Development of the Korean Medicine Core Outcome Set for Facial Palsy: herbal medicine treatment of patients with facial palsy in primary clinics.

Introduction: Facial palsy (FP) significantly affects the quality of life of patients and poses a treatment challenge in primary healthcare settings. This study aimed to develop a Korean medicine (KM) core outcome set (COS) for FP, with a focus on evaluating the effectiveness of herbal medicine (HM) treatments in KM primary clinics. Methods: Outcomes and effect modifiers related to FP treatments were initially identified through related review articles. Subsequently, experts in the field took part in three rounds of modified Delphi consensus exercises to refine and prioritize these outcomes and effect modifiers. Additionally, primary KM clinicians were involved in a Delphi consensus round to assess the suitability and feasibility of the proposed COS in real-world clinical settings. Results: The initial review of related literature identified 44 relevant studies, resulting in an initial selection of 23 outcomes and 10 effect modifiers. The expert consensus process refined these to 8 key outcomes and 6 effect modifiers, which established the foundation of the COS-FP-KM. Subsequently, primary KM clinicians confirmed the practicality and applicability of the COS, endorsing its suitability for use in KM primary clinics. Conclusion: The COS-FP-KM establishes a standardized approach for assessing HM treatment effectiveness in FP patients in KM primary clinics. The COS-FP-KM encourages consistent outcome reporting and enhances patient care quality. Future work should aim to integrate broader stakeholder perspectives to refine and validate the COS further.

Evaluation of clinical effectiveness of blood stasis leaflet in patients with blood stasis: A prospective, randomized, and crossover trial.

BACKGROUND: Blood stasis (BS) refers to a pattern of symptoms resulting from circulatory dysfunction or stagnation in the human body. Due to its historical origin and diverse interpretations, communication between patients and doctors of traditional Korean medicine (DKMs) presents challenges. Efforts to improve patients understanding in traditional Korean medicine (TKM) have led to the development of disease-specific standard clinical practice guidelines. However, there is a limited focus on creating clinical practice guidelines or informative leaflet specifically addressing BS, which is a frequently encountered pattern of symptoms in TKM. METHODS: This study aimed to bridge the gap between patients and DKMs by developing an informative leaflet focusing on BS for metabolic diseases. We assessed its appropriateness through expert advisory meetings and the Delphi process, and evaluated its clinical effectiveness. We conducted a prospective, randomized, crossover trial to compare the clinical effectiveness of using BS leaflets in TKM treatment. The hypothesis investigated whether the leaflet group would show higher scores in satisfaction of DKMs' explanations, understanding of DKMs' explanations, improving the reliability of TKM, satisfaction with treatment time, improvement in explanations compared to previous TKM experiences, and necessity of managing BS treatment, compared to the no-leaflet group. RESULTS: In a study involving 40 patients (mean age: 62.3 ±â€…7.8 years), symptoms persisted for an average of 16.75 ±â€…9.3 hours daily, with a severity rating of 2.53. The leaflet group exhibited significantly higher satisfaction scores than the no-leaflet group in all aspects (all P < .0001). After confirming the absence of sequence and period effects using a linear-mixed effect model, we were able to ascertain the presence of a treatment effect, as evidenced by statistically significant higher scores across all survey items in the leaflet group compared to the no-leaflet group (all P < .0001). CONCLUSION: Expert consensus on symptoms aligning with the BS pattern resulted in the development of an informative leaflet. Its utilization notably improved patient satisfaction, comprehension, and trust in TKM treatment, unaffected by temporal influences, thus demonstrating its clinical effectiveness. In summary, the BS leaflet significantly enhanced patient understanding and optimized treatment procedures.

Development of the Blood Stasis Questionnaire for Gynecological Diseases: An Analytical Cross-Sectional Study.

