A Randomized Double-Blind, Placebo-Controlled Study on Anti-Stress Effects of Nelumbinis Semen.

Introduction: Depression is a serious and common mental disease that causes low mood and loss of interest in activities. Nelumbinis semen (NS) has been widely used as a treatment for depression for hundreds of years in many Asian countries. Water extract of nelumbinis semen (WNS) is a standardized herbal medicine made from NS. Methods: The objective of the present research was to perform a randomized, double-blind, placebo-controlled trial to estimate the efficacy of WNS for improving depressive and stress symptoms using Beck depression inventory (BDI) and the stress response inventory (SRI) in 45 adults diagnosed with major depression or other forms of depressive disorders. They were randomized to either a placebo-treated group, a 2.4 g per day WNS-treated group, or a 4.8 g per day WNS-treated group. BDI and SRI were determined in order to evaluate changes in depression before and after two weeks of WNS treatment. Results: The average BDI and SRI of the 2.4 g WNS-treated group were significantly (p < 0.05) improved compared to those of the placebo-treated group. Their BDI subscale A (negative attitudes towards self) and subscale C (somatic disturbances), SRI E, and depression subscale of SRI were substantially shorter (p < 0.05). In addition, an analysis of collected EEG data of participants showed a significant increase in alpha/beta activity in the 4.8 g WNS-treated group, which might be explained as an advancement of their depression symptoms (p < 0.05). Conclusions: These results suggest that WNS treatment can decrease depression. Our study provides preliminary evidence for the safety of WNS and its potential to decrease depression.

Sedative-Hypnotic Activity of the Water Extracts of Coptidis Rhizoma in Rodents.

Many medicinal plants have been used in Asia for treating a variety of mental diseases, including insomnia and depression. However, their sedative-hypnotic effects and mechanisms have not been clarified yet. Accordingly, the objective of this study was to investigate the sedative-hypnotic effects of water extracts of five medicinal plants: Coptidis Rhizoma, Lycii Fructus, Angelicae sinensis Radix, Bupleuri Radix, and Polygonum multiflorum Thunberg. The binding abilities of five medicinal plant extracts to the GABAA-BZD and 5-HT2C receptors were compared. Their abilities to activate arylalkylamine N-acetyltransferase (AANAT), a melatonin synthesis enzyme, in pineal cells were also determined. Following in vitro tests, the sedative and hypnotic activities of extracts with the highest activities were determined in an animal sleep model. In the binding assay, the water extracts of Coptidis Rhizoma (WCR) showed high binding affinity to the GABAA-BZD and 5-HT2C receptors in a dose-dependent manner. Additionally, WCR increased the AANAT activity up to five times compared with the baseline level. Further animal sleep model experiments showed that WCR potentiated pentobarbital-induced sleep by prolonging the sleep time. It also decreased the sleep onset time in mice. In addition, WCR reduced wake time and increased non-rapid eye movement (NREM) sleep without EEG power density (percentages of δ, θ, and α waves) during NREM sleep in rats. WCR could effectively induce NREM sleep without altering the architectural physiologic profile of sleep. This is the first report of the sedative-hypnotic effect of Coptidis Rhizoma possibly by regulating GABAA and 5-HT2C receptors and by activating AANAT activity.

Impact of a family history of cardiovascular disease on prevalence, awareness, treatment, control of dyslipidemia, and healthy behaviors: Findings from the Korea National Health and Nutrition Examination Survey.

