The Journal of Korean Medicine (대한한의학회지)

The Society of Korean Medicine (대한한의학회)
권호 표지
DOI QR코드

DOI QR Code

Analysis of the current status of quantitative literature evidence for the prescription of 56 herbal medicines covered by health insurance

건강보험 급여 한약제제 56종 처방의 계량적 문헌 근거 현황 분석

  • Chul Kim (KM Data Division, Korea Institute of Oriental Medicine) ;
  • Hyeun-kyoo Shin (KM Science Research Division, Korea Institute of Oriental Medicine)
  • 김철 (한국한의학연구원 한의약데이터부) ;
  • 신현규 (한국한의학연구원 한의과학연구부)
  • Received : 2023.07.24
  • Accepted : 2023.08.22
  • Published : 2023.09.01
Download PDF
⟨ Previous Next ⟩

Abstract

Objectives: The purpose of this study is to analyze the current state of quantitative literature evidence for the prescription of 56 herbal medicines covered by health insurance that have been studied in Korea for the past 30 years, to evaluate the reliability of the evidence, and to find out the research direction of herbal medicine prescription in the future. Methods: 56 kinds of herbal medicine prescriptions were searched in domestic literature search databases OASIS, DBpia, and overseas PubMed, classified into chemistry, toxicity, cells, animals, clinical cases, and clinical trial studies, and built into an EBM pyramid structure. Results: When classified according to research contents, there were 61 cases (7.5%) of physicochemical analysis to identify constituent substances, 80 cases (9.8%) of toxicity evaluation, and 672 cases (82.7%) of efficacy evaluation. The efficacy evidence was classified according to the evidence-based medical pyramid structure: 196 cell trials (29.1%), 372 animal trials (55.4%), 89 case and case reporting series (13.3%), 7 comparative case studies (1.1%), and 8 randomized control clinical trials (1.2%). In the pyramid composition, the basis for the validity of 56 kinds of herbal medicines prescribed was 568 cases (84.5%) in cell and animal units, which could not be said to be highly reliable. There was no relationship between the ranking of quantitative literature evidence for herbal medicine prescriptions and the ranking of salary administration. Conclusions: In an era that continues to require scientific evidence for herbal medicine, traditional herbal medicine should secure the basis for safety validity even for the 10th most frequent prescription among 56 herbal medicine prescriptions for consumers. In particular, traditional herbal medicine should increase the quantitative and qualitative level of case reports on related herbal medicine prescriptions, focusing on each clinical society, and move toward comparative case studies and randomized clinical trial so that traditional herbal medicine is positioned as Evidence-based medicine.

Keywords

Acknowledgement

본 연구는 한국한의학연구원의 '한방의료기관 한약처방 안전성·유효성 구축 사업 (KSN1823310, KSN1823311)' 에서 연구비를 지원 받아 진행되었습니다.

