Efficacy of acupuncture for whiplash injury: a systematic review and meta-analysis.

OBJECTIVES: This study aimed to establish clinical evidence for acupuncture by analysing data from trials that demonstrated the efficacy of acupuncture for whiplash-associated disorder (WAD) with the following research question: Is acupuncture treatment effective for symptom alleviation in patients with WAD compared with other usual care? DESIGN: A systematic review and meta-analysis. DATA SOURCES: PubMed, Ovid Medline, Embase, The Cochrane Library, China National Knowledge Infrastructure, ScienceOn, KMBASE, Korean Studies Information Service System, Korea Med, Oriental Medicine Advanced Searching Integrated System and Research Information Sharing Service were searched from their inception to 1 October 2023. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) using acupuncture on patients with WAD. The outcomes were the pain visual analogue scale (VAS) score or numerical rating scale score for neck pain, the range of motion (ROM) of the neck, the Neck Disability Index and safety. DATA EXTRACTION AND SYNTHESIS: Two independent researchers analysed and extracted data from the selected literatures. The risk of bias and the quality of evidence were assessed according to the Cochrane Handbook for Systematic Reviews of Interventions and the Grading of Recommendations Assessment, Development, and Evaluation method, respectively. RESULTS: A total of 525 patients with WAD from eight RCTs were included in this study. The meta-analysis revealed that the outcomes showed significant differences in the pain VAS score (standard mean difference (SMD): -0.57 (-0.86 to -0.28), p<0.001) and ROM-extension (SMD: 0.47 (0.05 to 0.89), p=0.03). The risk of bias assessment revealed that four studies published after 2012 (50%, 4 out of 8 studies) showed low bias in most domains. The pain VAS score was graded as having moderate certainty. CONCLUSION: Acupuncture may have clinical value in pain reduction and increasing the ROM for patients with WAD. High-quality RCTs must be conducted to confirm the efficacy of acupuncture in patients with WAD. TRIAL REGISTRATION NUMBER: PROSPERO CRD42021261595.

Effectiveness and safety of scalp acupuncture for treating migraine: A systematic review and meta-analysis.

OBJECTIVE: Migraine is a prevalent and disabling neurological disorder affecting a significant proportion of the global population. Although medications are the primary treatment option, their efficacy remains unclear. Thus, alternative therapies such as scalp acupuncture have gained momentum; however, evidence for the effectiveness of scalp acupuncture remains insufficient. Therefore, this review provides evidence regarding the effectiveness and safety of scalp acupuncture for the treatment of migraines. DESIGN: PubMed, EMBASE, CENTRAL, Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, Korean Medical Database, NDSL, Citation Information by NII, and China National Knowledge Infrastructure were searched from their inception to September 2022 to identify randomised controlled trials (RCTs) without language restrictions. Data were collected and analysed independently by two reviewers. The RoB 2.0 tool was used to evaluate the risk of bias, and a meta-analysis was conducted using RevMan software (V5.4). SETTING: Eight RCTs including 874 patients were selected. RESULTS: Scalp acupuncture had a higher total effective rate (relative risk [RR]:1.24; 95% confidence interval [CI]:1.08-1.43; P < 0.01) than that of ordinary acupuncture. The headache index decreased significantly (standardised mean differences [SMD]:-1.27; 95% CI:-2.06 to -0.48; P < 0.01), and the total effective rate was higher (RR:1.20; 95% CI:1.06-1.37; P < 0.01) with scalp acupuncture than with medications. However, evidence supporting the effectiveness of scalp acupuncture was not robust. No adverse events were reported. CONCLUSION: Scalp acupuncture appears to be more effective than other treatments for migraines. However, their safety remains uncertain. PROSPERO REGISTRATION NUMBER: CRD42022348879.

Economic evaluation of acupuncture as an adjunctive treatment with usual care for mild-to-moderate knee osteoarthritis: A Markov model-based analysis.