BACKGROUND: Family history (FH) is one of important risk factors for cardiovascular disease (CVD). However, little is known about its impact on dyslipidemia prevalence and management status. Thus, we aimed to investigate the impact of FH of CVD on dyslipidemia prevalence, awareness, treatment, control, and healthy behaviors in Korean adults. METHODS: We conducted a cross-sectional study using representative data from the Korea National Health and Nutrition Examination Survey (KNHANES) 2014-2018. A total of 22,024 participants aged ≥ 19 years without histories of CVDs were classified into two groups according to the presence of FH of CVD (with FH, n = 3,778; without FH, n = 18,246). FH of CVD was defined as having a first-degree relative with ischemic heart disease or stroke. Multivariate logistic regression analyses were performed to evaluate the association between FH of CVD and dyslipidemia prevalence, awareness, treatment, control, and healthy behaviors (weight control, non-smoking, non-risky drinking, sufficient physical activity, and undergoing health screening). RESULTS: FH of CVD was significantly associated with a higher dyslipidemia prevalence (adjusted odds ratio [aOR] 1.34, 95% confidence interval [CI] 1.18-1.51), better awareness (aOR 1.54, 95%CI 1.19-2.00), and treatment rates (aOR 1.34, 95%CI 1.12-1.60), but not control. Having an FH of CVD was not predictive of any healthy behaviors in dyslipidemia patients. For non-dyslipidemia patients, FH of CVD even showed significant association with smoking (aOR 1.18, 95%CI 1.02-1.36), and risky drinking (aOR 1.20, 95%CI 1.03-1.40) while it was predictive of receiving health screening (aOR 1.14, 95% CI 1.02-1.27). CONCLUSIONS: Having an FH of CVD might positively trigger dyslipidemia patients to start pharmacological intervention, but not non-pharmacological interventions. Therefore, physicians should make more efforts to educate and promote the importance of non-pharmacological behavioral modification in dyslipidemia patients with an FH of CVD.

Biopsychosocial characteristics associated with engagement in art making among older adults.

In order to design patient-centered art making interventions for health and well-being, investigators need to understand the population of interest regarding their relationship to engagement in art making activities. This study, therefore, aimed to examine older adults' characteristics that were associated with engagement in art making activities, and to provide practical examples of how to use the identified characteristics. We conducted correlation analyses to evaluate such associations, using cross-sectional survey data from the 2014 Health and Retirement Study (n=731). Female sex, higher education, personality traits, positive attitude toward the arts, and a larger social network size were positively associated with engagement in art making activities (p<.05). Males and those with lower education could be targeted, while the type of art making activity could be tailored based on personality traits for patient-centered art making interventions. Future studies can use this information to empirically study art making interventions for older adults.

Prevalence, awareness, treatment, and control of dyslipidemia among diabetes mellitus patients and predictors of optimal dyslipidemia control: results from the Korea National Health and Nutrition Examination Survey.

BACKGROUND: This study aimed to investigate the prevalence, awareness, treatment, and control rates of dyslipidemia and identify the predictors of optimal control (low-density lipoprotein cholesterol < 100 mg/dL) among patients with diabetes mellitus (DM). METHODS: A cross-sectional study was conducted using the representative Korea National Health and Nutrition Examination Survey (2014-2018). Overall, 4311 patients with DM, aged ≥19 years, and without cardiovascular diseases were selected, and the prevalence, awareness, treatment, and control rates of dyslipidemia were calculated. Univariate and multivariate logistic regression analyses were conducted to evaluate the factors influencing the optimal control of dyslipidemia. RESULTS: Dyslipidemia was prevalent in 83.3% of patients with DM, but the awareness and treatment rates were 36.5 and 26.9%, respectively. The control rate among all patients with dyslipidemia was 18.8%, whereas it was 61.1% among those being treated. Prevalence and awareness rates were also significantly higher in women than in men. Dyslipidemia was most prevalent in those aged 19-39 years, but the rates of awareness, treatment, and control among all patients with dyslipidemia in this age group were significantly lower than those in other age groups. The predictors of optimal control were age ≥ 40 years [range 40-49 years: adjusted odds ratio (aOR) 3.73, 95% confidence interval (CI) 1.43-9.72; 50-59 years: aOR 6.25, 95% CI 2.50-15.65; 60-69 years: aOR 6.96, 95% CI 2.77-17.44; 70-79 years: aOR 9.21, 95% CI 3.58-23.74; and ≥ 80 years: aOR 4.43, 95% CI 1.60-12.27]; urban living (aOR 1.44, 95% CI 1.15-1.80); higher body mass index (aOR 1.27, 95% CI 1.13-1.42); lower glycated hemoglobin levels (aOR 0.71, 95% CI 0.67-0.76); hypertension (aOR 1.53, 95% CI 1.22-1.92); poorer self-rated health status (aOR 0.72, 95% CI 0.62-0.84); and receiving regular health check-ups (aOR 1.58, 95% CI 1.25-2.00). CONCLUSIONS: Most patients with DM were diagnosed with dyslipidemia, but many were unaware of or untreated for their condition. Therefore, their control rate was suboptimal. Thus, by understanding factors influencing optimal control of dyslipidemia, physicians should make more effort to encourage patients to undergo treatment and thus, adequately control their dyslipidemia.

Impaired Odor Identification of Culturally Familiar Odorants Associated with Dementia in South Korean Older Adults.

