PMID- 35508956
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230916
IS  - 1598-9100 (Print)
IS  - 2288-1956 (Electronic)
IS  - 1598-9100 (Linking)
VI  - 20
IP  - 2
DP  - 2022 Apr
TI  - One-year clinical efficacy and safety of indigo naturalis for active ulcerative 
      colitis: a real-world prospective study.
PG  - 260-268
LID - 10.5217/ir.2021.00124 [doi]
AB  - BACKGROUND/AIMS: Recent 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. METHODS: Patients 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. RESULTS: Thirty-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. 
      CONCLUSIONS: One-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.
FAU - Matsuno, Yuichi
AU  - Matsuno Y
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
FAU - Torisu, Takehiro
AU  - Torisu T
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
FAU - Umeno, Junji
AU  - Umeno J
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
FAU - Shibata, Hiroki
AU  - Shibata H
AD  - Division of Genomics, Medical Institute of Bioregulation, Kyushu University, 
      Fukuoka, Japan.
FAU - Hirano, Atsushi
AU  - Hirano A
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
FAU - Fuyuno, Yuta
AU  - Fuyuno Y
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
FAU - Okamoto, Yasuharu
AU  - Okamoto Y
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
FAU - Fujioka, Shin
AU  - Fujioka S
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
FAU - Kawasaki, Keisuke
AU  - Kawasaki K
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
FAU - Moriyama, Tomohiko
AU  - Moriyama T
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
AD  - International Medical Department, Kyushu University Hospital, Fukuoka, Japan.
FAU - Nagasue, Tomohiro
AU  - Nagasue T
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
FAU - Zeze, Keizo
AU  - Zeze K
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
FAU - Hirakawa, Yoichiro
AU  - Hirakawa Y
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
AD  - Department of Epidemiology and Public Health, Graduate School of Medical 
      Sciences, Kyushu University, Fukuoka, Japan.
FAU - Kawatoko, Shinichiro
AU  - Kawatoko S
AD  - Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu 
      University, Fukuoka, Japan.
FAU - Koga, Yutaka
AU  - Koga Y
AD  - Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu 
      University, Fukuoka, Japan.
FAU - Oda, Yoshinao
AU  - Oda Y
AD  - Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu 
      University, Fukuoka, Japan.
FAU - Esaki, Motohiro
AU  - Esaki M
AD  - Division of Gastroenterology, Department of Internal Medicine, Saga University, 
      Saga, Japan.
FAU - Kitazono, Takanari
AU  - Kitazono T
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Fukuoka, Japan.
LA  - eng
PT  - Journal Article
DEP - 20220429
PL  - Korea (South)
TA  - Intest Res
JT  - Intestinal research
JID - 101572802
PMC - PMC9081999
OTO - NOTNLM
OT  - Colitis, ulcerative
OT  - Indigo naturalis
OT  - Maintenance therapy
OT  - Qing-Dai
COIS- Conflict of Interest No potential conflict of interest relevant to this article 
      was reported.
EDAT- 2022/05/06 06:00
MHDA- 2022/05/06 06:01
PMCR- 2022/04/01
CRDT- 2022/05/05 00:01
PHST- 2021/09/10 00:00 [received]
PHST- 2021/11/08 00:00 [accepted]
PHST- 2022/05/05 00:01 [entrez]
PHST- 2022/05/06 06:00 [pubmed]
PHST- 2022/05/06 06:01 [medline]
PHST- 2022/04/01 00:00 [pmc-release]
AID - ir.2021.00124 [pii]
AID - ir-2021-00124 [pii]
AID - 10.5217/ir.2021.00124 [doi]
PST - ppublish
SO  - Intest Res. 2022 Apr;20(2):260-268. doi: 10.5217/ir.2021.00124. Epub 2022 Apr 29.