European Journal of Integrative 18 (2018) 34–41

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European Journal of Integrative Medicine

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Research paper Clinical practice guidelines for the use of traditional Korean medicine in the T treatment of patients with traffic-related injuries: An evidence-based approach

Hyun-Tae Kima, Eui-Hyoung Hwanga,b, In Heoc, Jae-Heung Chod, Koh-Woon Kimd, In-Hyuk Hae, ⁎ Me-Riong Kime, Hyung-Won Kangf, Jun-Hwan Leeg,h, Byung-Cheul Shina,b, a School of Korean Medicine, Pusan National University, Yangsan, zip 50612, South Korea b Spine and Joint Center, Department of Rehabilitation Medicine, School of Korean Medicine, Pusan National University Korean Medicine Hospital, Yangsan, zip 50612, South Korea c Department of Korean Medical Science, Pusan National University, Yangsan, zip 50612, South Korea d Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, zip 02447, South Korea e Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, zip 06017, South Korea f Department of Neuropsychiatry, College of Oriental Medicine, Wonkwang University, Iksan, zip 54538, South Korea g Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, zip 34054, South Korea h Korean Medicine Life Science, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea

ARTICLE INFO ABSTRACT

Keywords: Introduction: In 2016, traditional Korean medicine (TKM) treatment for traffic-related injuries comprised 27.7% Clinical practice guidelines (CPG) of Korea’s total car insurance medical coverage, and that proportion has been increasing annually. However, Traffic-related injuries clinical practice guidelines (CPGs) that employ evidenced-based medicine (EBM) methodology for traffic-related Evidence-based medicine (EBM) injuries have not been established in TKM. Therefore, the aim of this study was to develop a CPG for the Traditional korean medicine (TKM) treatment of traffic-related injuries in TKM by conducting a systematic literature review following EBM. Systematic review Methods: First, a network of experts was established to develop the CPG. Then, a systematic search of TKM treatments for traffic-related injuries was conducted using the Patients/ Populations–Intervention–Comparison–Outcome method. To measure the methodological quality of the sys- tematic reviews and meta-analyses, the assessment of multiple systematic reviews was used. The Cochrane collaboration’s risk of bias tool was used to assess the randomised controlled trials. Results: The CPG for the treatment of traffic-related injuries in TKM consisted of three parts: diagnosis, treat- ment, and prognosis. In total, 13 recommendations were developed, with two regarding diagnosis, 10 regarding treatment, and one regarding prognosis. Conclusions: This CPG was developed by conducting a systematic literature review of randomised controlled trials. Therefore, this CPG can be adapted to different clinical status for traffic-related injuries. Specifically, it can be useful reference for traditional Chinese medicine and medicine practitioners using the same or similar interventions. In addition, the CPG can serve as an EBM model for countries unfamiliar with the complementary and treatment of traffic-related injuries.

1. Introduction 223,552 cases were reported. In 2016, traditional Korean medicine (TKM) treatment for traffic-related injury comprised 27.7% of Korea’s According to the 2015 World Health Organization (WHO) global total car insurance medical coverage, and that proportion has been status report on road safety, 1.25 million people die every year from increasing annually [1]. In 2016, the Korean Ministry of Health & traffic accidents worldwide. In 2014, a steady increase in the number of Welfare reported that approximately 720,000 patients visit TKM clinics traffic accidents in Korea was observed. Specifically, a remarkable for traffic-related injuries, which was a 50.7% increase from the

⁎ Corresponding author at: Spine and Joint Center, Department of Rehabilitation Medicine, School of Korean Medicine, Pusan National University Korean Medicine Hospital, 20, Geumo−ro, Mulgeum−eup, Yangsan−si, Gyeongsangnam−do, 50612, South Korea. E-mail addresses: [email protected] (H.-T. Kim), [email protected] (E.-H. Hwang), [email protected] (I. Heo), [email protected] (J.-H. Cho), [email protected] (K.-W. Kim), [email protected] (I.-H. Ha), [email protected] (M.-R. Kim), [email protected] (H.-W. Kang), [email protected] (J.-H. Lee), [email protected] (B.-C. Shin). https://doi.org/10.1016/j.eujim.2018.01.003 Received 29 August 2017; Received in revised form 18 December 2017; Accepted 13 January 2018 1876-3820/ © 2018 Elsevier GmbH. All rights reserved. H.-T. Kim et al. European Journal of Integrative Medicine 18 (2018) 34–41

