Beneficial effect of Gyejibokryeong-hwan on climacteric syndrome with blood stasis pattern: A randomized, double-blinded, placebo-controlled clinical pilot trial.

Background: Gyejibokryeong-hwan (GBH), a herbal mixture that is widely used for climacteric syndrome, is studied for its efficacy; however, no study evaluated the GBH indication, which is a blood-stasis pattern based on traditional Chinese medicine theory. Methods: This is a randomized, double-blinded, placebo-controlled clinical pilot trial. Fifty subjects with climacteric syndrome were recruited and randomly assigned to GBH group or placebo group. Subjects were administered GBH or placebo granules for 4 weeks followed by 4 weeks of observation period. For the primary outcome, the Menopause Rating Scale (MRS) was evaluated. For the secondary outcomes, quality of life, degrees of abdominal resistance and tenderness, blood-stasis pattern questionnaire and degree of upward movement of Qi were evaluated. Results: After 4-week intervention, the mean change of total MRS score significantly decreased in the GBH group compared to the placebo group (p = 0.037). The quality of life related to physical health (p = 0.008) and blood-stasis pattern (p = 0.018) significantly improved in the GBH group but not in the placebo group. Conclusion: Our findings provide evidence of the feasibility of recruiting subjects with GBH indications and show that GBH may have clinical efficacy for the treatment of menopausal symptoms, especially urogenital symptoms, without any significant adverse events. Trial registration: Clinical Research Information Service (CRIS identifier: KCT0002170).

Cine gastric MRI reveals altered Gut-Brain Axis in Functional Dyspepsia: gastric motility is linked with brainstem-cortical fMRI connectivity.

BACKGROUND: Functional dyspepsia (FD) is a disorder of gut-brain interaction, and its putative pathophysiology involves dysregulation of gastric motility and central processing of gastric afference. The vagus nerve modulates gastric peristalsis and carries afferent sensory information to brainstem nuclei, specifically the nucleus tractus solitarii (NTS). Here, we combine MRI assessment of gastric kinematics with measures of NTS functional connectivity to the brain in patients with FD and healthy controls (HC), in order to elucidate how gut-brain axis communication is associated with FD pathophysiology. METHODS: Functional dyspepsia and HC subjects experienced serial gastric MRI and brain fMRI following ingestion of a food-based contrast meal. Gastric function indices estimated from 4D cine MRI data were compared between FD and HC groups using repeated measure ANOVA models, controlling for ingested volume. Brain connectivity of the NTS was contrasted between groups and associated with gastric function indices. KEY RESULTS: Propagation velocity of antral peristalsis was significantly lower in FD compared to HC. The brain network defined by NTS connectivity loaded most strongly onto the Default Mode Network, and more strongly onto the Frontoparietal Network in FD. FD also demonstrated higher NTS connectivity to insula, anterior cingulate and prefrontal cortices, and pre-supplementary motor area. NTS connectivity was linked to propagation velocity in HC, but not FD, whereas peristalsis frequency was linked with NTS connectivity in patients with FD. CONCLUSIONS & INFERENCES: Our multi-modal MRI approach revealed lower peristaltic propagation velocity linked to altered brainstem-cortical functional connectivity in patients suffering from FD suggesting specific plasticity in gut-brain communication.

Carthami Semen Pharmacopuncture Combined with Electroacupuncture on Carpal Tunnel Syndrome: A Retrospective Case Series Study.

While carpal tunnel syndrome (CTS) is the most common entrapment neuropathy affecting the wrist, resulting in substantial physical, psychological, and economic effects, there is no gold standard therapy for CTS. In this case series study, we aimed to report CTS patients treated with Carthami Semen Pharmacopuncture (CSP) and electroacupuncture (EA) showing improvements in their symptoms, and the combinatorial effects of CSP and EA. We collected medical records of CTS outpatients who received CSP and EA at Chuk-u Acupuncture & Moxibustion Korean Medicine Clinic from August 2017 to September 2018. The outcome measures were the visual analog scale (VAS) for pain, paresthesia, the Korean version of the Boston carpal tunnel questionnaire (K-BCTQ) score, and changes in nocturnal pain, Tinel sign, and Phalen's test. We included patient satisfaction at the completion of all treatments. 17 patients were included for this case series study. After treatment, VAS for pain decreased significantly from 50.41 ± 16.19 to 9.59 ± 9.46, VAS for paresthesia also decreased significantly from 63.50 ± 11.49 to 14.75 ± 12.97, and K-BCTQ symptom severity scale decreased from 2.48 ± 0.68 to 1.89 ± 0.70 (all p < 0.001). Nocturnal pain, Tinel signs, and Phalen's test showed improvements after all the treatments. All the patients reported favorable overall satisfaction with the treatments, and 69.23% wanted future pharmacopuncture treatments if CTS recurred. No complications were detected. The combination of CSP and EA could be an effective and safe option in treating CTS.

