Clinical Research in Eight Constitution Medicine: A Scoping Review of Current Evidence

Abstract

Introduction:

Understanding human differences is essential for managing chronic diseases. To establish robust evidence for Eight Constitution Medicine (ECM), a Korean personalized medical system, it is necessary to identify the status of clinical research in ECM and develop validated measurements. This study aims to confirm the types of clinical research on ECM and how they have been conducted.

Methods:

A scoping review covered three international databases (PubMed, Embase, and Cochrane) and five domestic electronic databases (DataBase Periodical Information Academic, Research Information Sharing Service, Korean Studies Information Service System, National Digital Science Library, and Oriental Medicine Advanced Searching for Integrated System), using strategies such as reference searches and gray literature searches. Mapping was attempted, and subcategories were established, synthesized, and presented in tables. All relevant content in Korean and English was considered, excluding theses, dissertations, and editorials.

Results:

Sixty ECM studies were selected. There were 47 (78.3%) original studies, of which 39 (65.0%) were observational and eight (13.3%) were experimental. There were six eight constitution diet (ECD)-related studies (12.8%), much less than the 15 (31.9%) eight constitution acupuncture (ECA)-related studies. Original studies that measured the effectiveness of ECM used various methods of exposure/intervention and outcome measurement tools.

Conclusions:

The original research evidence for ECM mainly came from observational studies on ECA and eight constitution diagnosis. Active clinical research related to ECD and a tool that effectively measures adherence and target diseases are required. Furthermore, it is necessary to introduce electronic patient-reported outcome measurements that can be used in community-based clinical environments.

Introduction

Medicine has a history of pursuing “difference” or “diversity” since ancient times, whether in the east or west. In the west, a humoral pathology theory led to Hippocrates’ four humoral theory and Galen’s four temporal theory, influenced by Empedocles’ four elements theory. This is the theory that appearance, temperament, and physical and mental illness are different because of the difference in the ratio of the four body fluids. This viewpoint has dominated the perspective of Western medicine for nearly 2000 years¹ and has contributed to the development of constitutional typology in the 19th century and the emergence of genetics in the 20th century. Through the pursuit of personalized and precision medicine, individual differences have been identified as one of the important factors in various noninfectious chronic diseases.^2,3

In the east, there has been an attempt to interpret the differences between people and use them to treat disease. Based on the historical background of the pursuit of human “differences,” Dr. Dowon Kuon, a Korean medicine doctor founded eight constitution medicine (ECM) in the mid-1950.^4–7 The ECM formed a new theoretical base incorporating the principles of meridians, Epinger and Hess’s autonomic nervous system variability theory, and the theory of internal organs' variations in traditional Korean Sasang medicine.^4–7

Specifically, the core principle of ECM is that the constitution of each individual is determined by the inherent strength and arrangement of internal organs.^4–9 The ECM has been included in the curriculum of Korean medicine and taught at major Korean medicine colleges.¹⁰ It is also used in some other countries, including Australia and Germany.^11,12 The diagnosis of eight constitutions (ECDx) is confirmed through the manual pulse diagnosis method, which identifies the signs of the eight constitutions found in the radial artery of both wrists, and it is currently a major diagnostic method for the eight constitutions.^4–9 With the classification of eight constitutions, various diseases were treated and prevented by applying the two major treatments of the ECM: Eight constitution acupuncture (ECA) and eight constitutional lifestyle interventions (ECLIs).

The ECA is completely different from traditional acupuncture methods. It is based on a new interpretation of the meridians and a new understanding of the strengths and weaknesses of the organs.^4–6 ECA accepts Western medicine’s autonomic nervous system deviation theory and stress theory and constructs acupuncture prescriptions through mathematical calculations of acupuncture points to treat pathological phenomena in specific anatomical structures.^4–7,9 ECLI consists mainly of applying different dietary, exercise, and bathing methods according to each constitution. Among these, the eight constitution diet (ECD) plays a central role in prevention and treatment and is implemented in parallel with ECA.^5,9 However, clinical research related to ECM is limited. Therefore, in this study, we aimed to determine the types of clinical studies that have been conducted on ECM.