OBJECTIVES: Blood stasis is the slowing or stagnation of blood and can cause metabolic, musculoskeletal, and gynecological diseases. This study developed the Blood Stasis Questionnaire for gynecological disease (BSQ-GD) by extracting clinical indicators related to gynecological diseases using the Blood Stasis Questionnaires I and II (BSQ-I and II, respectively) and analyzed the clinical data of a cross-sectional study. PATIENTS AND METHODS: In total, 103 women aged between 25 and 65 years who met gynecological disease criteria were enrolled in this study. Blood stasis scores (BSS) were evaluated using the BSQ-II and categorized into BSS and non-BSS groups. To assess the reliability of BSQ-GD, the internal consistency coefficient was employed using Cronbach's α. Furthermore, correlation analyses were conducted for the clinical symptoms related to gynecological diseases, and the discriminant validity was confirmed by comparing the two groups. The prediction accuracy was determined using logistic regression and the cut-off value of the BSQ-GD was established via the sensitivity and specificity calculations. RESULTS: The BSQ-GD showed satisfactory internal consistency (Cronbach's α coefficient = 0.71) and validity, with significant differences in mean scores between blood stasis (22.30 ± 3.34) and non-blood stasis (14.93 ± 3.49) groups. The cut-off value of the BSQ-GD score was 19 points when the Youden index (73.45) and the concordance probability (0.75) were at their maximum. The area under the receiver operating characteristic curve was approximately 96%, and the sensitivity and specificity of the diagnostic accuracy according to the cut-off value are 80.95% and 92.50%, respectively. CONCLUSION: The BSQ-GD can be an appropriate instrument to estimate blood stasis in patients with gynecological diseases; its diagnostic sensitivity according to the cut-off value is high.

Reliability and validity of a Korean version of the children's eating behavior questionnaire in anorexia context.

Background: Although childhood anorexia is a common clinical disorder, there is no established tool for evaluating it. The Children's Eating Behavior Questionnaire (CEBQ) is a parent-reported measure designed to assess the eating behavior of children. We aimed to investigate the reliability and validity of the Korean version of the CEBQ (K-CEBQ) for children with anorexia. Methods: Parents of children with anorexia aged between 2 and 9 years participated in a survey conducted twice at 1-month intervals. The general characteristics and K-CEBQ scores of the children were recorded. To assess the reliability of the K-CEBQ, the internal consistency and test-retest methods were used. Furthermore, correlation analysis was performed for each item and factor, and the discriminant validity was determined through comparison with the normal group. Optimal cut-off scores, which are based on the maximum area under the curve of the receiver operating characteristic curve, were calculated in two categories. Results: A total of 336 participants responded to the first survey, and the responses from 171 participants from the second survey were included in the analysis. The K-CEBQ showed relatively high internal consistency reliability (Cronbach's alpha = 0.738), and the retest demonstrated sufficient temporal stability. The relationship between each item of the K-CEBQ and the factor to which the item belongs showed a high correlation. There were significant differences between the anorexia and normal groups in two categories of the K-CEBQ: 'food approach' (p = 0.0063) and 'food avoidant' (p < 0.0001). The optimal cut-off values for the 'food approach' and 'food avoidant' category scores were 39.50 and 58.50 points, respectively. Conclusion: This study demonstrated that the K-CEBQ may be a reliable and valid tool for assessing the eating behavior of children with anorexia.

The clinical effects of Gyejibongnyeong-Hwan (Gui Zhi Fu Ling Wan) on patients with hyperlipidemia: A study protocol for a multicenter, double-blind, two-armed parallel, investigator-initiated, exploratory randomized controlled trial.

BACKGROUND: Hyperlipidemia, the most common form of dyslipidemia, is associated with an increased risk of atherosclerotic cardiovascular diseases. There is a constant demand for therapeutic agents with relatively few side effects that can be administered from the initial stage of hyperlipidemia, herbal medicines derived from natural products can be considered candidates for treating dyslipidemia. This study aims to explore the feasibility, preliminary effectiveness, and safety of Gyejibongnyeong-Hwan (GBH) in patients with hyperlipidemia. METHODS: This was a 2-armed, parallel, multicenter, and exploratory randomized controlled trial on dyslipidemia. We will recruit 90 patients aged 20 to 65 years with hyperlipidemia between November 2021 and December 2022. Eligible participants will be randomly assigned to receive GBH or placebo granules for 8 weeks and followed up for 4 weeks after 4 weeks of lifestyle modification. The primary outcome is the percentage changes in low-density lipoprotein cholesterol from baseline to week 8. The secondary outcomes are percentage changes in other blood lipid parameters, blood glucose parameters, and blood stasis scores. As an exploratory outcome measure, metabolite analysis will be conducted to observe changes in metabolic patterns. DISCUSSION: This is the first randomized controlled trial to explore the clinical effect and safety of GBH compared to placebo control in patients with hyperlipidemia, thereby potentially facilitating better management of hyperlipidemia. The results of this pilot study could form a foundation for future large-scale confirmatory clinical trials. ETHICS AND DISSEMINATION: This study was permitted by the Ministry of Food and Drug Safety on investigational new drug application on August 12, 2021 and approved by the Institutional Review Board of Kyung Hee University, Seoul, Republic of Korea (KOMCIRB202110012001) on November 26, 2021. The results will be published in a peer-reviewed journal and disseminated electronically and in print.