Background: Collaborative care (CC), in which acupuncture is combined with usual care (UC), improves clinical outcomes and increases costs in knee osteoarthritis (KOA). We evaluated the economic feasibility of CC for Korean female patients with mild-to-moderate KOA by using a cost-effectiveness approach. Methods: Two alternatives for KOA (1. UC as a comparator; and 2. CC as an intervention) were defined based on clinical guidelines, official Korean statistics, and expert validation. Each alternative was simulated in a Markov model every 6 months for 10 years. Estimates of costs, utilities, and transition probabilities were obtained from official statistics and previous studies. The effectiveness of CC was synthesized from randomized controlled trials. A base-case analysis of a limited societal perspective, univariate sensitivity analysis, and probability sensitivity analysis were performed. An annual discount rate of 4.5% and threshold of 20,000 United States dollar per Quality-adjusted life year (USD/QALY) were applied. Results: Every incremental cost-effectiveness ratio (ICER) of CC calculated from the analyses was sub-threshold. In the base-case analysis, with a limited societal perspective, the ICER was 11,085 USD/QALY. The ICERs from the univariate sensitivity analyses were -2,577-16,748 USD/QALY. The average ICER in the probability sensitivity analysis was 12,412 USD/QALY. When the threshold surpassed 8,000 USD/QALY, the cost-effectiveness of CC exceeded 50%. The probability was 70.27% when the threshold was 20,000 USD/QALY. Conclusions: CC for Korean female patients with mild-to-moderate KOA was generally cost-effective. Considering the limitations of the evidence, we propose a re-evaluation using further clinical studies in the future.

Efficacy of scalp acupuncture for migraine: A protocol for systematic review and meta-analysis.

INTRODUCTION: Migraine is a disorder that is prevalent worldwide. However, there is still no clear and effective treatment for migraine. Recently, acupuncture as a treatment has been attracting attention and studies have shown the value of scalp acupuncture. Therefore, this protocol for a systematic review and meta-analysis was created to assess the evidence of effectiveness and safety of scalp acupuncture in the treatment of migraine. METHODS: All published randomized controlled trials (RCTs) in the following databases will be searched from their inception to September 2022: PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), OASIS, Korean Studies Information Service System (KISS), Korean Medical Database and NDSL, CiNii (Citation Information by NII), and the China National Knowledge Infrastructure (CNKI), without language restrictions. The data collection and analysis will be conducted independently by two reviewers. The Cochrane Collaboration tool will be used to evaluate the risk of bias by evaluating the available studies. A meta-analysis will be conducted using RevMan V.5.4 software. RESULTS: The purpose of the proposed systemic review is to systematically assess the effectiveness and safety of scalp acupuncture for the treatment of migraine. CONCLUSIONS: To sum up, this review will assess the effectiveness and safety of scalp acupuncture for the treatment of migraine. The results of this review are expected to provide new guidelines for the treatment of migraine. ETHICS AND DISSEMINATION: The review and meta-analysis will not require ethical approval because personal information from individuals will not be involved. The results will be published in a peer-reviewed journal.

Scalp acupuncture for stroke: A protocol for an overview of systematic reviews and meta-analysis.