The first objective of this study was to collect literature related to ECM, which is heterogeneous, and to identify the status of research on ECM. Second, we sought evidence from clinical research on the effectiveness of two major ECM treatments: ECA and ECD. Third, we aimed to identify the standardized measurement tools or methods used to confirm the effectiveness of the ECM. Therefore, a scoping review was conducted.¹³

Methods

According to Arksey and O’Malley’s definition, a scoping review aims to examine the scope and nature of a research field by identifying the main concepts, information, and types of available evidence constituting the research area and summarizing the results.¹⁴ In this study, a five-step framework was developed by Arksey and O’Malley and Levac et al.^14,15 The framework aims to (1) identify research questions, (2) locate related studies, (3) select studies, (4) extract the collected data, and (5) report the results. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews (PRISMA-ScR) checklist was referenced (Supplementary Data).^16,17

Step 1: Identifying the research question

Three research questions were developed, which reflect the purpose of this scoping review.

What types of clinical studies related to ECM have been published in international or domestic journals?

Which topics of ECM have been studied?

What methods or tools are used to measure the effectiveness of ECM?

These questions provided a comprehensive understanding of the status of clinical research on ECM, study topics in ECM, and tools and methods for measuring the effectiveness of ECM.

Step 2: Identifying relevant studies

Search strategy

For the literature search, three international databases and five domestic electronic databases were utilized, employing strategies such as a reference search and a gray literature search. The international databases used were (1) PubMed, (2) Embase, and (3) Cochrane, while the domestic databases were (1) DataBase Periodical Information Academic (DBpia), (2) Research Information Sharing Service (RISS), (3) Korean Studies Information Service System (KISS), (4) National Digital Science Library (NDSL), and (5) Oriental Medicine Advanced Searching for Integrated System (OASIS).

Search terms, such as “8 constitutions”, “8 constitution medicine”, “eight constitutions”, “eight constitution medicine”, were used to explore a wide range of related literature and studies, with no restriction on the year and region of publication.

All the selected literature in the above process has been thoroughly reviewed, and while referencing the literature, documents not chosen in the database or ones that have not been published have been additionally checked.

Eligibility criteria

All content related to ECM clinical research published internationally and domestically was included, excluding theses, dissertations, and editorials. Studies and literature were not limited by publication year, country, or study design, and only those published in Korean or English were included.

Step 3: Study selection

Using the search strategy, titles and abstracts were initially read to select studies and check whether they met the inclusion/exclusion criteria. In total, 240 articles were selected from PubMed (n = 5), Embase (n = 6), Cochrane Central (n = 3), DBpia (n = 45), KISS (n = 58), RISS (n = 69), NDSL (n = 53), and OASIS (n = 1). In addition, 12 articles were found with reference to the searched articles and textbooks, resulting in 252 articles. In total, 151 duplicates were removed, and 17 studies whose research purpose and content did not fall within the ECM category were excluded. Furthermore, theses or dissertations of 10 students were excluded, and 14 editorials were removed after assessing full-text articles for eligibility, resulting in 60 studies being included in this scoping review (Fig. 1).

FIG. 1.

Flowchart of study selection.

Step 4: Data charting and summarizing the results

All studies and literature meeting the eligibility criteria were read in full, and the related data were extracted. Mapping was attempted to briefly identify and analyze all literature related to ECM clinical research. For this purpose, subcategories were established by repeatedly analyzing the literature. First, the literature was sorted into original and nonoriginal studies related to ECM clinical research. Second, the original research literature was divided into experimental and observational studies and then subdivided according to study design. Third, studies were categorized into ECA, ECD, and eight constitution diagnosis/classification (ECDx); studies included in more than three types of ECM were classified as mixed, and studies that did not belong to these categories were classified as others. Finally, the intervention/exposure and outcome measures of ECM clinical research were summarized. Each article was organized by author, publication year, study design, population/disease, setting/place, intervention (exposure)/control, outcome measures, and outcomes (results).

As this scoping review did not involve the participation of human subjects, approval from the ethics committee was not required.

Step 5: Reporting results

The results of this scoping review were used for both quantitative and qualitative analysis.

Results

Categorization and mapping of included studies

Sixty studies were selected to confirm the overall research and studies on the ECM. There were 47 (78.3%) original studies, of which 39 (65.0%) were observational and eight (13.3%) were experimental. Among the observational studies, cross-sectional studies were the most frequent, with 20 studies (33.3%), followed by 14 case reports (23.3%) and five cohort studies (8.4%). The experimental studies consisted of five (8.3%) randomized controlled trials (RCTs) and three (5.0%) clinical trials. There were 13 (21.7%) nonoriginal studies, of which 13 (21.7%) were reviews. Among review articles, literature review was the most common, with 11 (11.8%), followed by 1 (1.7%) systematic review and meta-analysis, and 1 (1.7%) systematic review (Table 1).

Table 1.

