A randomized, double blind, placebo-controlled human intervention study involving 62 healthy volunteers was performed to investigate the effects of Keumsa sangwhang (Phellinus linteus) mushroom extracts (KPLE) on natural killer (NK) cell activity in peripheral blood. The volunteers were randomly distributed into two groups, one receiving KPLE (3.3 g/day) and the other a placebo by oral administration for 8 weeks. In this study, the number of NK cells did not increase with KPLE administration, however the cytotoxic activity of NK cells against the Jurkat leukemia cell line increased significantly. This result suggests that administration of KPLE induces cell-mediated immunity by increasing NK cell activity in humans.
Objective : SCP-20, a yeast hydrolysate from Saccharomyces cerevisiae, has exhibited anti-stress, anti-anxiety, and antidepressant effects in animal studies. The objective of this study was to test the effects of SCP-20 on healthy controls and to assess its effects on stress response, depression and, anxiety. Methods : Sixty-one healthy volunteers (30 male, 31 female) were recruited and screened for significant psychiatric and medical conditions. Baseline measures of stress, anxiety, and depression were taken using questionnaires such as the Stress Response Inventory (SRI), Beck's Anxiety Inventory (BAI), Beck's Depression Inventory (BDI), and the physiological measure of heart rate variability (HRV). Each subject was assigned randomly to a group taking capsules containing either 70% SCP-20 (i.e. the SCP70 group), 99.5% SCP-20 (i.e. the SCP99.5 group), or a placebo. Follow up measures were taken at week 4. Results : Subjects taking SCP-20 showed significant improvement in SRI and BAI scores compared to those taking placebo. For BDI scores, there was no significant difference between groups. No significant adverse effects were reported. Conclusions : This study suggests that SCP-20 is effective in alleviating stress and anxiety symptoms in healthy individuals, and has little or no side effects. However, the role of of SCP-20 in alleviating depression needs further clarification. Studiess examining its effects in psychiatric populations are needed to establish its role in alternative medicine.
Journal of the Society of Cosmetic Scientists of Korea
/
v.35
no.3
/
pp.219-228
/
2009
This study was performed to evaluate a deodorant body wash with 1.0 wt% of triclosan and 0.4 wt% of bamboo salt, which have an inhibitory effect on axillary malodor. In this studies, in vitro antibacterial study and the clinical study, which was designed by randomized assignment, double-blind and cross-over, were performed. In the antibacterial study, test sample, which was body wash having 1.0 wt% of triclosan and 0.4 wt% of bamboo salt, have a potent antibacterial effect on Corynebacterium glutamicum, Corynebacterium xerosis, Corynebacterium jeikeium. In the clinical study, test sample has a potent and significant deodorizing effect on axillary malodor and an antibacterial efficacy. And its efficacy was maintained for 9 h at least. There was no side effect during the period of clinical study. Consequently, body wash, containing 1.0 wt% of triclosan and 0.4 wt% of bamboo salt, has the effectiveness and the safety about axillary malodor reduction.
Context: Interest exits in whether TNF-alpha antagonists increase the risk of breast cancer and total malignancies in patients with rheumatoid arthritis (RA). Objectives: To analyze the risk of malignancies, especially breast cancer, in patients with RA enrolled in randomized control trials (RCTs). Methods: A systematic literature search for RCTs from 1 January 1998 to 1 July 2013 from online databases, such as PubMed, WILEY, EMBASE, ISI web of knowledge and Cochrane Library was conducted. Studies included RCTs that compared the safety of at least one dose of the five TNF-${\alpha}$ antagonists with placebo or methotrexate (MTX) (or TNF-${\alpha}$ antagonists plus MTX vs placebo plus MTX) in RA patients for more than 24 weeks and imported all the references into document management software EndNote${\times}6$. Two independent reviewers selected studies and extracted the data about study design, patients' characteristics and the type, number of all malignancies. Results: 28 RCTs from 34 records with 11,741 patients were analyzed. Of the total, 97 developed at least one malignancy during the double-blind trials, and breast cancer was observed in 17 patients (17.5% of total malignancies). However, there was no statistically significant increased risk observed in either the per protocol (PP) model (OR 0.65, 95%CI [0.22, 1.93]) or the modified intention to treat (mITT) model (OR 0.75, 95%CI [0.25, 2.21]). There were also no significant trend for increased risk of total malignancies on anti-TNF-${\alpha}$ therapy administered at approved doses in either model (OR, 1.06, 95%CI [0.64, 1.75], and OR, 1.30, 95%CI [0.80, 2.14], respectively). As to the two models, modified intention to treat model analysis led to higher estimation than per protocol model analysis. Conclusions: This study did not find a significantly increased risk of breast cancer and total malignancies in adults RA patients treated with TNF-${\alpha}$ antagonists at approved doses. However, it cannot be ignored that more patients developed malignancies with TNF-${\alpha}$ antagonists therapy compared with patients with placebo or MTX, in spite of the lack of statistical significance, so that more strict clinical trials and long-term follow-up are needed, and both mITT and PP analyses should be used in such safety analyses.