Moxibustion for treating cancer-related fatigue: A multicenter, assessor-blinded, randomized controlled clinical trial.

Cancer-related fatigue (CRF) is one of the most common chronic symptoms experienced by cancer patients. As moxibustion is a popular traditional therapy for managing fatigue, it can be an alternative strategy to treat CRF as well. Therefore, we rigorously designed a full-scale, multicenter, assessor-blinded, randomized controlled trial to evaluate the efficacy and safety of moxibustion treatment for CRF. Ninety-six subjects suffering from CRF were recruited and randomly assigned to moxibustion group, sham moxibustion group, or usual care group. Both the moxibustion group and the sham group received moxibustion treatment for 8 weeks and the usual care group did not. Brief fatigue inventory (BFI) score and Functional Assessment of Cancer Therapy-Fatigue score were used to assess CRF at baseline and weeks 5, 9, and 13. Questionnaires for the assessment of cognitive impairment, quality of life, and Cold-Heat and Deficiency-Excess patterns were also evaluated. BFI scores significantly decreased in moxibustion group compared to the usual care group (mean difference of -1.92, p < 0.001 at week 9 and mean difference of -2.36, p < 0.001 at week 13). Although the sham group also showed significant improvement during the treatment period, only the moxibustion group showed improvement after 4 weeks of follow-up period (mean difference of -1.06, p < 0.001). There were no serious adverse events. Our findings confirmed the efficacy and safety of moxibustion for CRF compared to usual care. We also found that moxibustion has a prolonged treatment effect during 4 weeks of follow-up period.

Acupuncture for dry eye syndrome after refractive surgery: A randomized controlled pilot trial.

BACKGROUND: Dry eye syndrome is the most common complication of refractive surgery. Acupuncture is widely used for the treatment of ophthalmologic diseases, but to date, few have explored the effects of acupuncture for the treatment of this condition following refractive surgery. The objective of this study is to assess the feasibility of a study design for evaluating the effectiveness of acupuncture treatment along with usual care compared with usual care only for dry eye syndrome after refractive surgery. METHODS: A total of 18 patients with dry eye syndrome occurring after refractive surgery participated in this study. For 4 weeks, the acupuncture plus usual care and usual care only groups received treatment three times a week. A series of assessments, namely the ocular surface disease index (OSDI), visual analog scale for ocular discomfort, quality of life, tear film break-up time, Schirmer 1 test, and fluorescein-stained corneal-surface photography, along with other general assessments were carried out. RESULTS: Although preliminary, changes in OSDI from the baseline values were significantly different between the two groups at week 5 (p = 0.0003). There was a significant difference in the trends of OSDI changes between the acupuncture plus usual care and the usual care only groups (p = 0.0039). No serious adverse events were reported during the study. CONCLUSION: Four weeks of acupuncture treatment in addition to usual care is a feasible treatment for dry eye syndrome after refractive surgery. A full-scale randomized controlled trial is needed to confirm the clinical effectiveness of acupuncture.

Qualitative study on the key elements of obesity counseling in Korean Medicine.

INTRODUCTION: The increasing prevalence of obesity worldwide necessitates the provision of support for many patients. Patients with obesity appreciate receiving advice from doctors. Previous studies have qualitatively explored clinicians' counseling for weight loss; however, this is limited to primary physicians or general practitioners working in community health centers. In contrast, Korean Medicine Doctors (KMDs) have treated patients with obesity using a holistic approach with a multicomponent approach on counseling. However, there is currently no data regarding KMDs' consulting practices for weight loss. Therefore, the present study will explore KMDs' experience in counseling for weight loss and describe the constituents of counseling for weight loss in Korean medicine practice. METHODS: This qualitative study utilizes a phenomenological framework. The KMDs who have worked >1 year as practitioners in treating patients with obesity will be invited to describe their lived experiences of counseling patients for weight loss. Purposive and snowball sampling will be undertaken to ensure that the sample provides information-rich cases that are representative of KMDs' experiences of counseling for weight loss. Face-to-face, individual, and semi-structured interviews will be conducted with the participants, which will be analyzed using a phenomenological method. ETHICS AND DISSEMINATION: Ethical approval was granted by the Human Research Ethics Committee of the Korea Institute of Oriental Medicine (I-1908/006-001). The results will be disseminated via journal articles and conference presentations. TRIAL REGISTRATION NUMBER: Korean Clinical Trial Registry, KCT0004985.

