Effect on music therapy on quality of recovery and postoperative pain after gynecological laparoscopy.

BACKGROUND: Music therapy is safe, inexpensive, simple, and has relaxing properties for mental and physical capacities, as well as few side effects. Moreover, it improves patient satisfaction and reduces postoperative pain. Thus, we intended to evaluate the effect of music intervention on the quality of comprehensive recovery using quality of recovery 40 (QoR-40) survey in patients undergoing gynecological laparoscopic surgery. METHODS: Patients were randomly assigned to music intervention group or control group: 41 patients each. After anesthetic induction, headphones were placed on the patients, and then classical music selected by an investigator was started in the music group with individual comfortable volume during surgery, while the player was not started in the control group. On postoperatively 1 day, the QoR-40 (5 categories: emotions, pain, physical comfort, support, and independence) survey was evaluated, while postoperative pain, nausea, and vomiting were assessed at 30 minutes and 3, 24, and 36 hours postoperatively. RESULTS: Total QoR-40 score was statistically better in the music group, and among the 5 categories, the music group had a higher pain category score than the control group. The postoperative pain score was significantly lower in the music group at 36 hours postoperatively, although the requirement for rescue analgesics was similar in both groups. The incidence of postoperative nausea did not differ at any time point. CONCLUSION: Intraoperative music intervention enhanced postoperative functional recovery and reduced postoperative pain in patients who underwent laparoscopic gynecological surgery.

Effect of processed aloe vera gel on immunogenicity in inactivated quadrivalent influenza vaccine and upper respiratory tract infection in healthy adults: A randomized double-blind placebo-controlled trial.

BACKGROUND: Aloe vera is a functional food with various pharmacological functions, including an immune-modulating effect. Until now, A. vera has never been studied as an adjuvant in influenza vaccine, and its effects on upper respiratory tract infection (URI) are unknown. PURPOSE: The objective of our study was to investigate the effect of processed A. vera gel (PAG) on immunogenicity of quadrivalent inactivated influenza vaccine and URI in healthy adults. STUDY DESIGN: A randomized, double-blind, placebo-controlled clinical trial was performed. METHODS: This study was conducted in 100 healthy adults at a single center from September 2017 to May 2018. Subjects were randomly divided into a PAG group (n = 50) and a placebo group (n = 50). The enrolled subjects were instructed to ingest the study drug for 8 weeks. The participants received a single dose of quadrivalent inactivated influenza vaccine after taking the study drug for the first 4 weeks of the study. The primary endpoint was seroprotection rate against at least one viral strain at 4 weeks post-vaccination. Other outcomes were seroprotection rate at 24 weeks post-vaccination, seroconversion rate, geometric mean fold increase (GMFI) at 4 and 24 weeks post-vaccination, seroprotection rate ratio and geometric mean titer ratio (GMTR) at 4 weeks post-vaccination between PAG and placebo groups, and incidence, severity, and duration of URI. RESULTS: The European Committee for proprietary medicinal products (CPMP) evaluation criteria were met at least one in the PAG and placebo groups for all strains. However, there was no significant difference in the seroprotection rate at 4 weeks post-vaccination against all strains in both PAG and placebo groups. Among secondary endpoints, the GMFI at 4 weeks post-vaccination for the A/H3N2 was significantly higher in the PAG than in placebo group. The GMTR as adjuvant effect was 1.382 (95% CI, 1.014-1.1883). Kaplan-Meier curve analysis showed a reduction in incidence of URI (p = 0.035), and a generalized estimating equation model identified a decrease in repeated URI events (odds ratio 0.57; 95% CI, 0.39-0.83; p = 0.003) in the PAG group. CONCLUSIONS: Oral intake of PAG did not show a significant increase in seroprotection rate from an immunogenicity perspective. However, it reduced the number of URI episodes. A well-designed further study is needed on the effect of PAG's antibody response against A/H3N2 in the future.