Categorization and Mapping of Included Studies

Type of research	Type of study	Study design	Type of ECM	Contents
Original (47, 78.3 %)	Experimental (8, 13.3 %)	Randomized clinical trial (5, 8.3 %)	ECA (4, 6.7 %)	[18,43 –45]
		Randomized clinical trial (5, 8.3 %)	ECDx (1, 1.7 %)	[35]
		Clinical trial (3, 5.0 %)	ECA (1, 1.7 %)	[42]
			ECD (1, 1.7 %)	[46]
			ECDx (1, 1.7 %)	[34]
	Observational (39, 65.0 %)	Cohort, prospective (1, 1.7 %)	ECA (1, 1.7 %)	[52]
		Cohort, retrospective (4, 6.7 %)	ECDx (2, 3.3 %)	[24,51]
		Cohort, retrospective (4, 6.7 %)	Other (2, 3.3 %)	[54,55]
		Cross-sectional (20, 33.3 %)	ECA (1, 1.7 %)	[53]
			ECD (4, 6.7 %)	[11,47 –49]
			ECDx (11, 18.3 %)	[8,22,23,25 –32]
			Other (3, 5.0 %)	[56 –58]
			Mixed (1, 1.7 %)	[61]
		Case report (14, 23.3 %)	ECA (8, 13.3 %)	[19 –21, 36 –40]
			ECD (1, 1.7 %)	[50]
			ECDx (1, 1.7 %)	[33]
			ECA & ECD (2, 3.3 %)	[12,41]
			ECA & ECDx (2, 3.3 %)	[59,60]
Nonoriginal (13, 21.7 %)	Review (13, 21.7 %)	Literature review (11, 18.3 %)	ECA (5, 8.3 %)	[65 –69]
			ECD (2, 3.3 %)	[71,78]
			Other (2, 3.3 %)	[70,72]
			Mixed (2, 3.3 %)	[73,74]
		Systematic review (1, 1.7 %)	ECDx (1, 1.7 %)	[79]
		Systematic review and Meta analysis (1, 1.7 %)	ECA (1, 1.7 %)	[64]

ECA, eight constitution acupuncture; ECDx, eight constitution diagnosis; ECD, eight constitution diet; Other, not ECA, ECD, ECDx, within the ECM; Mixed, combination of ECA, ECD, ECDx, and other.

The original studies were rearranged according to ECM type. ECDx-related studies accounted for the majority, with 16 (34.0%) studies, followed by 15 (31.9%) ECA-related studies, six (12.8%) ECD-related studies, and five (10.6%) other studies in various fields beyond these three categories. There were two (4.3%) studies that combined ECA and ECDx, two (4.3%) case reports that applied ECA and ECD together, and one (2.1%) combined ECA, ECD, ECDx, and other. Almost all studies were conducted on outpatients at community clinics, public health centers, and university hospitals in Korea; however, there were also ECA studies on inpatients.^18–21 ECM has also been used internationally as there were studies conducted at a German university hospital targeting German people¹¹ and at an Australian community clinic targeting Australian asthma patients.¹² Most ECDx studies have focused on developing and verifying diagnostic tools using questionnaires.^22–32

There was one study on the development of pulse diagnosis devices³³ and one on attempting constitutional classification by genetic analysis.⁸ Two studies focused on the consistency, reliability, and validity measurement of the eight constitutional pulse diagnosis method.^34,35 The ECA category has seven single-case studies on incurable diseases,^{19–21,36–39} one case series on cancer treatment,⁴⁰ two case series on allergic rhinitis and asthma treatment,^12,41 and five trials comparing body acupuncture, and eight constitutional acupuncture treatment groups.^18,42–45 Studies on ECD included the observation of blood components according to ECD,^46–48 ECs’ distribution according to food preference,⁴⁹ a qualitative study to confirm physical perception according to ECD,⁵⁰ and a study measuring health outcomes according to ECD¹¹ (Table 2).

Table 2.

