Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial.

BACKGROUND: Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. METHODS: We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. RESULTS: In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. CONCLUSION: The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.

Health inequalities in hypertension and diabetes management among the poor in urban areas: a population survey analysis in south Korea.

BACKGROUND: This study investigated whether the prevalence, awareness, treatment, and control of hypertension and diabetes differed by residential areas. In addition, the rate of good hypertension or diabetes control was examined separately in men and women, and in urban and rural areas. METHODS: This study used Korea National Health and Nutrition Examination V (2010-2012) data, a nationwide cross-sectional survey of general South Korean population. Residential areas were categorized into urban and rural areas. To examine differences between the residential areas in terms of prevalence, awareness, treatment, and control of hypertension and diabetes we performed a multivariate logistic regression adjusting for age, body mass index, physical activity, alcohol use, smoking, marital status, monthly income, and educational level. To investigate control of hypertension or diabetes within each residential area, we performed a subgroup analysis in both urban and rural areas. RESULTS: The prevalence of hypertension is higher among men in urban areas than among those in rural areas (OR = 0.80; 95 % CI = 0.67-0.96, reference group = urban areas). However, the subgroups did not differ in terms of diabetes prevalence, awareness, treatment, and control. Regardless of both sex and residential area, participants in good control of their hypertension and diabetes were younger. Inequality in good control of hypertension was observed in men who lived in urban (≤Elementary school, OR 0.74, 95 % CI 0.60-0.92) and rural areas (≤Elementary school, OR 0.67, 95 % CI 0.46-0.99). Inequality in health status was found in women who resided in urban areas (≤Elementary school, OR 0.53, 95 % CI 0.37-0.75). Good control of diabetes also showed inequalities in health status for both men (≤Elementary school, OR 0.61, 95 % CI 0.40-0.94; Middle/High school, OR 0.69, 95 % CI 0.49-0.96) and women in urban areas (≤1 million won, OR 0.56, 95 % CI 0.33-0.93) (Reference group = '≥College' for education and '>3 million' Korean won for income). CONCLUSIONS: After correction for individual socioeconomic status, differences by residential area were not observed. However, when the participants with good disease control were divided by region, inequality was confirmed in urban residents. Therefore, differentiated health policies to resolve individual and regional health inequalities are necessary.

Influenza vaccination and associated factors among Korean cancer survivors : a cross-sectional analysis of the Fourth & Fifth Korea National Health and Nutrition Examination Surveys.

Influenza vaccination is important for cancer survivors, a population with impaired immunity. This study was designed to assess influenza vaccination patterns among Korean cancer survivors. In this cross-sectional analysis, data were obtained from standardized questionnaires from 943 cancer survivors and 41,233 non-cancer survivors who participated in the Fourth and Fifth Korea National Health and Nutrition Examination Surveys (2007-2011). We identified the adjusted influenza vaccination rates and assessed factors associated with influenza vaccination using multivariate logistic regression. Cancer survivors tended to have a higher adjusted influenza vaccination rate than the general population. The rates for influenza vaccination in specific cancer types such as stomach, hepatic, colon, and lung cancers were significantly higher than non-cancer survivors. Among all cancer survivors, those with chronic diseases, elderly subjects, and rural dwellers were more likely to receive influenza vaccination; those with cervical cancer were less likely to receive influenza vaccination. Cancer survivors were more likely to receive influenza vaccinations than non-cancer survivors, but this was not true for particular groups, especially younger cancer survivors. Cancer survivors represent a sharply growing population; therefore, immunization against influenza among cancer survivors should be concerned as their significant preventative healthcare services.

A coronary heart disease prediction model: the Korean Heart Study.

OBJECTIVE: The objectives of this study were to develop a coronary heart disease (CHD) risk model among the Korean Heart Study (KHS) population and compare it with the Framingham CHD risk score. DESIGN: A prospective cohort study within a national insurance system. SETTING: 18 health promotion centres nationwide between 1996 and 2001 in Korea. PARTICIPANTS: 268 315 Koreans between the ages of 30 and 74 years without CHD at baseline. OUTCOME MEASURE: Non-fatal or fatal CHD events between 1997 and 2011. During an 11.6-year median follow-up, 2596 CHD events (1903 non-fatal and 693 fatal) occurred in the cohort. The optimal CHD model was created by adding high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol and triglycerides to the basic CHD model, evaluating using the area under the receiver operating characteristic curve (ROC) and continuous net reclassification index (NRI). RESULTS: The optimal CHD models for men and women included HDL-cholesterol (NRI=0.284) and triglycerides (NRI=0.207) from the basic CHD model, respectively. The discrimination using the CHD model in the Korean cohort was high: the areas under ROC were 0.764 (95% CI 0.752 to 0.774) for men and 0.815 (95% CI 0.795 to 0.835) for women. The Framingham risk function predicted 3-6 times as many CHD events than observed. Recalibration of the Framingham function using the mean values of risk factors and mean CHD incidence rates of the KHS cohort substantially improved the performance of the Framingham functions in the KHS cohort. CONCLUSIONS: The present study provides the first evidence that the Framingham risk function overestimates the risk of CHD in the Korean population where CHD incidence is low. The Korean CHD risk model is well-calculated alternations which can be used to predict an individual's risk of CHD and provides a useful guide to identify the groups at high risk for CHD among Koreans.

