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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

Four Subgroups of Blood Stasis Syndrome Are Identified by Manifestation Cluster Analysis in Males.

Blood stasis syndrome (BSS) is an important pathological condition in traditional East Asian medicine and is associated with ischemic heart disease, cerebral vascular accident, diabetes mellitus, chronic renal failure, severe traumatic injury, and dysmenorrhea. However, previous studies have been unable to reveal the clinical and biological characteristics or biological markers of BSS. We hypothesized that the heterogeneity among the manifestations of BSS or non-BSS could interfere with an analysis to describe the characteristics of BSS. In this study, male participants based on the severity of BSS-associated symptoms and signs were clustered and classified into four subgroups: BSS subgroups (1), (2), (3), and (4). Non-BSS core subgroup was redefined using manifestation cluster analysis. Biological characteristics of subgroups BSS(1) and BSS(2) belong to the range of the non-BSS core subgroup (1), whereas that of subgroups BSS(3) and BSS(4) are characterized by different biological parameters such as systemic inflammatory conditions and elevated D-dimer level. Our results suggested that patients in subgroups of BSS(3) and BSS(4) are more likely to be exposed in an inflammatory state than other BSS subgroups. We found the heterogeneity among the manifestations which could mask the characteristics of BSS and identified the clinical and biological profiles of the four BSS subgroups through comparisons of the redefined non-BSS and BSS subgroups. This finding could provide accurate diagnostic criteria and new approaches for BSS treatments in different subgroups.

A Study on the Development of a Korean Metabolic Syndrome Questionnaire Using Blood Stasis Clinical Data.

OBJECTIVE: The aims of this study were to extract clinical indicators related to metabolic diseases using the Blood Stasis Questionnaires I and II (BSQ-I and II) developed in 2013 and 2014, respectively, and to develop a BSQ on metabolic syndrome (BSQ-MS). METHODS: A total of 2,158 patients, comprising 1,214 from 7 traditional Korean medical hospitals in 2013 and 944 from 3 traditional Korean medical hospitals in 2014, were asked to complete the BSQ-I and BSQ-II. For the 370 patients who met the metabolic syndrome criteria, reliability and validity of the BSQ-MS were assessed using Cronbach's alpha, while prediction accuracy was determined by logistic regression. RESULTS: The BSQ-MS included a total of 15 clinical signs and symptoms. It showed satisfactory internal consistency (Cronbach's α coefficient=0.70) and validity, with significant differences in mean scores between the blood stasis (14.09±6.14) and non-blood stasis (9.09±5.60) subject groups. The cut-off value of BSQ-MS score was 9 points, the area under the receiver operating characteristic curve was approximately 77%, the sensitivity and specificity of the diagnostic accuracy according to the cut-off value were 82.9% and 49.7%, respectively, and the sensitivity and specificity of the prediction accuracy by logistic regression were 72.2% and 71.6%, respectively. CONCLUSION: These results suggest that the BSQ-MS is an appropriate instrument for estimating blood stasis in patients with metabolic syndrome, although its sensitivity for diagnosis according to the cut-off value is low.

Herbal medicines for metabolic diseases with blood stasis: A protocol for a systematic review and meta-analysis.

BACKGROUND: Herbal medicines have the potential to be alternative treatments for metabolic diseases. This systematic review will assess the efficacy of herbal medicines in treating metabolic diseases with blood stasis. METHODS AND ANALYSIS: We will search MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, 2 Korean medical databases (OASIS, NDSL), a Chinese database (China National Knowledge Infrastructure, CNKI), and a Japanese database (J-STAGE) for relevant literature. We will include all randomized controlled trials (RCTs) or quasi-RCTs evaluating the effectiveness of herbal medicine. Participants of both sexes and of any age with clinically diagnosed metabolic disease with blood stasis will be included. Primary outcomes will include Blood-stasis syndrome score, TC, TG, HDL-C and LDL-C. Secondary outcomes will Blood pressure, FBS. ECG, prevalence rate of heart disease, and response rate. The risk of bias will be assessed using the Cochrane tool for assessing risk of bias. DISCUSSION: The findings of this study will provide a summary of the current state of evidence regarding the effectiveness of types of herbal medicine in managing metabolic disease with blood stasis. In addition, this review will be expected to provide a base for clinical trials to confirm the efficacy of herbal medicine for treatments of metabolic disease with blood stasis. TRIAL REGISTRATION NUMBER: PROSPERO 2018 CRD42018090179.

Blood Stasis Therapy for Traumatic Injury: A Prospective, Single-Arm, Pre-Post Pilot Study.