480,000 patients who visited TKM clinics in 2014. Moreover, medical 2.1. Establishing the network of experts to develop the CPG expenses associated with traffic-related injuries were reported to be approximately 459 billion won in 2016, which was a 68.9% increase Three groups were placed in charge of this CPG: a professional from the estimated 272 billion won in 2014 [2]. group, a working group, and a review committee group (Appendix Eq. Patients with traffic-related injuries often present with systemic (I.1) in Supplementary material). The professional group oversaw the symptoms, such as sprains, fractures, nerve damage, traumatic brain general review of specialty and academic research for the use of TKM in injuries, and severe organ damage to organ. A common ailment of the treatment of traffic-related injuries. The working group collected traffic-related injuries is whiplash-associated disorder (WAD) caused by data about key clinical questions and used this data to draft a version of hyperextension or hyperflexion of the neck as a result of rapid accel- the CPG. The review committee reviewed, revised, and supplemented eration or deceleration. However, patients with traffic-related injuries the final CPG. present with varying complexities of symptoms depending on the nature of the accident [3–5]. Since 1999, the Car Insurance Medical 2.2. CPG development process Coverage for traffic accident patients has also paid for traditional Korean medicine services alongside conventional medicine. The range The CPG was developed in accordance with NECA guidelines. First, of coverage in this program include Chuna , pharma- 13 key clinical questions were identified through the analysis of do- copuncture, digital infrared imaging, transcutaneous electrical nerve mestic and international CPGs. There were two clinical questions of stimulator, interference current therapy, and meridian laser therapy in diagnosis, ten clinical questions of treatment, and one clinical question addition to the treatments covered by National Health Insurance. Tra- or prognosis (Appendix Eq. (C.1) in Supplementary material). Second, ditional Korean medicine services for traffic accident patients comple- meaningful clinical data were extracted from the literature and used to ments Conventional Medicine treatments by relieving pain and pro- make recommendations. All systematic review processes followed the moting recovery of function, which explains the increasing use of TKM preferred reporting items for systematic reviews and meta-analyses [6]. However, there are no useful clinical practice guidelines (CPG) for (PRISMA) recommendation of summarizing the evidence of each clin- the use of TKM in the treatments of traffic-related injuries. Therefore, a ical question. During this process, objective and validated methodolo- comprehensive and standardised CPG for TKM that addresses the di- gical tools, such as Review Manager 5.3, Cochrane collaboration’s tool agnosis, treatment, and prognosis of traffic-related injuries is needed. In for assessing risk of bias (ROB) for randomised controlled trials, and 2016, the Korean government ordered the development of CPG for TKM assessment of multiple systematic reviews (AMSTAR), were used to in the treatment of traffic-related injuries and 30 other diseases to ex- evaluate the systematic reviews. The RAND-UCLA Appropriateness pand the contribution of TKM to the national public system Method, which is a modified Delphi method, was applied to validate the [7]. final recommendation [12]. The Korean Academy of Oriental Re- Western countries have many CPG, such as the Quick Reference habilitation Medicine, Korean Society of Chuna Manual Medicine for Guide for the Management of Acute Whiplash-Associated Disorder Spine and Nerves, Korean Society of Oriental Neuropsychiatry, and the (Sydney, 2015) [8], the Minor Injury Guideline (Canada, 2011) [9], and Korea Immuno-Pharmacoacupuncture Association reviewed and ap- the Clinical Guidelines for the Physiotherapy Management of Whiplash- proved this CPG for traffic-related injuries. The Korea and Associated Disorder (London, 2005) [10]. However, CPGs that employ Moxibustion Medicine Society did not review and approve this CPG. evidenced-based medicine (EBM) methodology for traffic-related in- The overall process is summarised in Fig. 1. juries have not been established in TKM despite the increasing demand for TKM services. 2.3. Search strategy The CPG presented here is based on a strict systematic literature review of EBM methodology and developed in accordance with the CPG A search was conducted in the order of diagnosis, treatment, and development manual provided by the National Evidence-based prognosis. The core, standard, ideal model proposed by the National Healthcare Collaborating Agency (NECA) in Korea [11]. This CPG for Library of Medicine was used to select the databases to be included in the use of TKM in the treatment of traffic-related injuries provides the literature search [13]. Pubmed, Ovid-MedLine, EMBASE, and Co- appropriate recommendations that address key clinical questions. This chrane CENTRAL were used as the foreign core databases. KoreaMed, CPG can aid in the clinical decision-making process, improve the Kmbase, KISS, and NDSL were used as the domestic core databases. A overall quality of TKM practice, and serve as a model for countries that standard database is characterised by themes different from those of a are unfamiliar with the use of in the treatment of core database. CNKI was used as a foreign standard database and OASIS traffic-related injuries. In addition, this CPG can be useful reference for and RISS were used as domestic standard databases. The ideal database traditional Chinese medicine (TCM) and Kampo medicine practitioners includes abstracts of academic conferences, unpublished literature, and using the same or similar interventions such as acupuncture, mox- current clinical trials. In this study, the clinical manual textbook was ibustion, and cupping. considered to be an ideal database.