Among olfactory functions, odor identification is the most studied predictor of dementia. We aimed to verify whether patients with dementia are less aware of specific odors than cognitively normal individuals using an odor identification test, which includes odorants that are culturally familiar to South Koreans. We divided 139 older adults aged 57-79 years into the dementia and normal cognition groups. Odor identification function was assessed in all participants. We conducted hierarchical logistic regression analyses with the diagnosis of dementia as a dependent variable and three demographic characteristics, as well as 12 odor identification items, as independent variables. Impaired odor identification for herbal medicine (odds ratio (OR) = 9.420; p = 0.012) and Korean grilled meat (OR = 5.361; p = 0.019) and older age (OR = 1.176; p = 0.005) were significant predictors of dementia. Impaired odor identification of culturally familiar odorants was associated with dementia risk. This may be explained by the fact that compared with culturally non-specific universal odorants, familiar odorants are more related to episodic memory, which is impaired in the early stages of dementia. Thus, an optimal combination of odor identification items should be used for screening individuals with cognitive decline requiring further neurocognitive function tests.

How does art making work? Testing the hypothesized mechanisms of art making on pain experience.

BACKGROUND: Pain is a multidimensional experience that requires a holistic pain management approach. Art making, a holistic, mind-body-spirit approach, has been used as a pain management strategy. Although findings of empirical studies point toward several potential mechanisms through which art making activity may affect the pain experience, these mechanisms have not yet been tested. Therefore, the purpose of this study is to evaluate whether perceived control, self-efficacy, spirituality, and mood mediate the effect of art making activity on pain. MATERIALS AND METHODS: This study is a secondary analysis of cross-sectional survey data collected in 2014 for the Health and Retirement Study (HRS). Data from a national sample of 731 adults, 50 years of age or older were analyzed for the current study. Participants completed a health survey which included measures of art engagement (representing 'effect of art making' in this study), pain severity and interference, and proposed mediating variables (e.g., perceived control, self-efficacy, spirituality and mood). The joint significance test was used to test hypothesized mediation. RESULT: We found that positive mood mediated the effects of art engagement on pain, but perceived control, self-efficacy, spirituality, and negative mood did not. Engagement in art making activity was associated with more positive mood (ß = 0.213, p = .001). In turn, greater positive mood was associated with lower pain severity (ß = -.147, p = .010) and pain interference (ß = -.519, p = .034). CONCLUSION: Results of this study provide preliminary evidence that engagement in art making activity impacts pain experience by enhancing positive mood. A large prospective study examining the hypothesized mediating relationship is necessary to confirm our findings.

Restoration of Cellular Proliferation and Characteristics of Human Tenocytes by Vitamin D.

Vitamin D (Vit D) increases calcium absorption in the intestine after binding to the Vit D receptor (VDR). The VDR has also been identified in muscle cells. Vit D supplementation resulted in improved muscle strength. However, there is a paucity of studies of the role of Vit D on tenocytes. We investigated the effects of Vit D on damaged tenocytes. Human tenocytes were treated with dexamethasone (Dex) to induce cell injury. Expression of the tenocyte-related markers tenomodulin (Tnmd), tenascin C (Tnc), scleraxis (Scx), mohawk (Mkx), and collagen (Col) 1 and 3 were measured. Then, tenocytes were cotreated with Vit D. 1-α-Hydroxylase and VDR were explored in tenocytes. With 10 µM Dex, the growth of tenocytes was significantly inhibited, and the gene expression of Tnmd, Tnc, Scx, Mkx, Col 1 and 3 also decreased. When tenocytes were cotreated with Vit D, cell proliferation recovered in a dose-dependent manner, and the expression of TNMD and Col 1 improved. When studying the mechanisms of the effects of Vit D on tenocytes, reactive oxygen species produced by Dex decreased with Vit D, and the phosphorylation of extracellular signal-regulated kinase and p38 was stimulated by Vit D cotreatment. 1-α-Hydroxylase and VDR were found in tenocytes, indicating that the cells have the ability to use an inactive form of Vit D and interact with it. Vit D is known to perform diverse actions and its protective effects on tenocytes suggest its beneficial role in tendon in addition to muscle and bone. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:2241-2248, 2019.

Antinociceptive and anti-inflammatory effects of ginsenoside Rf in a rat model of incisional pain.