BACKGROUND: Scalp acupuncture (SA) is a new acupuncture method that connects head acupoints and aculines, and many systematic reviews (SRs) have been published on its use against neuropsychiatric diseases. However, no overview of SRs on the effectiveness of SA in stroke recovery has been conducted. Therefore, our overview aims to evaluate the methodological bias and reliability of the conclusions of SRs regarding SA for stroke recovery and help clinical decision-makers translate this research into clinical policy and practice. METHODS: We will consider SRs and meta-analyses of randomized controlled trials to evaluate the effects of SA on stroke recovery. Two reviewers will identify relevant studies, extract data information, and assess the methodological quality using the Assessment of Multiple Systematic Reviews-2 tool. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses report checklist will also be included in the study to assess the quality of the reports. We will use evaluations of the Grading of Recommendations Assessment, Development and Evaluation of the authors of the included SRs. The Risk of Bias in Systematic Review tool will be used to assess the risk of bias of SRs. The screening of SRs, eligibility evaluation, data extraction, methodological quality, and quality of evidence will be conducted by independent reviewers in pairs. The outcomes of interest include the Modified Edinburgh-Scandinavian Stroke Scale, Ability of Daily Living, Functional Independence Measure, Barthel index, Fugl-Meyer assessment, clinical effective rate, and adverse events. Data will be extracted using predefined forms designed to summarize the important characteristics of each review. The evidence will be a descriptive synthesis of the type and content of the intervention and the results reported. RESULTS: The results will be published in a peer-reviewed journal. CONCLUSIONS: We expect to organize evidence from multiple SRs on the effectiveness of SA for stroke recovery and synthesize the findings in an accessible and useful documentation.

Herbal Decoctions for the Levels of Sulfur Dioxide, Benzopyrene, and Mycotoxin from Traditional Korean Medicine Clinics: A Preliminary Study.

In this study, we investigated whether the levels of sulfur dioxide (SO2), benzopyrene, and mycotoxins in herbal decoctions in Korea in 2019 were within normal limits. In total, 30 decoctions composed of multi-ingredient traditional herbs were sampled from traditional Korean medicine (TKM) clinics, TKM hospitals, and external herbal dispensaries in 2019. The decoctions were analyzed for SO2, benzopyrene, and mycotoxins using 10 samples. SO2 and benzopyrene were not detected in any of the herbal decoctions. With regard to mycotoxins, aflatoxin B1 was not detected, but B2 was detected in 7 cases (0.00~0.04 ppb), G1 in 13 cases (0.03~0.29 ppb), and G2 in 9 cases (0.02~0.93 ppb). None of these values exceeded the restrictions in prior studies. Thus, we confirm that the amounts of SO2, benzopyrene, and mycotoxins in herbal decoctions are at safe levels and provides the basis of establishing safety management criteria for herbal decoctions.

Comparative Effectiveness and Safety of Concomitant Treatment with Chuna Manual Therapy and Usual Care for Whiplash Injuries: A Multicenter Randomized Controlled Trial.

OBJECTIVES: We aimed to compare the effectiveness and safety of Chuna manual therapy combined with usual care to those of usual care alone for treating whiplash injuries. DESIGN: A two-arm, parallel, assessor-blinded, multicenter pragmatic randomized clinical trial. SETTING: Three hospitals in Korea. PARTICIPANTS: Overall, 132 participants between 19 and 70 years of age, involved in traffic accidents and treated at three hospitals in Korea, >2 but <13 weeks prior to enrollment, with neck pain consistent with whiplash-associated disorder grades I and II and a numeric rating scale score ≥5 were included. INTERVENTIONS: Participants were equally and randomly allocated to the Chuna manual therapy and usual care (n = 66) or usual care (n = 66) groups and underwent corresponding treatment for three weeks. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the number of days to achieve a 50% pain reduction. Secondary outcomes included areas under the 50% numeric rating scale reduction curve: pain, disability, quality of life, and safety. RESULTS: The Chuna manual therapy + usual care group (23.31 ± 21.36 days; p = 0.01) required significantly fewer days to achieve 50% pain reduction compared to the usual care group (50.41 ± 48.32 days; p = 0.01). Regarding pain severity, functional index, and quality of life index, Chuna manual therapy and usual care were more effective than usual care alone. Safety was acceptable in both groups. CONCLUSIONS: In patients with subacute whiplash injury, Chuna manual therapy showed a rapid rate of recovery, high effectiveness, and safety.

Utilization of Traditional Korean Medicine Services by the Older Population: A Cross-Sectional Study.