2.4. Literature search 2. Methods A committee that met once a month selected the databases to be In accordance with the NECA CPG developmental manual, a pro- included in the study based on the inclusiveness and accessibility of the fessional group, a review committee group, and a working group were literature searches. The study design of this CPG was a randomised established through the cooperation of six related academic societies. controlled trial. A systematic search of TKM treatments for traffic-re- The CPG was developed for adult patients with traffic-related injuries lated injuries was conducted using the Patients/ and consisted of three parts: diagnosis, treatment, and prognosis. Populations–Intervention–Comparison–Outcome method, with a focus Furthermore, this CPG includes clinically effective therapies derived on the Patients/Populations and Intervention components to ensure a from real clinical practice conditions. The target group of CPG is TKM comprehensive search. In the domestic databases, complex searches doctors who are involved in the treatment of traffic-related injuries. could not be correctly performed, so the databases were mined with a Additionally, TCM and Kampo medicine practitioners who use same or comprehensive keyword based on Patients/Populations component. similar interventions could also be a target group of this CPG. Patients/Populations and Interventions are explained in Table 1. Comparisons: Controls were included if they were real and valid clinical cases in South Korea. The following groups were compared:

35 H.-T. Kim et al. European Journal of Integrative Medicine 18 (2018) 34–41

Fig. 1. Overall development process of CPG. sham acupuncture group, inactive control group, simple conventional 2.5. Selection of data treatment group, a single Korean medicine treatment group, and a combined Korean medicine treatment group. Two independent researchers selected the data to be included from Outcomes: Outcomes were included if they were valid and accep- the literature search. First, the literature was screened by title and table key clinical questions. The following tools were used to measure abstract and any duplicate articles or studies were excluded. Second, pain outcomes: visual analogue scale, numeric rating scale, Short-Form the literature was screened for full-text articles only. If there was a McGill Pain Questionnaire, Brief Pain Inventory–Short Form, and neck disagreement in the selection process, consensus was achieved through pain questionnaire. Disability outcomes were measured using range of discussion or the consultation of a third party. PRISMA was used to motion and the neck disability index. In addition, the adverse events of select the inclusion and exclusion criteria (Appendix Eq. (B.1) in each intervention group [14–17] when used improperly were sum- Supplementary material). marised in the Appendix Eq. (A.2) in Supplementary material. Inclusion criteria:

1) Study population of adult patients (19–70-years-old) with neck pain or low back pain;

Table 1 Population/Intervention.

Clinical Key Question P I

Diagnosis CQD 01 patients who visited the hospital due to traffic accident injury Diagnostic situations requiring collaboration of traditional Korean medicine – western involving all ages medicine CQD 02 Same as CQD 01 Pattern identification

Treatment CQT 01 WAD Ⅰ, Ⅱ adults(19 ∼ 70 years old) patients having neck pain Various acupuncture treatments and low back pain CQT 02 WAD Ⅰ, Ⅱ adults(19 ∼ 70 years old) patients having neck pain Pharmacopuncture only or combining therapy with other interventions and low back pain CQT 03 WAD Ⅰ, Ⅱ adults(19 ∼ 70 years old) patients having neck pain Chuna manual therapy only or combining therapy with other interventions and low back pain CQT 04 WAD Ⅰ, Ⅱ adults(19 ∼ 70 years old) patients having neck pain Moxibustion only or combining therapy with other interventions and low back pain CQT 05 WAD Ⅰ, Ⅱ adults(19 ∼ 70 years old) patients having neck pain Cupping only or combining therapy with other interventions and low back pain CQT 06 WAD Ⅰ, Ⅱ adults(19 ∼ 70 years old) patients having neck pain Oriental physiotherapy and low back pain CQT 07 WAD Ⅰ, Ⅱ adults(19 ∼ 70 years old) patients having neck pain treatment according to pattern identification or combining therapy and low back pain with other interventions CQT 08 WAD Ⅰ, Ⅱ adults(19 ∼ 70 years old) patients having neck pain Combination of Korean medicine interventions such as acupuncture, herbal medicine and low back pain CQT 09 WAD Ⅰ, Ⅱ adults(19 ∼ 70 years old) patients having neck pain Combination of Korean medicine interventions such as acupuncture, herbal medicine and low back pain CQT 10 WAD Ⅰ, Ⅱ adults(19 ∼ 70 years old) patients having neck pain Combination of Chuna manual therapy and pharmacopuncture and low back pain

