Evidence map›Paper›PMID 38486172›Full record

ArticleBMC complementary medicine and therapies2024

Analysis of drug-induced interstitial lung disease caused by herbal medicine using the Japanese Adverse Drug Event Report database.

Keita Oura, Mizuki Tanaka, Kiyoka Matsumoto, Riko Satake, Misaki Inoue, Yu Yoshida, Wataru Wakabayashi, Shiori Hasegawa, Mari Iwata, Takaaki Suzuki and 5 more

Abstract read
In one paragraph

Article in BMC complementary medicine and therapies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

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

  1. Pooled it
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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

15 authors.

Keita OuraLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Mizuki TanakaLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Kiyoka MatsumotoLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Riko SatakeLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Misaki InoueLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Yu YoshidaLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Wataru WakabayashiLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Shiori HasegawaLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Mari IwataLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Takaaki SuzukiLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Mika MaezawaLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Satoshi NakaoLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan.
Jun LiaoDepartment of Information Science and Information System, China Pharmaceutical University, Nanjing, China.
Kazuhiro IguchiLaboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, Japan.
Mitsuhiro NakamuraLaboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-Nishi, Gifu, 501-1196, Japan. mnakamura@gifu-pu.ac.jp.

Funding

Japan Society for the Promotion of Science 21K06646
6 · The paper itself

Abstract

backgroundDrug-induced interstitial lung disease (DIILD) is a severe adverse event leading to morbidity and mortality. This study evaluated the adverse event indicators of DIILD and time-to-onset profiles following the daily intake of herbal drugs (Scutellariae radix ["ogon" in Japanese], Bupleuri radix ["saiko" in Japanese], and Pinelliae tuber ["hange" in Japanese]) using the Japanese Adverse Drug Event Report database. DIILD was defined in accordance with the Medical Dictionary for Regulatory Activities.

methodsThe Japanese Adverse Drug Event Report database contained 830,079 reports published between April 2004 and April 2023. The association between herbal medicines and DILLD was evaluated using the pharmacovigilance index as the reporting odds ratio (ROR), logistic regression models, propensity score-matching techniques, and Weibull shape parameters.

resultsThe adjusted RORs using multivariate logistic regression models for Scutellariae radix (daily intake), Pinelliae tuber (daily intake), sex (male), age (≥ 60 years), Scutellariae radix (daily intake)*age (≥ 60 years), and Scutellariae radix (daily intake)* Pinelliae tuber (daily intake) were 1.47 (1.36 - 1.59), 1.05 (1.01 - 1.10), 1.45 (1.34 - 1.57), 1.92 (1.74 - 2.11), 3.35 (3.12 - 3.60), and 1.49 (1.46 - 1.53), respectively. DIILD onset profiles were evaluated using the Weibull shape parameter. A logistic plot of daily intake and onset of DIILD was drawn. ROR signals were detected in 32 of 54 herbal medicines, including Scutellariae radix, Bupleuri radix, and Pinelliae tuber. The median duration (days) (interquartile range) to DIILD onset was 36.0 (27.0-63.0) for Saikokaryukotsuboreito, 35.0 (21.0-55.0) for Saireito, and 31.0 (13.5-67.5) for Shosaikoto. The Weibull shape parameter beta (95% confidence interval) values for Saikokaryukotsuboreito, Saireito, and Shosaikoto were 1.36 (1.08-1.67), 1.36 (1.20-1.52), and 1.31 (0.98-1.68), respectively.

conclusionsDIILD demonstrated a dose-dependent to crude drugs. Clinicians should strive for the early detection of DIILD and avoid the inadvertent administration of herbal medicines.

Indexed as

Drug-Related Side Effects and Adverse ReactionsLung Diseases, InterstitialPlants, MedicinalFemaleHumansJapanMaleMiddle AgedDrug-induced interstitial lung diseaseHerbal medicineJADERJapanese Adverse Drug Event Report databaseScutellariae radix

Identifiers

PMID38486172
PMCPMC10938654

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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.