Factors associated with the treatment of osteoporosis in Korean postmenopausal women.

This retrospective study was designed to investigate the treatment rate of osteopenia and osteoporosis after diagnosis and determine factors related to osteoporosis treatment in Korea. This analysis included postmenopausal women who had visited the health promotion center from March 2010 to May 2011 (n = 375) and been diagnosed with osteoporosis (19.5%) or osteopenia (45.9%). Telephone surveys were performed one year after diagnosis. We employed multiple logistic regression to determine factors associated with treatment using clinical risk factors as covariates in a FRAX model. Receipt of osteoporosis treatment (nutrition, exercise, and medications) to prevent osteoporotic fracture was reported by 108 of 172 (63.4%) women with osteopenia and 66 of 73 (90.4%) with osteoporosis. Only consultation with a doctor for osteopenia or osteoporosis was significantly related to receiving osteoporosis treatment for osteopenia (odds ratio [OR], 5.01; 95% confidence interval [CI], 2.01-12.00) and osteoporosis (OR, 4.91; 95% CI, 1.16-20.75). In the osteopenic group, increased age, being a current smoker, having a history of parental fracture or previous fracture, and secondary osteoporosis were related to consultation with a doctor. Of women with osteopenia 36.6% and 64.4% with osteoporosis received consultation with a doctor. Consultation with a doctor for osteopenia or osteoporosis after being diagnosed could be an effective strategy to increase osteoporosis treatment.

The Korean Heart Study: rationale, objectives, protocol, and preliminary results for a new prospective cohort study of 430,920 men and women.

BACKGROUND: To describe the rationale, objectives, protocol, and preliminary results for a new prospective cohort study of cardiovascular disease (CVD) risk factors in South Korea. METHODS: Study members were recruited from participants in routine health assessments at health promotion centres across South Korea. Established and emerging CVD risk factors were measured. Eighteen centres holding electronic health records agreed to linkage of participants' records to future health insurance claims for monitoring of disease events. The recruitment of 430,920 participants (266,782 men, 164,138 women), aged 30-74 years, provides broad geographical reach across South Korea. RESULTS: Risk factor prevalence was more favourable in women than men, and, in general, in the younger rather than older study members. There was also close similarity between the characteristics of the present sample and the Korean National Health and Nutrition Examination Survey. The expected associations between risk factors and both CVD and death were also apparent. CONCLUSIONS: Data from the present sample, based on data linkage, show close agreement with South Korea-wide surveys (for risk factor prevalence) and the extant literature (for risk factor associations). These findings gives confidence in future results anticipated from this cohort study of east Asians - a group that has been traditionally under-researched.

Prevalence of and factors associated with osteoporosis among Korean cancer survivors: a cross-sectional analysis of the Fourth and Fifth Korea National Health and Nutrition Examination Surveys.

BACKGROUND: Identifying and managing osteoporosis among cancer survivors is an important issue, yet little is known about the bone health of cancer survivors in Korea. This study was designed to measure the prevalence of osteoporosis and to assess related factors among Korean cancer survivors. MATERIALS AND METHODS: This study was designed as a cross-sectional analysis. Data were obtained from dual energy X-ray absorptiometry measurement of the lumbar vertebrae and femoral neck, and from standardized questionnaires among 556 cancer survivors and 17,623 non-cancer controls who participated in the Fourth and Fifth Korea National Health and Nutrition Examination Surveys (2008-2011). We calculated adjusted proportions of osteoporosis in non-cancer controls vs. cancer survivors, and we performed multivariate logistic regression analysis. RESULTS: The prevalence of osteoporosis among cancer survivors was significant higher than that of the non-cancer controls after adjusting for related factors. Furthermore, osteoporosis among cancer survivors was higher in elderly subjects (60-69 years : adjusted odds ratio (aOR) 3.04, 95% CI : 1.16-8.00, ≥70 years : aOR 6.60, 95% CI 2.20-19.79), in female cancer survivors (aOR: 7.03, 95% CI: 1.88-26.28), and in a group with lower monthly income (aOR: 3.38, 95% CI: 1.31-8.71). In male cancer survivors, underweight and lower calcium intake were risk factors. CONCLUSIONS: These data suggest that the osteoporosis among cancer survivors varies according to non-oncologic and oncologic factors. Effective screening should be applied, and a sufficient and comprehensive management should be matched to individual cancer survivors early after cancer treatment.