Korean healthcare service is divided into conventional medicine and traditional Korean medicine (TKM). This cross-sectional study compared the older population (65 years and older) with two groups of the general population (19-50 years and 51-64 years) to understand the current patterns in the use of TKM services by the older population. Using data from the 2017 National Survey of TKM Usage, we analyzed the main purpose and diseases or symptoms for TKM use, the reason for choosing TKM over other types of medicine, and the treatments provided. Both age groups sought TKM services to "[treat] a disease". The top five diseases and symptoms in the older adult (65 and older) group were musculoskeletal and are as follows: arthritis and joint diseases (37.8%, n = 166), disc-related diseases (25.5%, n = 112), back pain (8.4%, n = 37), frozen shoulder and shoulder pain (7.7%, n = 34), and sprain (5.9%, n = 26). The most frequently used treatments for these diseases were acupuncture, moxibustion, cupping, and physiotherapy. The present study suggests that older adults primarily used TKM clinics for the treatment of musculoskeletal diseases. Further studies are necessary to assess the clinical effectiveness of conventional medicine versus TKM versus a combination of both in treating musculoskeletal disorders.

Adaptation and Dissemination of Korean Medicine Clinical Practice Guidelines for Traffic Injuries.

In South Korea, car insurance that includes medical coverage of traditional Korean medicine (TKM) has increased exponentially. Clinical practice guidelines (CPG) for traffic injuries were established in 2016. We aimed to revise and update de novo CPG and distribute the adapted CPG to TKM practitioners and patients. Clinical key questions from previous CPG were identified and updated regarding the grade of recommendation and level of evidence using additional evidence from the literature obtained through a systematic search and the use of the Grading of Recommendations Assessment, Development, and Evaluation methodology. The dissemination and implementation of the updated CPG were conducted at the CPG Center of Korean Medicine. Ultimately, 25 recommendations based on 13 clinical key questions were developed: 2 for diagnosis, 22 for TKM treatments, and 1 for prognosis. After recognition by professional societies and certification by the CPG Center of Korean Medicine, leaflets, card news, and infographics for TKM doctors in South Korea were produced and distributed. These are the only TKM CPG for patients who have experienced traffic injuries. They are expected to contribute to standardized and evidence-based treatment using TKM and similar interventions. Moreover, disseminating the adapted CPG will promote treatment reliability and strengthen insurance coverage.

Monitoring of Heavy Metals and Pesticide Residues of Herbal Decoctions in Traditional Korean Medicine Clinics in Korea.

In this study, we investigated whether the levels of heavy metal and pesticide residues in herbal decoctions in Korea in 2019 were within normal limits. In total, 30 decoctions composed of multi-ingredient traditional herbs were sampled from traditional Korean medicine (TKM) clinics, TKM hospitals, and external herbal dispensaries in 2019. The decoctions were analyzed for heavy metal content such as lead, arsenic, and cadmium using inductively coupled plasma optical emission spectrometry. For mercury, an automatic mercury analyzer based on the gold amalgamation process was used. For pesticide residues, gas chromatography with electron capture detection and gas chromatography with mass selective detection were used for the analyses. Based on the testing, heavy metals were identified in most of the decoctions (Cd: 0.000-0.003 ppm, Pb: 0.003-0.023 ppm, As: 0.000-0.016 ppm, Hg: 0.000-0.002 ppm). Pesticide residues (e.g., total DDT, total BHC, aldrin, endrin, dieldrin) were not detected at all. All of these were no more than the limit values in preceding studies. Therefore, this study confirms that the contents of heavy metals and pesticides in herbal decoctions are within safe levels based on a previous study and provides evidence for establishing safety management standards for herbal decoctions in Korea.

Pain, disability, and MRI changes in lumbar disc herniation patients treated with integrative medicine: Ten-year results of an observational study.

