Evidence map›Paper›PMID 36271126›Full record

ArticleScientific reports2022

Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database.

Kaito Yamashiro, Mika Jouta, Kouichi Hosomi, Satoshi Yokoyama, Yuu Ozaki, Atsushi Hirata, Fumihiko Ogata, Takehiro Nakamura, Shigeharu Tanei, Naohito Kawasaki

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
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

10 authors at 2 institutions in 1 country.

Kaito YamashiroLaboratory of Public Health, Faculty of Pharmacy, Kindai University, 3-4-1, Kowakae, Higashi-Osaka, Osaka, 577-8502, Japan.
Mika JoutaDepartment of Pharmacy, Kindai University Nara Hospital, 1248-1, Otodacho, Ikoma, Nara, 630-0293, Japan.
Kouichi HosomiDivision of Drug Informatics, Faculty of Pharmacy, Kindai University, 3-4-1 Kowakae, Higashi-Osaka, Osaka, 577-8502, Japan.
Satoshi YokoyamaDivision of Drug Informatics, Faculty of Pharmacy, Kindai University, 3-4-1 Kowakae, Higashi-Osaka, Osaka, 577-8502, Japan.
Yuu OzakiDepartment of Pharmacy, Kindai University Nara Hospital, 1248-1, Otodacho, Ikoma, Nara, 630-0293, Japan.
Atsushi HirataDepartment of Pharmacy, Kindai University Nara Hospital, 1248-1, Otodacho, Ikoma, Nara, 630-0293, Japan.
Fumihiko OgataLaboratory of Public Health, Faculty of Pharmacy, Kindai University, 3-4-1, Kowakae, Higashi-Osaka, Osaka, 577-8502, Japan.
Takehiro NakamuraLaboratory of Public Health, Faculty of Pharmacy, Kindai University, 3-4-1, Kowakae, Higashi-Osaka, Osaka, 577-8502, Japan.
Shigeharu TaneiFaculty of Pharmaceutical Sciences, Nihon Pharmaceutical University, 10281 Komuro, Ina-Machi, Kitaadachi-Gun, Saitama, 362-0806, Japan.
Naohito KawasakiLaboratory of Public Health, Faculty of Pharmacy, Kindai University, 3-4-1, Kowakae, Higashi-Osaka, Osaka, 577-8502, Japan. Kawasaki@phar.kindai.ac.jp.
Kindai University · JPNihon Pharmaceutical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Microscopic colitis (MC) is a chronic inflammatory bowel disease that is characterized by nonbloody watery diarrhea. The epidemiology in Japan differs from that in Europe and the United States, but little information is available from epidemiological surveys of MC in Japan. This study aimed to provide a new hypothesis regarding the factors associated with MC by using the Japanese Adverse Drug Event Report (JADER) database. "Colitis microscopic" (preferred term code: 10056979) cases entered into the JADER database between 2004 and 2021 were analyzed. Of the 246,997 cases in the JADER database, 161 cases were observed to be associated with MC. A Weibull analysis revealed that the median onset duration of MC (interquartile range) was 72.5 (36.0‒125.5) days in lansoprazole users and 116.0 (60.3‒1089.0) days in aspirin users. A multiple logistic regression analysis revealed that MC was significantly associated with the female sex, as well as ages ≥ 60 years and drugs including lansoprazole, aspirin, and nicorandil. A subset analysis revealed that MC was positively associated with obesity in female cases. Our study cannot demonstrate a causal inference between MC and each drug; however, the findings suggest that MC was associated with nicorandil as well as with lansoprazole and aspirin.

Indexed as

Colitis, MicroscopicDrug-Related Side Effects and Adverse ReactionsAdverse Drug Reaction Reporting SystemsAspirinFemaleHumansJapanLansoprazoleMiddle AgedNicorandilUnited StatesAspirinLansoprazoleNicorandil

Identifiers

PMID36271126
PMCPMC9587040
OpenAlexW4307047871

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.