A randomized, double-blind, placebo-controlled crossover clinical trial to evaluate the anti-diabetic effects of Allium hookeri extract in the subjects with prediabetes.

BACKGROUND: Allium hookeri is widely consumed as a vegetable and herbal medicine in Asia. A. hookeri has been reported anti-inflammatory, anti-obesity, osteoblastic, anti-oxidant, and anti-diabetic effects in animal studies. We investigated the anti-diabetic effects of A. hookeri aqueous extract (AHE) in the Korean subjects. METHODS: Prediabetic subjects (100 ≤ fasting plasma glucose (FPG) < 126 mg/dL) who met the inclusion criteria were recruited for this study. The enrolled subjects (n = 30) were randomly divided into either an AHE (n = 15, 486 mg/day) or placebo (n = 15) group. Outcomes were measurements of FPG, glycemic response to an oral glucose tolerance test (OGTT), insulin, C-peptide, hemoglobin A1c (HbA1c), total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol. The t-test was used to assess differences between the groups. A p-value < 0.05 was considered statistically significant. RESULTS: Eight weeks after AHE supplementation, HbA1c level was significantly decreased in the AHE group compared with the placebo group. No clinically significant changes in any safety parameter were observed. CONCLUSION: The findings suggest that AHE can be effective in reducing HbA1c, indicating it as an adjunctive tool for improving glycemic control. TRIAL REGISTRATION: The study protocol was retrospectively registered at www.clinicaltrials.gov ( NCT03330366 , October 30, 2017).

Cutting Edge: Activation-Induced Iron Flux Controls CD4 T Cell Proliferation by Promoting Proper IL-2R Signaling and Mitochondrial Function.

Iron has long been established as a critical mediator of T cell development and proliferation. However, the mechanisms by which iron controls CD4 T cell activation and expansion remain poorly understood. In this study, we show that stimulation of CD4 T cells from C57BL/6 mice not only decreases total and labile iron levels but also leads to changes in the expression of iron homeostatic machinery. Additionally, restraining iron availability in vitro severely inhibited CD4 T cell proliferation and cell cycle progression. Although modulating cellular iron levels increased IL-2 production by activated T lymphocytes, CD25 expression and pSTAT5 levels were decreased, indicating that iron is necessary for IL-2R-mediated signaling. We also found that iron deprivation during T cell stimulation negatively impacts mitochondrial function, which can be reversed by iron supplementation. In all, we show that iron contributes to activation-induced T cell expansion by positively regulating IL-2R signaling and mitochondrial function.

Impact of dietary manganese on experimental colitis in mice.

Diet plays a significant role in the pathogenesis of inflammatory bowel disease (IBD). A recent epidemiological study has shown an inverse relationship between nutritional manganese (Mn) status and IBD patients. Mn is an essential micronutrient required for normal cell function and physiological processes. To date, the roles of Mn in intestinal homeostasis remain unknown and the contribution of Mn to IBD has yet to be explored. Here, we provide evidence that Mn is critical for the maintenance of the intestinal barrier and that Mn deficiency exacerbates dextran sulfate sodium (DSS)-induced colitis in mice. Specifically, when treated with DSS, Mn-deficient mice showed increased morbidity, weight loss, and colon injury, with a concomitant increase in inflammatory cytokine levels and oxidative and DNA damage. Even without DSS treatment, dietary Mn deficiency alone increased intestinal permeability by impairing intestinal tight junctions. In contrast, mice fed a Mn-supplemented diet showed slightly increased tolerance to DSS-induced experimental colitis, as judged by the colon length. Despite the well-appreciated roles of intestinal microbiota in driving inflammation in IBD, the gut microbiome composition was not altered by changes in dietary Mn. We conclude that Mn is necessary for proper maintenance of the intestinal barrier and provides protection against DSS-induced colon injury.

Immunomodulatory effects of a mycelium extract of Cordyceps (Paecilomyces hepiali; CBG-CS-2): a randomized and double-blind clinical trial.