Safety and Efficacy of Bojungikki-Tang in Advanced NSCLC Patients Receiving Treatment with Immune Checkpoint Inhibitors: Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Pilot Trial.

Cancer immunotherapy with immune checkpoint inhibitors (ICIs) is a major treatment option for several types of cancer, including non-small cell lung cancer (NSCLC). The proposed study aims to investigate the safety and efficacy of Bojungikki-tang (BJIKT) therapy (an herbal medicine) in patients with advanced NSCLC treated with ICIs. This multicenter, randomized, placebo-controlled pilot study will be performed at three academic hospitals. Thirty patients with advanced NSCLC, undergoing atezolizumab monotherapy as second- and subsequent-line treatment, will be recruited and randomly assigned to either BJIKT treatment (atezolizumab + BJIKT) or placebo (atezolizumab + placebo). The primary and secondary outcomes are the incidence of adverse events (AEs), including immune- related AEs (irAEs) and non-immune-related AEs (non-irAEs); and early termination rate, withdrawal period, symptom improvement of fatigue, and skeletal muscle loss, respectively. The exploratory outcomes are patient objective response rate and immune profile. This is an ongoing trial. Recruitment started on 25 March 2022 and is expected to be completed by 30 June 2023. This study will provide basic evidence for the safety profiles, including irAEs, of herbal medicine in patients with advanced NSCLC treated with ICIs.

Development of the Korean Medicine Core Outcome Set for Primary Dysmenorrhea (COS-PD-KM) for Herbal Medicine Treatment of Primary Dysmenorrhea in Primary Clinics.

The aim of this study was to develop a Korean medicine (KM) core outcome set (COS) for primary dysmenorrhea to evaluate the effectiveness of herbal medicine (HM) in treating primary dysmenorrhea in patients visiting KM primary clinics. Previously reported outcomes were identified through a literature review to define outcomes and effect modifiers (EMs) for the questionnaire. Experts were invited to conduct modified Delphi consensus exercises, and primary care clinicians were invited to conduct Delphi consensus exercises to evaluate suitability and feasibility. Finally, an additional round of a modified Delphi exercise was conducted with experts to obtain a final agreement on the COS. Seventeen outcomes and 15 EMs were included from a literature review, and one effect modifier was suggested by the experts (Phase 1). In Phase 2, after the modified Delphi consensus exercises by experts, 10 outcomes and 11 EMs were included in the COS. The clinicians all agreed on the feasibility of COS (Phase 3). Finally, 10 outcomes and 6 EMs were included in the COS-PD-KM after the final modified Delphi consensus exercise (Phase 4). The effectiveness of HM used in primary clinics could be evaluated with this COS in patients with primary dysmenorrhea. Further studies that involve more relevant stakeholder groups, such as patient representatives and gynecological experts, are needed.

Acupuncture for the treatment of childhood anorexia: A systematic review and meta-analysis.

OBJECTIVES: Childhood anorexia, among the commonest symptoms of children, involved long-term loss of appetite/decreased food intake and refusal to try or eat certain foods. Acupuncture is increasingly popular in childhood anorexia due to the side effects and dissatisfaction of conventional treatment, but, the efficacy and safety of acupuncture for childhood anorexia have not been reviewed systematically. METHODS: From 12 electronic databases, randomized controlled trials (RCTs) assessing acupuncture for childhood anorexia were identified in June 2021, with posttreatment improvement in clinical symptoms of anorexia as the primary outcome. A meta-analysis was conducted if two or more studies used the same interventions or same outcome measures. The risk of bias and quality of evidence were evaluated. RESULTS: A total of 32 RCTs with 3518 participants were included. When acupuncture was used as monotherapy or adjunctive therapy, the total effectiveness rate based on anorexia symptoms, hemoglobin levels, abdominal subcutaneous fat, and body weight significantly improved. However, results in nutritional indices were inconsistent. The recurrence rate of anorexia was significantly lower in the acupuncture group. No serious adverse events in relation to acupuncture were reported. in general, the risk of bias of the included studies was unclear and the quality of evidence for the main findings was low to moderate. CONCLUSIONS: Acupuncture may improve symptoms of childhood anorexia without serious adverse events. However, because of the low methodological quality and quality of evidence in existing reports, further high-quality clinical trials are needed to conclusively establish the efficacy and safety of this treatment.

