Makoto Naganuma1, Shinya Sugimoto2, Hideo Suzuki3, Yuichi Matsuno4, Toshimitsu Araki5, Hirotaka Shimizu6, Ryohei Hayashi7, Tomohiro Fukuda2, Nobuhiro Nakamoto2, Hideki Iijima8, Shiro Nakamura9, Masaharu Kataoka10, Yuichi Tamura11, Koichiro Tatsumi12, Toshifumi Hibi13, Yasuo Suzuki14, Takanori Kanai15. 1. 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. 2. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. 3. Department of Gastroenterology, Institute of Clinical Medicine, University of Tsukuba Graduate School, Ibaraki, Japan. 4. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 5. Department of Gastrointestinal and Pediatric Surgery, Mie University Graduate School of Medicine, Tsu, Japan. 6. Division of Gastroenterology, National Center for Child Health and Development, Tokyo, Japan. 7. Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan. 8. Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan. 9. Department of Intestinal Inflammation Research, Hyogo College of Medicine, Nishinomiya, Japan. 10. Division of Cardiology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. 11. Pulmonary Hypertension Center, International University of Health and Welfare Mita Hospital, Tokyo, Japan. 12. Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan. 13. Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan. 14. IBD Center, Toho University Sakura Medical Center, Sakura, Japan. 15. 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.
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.
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.
Authors: Yang Qi-Yue; Zhang Ting; He Ya-Nan; Huang Sheng-Jie; Deng Xuan; Han Li; Xie Chun-Guang Journal: Chin Med Date: 2020-12-14 Impact factor: 5.455
Authors: Julie P Saiki; Johan Ol Andreasson; Kevin V Grimes; Lyn R Frumkin; Elvi Sanjines; Matthew G Davidson; K T Park; Berkeley Limketkai Journal: BMJ Open Gastroenterol Date: 2021-12