Safety and efficacy evaluation of Simo decoction and Arecae semen in herbal medicine practice
Jukai Huang,
Yalu Wen,
Tianyi Yang,
Haibo Song,
Ronald Meyboom,
Xiaohui Yang,
Lida Teng,
Pierre Duez,
Li Zhang
Affiliations
Jukai Huang
Department of Endocrinology, Beijing University of Chinese Medicine, Dongzhimen Hospital, PR China
Yalu Wen
Department of Endocrinology, Beijing University of Chinese Medicine, Dongzhimen Hospital, PR China; Department of Respiratory Medicine, Beijing Hepingli Hospital, PR China; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30329, United States; Center for Drug Reevaluation, National Medical Products Administration, Beijing, PR China; Department of Pharmacoepidemiology and Clinical Pharmacology, University of Utrecht, the Netherlands; Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan; Unit of Therapeutic Chemistry and Pharmacognosy, Université de Mons (UMONS), Mons, Belgium; Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, No. 6, District 1, Fangxingyuan, Fangzhuang, Fengtai District, Beijing, PR China
Tianyi Yang
Department of Endocrinology, Beijing University of Chinese Medicine, Dongzhimen Hospital, PR China; Department of Respiratory Medicine, Beijing Hepingli Hospital, PR China; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30329, United States; Center for Drug Reevaluation, National Medical Products Administration, Beijing, PR China; Department of Pharmacoepidemiology and Clinical Pharmacology, University of Utrecht, the Netherlands; Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan; Unit of Therapeutic Chemistry and Pharmacognosy, Université de Mons (UMONS), Mons, Belgium; Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, No. 6, District 1, Fangxingyuan, Fangzhuang, Fengtai District, Beijing, PR China
Haibo Song
Center for Drug Reevaluation, National Medical Products Administration, Beijing, PR China
Ronald Meyboom
Department of Pharmacoepidemiology and Clinical Pharmacology, University of Utrecht, the Netherlands
Xiaohui Yang
Department of Endocrinology, Beijing University of Chinese Medicine, Dongzhimen Hospital, PR China
Lida Teng
Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan
Pierre Duez
Unit of Therapeutic Chemistry and Pharmacognosy, Université de Mons (UMONS), Mons, Belgium
Li Zhang
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, No. 6, District 1, Fangxingyuan, Fangzhuang, Fengtai District, Beijing, PR China; Corresponding author. Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, No. 6, District 1, Fangxingyuan, Fangzhuang, Fengtai District, Beijing, PR China.
Objective: The traditional Chinese patent medicine (TCPM), Simo decoction (Simo decoction oral solution), with its primary ingredient Arecae semen (Binglang, Areca catechu L.), known for its potential carcinogenic effects, is the subject of this study. The research aims to analyze the effectiveness and potential risks of Simo decoction, particularly as a carcinogen, and to suggest a framework for evaluating the risks and benefits of other herbal medicines. Methods: The study is based on post-marketing research of Simo decoction and Arecae semen. It utilized a wide range of sources, including ancient and modern literature, focusing on the efficacy and safety of Simo decoction. The research includes retrospective data on the sources, varieties, and toxicological studies of Arecae semen from databases such as Pubmed, Clinical Trials, Chinese Clinical Trial Registry, China National Knowledge Infrastructure, WHO-UMC Vigibase, and China National Center for ADR Monitoring. Results: Common adverse drug reactions (ADRs) associated with Simo decoction include skin rash, nausea, vomiting, abdominal pain, and diarrhea. However, no studies exist reporting the severe ADRs, such as carcinogenic effects. Arecae semen is distributed across approximately 60 varieties in tropical Asia and Australia. According to the WHO-UMC Vigibase and the National Adverse Drug Reaction Monitoring System databases, there are currently no reports of toxicity related to Arecae semen in the International System for Classification of ADRs (ISCR) or clinical studies. Conclusion: Risk-benefit analysis in TCPM presents more challenges compared to conventional drugs. The development of a practical pharmacovigilance system and risk-benefit analysis framework is crucial for marketing authorization holders, researchers, and regulatory bodies. This approach is vital for scientific supervision and ensuring the safety and efficacy of drug applications, thus protecting public health.