BACKGROUND: Ginseng saponin has long been used as a traditional Asian medicine and is known to be effective in treating various kinds of pain. Ginsenoside Rf is one of the biologically active saponins found in ginseng. We evaluated ginsenoside Rf's antinociceptive and anti-inflammatory effects, and its mechanism of action on adrenergic and serotonergic receptors, in an incisional pain model. METHODS: Mechanical hyperalgesia was induced via plantar incision in rats followed by intraperitoneal administration of increasing doses of ginsenoside Rf (vehicle, 0.5 mg/kg, 1 mg/kg, 1.5 mg/kg, and 2 mg/kg). The antinociceptive effect was also compared in a Positive Control Group that received a ketorolac (30 mg/kg) injection, and the Naïve Group, which did not undergo incision. To evaluate the mechanism of action, rats were treated with prazosin (1 mg/kg), yohimbine (2 mg/kg), or ketanserin (1 mg/kg) prior to receiving ginsenoside Rf (1.5 mg/kg). The mechanical withdrawal threshold was measured using von Frey filaments at various time points before and after ginsenoside Rf administration. To evaluate the anti-inflammatory effect, serum interleukin (IL)-1ß, IL-6, and tumor necrotizing factor-α levels were measured. RESULTS: Ginsenoside Rf increased the mechanical withdrawal threshold significantly, with a curvilinear dose-response curve peaking at 1.5 mg/kg. IL-1ß, IL-6, and tumor necrotizing factor-α levels significantly decreased after ginsenoside Rf treatment. Ginsenoside Rf's antinociceptive effect was reduced by yohimbine, but potentiated by prazosin and ketanserin. CONCLUSION: Intraperitoneal ginsenoside Rf has an antinociceptive effect peaking at a dose of 1.5 mg/kg. Anti-inflammatory effects were also detected.

Use of Art-Making Intervention for Pain and Quality of Life Among Cancer Patients: A Systematic Review.

BACKGROUND: Although pain is one of the most prevalent symptoms among cancer patients, medications do not always result in sufficient pain relief. Furthermore, these medications only address the physical component of pain. Art making, a holistic approach, may distract the user's attention from pain and allow expression of the nonphysical (e.g., psychological, spiritual) components of pain. The purpose of this systematic review was to evaluate evidence for the efficacy of art-making interventions in reducing pain and improving health-related quality of life (QoL) among cancer patients. METHOD: PubMed, Academic Search Premier, ProQuest, and CINAHL were searched from database inception to September 2016 using the following search terms: neoplasm, cancer, tumor, pain, pain management, quality of life (QoL), well-being, art therapy, painting, and drawing. RESULTS: Fourteen articles reporting 13 studies were reviewed. Some studies reported beneficial effects of art making on pain and QoL, but the evidence was weakened by poor study quality ratings, heterogeneity in art-making interventions and outcome measures, interventions including non-art-making components, and few randomized controlled studies. CONCLUSION: More rigorous research is needed to demonstrate the efficacy of art making in relieving cancer-related pain and improving QoL.

Mixed-Modality Stimulation to Evoke Two Modalities Simultaneously in One Channel for Electrocutaneous Sensory Feedback.

One of the long-standing challenges in upper limb prosthetics is restoring the sensory feedback that is missing due to amputation. Two approaches have previously been presented to provide various types of sensory information to users, namely, multi-modality sensory feedback and using an array of single-modality stimulators. However, the feedback systems used in these approaches were too bulky to be embedded in prosthesis sockets. In this paper, we propose an electrocutaneous sensory feedback method that is capable of conveying two modalities simultaneously with only one electrode. The stimulation method, which we call mixed-modality stimulation, utilizes the phenomenon in which the superposition of two electric pulse trains of different frequencies is able to evoke two different modalities (i.e., pressure and tapping) at the same time. We conducted psychophysical experiments in which healthy subjects were required to recognize the intensity of pressure or the frequency of tapping from mixed-modality or two-channel stimulations. The results demonstrated that the subjects were able to discriminate the features of the two modalities in one electrode during mixed-modality stimulation and that the accuracies of successful recognitions (mean ± standard deviation) for the two feedback variables were 84.3 ± 7% for mixed-modality stimulation and 89.5 ± 6% for two-channel dual-modality stimulation, showing no statistically significant difference. Therefore, mixed-modality stimulation is an attractive method for modulating two modalities independently with only one electrode, and it could be used for implementing a compact sensory feedback system that is able to provide two different types of sensory information from prosthetics.