BACKGROUND: Cordyceps is a traditional Chinese herb that produces various biopharmaceutical effects, including immune-enhancing effects. In this study, we prepared a Cordyceps mycelium culture extract (Paecilomyces hepiali, CBG-CS-2) to confirm its efficacy in enhancing the immune system and to evaluate its safety in healthy adults. METHODS: Healthy adults were divided into the intervention group (n = 39), who were given 1.68 g/day of CBG-CS-2 in capsules, and the control group (n = 40) for 8 weeks. The activities of natural killer (NK) cells and serum levels of monocyte-derived mediators were assessed initially for a baseline measurement and after 8 wks. RESULTS: The CBG-CS-2 group showed a significant 38.8 ± 17.6% enhancement from the baseline of NK cell cytotoxic activity relative to the placebo group after the administration of the capsules for 8 wks. (P < 0.019). CONCLUSION: The results suggest that the immune system functions well with CBG-CS-2 supplementation, perhaps with less accompanying inflammation. Thus, CBG-CS-2 is safe and effective for enhancing cell-mediated immunity in healthy adults. TRIAL REGISTRATION: This study was registered at Clinical Trials.gov ( NCT 02814617 ).

Supplementation with extract of Gynostemma pentaphyllum leaves reduces anxiety in healthy subjects with chronic psychological stress: A randomized, double-blind, placebo-controlled clinical trial.

BACKGROUND: The ethanol extract of Gynostemma pentaphyllum Makino leaves (EGP) has been reported recently to have anxiolytic effects on chronically stressed mice models. PURPOSE: We aimed to investigate the efficacy and safety of EGP on anxiety level in healthy Korean subjects under chronic stressful conditions. STUDY DESIGN: Double-blind, placebo-controlled trial. METHODS: This study was conducted with 72 healthy adults who had perceived chronic stress and anxiety with a score on the State-Trait Anxiety Inventory (STAI) from 40 to 60. Participants were randomly assigned to receive either EGP (200 mg, twice a day, N = 36) or placebo (N = 36). All participants were exposed to repetitive loads of stress by performing the serial subtraction task for 5 min every second day during the 8-week intervention. Primary outcome of Trait-STAI and secondary outcomes of State-STAI, total score of STAI, Hamilton Anxiety Inventory (HAM-A), Beck Anxiety Inventory (BAI), blood norepinephrine and adrenocorticotropic hormone (ACTH), salivary cortisol and alpha-amylase, cardiovascular autonomic nervous system (ANS) functional test, and heart rate variability (HRV) test were measured before and after intervention. RESULTS: After the 8-week intervention, the EGP significantly lowered the score of the Trait Anxiety Scale of the STAI (T-STAI) by 16.8% compared to the placebo (p = 0.041). The total score on the STAI decreased by 17.8% in the EGP group and tended to improve compared with that of the placebo group (p = 0.067). There were no significant differences in the changes in score of S-STAI, HAM-A, BAI, and other parameters from baseline between the two groups. There was no causal relationship between the ingestion of EGP and adverse drug reactions. CONCLUSION: We found that supplementation with EGP reduced "anxiety proneness" in subjects under chronic psychological stress, as shown by a decrease in the score of T-STAI and the tendency for decrease in the total score of STAI. This result suggests that EGP supplementation can be used as a regimen to safely reduce stress and anxiety; however, more studies are needed to establish the long-term safety and effectiveness.

