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Background Peer-support programs are a useful social support strategy for populations trying to quit smoking who are willing to maintain smoking abstinence. This study is a protocol for a systematic review and meta-analysis to assess the effectiveness of peer support for smoking cessation. Methods This protocol will be conducted in accordance with the Cochrane Handbook of Systematic Reviews of Interventions 6.2. We will conduct a comprehensive search in the Cochrane Central Register of Controlled Trials, ovidEmbase, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature, ovidMEDLINE, Google Scholar, and Open Grey, as well as the Trials Register of Promoting Health Interventions in EPPI-Centre, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform, and reference lists of included papers. The review will include randomized controlled trials of peer support interventions aimed to stop smoking in any population. Two reviewers will independently screen and select relevant studies. Version 2 of the Cochrane tool that assesses risk of bias in randomized trials will be used to assess the risk of bias in the included studies. The primary outcomes will be defined as the tobacco abstinence rate and adverse events. If a quantitative synthesis is not appropriate, a synthesis without meta-analysis will be undertaken. Discussion This review will provide the best available evidence regarding the effects of peer support interventions to quit smoking. The results from this study will help to inform healthcare providers on the optimal peer support intervention modalities such as intensity, delivery methods, type of support provider, and duration of the intervention. Systematic review registration PROSPERO CRD42020196288

Background CD9 is implicated in cancer progression and metastasis by its role in suppressing cancer cell proliferation and survival. However, the prognostic and clinicopathological significance of CD9 expression is controversial. Therefore, the current meta-analysis was conducted to determine the prognostic and clinicopathological significance of CD9 expression in cancer patients. Methods Eligible studies were selected through database search of PubMed, Embase and Cochrane library up to April 5 2020. The necessary data were extracted from the included studies. Pooled hazard ratio (HR) and odds ratio (OR) with 95% confidence interval (CI) were calculated to evaluate the prognostic and clinicopathological significance of CD9 expression in cancer patients. Results A total of 17 studies consisting of 3456 cancer patients were included in this meta-analysis. An increased CD9 expression was significantly associated with a more favorable overall survival (OS) (HR 0.47, 95% CI 0.31–0.73, p = 0.001) and disease-free survival (DFS) (HR 0.48, 95% CI 0.30–0.79, p = 0.003). In subgroup analysis of cancer type, an increased CD9 expression was associated with increased OS in breast cancer and digestive system cancer, and with increased DFS in head and neck cancer and leukemia/lymphoma. Additionally, an increased CD9 expression significantly correlated with lower overall stage (OR 0.45, 95% CI 0.29–0.72, p = 0.001). Conclusion An increased CD9 expression was associated with favorable survival in cancer patients suggesting that CD9 expression could be a valuable survival factor in cancer patients.

Background CXC chemokine receptor 3 (CXCR3) plays a critical role in tumorigenesis, and CXCR3 expression is associated with prognosis in many cancers. Recently, CXCR3 expression is recognized as a potential prognostic factor for patients with gastric cancer. In this study, we analyzed the prognostic significance of CXCR3 expression in gastric cancer. Methods We conducted a meta-analysis after selecting eligible studies through a literature search. We calculated pooled results to assess the associations between CXCR3 expression and overall survival (OS) and clinicopathological factors for gastric cancer. Results The pooled hazard ratio (HR) with 95% confidence interval (CI) between high expression of CXCR3 and OS was 0.46 (95% CI 0.30–0.71, P

Background Programmed death‐ligand 1 (PD‐L1) is one of the immune checkpoint proteins, and plays an important role in the progression and microenvironment of cancer. PD‐L1 expression has been associated with poor survival in many cancers. Several studies have also shown an association between PD‐L1 expression and the prognosis of patients with thymic epithelial tumors (TETs). In this study, we systematically evaluated the prognostic and clinicopathological roles of PD‐L1 expression in TETs. Methods We searched the literature through PubMed, Embase and Cochrane library and chose the eligible studies, and subsequently performed a meta‐analysis to evaluate the prognostic and clinicopathological roles of PD‐L1 expression in TETs. Results Six of the 75 articles found in the literature were selected. PD‐L1 expression was significantly related to unfavorable overall survival (hazard ratio 1.52, 95% confidence interval [CI]: 1.01–2.30, P = 0.046) in TETs. PD‐L1 expression was significantly associated with male gender (odds ratio [OR] 1.55, 95% CI: 1.08–2.22, P = 0.017) and higher Masaoka stage (OR 3.93, 95% CI: 2.44–6.32, P

BACKGROUND Recent studies have revealed that ephrin receptor (EPH) is implicated in important signal transduction of cancer development and progression. EPHB2 is expressed in human cancer, and reported to be related to the prognosis of colorectal, gastric and breast cancer. This meta-analysis was systematically assessed the prognostic roles of EPHB2 expression in patients with cancer. PATIENTS AND METHODS PubMed, Embase and Cochrane library were searched for eligible studies up to May 2020. Pooled hazard ratio (HR) and 95% confidence interval (CI) were calculated to evaluate the relationship of EPHB2 expression with overall and disease-free survival in patients with cancer. RESULTS The pooled HRs for low expression of EPHB2 were 1.65 (95% CI=1.30-2.09, p

WHAT IS KNOWN AND OBJECTIVE We evaluated the effect of the proportion of time maintained within the target international normalized ratio (INR) postoperatively in hospitalized patients who underwent On-X mechanical heart valve replacement on warfarin therapy after discharge. METHODS Inclusion was patients who were ≥18 years, received warfarin for a minimum of 10 days without any interruptions during hospitalization and followed by the anticoagulation service (ACS) clinic after discharge between June 2006 and June 2016. Patients were excluded if they had incomplete medical records, INR goal changes, known as warfarin resistance, transferred to another facility or expired during the study. The patients were divided into 3 groups according to the proportion of time maintained within therapeutic INR range (TTR) from day 4 to 10 of warfarin initiation (low

Ankylosing spondylitis (AS) is vulnerable to fracture, and the missed diagnosis can lead to neurological deterioration. Herein, we present the conus medullaris syndrome due to aggravation of the missed spinal fracture in an 85-year-old woman with AS who underwent hip surgery. She underwent osteosynthesis in a supine position with supports under her shoulders and head due to spine deformity with AS, but was fully supine without supports after surgery. She showed complete paraplegia at postoperative 12 h. The re-reading radiological imaging showed the missed spinal fracture, of which the deteriorated dislocation was revealed on the re-examined radiological evaluation. This deterioration was not recovered ultimately despite an emergent surgery. A thorough preoperative assessment is essential to prevent the missed diagnosis of spinal fracture and minimise deterioration due to its dislocation, with specific spine precaution during transport, transfer and positioning.