Prognosis CQP 01 Patients who visited the hospital due to traffic accident injury Patients who are treated by Korean medicine treatment involving all ages

Clinical Question of Diagnosis (CQD)/Clinical Question of Treatment (CQT)/Clinical Question of Prognosis (CQP).

36 H.-T. Kim et al. European Journal of Integrative Medicine 18 (2018) 34–41

2) Study population of adult patients (19–70-years-old) with fracture 2.6.3. Developing recommendations or acute post-traumatic stress disorder (PTSD); Recommendations were made based on the clinical questions. The 3) Systematic reviews and meta–analyses related to traffic injuries and recommendation grade was obtained by considering the difference randomised controlled trials including traditional Korean medicine between the desirable and undesirable results, with the acknowl- methods in the treatment of patients with traffic-related injuries. edgment of potential net benefits from TKM interventions. The re- commendation grade was classified from A to D and with the Good Exclusion criteria: Practice Point (GPP), which referred to a previous CPG [22–26]. Grade A was given when the net benefit of implementing the re- 1) Studies in which the objective evaluation method was not specified; commendation was large. Grades B, C, and D were given in a des- 2) Studies that did not include traditional Korean medicine treatment cending order in accordance with ratio of bene fit and harm. The GPP methods; grade was recommended based on a consensus of clinical experts on 3) Non–randomised controlled trials; and traffic injuries, even if the evidence was lacking. Specifically, the de- 4) A manual therapy that cannot be performed by a legal medical li- velopment committee made a formal agreement based on the draft of cense holder (i.e., Korean medicine doctor). the recommendation through one external review and one face-to-face expert panel meeting through the pre-configured online questionnaires. Formal agreements were derived using the modified Delphi method 2.6. Analysis and assessment of literature (RAM). GPP was then drawn up through one expert meeting on the agreed recommendations. 2.6.1. Quality assessment If the recommendation had a low level of evidence, but had an To measure the methodological quality of the systematic reviews obvious benefit or clinical value, the recommendation grade was up- and meta-analyses, AMSTAR was used. The Cochrane collaboration’s graded after the careful consideration of the committee. ROB tool was used to assess the randomised controlled trials [18,19]. Recommendations on TKM treatments for traffic-related injuries are We used Appraisal of Guidelines for Research and Evaluation Ⅱ in- summarised in the Appendix Eq. (E.1) in Supplementary material. strument to assess the quality of guidelines [20]. All studies were evaluated and approved by two or more in- dependent researchers. 2.6.4. Peer review and consensus of recommendations A draft of the CPG was created by the working group after con- ducting a literature search and analysing the articles for methodology, 2.6.2. Classification of the level of evidence systematic reviews, and meta-analyses related to TKM treatment and The grading of recommendations assessment, development and traffic-related injuries. A final version was approved by an independent evaluation (GRADE) method, developed by the GRADE working group expert panel. [21], was used to evaluate the level of evidence of the CPG guidelines. The expert panel consisted of specialists recommended by academic The GRADE evaluation process consisted of three steps. societies associated with the development of the CPG. In total, there In the first step, health care questions that are important to real were 11 experts from the following societies: the Korean Academy of clinical conditions were defined and supporting literature was col- Oriental Rehabilitation Medicine (n = 1), Korea Immuno- lected. In the second step, key clinical questions were selected from a Pharmacoacupuncture Association (n = 1), Korean Society of Oriental review of the literature. In the third step, the level of evidence was Neuropsychiatry (n = 1), Society of Sports Korean Medicine (n = 1), determined by summarizing the results. In the present study during this Korea Institute of Oriental Medicine (n = 2), including a CPG metho- process, the initial level of evidence was determined for each study dology specialist, and current TKM practitioners (n = 2). design (i.e., randomised controlled trials have a high level of evidence, The expert panel approved the CPG in accordance with the Delphi while observational studies have a low level of evidence). Then, the method. Two separate meetings were conducted: one external review final level of evidence was determined by adjusting the evidence level using an online questionnaire and one face-to-face meeting based on according to the ROB, consistency, and directness of the study. As a the draft version of recommendations. result, this CPG has four levels of evidence. Details of evidence are given in the Appendix Eq. (D.1) in Supplementary material. We added GRADE information about acupuncture, pharmaco- 2.6.5. Updates of the CPGs puncture, and moxibustion in Table 2. However, GRADE evaluation of Two years after the publication of the CPG, we plan to supplement the other intervention in this CPG could not be performed because the the shortcomings of the current CPG and update the recommendations evidence level was low. We explained the GRADE approach regarding with new clinical research results. This process will involve the col- evidence and summary of clinical findings in Appendix Eq. (L.1) in lection of opinions from various experts and patients through post- Supplementary material. clinical monitoring and clinical evidence accumulation.

