Short-term and long-term outcomes of indigo naturalis treatment for inflammatory bowel disease.


Journal

Journal of gastroenterology and hepatology
ISSN: 1440-1746
Titre abrégé: J Gastroenterol Hepatol
Pays: Australia
ID NLM: 8607909

Informations de publication

Date de publication:
Mar 2020
Historique:
received: 15 05 2019
revised: 24 07 2019
accepted: 03 08 2019
pubmed: 8 8 2019
medline: 15 9 2020
entrez: 8 8 2019
Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

BACKGROUND AND AIM OBJECTIVE
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 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 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 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.

Identifiants

pubmed: 31389626
doi: 10.1111/jgh.14823
doi:

Substances chimiques

Drugs, Chinese Herbal 0
Indigo Carmine D3741U8K7L

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

412-417

Informations de copyright

© 2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Références

Cosnes J, Gower-Rousseau C, Seksik P, Cortot A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology 2011; 140: 1785-1794.
Lichtenstein GR, Abreu MT, Cohen R, Tremaine W, American Gastroenterological A. American Gastroenterological Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology 2006; 130: 940-987.
Deng S, May BH, Zhang AL, Lu C, Xue CC. Plant extracts for the topical management of psoriasis: a systematic review and meta-analysis. Br. J. Dermatol. 2013; 169: 769-782.
Lin YK, See LC, Huang YH et al. Efficacy and safety of Indigo naturalis extract in oil (Lindioil) in treating nail psoriasis: a randomized, observer-blind, vehicle-controlled trial. Phytomedicine 2014; 21: 1015-1020.
Yuan G, Ke Q, Su X, Yang J, Xu X. Qing Dai, a traditional Chinese medicine for the treatment of chronic hemorrhagic radiation proctitis. The Chinese-German Journal of Clinical Oncology. 2009; 8: 114-116.
Han R. Highlight on the studies of anticancer drugs derived from plants in China. STEM CELL. 1994; 12: 53-63.
Xue-Liang Jiang H-FC. An analysis of 10218 ulcerative colitis cases in China. World J. Gastroenterol. 2002; 8: 158-161.
CHINESE COOPERATIVE GROUP FOR THE STUDY ON IBD CSOG. Consensus on the management of inflammatory bowel disease in China in 2007. J. Dig. Dis. 2008; 9: 52-62.
Suzuki H, Kaneko T, Mizokami Y et al. Therapeutic efficacy of the Qing Dai in patients with intractable ulcerative colitis. World J. Gastroenterol. 2013; 19: 2718-2722.
Sugimoto S, Naganuma M, Kiyohara H et al. Clinical efficacy and safety of oral Qing-Dai in patients with ulcerative colitis: a single-center open-label prospective study. Digestion 2016; 93: 193-201.
Naganuma M, Sugimoto S, Mitsuyama K et al. Efficacy of indigo naturalis in a multicenter randomized controlled trial of patients with ulcerative colitis. Gastroenterology 2018; 154: 935-947.
Nishio M, Hirooka K, Doi Y. Chinese herbal drug natural indigo may cause pulmonary artery hypertension. Eur. Heart J. 2016; 37: 1992.
Matsuno Y, Hirano A, Esaki M. Possible association of phlebitis-induced colitis with indigo naturalis. Gastroenterology 2018; 155: 576-577.
Yanai S, Nakamura S, Matsumoto T. Indigo naturalis-induced colitis. Dig. Endosc. 2018; 30: 791.
Kondo S, Araki T, Okita Y et al. Colitis with wall thickening and edematous changes during oral administration of the powdered form of Qing-dai in patients with ulcerative colitis: a report of two cases. Clin J Gastroenterol. 2018; 11: 268-272.
Matsuoka K, Kobayashi T, Ueno F et al. Evidence-based clinical practice guidelines for inflammatory bowel disease. J. Gastroenterol. 2018; 53: 305-353.
Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut 2006; 55: 749-753.
Rachmilewitz D. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. BMJ 1989; 298: 82-86.
William R, Best JMB, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index national cooperative Crohn's disease study. Gastroenterology 1976; 70: 439-444.
Suzuki H, Mizokami Y, Gosho M, Kaneko T, Matsui H, Yanaka A. Long-term maintenance effect of Qing Dai for ulcerative colitis. J. Altern. Complement. Med. 2018; 24: 1130-1131.
Adachi J, Mori Y, Matsui S et al. Indirubin and indigo are potent aryl hydrocarbon receptor ligands present in human urine. J. Biol. Chem. 2001; 276: 31475-31478.
Stockinger B, Di Meglio P, Gialitakis M, Duarte JH. The aryl hydrocarbon receptor: multitasking in the immune system. Annu. Rev. Immunol. 2014; 32: 403-432.
Qiu J, Guo X, Chen ZM et al. Group 3 innate lymphoid cells inhibit T-cell-mediated intestinal inflammation through aryl hydrocarbon receptor signaling and regulation of microflora. Immunity 2013; 39: 386-399.
Zelante T, Iannitti RG, Cunha C et al. Tryptophan catabolites from microbiota engage aryl hydrocarbon receptor and balance mucosal reactivity via interleukin-22. Immunity 2013; 39: 372-385.
Mizoguchi A, Yano A, Himuro H, Ezaki Y, Sadanaga T, Mizoguchi E. Clinical importance of IL-22 cascade in IBD. J. Gastroenterol. 2018; 53: 465-474.
Monteleone I, Rizzo A, Sarra M et al. Aryl hydrocarbon receptor-induced signals up-regulate IL-22 production and inhibit inflammation in the gastrointestinal tract. Gastroenterology 2011; 141: 237-248 48 e1.
Kawai S, Iijima H, Shinzaki S et al. Indigo Naturalis ameliorates murine dextran sodium sulfate-induced colitis via aryl hydrocarbon receptor activation. J. Gastroenterol. 2017; 52: 904-919.
Xue P, Fu J, Zhou Y. The aryl hydrocarbon receptor and tumor immunity. Front. Immunol. 2018; 9: 286.
Liu JZ, van Sommeren S, Huang H et al. Association analyses identify 38 susceptibility loci for inflammatory bowel disease and highlight shared genetic risk across populations. Nat. Genet. 2015; 47: 979-986.
Zhao Y, Ma T, Chen W et al. MicroRNA-124 promotes intestinal inflammation by targeting aryl hydrocarbon receptor in Crohn's disease. J. Crohns Colitis 2016; 10: 703-712.
Nishio M, Hirooka K, Doi Y. Pulmonary arterial hypertension associated with the Chinese herb indigo naturalis for ulcerative colitis: it may be reversible. Gastroenterology 2018; 155: 577-578.

Auteurs

Yuichi Matsuno (Y)

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Atsushi Hirano (A)

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Takehiro Torisu (T)

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Yasuharu Okamoto (Y)

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Yuta Fuyuno (Y)

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Shin Fujioka (S)

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Junji Umeno (J)

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Tomohiko Moriyama (T)

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Shuntaro Nagai (S)

Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Yoshifumi Hori (Y)

Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Minako Fujiwara (M)

Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Takanari Kitazono (T)

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

Motohiro Esaki (M)

Department of Endoscopic Diagnostics and Therapeutics, Saga University Hospital, Saga, Japan.

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