Objective The purpose of this study was to evaluate the effects of erythropoietin (EPO) on mortality and neurological outcomes in patients with traumatic brain injury (TBI). Materials and methods Electronic databases of studies published up to January 5, 2017 were searched to retrieve relevant investigations comparing the outcomes of EPO-treated patients and untreated patients following TBI. We calculated the relative risk (RR) of mortality, neurologic outcomes, and deep vein thrombosis (DVT) with corresponding 95% confidence interval (CI) using meta-analysis. Results Six randomized controlled clinical trials met the eligibility criteria. In total, 1041 patients were included among the studies. EPO was found to significantly reduce the occurrence of mortality (RR 0.68 [95% CI 0.50–0.95]; P = 0.02), but did not significantly reduce poor functional outcome (RR 1.22 [95% CI 0.82–1.81]; P = 0.33). There were no significant differences in the occurrence of complications, such as DVT, between the treatment groups (RR −0.02 [95% CI −0.06–0.02]; P = 0.81). Conclusions Results of the present meta-analysis suggest that the use of EPO may prevent death following TBI without causing adverse events, such as deep vein thrombosis. However, the role of EPO in improving neurological outcome(s) remains unclear. Further well-designed, randomized controlled trials using modified protocols and involving specific patient populations are required to clarify this issue, and to verify the findings.

Aim This study aimed to seek evidence for the usefulness of the procalcitonin as a prognostic blood biomarker for outcomes in post-cardiac arrest patients. Methods We systematically searched MEDLINE, EMBASE, and the Cochrane Library (search date: 8 January, 2019). Studies on patients who experienced return of spontaneous circulation, who had out of hospital cardiac arrest and had their level of procalcitonin measured and outcomes assessed at and after hospital discharge, were included. We additionally performed subgroup analyses for confounding factors affecting patients’ outcomes. To assess the risk of bias of each included study, the Quality in Prognosis Studies tool was used. Results A total of 1065 patients from 10 studies were finally included. Elevated procalcitonin level during hospital admission (at 0–24 h) was associated with in-hospital mortality (standardized mean difference (SMD) 0.64, 95% confidence interval (CI) 0.33–0.95, I2 = 26%). The elevation of procalcitonin level (at 0–48 h) was also associated with poor neurologic outcomes (at 0–24 h, SMD 0.61; 95% CI 0.44–0.79, I2 = 0%; at 24–48 h, SMD 0.58, 95% CI 0.35–0.82, I2 = 0%) as well as at 1–6 months (at 24–48 h, SMD 0.62; 95% CI 0.36–0.88, I2 = 0%). Conclusions Overall, the findings suggested that an elevated procalcitonin level measured at 0–48 h of post-cardiac arrest syndrome was associated with poor outcomes.

Introduction Pharmacopuncture is a traditional therapy combining acupuncture and herbal medicines. In this study, we investigated the usage status of pharmacopuncture among Korean medicine doctors (KMDs) and differences in satisfaction regarding pharmacopuncture use. Methods We conducted a self-reporting online survey via e-mail from April 25 to 7 May 7, 2018, and analyzed the responses of a total of 393 KMDs. Results Eighty-eight percent of respondents had used pharmacopuncture during the previous year. Their average clinical experience of using pharmacopuncture was 8.04 years and the percentage of patients treated using pharmacopuncture was 39.2%. Pharmacopuncture was used mainly to treat musculoskeletal, neurological, and gastrointestinal diseases. Bee venom and blood stasis pharmacopuncture were the most commonly used types. Participants were highly satisfied with treatment efficacy but were less satisfied with treatment cost. KMD satisfaction with pharmacopuncture was assessed with regards to two aspects: practitioner and patient (as evaluated by the practitioner) satisfaction. In both cases, satisfaction with pharmacopuncture was high in KMDs who use it for gastrointestinal diseases. However, practitioner satisfaction was low among KMDs who used bee venom and blood stasis pharmacopuncture, whereas patient satisfaction was high among those KMDs who treated them using ginseng pharmacopuncture. Conclusions Satisfaction with pharmacopuncture treatment tended to contrast with the frequency of use. Although KMDs are currently focusing on pain-related disorders, our results indicate that pharmacopuncture can be highly applicable in other areas such as the treatment of gastrointestinal diseases; however, this needs to be verified by further research.

Background/Aims There have been numerous efforts to reduce mother-to-child transmission (MTCT) of hepatitis B virus (HBV) with antiviral agents during pregnancy. However, there are limited data regarding the outcomes of pregnant women after delivery. This study was performed to evaluate the efficacy of antiviral agents in preventing MTCT of HBV and maternal long-term outcomes. Methods The HBV-infected pregnant women treated with antiviral agents to prevent MTCT were retrospectively reviewed. Forty-one pregnant women who received telbivudine or tenofovir during late pregnancy (28-34 week) were analyzed. Hepatitis B virus surface antibody (HBsAb) positivity was tested in 43 infants after 7 months of birth. Eleven mothers were followed >1 year after delivery. Results The mean HBV DNA titer before antiviral therapy was 8.67 (6.60–9.49) log copies/mL, and the median age at delivery was 32 years (range, 22–40). Eleven patients were treated with tenofovir and 30 with telbivudine. The median duration was 57 days (range, 23–100), and the median HBV DNA titer at birth was 5.06 log copies/mL (range, 2.06–6.50). Antiviral treatments were associated with significant HBV DNA reduction (P12 months, and an antiviral agent was administered. Conclusions Antiviral treatment during late pregnancy effectively reduced MTCT. Long-term follow-up should be required in such cases. In addition, given that maternal biochemical flare occurred in 18% of mothers, re-administration of antiviral agents might be required.

