Evidence map›Paper›PMID 31102012›Full record

ArticleJournal of gastroenterology2019

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

Makoto Naganuma, Shinya Sugimoto, Hideo Suzuki, Yuichi Matsuno, Toshimitsu Araki, Hirotaka Shimizu, Ryohei Hayashi, Tomohiro Fukuda, Nobuhiro Nakamoto, Hideki Iijima and 8 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Journal of gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
3.2field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 52 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 1 country.

Makoto NaganumaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. nagamakoto@keio.jp.ORCID http://orcid.org/0000-0002-4244-3243
Shinya SugimotoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Hideo SuzukiDepartment of Gastroenterology, Institute of Clinical Medicine, University of Tsukuba Graduate School, Ibaraki, Japan.
Yuichi MatsunoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Toshimitsu ArakiDepartment of Gastrointestinal and Pediatric Surgery, Mie University Graduate School of Medicine, Tsu, Japan.
Hirotaka ShimizuDivision of Gastroenterology, National Center for Child Health and Development, Tokyo, Japan.
Ryohei HayashiDepartment of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan.
Tomohiro FukudaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Nobuhiro NakamotoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Hideki IijimaDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan.
Shiro NakamuraDepartment of Intestinal Inflammation Research, Hyogo College of Medicine, Nishinomiya, Japan.
Masaharu KataokaDivision of Cardiology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Yuichi TamuraPulmonary Hypertension Center, International University of Health and Welfare Mita Hospital, Tokyo, Japan.
Koichiro TatsumiDepartment of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Toshifumi HibiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Yasuo SuzukiIBD Center, Toho University Sakura Medical Center, Sakura, Japan.
Takanori KanaiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. takagast@keio.jp.
INDIGO survey Group
Keio University · JPChiba University · JPHyogo Medical University · JPKyushu University · JPToho University · JPHiroshima University Hospital · JPMie University · JPUniversity of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough 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.

methodsA 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.

resultsAcross 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.

conclusionsIN-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.

Indexed as

AdultChemical and Drug Induced Liver InjuryColitis, UlcerativeDose-Response Relationship, DrugDrugs, Chinese HerbalFemaleGastrointestinal AgentsHealth SurveysHumansHypertension, PulmonaryIntussusceptionJapanMaleMiddle AgedDrugs, Chinese HerbalGastrointestinal AgentsQingdai compoundIndigo naturalisIntussusceptionLiver dysfunctionPulmonary arterial hypertensionUlcerative colitis

Identifiers

PMID31102012
OpenAlexW2946654151

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.