Psychosocial needs of cancer patients and related factors: a multi-center, cross-sectional study in Korea.

BACKGROUND: Identifying psychosocial needs and satisfying them are important issues to many cancer patients. The aim of this study was to investigate the psychosocial needs of cancer patients and its related factors, based on a nationwide sample of cancer patients in Korea. METHODS: A multi-center survey was administered to 2661 cancer patients from 10 cancer centers in Korea. The survey measured the needs for psychosocial support, using the Comprehensive Needs Assessment Tool in Cancer, and potential correlates, such as socio-demographic and clinical factors. Multivariate ordinal regression and binary logistic regression were conducted to identify factors that may predict psychosocial needs. RESULTS: On the measure for psychosocial needs, the median score of psychological problems was 2.73 points and that of social support was 1.92 points, as the standardized score on a scale of 10 points. Needs for psychological problems were positively correlated with intensive treatment, degree of stress, problems with EQ5-D, needs for information and education, needs for hospital facilities/services and needs for physical symptoms. The need for social support was positively correlated with problems with EQ5-D and other unmet needs of cancer patients. Income levels and the number of years since diagnosis were negatively correlated with the need for social support. CONCLUSION: Unmet psychosocial needs were common in cancer patients and have varied according to patients' socio-demographic and clinical factors. These results suggest that a psychosocial approach to treatment should be applied comprehensively and that such an approach should be matched to patients' socio-demographic and clinical circumstances.

Prevalence, awareness, control, and treatment of hypertension and diabetes in korean cancer survivors: a cross-sectional analysis of the fourth and fifth Korea national health and nutrition examination surveys.

BACKGROUND: Management of hypertension and diabetes in cancer survivors is an important issue; however, not much is known about the level of management of such chronic disease in Korea. This study therefore assessed the prevalence, awareness, control, and treatment of hypertension and diabetes in Korean cancer survivors compared to non-cancer survivors. MATERIALS AND METHODS: A cross-sectional design was employed, wherein data were obtained from standardized questionnaires completed by 943 cancer survivors and 41,233 non-cancer survivors who participated in the Fourth and Fifth Korea National Health and Nutrition Examination Surveys (2007-2011). We calculated adjusted proportions for prevalence and management of hypertension and diabetes in non-cancer survivors and cancer survivors. We also assessed the associated factors with prevalence and management of cancer survivors. RESULTS: Cancer survivors are more likely than the general population to have higher prevalence, awareness, treatment, and control of hypertension. However, diabetic management was not significantly higher in cancer survivors than in non-cancer survivors, despite their having a higher prevalence. Several factors, such as, age, drinking, years since cancer diagnosis, self-perceived health status, and specific cancer types were found to affect to management of hypertension and diabetes. CONCLUSIONS: These data suggest that cancer survivors appear to be better than non-cancer survivors at management of hypertension, but not diabetes. There is a need for healthcare providers to recognize the importance of long-term chronic disease management for cancer survivors and for the care model to be shared between primary care physicians and oncologists.

Association of chronic viral hepatitis B with insulin resistance.