Efficacy and Safety of "URSA Complex" in Subjects with Physical Fatigue: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial.

BACKGROUND: Fatigue is a common symptom both in diseases status and in healthy subjects. Various supplements and nutraceuticals for relieving of fatigue have been used. However, there are a few studies to evaluate the efficacy and the safety of the drug for fatigue alleviation, we conducted using URSA Complex to evaluate the efficacy on physical fatigue via score changes in the checklist individual strength (CIS). METHODS: The study was designed as a multicenter, randomized, double-blind, placebo-controlled trial, with subjects randomized to one of the two arms, receiving either placebo or URSA Complex administered as identical capsules. The primary efficacy endpoints of this clinical trials are the ratio of improving CIS scores < 76 points in patients at the end (4 weeks). Secondary efficacy variables are as follows one is an improvement of fatigue and the other is an improvement of the liver enzyme. RESULTS: The fatigue recovery rate in who had improved CIS scores of < 76 points were 70.0%, 50.9% in the therapy group and placebo group, respectively (P = 0.019). The fatigue recovery rate in CIS score was higher in URSA Complex therapy group than placebo group. The difference between therapy group and placebo group was statistically significant at 4 weeks later, but not 2 weeks. CONCLUSIONS: Our results provided that the URSA Complex was effective in alleviating physical fatigue. The adverse event frequency in the therapy groups was similar to that in the placebo group.

Simple intrapleural hyperthermia at thoracoscopic exploration to treat malignant pleural effusion.

BACKGROUND: Malignant pleural effusion (MPE) occurs at a terminal stage of cancer, and related symptoms may considerably reduce a patient's respiratory function and quality of life. We assessed the benefit of simple intrapleural hyperthermia (SIH) during thoracoscopic exploration for MPE. METHODS: We conducted a retrospective review of 34 patients underwent thoracoscopic exploration and SIH procedures for MPE between April, 2009 and July, 2014 at our institution. One month after removal of the tube, therapeutic efficacy was evaluated, calculating response rates and recurrence rate. RESULTS: In this cohort (male, 11; female, 23; average age, 54.2 ± 12.7 years), the most frequent primary cancers were breast (n = 11, 32.4 %), lung (n = 10, 29.4 %), and ovarian (n = 6, 17.6 %). Therapeutic response (ie, presence of pleural effusion) was assessed 1 month after chest tube removal, with 19 (55.9 %) showing complete response (CR), 9 (26.5 %) showing partial response (PR), and non-response (NR) seen in 6 (17.6 %). The combined (CR + PR) response rate was 82.4 %. During follow-up, there were seven instances of recurrence, requiring repeat drainage. Three- and 7-month recurrence-free rates were 86.9 and 73.9 %, respectively. No postoperative respiratory complications or fever developed. Early death within 3 months from progression of primary cancer was identified as a risk factor in patients of NR status (HR = 18.36, p = 0.043). CONCLUSIONS: If thoracoscopic exploration is indicated for MPE, SIH is a safe and effective management alternative in patients whose primary malignancy is not rapidly progressing.

Mechanical properties and in vivo healing evaluation of a novel Centella asiatica-loaded hydrocolloid wound dressing.

To develop a novel sodium alginate based Centella asiatica (CA)-loaded hydrocolloid wound dressing (HCD) providing excellent mechanical properties and improved wound healing, numerous CA-loaded HCDs were prepared with various ingredients using the hot melting method. The effect of sodium alginate, styrene-isoprene-styrene copolymer (SIS) and petroleum hydrocarbon resin (PHR) on the mechanical properties of CA-loaded HCDs was investigated. The effect of disintegrants on swelling and drug release was assessed. Moreover, the in vivo wound healing potentials of the selected CA-loaded HCD in various wound models such as abrasion, excision and infection were evaluated in comparison with the commercial product. Polyisobutylene and SIS hardly affected the mechanical properties, but PHR improved the tensile strength and elongation at break. Disintegrants such as croscarmellose sodium, sodium starch glycolate and crospovidone improved the swelling ratio of the CA-loaded HCD. Furthermore, the CA-loaded HCD without croscarmellose sodium poorly released the drug, but that with 2% croscarmellose sodium showed about 27% drug release in 24h. In particular, the CA-loaded HCD composed of CA/polyisobutylene/SIS/PHR/liquid paraffin/sodium alginate/croscarmellose sodium at the weight ratio of 1/8/25/25/12/27/2 furnished excellent mechanical properties and drug release. As compared with the commercial product, it offered improved healing effects in excision, infection and abrasion type wounds in rats. Thus, this novel CA-loaded HCD could be a potential candidate for the treatment of various wounds.