BACKGROUND: To date, a 10-year follow-up study on complementary and alternative medical treatment of lumbar intervertebral disc herniation (LDH) has never been conducted. Therefore, we aimed to perform a prospective 10-year follow-up study on the integrated treatment of LDH in Korea. METHODS: One hundred and fifty patients from the baseline study, who initially met the LDH diagnostic criteria with a chief complaint of radiating pain and received integrated treatment, were recruited for this follow-up study. The 10-year follow-up was conducted from February 2018 to March 2018 on pain, disability, satisfaction, quality of life, and changes in herniated disc, muscles, and fat through magnetic resonance imaging. RESULTS: Sixty-five patients were included in this follow-up study. Visual analogue scale score for lower back pain and radiating leg pain were maintained at a significantly lower level than the baseline level. Significant improvements in Oswestry disability index and quality of life were consistently present. MRI confirmed that disc herniation size was reduced over the 10-year follow-up. In total, 95.38% of the patients were either "satisfied" or "extremely satisfied" with the treatment outcomes and 89.23% of the patients claimed their condition "improved" or "highly improved" at the 10-year follow-up. CONCLUSIONS: The reduced pain and improved disability was maintained over 10 years in patients with LDH who were treated with nonsurgical Korean medical treatment 10 years ago. Nonsurgical traditional Korean medical treatment for LDH produced beneficial long-term effects, but future large-scale randomized controlled trials for LDH are needed. STUDY REGISTRATION: ClinicalTrials.gov, NCT03426215.

The process of National Health Insurance coverage for Chuna Manual Therapy in Korea: A qualitative study.

BACKGROUND: Chuna Manual Therapy (CMT) has been widely used in Korea, and coverage in Korean National Health Insurance (NHI) was finally implemented in 2019. The objectives of this study were to analyze the process of NHI coverage for CMT qualitatively, and to summarize important roles, streams, and implications regarding its inclusion in the modern public health insurance system. METHODS: Related literature was collected and 8 key personnel involved in the policy-making process were qualitatively interviewed, and Zahariadis' version of the Multiple Streams Framework (MSF) was applied to analyze the policy agenda setting and the roles of stakeholders. RESULTS: Through the collaborative efforts of various stakeholders, a pilot coverage project for CMT was implemented in 2017, and coverage was expanded nationwide in 2019. MSF showed that it was mainly achieved through three streams: governmental change (political stream), demand from the general public and KM doctors (problem stream), and strengthening/reinforcement of the feasibility and acceptability of the policy (policy steam). Also, the roles of policy entrepreneurs and resulting changes were shown to be significant for the overall process. CONCLUSION: NHI coverage for CMT was realized through collective policy and research efforts from the government and academic sectors. The roles of stakeholders were shown to be significant in the overall process, and documentation of their involvement is hoped to be of use of other countries that utilize traditional and/or manual medicine.

Efficacy of acupuncture for whiplash injury: A protocol for systematic review and meta-analysis.

BACKGROUND: Studies in both Eastern & Western countries such as the United States and Europe have evaluated the efficacy of acupuncture for whiplash injury or whiplash-associated disorder (WAD). However, no systematic reviews on the effectiveness of acupuncture on WAD have been conducted since 2014. Therefore, we are planning an updated systematic review of studies published since 2014 to overcome the limitations of existing evidence. METHODS: Literature will be identified from searches of relevant databases, including international databases such as PubMed, Ovid-Medline, Embase, The Cochrane Library, and China National Knowledge Infrastructure and Korean databases such as Korea Med, Korean Studies Information Service System, Oriental Medicine Advanced Searching Integrated System, and National Digital Science Library. Only randomized controlled trials using acupuncture or electro-acupuncture for whiplash injury will be included. The primary outcomes will be the visual analog scale or numerical rating scale of the neck pain, while the secondary outcome is the range of motion of the neck. The risk of bias for individual papers will be assessed by two independent investigators using the Cochrane "Risk of Bias" assessment tool. DISSEMINATION: We plan to report the results of the study in a peer-reviewed journal after completing the research. In addition, we expect this study to provide invaluable information to clinicians treating patients with WAD with acupuncture or electro-acupuncture. TRIAL REGISTRATION NUMBER: PROSPERO 2021: CRD42021261595. Registered on 18 July 2021. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=261595.