Korean medicine registry of herbal medicine for weight loss.

INTRODUCTION: In South Korea, the prevalence of obesity has continuously increased over the last decade, and the burden of social and economic costs has also increased immensely. The purpose of this study is to investigate the clinical characteristics and current status of patients receiving herbal medicine (HM) treatment for weight loss in Korean medicine (KM) by constructing a multi-institutional prospective registry. METHODS AND ANALYSIS: This is a prospective, observational, multi-center registry, including patients visiting the KM clinics in South Korea for weight loss. This study will collaborate with 15 KM clinics and recruit patients into the registry between October 2021 and October 2022. The study population will include patients visiting the KM clinics for weight loss. A total of 1000 eligible patients visiting the KM clinics for weight loss who decide to undergo HM treatment will be enrolled in the registry. After enrollment, we will collect the individual characteristics of each patient, such as body mass index, body composition test, liver and kidney function tests, and information on prescribed HM. We will also record the adverse events at each visit. DISCUSSION: This study is the first prospective, multicenter registry of HM for weight loss in KM clinics. The results of this registry may show the current status of patients who receive HM treatments for weight loss and provide evidence for reasonable decision-making on KM healthcare policy for obese patients in the future.

Metabolomic analysis of Gyejibongnyeong-Hwan for shoulder pain: A randomized, wait-list controlled pilot trial.

BACKGROUND: In Korea, Gyejibongnyeong-Hwan (GBH), a herbal decoction used to treat blood stasis (BS), is widely used to treat shoulder pain in clinics. Nevertheless, the therapeutic mechanism of GBH in alleviating shoulder pain has not yet been elucidated. PURPOSE: In this study, we applied mass spectrometry-based metabolomics to explore the therapeutic mechanism of GBH in BS-induced shoulder pain. STUDY DESIGN: We conducted a two-center, randomized, wait-list controlled pilot trial to explore the therapeutic effect of GBH on shoulder discomfort related to BS. METHODS: A total of 40 participants with shoulder pain were randomly assigned to either the immediate treatment (GBH-Treat; n = 20) or waiting treatment (Wait-List; n = 20) group. A non-targeted metabolomics approach was then applied to investigate the therapeutic mechanism of GBH. RESULTS: After 8 weeks of treatment, the visual analog scale (VAS) scores for shoulder pain decreased significantly in the GBH-Treat and Wait-List groups compared with baseline VAS scores (p = 0.004 and p = 0.013, respectively). However, the VAS and BS scores were significantly more reduced in the GBH-Treat group than in the Wait-List group. The plasma metabolic pattern between GBH-Treat and Wait-List groups also differed significantly, which was shown by the score plot of a partial least-squared-discriminant analysis (R2 = 0.806 and Q2 = 0.229, p = 0.016). Arginine, bilirubin, carnitine, glutamine, maltol, mystic acid, N,N dimethylarginine, trimethylamine N-oxide, valine, kynurenine, and linoleic acid significantly contributed to the different metabolic patterns between the GBH-Treat and Wait-List groups (all p < 0.05). Pathway analysis revealed that these metabolites were involved in arginine biosynthesis and tryptophan metabolism, which are related to pain generation and transmission. We also confirmed that the ratio of kynurenine to tryptophan, one of the indicators for chronic pain and neuro-inflammation, was significantly lower in the GBH-Treat group than in the Wait-List group (p = 0.02). CONCLUSION: These results demonstrated that GBH may be a potential treatment option for shoulder pain, and it acts by regulating metabolic patterns. In particular, our study provides evidence for the use of GBH treatment for patients with should pain caused by BS, and we believe that our findings can provide evidence for precision medicine based on traditional Chinese medicine (TCM) or traditional Korean medicine (TKM). We also verified that metabolomics studies provide comprehensive understanding of herbal decoctions in TCM or TKM.

Development of the Korean Medicine Core Outcome Set for Stroke Sequelae: Herbal Medicine Treatment of Elderly Patients With Stroke Sequelae in Primary Clinics.