Original Research of ECM (n = 47)

Type of ECM (n, %)	Author	Year	Study design	Population/disease (Sx)	Setting/place	Intervention (exposure)/control	Outcome measures	Outcomes (results)
ECDx (16, 34.0)	S Moon et al.³³	2001	Case report	20 ECDx confirmed people	University, S. Korea		Pulse Dx Device	70% matching rate
	SB Lee et al.²²	2002	Cross-sectional	455 outpatients (M:F 168:287, mean age 42, range 15–78)	Community clinic, S.Korea		Survey	Comparing characteristics of Eight Constitutions
	HS Lee et al.³⁴	2005	Clinical trial	38 healthy college students (M;F 21:17, mean age 23.8, range 19–33)	Community clinic, S. Korea	Diagnostician A/B (Manual pulse Dx)		Inter-rater reliability 35.7%Intrarater reliability (A: 89%, B: 66.83%)
	SB Lee et al.²³	2005	Cross-sectional	720 outpatients (M:F 262:458, mean age 40.7, range 12–79)	Community clinic, S. Korea		Survey	Comparing characteristics of Eight Constitutions
	SB Rhee et al.²⁴	2006	Retrospective cohort	262 outpatients (M, range 14–49)	Community clinic, S. Korea		Survey	Comparing characteristics of eight constitutions
	Y Shin et al.³⁵	2006	RCT	13 volunteers (3 diagnosticians and 10 participants)	Community clinic, S. Korea	Diagnostician A/B/C (manual pulse Dx)		Consistency (A: 70%, B: 80%, C: 50%)Accuracy (A: 60%, B: 70%, C: 0%)Confidence (A: 70%, B: 64%, C: 75%)
	J Min et al.²⁵	2007	Cross-sectional	409 outpatients (M:F 86:323, mean age 45.1, range 24–69)	Community clinic, S. Korea		Survey	7 factors,74 itemsconfirmed
	E Jang et al.⁵¹	2008	Retrospective cohort	247 outpatients (M:F 70:177)	Community clinic, S. Korea	Sasang Dx/eight constitution Dx		Association between Sasang constitution and eight constitution
	Y Shin et al.²⁶	2008	Cross-sectional	925 outpatients (M:F 225:699, range 20–60)	Community clinic, S. Korea		Survey/8 Constitution Expert System	Dx rate
	Y Shin et al.²⁷	2008	Cross-sectional	925 outpatients (M:F 225:699, range 20–60)	Community clinic, S. Korea		Survey/8 Constitution Expert System	Dx rate
	H Kim et al.²⁸	2008	Cross-sectional	925 outpatients (M:F 225:699, range 20–60)	Community clinic, S. Korea		Eight-Constitution Questionnaire	Appearance items analysis
	H Kim et al.²⁹	2009	Cross-sectional	925 outpatients (M:F 225:699, range 20–60)	Community clinic, S. Korea		Eight-Constitution Questionnaire	Character items analysis
	H Kim et al.³⁰	2009	Cross-sectional	925 outpatients (M:F 225:699, range 20–60)	Community clinic, S. Korea		Eight-Constitution Questionnaire	Body reaction, Physiology and Pathology and Food reaction items analysis
	D Kang et al.³¹	2011	Cross-sectional	32 outpatients (M:F 8:24, mean age 41.6)	Community clinic, S. Korea		Eight-Constitution Questionnaire-32 (ECM-32), Temperament and Character Inventory (TCI)	Significant interrelationship between Feature of each Eight Constitutions and Temperament and Character in TCI
	J Lee et al.³²	2012	Cross-sectional	1027 outpatients	Community clinic, S. Korea		ECM-32 system	Stage classification of Eight Constitution Questionnaire
	C Kim et al.⁸	2022	Cross-sectional	63 healthy volunteers (M:F 19:44, mean age 55, range 24–87)	Community clinic, S. Korea		Oral mucosa DNA	Lung and liver phenotype-related SNP phylogenetic tree showed two clusters reflecting a distinct difference between HEP and PUL
ECA (15, 31.9)	SJ Chae et al.¹⁸	2001	RCT	29 inpatients (17 BA group-M:F 11:6, mean age 40.4 / 12 ECA group—M:F 9:3, mean age 40.1)/Low-back pain (HNP)	University hospital, S. Korea	ECA/BA	Visual analog scale (VAS)	More improvement of subjective symptoms in ECA
