PMID- 31389626 OWN - NLM STAT- MEDLINE DCOM- 20200914 LR - 20200914 IS - 1440-1746 (Electronic) IS - 0815-9319 (Linking) VI - 35 IP - 3 DP - 2020 Mar TI - Short-term and long-term outcomes of indigo naturalis treatment for inflammatory bowel disease. PG - 412-417 LID - 10.1111/jgh.14823 [doi] AB - BACKGROUND AND AIM: Indigo naturalis (IN) is a traditional Chinese herbal medicine reported to be effective in inducing remission in ulcerative colitis (UC). We conducted a retrospective observational study to investigate the efficacy and safety of IN for induction and maintenance therapy in patients with inflammatory bowel disease. METHODS: Data were collected from the electric medical records of patients with inflammatory bowel disease who had started IN treatment between March 2015 and April 2017 at Kyushu University Hospital. Clinical response and remission rates were assessed based on the clinical activity index determined by Rachmilewitz index or Crohn's disease (CD) activity index. Cumulative IN continuation rates were estimated using the Kaplan-Meier method. Overall adverse events (AEs) during follow-up were also analyzed. RESULTS: Seventeen UC patients and eight CD patients were enrolled. Clinical response and remission rates at week 8 were 94.1% and 88.2% in UC patients and 37.5% and 25.0% in CD patients, respectively. Clinical remission rates, as assessed through non-responders imputation analyses at weeks 52 and 104, were 76.4% and 70.4% in UC patients and 25.0% and 25.0% in CD patients, respectively. Ten patients (40%) experienced AEs during follow-up. Three patients (12%) experienced severe AEs, including acute colitis requiring hospitalization in two patients and acute colitis with intussusception requiring surgery in one patient. CONCLUSIONS: Indigo naturalis showed favorable therapeutic efficacy in UC, whereas its therapeutic efficacy in CD appeared to be modest. The risk of severe AEs should be recognized for IN treatment. CI - (c) 2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd. FAU - Matsuno, Yuichi AU - Matsuno Y AUID- ORCID: 0000-0002-1973-2573 AD - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Hirano, Atsushi AU - Hirano A AUID- ORCID: 0000-0002-4791-4550 AD - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Torisu, Takehiro AU - Torisu T AD - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Okamoto, Yasuharu AU - Okamoto Y AD - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Fuyuno, Yuta AU - Fuyuno Y AD - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Fujioka, Shin AU - Fujioka S AD - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Umeno, Junji AU - Umeno J AD - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Moriyama, Tomohiko AU - Moriyama T AD - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Nagai, Shuntaro AU - Nagai S AD - Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Hori, Yoshifumi AU - Hori Y AD - Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Fujiwara, Minako AU - Fujiwara M AD - Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Kitazono, Takanari AU - Kitazono T AD - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Esaki, Motohiro AU - Esaki M AD - Department of Endoscopic Diagnostics and Therapeutics, Saga University Hospital, Saga, Japan. LA - eng PT - Journal Article DEP - 20190826 PL - Australia TA - J Gastroenterol Hepatol JT - Journal of gastroenterology and hepatology JID - 8607909 RN - 0 (Drugs, Chinese Herbal) RN - D3741U8K7L (Indigo Carmine) SB - IM MH - Adult MH - Drugs, Chinese Herbal/adverse effects/*therapeutic use MH - Female MH - Follow-Up Studies MH - Humans MH - Indigo Carmine/*chemistry MH - Inflammatory Bowel Diseases/*drug therapy/mortality MH - Maintenance Chemotherapy MH - Male MH - *Phytotherapy MH - Remission Induction MH - Survival Rate MH - Time Factors MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Crohn's disease OT - Qing-Dai OT - indigo naturalis OT - inflammatory bowel disease OT - ulcerative colitis EDAT- 2019/08/08 06:00 MHDA- 2020/09/15 06:00 CRDT- 2019/08/08 06:00 PHST- 2019/05/15 00:00 [received] PHST- 2019/07/24 00:00 [revised] PHST- 2019/08/03 00:00 [accepted] PHST- 2019/08/08 06:00 [pubmed] PHST- 2020/09/15 06:00 [medline] PHST- 2019/08/08 06:00 [entrez] AID - 10.1111/jgh.14823 [doi] PST - ppublish SO - J Gastroenterol Hepatol. 2020 Mar;35(3):412-417. doi: 10.1111/jgh.14823. Epub 2019 Aug 26.