References

  1. Jeong, W. S., Shin, W. C., Hong, I. H., Choi, J. U., & Kim, Y. Kyung. (2017). A survey on additional needs for herbal preparations in national health insurance service. Herbal Formula Science, 25(3), 1229-1218. 
  2. Ministry of Health and Welfare. (2023). Matters concerning the application standards and methods of medical care benefits.
  3. Ministry of Health and Welfare. (2023). List of benefits for herbal medicine preparations and maximum amount table (No 2023-95). 
  4. Ministry of Food and Drug Safety. (2022). Korean Pharmacopoeia and traditional herbal medicine (herbal medicine) specification book (Ministry of Food and Drug Safety (No 2022-12) 
  5. The Minjok medicine news. Insured traditional herbal medicine with no product change for over 30 years [cited 2023 Jun 1]; [1 screens]. Available from: URL:http://www.mjmedi.com/news/articleView.html?idxno=54135 
  6. Joo Y. J., Kim, J. C., Lee, E. K., Jang, B. H., Park, S. A., Park, J. S., et al. (2018). Survey on the Korean Medicine Doctor's Awareness of the Extension and Activation of Herbal Medicine Preparations Insurance Benefits. Journal of Society of Preventive Korean Medicine, 22(3), 31-44. https://doi.org/10.25153/spkom.2018.22.3.004 
  7. Daily pharm. Compared to Ojeog-san extracts and decoctions, the content is lower and there is a difference between products [cited 2023 Jun 1]; [1 screens]. Available from: URL:http://www.dailypharm.com/News/235942 
  8. Ministry of Health and Welfare. (2022). PHARMACEUTICAL AFFAIRS ACT. (Act No.18307, 20. Jul, 2021). 
  9. Ministry of Food and Drug Safety. (2021). Regulations on notification of product approval for traditional herbal medicine & herbal medicine preparations etc (No. 2021-38). 
  10. Han, S. S., Koo, C., M, Hong, K. E., Park, Y. C., & Choi, S. M. (2006). The Problem and Improvement Plan on Acupuncture Treatment in Clinical Trial Based on EBM. Journal of Acupuncture Research, 23(6), 1229-1137. 
  11. Yun, Y.J., Lee, J.M., Lee, C.H., Cho, J. H., Jang, J. B., & Lee, K. S. (2011). Analytic Study on Treatises of the Journal of Oriental Obstetrics & Gynecology. The Society of Korean Medicine Obstetrics and Gynecology, 24(2), 97-103. 
  12. Korea Institute of Oriental Medicine. 2021 Yearbook of traditional Korean medicine. 2023. 1-488. 
  13. Kim, S. J., Seo, Y. H., Lee, H. S., Chang, H. K., Cho, J. H., Kim, K. W., et al. (2020). Research Trends of Herbal Medicines for Obesity: Mainly since 2015 to 2019. Journal of Korean Medicine Rehabilitation, 30(4), 89-103. https://doi.org/10.18325/jkmr.2020.30.4.89 
  14. Kim, M. K., & Han, C. H. (2023). Effects of Bojungikgi-tang and its modifications for Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. The Journal of Korean Medicine, 44(2), 181-200.  https://doi.org/10.13048/jkm.23024
  15. Yang, D. H., Park, J. K., Sung, H. K., & Sung, S. H. (2018). Trend Analysis of Clinical Studies Published in the Journal of Pediatrics of Korean Medicine. The Journal of Pediatrics of Korean Medicine, 32(4), 141-162.  https://doi.org/10.7778/JPKM.2018.32.4.141
  16. Kim, O. S., Seo, C. S., & Shin, H. K. (2013). Simultaneous Determination of Gumiganghwal-tang and Its Anti-atherosclerotic Effect. Journal of Society of Preventive Korean Medicine, 17(3), 165-176. 
  17. Ministry of Food and Drug Safety. pharmaceutical safety information system 'Pharmaceutical Safety Nara', (https://nedrug.mfds.go.kr/index) 
  18. Choi, M. K., Kim, H. G., Wang, J. H., & Son C. G. (2011). The Application of High Performance Thin Layer Chromatography for Herbal Formula Standardization. The Journal of Korean Medicine, 32(4), 68-74. 
  19. Cheon, C. H., Park, J. S., Park, S. J., Kweon, K. T., Shin, Y. C., & Ko, S. K. (2011). Necessity of Adverse Event Reporting System through the Trend of Internet News about Safety of Herbal Medicine. The Journal of Oriental Medical Preventive, 15(2), 131-143. 
  20. Ministry of Food and Drug Safety. (2022). Toxicity test standards for pharmaceuticals etc (No.2022-18). 
  21. National Institute of Food and Drug Safety Evaluation. (2021). Toxicity test method guideline for foods, etc. -Single dose toxicity test method. 1-51. 
  22. Chloros, G. D., Prodromidis, A. D., & Giannoudis, P. V. (2023). Has anything changed in Evidence-Based Medicine?. Injury, 54, 20-25. https://doi.org/10.1016/j.injury.2022.04.012 
  23. Lim, H. S., Kim, Y. J., Kim, Y. J., Kim, B. Y., & Jeong, S. J. (2018). Screening of 56 Herbal formulas covered by the National Health Insurance Service on Dementia-related Factors. Journal of Korean Medicine, 39(3), 1-16. https://doi.org/10.13048/jkm.18020 