	Y Kang et al.³⁶	2001	Case report	1 outpatient (F/37 years)/Knee pain (Meniscus tear)	Community hospital, S. Korea	ECA	Pain scalePain frequencyRange of Motion (ROM)	Improvement of pain scale and ROM
	NY Kim et al.¹⁹	2001	Case report	1 inpatient (M/67 years)/Idiopathic hiccups	University hospital, S. Korea	ECA & Herbal medication		Sx disappeared
	HH Lee et al.²⁰	2002	Case report	1 inpatient (M/66 years)/ Vertigo (Menieres Syndrome)	University hospital, S. Korea	ECA & Herbal medication		Sx disappeared
	YW Kim et al.⁴²	2003	Clinical Trial	20 outpatients (10 test group-M:F 5:5, mean age 33.7 / 10 Control group—M:F 5:5, mean age 37.5)/Neck pain	University hospital, S. Korea	ECA/BA	VAS,Pain Disability Index (PDI)	No significant difference between the two groups in VAS score and PDI scores
	SJ Chae et al.⁴³	2004	RCT	40 outpatients (20 Test group-M:F 5:15, range 40–70)/20 Control group—M:F 4:16, S 40–80)/Knee pain (degenerative arthritis)	Public health center, S. Korea	ECA/BA	VAS	After 10 treatment—no significant difference.After 20 treatment—improvement of subjective symptoms in ECA group
	Y Shin et al.⁵²	2005	Prospective cohort	42 outpatients (M:F 11:31, mean age 46.02, range 14–73)	Community clinic, S. Korea	ECA	Heart Rate Variability (HRV)	ECA is associated with changed activity in sympathetic and parasympathetic nervous system
	YW Seo et al.³⁷	2006	Case report	1 outpatient (F/20 years)/idiopathic thrombocytopenic purpura	Community clinic, S. Korea	ECA	Platelet count	Improvement of thrombocytopenia
	J Min et al.⁵³	2007	Cross-sectional	35 ECM Clinicians	Online, S. Korea		Survey	ECA is effective therapy in clinic
	MJ Paik et al.⁴⁰	2008	Case series report	3 outpatients (M/55 years-Rectal Ca. F/52 years-Lung Ca., F/59 years-Breast Ca.)	Community clinic, S. Korea	ECA	Urinary polyamine levels	Normalization of polyamine levels after ECA
	YK Lee et al.⁴⁴	2009	RCT	50 outpatients (25 Test group-M:F 11:14, mean age 39.16 / 25 Control group—M:F 8:17, mean age 37.36)/Acute stage lumbago	University hospital, S. Korea	ECA/BA	VAS,Dorsolumbar ROM	Better effect on decreasing of VAS and improving of lumbar flexion and extension in ECA group
	YK Lee et al.⁴⁵	2010	RCT	80 outpatients (40 Test group-M:F 18:22, mean age 38.73/ 40 Control group—M:F 14:26, mean age 37.58) /Acute stage lumbago	University hospital, S. Korea	ECA/BA	VAS,Dorsolumbar ROM	Better effect on decreasing of VAS and improving of lumbar flexion and extension in ECA group
	H Choi et al.³⁸	2010	Case report	1 outpatient (F/13 years)/Melalgia (r/o JRA)	University hospital, S. Korea	ECA, BA, Moxibustion & Herbal medication	VAS, K-WOMAC, SF-36	VAS: 8–>1.5WOMAC index: 22–>57
	YK Lee et al.³⁹	2012	Case report	1 outpatient (F/58 years)/Trigeminal neuralgia	University hospital, S. Korea	ECA	VAS	Disappearance of pain (level and frequency)
	M Hwang et al.²¹	2016	Case report	1 inpatient (M/51 years)/CRPS_Type 1	University hospital, S. Korea	ECA	VAS,Sleeping time	VAS: 10–>4Sleeping time: 30 min–>3 h
ECD (6, 12.8)	SH Kim et al.⁴⁶	1985	Clinical Trial	124 healthy female university students	University, S. Korea	ECD	Food preference score (FPS), Cornel Medical index (CMI),Blood components	No difference among constitutional groups in food preference score, health status and the values of the most blood components
	M Han⁴⁹	2002	Cross-sectional	101 outpatients (M:F 45:56, Range 10–60)	University hospital, S. Korea	ECD	Food preference score (FPS)	Positive association between FPS and ECD