Objectives: We developed a Korean medicine core outcome set for stroke sequelae (COS-SS-KM) to evaluate the effectiveness and safety of herbal medicine (HM) for stroke sequelae, especially for elderly stroke patients in primary clinics. Methods: We identified previously reported outcomes from a literature review and defined the list of outcomes and effect modifiers for the core outcome set (COS) questionnaire. Three rounds of modified Delphi consensus exercises with experts were conducted online for suitability assessment, and one round of a modified Delphi consensus exercise with primary clinicians was conducted for feasibility assessment. Results: The review identified 17 outcomes and 16 effect modifiers; moreover, six outcomes and one effect modifier were suggested by the experts. The final COS comprised 8 outcomes and 12 effect modifiers for history taking, and experts listed 13 major symptoms of stroke sequelae for symptom assessment. The clinicians agreed on the feasibility of the COS. Conclusion: This COS will help primary care researchers assess the effectiveness of pharmacotherapy, including HM, for elderly patients with stroke sequelae. Future studies should focus on reflecting the opinions of all stakeholders.

Effects of Bojungikgi-tang on anorexic patients with atopic dermatitis: A protocol for a randomized, usual care-controlled, assessor-blinded, parallel, pilot clinical trial.

BACKGROUND: Anorexia and atopic dermatitis (AD) are highly prevalent diseases, and the herbal medicine Bojungikgi-tang (BJT) has been frequently used for the treatment of both anorexia and AD. However, no study has simultaneously evaluated the effects of BJT for both anorexia and AD. METHODS: A prospective, randomized, usual care-controlled, assessor-blinded. parallel, pilot clinical trial has been designed to explore the feasibility, preliminary effectiveness, and safety of BJT for the treatment of anorexic patients with AD. Forty anorexic patients with AD will be randomly assigned (1:1) to BJT or the usual care group. The BJT group will be administered BJT granules twice a day for 8 weeks and followed up for 4 weeks whereas the usual care group will not receive BJT granules. All participants in both groups will be provided with over-the-counter topical corticosteroids as a relief drug. Data will be collected at baseline and at 4, 8, and 12 weeks after randomization. The primary outcome is the score on the anorexia visual analog scale at 8 weeks post-treatment. The secondary outcomes include body weight, body fat percentage, body fat mass, skeletal muscle mass, SCORing of Atopic Dermatitis index, Validated Investigator Global Assessment scale for Atopic Dermatitis, Dermatology Life Quality Index, EuroQoL 5 Dimension 5 Level, deficiency and excess pattern identification questionnaire, total immunoglobulin E, eosinophil count, and frequency and amount of use of topical corticosteroids. Adverse events and laboratory test results will be monitored to assess safety. Fecal samples to check for gut microbiome changes and blood samples to check immune and metabolic markers will be collected before and after taking BJT. DISCUSSION: This is the first trial that explores the preliminary effectiveness and safety of BJT for the treatment of anorexic patients with AD. The results of this pilot study will provide the basic evidence for large-scale, confirmatory, multicenter, high-quality clinical trials. TRIAL REGISTRATION: Clinical Research Information Service, KCT0006784 (registered on November 26, 2021).

A national survey on current clinical practice pattern of Korean Medicine doctors for treating obesity.

BACKGROUND AND AIMS: Given the multifactorial nature of obesity, there is current interest on Korean medicine (KM) for weight loss. This survey aimed to investigate current practice patterns of KM treatment for obesity among doctors. METHODS: A questionnaire on clinical practice patterns of KM treatment for obesity was constructed and distributed to 21,788 KM doctors (KMDs). The questionnaire was consisted of respondent characteristics, state of treated patient, diagnosis, treatment, and usage pattern of herbal medicine for obesity. RESULTS: A total of 4.9% of KMDs (n = 1,084/21,788) validly completed the survey. Patients with Obesity Class I (25 ≤ Body mass index (BMI) ≤ 29.9) are the most common in KM clinics. Bioelectric impedance and KM Obesity Pattern Identification Questionnaire were routinely used for diagnosis. The average treatment duration was 4.16 weeks, and patients visited on an average 4.25 times per month for treatment. Herbal medicine is the most commonly used for obesity treatment by KMDs, and Taeeumjowui-tang was the most frequently prescribed. Ephedrae Herba, which is identified as the most used herbs for weight loss, was prescribed 5.18 ± 2.7 g/day at minimum and 10.06 ± 4.23 g/day at maximum. A total of 62.9% of responded KMDs had ever a patient with uncomfortable symptoms due to Ephedrae Herba use, neuropsychiatric events were the most common symptoms, followed by gastrointestinal events. CONCLUSION: Taken together, this study provides information on real clinical practice patterns of KM including patients, diagnosis, treatments, and herbal medicine for obesity.

