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

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

Acid Inhibitory Effect of a Combination of Omeprazole and Sodium Bicarbonate (CDFR0209) Compared With Delayed-Release Omeprazole 40 mg Alone in Healthy Adult Male Subjects.

CDFR0209, a combination of an immediate-release formulation of omeprazole 40 mg and sodium bicarbonate 1100 mg, has been developed to treat acid-related disorders. We compared the acid inhibitory effects of CDFR0209 and delayed-release omeprazole (omeprazole-DR, Losec 40 mg) after repeated dosing in Helicobacter pylori-negative healthy adult male subjects. In this 2-period crossover study, 30 subjects were randomized to CDFR0209 or omeprazole-DR daily for 7 days. An ambulatory continuous 24-hour intragastric pH recording was performed at baseline and on days 1 and 7 of each administration period. Integrated gastric acidity was calculated from time-weighted average hydrogen ion concentrations at each hour of the 24-hour record. An analysis of variance model was used to test the pharmacodynamic equivalence of CDFR0209 and omeprazole-DR, using the natural logarithmic transformation of the percent decrease from baseline in integrated gastric acidity for the 24-hour interval after the seventh dose of each omeprazole formulation. The geometric least-squares mean ratios (CDFR0209/omeprazole-DR) of the percent decrease from baseline in integrated gastric acidity was 0.98 (90%CI, 0.93-1.07). Both CDFR0209 and omeprazole-DR are equally effective in decreasing integrated gastric acidity at steady state.

The effect of an interfragmentary gap on the clinical outcome after mandibular angle fracture surgery.

BACKGROUND/AIM: The mandibular angle fracture occasionally widens at the lower border after surgery using a single miniplate. However, the effects of an interfragmentary gap have not been fully investigated. The aim of this study was to determine the effects of gaps caused by mandibular angle fracture surgery using a single superior border miniplate technique. MATERIAL AND METHODS: In this prospective study, the interfragmentary gap was measured by panoramic radiography and cone-beam computed tomography (CBCT) postoperatively. The width of the gap measured by panoramic radiography and CBCT scans was compared. The patients were divided into two groups based on the gap width (more or less than 1.5 mm). In CBCT scans, bucco-lingual displacement of the proximal segment was evaluated. Clinical results and complication rates were investigated according to the gap and displacement. The findings were statistically analyzed. RESULTS: Thirty-two patients were included in the study. The mean interfragmentary gap widths were 1.56 ± 0.83 mm by panoramic radiography and 2.12 ± 0.87 mm by CBCT scans. CBCT measured a gap width of approximately 0.5 mm wider than panoramic radiography (P = 0.001). Twenty-two patients (68.8%) had an interfragmentary gap width of >1.5 mm, and ten patients (31.2%) had a gap width of <1.5 mm. All patients had favorable occlusion at the last clinical examination. There were no statistically significant differences in intermaxillary fixation periods and complication rates (P > 0.05). One patient in the wider gap group experienced pain in the temporomandibular joint when opening the mouth. Six patients (18.8%) had lingual displacement of the proximal fragment. Displacement did not significantly influence the complication rate (P > 0.05). CONCLUSION: The presence of an interfragmentary gap after mandibular angle fracture surgery did not affect the clinical outcome.

Septic arthritis of the temporomandibular joint: a case report.

Septic arthritis of the temporomandibular joint (TMJ) is a rare disease. The most common symptoms of this disease are acute malocclusion, limited mouth opening, swelling, and tenderness of affected TMJ. These symptoms are often confused with internal derangement of the articular disc, rheumatoid arthritis, retrodiscitis, or osteoarthritis. Therefore, differential diagnosis by image examination is required. Usually, antimicrobial treatment and surgical drainage by needle aspiration, arthroscopy, or arthrotomy are effective treatment approaches. In this study, a patient who was diagnosed with septic arthritis was treated with arthrocentesis and antibiotics without significant complications. We present a case report with a review of the literature.

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.

Combined Effect of Blood Cadmium and Lead Levels on Coronary Heart Disease Prediction Risk in Korean Men.