	B Cho et al.⁴⁷	2007	Cross-sectional	258 volunteers (M;F 71:214, mean age 42.0)	Community clinic, S.Korea	ECD	Nutrition intake rate, physical examination (height, weight, and BMI),Blood components	Relationship among nutrition intake rate, blood components, physical examination, and ECD
	G Hwang et al.⁵⁰	2010	Case series report (qualitative research)	3 dancers (31 years, 29 years, 22 years)	Community clinic, S. Korea	ECD	Bulimis Test-Revised (BLUIT-R),Physical Self-Perception Profile (PSPP)	Association between physical self-perception and ECD
	B Cho et al.⁴⁸	2013	Cross-sectional	214 female outpatients (Range 20–70)	Community clinic, S. Korea	ECD	Food frequency questionnaire (FFQ), Physical examination (height, weight, BMI) & Blood pressure,Blood components	Relationship among nutrition intake rate, blood components, physical examination, and ECD
	C Kim et al.¹¹	2020	Cross-sectional	242 Germans healthy volunteers (M:F 49:193, mean age 44.3)	University hospital, Germany	ECD	13-item diet questionnaire,SF-36	No difference in the health outcome of SF-36 betweein the 2 groups (Hepatonia/Cholecystonia vs. Pulmotonia/Colonotonia)
Other (5, 10.6)	C Kim et al.⁵⁴	2014	Retrospective cohort	647 ECM clinical data + 17 Outpatients (M:F 3:14, range 60–70)	Community clinic, S. Korea	ECM	Genetic, environmental, and cultural factors	Disease ecology in geography
	K Choi et al.⁵⁵	2018	Retrospective cohort	171 outpatients (M:F 33:138, mean age 37.54, range 20–59)	Community clinic, S. Korea		Iris parameters,Eight-Constitution Questionnaire-32(ECM-32)	Relationship between iris parameters and 8 constitutions
	H Kim et al.⁵⁶	2020	Cross-sectional	245 outpatients (M:F 127:118, mean age 54.85)	Community clinic, S. Korea		Basic measures such as history of exercise, smoking, alcohol intake, body weight, height, waist circumference, blood pressure, and any treatment for previous diseases, Venous blood, Manual pulse diagnosis	Prevalence of and associations between metabolic syndrome and the constitutions
	E Lee et al.⁵⁷	2021	Cross-sectional	80 survey respondents (M:F 42:38, mean age 35)	Online survey, S. Korea		ECM-32 system	Association between color preference and constitution
	C Kim et al.⁵⁸	2022	Cross-sectional	75 announcers (M:F 29:46, mean age 44.2)	Community clinic, S. Korea		Age, Sex, Chief complaint, Diseases, Manual pulse diagnosis	The prevalence of disease types among ECM diagnosis in an announcer group
ECA&ECDx (2, 4.3)	T Yu⁵⁹	2000	Case series report	10 outpatients (M:F 5:5, mean age 37.4, range 18–60)	Community clinic, S. Korea	ECA	Pulse Diagnosis Device	Positive pulse wave changes
ECA&ECDx (2, 4.3)	J Kim⁶⁰	2000	Case series report	5 outpatients (M:F 3:2, mean age 56.4, range 38–79)	Community clinic, S. Korea	ECA	Pulse Diagnosis Device	Positive pulse wave changes
ECA& ECD (2, 4.3)	HK Kim et al.⁴¹	2009	Case series report	3 outpatients (M/24 years, F/29 years, M/33 years)/allergic rhinitis	Community clinic, S. Korea	ECA & ECD	VAS	Disappearance of symptoms
	HN Kang et al.¹²	2023	Case series report	3 outpatients(M/70 years, F/74 years, M/37 years)/Asthma	Community clinic, Australia	ECA & ECD	Peak expiratory flow (PEF), Asthma control questionnaire (ACQ), Asthma quality of life questionnaire (AQLQ)	(1) Reduced asthma meds(2) Good asthma control(3) Improved comorbidities(4) Significantly improved QoL(5) Positive change to attitude, feelings, and thoughts toward life
Mixed (1, 2.1)	J Park et al.⁶¹	2007	Cross-sectional	232 outpatients (M:F 49:151, mean age 43.64, range 17–74)	Community clinic, S. Korea	ECA, ECD, and other ECLI	16-item questionnaire for ECM recognition	Degree of confidence, reaction, satisfaction, valiancy, and superiority