Efficacy of Hwangryunhaedok-tang (Huang-lian-jie-du-tang, Oren-gedoku-to) for patients with hyperlipidemia: a study protocol for a randomized, double-blind, placebo-controlled, parallel, investigator-initiated clinical trial.

BACKGROUND: The prevalence of hyperlipidemia continues to increase due to aging and lifestyle changes. Statins are currently used as the first choice for treating hyperlipidemia, but are limited by adverse reactions. Hwangryunhaedok-tang (HHT) has received attention as a promising intervention for hyperlipidemia through a few experimental and clinical trials. This study aims to explore the feasibility, effectiveness, and safety of HHT for hyperlipidemia treatment. METHODS: This is a study protocol for a randomized, double-blind, placebo-controlled, parallel, investigator-initiated, pilot clinical trial held in Daejeon, Republic of Korea. Thirty patients with hyperlipidemia will be randomly allocated to HHT or placebo granule groups in equal proportions. Participants will be administered HHT or placebo granules three times per day for 8 weeks and followed up for another 4 weeks. The primary outcome is low-density lipoprotein cholesterol at 8 weeks from the commencement of treatment. Other blood lipid parameters, biomarkers of atherosclerosis, the degree of arteriosclerosis, blood glucose parameters, blood pressure, anthropometric parameters, health-related quality of life, and the changes in the general symptoms of cold and hot patterns will be measured as secondary outcomes. Adverse events and laboratory test results will be investigated to assess the safety. Changes in the gut microbiome before and after intervention will also be assessed as an exploratory outcome through next-generation sequencing. Data will be recorded in electronic case report forms and analyzed using SAS® Version 9.4. DISCUSSION: This is a rigorously designed pilot clinical trial to explore the effect and safety of Hwangryunhaedok-tang compared to placebo control for patients with hyperlipidemia, thereby potentially facilitating better management of hyperlipidemia. The results of this pilot study could form the foundation for a future large-scale, confirmatory clinical trial. TRIAL REGISTRATION: Clinical Research Information Service KCT0004564 . Registered on December 18, 2019.

Treatment of hypothyroidism using Korean medicine: 2 case reports.

INTRODUCTION: Hypothyroidism, the most common endocrine disease, comprises a deficiency of thyroid hormone, causing coldness, fatigue, and dysmenorrhea. Here, we report the improvement of hypothyroidism symptoms and thyroid hormone level normalization by using Korean herbal medicine and acupuncture therapy. PATIENT CONCERNS: A 30-year-old woman (Case 1) presented at the clinic with continuous seborrheic dermatitis on the scalp, accompanied by dysmenorrhea. A 55-year-old woman (Case 2) presented with symptoms of coldness of the limbs and fatigue. DIAGNOSIS: Both patients were diagnosed with "Yin deficiency and Yang hyperactivity" and hypothyroidism after serum thyroid function tests. INTERVENTIONS: Both patients received herbal medicine decoction, acupuncture, and electroacupuncture therapy. OUTCOMES: Korean medicine improved the symptoms of hypothyroidism and significantly normalized thyroid-stimulating hormone and free-thyroxine levels. CONCLUSION: These outcomes suggest that Korean medicine may be effective for resolution of hypothyroidism; however, further research is needed to confirm these findings.

Korean Traditional Medicine in Treating Patients with Mild Cognitive Impairment: A Multicenter Prospective Observational Case Series.