Purpose: The objective of this study was to investigate the effects of xyloologosaccharide (XOS)-sugar mixture on glycemic index (GI) and blood glucose in human subjects. Methods: Randomized double-blind cross-over studies were conducted to examine the effect of sucrose with 14% xyloologosaccharide powder (Xylo 14) and sucrose with 20% xylooligosaccharide powder (Xylo 20) on GI and postprandial glucose response at 15, 30, 45, 60, 90, and 120 min. Results: GIs of Xylo 14 and Xylo 20 were $60.0{\pm}23.5$ classified within medium GI range, and $54.3{\pm}17.7$ within low GI range, respectively. Xylo 14 and Xylo 20 showed significantly lower area under the glucose curve (AUC) for 0-15 min (p = 0.0113), 0-30 min (p = 0.0004), 0-45 min (p < 0.0001), 0-60 min (p < 0.0001), 0-90 min (p < 0.0001), and 0-120 min (p = 0.0001). In particular, compared with glucose, the blood glucose levels of Xylo 14 and Xylo 20 were significantly lower at every time point between 15 and 120 min. Conclusion: The results of this study suggested that Xylo 14 and Xylo 20 had an acute suppressive effect on GI and the postprandial glucose surge.
Lipid-lowering effects of the inulin have been demonstrated in animal, yet attempts to reproduce similar effects in humans have generated conflicting results. In this study, the lipid-lowering potential of inulin and especially its effect on bile acid and neutral sterol excretion were investigated in Korean postmenopausal women. Nineteen postmenopausal women were randomly divided into two groups in a double-blind parallel design and consumed one of two supplements for 12 weeks; placebo of 8g maltodextrins/sucrose mixture (placebo group) or 8g inulin (inulin group). There were no significant changes in body weight during the supplementation period in either inulin or placebo group. Dietary consumption of animal fat in both group tended to decrease after 12 weeks of experiment. Intake of cholesterol was lower in placebo group, whereas the decrease of cholesterol intake in inulin group did not reach statistical significance after 12 weeks. The levels of serum total cholesterol (TC) and LDL-cholesterol (LDL-C) were significantly decreased in both placebo (p<0.05) and inulin group (p<0.01) after supplementation for 12 weeks compared with the baseline. The levels of serum triglyceride (TG) and HDL-cholesterol (HDL-C) were not significantly affected by inulin supplements, but atherogenic index (AI) and LDL-C/HDL-C ratio (LHR) as a predictor for coronary heart disease were improved (p<0.01) significantly after inulin supplementation. Therefore, inulin supplement may decrease the risk of cardiovascular disease via improving blood cholesterol level. Fecal weight and pH were not changed after 12 weeks of supplementation. There were no statistically significant changes for the fecal short-chain fatty acids (SCFAs). In inulin group, fecal deoxycholic acid (DCA) was significantly lowered compared with the baseline (p<0.05) whereas other bile acids were not changed. During the 12 weeks of intervention, no differences were found in fecal excretion of neutral sterol in the two groups. In summary, dietary inulin decreases serum TC, LDL-C, AI, LHR and lowers excretion of fecal DCA in the Korean postmenopausal women. These results support the use of inulin for reducing risk factors for hyperlipidemic postmenopausal women. However, the exact mechanism (s) responsible for the blood lipid lowering action of inulin including altered fecal bile acid remain to be elucidated.
