT - Multicenter Study DEP - 20190517 PL - Japan TA - J Gastroenterol JT - Journal of gastroenterology JID - 9430794 RN - 0 (Drugs, Chinese Herbal) RN - 0 (Gastrointestinal Agents) RN - R1R8QUL21Z (Qingdai compound) SB - IM MH - Adult MH - Chemical and Drug Induced Liver Injury/epidemiology/etiology MH - Colitis, Ulcerative/*drug therapy/epidemiology MH - Dose-Response Relationship, Drug MH - Drugs, Chinese Herbal/administration & dosage/*adverse effects/therapeutic use MH - Female MH - Gastrointestinal Agents/administration & dosage/*adverse effects/therapeutic use MH - Health Surveys MH - Humans MH - Hypertension, Pulmonary/*chemically induced/epidemiology MH - Intussusception/chemically induced/epidemiology MH - Japan/epidemiology MH - Male MH - Middle Aged OTO - NOTNLM OT - Indigo naturalis OT - Intussusception OT - Liver dysfunction OT - Pulmonary arterial hypertension OT - Ulcerative colitis FIR - Naganuma, Makoto IR - Naganuma M FIR - Sugimoto, Shinya IR - Sugimoto S FIR - Fukuda, Tomohiro IR - Fukuda T FIR - Yoshimatsu, Yusuke IR - Yoshimatsu Y FIR - Chu, Po-Sung IR - Chu PS FIR - Nakamoto, Nobuhiro IR - Nakamoto N FIR - Kataoka, Masaharu IR - Kataoka M FIR - Kanai, Takanori IR - Kanai T FIR - Hibi, Toshifumi IR - Hibi T FIR - Iijima, Hideki IR - Iijima H FIR - Uchino, Motoi IR - Uchino M FIR - Watanabe, Kenji IR - Watanabe K FIR - Nakamura, Shiro IR - Nakamura S FIR - Suzuki, Yasuo IR - Suzuki Y FIR - Matsuno, Yuichi IR - Matsuno Y FIR - Hirano, Atsushi IR - Hirano A FIR - Esaki, Motohiro IR - Esaki M FIR - Hayashi, Ryohei IR - Hayashi R FIR - Ueno, Yoshitaka IR - Ueno Y FIR - Yamamoto, Takayuki IR - Yamamoto T FIR - Sawada, Koji IR - Sawada K FIR - Kawashima, Kosaku IR - Kawashima K FIR - Ishihara, Shunji IR - Ishihara S FIR - Araki, Toshimitsu IR - Araki T FIR - Hashimoto, Shinichi IR - Hashimoto S FIR - Yokoyama, Junji IR - Yokoyama J FIR - Ashizuka, Shinya IR - Ashizuka S FIR - Suzuki, Hideo IR - Suzuki H FIR - Toyokawa, Tatsuya IR - Toyokawa T FIR - Sakuraba, Hirotake IR - Sakuraba H FIR - Matsueda, Kazuhiro IR - Matsueda K FIR - Yoshimura, Naoki IR - Yoshimura N FIR - Ohmiya, Naoki IR - Ohmiya N FIR - Kayashima, Yoshiyuki IR - Kayashima Y FIR - Yanai, Shunichi IR - Yanai S FIR - Matsumoto, Takayuki IR - Matsumoto T FIR - Kobayashi, Hiroyuki IR - Kobayashi H FIR - Nakajima, Sachiko IR - Nakajima S FIR - Nishida, Tsutomu IR - Nishida T FIR - Takeuchi, Yoshiaki IR - Takeuchi Y FIR - Shimizu, Hirotaka IR - Shimizu H FIR - Ina, Kenji IR - Ina K FIR - Kawamura, Takuji IR - Kawamura T EDAT- 2019/05/19 06:00 MHDA- 2020/07/22 06:00 CRDT- 2019/05/19 06:00 PHST- 2019/03/13 00:00 [received] PHST- 2019/04/26 00:00 [accepted] PHST- 2019/05/19 06:00 [pubmed] PHST- 2020/07/22 06:00 [medline] PHST- 2019/05/19 06:00 [entrez] AID - 10.1007/s00535-019-01591-9 [pii] AID - 10.1007/s00535-019-01591-9 [doi] PST - ppublish SO - J Gastroenterol. 2019 Oct;54(10):891-896. doi: 10.1007/s00535-019-01591-9. Epub 2019 May 17.