Non-nutritive sweetened beverages versus water after a 52-week weight management programme: a randomised controlled trial.

BACKGROUND/OBJECTIVE: Sugar-sweetened beverages are a substantial source of dietary sugar that can contribute to weight gain and the risk of type 2 diabetes. Dietary guidelines recommend non-nutritive sweetened (NNS) beverages to reduce sugar consumption, however, there is a need for long-term randomised controlled trials on their use. We aimed to compare the effects of NNS beverages and water on body weight during weight loss and maintenance in a behavioural weight management programme. METHODS: In this parallel-group, open-label, controlled equivalence trial, adults with a BMI of 27-35 kg/m2 who regularly consumed cold beverages were randomised 1:1 to water or NNS beverages. Participants underwent a group behavioural weight management programme comprising weekly (during the 12-week weight-loss phase) then monthly (during the 40-week weight-maintenance phase) meetings. The primary endpoint was weight change at week 52 (equivalence: two-sided P > 0.05). Secondary endpoints included changes in anthropometrics, cardiometabolic risk factors, appetite and activity levels. RESULTS: Of 493 participants randomised (water: n = 246; NNS beverages: n = 247), 24.1% were NNS-naïve. At week 52, water and NNS beverages were non-equivalent, with significantly greater weight loss in the NNS beverages group. Participants consuming water maintained a weight loss of 6.1 kg over 52 weeks versus 7.5 kg with NNS beverages (difference [90% CI]: 1.4 kg [-2.6, -0.2]; p < 0.05). CONCLUSIONS: During a 52-week behavioural weight management programme, water and NNS beverages were non-equivalent, with weight loss maintained to a statistically greater extent with NNS beverages compared with water. However, this difference was not clinically significant. CLINICAL TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov: NCT02591134.

Effects of non-nutritive sweetened beverages versus water after a 12-week weight-loss program: A randomized controlled trial.

OBJECTIVE: The aim of this study was to compare non-nutritive sweetened (NNS) beverages versus water for weight loss after a 12-week behavioral weight-management program. METHODS: This is an ongoing, 2-year, parallel-group, open-label, controlled equivalence trial; week-12 data are reported. Adults with BMI of 27 to 35 kg/m2 who regularly drank cold beverages were randomized 1:1 to intention-to-treat water or NNS beverages while undergoing a weekly 12-week group behavioral weight-management program. Weight change to week 12 was the primary end point (equivalence: two-sided p > 0.05); changes in waist and hip circumference, blood pressure, glycemic control markers, fasting lipid profiles, liver function tests, hunger (visual analog scale), sugar and sweetener consumption, and activity levels were secondary end points. RESULTS: Overall, 493 participants were randomized (water: n = 246; NNS beverages: n = 247); 24.1% were NNS beverage naïve. Weight change was equivalent with water versus NNS beverages (-5.6 vs. -5.8 kg; difference [90% CI]: -0.2 kg [-0.7 to 0.4]). There were no significant differences between groups for secondary end points except reductions in waist circumference (greater with NNS beverages vs. water), glycated hemoglobin, and consumption of any type of sweetener (both greater with water vs. NNS beverages). CONCLUSIONS: Weight loss was equivalent with NNS beverages and water following a 12-week behavioral weight-management program.

Real-Life Results of Palliative Chemotherapy in Metastatic Pancreatic Ductal Adenocarcinoma.

PURPOSE: To assess the efficacy of FOLFIRINOX(FFX), gemcitabine-based regimens (GB), and gemcitabine monotherapy (Gem) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). METHODS: This is a retrospective study that included 83 patients with mPDAC treated with first-line chemotherapy (L1) with either FFX, GB or Gem between 2015 and 2017. Progression-free survival (PFS) for L1 and second-line chemotherapy (L2) (PFS-L1 and PFS-L2) and overall survival (OS) were estimated using the Kaplan-Meier method. RESULTS: Median PFS-L1 for FFX, GB and Gem groups was 9 months (95% (Confidence Interval) CI 2.76-15.24), 5 months (95%CI 3.44-6.56), and 5 months (95%CI 3.76-6.24), respectively (p = 0.04). OS was 14 months (95%CI 11.16-16.85), 12 months (95%CI: 9.44-11.56), and 7 months (95%CI: 5.7-8.3) for patients treated with FFX, GB, and Gem, respectively (p = 0.0001). ECOG-PS (0/1) (Hazard Ratio (HR) 6.74, p = 0.002), age > 70 years (HR 0.25, p = 0.04), body tumors (HR 2.8, p = 0.048), CA19-9 > 39 U/mL (HR 0.26, p = 0.02), and neutrophil-to-lymphocyte ratio (NLR) > 4.15 (HR 6.76, p = 0.001) were independent prognostic factors for PFS-L1. Male gender (HR 3.02, p = 0.026), ECOG-PS (0/1) (HR 4.21, p = 0.003), L1 with FFX (HR 0.255, p = 0.007), and NLR > 4.15 (HR 2.65, p = 0.04) were independent prognostic factors of OS. PFS-L2 (HR 6.91, p = 0.013) and OS-L2 (HR 6.95, p = 0.037) were significantly higher in patients first treated with FFX. CONCLUSIONS: The OS of patients who receive FFX or GB is comparable. The best PFS-L1 belongs to the FFX group. Male gender, ECOG-PS 0/1, the FFX regimen, and NLR > 4.15 were independent predictors of OS. PFS-L2 and OS-L2 were favorably impacted by L1 with FFX.

Awareness of ovarian cancer symptoms and risk factors in a young ethnically diverse British population.