Rationale: Dopamine replacement is currently the standard treatment for restless leg syndrome (RLS); however, various adverse effects are associated with long-term therapy, and the benefits disappear upon discontinuation. To overcome these limitations, interest in traditional East Asian medicine has increased. Patient concerns: A 72-year-old Asian woman originally admitted for an intracerebral hemorrhage presented with complaints of an unpleasant sensation throughout the body that appeared at night. Diagnoses: The patient was diagnosed with chronic persistent RLS based on the 2012 Revised International Restless Leg Syndrome Study Group Diagnostic Criteria. Interventions: The patient was treated with extracts of the traditional herbal medicines Dangguijakyak-san (DS) and Shihogyeji-tang (ST). After 47 days of therapy, all herbal medicines were discontinued, and symptoms had not returned by the last follow-up 244 days after the initial treatment. Outcomes: One week after initiating herbal treatment with DS and ST, the RLS symptoms began to improve, and the total hours of sleep had increased from 2 to 9 hours by day 21, with a Korean version of the international restless legs scale score of 11 points. On day 36, ST was discontinued, given the continued improvement of symptoms. On day 47, symptoms had disappeared (Korean version of the international restless legs scale score: 0), and sleep disturbances caused by RLS had completely resolved. After day 47, DS was also discontinued. There were no adverse effects associated with the administration of DS and ST, and the symptoms had not recurred by the last follow-up on day 244. Lessons: In this case, RLS related symptoms, which had been present for approximately 60 years, were improved using only the traditional herbal medicines DS and ST (without dopamine replacement), and no symptoms recurred for 244 days. This case suggests that if replacement therapy is difficult or not desired, herbal medicinal therapies may be an effective alternative. This also suggests that the effect of herbal medicine on RLS might be semi-permanent. Further investigations, including clinical trials, are needed to confirm these effects.

Background: Insomnia causes a huge socioeconomic burden among the elderly, and is not simply a health problem. This study aimed to determine the comparative advantage of the effectiveness and acceptability of non-pharmacological interventions available for elderly individuals with insomnia.Methods: Comprehensive searches in 13 medical databases were performed to find relevant randomized controlled trials (RCTs) up to August 2019. Two independent reviewers performed study selection, data extraction, and quality assessment of included RCTs using the Cochrane Collaboration's risk of bias. A network meta-analysis within the frequentist model was performed by combining direct and indirect evidence from all available RCTs. The primary outcomes were effectiveness as measured by the Pittsburgh Sleep Quality Index (PSQI) total score and acceptability by the incidence of all-cause drop-out.Results: Twenty-eight RCTs involving 2,391 participants were included. Compared to wait-list, acupuncture (standardized mean difference −4.37, 95% confidence interval −8.53 to −0.12), acupuncture combined with benzodiazepines (−5.20, −9.82 to −0.57), behavioral therapy (−10.44, −17.31 to −3.58), benzodiazepines (−4.28, −8.45 to −0.11), benzodiazepines combined with cognitive behavioral therapy (CBT) (−7.18, −12.17 to −2.19), and CBT (−4.93, −8.63 to −1.22) showed significant superiority in their effectiveness. No significant comparative superiority or inferiority was found in terms of acceptability.Conclusions: In terms of effectiveness as indicated by the PSQI total score, compared to wait-list, superior benefits were observed for acupuncture, acupuncture combined with benzodiazepines, behavioral treatment, benzodiazepines, benzodiazepines combined with CBT, and CBT. Importantly, combined treatments, including benzodiazepines combined with CBT or with acupuncture, were generally superior to other monotherapies. In terms of acceptability, there was not enough data to draw conclusions. However, most RCTs included had methodological problems related to the lack of blinding procedure, suggesting a risk of effect size overestimation.Registration: CRD42019145518.

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.

Aims Asian patients are known to be more prone to bleeding complications than patients of other ethnicities. Therefore, there are possibilities of other risk factors that should be given special consideration for dosage adjustment in this specific ethnic group. This study aimed to investigate the risk factors for bleeding complications in Asian patients under appropriate edoxaban dosage regimens. Methods Data on patients taking proper dosages, based on the Lixiana package insert, were analysed. Univariate and multivariable analyses were conducted to evaluate associations between risk factors and bleeding outcomes. Subgroup analysis was performed on high-risk patients for bleeding complications whose edoxaban dose was reduced according to the package insert. Results In total, 346 patients were included. Among them, 32 patients experienced bleeding complications. Patients with weight ≤60 kg and with cancer showed around 3.3- and 3.4-fold increased risk of bleeding complications compared to heavier patients (>60 kg) and those without cancer, respectively. In subgroup analysis with high-risk patients who took low-dose edoxaban (15 and 30 mg), weight ≤60 kg remained a significant factor for bleeding outcomes. Conclusion This study showed that weight ≤60 kg and the presence of cancers could affect bleeding complications, which occurred despite proper edoxaban treatment in Asian patients. Therefore, more strict dosage guideline could be considered in populations with high proportions of Asian ethnicities.

Rab27 is an essential molecule of vesicle fusion and trafficking in exosome secretion process, which plays important roles in cancer progression and metastasis. Recent studies reported that Rab27 expression is also associated with cancer prognosis. Therefore, we performed a meta-analysis to reveal the prognostic significance of Rab27 expression in solid cancer. Data were extracted by searching on PubMed, Embase and Cochrane library until February 15 2020. Pooled hazard ratio (HR) with confidence interval (CI) was calculated to evaluate the association between Rab27 expression and survival in solid cancer. Ten studies with 1434 cancer patients were including for this meta-analysis. High expression of Rab27 was associated with poor survival (HR 2.67, 95% CI 1.52–4.69, p = 0.001). High expression of Rab27A was significantly associated with lymph node metastasis (HR 1.53, 95% CI 1.00–2.34, p = 0.048). High expression of Rab27B was significantly correlated with lymph node and distant metastasis (HR 2.15, 95% CI 1.56–2.95, p p p

Supplemental Digital Content is available in the text, Introduction Chronic non-specific low back pain is one of the common health issues which reduce the quality of life and in working population. While combined therapeutic treatment method is widely used for musculoskeletal related disorders in Korea, well-developed trials on the efficacy of single or combine therapy on herbal medicine and Chuna manual therapy (CMT) are scarce. Objective This study aims to evaluate the clinical efficacy and safety of herbal medicine, Sogyeonghwalhyeol-tang (SGHH) on work related chronic low back pain patients. The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone. The secondary aim is to examine the naïve direct comparison between SGHH and placebo. Method This trial is designed as a multicenter, randomized, controlled, clinical trial. A total of 150 participants who have with chief complaint of low back pain in Korean medicine rehabilitation center will be randomly assigned to 1 of 3 treatments with a ratio of 1:1:1. Eligible participant will be randomized to treatment arm A receive single treatment of Sogyeonghwalhyeol-tang, in treatment Arm B Sogyeonghwalhyeol-tang and Chuna manual therapy are administered concurrently, in treatment arm C, where individuals receive placebo with Chuna manual therapy. They will receive assigned treatment in 4 weeks and follow-up for 4 weeks. The primary endpoint is to assess the change in severity of low back pain from baseline. The secondary endpoints are the following: the changes in disability and health related quality of life. Adverse events will also be reported. Discussion The study result will provide the valuable information for efficacy and safety of monotherapy and multiple therapy of herbal medicinal extract and Chuna manual therapy on chronic non-specific low back pain. Trial registration: ClinicalTrials.gov Identifier: NCT03132974.

