Efficacy and safety of APT036 versus simethicone in the treatment of functional bloating: a multicentre, randomised, double-blind, parallel group, clinical study.

BACKGROUND: Bloating is a common symptom reported by around 16% to 31% of the general population. Functional bloating is diagnosed in patients with recurrent symptoms of bloating who do not meet the diagnostic criteria of irritable bowel syndrome or other functional gastrointestinal disorders. METHODS: This double-blind, multicentre, randomised study compared the safety and efficacy of APT036 (xyloglucan plus tyndallized Lactobacillus reuteri and Bifidobacterium brevis; Aprotecol®) and simethicone in treating functional bloating in adults. APT036 or simethicone were administered orally (3 times/day) for 20 consecutive days, with evaluations at baseline, and on Days 2, 10, 20 (end of treatment) and 30 (follow-up visit). The main outcome measure was safety. Efficacy was assessed at each visit by patient-reported symptom severity (Likert scale) and abdominal girth measurement. A hydrogen breath test was performed at baseline and Day 20. RESULTS: Both APT036 (n=54) and simethicone (n=54) were well tolerated by study subjects; no adverse effects were reported with either treatment. Compared with simethicone, APT036 significantly reduced abdominal distension (P=0.008) and flatulence (P=0.010) from baseline to Day 30. The baseline hydrogen breath test confirmed the presence of small intestinal bacterial overgrowth (SIBO) in all subjects. At Day 20, mean hydrogen gas elevation was below the threshold for a diagnosis of SIBO (<12 ppm above basal on glucose administration) in both study arms. CONCLUSIONS: Both APT036 and simethicone had good safety profiles but APT036 was superior to simethicone in relieving symptoms of functional bloating.

Opportunistic colorectal cancer screening using colonoscopy. Comparative results between two historical cohorts in Bucharest, Romania.

BACKGROUND & AIMS: Even though Romania has one of the highest incidence and mortality in colorectal cancer (CRC) in Europe, there is currently no organized screening program. We aimed to assess the results of our opportunistic CRC screening using colonoscopy. METHODS: A single center retrospective study to include all opportunistic screening colonoscopies performed in two 18 month periods (2007-2008 and 2012-2013) was designed. All asymptomatic individuals without a personal or family history of adenoma or CRC and with complete colonoscopy performed in these two time periods were included. RESULTS: We included 1,807 individuals, 882 in the first period, 925 in the second period. There were 389 individuals aged below 50, 1,351 between 50 and 75 and 67 older than 75 years. There were 956 women (52.9%), with a mean age of 58.5 (median 59, range 23-97). The detection rates were 12.6% for adenomas (6.1% for advanced adenoma) and 3.4% for adenocarcinoma. Adenoma incidence (4.9% in subjects under 50, 14.7% in those aged 50 to 75, and 16.4% in those older than 75, p<0.0001) and size (6.3mm in subjects younger than 50, 9.2mm in those 50 to 75 and 10.8mm in those older than 75, p=0.015) significantly increased with age. Adenoma incidence increased in the second period (14.8% vs. 10.3%, p=0.005), while adenoma size decreased in the second period (8.4mm vs. 10mm, p=0.006). There were no procedure related complications. CONCLUSIONS: The neoplasia detection rate was 16% (12.6% adenoma, 3.4% adenocarcinoma). Adenoma incidence and size increased with age in both cohorts. In the second screening period significantly more and smaller adenomas were detected.

Endoscopic ultrasound guided fine needle aspiration biopsy in the diagnosis of pancreatic masses.

Endoscopic ultrasound (EUS) represents a highly sensitive method for the detection of pancreatic masses. When available, EUS-guided fine needle aspiration (FNA) is the best technique for the diagnosis and staging of pancreatic cancer due to its ability to obtain tissue for diagnosis. The standardized indications for pancreatic EUS-FNA comprise the definite diagnosis of malignancy and histopathological confirmation of adenocarcinoma before surgical resection, chemo/radiotherapy, or celiac plexus neurolysis. The technique of performing EUS-FNA is described in detail, from the vizualization of the target lesion and adequate placement of the transducer to allow optimal needle access, to needle penetration and sampling of the targeted lesion. We report a series of 9 patients who underwent EUS-FNA and shortly review the indications, technique, results and impact of EUS-FNA on the management of these patients.