A 14-week randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy and safety of ginseng polysaccharide (Y-75).

BACKGROUND: The Y-75 (Ginsan) acidic polysaccharide from Korean Panax ginseng has been shown to function as an immunomodulatory molecule. However, the efficacy of Y-75 has not been evaluated in clinical trial. METHODS: We verified Y-75 (6 g/day) for safety and immune efficacy in 72 healthy volunteers aged 50-75 years using a randomized, placebo-controlled, parallel, double-blind study. The activities of natural killer (NK) cells and peripheral blood phagocytes, as well as serum levels of monocyte-derived mediators, were assessed before and after administration for 8 and 14 weeks. This trial is registered at ClinicalTrials.gov (NCT02161198). RESULTS: Y-75 significantly enhanced NK cell cytotoxic activity by 35.2% and 40.2% from baseline after administration for 8 and 14 weeks, respectively. The phagocytic activity of peripheral blood cells was also significantly increased by 25.2% and 39.4% and serum level of TNF-α by 38.2% and 44.5% after treatment for 8 and 14 weeks, respectively. Differences in the efficacy of variables compared to the placebo group were also significant. Administration of Y-75 was well tolerated without treatment-related adverse events or alteration of complete blood cell count or blood chemistry over the entire study period. CONCLUSION: Y-75 was shown to be a safe and potentially effective natural alternative for enhancing immune function.

Anti-obesity and hypolipidaemic effects of Nelumbo nucifera seed ethanol extract in human pre-adipocytes and rats fed a high-fat diet.

BACKGROUND: We conducted this investigation in order to examine the anti-obesity and hypolipidaemic effects of Nelumbo nucifera seed ethanol extract (NSEE) in vitro and in vivo. METHODS: To study the anti-obesity effect of NSEE in vitro and in vivo, human pre-adipocytes were treated with NSEE, and male Sprague-Dawley rats were fed with a normal diet and a high-fat diet with or without NSEE, respectively. RESULTS: In vitro treatment with NSEE resulted in inhibition of lipid accumulation and decreased expression of peroxisome proliferator-activated receptor gamma (PPARγ), glucose transporter 4 (GLUT4), and leptin in cultured human adipocytes, indicating that it inhibited the differentiation of pre-adipocytes into adipocytes. Administration of NSEE resulted in significantly reduced body weight gain and adipose tissue weights in rats. Serum triglyceride and leptin level of the high-fat diet + NSEE group was significantly lower, compared to the high-fat group. CONCLUSION: These results demonstrate an inhibitory effect of NSEE on adipogenesis. In addition, NSEE had a beneficial effect, reducing adipose tissue weights, ameliorating blood lipid profile, and modulating serum leptin level in rats fed a high-fat diet. Therefore, we suggest that lotus seed has a potential to be developed as an effective agent against obesity-related diseases.

Efficacy and Safety of Taeeumjowi-tang in Obese Korean Adults: A Double-Blind, Randomized, and Placebo-Controlled Pilot Trial.

Objective. The purpose of this study was to assess the efficacy and safety of Taeeumjowi-tang (TJ001) as well as to estimate obesity-related factors. Methods. This was a 12-week trial with 5 visits. A total of 102 participants of both genders were randomized to either TJ001 (n = 57) group or the placebo group (n = 55). Subjects were administered 7 g of either TJ001 or placebo 3 times a day. The primary outcome was a rate of subjects who lost 5% or more of initial weight. Secondary outcomes included anthropometric parameters, lipid profiles, and body fat composition. Results. The subject response rate of ≥5% weight loss compared to baseline was similar in both groups, and no statistically significant difference was observed (P = 0.87). Changes in anthropometric parameters were greater during the first 4 weeks in the treatment group (P < 0.0001). There were no significant changes in both within groups and between groups for lipid profile and body fat composition. No adverse event was reported in either group. Conclusion. Although the difference between the groups regarding a rate of subjects who lost 5% or more of initial weight did not show statistical significance, TJ001 appears to be beneficial in safely controlling weight.

Effects of yoga on sexual function in women with metabolic syndrome: a randomized controlled trial.