Table 2 Grade.

Acupuncture Number of studies Risk of bias Inconsistency Indirectness Imprecision Other considerations Neck pain (4 RCTs) No serious No serious No serious Serious None NDI (3 RCTs) No serious No serious No serious Very serious None

Pharmacoupucnture Number of studies Risk of bias Inconsistency Indirectness Imprecision Other considerations VAS (2 RCTs) No serious No serious No serious Serious None NDI (1 RCT) No serious No serious No serious Very serious None ROM (1 RCT) No serious No serious No serious Serious None

Moxibustion Number of studies Risk of bias Inconsistency Indirectness Imprecision Other considerations VAS (1 RCTs) No serious Serious No serious Serious None NDI (1 RCTs) No serious Serious No serious Serious None

37 H.-T. Kim et al. European Journal of Integrative Medicine 18 (2018) 34–41

3. Results improvement of low-back pain in WAD I, II adult patients (19–70-years- old) (GPP/Insufficient) (Appendix Eq. (G.1) in Supplementary mate- The CPG consisted of three parts: diagnosis, treatment, and prog- rial). nosis. A total of 13 recommendations were developed. A summary of the total recommendations is in Appendix Eq. (E.2) in Supplementary 3.2.2. Pharmacopuncture treatment [33,36,40–43] material, and the full explanation of the total recommendations and Recommendation (grade/level of evidence) evidences is described in Appendix Eq. (F.1-H.1)/ in Supplementary material. 1. To decrease objective pain on the pain scale, a combination of acupuncture and pharmacopuncture according to differentiation of 3.1. Diagnosis syndromes should be considered for symptom alleviation of neck pain in WAD I, II adult patients (19–70-years-old), as compared to 3.1.1. Integrative treatment of TKM and conventional medicine [27] acupuncture treatment only (B/Moderate). Since 1951, when the dual health care system was first established 2. To improve indicators on the functional scale, a combination of in Korea, Korean Medicine doctors and conventional medicine doctors acupuncture and pharmacopuncture according to differentiation of have maintained a conflicting relationship. Although conflict between syndromes should be considered for functional improvement of neck Korean Medicine doctors and conventional medicine doctors has con- pain in WAD I, II adult patients (19–70-years-old), as compared to tinued, integrative treatments from both Korean and conventional acupuncture treatment only (C/Low). medicine have been provided expediently to inpatients in Korean 3. Pharmacopuncture only or combined therapy is recommended for Medicine hospitals. For example, when a cerebrovascular infarction alleviation of pain and functional improvement in WAD I, II adult patient is treated in a Korean Medicine hospital, he or she receives patients (19–70-years-old) with low-back pain (GPP/Insufficient) acupuncture and herbal medicine treatment while simultaneously un- (Appendix Eq. (G.2.) in Supplementary material). dergoing radiographic examination with antihypertensive and throm- bolytic medicine. To provide radiographic examinations and conven- 3.2.3. Chuna manual therapy [44,45] tional medications, most Korean Medicine hospitals have had to Manual medicine is a comprehensive term commonly used to refer establish separate conventional medicine clinics or form partnerships to all manipulation therapy. In Korea, manual medicine is usually re- with conventional medicine hospitals. ferred to as Chuna. Chuna Manual Therapy is only performed by doc- Recommendation (grade/level of evidence) tors of Korean medicine (KMDs) using hands or other body parts as Medical cooperation is recommended for WAD III, IV (Appendix Eq. necessary with of medical devices or tools such as Chuna manual tables. (K.1) in Supplementary material suspected patients by using physical Accordingly, we excluded manual therapies reflecting Korean medicine examination of all ages based on clinical experience of