Min, Ki Sung;Han, Daeseok;Kwon, Sang-Oh;Yeo, Kyung-Mok;Kim, Bok-Nam;Ly, Sun Yung
Journal of Nutrition and Health
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v.47
no.1
/
pp.23-32
/
2014
Purpose: This study was conducted in order to investigate the effect of Sargassum confusum extracts on the reduction of body fat for eight weeks in overweight women ($BMI{\geq_-}23kg/m^2$). Methods: Subjects were classified by double-blind randomized trial as the control group (C group, n = 14) and the Sargassum confusum extract supplementation group (SC group, n = 16), which consumed 12 tablets per day. Questionnaires related to their health status were assessed twice (week 0 and week 8). Their dietary intake status was evaluated by 24-recall method and body compositions were measured using a bioelectrical impedance analyzer. In addition, we assessed the anti-obesity effect and the occurrence possibility of health risk factors during the supplementation periods by hematological and clinical analysis of blood. Results: Waist circumference and body fat (%) were significantly decreased in the SC group. Serum leptin level was also significantly decreased in the SC group. Defecation frequency was significantly increased in the SC group. The above results indicate that Sargassum confusum extract supplementation improves overweight on visceral fat and blood leptin level by increasing bowel movement. These results imply a decrease of health risk factors in overweight women. Seven subjects withdrew from the study due to adverse events; however, no differences regarding adverse events were observed between the control and treatment group. Conclusion: Therefore, Sargassum confusum extract is a plausible effective agent for body fat reduction in humans.
Purpose: This study was conducted in order to develop morning bread using powdered citrus peels and to examine the effect of its several biological activities for 12 weeks in overweight adults ($$BMI{\geq_-}23$$) living in dormitories of Chonbuk National University. Methods: Control bread was prepared using the same formula except for replacing the wheat flour with 3% citrus peel powder. Subjects were classified according to two groups: Intake group of 3% citrus peel powder fortified morning bread (n = 30) and general morning bread (n = 30). Results: The results of our study showed no significant effects of citrus peel powdered morning bread on anthropometric indices and biochemical characteristics among overweight adults. Despite the slight reduction in total-cholesterol, LDL-cholesterol, GOT, and GPT (p < 0.05), no significant differences in changes of these values were observed between the two groups. Conclusion: The short duration of our intervention might have resulted in the lack of any significant effect. Therefore, conduct of further studies with longer duration is warranted in order that the results from this study can be utilized as a basis for the development of food products with citrus peel powder.
Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.
Journal of Physiology & Pathology in Korean Medicine
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v.22
no.1
/
pp.204-208
/
2008
This study was performed to investigate the effect of the extracts from Injinoryng-San on liver injury patients induced by alcohol. Injinoryung-San was recorded the drug for jaundice at Hwang-Je-Nae-Kyung. Twenty-seven patients who have intaked alcohol above 40 g, every day, 5 years, twenty-seventy ages were selected. After take a written consent, we divide them into experimental groups and control groups by double blind test. Each groups was evaluated every 2 weeks(2,4,6 weeks). After 2 weeks, Injinoryung-San groups significantly decreased GGT in comparison with control groups(p<0.05). After 4 weeks, Injinoryung-San groups significantly decreased MCV, GGT in comparison with control groups(p<0,05). After 6 weeks, Injinoryung-San groups significantly decreased MCV in comparison with control groups(p<0.05). Reviewing these experimental results, it appears that extracts of Injinoryung-San have pharmaceutical efficacy in GGT, MCV on liver injury patients induced by alcohol. But it has not efficacy in AST, ALT. According to drinking alcohol has becomes social problems, we should effort to make efficacious oriental medicines on alcoholic hepatitis.
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