Association of serum resistin with blood stasis syndrome in traditional Korean medicine for metabolic diseases: A cross-sectional multicenter observational study.

BACKGROUND: Blood stasis syndrome (BSS) is considered as the cause of several chronic disease including metabolic diseases in traditional East Asian medicine. In this study, we investigated the levels of serum resistin and other proteins related to metabolic syndrome (MS) and several other diseases categories to identify the association with BSS. METHODS: This was a cross-sectional, multicenter study of patients recruited from seven traditional Korean Medicine (TKM) hospitals. To identify whether there was an association with BSS in specific disease conditions, including MS, serum protein levels were evaluated using the multiplex method. RESULTS: A total of 885 patients (419 patients with BSS, 376 patients without BSS, and 90 healthy controls) participated in the study, and 139 patients had MS. The resistin and insulin levels were significantly higher in patients with BSS than in patients without BSS and normal subjects (P = 0.002 and P = 0.046, respectively). Patients with BSS who had MS exhibited significantly higher resistin levels than those in patients without BSS and normal subjects (P = 0.049). In addition, the levels of serum resistin were significantly correlated with symptoms of the BSS, especially dark red gums, dark facial complexion, and nocturnal pain. CONCLUSIONS: Despite several limitations, these results demonstrated that resistin levels are potentially associated with the pathogenesis of BSS in MS. TRIAL REGISTRATION NUMBER: Clinical Research Information Service (CRIS): KCT0000916.

Changes in plasma sclerostin level associated with use of a medium cut-off dialyzer in end-stage renal disease.

BACKGROUND: Larger middle molecules are important substances associated with cardiovascular complications in end- stage renal disease. Unfortunately, larger middle molecules are not reliably removed by a high-flux dialyzer. A medium cut-off (MCO) membrane could effectively remove larger middle molecules. This study aimed to identify the long -term effect of the MCO membrane for changes of larger middle molecules. METHODS: Thirty-four patients were prospectively analyzed for 12 months. The enrolled patients were divided into control and MCO groups. We measured the plasma levels of growth differentiation factor 15, sclerostin, and fibroblast growth factor 23 in larger middle molecules and those of biomarkers including small solutes. Single-pool Kt/V (spKt/V) and reduction ratios also were evaluated. RESULTS: Plasma sclerostin did not increase significantly in patients using the MCO dialyzer (135.3 [-637.7 to 908.3], p = 0.715). And there was a significant difference in change of plasma sclerostin level between the two groups (-1,646.9 [-3,015.2 to -278.7], p = 0.033). Furthermore, a negative association between calcium and sclerostin was not observed in the MCO group (r = -0.142, p = 0.587). Solute clearance of larger middle molecules in the MCO group was significantly higher. Moreover, spKt/V values for patients in the MCO group were significantly increased without albumin loss. Values are presented as mean (95% confidence interval [CI]) or adjusted mean (95% CI). CONCLUSION: The MCO dialyzer can increase dialytic adequacy and suppress the increase in plasma sclerostin level without significant albumin loss in patients with end-stage renal disease.

Treatment of ankle sprain or instability in Korean medicine clinics: A protocol for a prospective multicenter observational study.

BACKGROUND: Korean medicine (KM), including acupuncture, has been used to treat many patients with ankle sprains in Korea. The purpose of this prospective observational study is to determine how ankle sprains are treated using KM practice and to assess the outcomes of these treatments. METHODS: We will perform a prospective observational study to include around 200 participants from KM clinics with a chief complaint of ankle sprain or ankle instability. All participants will receive individualized KM treatments which may include acupuncture, pharmacopuncture, moxibustion, cupping therapy, and herbal medicine. The participants will be assessed on the information related to both ankle discomfort using a visual analogue scale and on the participant's overall condition including quality of life. DISCUSSION: Through this study, we would be able to collect specific and detailed data for various treatments from actual practice, such as the characteristics of the KM treatment system for treating ankle sprains or the method of acupuncture point selection. We also expect that the results of this study based on daily clinical practice will allow other researchers to create research questions that are beneficial from a clinical, societal, and patient's perspective. CLINICAL RESEARCH REGISTRATION: This study has been registered at the Clinical Research Information Service (CRiS) of Korea: KCT0004016.