the CPG de- because only KMDs practice Chuna manual medicine. Therefore, we velopment group (GPP/Insufficient) (Appendix Eq. (F.1) in focused on Chuna manual therapy instead of including all manual Supplementary material). therapies. There are contraindications when doing Chuna manual therapy; therefore, practitioners must understand these contra- 3.1.2. Pattern identification [28,29] indications, which are shown in Appendix Eq. (J.1) in Supplementary Pattern identification is a unique diagnostic system of Korean material. medicine that distinguishes itself from conventional medicine. It is an Recommendation (grade/level of evidence) important factor in determining treatment direction. The terms used in this paper were selected based on the WHO international standard 1. Chuna manual therapy only or combined treatment is recommended terminologies on traditional medicine in the western pacific region for alleviation of pain and functional improvement of neck pain in [30]. Recommendation of pattern identification in this CPG was based WAD I, II adult patients (19–70-years-old) based on the clinical on the questionnaire survey of 1294 Korean medicine doctors [31]. experience of the CPG development group (GPP/Insufficient). stagnation syndrome was the most frequent pattern identification 2. Chuna manual therapy only or combined treatment is recommended of the traffic accident injuries in this survey. for alleviation of pain and functional improvement of low-back pain Recommendation (grade/level of evidence) in WAD I, II adult patients (19–70-years-old) based on the clinical Static blood is the first pattern of patients with traffic-related in- experience of the CPG development group (GPP/Insufficient) juries regardless of age, and herbal medicine is recommended when a (Appendix Eq. (G.3) in Supplementary material). more detailed pattern is identified according to -blood, zang-fu or- gans, cold-heat, or yin-yang. TKM treatment is recommended to be 3.2.4. Moxibustion treatment [40,46,47] combined with standard care for the alleviation of pain and the im- There are two types of moxibustion: direct moxibustion and indirect provement of function in adult patients (19–70-years-old) with fracture moxibustion. Indirect moxibustion was used in this CPG; five to seven (GPP/Insufficient) (Appendix Eq. (F.2) in Supplementary material). cones of moxibustion per treatment are commonly used. [48] Recommendation (grade/level of evidence) 3.2. Treatment 1. To decrease objective pain on the pain scale, a combination of 3.2.1. Acupuncture treatment [32–39] acupuncture and indirect moxibustion may be considered for neck Recommendation (grade/level of evidence) pain in WAD I, II adult patients (19–70-years-old), as compared to 1. To decrease objective pain on the pain scale, a combination of acupuncture treatment only (C/Low). usual care with acupuncture treatment (or electroacupuncture) should 2. To improve indicators regarding the functional scale, a combination be considered in WAD I, II adult patients (19–70-years-old), as com- of acupuncture and indirect moxibustion may be considered for pared to other usual care. (B/Moderate). neck pain in WAD I, II adult patients (19–70-years-old), as compared 2. To improve indicators of functional scale, a combination of usual to acupuncture treatment only (C/Low). care with acupuncture treatment (or electroacupuncture) should be 3. Moxibustion only or combined therapy is recommended for considered in WAD I, II adult patients (19–70-years-old), as compared symptom alleviation and functional improvement of low-back pain to other usual care (C/Low). in WAD I, II adult patients (19–70-years-old) based on the clinical 3. Usual care with additional acupuncture treatment (or electro- experience of the CPG development group (GPP/Insufficient) acupuncture) is recommended for alleviation of pain and functional (Appendix Eq. (G.4) in Supplementary material).

