Evidence map›Paper›PMID 35508956›Full record

ArticleIntestinal research2022

One-year clinical efficacy and safety of indigo naturalis for active ulcerative colitis: a real-world prospective study.

Yuichi Matsuno, Takehiro Torisu, Junji Umeno, Hiroki Shibata, Atsushi Hirano, Yuta Fuyuno, Yasuharu Okamoto, Shin Fujioka, Keisuke Kawasaki, Tomohiko Moriyama and 8 more

Abstract read
In one paragraph

Article in Intestinal research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
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.

Yuichi MatsunoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Takehiro TorisuDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Junji UmenoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Hiroki ShibataDivision of Genomics, Medical Institute of Bioregulation, Kyushu University, Fukuoka, Japan.
Atsushi HiranoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Yuta FuyunoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Yasuharu OkamotoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Shin FujiokaDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Keisuke KawasakiDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Tomohiko MoriyamaDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Tomohiro NagasueDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Keizo ZezeDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Yoichiro HirakawaDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Shinichiro KawatokoDepartment of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yutaka KogaDepartment of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yoshinao OdaDepartment of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Motohiro EsakiDivision of Gastroenterology, Department of Internal Medicine, Saga University, Saga, Japan.
Takanari KitazonoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsRecent studies suggested a favorable effect of indigo naturalis (IN) in inducing remission for refractory ulcerative colitis (UC), however, the maintenance effect of IN for patients with UC remains unknown. Therefore, we conducted a prospective uncontrolled open-label study to analyze the efficacy and safety of IN for patients with UC.

methodsPatients with moderate to severe active UC (clinical activity index [CAI] ≥ 8) took 2 g/day of IN for 52 weeks. CAI at weeks 0, 4, 8, and 52 and Mayo endoscopic subscore (MES) and Geboes score (GS) at weeks 0, 4, and 52 were assessed. Clinical remission (CAI ≤ 4), mucosal healing (MES ≤ 1), and histological healing (GS ≤ 1) rates at each assessment were evaluated. Overall adverse events (AEs) during study period were also evaluated. The impact of IN on mucosal microbial composition was assessed using 16S ribosomal RNA gene sequences.

resultsThirty-three patients were enrolled. The rates of clinical remission at weeks 4, 8, and 52 were 67%, 76%, and 73%, respectively. The rates of mucosal healing at weeks 4 and 52 were 48% and 70%, respectively. AEs occurred in 17 patients (51.5%) during follow-up. Four patients (12.1%) showed severe AEs, among whom 3 manifested acute colitis. No significant alteration in the mucosal microbial composition was observed with IN treatment.

conclusionsOne-year treatment of moderate to severe UC with IN was effective. IN might be a promising therapeutic option for maintaining remission in UC, although the relatively high rate of AEs should be considered.

Indexed as

Colitis, ulcerativeIndigo naturalisMaintenance therapyQing-Dai

Identifiers

PMID35508956
PMCPMC9081999

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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.