OBJECTIVES: Blood stasis is an important pathophysiologic concept in Traditional East Asian Medicine. It has been considered to be a pathogenic factor in chronic and incurable conditions such as pain, infertility, cancer, coronary heart disease, and others. The aim of this study was to investigate the effects of pain reduction by blood stasis treatment for blood stasis syndromes with traumatic injury. METHODS: A single-center prospective pretest-post-test pilot study included 73 patients with a trauma that occurred within the past 2 weeks who were admitted into Jaseng Hospital of Korean Medicine from August 2015 through December 2015. Of the 50 patients analyzed in this study, 42 were women (mean age, 33.52). Triple Energizer-reinforcing Saam acupuncture set, herbal medicine (Dangkwisoo-san), and wet cupping on tender point, which are Korean medical therapies generally executed to treat post-traumatic pain, were performed. The patients had to receive at least six sessions of treatment during the 2 weeks, with subsequent treatment being performed within 3 ± 1 days after the previous treatment. Numeric rating scale (NRS) score and general pain severity indicator was measured as a primary outcome measure. The blood stasis questionnaire, oximetry, and patient's satisfaction were also measured. RESULTS: The mean size of subcutaneous bleeding (width and length) and NRS score as a general pain indicator significantly decreased over the visits (all p < 0.01, visit 1 vs. visit 6). Among the blood stasis symptoms in the questionnaire, 11 blood stasis indicators significantly decreased (all p < 0.05). The patients showed significant improvement in the minimum and maximum value of peripheral perfusion index after the treatment (p = 0.011 and p = 0.15, respectively). CONCLUSIONS: This study reveals that blood stasis treatment may help improve the pain of patients with traumatic injury by enhancing the peripheral blood flow. The significant results observed in this study support some evidence of the theories of diagnosing blood stasis pattern and treatments of that pattern in Korean Medicine.

Herbal medicine for Behcet's disease: A protocol for a systematic review and meta-analysis.

BACKGROUND: Herbal medicine treatment is often recommended in order to raise immunity levels and reduce the possibility of recurrence of symptoms, and treating the fundamental causes of the disease. This systematic review will assess the efficacy of herbal medicine in treating Behcet's disease. METHODS AND ANALYSIS: We will search the following 11 electronic databases from their inception: PubMed, EMBASE, and CENTRAL; 3 Chinese databases (CNKI, Wanfang, and VIP); and 5 Korean databases (OASIS, DBpia, RISS, KISS, and KoreaMed). The data will be extracted independently by 2 authors using predefined criteria. Disagreements will be resolved by discussion between the authors. The risk of bias will be assessed using the Cochrane tool for assessing risk of bias. ETHICS AND DISSEMINATION: Ethical approval will not be required, given that this protocol is for a systematic review. The review will be published in a journal. Updates of the review will be conducted periodically to inform and guide healthcare practice and policy. TRIAL REGISTRATION NUMBER: PROSPERO 2018 CRD42018085493.

Recognition of Association Between Blood Stasis Syndrome and Traumatic Injury among Doctors of Korean Medicine: A Cross-Sectional Observation Study.

OBJECTIVE: To investigate the diagnostic indicators and herbal treatments for blood stasis syndrome (BSS) patients with traumatic injuries and to identify the association between BSS and traumatic injury in Korea. METHODS: Two-hundred and four patients with traumatic injury were recruited from the Gangnam and Daejeon branches of Jaseng Hospital of Oriental Medicine between June 2014 and December 2014. Two independent doctors of Korean medicine (DKMs) determined the diagnosis of BSS or non-BSS based on the subjects signs and symptoms. The scores assigned to BSS symptoms and DKMs' reasons for diagnosing BSS in patients with traumatic injury were investigated. Both medication and herbal prescription records from a 3-month period were collected for all patients diagnosed with BSS by both DKMs. RESULTS: A total of 169 of 204 (82.8%) patients received consistent diagnosis related to BSS by two DKMs. Among them, 54.4% (92 cases) were diagnosed with BSS, and 45.6% (77 cases) were not diagnosed with BSS. DKMs most frequently cited symptoms of recent traumatic injury as justifications for BSS diagnoses, and also selected pain-related indicators such as abdominal pain, sharp pain and nocturnal pain as important reasons in diagnosing BSS. In addition, an inconsistency in the pattern identification theory with respect to traumatic injury was observed. Although only 92 cases (54.4%) of patients were diagnosed with BSS, 77.6% of them were prescribed decoctions for BSS. CONCLUSIONS: DKMs considered traumatic injury could cause BSS, and utilized decoction for BSS in patients with traumatic injury without confirming a diagnosis of BSS because they assumed the main symptoms or pathologies of traumatic injury to be closely related to BSS.

Diagnostic Indicators for Blood Stasis Syndrome Patients with Gynaecological Diseases.

OBJECTIVE: To investigate the important diagnostic indicators for blood stasis syndrome (BSS) in patients of childbearing age with gynaecological diseases. METHODS: A partial least squared-discriminant analysis (PLS-DA) were applied to BSS symptoms data of patients with gynaecological diseases, and the diagnostic indicators used by doctors of Korean medicine (DKMs) among BSS patients with gynaecological diseases were also investigated. RESULTS: A total of 103 patients of childbearing age with gynaecological diseases and 40 healthy controls were enrolled. Among the 103 patients, 63 (61.7%) and 40 (38.8%) were diagnosed with BSS and non-BSS, respectively, and BSS patients exhibited a more severe extent of disease. A score plot of PLS-DA showed clearly different patterns among the 3 groups. Based on the variable importance on projection of PLS-DA model, menstrual pains, dark lumps in the menstrual blood, ileocoecal tenderness and resistance, sharp pains, and sublingual varicosities were selected as the top five most important indicators. Moreover, more than 75% of DKMs chose dark lumps in menstrual blood, menstrual pain, and dark menstrual blood as the diagnostic indicators of BSS in patients with gynaecological diseases, and more than 49% of them also considered sharp pains, dark red tongue, sublingual varicosities, and tendency to bruise easily as diagnostic indicators of BSS. CONCLUSION: DKMs focused on menstrual symptoms and certain gynaecological symptoms to diagnose BSS patients of childbearing age with female diseases.