This study was designed to investigate the combined effects of cadmium (Cd) and lead (Pb) on 10-year coronary heart disease (CHD) risk calculated using the Framingham risk score. The heavy metal data set of the Korean National Health and Nutrition Examination Survey IV and V (2008-2010) was analyzed. The 10-year CHD risk was significantly associated with the log-transformed blood Cd and Pb levels in Korean men. For the highest quartile of Cd and Pb, the odds ratio (OR) of the intermediate risk and beyond for CHD (10-year risk ≥10%) compared to the lowest quartile was 6.870 (Cd, 95% confidence interval [CI]: 4.58-10.30) and 3.127 (Pb, 95% CI: 2.09-4.69) after adjusting for confounders, respectively. The adjusted OR of the intermediate risk and beyond for CHD (10-year risk ≥10%) in the fourth quartile of both Cd and Pb was 12.2 (95% CI: 8.0-18.5) compared to the reference group (first and second quartiles of Cd and Pb). However, the association between log-transformed blood Cd and Pb and the 10-year CHD risk was not significant in Korean women.

Milk Consumption and Framingham Risk Score: Analysis of the Korea National Health and Nutrition Examination Survey Data (2008-2011).

PURPOSE: The benefit of milk intake remains controversial. The association between milk consumption and Framingham Risk Score (FRS) in a population consuming relatively low amounts of dairy products is undetermined. MATERIALS AND METHODS: A total of 13736 adults (5718 male and 8018 female) aged 20-80 years from the Korea National Health and Nutrition Examination Survey (2008-2011) were divided into groups according to milk consumption (rarely, monthly, weekly, and daily) and compared according to FRS after relevant variable adjustments. RESULTS: The mean FRS in males and females were 6.53 and 5.74, respectively. Males who consumed milk daily (15.9%) had a significantly lower FRS than males having milk rarely (31.6%) or monthly (17.4%; p=0.007). Females who consumed milk daily (22.3%) also had significantly lower FRS than rarely (29.8%), monthly (13.8%), or weekly (34%; p=0.001) consumers. In particular, males ≥60 years old who consumed milk daily had a significantly lower FRS than males who consumed less milk (p<0.001). The odds ratio in this age group showed a significant and gradual increase in the weekly [OR=2.15; 95% confidence interval (CI) 1.14-4.03], monthly (OR=2.29; 95% CI 1.15-4.54), and rarely (OR=3.79; 95% CI 2.01-7.14) milk consumption groups when compared with the daily milk consumption group. CONCLUSION: Milk consumption was associated with a lower FRS in a low milk-consuming population. In particular, daily milk consumption in males over 60 years old may be beneficial for those at risk for cardiovascular disease.

Vitamin A intake, serum vitamin D and bone mineral density: analysis of the Korea National Health and Nutrition Examination Survey (KNHANES, 2008-2011).

The association of high vitamin A intake and low bone mineral density (BMD) is still controversial. To determine the association of dietary vitamin A intake and serum 25-hydroxyvitamin D (25(OH)D) concentration with BMD, a total of 6481 subjects (2907 men and 3574 women) aged ≥50 years from the Korean National Health and Nutrition Examination Survey (2008-2011) were divided into groups according to dietary vitamin A intake (tertiles) and serum 25(OH)D (<50, 50-75, >75 nmol/L), and evaluated for BMD after adjusting for relevant variables. Mean dietary vitamin A intakes were 737 and 600 µg RE (Retinol Equivalents) in men and women, respectively. Total hip and femoral neck BMD in men and lumbar spine BMD in women were both positively correlated with dietary vitamin A intake in subjects with serum 25(OH)D >75 nmol/L. Among men with serum 25(OH)D <50 nmol/L, both the top (mean 1353 µg RE) and bottom (mean 218 µg RE) tertiles of dietary vitamin A intake had lower BMD than the middle group (mean 577 µg RE). In this population, BMD was the highest among men and women with serum 25(OH)D = 50-75 nmol/L and that there were no differences in BMD by vitamin A intake in these vitamin D adequate groups. This cross-sectional study indicates that vitamin A intake does not affect bone mineral density as long as the serum 25(OH)D concentration is maintained in the moderate level of 50-75 nmol/L.

Association of rhinostomy shape and surgical outcome after endoscopic endonasal dacryocystorhinostomy.