Sx, Symptome; ECDx, eight constitution diagnosis; Dx, diagnosis; M, male; F, female; RCT, randomized controlled trial; DNA, deoxyribo nucleic acid; SNP, single nucleotide polymorphisms; HEP, hepatonia; PUL, pulmotonia; ECA, eight constitution acupuncture; BA, body acupuncture; HNP, herniated nucleus pulposus; ECM, eight constitution medicine; JRA, juvenile rheumatoid arthritis; K-WOMAC, Korean version of Western Ontario MacMaster; SF-36, short form-36; CRPS, complex regional pain syndrome; ECD, eight constitution diet; BMI, body mass index; Other, not ECA, ECD, ECDx, within the ECM; QoL, quality of life; Mixed, combination of ECA, ECD, ECDx, and other; ECLI, eight constitution lifestyle interventions.

Original studies that measured the effectiveness of ECM used various methods of intervention/exposure and outcome measurement tools. Of the ECA studies, nine used the visual analog scale (VAS) as a major outcome measure,^{18,21,36,38,39,42–45} one study measured the effects of ECA by blood tests,³⁷ and one by urine tests.⁴⁰ One study observed changes in heart rate variability (HRV) after ECA,⁵² and one investigated ECM clinician’s perceptions of the effects of ECA.⁵³

In the literature related to ECD, one study used the Food Preference Score (FPS) as an intervention to confirm health status⁴⁶ and one used it as an outcome measure to identify how FPS was distributed according to the ECs.⁴⁹ There were two studies that analyzed ECs’ distribution and blood components according to the nutrition intake rate using Food Frequency Questionnaires,^47,48 and there was one that studied health outcomes using the SF-36 by measuring adherence to the ECD regimen using a 13-item diet questionnaire.¹¹ In addition, one used the Bulimis Test-Revised (BLUIT-R) to measure the eating attitude of dancers following ECD.⁵⁰ Most of these articles were published domestically in Korean, but recently, articles that have been published in English in international and domestic journals are gradually appearing^{8,11,12,34,40,56} (Supplementary Table S1).

Discussion

This study is a scoping review to confirm the type of clinical research on ECM and how it has been conducted. The literature related to ECM confirmed through journal publications thus far was identified and analyzed. It was confirmed that most clinical studies utilize various tools to measure intervention/exposure and outcome. There were more original studies than nonoriginal studies, and among ECM, most studies were on ECA and ECDx, and relatively few on ECD.

In the original studies on ECM, observational studies are mainstream, and cross-sectional studies, which are studies on correlation rather than causation, and case reports with low evidence levels are the focus. For case reports, although the level of evidence is treated as low, they should be organized systematically according to the methodology of modern cases or case series reporting so that clinical and educational values can provide sufficient evidence.^62,63 There are a small number of RCTs, but as Lee et al. pointed out, problems with small sample size and low-quality methodology persist.⁶⁴ Much effort is needed to improve research methodology and increase the level of evidence on the effectiveness of ECM.

Among the nonoriginal articles, literature reviews are the most common. Since ECM is a medical system with a new approach and perspective in the history of Eastern medicine, there are many studies for comparative analysis with existing Korean medicine,^65–72 and other literature reviews have attempted to comprehensively understand the principles of ECM.^69,73,74 Although the theoretical basis and comprehensive summary have already been provided by the founder, Dr. Dowon Kuon^5–7,9,75 in the textbook of the Korean medicine colleges,¹⁰ a greater understanding of the principles of ECM is needed.

For ECDx, various studies have been attempted for a long time. Studies have been conducted to mechanize the manual eight constitutional pulse diagnosis method³³ and to diagnose eight constitutions (ECs) and verify the effect of ECA using Eastern medicine’s pulse diagnosis machine.^59,60 Most studies have been conducted to develop questionnaires as aids for ECDx^22–32 and attempted to diagnose ECs using the iris and DNA.^8,55 To ensure the accuracy and objectivity of diagnoses, it is necessary to develop more diverse, direct, and indirect diagnostic tools using the latest scientific and medical technologies.

Studies on ECA have mainly used the VAS.^{18,21,36,38,39,42–45} The effects on idiopathic hiccups and vertigo were measured by the self-reporting of symptoms,^19,20 while those on systemic lupus erythematosus (SLE) and cancers were measured through blood and urine tests, respectively.^37,40 The effect of ECA is mainly reported in case reports; thus, the level of evidence is evaluated as low. However, it should be noted that these case reports show excellent effects in incurable diseases that are difficult to solve in modern medicine, such as complex regional pain syndrome,²¹ thrombocytopenia after splenectomy,³⁷ cancer treatment,⁴⁰ and asthma,¹² so more research and reports are needed.

ECD is one of the two main treatments in ECM, and together with ECA, it plays an important role in disease treatment and prevention, and health maintenance; however, relatively few studies on the effect of ECD have been conducted. Studies on ECD are largely divided into two categories: Those that check the improvement of blood components and health status according to FPS and nutrient intake ratio,^46–49 and studies that measure the effect of overall health improvement following ECD.¹¹ The reason for this lack of research is thought to be the lack of standardized tools that can accurately measure adherence to the ECD. Therefore, there is an urgent need to develop an adherence measurement tool to assess the effectiveness of ECD and to build clinical evidence in the near future.

To measure specific symptoms or diseases more accurately and diversely, it is necessary to use a standardized patient-reported outcome (PRO) measurement tool that objectively and systematically measures changes in symptoms. The treatment approach of ECA and ECLI in ECM is distinctly patient centered, with a strong focus on subjective symptoms such as pain and quality of life, as well as functional impairments, which are best understood from the patient's perspective.^{11,12,18,21,36,38,39,41–45,50} Therefore, the use of PROs as an outcome measure is not only appropriate but also critical to building evidence for the clinical effectiveness of ECM treatments.