  24. Ko, S. K. (2003). Safety and efficacy of Korean medicine and therapeutics. Korean J. Orient. Int. Med, 24(3), 531-542. 
  25. Yang, H. J., Kim, S. J., & Chu, H. M. (2022). A Case Report of Chronic Urticaria Improved with Korean Medicine Treatment. Journal of Korean Medical Society of Acupotomology, 6(2), 166-169. https://doi.org/10.54461/jkmst.2022.6.2.166 
  26. Nam, H. I., Kim, D. W., Park, Y. C., Lee, J. E., Han, Y. J., Lim D. H, et al. (2005). Thle Chronic Perennial Allergic Rhinitis Sutterers Evaluated through the Eosinophil and Subject Symptom Numerical Index and Treated with Bojungiki-Tang. The Journal of Korean Oriental Internal Medicine, 26(2), 467-474. 
  27. Yoon, J. H., Park, S. B., Kim, E. H., Lee, J. Y., & Yoon, S. W. (2022). A Case Report on Opioid-Induced Constipation in a Patient with Cancer Treated by Jowiseunggi-tang. The Journal of Internal Korean Medicine, 43(2), 229-236. https://doi.org/10.22246/jikm.2022.43.2.229\ 229-236.
  28. Choi, S. Y. (2020). Evaluation of the Quality of Case Reports from the Journal of Korean Medicine Based on the CARE Guidelines. Journal of Korean Medicine, 41(2), 122-136. https://doi.org/10.13048/jkm.20019 
  29. Jung, J. H., Choi, C. M., Hong, J. W., Kim, T. H., Rhe, J. W., Lee, C. R., et al. (2005). Effects of Banhahubak-tang (Banxiahoupotang) on patients with poststroke depression. The Journal of Korean Oriental Internal Medicine, 26(3), 563-574. 
  30. Hwang, W. S., Chung, K. J., Ju, C. Y., Hong, J. P., Lee, J. S., Jeong, H. J., et al. (2002). The Clinical Effects of Socheongryong-tang in Asthmatic Patients. The Journal of Korean Oriental Internal Medicine, 23(4), 651-660. 
  31. Jeong, S. K., Heo, T. S., Hwang, W. S., Joo, C. Y., Kim, Y. W., & Jeong, H. J. (2002). The Effects of Sochongryong-tang on Serum IL-4, IL-5 and IFN-γ in Asthmatic Patients. Journal of Korean Medicine, 23(2), 258-265. 
  32. Jung, H. J., Ju, C. Y., Lee, J S., Lee, K. K., Rhee, H. K., Jung S. K., et al. (2002). A Study on Changes in Blood Eosinophil, Serum IgE and T Lympocyte Subpopulation after Sochongryongtang to Asthmatic Patients. The Journal of Korean Oriental Internal Medicine, 23(1), 83-89. 
  33. Oh, S. H., Lee, M. S., Jeong, W. N., No, J. W., An, Y. M., An, S. Y., et al. (2022). A Retrospective Study of the Effectiveness and Safety of Banhasasim-tang, Gumiganghwal-tang, or Pyeongwee-san in Patients with Type 2 Diabetes Mellitus. The Journal of Korean Oriental Internal Medicine, 43(3), 363-374. https://doi.org/10.22246/jikm.2022.43.3.363 
  34. Oh, R. Y., Seol, I. C., & Son, C G. (2010). Randomized Clinical Controlled Trials of a Herb Remedies in Korea - Systematic Review. Journal of Korean Medicine, 31(4), 1-8. 
  35. Park, D. M., Kim, S. H., Park, Y. C., Kang, W. C., Lee, S. R., & Jung, I. C. (2014). The comparative clinical study of efficacy of Gamisoyo-San (Jiaweixiaoyaosan) on generalized anxiety disorder according to differently manufactured preparations: Multicenter, randomized, double blind, placebo controlled trial. Journal of Ethnopharmacology, 158, 11-17. https://doi.org/10.1016/j.jep.2014.10.024 
  36. Lee, D. H., Han, H. J., Kim, L. H., Kang, S. Y., & Jang I. S. (2011). Effect of Saengmaeg-san Extract on Xerostomia in Stroke Patients: A Double-Blind Randomized Controlled Study. The Journal of Internal Korean Medicine, 32(4), 542-549. 
  37. Park, Y. C. (2005). Effect of Socheongryong-tang on Punghan and Pungyeol Type Common Cold: A Double Blind, Placebo Controlled Study. Journal of Physiology & Pathology in Korean Medicine, 19(2), 524-529. 
  38. Bae, H. H., Kang, W. C., & Park, Y. C. (2008). Effectiveness of a Yeonkyopaedok-san Extract in the Treatment of The Common Cold: Results of a Community-based, Double Blind, Randomized Placebo Controlled Trial. Journal of Physiology & Pathology in Korean Medicine, 22(1), 234-245. 
  39. Byun, J. S., Yang, S. Y., Jeong, I. C., Hong, K. E., Kang, W., Yeo, Y., et al. (2011). Effects of So-cheong-ryong-tang and Yeon-gyopae -dok-san on the common cold: randomized, double blind, placebo controlled trial. Journal of Ethnopharmacology, 133, 642-646. https://doi.org/10.1016/j.jep.2010.10.056 
  40. Choi, Y. J., & Cho, S. H. (2018). Role of the Baseline Heart Rate Variability to the Effect of the Huanglian-Jie-Du Granule in Hwa-Byung Patients - Supplementary Analysis from the Randomized Trial Comparing Huanglian-Jie-Du Granule and Placebo for Hwa-Byung. The Korean journal of stress research, 26(4), 305-311. https://doi.org/10.17547/kjsr.2018.26.4.305