In Korea, patients with mild cognitive impairment can choose to receive treatment of Korean medicine, and Korean medicine hospitals provide specialized medical care for the prevention and management of cognitive disorders. The aim of the study is to explore the role of Korean medicine therapy for patients with mild cognitive impairment in a real clinical setting. Fifteen patients with amnestic mild cognitive impairment were enrolled in this prospective observational study in three Korean medicine hospitals. Korean medicine treatments were delivered by experienced professionals and not restricted to standardized treatment. Outcome measures were prospectively planned to examine the Korean-Montreal Cognitive Assessment (K-MoCA), Korean-Mini Mental State Examination (K-MMSE), and other detailed neuropsychological assessment at the baseline and after 12 and 24 weeks of treatment. Korean medicine treatment for MCI treatment in the real-world clinical setting included herbal medicine and acupuncture. The most frequently used herbs in herbal decoctions were Acori Graminei Rhizoma, Polygalae Radix, and Poria Sclerotium Cum Pini Radix. The herbal medicine formulae used in this study were classified into three categories: tonifying Qi (33.3%), tonifying kidney (46.7%), and calming liver (20%) formulae. In the cognitive ability assessment, the K-MoCA score significantly improved after treatment (mean difference 2.6; 95% CI: 1.3 to 3.9, p=0.001). The K-MMSE score slightly increased after treatment; however, the improvement was not statistically significant (mean difference 0.8; 95% CI: -0.5 to 2.0, p=0.195). In detailed neuropsychological assessment, the cognitive domains of executive functions and memory after the treatment were distinctively improved. In this prospective observational case series, we could see the real clinical environments of treating patients with mild cognitive impairment in Korean medicine hospitals. Patients treated with Korean medicine showed improved results in the neuropsychological assessment after 12 and 24 weeks.

Effect of probiotics on obesity-related markers per enterotype: a double-blind, placebo-controlled, randomized clinical trial.

BACKGROUND: Prevention and improvement of disease symptoms are important issues, and probiotics are suggested as a good treatment for controlling the obesity. Human gut microbiota has different community structures. Because gut microbial composition is assumed to be linked to probiotic function, this study evaluated the efficacy of probiotics on obesity-related clinical markers according to gut microbial enterotype. METHODS: Fifty subjects with body mass index over 25 kg/m2 were randomly assigned to either the probiotic or placebo group. Each group received either unlabeled placebo or probiotic capsules for 12 weeks. Body weight, waist circumference, and body composition were measured every 3 weeks. Using computed tomography, total abdominal fat area and visceral fat area were measured. Blood and fecal samples were collected before and after the intervention for biochemical parameters and gut microbial compositions analysis. RESULTS: Gut microbial compositions of all the subjects were classified into two enterotypes according to Prevotella/Bacteroides ratio. The fat percentage, blood glucose, and insulin significantly increased in the Prevotella-rich enterotype of the placebo group. The obesity-related markers, such as waist circumference, total fat area, visceral fat, and ratio of visceral to subcutaneous fat area, were significantly reduced in the probiotic group. The decrease of obesity-related markers was greater in the Prevotella-rich enterotype than in the Bacteroides-rich enterotype. CONCLUSION: Administration of probiotics improved obesity-related markers in obese people, and the efficacy of probiotics differed per gut microbial enterotype and greater responses were observed in the Prevotella-dominant enterotype.

Jakyakgamcho-tang in the relief of delayed-onset muscle soreness in healthy adults: study protocol for a randomized, double-blind, placebo-controlled, crossover design clinical trial.

BACKGROUND: Muscle soreness after exercise, called delayed-onset muscle soreness (DOMS), may cause significant changes in muscle function and may increase the risk of sports injuries. Therefore, various therapeutic strategies have been studied to help recovery after exercise. Jakyakgamcho-tang (JGT) is a widely prescribed herbal medicine to treat muscle pain and cramps in traditional Eastern medicine. The aim of this study is to evaluate the effect of JGT for reducing pain and improving muscle damage after exercise. METHODS: This study is a randomized, double-blind, placebo-controlled, crossover design clinical trial. A total of 30 healthy male adults will be recruited. Subjects who voluntarily wish to participate in this study will be hospitalized for 4 days. On the first day, the subjects will perform a standardized treadmill exercise for 1 h to induce DOMS. After the exercise, the subjects will take either JGT or a placebo for 3 days. After a more than 1 week wash-out period, the subjects will repeat the same process with the other drug. Pain intensity, calf circumference, and pain threshold will be measured as outcome measures. Blood tests and blood pressure will be measured as safety assessments. In addition, blood tests for muscle damage and inflammation markers, such as creatine kinase, interleukin-6, and C-reactive protein, will be analyzed. DISCUSSION: This will be the first trial to assess the effect of JGT on exercise-induced muscle soreness. Our findings will provide valuable data to determine the clinical effects of JGT on DOMS. TRIAL REGISTRATION: Clinical Research Information Sevice, KCT0003457. Registered on 29 January 2019.