Background: CD63 has been described as a key factor in extracellular vesicle production and endosomal cargo sorting, and there have been certain reports suggesting an association between CD63 expression and survival in patients with tumors including gastric, colon and lung cancer. However, the prognostic value of CD63 expression remains contradictory. Hence, we performed this meta-analysis to assess the prognostic value of CD63 expression in solid tumors. Materials and Methods: Eligible studies were collected by searching the PubMed, Embase and Cochrane libraries. The hazard ratio (HR) with 95% confidence interval (CI) were evaluated to reveal the association between CD63 expression and survival in solid tumors. Results: Five studies with a total of 1,454 patients were included. The HR evaluating CD63 expression on survival was 1.34 (95%CI=0.92-1.97, p=0.129). In subgroup analysis, the HRs of lung cancer and other tumors were 0.50 (95% CI=0.32-0.77, p=0.002) and 2.16 (95% CI=1.93-2.42, p

Eight Constitution Medicine (ECM) is a Korean constitutional medicine system that classifies people into 8 types: Pulmotonia (PUL), Colonotonia (COL), Renotonia (REN), Vesicotonia (VES), Pancreotonia (PAN), Gastrotonia (GAS), Hepatonia (HEP), and Cholecystonia (CHO). Metabolic syndrome (MS) is a major public health problem worldwide. We assessed the prevalence of and associations between ECM and MS. Cross-sectional convenience sample of 245 adults was used at a medical check-up center in Seoul, South Korea, from 2010 to 2015. Adults were classified into 1 of 8 constitutions by an ECM specialist. MS was diagnosed on the basis of National Cholesterol Education Program Adult Treatment Panel III and Asian Pacific Criteria for abdominal obesity. We also computed the prevalence by percentage and calculated odds ratios (ORs) for MS among 6 constitutions with PUL as the reference. Among 245 adults, 20 (8.2%) were diagnosed with PUL, 43 (17.6%) with COL, 35(14.3%) with REN, 4 (1.6%) with VES, 71 (29.0%) with PAN, 0 (0.0%) with GAS, 54 (22.0%) with HEP, and 18 (7.3%) with CHO. The prevalence of MS in the constitutions was significantly different: CHO, 38.9%; HEP, 35.2%; PAN, 18.3%; COL, 11.6%; PUL, 5.0%; REN, 2.9% (P = .001). We observed higher ORs for HEP and CHO (OR = 13.03, 95% confidence interval [CI] = 1.61–105.70; and OR = 13.19, 95% CI = 1.39–125.46, respectively) than for the other constitutions. People with HEP and CHO constitutions could be at higher risk for MS. Therefore, ECM-based diagnosis may be useful for preventing and managing MS.

Introduction The aim of this systematic review was to assess the evidence from randomized controlled trials (RCTs) on the effectiveness and safety of pharmacopuncture in cervical spondylosis patients. Methods Seven databases were searched, including Chinese and Korean databases, through to January 2018. Eligible trials were those with intervention groups receiving pharmacopuncture for cervical spondylosis and control groups receiving other conventional treatments including acupuncture. Outcome measures included pain, disability, quality of life, and adverse events (AEs). For statistical pooling, the mean difference (MD) and 95% confidence intervals (CIs) were calculated using a random-effects model. Results Twenty RCTs were selected. Eight trials on pharmacopuncture as a single treatment reported significant pain decrease in patients with cervical spondylosis compared to acupuncture (MD −1.79, 95% CI −2.39, −1.19). Add-on pharmacopuncture treatment also showed significant effects in alleviating pain compared to the control (MD −1.79, 95% CI −2.24, −1.34). Add-on pharmacopuncture treatment significantly increased quality of life compared to the control, as shown with SF-36 scores (MD 18.31, 95% CI 13.33, 23.29). However, all analysis results were assessed to be low or very low quality evidence due to considerably high heterogeneity and high risk of bias. In addition, solid conclusions on safety could not be drawn as few studies reported on AEs related with pharmacopuncture. Conclusions Pharmacopuncture, both as a sole intervention and as an add-on treatment, was found to decrease pain in patients with cervical spondylosis. These results, however, should be interpreted with caution as the quality of evidence was found to be low.

Introduction In Korea, all traditional Korean medicine interventions for neck pain are actively used, including acupuncture, herbal medicine, Chuna, and pharmacopuncture; however, clinical practice guidelines do not exist. We aimed to develop a clinical practice guideline for treating neck pain in adults using traditional Korean medicine. Methods A committee comprising clinical and methodological experts was formed, and clinical questions were developed. A systematic review was conducted for each clinical question. The selected studies were analyzed and assigned a quality of evidence grade based on the Grading of Recommendations Assessment, Development, and Evaluation methodology. Recommendations were formulated considering the benefits and harms. A formal consensus was reached among the experts using the Delphi method. The final recommendations were recognized by relevant professional societies. Results In total, 25 recommendations were developed regarding traditional Korean medicine treatments (acupuncture, electroacupuncture, fire needling, miniscalpel acupuncture, herbal medicine, Chuna manual therapy, pharmacopuncture, bee-venom pharmacopuncture, cupping, thread-embedding acupuncture, and Doin therapy). Acupuncture (versus inactive control) and Chuna manual therapy and pharmacopuncture (versus usual care) are recommended for symptom alleviation in the clinical treatment of neck pain. Electroacupuncture (versus usual care) and cupping (versus inactive control) should be considered for the alleviation of symptoms in the clinical treatment of neck pain. Conclusions The guideline could assist traditional Korean medicine doctors in South Korea to provide evidence-based, standardized treatment for neck pain in adults. Consequently, implementing this guideline in traditional Korean- medicine practice could expand the scope of health-insurance coverage, thereby reducing the public burden of medical expenses.

Purpose Copeptin, the C-terminal portion of provasopressin, has emerged as a novel prognostic marker in neurocritical care, such as in traumatic brain injury (TBI). The aim of this study was to quantitatively assess the prognostic significance of initial plasma copeptin levels in the neurological outcome and mortality after traumatic brain injury. Materials and methods Six relevant studies with data from 552 patients were included in this meta-analysis. Results The plasma copeptin levels were found to be significantly higher in patients who died than in the survivors (standardized mean difference [SMD], 1.80). In the four studies reporting Glasgow outcome scale (GOS) data, patients with unfavorable outcomes had significantly higher copeptin levels than those with favorable outcomes (SMD, 1.62). The plasma copeptin level predicted mortality and unfavorable outcomes (AUC, 0.873; AUC, 0.876). Conclusions The present meta-analysis suggests that early measurement of plasma copeptin levels can provide better prognostic information about the functional outcome and mortality in patients with TBI.