PROs provide direct insight into how patients perceive their health and the impact of treatments, making them an invaluable component of outcome assessment in ECM.^{11,12,38,42,50} This approach is consistent with the broader medical community's growing recognition of the importance of patient-centered care and the value of PROs in capturing outcomes that matter most to patients. In addition, since current ECM clinical treatment is mainly performed at busy community-based clinics, it is necessary to utilize electric PRO (ePRO) tools using smartphones to obtain accurate PRO results, without interfering with the flow of treatment.^76,77,80 Therefore, through multidisciplinary studies, it will be possible to build high-level evidence for the effects of incurable diseases using various measurement tools such as blood, urine, and imaging combined with PROs.⁸¹

Based on our study findings, the following directions for future research in ECM are suggested. Despite the long-standing practice of ECM, the lack of substantive evidence in the literature underscores the imperative for further clinical investigation.^64,74 A deeper and more comprehensive understanding of ECM is necessary, particularly through the objectification of constitutional diagnosis. Clinical research employing diverse scientific methods, including pragmatic randomized controlled trials (RCTs), is essential to ascertain the comparative effectiveness of ECM-based treatments. Furthermore, the development of unique case reports and long-term prospective observational studies will enrich our understanding of ECM’s practical applications and long-term effects. Addressing the existing methodological gaps is critical.

Research should focus on standardizing outcome measurement tools, ensuring adequate sample sizes, and conducting long-term observations. These measures are paramount to enhancing the reliability and applicability of research findings within the clinical setting. The accumulation of rigorous and substantial evidence in ECM is crucial for its integration and recognition within the broader medical community. It aligns with the ongoing endeavors in contemporary medicine to tailor disease prevention and treatment strategies to individual needs.^2,3 As such, continued efforts in ECM research are vital for its substantiation and potential integration into comprehensive patient care.

Numerous studies have explored human differences, and in Korea, there has been active research on Sasang medicine.⁷² This field primarily utilizes herbal remedies tailored to an individual's physique and temperament.⁷² Efforts have been made to draw comparisons between Sasang medicine and ECM, exploring their origins and diagnostic approaches.^51,64,70,71 However, while ECM incorporates the theory of internal organ variations from Sasang medicine, it needs to be distinguished and marked as an entirely new field of medicine. ECM includes detailed differentiation among the intermediate organs, emphasizes the independence of the eight constitutions, accepts the autonomic nervous system theory of Western medicine, and involves a comprehensive reinterpretation of acupuncture and meridians.^4–7,9

Limitations

Due to the nature of the scoping review, a quality appraisal was not conducted, but all literature published in journals related to ECM clinical research were identified and analyzed. Second, the majority of the literature was published in Korean local journals; therefore, English literature was lacking. However, the contents of all the selected Korean literature were checked and analyzed to supplement them. Third, many studies related to ECM clinical research have not been published in journals, but the main content is mostly absorbed in the selected literature in this review. More theoretical analysis and clinical research are needed in the future.

Conclusions

The original research evidence of ECM that has been studied so far has been focused on observational studies; studies on ECA and ECDx have been active with various methodologies, but studies on ECD have been lacking. In addition, there were many cases in which the measurement tools for intervention/exposure and outcome were inappropriate or did not fit the eight constitutional clinical and research environments. Therefore, for active clinical research related to ECD in the future, it is necessary to develop and verify a tool that effectively measures adherence, select an appropriate tool that accurately measures the target disease, and introduce ePRO that can be used smoothly in a community-based clinical environment.

Footnotes

Acknowledgments

We would like to thank Editage (www.editage.co.kr) for English language editing. A preliminary report of this work was previously published on Research Square on August 4, 2023, by Choi, Y., and Cho, J. The report, titled 'Clinical Research in Eight Constitution Medicine (ECM): A Scoping Review,' can be accessed at .

Data Availability

All data generated or analyzed during this study are included in this published article.

Authorship Contribution Statement

Y.C.: Conceptualization, methodology, validation, formal analysis, investigation, resources, data curation, writing—original draft, writing—review & editing, visualization, and project administration. J.C.: Conceptualization, writing—review & editing, and supervision.

Author Disclosure Statement

The authors declare that they have no conflicts of interest.

Funding Information

There is no funding information to declare.

Supplementary Material

Abbreviations Used

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