Effect of Daesiho-tang on obesity with non-alcoholic fatty liver disease: a study protocol for a randomised, double-blind, placebo-controlled pilot trial.

BACKGROUND: The high prevalence of obesity and non-alcoholic fatty acid disease has become an important public health problem. Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liver diseases. This pilot study will assess the feasibility of using DST in obese patients with a non-alcoholic fatty liver disease (NAFLD) prior to undertaking a full-scale clinical trial. METHODS/DESIGN: This is a study protocol for a randomised, double-blind, parallel-group, stratified, placebo-controlled pilot trial. We will recruit a total of 60 participants with NAFLD who have a body mass index ≥ 25 kg/m2. They will take either DST or placebo (3 g, three times daily) for 12 weeks with a 4-week follow-up period. The effects of DST will be evaluated by the mean change in body weight as the primary measurement and other secondary parameters (body composition, anthropometric measurements, blood tests, hepatic fat quantification through transient elastography and a physical symptoms questionnaire). Faecal samples will be collected before and after the intervention for a gut microbial analysis. DISCUSSION: In anticipation of conducting further large-scale trials, in this study we will explore the effect of DST on weight loss and obesity-related markers, along with NAFLD-related clinical parameters, in obese patients with NAFLD. Furthermore, it will provide insight into the DST pharmacological mechanism of action through a gut microbiome analysis. TRIAL REGISTRATION: Korean Clinical Trial Registry, KCT0003554. Registered on 25 February 2019.

A Randomized Clinical Trial of Synbiotics in Irritable Bowel Syndrome: Dose-Dependent Effects on Gastrointestinal Symptoms and Fatigue.

BACKGROUND: This double-blind, randomized controlled design study aimed to assess the dose-dependent effects of synbiotics on gastrointestinal symptoms of and fatigue in irritable bowel syndrome (IBS). METHODS: Thirty subjects with IBS were randomly assigned into the following three groups and received 2 capsules a day for 8 weeks: (1) high-dose (2 capsules of synbiotics); (2) low-dose (1 capsule of synbiotics and 1 capsule of placebo); and (3) placebo (2 capsules of placebo). At baseline and 8 weeks, they completed the study questionnaires. RESULTS: Two subjects in the high-dose group were lost to follow-up, leaving a total of 28 patients for the analysis. After 8 weeks, abdominal discomfort, abdominal bloating, frequency of formed stool, fatigue Visual Analog Scale (VAS), and Multidimensional Fatigue Inventory were significantly different among the groups (P=0.002, 0.006, 0.007, 0.028, and 0.041, respectively, by Kruskal-Wallis test). However, only abdominal discomfort, abdominal bloating, frequency of formed stool, and fatigue VAS were significantly improved in the high-dose group compared with those in the placebo group (P=0.002, 0.003, 0.002, and 0.013, respectively) by Mann-Whitney test with Bonferroni correction. No adverse drug reactions were reported. CONCLUSION: High-dose synbiotics were superior to placebo in improving bowel symptoms and fatigue of IBS patients, suggesting that synbiotic dosage plays an important role in the treatment of IBS.

Efficacy of Bee Venom Acupuncture for Chronic Low Back Pain: A Randomized, Double-Blinded, Sham-Controlled Trial.

Bee venom acupuncture (BVA) is an effective treatment for chronic low back pain (CLBP) through the pharmacological effects of bee venom and the simultaneous stimulation of acupoints. However, evidence of its efficacy and safety in humans remains unclear. Using a double-blind, randomized study, 54 patients with non-specific CLBP were assigned to the BVA and sham groups. All participants underwent six sessions of real or sham BVA for 3 weeks, in addition to administration of 180 mg of loxonin per day. The primary outcome, that is, "bothersomeness" derived from back pain, was assessed using the visual analog scale. Secondary outcomes included pain intensity, dysfunction related to back pain (Oswestry Disability Index), quality of life (EuroQol 5-Dimension), and depressive mood (Beck's depression inventory). Outcomes were evaluated every week during the treatment period and followed up at weeks 4, 8, and 12. After 3 weeks of the treatment, significant improvements were observed in the bothersomeness, pain intensity, and functional status in the BVA group compared with the sham group. Although minimal adverse events were observed in both groups, subsequent recovery was achieved without treatment. Consequently, our results suggest that it can be used along with conventional pharmacological therapies for the treatment of CLBP.