Syndrome differentiation (SD) results in a diagnostic conclusion based on a cluster of concurrent symptoms and signs, including pulse form and tongue color. In Korea, there is a strong interest in the standardization of Traditional Medicine (TM). In order to standardize TM treatment, standardization of SD should be given priority. The aim of this study was to explore the SD, or symptom clusters, of patients with atopic dermatitis (AD) using non-negative factorization methods and k-means clustering analysis. We screened 80 patients and enrolled 73 eligible patients. One TM dermatologist evaluated the symptoms/signs using an existing clinical dataset from patients with AD. This dataset was designed to collect 15 dermatologic and 18 systemic symptoms/signs associated with AD. Non-negative matrix factorization was used to decompose the original data into a matrix with three features and a weight matrix. The point of intersection of the three coordinates from each patient was placed in three-dimensional space. With five clusters, the silhouette score reached 0.484, and this was the best silhouette score obtained from two to nine clusters. Patients were clustered according to the varying severity of concurrent symptoms/signs. Through the distribution of the null hypothesis generated by 10,000 permutation tests, we found significant cluster-specific symptoms/signs from the confidence intervals in the upper and lower 2.5% of the distribution. Patients in each cluster showed differences in symptoms/signs and severity. In a clinical situation, SD and treatment are based on the practitioners' observations and clinical experience. SD, identified through informatics, can contribute to development of standardized, objective, and consistent SD for each disease.

Background Atopic dermatitis (AD) is a common pruritic inflammatory skin disease with increasing prevalence. It can manifest with many different clinical phenotypes; however, in its chronic stage, hyperpigmentation, excoriation, lichenification, and dryness are the main symptoms. Jaungo comprises two herbs, Lithospermi radix and Angelica gigantis radix, and three carrier oils, and is an approved herbal ointment for xerosis cutis in Korea. In past studies, we demonstrated that Jaungo had anti-inflammatory and antiallergic activity in in vitro and in vivo AD models; however, there are few relevant randomized controlled clinical trials on Jaungo in AD. Methods/design A randomized, double-blind, placebo-controlled, single-center, phase IIa clinical trial was designed to investigate the safety, preliminary efficacy, and dose response of Jaungo in AD. The study protocol was approved by the Institutional Review Boards of the Kyung Hee University Korean Medicine Hospital (No. KOMCIRB-160617-HR-027) and the Korea Food and Drug Administration (No. 30907). The study aims to enroll 34 AD patients to be randomly distributed among three parallel groups: treatment 1, treatment 2, and the placebo group. Treatment group 1 applies Jaungo twice a day, while treatment group 2 applies Jaungo and the placebo ointment once a day, separately, and the placebo group applies the placebo ointment twice a day, for a total of 3 weeks each. Participants will be evaluated for eczema before and after the application of the ointments based on several parameters including the Eczema Area and Severity Index, the SCORing of Atopic Dermatitis Index, the Dermatology Life Quality Index, transepidermal water loss, total IgE level, eosinophil count, and IL-17, IL-22, and IFN-γ levels. Discussion The trial is currently ongoing and the enrollment of subjects has been initiated. There is an urgent need to develop a drug for the treatment of dry, hyperpigmented, scaly, and thickened skin in chronic-stage AD. This study will determine the efficacy and safety of Jaungo in AD, providing evidence for specific AD symptoms treated by Jaungo. Trial registration Clinical Trials.gov, identifier: NCT02900131. Registered on 2 September 2016. Korea Clinical Research Information Service, identifier: KCT0002060. Registered on 22 July 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1920-9) contains supplementary material, which is available to authorized users.

Mammalian epidermis, which is composed of hair follicles, sebaceous glands, and interfollicular epidermis, is maintained by discrete stem cells. In vivo lineage tracing demonstrated that murine LGR5 cells are mainly responsible for hair follicle regeneration whereas LGR6 cells generate sebaceous glands and interfollicular epidermis. However, little is known about their expression in the human skin tumors. In this study, we investigated the expression profile of LGR5 and LGR6 in a variety of human skin tumors including basaloid tumors with follicular differentiation (94 basal cell carcinomas, 18 trichoepitheliomas, 3 basaloid follicular hamartomas, and 12 pilomatricomas) and tumors with ductal differentiation (7 eccrine poromas, 8 hidradenomas, and 5 spiradenomas). LGR5 expression was highest in basal cell carcinomas (BCCs) followed by trichoepitheliomas (TEs) and basaloid follicular hamartomas. LGR6 had the same expression pattern as LGR5, even though its expression was lower. Interestingly, LGR6 expression was detected in stromal cells around the tumor and papillary mesenchymal bodies of TEs but not in stromal cells of BCCs, suggesting different characteristics of tumor-associated fibroblasts between TEs and BCCs. It was unexpected to find that pilomatricomas exclusively expressed LGR6, and its expression was limited to the basaloid cells. Notably, LGR6-positive cells were observed in sweat gland ductal cells in normal skin. This might explain, in part, the finding that LGR6 expression was relatively higher in basaloid tumors with ductal differentiation than in those with follicular differentiation. In particular, spiradenomas displayed the same distribution pattern of LGR6 as normal sweat glands, suggesting the possibility of LGR6-positive cells as tumor stem cells. In conclusion, we documented the different expression patterns of stem cell markers, LGR5 and LGR6 in various skin tumors. These data may provide important insights to understand the origin and development of basaloid skin tumors.

Background Patients with atopic dermatitis (AD) exhibit various symptoms, especially itching. Recently, herbal medicines (HMs) are being used in combination with antihistamines for the treatment of AD in Korea. While oral antihistamines can alleviate itching, HMs appear to exert anti-inflammatory effects with minimal side effects. However, there is little evidence regarding the effectiveness and safety of using HMs in combination with antihistamines for AD. Methods To observe the effectiveness and safety of combination treatment with HMs and antihistamines, we performed a retrospective chart review of inpatients with AD who received this combination treatment for at least 7 days in a hospital. Results Of 163 inpatients, 40 met the inclusion criteria. All patients received HMs three times, and one or two antihistamines, a day after HM intake. A large proportion of patients received first-generation antihistamines. HMs comprised a mixture of an average of 20.69 different herbs in decoction. The mean total, objective, and subjective SCORing Atopic Dermatitis scores showed a significant decrease after combination treatment. Changes in the mean levels of aspartate transaminase, alanine transaminase, blood urea nitrogen, and creatinine were not statistically significant among treatments. There were no adverse events of pseudoaldosteronism or interstitial pneumonia. Conclusion We observed that the short-term use of HMs in combination with oral antihistamines was safe and effective, with a low risk of adverse reactions. This study was limited by its retrospective design, and prospective studies with long-term follow-up periods are warranted to further elucidate the safety of this combination treatment for AD.

