ArticleEvidence-based complementary and alternative medicine : eCAM2019
Adverse Events Associated with Ethical Kampo Formulations: Analysis of the Domestic Adverse-Event Data Reports of the Ministry of Health, Labor, and Welfare in Japan.
Article in Evidence-based complementary and alternative medicine : eCAM, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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The trial behind it
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Who cites it
21 citing papers in PubMed, 32 citations in OpenAlex.
- Effects of Bojungikki-Tang on immune response and clinical outcomes in NSCLC patients receiving immune checkpoint inhibitors: a randomized pilot study.BMC cancer · 2025Trial
- Ninjin'yoeito improves respiratory symptoms after lung cancer surgery: a prospective randomized study.Surgery today · 2025Trial
- Drug-induced Pleuritis Associated with Hachimijiogan.Internal medicine (Tokyo, Japan) · 2026Article
- Clinical risk factors of licorice-induced pseudohyperaldosteronism: a 2026-updated narrative review.Frontiers in pharmacology · 2026Review
- Trends in Kampo Medicine Usage as Supportive Care During Anticancer Drug Treatment in Japanese Patients: A Nationwide Cohort Analysis from Fiscal Years 2015 to 2021.Current oncology (Toronto, Ont.) · 2025Article
- Effectiveness of Japanese traditional medicine (Kamikihito and Saikokeishito) for treating long COVID: a prospective observational study.Frontiers in medicine · 2025Article
- Organizing Pneumonia With Diffuse Alveolar Hemorrhage Induced by the Kampo Medicine Choreito.Journal of medical cases · 2024Article
- Analysis of drug-induced interstitial lung disease caused by herbal medicine using the Japanese Adverse Drug Event Report database.BMC complementary medicine and therapies · 2024Article
- Hangeshashinto-Associated Mesenteric Phlebosclerosis and Highly Atypical Adenoma Requiring Laparoscopic Right Hemicolectomy.Diagnostics (Basel, Switzerland) · 2024Article
- Article
- Efficacy of combination therapy with unkeito and boiogito for menopausal arthralgia: A retrospective observational study.Journal of family medicine and primary care · 2024Article
- Adverse events associated with herbal medicine products reported in the Korea Adverse Event Reporting System from 2012 to 2021.Frontiers in pharmacology · 2024Article
- Safety and Efficacy ofInternational journal of environmental research and public health · 2023Article
- Severe hypokalemia in the emergency department: A retrospective, single-center study.Health science reports · 2022Article
- Adverse Effects of Kampo Medicines.Internal medicine (Tokyo, Japan) · 2022Review
- Utility of Basophil Activation Test in a Case of Daisaikoto- and Yokukansan-induced Lung Injury.Internal medicine (Tokyo, Japan) · 2021Article
- The use of Kampo medications that may cause heart failure in hospitalized acute heart failure patients in a Japanese hospital.Journal of general and family medicine · 2021Article
- Idiopathic mesenteric phlebosclerosis: one case report and systematic literature review of 240 cases.American journal of translational research · 2021Article
- The effect of Hangeshashinto on Oral Mucositis Caused by Induction Chemotherapy in Patients with Head and Neck Cancer.Yonago acta medica · 2020Article
- Kampo for the Treatment of Pain in Japan: A Review.Pain and therapy · 2020Review
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTraditional Japanese Kampo medicines have been integrated into the Japanese national health-care system. In Japan, the Ministry of Health, Labor, and Welfare's website discloses adverse drug-event data that have been obtained from medical personnel reports investigated by the Pharmaceutical and Medical Devices Agency. Using these data, we investigated adverse events associated with ethical Kampo formulations.
methodsReports of adverse events associated with ethical Kampo formulations from the domestic adverse-event data were obtained from July 30, 2003, to March 31, 2018. Adverse events were then categorized, and the relationships between categories of adverse events and crude drugs were analyzed.
resultsThere were 4,232 reported adverse events associated with ethical Kampo formulations. The numbers of events by category were as follows: events related to liver injury, 1,193; lung injury, 1,177; pseudoaldosteronism, 889; mesenteric phlebosclerosis, 223; drug eruption, 185; and others, 565. Among events related to both liver injury and lung injury, approximately 70% were suspected to be induced by Kampo formulations containing Scutellariae Radix. The pseudoaldosteronism-related events, which are induced by Glycyrrhizae Radix, included several events related to muscle injury, heart failure, and arrhythmia. Events related to mesenteric phlebosclerosis, believed to be induced by long-term use of Kampo formulas containing Gardeniae Fructus, increased remarkably during the study period. Among the events related to drug eruption, approximately 35% were suspected to be induced by Kampo formulations containing Ephedrae Herba.
conclusionKampo medicines may cause various adverse events. The present results provide valuable information regarding adverse events associated with Kampo medicines from the viewpoint of patient safety.
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Registered trials
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.