A standardized extract of the fruit of Hovenia dulcis alleviated alcohol-induced hangover in healthy subjects with heterozygous ALDH2: A randomized, controlled, crossover trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Hovenia dulcis, known as the oriental raisin tree, is mainly found in East Asia. It has long been used as traditional folk remedies for alcohol intoxication. AIM OF THE STUDY: To examine the anti-hangover effect of Hovenia dulcis Thunb. fruit extract (HDE) in a randomized controlled crossover trial. MATERIALS AND METHODS: Twenty-six eligible male adults with heterozygous ALDH2 (23.7±0.3 years old) consumed 360mL of Korean Soju (50g alcohol) together with HDE (2460mg) or matched placebo with subsequent crossover. The blood samples were taken at baseline and 1, 4, and 12h post-treatment. RESULTS: Blood alcohol, acetaldehyde, and total hangover scores were highest at 1h post-treatment with no difference between groups, but declines in hangover symptom scores were significant in the HDE group compared to the placebo group. Significant differences between groups were also observed on interleukin (IL)-6, IL-10, IL-10/IL-6 ratio, and aspartate aminotransferase levels, but not on endotoxins. Pearson correlation analysis revealed a positive correlation between total hangover symptom scores and IL-6 and IL-10 level. Further analyses by CYP2E1 polymorphism at rs10776687, rs2031920, rs3813867, and rs4838767 alleles showed a reversed association, suggesting that CYP2E1 polymorphism might be an effect modifier. CONCLUSIONS: The results suggest that a favorable effect of HDE on alcohol hangovers might be associated with enhancing homeostatic regulation of inflammatory response. The magnitude of impact might be different in the presence of CYP2E1 polymorphism.

Who are happy survivors? Physical, psychosocial, and spiritual factors associated with happiness of breast cancer survivors during the transition from cancer patient to survivor.

OBJECTIVE: This study aims to evaluate physical, psychosocial, and spiritual factors associated with happiness in breast cancer survivors during the reentry period. METHODS: It is a cross-sectional study with 283 nonmetastatic breast cancer survivors who completed treatment within 1 year. We included survivors who completed questionnaires on happiness and health-related quality of life (QoL) 2 years after cancer diagnosis. Happiness and QoL was measured using the Subjective Happiness Scale and EORTC QLQ-C30, respectively. Multivariable logistic regression was used to find factors associated with happiness. RESULTS: The mean age of the study participants was 48.5 ± 7.8 years. Among the 283 survivors, 14.5%, 43.8%, 32.5%, and 2.1% reported being "very happy," "happy," "neutral," and "not happy at all," respectively. Happy survivors reported a better general health status and QoL (67.6 vs 49.6; P < .01), and fewer symptoms compared to unhappy survivors. Happy survivors were more likely to feel certain about the future (27.2% vs 11.9%, P < .01), have a strong purpose in life (22.4% vs 9.3%, P < .01), and feel hopeful (36.4% vs 8.5%, P < .01) compared to unhappy survivors. In a multivariate model, having purpose (OR = 2.50, 95% CI 1.42-4.40) and hope (OR = 4.07, 95% CI 2.23-7.45) in life were found to be associated with happiness. CONCLUSIONS: During the reentry period, breast cancer survivors who are hopeful and have a clear purpose in life are more likely to be happy than those who are not. Setting proper life goals might be beneficial to help breast cancer survivors who experience persistent QoL issues.

Chrysin Increases the Therapeutic Efficacy of Docetaxel and Mitigates Docetaxel-Induced Edema.

Docetaxel (DTX) is an effective commercial anticancer agent for chemotherapy in non-small cell lung cancer (NSCLC), breast cancer, gastric cancer, and prostate cancer, but its adverse effects including edema, neurotoxicity, and hair loss limit its application. To improve the chemotherapeutic efficacy of DTX and reduce adverse effects, combination therapy is one of the alternative methods. So chrysin, which has various biological activities including anticancer effects, was considered. In vitro, the combination of chrysin and DTX was investigated in A549 cells. Increased cytotoxicity, suppressed cellular proliferation, and induced apoptosis were observed with posttreatment of chrysin following DTX treatment. In vivo, chrysin enhanced the tumor growth delay of DTX and increased DTX-induced apoptosis in the A549-derived xenograft model. Furthermore, chrysin prevented DTX-induced edema in ICR mouse. These results indicated that chrysin strengthened the therapeutic efficacy of DTX and diminished the adverse effect of DTX, suggesting chrysin could be exploited as an adjuvant therapy for NSCLC.