Background. This study aimed to investigate medical records using traditional Korean medicine (TKM) in Sewol Ferry disaster in 2014 and further explore the possible role of traditional medicine in disaster situation. Methods. After Sewol Ferry accident, 3 on-site tents for TKM assistance by the Association of Korean Medicine (AKOM) in Jindo area were installed. The AKOM mobilized volunteer TKM doctors and assistants and dispatched each on-site tent in three shifts within 24 hours. Anyone could use on-site tent without restriction and TKM treatments including herb medicine were administered individually. Results. The total of 1,860 patients were treated during the periods except for medical assistance on the barge. Most patients were diagnosed in musculoskeletal diseases (66.4%) and respiratory diseases (7.4%) and circulatory diseases (8.4%) followed. The most frequently used herbal medicines were Shuanghe decoction (80 days), Su He Xiang Wan (288 pills), and Wuji powder (73 days). Conclusions. TKM in medical assistance can be helpful to rescue worker or group life people in open shelter when national disasters occur. Therefore, it is important to construct a rapid respond system using TKM resources based on experience.

Background Aurora kinase A (AURKA), or STK15/BTAK, is a member of the serine/threonine kinase family and plays important roles in mitosis and chromosome stability. This study investigated the clinical significance of AURKA expression in colorectal cancer patients in Korea. Methods AURKA protein expression was evaluated by immunohistochemistry in 151 patients with colorectal adenocarcinoma using tissue microarray blocks. We analyzed the relationship between clinicopathological characteristics and AURKA expression. In addition, the prognostic significance of various clinicopathological data for progression-free survival (PFS) was assessed. Also we evaluated copy number variations by array comparative genomic hybridization and AURKA gene amplification using fluorescence in situ hybridization in colorectal carcinoma tissues. Results AURKA gene amplification was found more frequently in the 20q13.2–13.33 gain-positive group than the group with no significant gain on the AURKA-containing locus. AURKA protein expression was detected in 45% of the cases (68/151). Positive staining for AURKA was observed more often in male patients (p = .035) and distally located tumors (p = .021). PFS was shorter in patients with AURKA expression compared to those with low-level AURKA expression (p < .001). Univariate analysis revealed that AURKA expression (p = .001), age (p = .034), lymphatic invasion (p = .001), perineural invasion (p = .002), and TNM stage (p = .013) significantly affected PFS. In a multivariate analysis of PFS, a Cox proportional hazard model confirmed that AURKA expression was an independent and significant prognostic factor in colorectal adenocarcinoma (hazard ratio, 3.944; p < .001). Conclusions AURKA could serve as an independent factor to predict a poor prognosis in Korean colorectal adenocarcinoma patients.

ObjectiveThis study aimed to promote an understanding of spontaneous pneumothorax by analysing the prevalence rate and medical service use by patients with spontaneous pneumothorax according to sociodemographic characteristics.DesignA 12-year nationwide study.SettingData obtained from the Korean National Health Insurance Service Sharing Service.ParticipantsA total of 4658 participants who used medical services due to spontaneous pneumothorax between 2002 and 2013 in Korea.Outcome measuresFor those diagnosed with spontaneous pneumothorax, use of medical services, hospitalisation data, sociodemographics, comorbidity, treatment administered and medication prescribed were recorded.ResultsThe annual prevalence of spontaneous pneumothorax ranged from 39 to 66 per 100 000 individuals, while the prevalence of hospitalisation due to spontaneous pneumothorax ranged from 18 to 36 per 100 000 individuals. The prevalence rate of spontaneous pneumothorax in Korea has increased since 2002. The male to female ratio was approximately 4–10:1, with a higher prevalence rate in men. By age, the 15–34 years old group, and particularly those aged 15–19 years old, showed the highest prevalence rate; the rate then declined before increasing again for those aged 65 years or older. In total, 47%–57% of patients with spontaneous pneumothorax underwent hospitalisation. The average number of rehospitalisations due to pneumothorax was 1.56 per person, and more than 70% of recurrences occurred within 1 year. Chronic obstructive pulmonary disease was the most common comorbidity. The average treatment period was 11 days as an outpatient and 14 days in-hospital. The average medical costs were $94.50 for outpatients and $2523 for hospital admissions. The most common treatment for spontaneous pneumothorax was oxygen inhalation and thoracostomy, and the most commonly prescribed medications were analgesics, antitussives and antibiotics.ConclusionsWe here detailed the epidemiology and treatments for spontaneous pneumothorax in Korea. This information can contribute to the understanding of spontaneous pneumothorax.

The application of systematic review (SR) has been increased rapidly in the field of cancer treatment. Complementary and alternative medicine (CAM) for cancer is no exception. The aim of this review is to evaluate and summarize systematic reviews on the CAM use in breast cancer patients. Search sources were Centre for Reviews and Dissemination (CRD), Cochrane Database of Systematic Reviews (CDSR), and PubMed. In addition, we assessed the quality of SR with the Assessing the Methodological Quality of Systematic Reviews (AMSTAR). This review did not consider control groups and outcomes. Thirty-four SRs met a set of criteria. According to interventions, there were twenty SRs which included yoga, acupuncture, and herbal medicines. Meta-analysis of 19 out of 34 reviews showed the followings: (1) acupuncture had a beneficial effect on the frequency of hot flushes, (2) yoga had a beneficial effect on depression and health-related QOL, (3) mindfulness-based stress reduction (MBSR) had a beneficial effect on anxiety and depression, (4) combination of herbal medicine and chemotherapy synergistically improved clinical outcomes, (5) acupuncture did not show significant effect on the severity of hot flushes and cancer-related pain, (6) yoga was unable to be confirmed as having an effect on cancer-related pain and physical well-being. Given the results of AMSTAR, 9 out of 34 reviews were of high quality and 3 reviews were deemed to be of low quality. In conclusion, since most SRs were at moderate or high quality levels, CAM could be helpful for treating specific symptoms related to breast cancer.