Cost-Effectiveness of Chuna Manual Therapy and Usual Care, Compared with Usual Care Only for People with Neck Pain following Traffic Accidents: A Multicenter Randomized Controlled Trial.

This is the first cost-effectiveness analysis of Chuna manual therapy (CMT) plus usual Korean traditional medicine for traffic accident victims using a randomized controlled trial. A total of 132 participants were equally allocated to the intervention group receiving 6-11 sessions of CMT plus usual Korean traditional medicine care for three weeks or usual care including acupuncture, cupping, herbal medicine, moxibustion, and traditional physiotherapy at three hospitals. At 12 weeks, from a healthcare perspective, the intervention group had significantly higher costs (mean (SD), $778 (435) vs. $618 (318); difference, $160; 95% CI, $15 to $289; p = 0.005). From a societal perspective, total costs were insignificantly lower in the intervention group (mean (SD), $1077 (1081) vs. $1146 (1485); difference, $-69; 95% CI, $-568 to $377; p = 0.761). The intervention group dominated, with significantly higher QALYs gained at lower overall cost with a 72% chance of being cost-effective. From a societal perspective, the intervention was cost-saving for individuals who had neck pain after car accidents, although it was not cost-effective from the healthcare perspective ($40,038 per QALY gained). Findings support use of CMT as an integrated care treatment for whiplash from a societal perspective. Further studies with larger sample sizes are needed to determine cost-effectiveness in other cultural contexts.

Chuna Manual Therapy vs Usual Care for Patients With Nonspecific Chronic Neck Pain: A Randomized Clinical Trial.

Importance: The incidence rate of neck pain is increasing worldwide, and the disease is associated with a high social burden. Manual therapy has been widely applied in the treatment of neck pain, but a high-quality, pragmatic randomized clinical trial for this treatment has not been conducted to date. Objective: This study aimed to compare the effectiveness of Chuna manual therapy with that of usual care for patients with chronic neck pain. Design, Setting, and Participants: A multicenter, assessor-blinded, pragmatic, randomized clinical trial was conducted between October 18, 2017, and June 28, 2019. This intention-to-treat analysis included 108 patients with chronic neck pain persisting for at least 3 months; patients were recruited from 5 hospitals in Korea. Interventions: Ten sessions (2 sessions per week for 5 weeks) of Chuna manual therapy or usual care (electrotherapy and oral medication) were conducted. Main Outcomes and Measures: The main outcome was the difference in visual analog scale (VAS) score for chronic neck pain between baseline and 5 weeks after randomization. Results: This randomized clinical trial recruited 108 patients (mean [SD] age, 38.4 [9.3] years; 73 women [67.6%]). Fifty-four patients were allocated to the Chuna therapy group, and 54 received usual care. At 5 weeks after randomization, manual therapy showed statistically superior results compared with usual care in terms of pain (difference in chronic neck pain VAS, 16.8 mm; 95% CI, 10.1-23.5 mm), function (difference in Neck Disability Index, 8.6%; 95% CI, 4.2%-13.1%), and quality of life (difference in the European Quality of Life-5 Dimension 5 Levels (EQ-5D-5L) scores, -0.07 points; 95% CI, -0.11 to -0.02 points). Regarding the 1-year cumulative values measured using area under the curve analyses, superior outcomes were attained in the manual therapy group in terms of the numerical rating scale for chronic neck pain (1.3 points; 95% CI, 0.5-2.0 points), Neck Disability Index (6.7%; 95% CI, 2.5%-10.9%), Neck Pain Questionnaire (7.4%; 95% CI, 2.3%-12.6%), and EQ-5D-5L scores (-0.03 points; -0.07 to 0.00 points). Conclusions and Relevance: In this randomized clinical trial, for patients with chronic neck pain, Chuna manual therapy was more effective than usual care in terms of pain and functional recovery at 5 weeks and 1 year after randomization. These results support the need to consider recommending manual therapies as primary care treatments for chronic neck pain. Trial Registration: ClinicalTrials.gov identifier: NCT03294785.