38 H.-T. Kim et al. European Journal of Integrative Medicine 18 (2018) 34–41

3.2.5. Cupping [49,50] 3. Acupuncture treatment is considered for pain control, joint stiffness, Recommendation (grade/level of evidence) reduction of range of motion. If a patient has a cast, remote acu- puncture point needling can be useful. 1. Cupping only or combined therapy is recommended for symptom 4. In the case of herbal medicine, it can be divided into early, middle, alleviation and functional improvement of neck pain in WAD I, II and late regimens. adult patients (19–70-years-old) based on the clinical experience of the CPG development group (GPP/Insufficient). 4-1. At 1–2 weeks after fracture injury, herbal medicine to activate 2. Cupping only or combined therapy is recommended for symptom blood and resolve stasis can be used to clear heat and to cool the blood alleviation and functional improvement of low-back pain in WAD I, 4-2. At 3–6 weeks after injury, herbal medicine can be used ther- II adult patients (19–70-years-old) based on the clinical experience apeutically to treat blockage of meridian with muscle contraction. of the CPG development group (GPP/Insufficient) (Appendix Eq. 4-3. In the post-injury period after 7 weeks, herbal medicine for (G.5) in Supplementary material). tonifying qi and blood can be used to nourish blood and qi. Korean medicine terms used in this CPG are selected from the WHO 3.2.6. Oriental physiotherapy [51,52] international standard terminology on traditional medicine in the Oriental physiotherapy encompasses non-invasive therapies applied western Pacific region. to treat traffic accident injuries more efficiently. It includes conduction exercises, which are specially designed physical movements and 3.2.9. Treatments for PTSD [56,57] breathing exercises; electrotherapy, which applies modern physical Recommendation (grade/level of evidence) therapy to meridian and acupoints; and hydrotherapy, which is physical therapy to promote blood circulation and treat diseases by applying 1. A combination of traditional Korean medicine interventions such as water’s physical characteristics such as temperature and pressure [53]. acupuncture and herbal medicine is recommended for improving Recommendation (grade/level of evidence) psychological symptoms of adult patients (19–70-years-old) with acute PTSD as a result of a traffic accident based on the clinical 1. A combination of oriental physiotherapy and usual care is re- experience of the CPG development group, as compared to usual commended for symptom alleviation and functional improvement of care only (GPP/Insufficient) (Appendix Eq. (G.9) in Supplementary neck pain in WAD I, II adult patients (19–70-years-old) based on the material). clinical experience of the CPG development group, as compared to other usual care alone (GPP/Insufficient). 3.2.10. Combination of Chuna manual therapy and pharmacopuncture 2. A combination of oriental physiotherapy and usual care is re- Recommendation (grade/level of evidence) commended for symptom alleviation and functional improvement of low back pain in WAD I, II adult patients (19–70-years-old) based on 1. A combination of Chuna manual therapy and pharmacopuncture is the clinical experience of the CPG development group, as compared recommended for symptom alleviation of neck pain and functional to other usual care alone (GPP/Insufficient) (Appendix Eq. (G.6.) in improvement in WAD I, II adult patients (19–70-years-old), as Supplementary material). compared to Chuna manual therapy alone or pharmacopuncture alone (GPP/Insufficient). 3.2.7. Herbal medicine treatment 2. A combination of Chuna manual therapy and pharmacopuncture is Based on the survey results mentioned in the pattern syndrome, we recommended for symptom alleviation of low back pain and func- made a recommendation with herbal medicine prescriptions widely tional improvement in WAD I, II adult patients (19–70-years-old), as used in the clinical field. The mainly prescribed herbal medications compared to Chuna manual therapy alone or pharmacopuncture related to the traffic injury diagnosis are Dangguixu-san, Wuji-san, and alone (GPP/Insufficient) (Appendix Eq. (G.10) in Supplementary Gegen-tang. Recommendation (grade/level of evidence) material).

1. Herbal medicine only or combined therapy according to pattern 3.3. Prognosis [58,59] identification is recommended for symptom alleviation and func- tional improvement of neck pain in WAD I, II adult patients (19–70- Recommendation (grade/level of evidence) years-old) based on the clinical experience of the CPG development A combination of traditional Korean medicine interventions such as group (GPP/Insufficient). acupuncture and herbal medicine is recommended for improving the 2. Herbal medicine only or combined therapy according to pattern rate of returning to everyday life or workplace for patients with traffic identification is recommended for symptom alleviation and func- accident injuries (GPP/Insufficient) (Appendix Eq. (H.1) in tional improvement of low back pain in WAD I, II adult patients Supplementary material). (19–70-years-old) based on the clinical experience of the CPG de- velopment group (GPP/Insufficient) (Appendix Eq. (G.7) in 4. Discussion Supplementary material). Traffic-related injuries are associated with a complicated range of 3.2.8. Treatments for fracture [52,54,55] symptoms that depend on a number of factors, such as the severity of Recommendation (grade/level of evidence) the accident, insurance and litigation issues, and physical and mental factors [4,5,60,61]. In the differential diagnosis of patients with traffic- 1. In combination with traditional Korean medicine interventions such related injuries, abnormal clinical findings may not necessarily be di- as acupuncture, herbal medicine is recommended for symptom al- rectly related to the cause of the symptoms. Conversely, a symptom can leviation and functional improvement of fracture in adult patients be present without any abnormal clinical findings. Therefore, qualita- (19–70-years-old) based on the clinical experience of the CPG de- tive research literature on the treatment of patients with traffic-related velopment group, as compared to usual care alone (GPP/ injuries was reviewed [62–66]. Furthermore, we examined the sys- Insufficient) (Appendix Eq. (G.8) in Supplementary material). tematic review titled “CPG for the management of conditions related to 2. After fracture, traditional Korean medicine treatments can be con- traffic collisions”, published in 2015 [67], which included studies sidered for conservative treatment, rehabilitation treatment, or de- ranging from musculoskeletal disorders to psychological disorders. layed union. However, most recommendations focused on WAD and mild traumatic