Background The effect of prophylactic antiviral therapy (AVT) on survival of patients with hepatitis B virus (HBV)–related hepatocellular carcinoma (HCC) remains unknown. This study aimed to determine whether prophylactic AVT could improve long-term survival in patients undergoing transarterial chemotherapy (TAC). Methods Between 2002 and 2016, 2860 newly diagnosed HBV-related patients with HCC treated with TAC were screened to analyze 2 groups based on prophylactic use of antivirals. Treatment effects were analyzed using propensity score (PS) matching (1:1) separately for the entire cohort and each subgroup. The primary endpoint was overall survival. Results A total of 1547 patients met the inclusion criteria and 1084 were PS matched for the 2 groups. Median follow-up duration was 16.55 months. In the entire unmatched cohort, patients receiving prophylactic AVT survived significantly longer than those who did not. Among AVT-untreated patients, baseline high viremia and HBV reactivation during treatment were significantly associated with shorter survival. Regarding types of antivirals, survival was significantly longer for patients receiving high-potency antivirals than those receiving low-potency antivirals. Survival differed with antiviral response. In the PS-matched cohort, the prophylactic AVT group survived significantly longer than the nonprophylactic group, irrespective of viral status or tumor stage. Prophylactic AVT remained an independent factor for survival. The association of prophylactic AVT with decreased risk of mortality persisted in patient subgroups after adjusting for baseline risk factors. Sensitivity analyses also confirmed estimated treatment effects. Conclusions Prophylactic AVT is associated with significantly improved long-term survival among patients undergoing TAC. High-potency antivirals are indicated for this approach. Hepatitis B virus–associated morbidity is a well-known complication during transarterial chemotherapy (TAC). Our large-scale study demonstrated that prophylactic therapy with high-potency antivirals provides a significantly better survival in TAC-treated patients, irrespective of baseline viremia status or tumor stage.

Objective This review aimed to compare the efficacy of endovascular cooling devices (ECD), such as Thermogard®, with surface cooling devices (SCD), such as Arctic Sun®, in reducing mortality and improving neurological status for patients with post-cardiac arrest undergoing targeted temperature management. Data sources A systematic literature search was conducted using MEDLINE, EMBASE, and the Cochrane Library to identify randomized controlled trials (RCT) and observational studies (OS) comparing mortality and neurological status for patients treated with ECD or SCD. Results The meta-analysis comprised 4,401 patients from 2 RCT and 7 OS. For mortality, the overall pooled analysis showed no statistically significant difference between ECD and SCD recipients (RR, 0.93; 95% CI 0.86–1.00; I2 = 0%). Further, no statistically significant difference was observed between RCT (RR, 0.80; 95% CI 0.56–1.14; I2 = 0%) and OS (RR, 0.94; 95% CI 0.85–1.04; I2 = 18%) for in-hospital mortality. For good neurological status of survivors after TTM, the overall pooled analysis showed no statistically significant difference between ECD and SCD (RR, 1.08; 95% CI 0.99–1.18; I2 = 71%). No statistically significant difference was found between ECD and SCD at hospital discharge in RCT (RR, 0.88; 95% CI 0.61–1.28; I2 = 0%) and at 6 months in OS (RR, 1.03; 95% CI 0.99–1.09; I2 = 32%). Conclusions The study findings could not show that either ECD or SCD was more effective in terms of survival and improved neurological status for post-cardiac arrest patients. Systematic review registration number CRD42019129770.

The aim of this study was to evaluate the appropriateness and clinical outcomes of edoxaban use, and to determine the role of clinical pharmacists in improving the efficacy and safety of edoxaban use.A retrospective study was performed by using an electronic medical record and anticoagulation clinical data from 600 patients who received edoxaban from 1 March 2016 to 16 July 2017 at a tertiary teaching university hospital. The appropriateness of edoxaban use was assessed using eight criteria based on drug use evaluation criteria developed by the American Society of Health-System Pharmacists drug use evaluation guidelines, details in Korea Food and Drug Administration approval of edoxaban. Clinical outcomes were evaluated between the appropriately prescribed and inappropriately prescribed groups regarding the incidence of thrombosis and bleeding episodes.After excluding 86 patients due to the inability to assess renal function, 514 were eligible. Appropriate use was found in 294 patients (57.2%). The most frequent inappropriate use of edoxaban was dose adjustment (60.8%) in accordance with the dosing recommendation in patients with renal insufficiency (creatinine clearance [CrCl] of 15-50 mL/min) and a low body weight of60 kg. Moreover, there were three cases of edoxaban use in patients with prosthetic heart valves and moderate-to-severe mitral stenosis, and 15 cases of non-valvular atrial fibrillation in patients with CrCl95 mL/min in whom edoxaban use is not recommended. Furthermore, we found that the factors related to the appropriateness of edoxaban use were60 kg body weight (adjusted odds ratio [OR]: 0.310; confidence interval [CI]: 0.197-0.488) and CrCl50 mL/min (adjusted OR: 0.629; CI: 0.404-0.980). There were 45 events (8.75%) of any bleeding, 9 (1.8%) of stroke/transient ischaemic attack (TIA) and four events (0.8%) of deep vein thrombosis (DVT)/pulmonary embolism (PE). However, there was no difference between the appropriately prescribed group (294 patients) and inappropriately prescribed group (220 patients) in the incidence of bleeding events (27 [9.2%] vs 18 [8.2%]), stroke/TIA (7 [2.4%] vs 2 [0.9%]) and DVT/PE (2 [0.7%] vs 2 [0.9%]), respectively.Although edoxaban has a broad therapeutic window that does not require routine monitoring, it should be cautiously used in patients with renal insufficiency (CrCl50 mL/min) and body weight60 kg.

Objectives Population-based information on the costs of complementary medicine for treatment-related side effects in patients with breast cancer is scarce. We aimed to investigate the prevalence and expenditure on complementary medicine in patients with breast cancer who experienced treatment-related side effects. Design and setting Two datasets were analyzed: 1) a 2017 survey on direct and indirect costs for treatment-related side effects, which was completed by 100 patients with stage 0-IV breast cancer, and 2) a Korean representative cross-sectional survey (Patient Survey 2014) that examined the prevalence of integrative medicine in 41 patients with breast cancer. Main outcome measures The direct and indirect costs for treatment-related side effects. Results In the first dataset, the mean total direct medical cost for complementary medicine was US$1,584 and the mean indirect cost was US$6,988 per patient per year. Some patients (6%) visited non-medical institutions to utilize complementary medicine and additionally spent US$460 per patient per year. Approximately one-third of participants reported a substantial-to-heavy financial burden for using complementary medicine. However, only 17% of patients got information about complementary medicine through their physician. In the second dataset, 49% of patients with breast cancer who were discharged from Korean Medicine hospitals in Patient Survey 2014 data indicated that integrative medicine had been used. Conclusions Despite some complementary medicine could be reimbursed by National Health Insurance in Korea, a considerable number of patients reported an economic burden associated with their use of complementary medicine. Strategies for guiding patients to receive evidence-based and cost-effective complementary medicine are needed.