INTRODUCTION: Female sexual dysfunction is an important public health issue; it has a high global prevalence, but no effective and safe treatment options. The prevalence of sexual dysfunction is higher in women with metabolic syndrome than in the general population. AIM: The aim of this study was to investigate the efficacy of yoga as a treatment for sexual dysfunction in women with metabolic syndrome. METHODS: In this randomized, controlled study, 41 women with metabolic syndrome (age 30-60 years) were assigned to a 12-week yoga exercise group (n=20) or a wait-listed control group (n=21). MAIN OUTCOME MEASURES: Primary end points were changes in total and individual domain scores on the Female Sexual Function Index. RESULTS: The 12-week yoga intervention resulted in significant improvement in arousal (0.74±1.18 vs. 0.16±0.82, respectively; P=0.042) and lubrication (0.72±1.12 vs. 0.06±0.87, respectively; P=0.008) compared with the control group. Systolic blood pressure showed significantly greater improvement in the yoga group than in the control group at the 12-week follow up (-3.5±13.7 vs. 2.0±14.7, respectively; P=0.040). CONCLUSION: These findings suggest that yoga may be an effective treatment for sexual dysfunction in women with metabolic syndrome as well as for metabolic risk factors.

Body fat distribution after menopause and cardiovascular disease risk factors: Korean National Health and Nutrition Examination Survey 2010.

BACKGROUND: The prevalence of cardiovascular disease in women increases sharply after menopause. The purpose of this study was to clarify the relationship between menopause and body fat distribution and to investigate their association with cardiovascular disease risk factors. METHODS: We analyzed 2035 women 20-79 years of age using the National Health and Nutrition Examination Survey (KNHANES) 2010 database. Body fat was measured using dual-energy X-ray absorptiometry. RESULTS: The percentage of total body fat and the body fat distribution (BFD) index (the ratio of the trunk fat mass to leg fat mass) are significantly higher in postmenopausal women than in premenopausal women (all p<0.001). When adjusted for age, menopause was associated with higher total body fat percentage (adjusted ß=1.082, 95% confidence interval [CI] 0.074-2.090, p=0.035). In women with a body mass index<25 kg/m(2), the higher BFD index was also independently associated with menopause (adjusted ß=14.408, 95% CI 1.672-27.145, p=0.027). After adjusting for age and body fat percentage, the BFD index showed significant and independent associations with systolic and diastolic blood pressure (adjusted ß=0.060 and 0.042, all p<0.001, respectively), fasting glucose (adjusted ß=0.007, p<0.001), total and high density lipoprotein cholesterol (adjusted ß=0.001 and -0.002, p<0.05 and p<0.001, respectively), and triglyceride levels (adjusted ß=0.007, p<0.001- except for low density lipoprotein cholesterol. CONCLUSIONS: After menopause, women have not only higher total body fat percentage but also its different distribution, which independently correlates with cardiovascular disease risk factors. Therefore, this change in body fat may cause the sharp increase in cardiovascular disease incidence in middle-aged women, especially after menopause.

A single-center, randomized double-blind placebo-controlled study evaluating the effects of poly-gamma-glutamate on human NK cell activity after an 8-week oral administration in healthy volunteers.

A randomized double-blind placebo-controlled immunity study involving 99 healthy volunteers was performed to investigate the effect of poly- γ -glutamate ( γ -PGA) on human natural killer (NK) cell activity in peripheral blood. The volunteers were randomly assigned to one of three groups and orally treated with solutions (25 mL) containing 0 mg (placebo), 250 mg (low dosage), or 500 mg (high dosage) of γ -PGA. Each volunteer took one dose every 12 hours for 8 weeks. Blood samples were drawn before the initial treatment and at the 4th and the 8th weeks of treatment. NK cell activity was assessed by measuring its degranulation, cytokine production, and cytotoxicity against the K562 cell line. Our results revealed that the cytotoxic activities of NK cells from the high-dosage γ -PGA group were significantly higher (P < 0.05 for all comparisons) compared to the low dosage and placebo groups at weeks 4 and 8 after the initial treatment. This increase in the NK cell activity among peripheral blood mononuclear cells (PBMCs) of healthy individuals was also confirmed in vitro (as assessed by the degranulation and cytokine production). These results suggest that the oral administration of γ -PGA induces a cell-mediated immunity by increasing the NK cell activity in humans.