Angelica gigas Ameliorates Hyperglycemia and Hepatic Steatosis in C57BL/KsJ-db/db Mice via Activation of AMP-Activated Protein Kinase Signaling Pathway.

The prevention and management of type 2 diabetes mellitus has become a major global public health challenge. Decursin, an active compound of Angelica gigas Nakai roots, was recently reported to have a glucose-lowering activity. However, the antidiabetic effect of Angelica gigas Nakai extract (AGNE) has not yet been investigated. We evaluated the effects of AGNE on glucose homeostasis in type 2 diabetic mice and investigated the underlying mechanism by which AGNE acts. Male C57BL/KsJ-db/db mice were treated with either AGNE (10 mg/kg, 20 mg/kg, and 40 mg/kg) or metformin (100 mg/kg) for 8 weeks. AGNE supplementation (20 and 40 mg/kg) significantly decreased fasting glucose and insulin levels, decreased the areas under the curve of glucose in oral glucose tolerance and insulin tolerance tests, and improved homeostatic model assessment-insulin resistant (HOMA-IR) scores. AGNE also ameliorated hepatic steatosis, hyperlipidemia, and hypercholesterolemia. Mechanistic studies suggested that the glucose-lowering effect of AGNE was mediated by the activation of AMP activated protein kinase, Akt, and glycogen synthase kinase-3[Formula: see text]. AGNE can potentially improve hyperglycemia and hepatic steatosis in patients with type 2 diabetes.

Polymeric nanoparticle-docetaxel for the treatment of advanced solid tumors: phase I clinical trial and preclinical data from an orthotopic pancreatic cancer model.

We assessed the efficacy of the polymeric nanoparticle containing docetaxel (PNP-DTX) in preclinical mouse models and determined the maximum tolerated dose (MTD) through clinical study. Subcutaneous and orthotopic mouse models were dedicated. Tumor growth delay in orthotopic model and quantification of in vivo imaging in orthotopic model were evaluated. Phase I clinical study was a single-center, prospective, open-label trial in advanced solid tumors. PNP-DTX was injected intravenously and the starting dose was 20 mg/m2 escalated to 35 mg/m2, 45 mg/m2, 60 mg/m2 and 75 mg/m2. Pharmacokinetics, tumor response, toxicities were evaluated. Preclinical result revealed the more potent cytotoxic effect of PNP-DTX than docetaxel (DTX). However, there was no difference between PNP-DTX and DTX in subcutaneous model. Tubulin polymerization assay showed that PNP-DTX preserved original mode of action of DTX. For phase I clinical trial, 18 patients were analyzed. The dose of 75 mg/m2 was tentatively determined as the MTD and the most common toxicity was grade 4 neutropenia not lasting over 7days. The Cmax of 60 mg/m2 PNP-DTX and AUClast of 45 mg/m2 PNP-DTX were measured to be comparable to those of 75 mg/m2 DTX. Partial remission (PR) was achieved in 4 (22%) patients. The potency of PNP-DTX was revealed especially in orthotopic mouse model. The MTD of PNP-DTX could not be confirmed, but 75 mg/m2 was tentatively determined. The PNP-DTX of 45 mg/m2 had the same pharmacokinetic profile with that of 75 mg/m2 DTX.

Randomized, double-blind, placebo-controlled trial of Ficus carica paste for the management of functional constipation.