39 H.-T. Kim et al. European Journal of Integrative Medicine 18 (2018) 34–41 brain injuries. In addition, they did not consider complementary and clinical settings to treat patients with traffic-related injuries. The alternative medicine therapies intervention. Therefore, we focused on combination of these two treatments is believed to promote synergistic establishing CPG based on complementary and alternative medicine, treatment effects; however, these e ffects have not been confirmed be- especially East Asian medicine, including TKM, TCM, and Kampo. cause there have been no well-designed clinical studies. Similarly, there Moreover, we wanted to provide patients with sufficient information, is a lack of clinical research on the use of TKM to treat patients with such as a definitive diagnosis and treatment options and methods: this PTSD or acute stress disorders. Therefore, future research is needed on point was incorporated into the CPG. these topics. This CPG was developed by collecting all of the relevant literature to The quality and quantity of studies regarding TKM treatment for date and systematically assessing the quality and clinical efficacy of fracture are too weak to draw definitive guidelines. This shortcoming each study. This allowed the clinical status and level of evidence for the should be addressed through pilot studies and multi-centre studies from traffic injury to be analysed; however, this study found a lack of evi- 2018 to 2019. dence for making some of the recommendations. This study also iden- tified fields that need future clinical research support. This CPG is not Funding intended to restrict the medical activities of TKM practitioners and it is not made for health insurance screening standards. Furthermore, it This work was part of the Korean government’s leading TKM tech- cannot be the basis of legal judgments concerning the medical treat- nology project and was tasked as part of the Korea Standard CPG ment performed on patients in a specific clinical situation. This CPG is Development Agency supported by the Korean Ministry of Health and solely intended to help the decision-making process of doctors treating Welfare [grant numbers HB16C0013]. patients with traffic-related injuries and to assist with the policy- making process. Conflict of interest

4.1. Limitations All members of the development group have demonstrated a prac- tical and economic stakeholder relationship with a specific institution This CPG had three limitations. First, the CPG had a lack of quali- or researcher involved in this CPG. To minimise the conflicts of interest, tative and quantitative evidence for recommending TKM practices in we have declared a conflict of interest and indicate that the opinion of the treatment of traffic-related injuries. Many of the recommendations the financial sponsoring organisation did not influence any part of the had low levels of evidence or an insufficient GPP when the GRADE recommendation. All members signed and submitted a declaration of method was applied. In addition, since many studies did not describe conflict of interest. the randomisation methodology, the ROBs were often high or unclear. In particular, studies regarding TKM treatment for fracture were lim- Acknowledgements ited, thus the level of evidence of fracture-related TKM treatments was low. Accordingly, it was replaced by the GPP recommendation. We appreciate all members of the CPG development committee and Additionally, whiplash-related research has been mainly included be- also thank all the societies who supported the CPG development. cause of the high level of evidence-based data. Further, there was a large variation in the treatment effect estimates because of high het- Appendix A. Supplementary data erogeneous controls and treatment methods. As a result, the hetero- geneity of evidence was often high and resulted in weak re- Supplementary data associated with this article can be found, in the commendations. online version, at https://doi.org/10.1016/j.eujim.2018.01.003. The second limitation of the CPG was the difficulty of developing recommendations for individual therapies because of the limited References number of studies on individual studies, with the exception of acu- puncture, moxibustion, pharmacopuncture, and Chuna manual therapy. [1] Health Insurance Review & Assessment Service, http://www.hira.or.kr./ Many cases were not included in the analysis because they involved bbsDummy.do?pgmid=HIRAA020041000100&brdScnBltNo=4&brdBltNo= ff 9411#none. combination therapy, so a single treatment e ect could not be de- [2] Korean Ministry of Health & Welfare, http://www.mohw.go.kr/front_new/al/ termined. sal0301vw.jsp?PAR_MENU_ID=04&MENU_ID=0403&CONT_SEQ=340291& The third limitation of the CPG is that not all TKM doctors agree page=1, 2017. 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