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

Chul Kim; Hyeun-kyoo Shin; Kim, Chul; Shin, Hyeun-kyoo

doi:10.13048/jkm.23041

JKM > Volume 44(3); 2023 > Article

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

Review Article

The Journal of Korean Medicine 2023; 44(3): 189-200.

Published online: September 1, 2023

DOI: https://doi.org/10.13048/jkm.23041

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

Chul Kim¹

, Hyeun-kyoo Shin²^{, *}

¹KM Data Division, Korea Institute of Oriental Medicine

²KM Science Research Division, Korea Institute of Oriental Medicine

Correspondence to: Hyeun-kyoo Shin, KM Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Daejeon 34054, Republic of Korea, Tel : +82-42-868-9464, E-mail : hkshin@kiom.re.kr

Received July 24, 2023 Revised August 20, 2023 Accepted August 22, 2023

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: national health insurance, traditional herbal medicine, stability, safety, effectiveness, evidence-based medicine

Fig. 1

Flowchart of the search selection process with 56 herbal medicine prescriptions

Fig. 2

Confidence in evidence for 56 herbal medicine prescriptions according to EBM pyramid

Table 1

Number of Studies on the Prescription of 56 Herbal Medicines and the Status of Insurance Benefit Cost

Prescriptions	Material analysis	Safety Evidence Study				Efficacy Evidence Study					Total	Rank

		Single dose toxicity	Repeated dose toxicity (W)	Genotoxicity	Cardiotoxic	In vitro	In vivo	Case report	Case control studies	RCT		Number of research	Benefit cost
1. Gamisoyo-san	1	1			1	10	13	6		1	33	6	11
2. Galgeun-tang	4	2	1 (13)		1	8	10	1			27	9	12
3. Galgeunhaegi-tang						4	3	3			10
4. Gumiganghwal-tang	2	3	2 (4/13)	1	1	4	6	1	1		21	14	4
5. Kungso-san						1	1	1			3
6. Gungha-tang	1				1	1	1				4		2
7. Naeso-san					1	3	4				8
8. Dangguiyeonkuo-eum						1	1				2
9. Dangguiyukhwang-tang						1	1				2
10. Daeshiho-tang	1				1	3	11	2		1	19	15
11. Daecheongryong-tang						3	3	2			8
12. Daewhajung-eum					1	1	3				5
13. Daewhangmokdanpi-tang						1	2				3
14. Doinseunggi-tang						4	5	1			10
15. Banhabaeckchulchunma-tang	1				1	2	5	6			15	18	10
16. Banhasasim-tang	3	1			1	4	20	5	1		35	5	3
17. Banhahubag-tang					1	2	8		1		12
18. Bakchul-tang						1	1				2
19. Bojungikgi-tang	4	4	2 (4/13)	1	1	16	41	12			81	1	5
20. Boheo-tang						2	6				8
21. Bokryungbosim-tang						1	1				2
22. Bulhwangeum jeonggi-san	2				1	1	3				7		19
23. Samso-eum		1			1	2	6				10		15
24. Samchulkunbi-tang	2				1	3	3	1			10
25. Samhojakyak-tang						1	1				2
26. Samhwangsasim-tang	1					4	14	2			21	13
27. Saengmaek-san	3				1	6	10	4		1	25	10
28. Sosiho-tang	3		2 (4/13)	1	1	2	24	10			43	4	17
29. Socheongyong-tang	2	2	2 (4/13)	1	1	10	18	6	3	3	48	3	9
30. Seungyangbowi-tang						1	1				32
31. Sikyungbanha-tang						3	1	1			36
32. Sihogyeji-tang						2	7	4			45
33. Sihosogan-tang						2	2				37
34. Sihochengan-tang						3	2				39
35. Antae-eum						2	1				38
36. Yeonkyopaedok-san	1	1				2	3			1	44		14
37. Orim-san						1	1	1			40
38. Ojeok-san	5	2	2 (4/13)	1	1	7	10	4			70	8	1
39. Yijung-tang	2	2			1	5	5	1			55	16
40. Yijin-tang	2	1			1	3	17				64	11	6
41. Ikwiseungyang-tang						2	3				46
42. Insampaedok-san	2	2			1	1	3				51
43. Injinho-tang		1				4	9	2			59	16
44. Jaeumganghwa-tang	3	1			1	3	5	1			58	19	20
45. Jowiseunggi-tang						1	1	1			48
46. Chungsanggyuntong-tang					1	3	4				54
47. Chungseoikgi-tang						2	2				51
48. Cheongwi-san						1	1				50
49. Palmul-tang	3	2	1 (4)		1	9	13	4			82	6	16
50. Pyungwi-san	5	2			1	3	10	1	1		73	12	8
51. Haengso-tang						4	2				57
52. Hyangsapyeongwi-san	1				1	3	5				62		7
53. Hyunggyeyungyo-tang	2		1 (4)	1	1	3	6				67	19	18
54. Hwanggeumjakyak-tang	1					3	2				60
55. Hwangryunheadok-tang	4	2	2 (4/13)	1	1	18	29	6		1	119	2	13
56. Hoechunyanggyeok-san						3	2				61

Total	61	30	15	7	28	196	372	89	7	8	813

Benefit cost: review records of benefit cost by 56 herbal medicines prescription, RCT: randomized clinical trial, W: week

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