BACKGROUND AND OBJECTIVES: Constipation affects up to 20% of the world's population. The aim of this study was to investigate whether supplementation with Ficus carica paste could be used to treat constipation in Korean subjects with functional constipation. METHODS AND STUDY DESIGN: We conducted a randomized, double-blind, placebo-controlled trial. Subjects with functional constipation were orally supplemented with either F. carica paste (n=40) or placebo (n=40) for 8 weeks. We measured the efficacy and safety of F. carica paste. Primary outcomes (colon transit time) and secondary outcomes (questionnaire related to defecation) were compared before and after the 8-week intervention period. RESULTS: F. carica paste supplementation was associated with a significant reduction in colon transit time and a significant improvement in stool type and abdominal discomfort compared with the placebo. Blood parameters and clinical findings for organ toxicity remained within normal ranges. CONCLUSION: These results suggest that F. carica paste may have beneficial effects in subjects suffering from constipation.

Effect of low-level laser therapy on orthodontic tooth movement into bone-grafted alveolar defects.

INTRODUCTION: The objective of this study was to investigate the effect of low-level laser therapy (LLLT) on the rate of orthodontic tooth movement (OTM) into bone-grafted alveolar defects based on different healing states. METHODS: Ten male beagles were randomly allocated to 3 groups: group C, OTM alone as a control; group G, OTM into the grafted defects; group GL, OTM into the grafted defects with LLLT. The maxillary second premolars were protracted into the defects for 6 weeks, immediately (G-0 and GL-0) and at 2 weeks (G-2 and GL-2) after surgery. The defects were irradiated with a diode laser (dose, 4.5 J/cm(2)) every other day for 2 weeks. The rates of OTM and alveolar bone apposition, and maturational states of the defects were analyzed by histomorphometry, microcomputed tomography, and histology. RESULTS: The total amounts of OTM and new bone apposition rates were decreased by LLLT, with increased bone mineral density and trabecular maturation in the defects. Group GL-2 had the slowest movement with root resorption in relation to less woven bone in the hypermatured defect. CONCLUSIONS: LLLT significantly decreased the rate of OTM into the bone-grafted surgical defects by accelerating defect healing and maturation, particularly when the start of postoperative OTM was delayed.

Supplementation with Aspergillus oryzae-fermented kochujang lowers serum cholesterol in subjects with hyperlipidemia.

BACKGROUND & AIMS: Kochujang, a traditional fermented red pepper paste, is known for its hypocholesterolemic effect; however, these studies used non-commercial preparations of kochujang. In this study, we examined whether commercially-made kochujang in which Aspergillus oryzae (also known as koji) was used as a microorganism for fermentation has the same cholesterol-lowering effects. METHODS: Hyperlipidemic subjects (based upon criteria of 110 ∼ 190 mg/dL LDL cholesterol or 200 ∼ 260 mg/dL total cholesterol) who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 30 subjects were randomly divided into either the kochujang (n = 15) or placebo (n = 15) group. All subjects ingested either the kochujang pill (34.5 g/d) or a placebo three times daily during meals for 12 weeks. Outcomes included measurements of efficacy (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglyceride) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). RESULTS: In the kochujang-supplemented group, subjects' total cholesterol level significantly decreased (from 215.5 ± 16.1 mg/dL to 194.5 ± 25.4 mg/dL, p = 0.001). LDL-C cholesterol levels were also decreased by kochujang supplementation (from 133.6 ± 14.8 mg/dL to 113.5 ± 23.1 mg/dL); however no significant difference was seen between groups (p = 0.074). There were no statistically significant differences in HDL-cholesterol and triglyceride levels between the supplemented and non-supplemented groups. None of the subjects complained of any adverse effects. CONCLUSIONS: These results indicate that A. oryzae-fermented kochujang elicits a significant hypocholesterolemic effect and might be useful for improving blood cholesterol levels in subjects at high risk for cardiovascular disease. CLINICAL TRIAL REGISTRATION: NCT01865370.

Reduction of blood lipid parameters by a 12-wk supplementation of aged black garlic: a randomized controlled trial.