AIM: To investigate the relationship between chronic viral hepatitis B (CVHB) and insulin resistance (IR) in Korean adults. METHODS: A total of 7880 adults (3851 men, 4029 women) who underwent a comprehensive medical examination were enrolled in this study. Subjects diagnosed with either diabetes mellitus, or any other disorder that could influence their insulin sensitivity, were rejected. Anthropometry, metabolic risk factors, hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody, fasting plasma glucose and insulin were measured for all subjects. Homeostasis model assessment (HOMA), quantitative insulin check index (QUICKI), and Mf(fm) index were used for determining insulin sensitivity. Each participant was categorized into a negative, recovery, or CVHB group. To compare variables between groups, a t-test and/or one-way analysis of variance were used. Partial correlation coefficients were computed to present the association between insulin resistance and other variables. Multiple logistic regression analysis was used to assess the independent association between CVHB and IR. RESULTS: The mean age of men and women were 48.9 and 48.6 years, respectively. Subjects in the CVHB group had significantly higher waist circumference [(86.0 ± 7.7 cm vs 87.3 ± 7.8 cm, P = 0.004 in men), (78.3 ± 8.6 cm vs 80.5 ± 8.5 cm, P < 0.001 in women)], cystatin C [(0.96 ± 0.15 mg/dL vs 1.02 ± 0.22 mg/dL, P < 0.001 in men), (0.84 ± 0.15 mg/dL vs 0.90 ± 0.16 mg/dL, P < 0.001 in women)], fasting insulin [(5.47 ± 3.38 µU/mL vs 6.12 ± 4.62 µU/mL, P < 0.001 in men), (4.57 ± 2.82 µU/mL vs 5.06 ± 3.10 µU/mL, P < 0.001 in women)] and HOMA index [(1.24 ± 0.86 vs 1.43 ± 1.24, P < 0.001 in men), (1.02 ± 0.76 vs 1.13 ± 0.87, P = 0.033 in women)] compared to control group. The HOMA index revealed a positive correlation with body mass index (BMI) (r = 0.378, P < 0.001), waist circumference (r =0.356, P < 0.001), percent body fat (r = 0.296, P < 0.001), systolic blood pressure (r = 0.202, P < 0.001), total cholesterol (r = 0.134, P < 0.001), triglycerides (r = 0.292, P < 0.001), cystatin C (r = 0.069, P < 0.001) and uric acid (r = 0.142, P < 0.001). The QUICKI index revealed a negative correlation with BMI (r = -0.254, P < 0.001), waist circumference (r = 0-0.243, P < 0.001), percent body fat (r = -0.217, P < 0.001), systolic blood pressure (r = -0.132, P < 0.001), total cholesterol (r = -0.106, P < 0.001), triglycerides (r = -0.205, P < 0.001), cystatin C (r = -0.044, P < 0.001) and uric acid (r = -0.096, P < 0.001). For subjects identified with IR, the odds ratio of an accompanying diagnosis of chronic hepatitis B was 1.534 (95% CI: 1.158-2.031, HOMA index criteria) or 1.566 (95% CI: 1.124-2.182, QUICKI criteria) after adjustment for age, gender, BMI, and amount of alcohol consumption. CONCLUSION: Our study demonstrates that CVHB is associated with IR. CVHB may need to be monitored for occurrence of IR and diabetes mellitus.

Synthetic CDCA derivatives-induced apoptosis of stomach cancer cell line SNU-1 cells.

PURPOSE: This study was conducted to explore whether CDCA derivatives induce apoptosis in a stomach cancer cell line, and to dissect the detailed mechanism underlying apoptosis. MATERIALS AND METHODS: The human stomach cancer cell line, SNU-1, cells were treated with the synthetic CDCA derivatives, HS-1199 and HS-1200. DNA and mitochondrial stains were used to detect apoptotic cells by fluorescence imaging or flow cytometry. The caspase-3 activity was measured by Western blotting. RESULTS: Both the HS-1199 and HS-1200 induced decreased viabilities of the SNU-1 cells, in time-dependent manners. The CDCA derivatives demonstrated various apoptosis hallmarks, such as mitochondrial changes (reduction of MMP, cytochrome c release, and Smac/ DIABLO translocation), activation of caspase-3 (resulting in the degradation of PARP and DFF45), DNA fragmentation and nuclear condensation. CONCLUSION: The CDCA derivatives, HS-1199 and HS-1200, both induced apoptosis of the SNU-1 gastric cancer cells in caspase- and mitochondria-dependent fashions. Many important issues relating to their therapeutic applications remain to be elucidated.

Orphan nuclear receptor Nur77 translocates to mitochondria in the early phase of apoptosis induced by synthetic chenodeoxycholic acid derivatives in human stomach cancer cell line SNU-1.

Apoptosis-inducing activity of synthetic CDCA derivatives, HS-1199 and HS-1200, on gastric cancer cell line SNU-1 cells was explored. CDCA derivatives demonstrated various apoptosis hallmarks, such as mitochondrial changes, activation of caspase, DNA fragmentation, and nuclear condensation. Importantly, the orphan receptor Nur77 (TR3) was shown to translocate from the nucleus to mitochondria at the early time points after CDCA derivatives treatment. These data support the theory that CDCA derivatives-induced apoptosis of SNU-1 gastric cancer cell lines is mediated by mitochondria and caspase, and, at least in part, by Nur77.