Factors influencing clinical symptoms and treatment of patients with traffic accident injuries: A retrospective chart review with a questionnaire survey.

This study analyzed factors influencing clinical symptoms and treatment of patients with traffic accident injuries. It used a retrospective chart review and questionnaire survey obtained from 560 patients (266 men and 294 women). It also conducted follow-up observations of progress after car insurance settlements and investigated the usefulness of and patient satisfaction with integrative Korean medicine treatment for traffic accident injuries. Retrospective data of patients admitted for traffic accident injury were obtained. A questionnaire survey was conducted to collect data regarding the degree of traffic accident damage, severity of pain at settlement, any treatment after settlement and duration and cost of such treatment, and patient satisfaction with car insurance services and Korean medicine treatment for traffic accident injury. The results showed no significant association between pain and the degree of damage to the car at the time of traffic accident (P = 0.662), although the degree of damage to the car was more significantly associated with time to reach a car insurance settlement than severity of pain in the patient (P = 0.003). There was no significant association between the degree of damage to the car in a traffic accident and pain after a traffic accident. Greater severity of pain at the time of the car insurance settlement was associated with greater cost and longer time spent in treatment after the car insurance settlement.

Animal Venom for Medical Usage in Pharmacopuncture in Korean Medicine: Current Status and Clinical Implication.

Animal venoms, widespread throughout the world, are complex mixtures, the composition of which depends on the venom-producing species. The objective of this study was to contribute to the development of animal venom-based medicines by investigating the use of animal venom pharmacopuncture in Korean medicine (KM) institutions. We surveyed 256 public health centers from 1 through 31 October 2019 as guided by the Ministry of Health and Welfare (MoHW). A questionnaire developed by an expert group was distributed and collected for statistical analysis. The survey identified three types of animal venom-based pharmacopuncture: bee, snake, and toad venoms. The medications are based on a single animal venom ingredient and produced in 11 external herbal dispensaries (EHDs). Each animal venom is processed, refined, and freeze-dried in a cleanroom to produce a powder formulation that is later measured, diluted, filtered, filled, sealed, sterilized, and packaged as pharmacopuncture injections used in KM institutions. Bee venom therapy is effective in treating musculoskeletal pain, snake venom therapy is effective in controlling bleeding during surgery, and toad venom therapy is effective in cancer treatment. The study suggests that bee, snake, and toad venoms could be used in medical institutions and have the potential for drug development.

Multicentre randomised controlled clinical trial of electroacupuncture with usual care for patients with non-acute pain after back surgery.

BACKGROUND: The purpose of this study was to investigate the effectiveness and safety between electroacupuncture (EA) combined with usual care (UC) and UC alone for pain reduction and functional improvement in patients with non-acute low back pain (LBP) after back surgery. METHODS: In this multicentre, randomised, assessor-blinded active-controlled trial, 108 participants were equally randomised to either the EA with UC or the UC alone. Participants in the EA with UC group received EA treatment and UC treatment twice a week for 4 weeks; those allocated to the UC group received only UC. The primary outcome was the VAS pain intensity score. The secondary outcomes were functional improvement (Oswestry Disability Index [ODI]) and the quality of life (EuroQol-5-dimension questionnaire [EQ-5D]). The outcomes were measured at Week 5. RESULTS: Significant reductions were observed in the VAS (mean difference [MD] -8.15; P=0.0311) and ODI scores (MD -3.98; P=0.0460) between two groups after 4 weeks of treatment. No meaningful differences were found in the EQ-5D scores and incidence of adverse events (AEs) between the groups. The reported AEs did not have a causal relationship with EA treatment. CONCLUSIONS: The results showed that EA with UC treatment was more effective than UC alone and relatively safe in patients with non-acute LBP after back surgery. EA with UC treatment may be considered as an effective, integrated, conservative treatment for patients with non-acute LBP after back surgery. CLINICAL TRIAL REGISTRATION: KCT0001939.