OBJECTIVE: The cholesterol-lowering effects of garlic as part of a healthy diet remain controversial. The aim of this study was to investigate whether supplementation with aged black garlic (ABG) could improve blood lipid profiles in patients with mild hypercholesterolemia. METHODS: We conducted a double-blind, randomized placebo-controlled trial. Sixty participants were randomly assigned to receive either ABG or placebo twice daily (total 6 g/d) before consumption of a meal every morning and evening for 12 wk. During the study, two participants dropped out of the ABG group, and three participants dropped out of the placebo group. Thus, the effects of AGB on fasting blood levels of lipids were evaluated in 28 participants and compared with the placebo group (n = 27). RESULTS: Among lipid components, no significant differences in triglycerides, low-density lipoprotein cholesterol, total cholesterol, or free fatty acid levels were observed between the two groups. However, ABG increased high-density lipoprotein cholesterol levels compared with the placebo group at the end of the study. Moreover, a significant decrease in the levels of alipoprotein B and a significant increase in the ratio of low-density lipoprotein cholesterol/alipoprotein B were observed in the ABG group. No adverse effects were reported in any of the patients. CONCLUSION: ABG supplementation reduced atherogenic markers and thus may have a cardioprotective effect beyond the gold standard medication in patients with mild hypercholesterolemia.

Beneficial effects of Korean traditional diets in hypertensive and type 2 diabetic patients.

The prevalence of metabolic syndrome, hypertension, and diabetes has been increasing rapidly in Korea. The rate of increase has paralleled the replacement of Korean traditional diets (KTD), which emphasize vegetables and fermented foods, with western style dietary patterns that are rich in animal foods and saturated fat. We aimed to investigate the efficacy of the KTD in controlling fasting plasma glucose, blood pressure, and cardiovascular disease risk factors in hypertensive and type 2 diabetic (T2D) patients. Forty-one patients (61.8±1.5 years) who were taking medications prescribed for respective diseases were recruited from the Chonbuk National University Hospital for participation in a 12-week, parallel, controlled clinical trial. The control group (n=20) was advised to "eat as usual," whereas the experimental KTD diet group (n=21) was fed the KTD three times a day for 12 weeks. At the end of the trial, both groups had lower body mass index, % body fat, and waist-hip ratio compared to the baseline values (P<.05). Compared to the control group, the KTD group had a greater mean change (P<.05) from the baseline for glycated hemoglobin (HbA1c) (-0.72% vs. -0.25%) and heart rate (-7.1 vs. +1.6). Regular consumption of the KTD for 12 weeks by hypertensive and T2D patients resulted in favorable changes in cardiovascular risk factors.

The effectiveness of fermented turmeric powder in subjects with elevated alanine transaminase levels: a randomised controlled study.

BACKGROUND: Previous animal studies have shown that Curcuma longa (turmeric) improves liver function. Turmeric may thus be a promising ingredient in functional foods aimed at improving liver function. The purpose of the study is to investigate the hepatoprotective effect of fermented turmeric powder (FTP) on liver function in subjects with elevated alanine transaminase (ALT) levels. METHODS: A randomised, double-blind, placebo-controlled trial was conducted between November 2010 and April 2012 at the clinical trial center for functional foods of the Chonbuk National University Hospital. The trial included 60 subjects, 20 years old and above, who were diagnosed mild to moderate elevated ALT levels between 40 IU/L and 200 IU/L. Sixty subjects were randomised to receive FTP 3.0 g per day or placebo 3.0 g per day for 12 weeks. The treatment group received two capsules of FTP three times a day after meals, for 12 weeks. The primary efficacy endpoint was change in the ALT levels in the two groups. The secondary efficacy endpoints included its effect on aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), total bilirubin (TB), and lipid profiles. Safety was assessed throughout the study using ongoing laboratory tests. Adverse events (AEs) were also recorded. RESULTS: Sixty subjects were randomised in the study (30 into the FTP group, 30 into the placebo group), and among them, twelve subjects were excluded from the analysis for protocol violation, adverse events or consent withdrawal. The two groups did not differ in baseline characteristics. After 12 weeks of treatment, 48 subjects were evaluated. Of the 48 subjects, 26 randomly received FTP capsules and 22 received placebo. The FTP group showed a significant reduction in ALT levels after 12 weeks of treatment compared with the placebo group (p = 0.019). There was also observed that the serum AST levels were significantly reduce in the FTP group than placebo group (p = 0.02). The GGT levels showed a tendency to decrease, while the serum alkaline phosphatase (ALP), TB, and lipids levels were not modified. There were no reported severe AEs during this study, or abnormalities observed on blood glucose, total protein, albumin, blood urea nitrogen (BUN), and creatinine levels. CONCLUSION: The data of this trial indicate that FTP is effective and safe, generally well-tolerated without severe AEs, in the treatment of subjects with elevated ALT levels over a 12 weeks period. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01634256