Background Post-stroke constipation is a major complication of stroke and increases the incidence of poor neurological outcomes and infectious complications and, therefore, warrants active and prompt treatment. In East Asian countries, several types of herbal medicines have been used for the treatment of post-stroke constipation because they are considered safer than existing pharmacotherapies. However, no systematic review has investigated the efficacy and safety of traditional East Asian herbal medicine in the treatment of post-stroke constipation. With this systematic review and meta-analysis, we aimed to evaluate the efficacy and safety of traditional East Asian herbal medicines for the treatment of post-stroke constipation. Methods and analysis Eight electronic databases will be searched for relevant studies published from inception to April 2021. Only randomized controlled trials (RCTs) that assess the efficacy and safety of traditional East Asian herbal medicines for the treatment of post-stroke constipation will be included in this study. The methodological qualities, including the risk of bias, will be evaluated using the Cochrane risk of bias assessment tool. After screening the studies, a meta-analysis of the RCTs will be performed, if possible. Results This study is expected to generate high-quality evidence of the efficacy and safety of herbal medicines to treat post-stroke constipation. Conclusion Our systematic review will provide evidence to determine whether herbal medicines can be effective interventions for patients with post-stroke constipation. Ethics and dissemination Ethical approval is not required, as this study was based on a review of published research. This review will be published in a peer-reviewed journal and disseminated electronically and in print. Trial registration number Research registry reviewregistry1117.

Background: Hepatoma-derived growth factor (HDGF) promotes cancer progression and metastasis by interacting with vascular endothelial growth factor, thereby inducing epithelial-to-mesenchymal transition and angiogenesis. Recent studies have correlated increased HDGF levels with poor prognosis in various malignancies, including lung cancer. This meta-analysis systematically assessed the prognostic significance of HDGF expression in patients with non-small cell lung cancer (NSCLC). Methods: Eligible studies were identified by searching literature in PubMed, Embase, Scopus, and the Cochrane library until June 2020. The pooled hazard ratio (HR) or odds ratio (OR) with 95% confidence interval (CI) was determined to assess the relationship between HDGF expression and clinical outcome in patients with NSCLC. Results: The pooled HRs between high HDGF expression and clinical outcome were 2.20 (95% CI 1.75–2.76, P

Repeated dose oral toxicity and toxicokinetic of KDS2010, a new drug for Parkinson's disease, was investigated after 4-week repeated oral administration at 30, 50, 75, or 100 mg/kg/day in rats. Body weight and body weight gain decreased in rats of both sexes in the 75 and 100 mg/kg groups, and food consumption was reduced in male rats of the 75 and 100 mg/kg male groups. Histological alterations were observed in the kidney (urothelial hyperplasia, inflammatory cell infiltration in the renal pelvis, tubular vacuolation/degeneration, basophilic tubules, and hyaline droplets in the proximal tubules) of the 75 and 100 mg/kg male groups and the 50 and 100 mg/kg female groups. The 75 and 100 mg/kg male groups showed adverse effect in the testes (degeneration/exfoliation of germ cells, seminiferous tubules atrophy) and epididymis (cellular debris, oligospermia). These changes were partially recovered after a 2-week recovery period. However, basophilic tubules and hyaline droplets in the proximal tubules in the kidney and germ cell degeneration/exfoliation in the testis were not recovered. In toxicokinetics study, systemic exposure to KDS2010 increased proportionally in both sexes by in a dose -dependent manner. In addition, repeated administration for 4 weeks led to increased tendency of systemic exposure in both sexes compared with that in Day 1. In conclusion, KDS2010 was shown to target the kidney and testis with a no-observed-adverse-effect level of 50 and 30 mg/kg/day for males and females, respectively.

Objective : We performed a literature review for developing the clinical ph enotype evaluation system of atopic dermatitis. Methods : We searched the papers that describe symptoms for atopic dermat itis through Oriental Medicine Advanced Searching Integrated System(OASIS) and Korean Studies Incategoryation Service System(KISS). We looked through all the papers and finally chose 47 papers that are suitable for inclusion. Then, we extracted symptoms from these papers and arranged them in order of frequency and validity through experts' conference. Results : We found 360 papers and chose 47 papers. We decided to include general information of patients, systemic and dermatologic symptoms in evaluation category of at opic dermatitis. Through experts' conference, it was decided that general information has age, sex and body type ; Systemic symptoms have 9 items; Dermatologic symptoms have 15 items. Conclusion : To evaluate atopic dermatitis objectively, the standardization of diagnostic tool is needed. Therefore we developed a clinical phenotype evaluation system of atopic d ermatitis.Key words : atopic dermatitis; clinical phenotype; pattern identification ; Traditional Korean Medicine

Background The prevalence of obesity among women is increasing. Obesity is associated with various metabolic syndromes; conventional treatments are limited and may induce serious adverse events due to polytherapy regimens. Currently, demands for complementary and alternative medicine that has a proven safety profile for the treatment of obesity with or without metabolic risk factors are increasing.Our team of preclinical experts reported a significant anti-obesity effect of the Korean herbal medicine, Galgeun-tang (GGT). Thus, we designed this trial to explore the effects of GGT among obese women to accumulate optimal clinical evidence.Obesity is not only a component of metabolic syndrome and a factor associated with an increased risk of cardiovascular disease but is also related to insulin resistance. Previous research has confirmed that an increasing body mass index is highly related with increased risk of metabolic syndrome among overweight and obese individuals. The effectiveness of the Korean medicine herbal formula, GGT on obesity has been previously reported. The objective of this study is to assess the efficacy and safety of GGT for weight loss among obese Korean women with or without high risk for metabolic syndrome. Methods/design This study is a randomized, double-blinded, placebo-controlled, multi-center clinical trial. A total of 160 participants will be randomly distributed in 2 groups, the GGT group or the placebo group in a 1:1 ratio using a web-based randomization system. Each group will be administered GGT or placebo 3 times a day for 12 weeks. The primary endpoint is to assess the change in weight from baseline. The secondary endpoints are the following: the changes in body composition measurements, anthropomorphic measurements, obesity screening Laboratory tests, patient self-reported questionnaires, and economic evaluation outcomes. Adverse events will also be reported. Discussion The findings of this study will confirm methodologies regarding the efficacy and safety of GGT for weight loss among obese Korean women with or without metabolic risk factors.