In vivo therapeutic effect of combination treatment with metformin and Scutellaria baicalensis on maintaining bile acid homeostasis.

The radix of Scutellaria baicalensis (SB) is a herb widely used in traditional Chinese medicine to treat metabolic diseases. Several main components, including baicalin and wogonoside, possess anti-dyslipidemia, anti-obesity and anti-diabetic effects. We hypothesized that co-administration of SB extract and metformin exerts a better effect on obesity-induced insulin resistance and lipid metabolism than treatment with metformin alone. We compared the effect of metformin (100 mg/10 mL/kg/day) alone with co-administration of metformin (100 mg/5 mL/kg/day) and SB extract (200 mg/5 mL/kg/day) on Otsuka Long Evans Tokushima Fatty rats, a useful model of type II diabetes with obesity, and used Long-Evans Tokushima Otsuka rats as a control. Weight, fasting glucose, oral glucose tolerance test, intraperitoneal insulin tolerance test, and serum total cholesterol were measured after 12 weeks of drug administration. We observed a synergetic effect of metformin and SB on lowering cholesterol level by excretion of bile acid through feces. We found that this accompanied activation of FXR, CYP7A1 and LDLR genes and repression of HMGCR in the liver. Although there were no significant changes in BSH-active gut microbiota due to high variability, functional prediction with 16S sequences showed increased primary and secondary bile acid biosynthesis in the combination treatment group. Further study is needed to find the specific strains of bacteria which contribute to FXR-related cholesterol and bile acid regulations.

Ephedra-Treated Donor-Derived Gut Microbiota Transplantation Ameliorates High Fat Diet-Induced Obesity in Rats.

Changes in gut microbiota (GM) are closely associated with metabolic syndrome, obesity, type 2 diabetes and so on. Several medicinal herbs, including Ephedra sinica (Es), have anti-obesity effects that ameliorate metabolic disorders. Therefore, in this study we evaluated whether Es maintains its anti-obesity effect through Es-altered gut microbiota (EsM) transplantation. GM was isolated from cecal contents of Es treated and untreated rats following repeated transplants into obese rats via oral gavage over three weeks. High-fat-diet (HFD)-induced obese rats transplanted with EsM lost significant body weight, epididymal fat, and perirenal fat weight, but no remarkable changes were observed in abdominal fat, liver, cecum weight and food efficiency ratio. In addition, treatment with EsM also significantly lowered the fasting blood glucose, serum insulin level, and insulin resistance index. Meanwhile, EsM transplantation significantly reduced gene expression of proinflammatory cytokines interleukin-1 and monocyte chemotactic protein-1. Rats treated with EsM also showed changed GM composition, especially blautia, roseburia and clostridium, significantly reduced the level of endotoxin and markedly increased the acetic acid in feces. Overall, our results demonstrated that EsM ameliorates HFD-induced obesity and related metabolic disorders, like hyperglycemia and insulin resistance, and is strongly associated with modulating the distribution of GM, enterogenous endotoxin and enteral acetic acid.

Efficacy of double-coated probiotics for irritable bowel syndrome: a randomized double-blind controlled trial.

BACKGROUND: The purpose of this study was to elucidate the effects of a dual-coated probiotic supplement (Duolac Care) on symptoms of diarrhea-predominant irritable bowel syndrome in a randomized double-blind clinical trial. METHODS: Fifty subjects with diarrhea-predominant irritable bowel syndrome were randomly assigned to either the non-coating group or the dual-coating group in order to receive two capsules per day of multi-species probiotics containing 5 billion bacteria per capsule for 4 weeks. Data from an adequate relief questionnaire were used in assessment of primary outcome. Daily records of stool frequencies and the Bristol stool scale, a weekly symptom diary using 100-mm visual analog scale, and Beck depression inventories were collected. Blood tests including blood cell counts, interleukin-10, tumor necrosis factor-alpha and inducible nitric oxide synthase, and regulatory T cells-CD4 + CD25high T cells, CD4 + LAP + T cells and CD25high + LAP + T cells-were analyzed before and after the study. The shift of gut microbiota was investigated using a quantitative real-time polymerase chain reaction assay. RESULTS: Responses to the adequate relief questionnaire indicated significant improvement in overall discomfort in the dual-coating group and the ratio of normal stools to hard or watery stools had a better effect from dual-coated probiotics compared to non-coated probiotics. This may be due to a shift of intestinal microbiota, as our correlation analysis showed significant negative correlation between Bifidobacterium and urgency of defecation. CONCLUSIONS: Our result implies that dual-coating layers of probiotic supplement can be a candidate for treatment of diarrhea-predominant irritable bowel syndrome.