An observational study on diagnosis index of metabolic disease with blood-stasis.

INTRODUCTION: Treating blood stasis is effective in treating obesity and metabolic diseases in traditional Korean medicine. The aim of this prospective observational study is to determine the effectiveness of the diagnosis index for metabolic diseases with blood stasis by analyzing clinical data and blood samples. METHODS AND ANALYSIS: We will perform a prospective observational study. Participants who meet the inclusion criteria will be recruited from the Dongguk university Ilsan Oriental hospital. The outcomes are resistin, serum amyloid P component, C-reactive protein, D-dimer, and blood stasis scores. In addition, the blood pressure, ankle-brachial pressure index, brachial-ankle pulse wave velocity, body mass index, waist circumference, and levels of blood lipid will be assessed. DISCUSSION: Through this study, we could collect specific data for diagnosing metabolic diseases with blood stasis. Therefore, the findings of this study will provide a summary of the current state of evidence regarding the effectiveness of the diagnosis index in managing metabolic disease with blood stasis. ETHICS AND DISSEMINATION: The study was approved by the Institutional Review Board of the Dongguk University Ilsan Oriental Hospital (DUIOH-2018-09-001-007). The results will be published in a peer-reviewed journal and will be disseminated electronically and in print. TRIAL REGISTRATION NUMBER: Clinical Research Information Service: KCT0003548.

Current clinical practice status of Korean medicine for managing female infertility: A cross-sectional survey.

BACKGROUND: This survey aimed to investigate clinicians' perceptions and current practice patterns of Korean medicine (KM) treatment for female infertility. METHODS: A questionnaire on clinical practice patterns of KM treatment for female infertility was constructed and distributed to 703 KM doctors (KMDs). RESULTS: A total of 20.5% of physicians (n = 144/703) completed the survey and delivered integrative care for female infertility patients. Integrative care mainly consisted of acupuncture, herbal medicine, and moxibustion. The participants largely relied on radiological findings on ultrasonography and hormone tests for diagnosis. The most frequently prescribed herbal medication was Jogyeongjongok-tang (Tiaojing Zhongyu decoction), and the most frequently applied acupoints were SP6, CV4 and ST36. CONCLUSIONS: This study provides expert opinions and information on actual clinical practice patterns of KM for treating female infertility. However, we cannot completely discount the possibility that biased selection of subjects and the low response rate limit the interpretations of the study results.

Correction to: Effectiveness of Gyejibongnyeong-Hwan for shoulder pain: study protocol for a randomised, wait-list controlled pilot trial.

After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled.

Effectiveness of Gyejibongnyeong-Hwan for shoulder pain: study protocol for a randomised, wait-list controlled pilot trial.

BACKGROUND: Shoulder pain is an uncomfortable feeling in the muscle around the shoulder. The cause of myalgia is the accumulation of lactic acid in muscles and impaired blood circulation, which is called blood stasis in traditional East Asian medicine. This study aimed to explore the therapeutic effect of Gyejibongnyeong-Hwan (GBH) for shoulder discomfort related to blood stasis before and after treatment. METHODS/DESIGN: This study will be a double-centre, randomised, wait-list controlled pilot trial. Participants with shoulder pain and with a visual analogue scale score of 4 or higher out of 10, blood stasis score of 9 or higher, and triglyceride level of ≥150 mg/dl or total cholesterol level of ≥200 mg/dl will be recruited from two university hospitals. A total of 40 participants will be assigned to the immediate and waiting treatment groups. The immediate treatment group will receive GBH for 8 weeks on enrolment while the waiting treatment group will receive GBH for 8-16 weeks after 8 weeks of controlled waiting. The primary outcome is shoulder pain, and the secondary outcomes are the blood stasis score, blood pressure, ankle-brachial pressure index, brachial-ankle pulse wave velocity, body mass index, waist circumference, indexes of oximetry, and levels of blood lipid, blood sugar, resistin, C-reactive protein, serum amyloid P, and D-dimer. DISCUSSION: The results of this pilot trial will be the bases for a full-scale clinical trial of GBH. TRIAL REGISTRATION: Clinical Research Information Service, KCT0003837. Registered on 23 April 2019. https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14258.