Therapeutic potential of Gastrodia elata Blume for the treatment of Alzheimer's disease.

Several studies have demonstrated that the Chinese herb Gastrodia elata Blume can protect against amyloid beta-peptide (Aß)-induced cell death. To investigate the possible therapeutic effects of Gastrodia elata Blume on Alzheimer's disease, we established a rat model of Alzheimer's disease by injecting Aß25-35 into bilateral hippocampi. These rats were intragastrically administered 500 or 1 000 mg/kg Gastrodia elata Blume per day for 52 consecutive days. Morris water maze tests showed that Gastrodia elata Blume treatment significantly improved the spatial memory of Alzheimer's disease rats. Congo red staining revealed that Gastrodia elata Blume significantly reduced the number of amyloid deposits in the hippocampus of these rats. Western blot analysis showed that choline acetyltransferase expression in the medial septum and hippocampus was significantly increased by the treatment of Gastrodia elata Blume, while Ellman method showed significant decrease in the activity of acetylcholinesterase in all three regions (prefrontal cortex, medial septum and hippocampus). These findings suggest that long-term administration of Gastrodia elata Blume has therapeutic potential for Alzheimer's disease.

Long-term outcomes of concomitant chemoradiotherapy incorporating high-dose-rate brachytherapy to treat locally advanced cervical cancer.

AIM AND BACKGROUND: We reviewed the long-term clinical outcomes of patients treated with cisplatin-based concurrent chemoradiotherapy (CCRT) incorporating high-dose-rate (HDR) intracavitary brachytherapy (ICBT) in terms of toxicity, local control and survival rates. In addition, we identified prognostic factors for overall and disease-free survival. METHODS AND STUDY DESIGN: . Two hundred and nine patients with stage IB2-IVA cervical cancer underwent curative cisplatin-based CCRT plus HDR ICBT. Women with stage IB2-IIB disease were given 41.4 Gy of external radiotherapy followed by 35 Gy (in 7 fractions) of ICBT. Women with stage IIIA-IVA were given 50.4 Gy followed by 30 Gy (in 6 fractions) of ICBT. Patients with parametrial disease or pelvic lymphadenopathy were given parametrial boosts via external beam radiation at a dose of up to 65 Gy to thickened and 60 Gy to unthickened parametrial regions. RESULTS: One hundred and thirty (62%) patients experienced acute grade 3-4 hematological toxicities and 11 (5%) patients had late grade 3 gastrointestinal or genitourinary complications. Complete responses occurred in 168 (80%) women as determined by clinical and imaging studies. The median follow-up period was 52 months for surviving patients and the 5-year overall and disease-free survival rates were 74% and 67%, respectively. Multivariate analysis indicated that tumor size and paraaortic lymph node involvement were prognostically significant in terms of overall survival, and that tumor diameter was a significant prognostic factor and pelvic lymph node status a marginally significant prognostic factor for disease-free survival. CONCLUSIONS: Patients treated with our current HDR ICBT protocol have acceptably low late complication rates and local control and survival rates comparable to those reported in other studies. Tumor diameter was an important prognostic factor in terms of both overall and disease-free survival, emphasizing the need for modern ICBT methodologies.