Current status and future perspective of external herbal dispensaries preparing traditional herbal medicine in South Korea: the first National-Wide Survey results.

BACKGROUND: An external herbal dispensary (EHD) is a type of pharmacy that provides various types of personalized herbal medicines (PHMs) to other traditional Korean medicine (TKM) institutions. Such dispensaries were legalized by the Ministry of Health and Welfare (MoHW) in 2008 in South Korea. The purpose of this study is to understand the current status of the EHD facilities and their quality controls and compare them with the good manufacture practice (GMP) guidelines to contribute to the establishment of the safety and quality control criteria for PHMs. METHODS: We contacted 107 EHD representatives or people in charge of the preparation of PHMs (TKM pharmacists) and invited them to complete a survey questionnaire; of the total, 81 responded. The survey questionnaire was developed in 3 stages: drafting, revision by external experts, and final editing. It consisted of 20 questions covering 3 sections: basic characteristics of EHDs, facility, and quality control. The survey was hosted online from December 2017 to January 2018 as guided by the MoHW. RESULTS: The completion rate was 75.7% (n = 81). In terms of facilities, the five facilities (water supply, manufacture, pest control, hygiene management and warehousing) that corresponded to the legal requirements of EHD were mostly equipped, but the types of facilities and equipment differed. Two facilities (sterilization and cross-contamination that were not legally required for EHD were found to have mostly pharmacopuncture-EHD (P-EHD), but hardly any herbal medicine-EHD (H-EHD). In our findings regarding quality control of non-medicinal herbs, sensory evaluation that included checks for foreign bodies and deterioration were conducted. In terms of the quality control of herbal medicines, residual pesticides and heavy metals tests were performed and for pharmacopuncture, pH, salinity, sterility, and endotoxin tests along with gross examination were performed. In the end, we found that 6 of the 38 standard items as required by the Korea GMP were suitable. CONCLUSIONS: In this study, detailed information for each existing EHD law was determined through a nationwide questionnaire. Moreover, the basis for its reflection in additional legal standards should be introduced so that safe herbal medicine can be prepared in EHDs.

Korean medicine registry for low back pain - A study protocol for prospective observational multi-center study (KLOS).

BACKGROUND: Low back pain (LBP) is a major burden in Korea. Despite its high prevalence, the government and the public health sector do not address the specific evidences of symptom control and prevention of LBP to reduce long-term healthcare costs and increase the quality of life. Thus, the Korean medicine sector encourages to collection and analysis of the medical utilization pattern of patients with LBP in Korea to provide evidences of LBP control strategy as well as political decisions. METHODS: KLOS, a prospective, multi-center, patient registry pilot study will collaborate with 7 traditional Korean medicine hospitals and recruit patients with LBP into the registry. A total of 150 eligible patients with new episodes of LBP, who visit a Korean hospital without any other treatment history, will be enrolled in the registry. After enrollment, we will collect the individual characteristics of each patient, such as pain intensity, LBP-related daily disability, anthropometrics, and Health-Related Quality of Life (HRQoL) at baseline and FU1 and FU2. We will also access the patients' clinical and administrative electronic records to analyze the pattern of patients' resource utilization. Overall, the aims of KLOS are to (1) explore the general characteristics of patients with new episodes of LBP and (2) evaluate the efficacy and safety of various Korean medicine treatments for LBP, based on nationwide registry outcome collecting process. DISCUSSION: The first pilot study of prospective, multi-center registry of newly diagnosed LBP patients in traditional Korean medicine hospitals. The result of this study may show the current status of LBP patients who receive Korean medicine treatments and provide evidences for reasonable decision-making on Korean medicine healthcare policy in the future. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT02418286.