Nutritional status in cirrhotic patients.

BACKGROUND: Malnutrition is prevalent in all forms of liver disease: from 20% in compensated liver disease to more than 80% in those patients with decompensated liver disease. Protein-calorie malnutrition (PCM) can be identified in all clinical stages but is easier observed in advanced stages of liver disease. The presence of malnutrition is associated with increased number of complications and increased short and long term mortality. AIM: to evaluate the nutritional status using of combination of BMI (Body Mass Index), TST (triceps skinfold thickness) and MAMC (mid-arm muscle circumference). Subjective Global Assessment (SGA) of nutritional status was determined for every patient. The features of subjective global assessment are history, physical evaluation and SGA rating. Based on this evaluation, patients were classified into three groups: well, moderately malnourished and severely malnourished. MATERIAL AND METHODS: Our study was designed as a descriptive prospective analysis of patients with cirrhosis, admitted in Elias Emergency Hospital, Gastroenterology Department, during a year, January 2010-January 2011. The diagnosis of cirrhosis was based on the medical history, physical exa-mination, biochemical findings and imagistic methods (ultrasound and / or computed tomography). A series of 176 hospitalized patients with cirrhosis, 114 (65%) male and 62 (35%) female, median age 52 (range 18-68 years). Etiology of liver disease was alcoholic in 98 (56%), hepatitis B virus in 14 (8%), HCV in 43 (24%), HBV and HDV in 10 (7%), 11 patients have other etiology. The evaluation of nutritional status was made by different methods. A detailed history was recorded with appetite, caloric intake, change in body weight. Subjective Global Assessment (SGA) of nutritional status was determined for every patient. CONCLUSIONS: Malnutrition was correlated with clinical severity of liver disease. The mild-moderate malnourished patients are 88% Child B, over 58% with viral etiology. 22% from these patients are alcoholic and 11% have Child C score (p<0.01). In severely malnourished group, 43% have alcoholic disease and 31% are Child C classification(p<0.01). Triceps skinfold thickness (mm) and mid-arm circumference(cm) decrease significantly according to the Child score, a positive correlation was found between these two parameters and the severity of cirrhosis.

Nuclear Division Index may Predict Neoplastic Colorectal Lesions.

BACKGROUND: Colorectal cancer (CRC) develops by accumulation of multiple genetic damages leading to genetic instability that can be evaluated by cytogenetic methods. In the current study we used Cytokinesis-Blocked Micronucleus Assay (CBMN) technique to assess the behavior of Nuclear Division Index(NDI) in peripheral lymphocytes of patients with CRC and polyps versus patients with normal colonoscopy. METHODS: Blood samples were collected from patients after informed consent. By CBMN technique we assessed the proportion of mono-nucleated, bi-nucleated, tri-nucleated and tetra-nucleated cells/500 cells, to calculate NDI. Data were statistically analyzed using the SPSS 11.0 package. RESULTS: 45 patients were available for analysis, 23 men and 22 women, with a mean age of 58.7±13.5. 17 had normal colonoscopy, 17 colonic polyps and 11 CRC. The mean NDI values were significantly smaller for patients with CRC or polyps than in patients with normal colonoscopy (1.57 vs 1.73, p=0.013). The difference persisted for patients with neoplastic lesions (adenomas and carcinomas) when compared with patients with normal colonoscopy or non neoplastic (hyperplastic) polyps (1.56 vs.1.71, p=0.018). The NDI cut-off value to predict the presence of adenomas or carcinomas was equal to 1.55 with a 54.2% sensitivity and 81% specificity of lower values (p=0.019). The NDI cut off value to predict the presence of advanced adenomas or cancer was 1.525 for a sensitivity of 56.3% and a specificity of 82.8% (p=0.048). CONCLUSION: NDI may be useful in screening strategies for colorectal cancer as simple, noninvasive, inexpensive cytogenetic biomarker.