Understanding the molecular aspects of oriental obesity pattern differentiation using DNA microarray.

BACKGROUND: Human constitution, the fundamental basis of oriental medicine, is categorized into different patterns for a particular disease according to the physical, physiological, and clinical characteristics of the individuals. Obesity, a condition of metabolic disorder, is classified according to six patterns in oriental medicine, as follows: spleen deficiency syndrome, phlegm fluid syndrome, yang deficiency syndrome (YDS), food accumulation syndrome (FAS), liver depression syndrome (LDS), and blood stasis syndrome. In oriental medicine, identification of the disease pattern for individual obese patients is performed on the basis of differentiation in obesity syndrome index and, accordingly, personalized treatment is provided to the patients. The aim of the current study was to understand the obesity patterns in oriental medicine from the genomic point of view via determining the gene expression signature of obese patients using peripheral blood mononuclear cells as the samples. METHODS: The study was conducted in 23 South Korean obese subjects (19 female and four male) with BMI ≥25 kg/m(2). Identification of oriental obesity pattern was based on the software-guided evaluation of the responses of the subjects to a questionnaire developed by the Korean Institute of Oriental Medicine. The expression profiles of genes were determined using DNA microarray and the level of transcription of genes of interest was further evaluated using quantitative real-time PCR (qRT-PCR). RESULTS AND CONCLUSION: Gene clustering analysis of the microarray data from the FAS, LDS, and YDS subjects exhibited disease pattern-specific upregulation of expression of several genes in a particular cluster. Further analysis of transcription of selected genes using qRT-PCR led to identification of specific genes, including prostaglandin endoperoxide synthase 2, G0/G1 switch 2, carcinoembryonic antigen-related cell adhesion molecule 3, cystein-serine-rich nuclear protein 1, and interleukin 8 receptor, alpha which were highly expressed in LDS obesity constitution. Our current study can be considered as a valuable contribution to the understanding of possible explanation for obesity pattern differentiation in oriental medicine. Further studies can address a novel possibility that the genomic and oriental empirical approaches can be combined and implemented in systematic and synergistic development of personalized medicine. This clinical trial was registered in Clinical Research Information Service of Korea National Institute of Health ( https://cris.nih.go.kr/cris/index.jsp ). REGISTRATION NUMBER: KCT0000387.

Serum Gamma-glutamyl Transferase Concentration Within the Reference Range is Related to the Coronary Heart Disease Risk Prediction in Korean Men: Analysis of the Korea National Health and Nutrition Examination Survey (V-1, 2010 and V-2, 2011).

BACKGROUND: Limited data exist on the association of serum gamma-glutamyl transferase (GGT) level within the reference range with the increased risk of coronary heart disease (CHD) prediction in men. The study examined the association between serum GGT concentration within the reference range and the CHD risk prediction in Korean men. METHODS: The study employed data from Korean National Health and Nutrition Examination Survey (V-1, 2010 and V-2, 2011) where a total of 1301 individuals were analyzed. A 10-year CHD risk prediction was computed using the Framingham Risk Score (FRS) modified by the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III). RESULTS: Positive correlations were established between log-transformed GGT concentration and FRS (r = 0.237, P < 0.001). After adjustment of body mass index, the amount of alcohol intake and low-density lipoprotein-cholesterol, the odds ratio (95% confidence interval) for intermediate risk and beyond of 10-year CHD prediction (10-year risk ≥10%) with lowest quartile of participants was 1.21 (0.78-1.87) for second quartiles, 1.39 (0.88-2.21) for third quartiles and 2.03 (1.23-3.34) for highest quartiles. CONCLUSIONS: Higher serum GGT within its reference range was significantly correlated with a 10-year CHD risk prediction estimation using NCEP ATP III in Korean men.