PURPOSE: The purpose of this study was to investigate surgical outcomes and complications after endoscopic endonasal dacryocystorhinostomy (EDCR) in relation to rhinostomy shape. METHODS: A retrospective electronic medical record review of patients who underwent EDCR for primary acquired nasolacrimal duct obstruction (PANDO) was performed. Surgical success rates and postoperative complications were compared among three groups of patients in relation to rhinostomy shape (alcove, cavern, or concealed cavern). RESULTS: A total of 280 patients (358 eyes) were included in the study. Of the 358 eyes, 194 rhinostomies were alcove-shaped, 157 were cavern-shaped, and 7 were concealed cavern-shaped. There were no patients with flat-shaped rhinostomies. The nasal cavity was wider in patients in the alcove group than those in the cavern and concealed cavern groups (p = 0.012). The mean time to tube removal was longest in the concealed cavern group (p = 0.029). There were no significant differences in anatomical success rates among the three groups (p = 0.338). With regard to functional success for patients with anatomically patent DCR, the cavern and concealed cavern groups had significantly poorer results than the alcove group (p = 0.001). Functional success rates were 91.6 %, 84.8 %, and 57.1 % for the alcove, cavern, and concealed cavern groups, respectively. Development of postoperative granuloma was more frequent in the concealed cavern group (85.7 %) than in the alcove (29.3 %) or cavern groups (26.1 %) (p= 0.003). Multiple logistic regression models for surgical outcome showed that rates of functional failure after EDCR were influenced by patient age and rhinostomy shape (odds ratio 1.824, p = 0.045 for age; odds ratio = 9.605, p = 0.000 for rhinostomy shape) (Table 5). CONCLUSIONS: The incidence rate of symptomatic epiphora after EDCR was approximately 12 %, and this result may have been associated with cavernous and concealed rhinostomy shapes. For patients with persistent epiphora and anatomically patent DCR, it is important to identify rhinostomy shape by endoscopy in order to differentiate causes of functional failure.

Effects of matrix metalloproteinase 13 on vascular smooth muscle cells migration via Akt-ERK dependent pathway.

Migration of vascular smooth muscle cells (VSMCs) is an early event of atherosclerosis, which is mediated mainly by matrix metalloproteinase (MMP) 2 and 9. Because MMP13 is associated with tumor cells migration, we hypothesized that MMP13 participates in VSMC migration induced by certain stimuli such as platelet-derived growth factor (PDGF) and angiotensin II (Ang II). We found that the mRNA level of MMP13 in rat aortic smooth muscle cells (RAoSMCs) was increased by both PDGF and Ang II. We observed the significant decrease of migration in PDGF- or Ang II-treated RAoSMCs by MMP13 specific inhibitor treatment. Silencing of MMP13 by a specific small interfering RNA (siRNA) significantly decreased expression of the active form of MMP13, which is followed by the decreased migration of PDGF- or Ang II-treated RAoSMCs. Interestingly, we observed synergistic inhibitory effects on migration by treatment with MMP2 and 13 or MMP9 and 13 inhibitors compared with that in single treatments. Moreover, we found that cordycepin, a known inhibitor of VSMC migration, caused significant downregulation of MMP2, 9, and 13 expression in PDGF-treated RAoSMCs. We further show that the expression level of MMP13 was significantly decreased by the treatment of Akt or ERK specific inhibitor in PDGF-treated RAoSMCs. Together, our data strongly suggest that MMP13 involves VSMCs migration via an Akt and ERK-dependent regulation [corrected].

Effects of short-term chromium supplementation on insulin sensitivity and body composition in overweight children: randomized, double-blind, placebo-controlled study.

Excessive body weight is inversely associated with insulin sensitivity in children and adults. Chromium supplementation produces modest improvement in insulin sensitivity in adults. The aim of this study was to examine the beneficial effects of chromium supplementation on insulin sensitivity and body composition in overweight children simultaneously modifying lifestyle. Twenty-five overweight children aged 9-12 years were randomized to receive either 400 µg of chromium chloride or placebo in double-blind fashion, during a 6-week lifestyle modification regimen that included nutritional education and 3×90 min of aerobic physical activity weekly. Insulin sensitivity was demonstrated using homeostasis model assessment-insulin resistance and quantitative insulin sensitivity check index (QUICKI). Changes in body mass index (BMI; kg/m(2)), BMI Z-score, waist circumference, body composition and fasting plasma glucose were measured. Although no significant benefit of chromium supplementation over placebo was evident for BMI, BMI Z-score and fasting insulin level, children who received chromium chloride demonstrated more positive changes versus the placebo group in HOMA (-1.84±1.07 vs. 0.05±0.42, P=.05), QUICKI (0.02±0.01 vs. -0.002±0.01, P=.05), lean body mass (2.43±0.68 kg vs. 1.36±1.61 kg, P=.02) and percentage body fat (-3.32±1.29% vs. 0.65±1.05%, P=.04). The desirable effects of chromium supplementation on insulin sensitivity and body composition were more apparent in pre-pubertal children. These results suggest that short-term chromium supplementation can improve insulin sensitivity and body composition in overweight children.