BACKGROUND: Ovarian cancer does not cause many symptoms in the early stages, which is why the majority of cases are of advanced disease. Increasing awareness of ovarian cancer symptoms may lead to earlier diagnosis and improved outcomes. METHODS: Participants in Britain completed the Ovarian Cancer Awareness Measure by online survey (n = 459). RESULTS: Our participants were 75% female, 25% male and a young (27.89 ± 11.44 years) ethnically diverse population (40.3% White, 29.3% Asian and 18.0% Black). Individuals recalled 1.24 ± 1.30 symptoms, and recognised 5.96 ± 2.4 symptoms. We found higher levels of recall and recognition compared to previous research possibly due to using an online survey. Recognition was lowest for difficulty eating (39.4%) and persistently feeling full (38.7%). Males had slightly lower symptom recall and recognition than females. Participants incorrectly recalled an irregular menstrual cycle (22.4%) as an ovarian cancer symptom and 67% answered the age of incidence question incorrectly. Suggesting that participants incorrectly associate ovarian cancer as a disease of pre-menopausal women. Individuals recalled 1.47 ± 1.20 risk factors, and recognised 6.1 ± 2.4 risk factors. Family history of ovarian cancer was recalled by 59% of participants. Recognition was lowest for in vitro fertilisation treatment (23.0%) and talcum powder in the genital area (23.0%). The generic cancer risk factors of alcohol (9.3%) and poor diet (8.8%) were recalled as specific ovarian cancer risk factors. 57.9% of participants incorrectly answered that there is an ovarian cancer screening programme. Suggesting confusion between ovarian and cervical cancer as participants also recalled cervical cancer risk factors of sexually transmitted diseases (6.3%) and human papillomavirus (1.5%). 29.7% of female participants would seek help for an ovarian cancer symptom within 1-2 days. Help seeking was higher in the Black and Asian ethnicities (44.4% and 45.0%; p = 0.018). CONCLUSION: Awareness of ovarian cancer symptoms is low. Ovarian cancer awareness campaigns should include common misconceptions identified in this research.

A Single Center Experience in Liver Resection and Ablative Techniques: An Analysis of Six Years.

Introduction: We present our 6-year experience with liver surgery and ablative techniques. Method: An observational retrospective analysis from a prospectively maintained database was performed in our department. All the patients with liver resection, liver resection combined with intraoperative ablative techniques and percutaneous ablative techniques were included from January 1st 2014 to December 31st 2020. Results: There were 249 patients analyzed: 273 patients with liver resection, 12 patients with liver resection combined with intraoperative MWA, 9 patients with open surgery MWA, 12 patients with percutaneous MWA, 1 patient with TACE and MWA, 1 patient with TACE and PEI, 10 patients with TACE, and 2 patients with PEI. Conclusion: Liver disease should be managed in specialized centers which can offer a wide range of therapeutic options. With the improvement of the surgical technique and perioperative care, including optimized postoperative complication management, and carried out by well-trained surgeons, liver surgery can be performed with low mortality and acceptable morbidity.

Triple Antioxidant Therapy, an Alternative for Patients with Chronic Liver Disease - A Prospective Multicenter Interventional Study.

Background: Non-alcoholic fatty liver disease (NAFLD) has increased exponentially in recent years in Western European countries, where the number of hepatitis of viral etiology has been declining, and it is thought to be the most common cause of chronic liver disease in the near future (1). Currently, NAFLD is both the second most common cause of hepatocellular carcinoma (HCC) and the second most common indication for liver transplantation (2-4). This problem is very serious, as cases of NAFLDs are increasingly in children, a population with a long life ahead, and in whom the disease has all the time to progress to cirrhosis and HCC (5, 6). Objectives: The goal of this prospective study is to determine the effect of an original formula consisting in silymarin, organic selenium and alpha lipoic acid, in reducing liver damage in patients with chronic liver disease. Material and methods: The study started in March 2018, initially with a group of patients from Bucharest, integrated in the study at St. Mary's Hospital. In October 2018 it was expanded at the national level to 1 718 patients, monitored by 145 investigating physicians from 134 centers, with an average of 11.8 patients per investigating physician. Outcomes: Taking each stage of fatty liver disease (FLD) at T0 moment (the beginning of the study), we observed that 25% of patients with grade I FLD had no sign of disease at the end of the study, 74% of those with grade II FLD recovered or improved their health, and 83% of patients with grade III FLD recovered or improved their health. There were 149 patients with no FLD detected at the end of the study (recovered). Conclusion: Based on triple antioxidant therapy, the original formula improved the evolution and prognosis of patients with chronic liver disease.

Very Early Onset Pancreatic Adenocarcinoma - Clinical Presentation, Risk Factors and Therapeutic Options.

Background: Pancreatic cancer (PC) is usually diagnosed in the 7th decade, but cases diagnosed in younger patients are associated with a greater disease burden, through the potential years of life lost. The aim of our study was to compare the differences in risk factors, clinical presentation and treatment options between patients diagnosed with pancreatic adenocarcinoma below 45 years of age (very early onset pancreatic adenocarcinoma - VEOPC), and those diagnosed over 45 years. Methods: A retrospective study has been conducted by registering in standardized Excel Worksheets all PC cases diagnosed in our tertiary referral center between 01.01.2015 and 31.12.2017. Only patients with a documented diagnosis of pancreatic adenocarcinoma (PDAC) were included in the statistical analysis that has been conducted using the NCSS v9 Statistical Software package. Categorical data have been compared using Chi2 test or Fisher Exact as appropriate, with a statistical significance p value 0.05. Results: There were 296 patients diagnosed with pancreatic solid tumors during the study period, 183 cases with documented histology: 80.87% PDAC, 17.5% neuroendocrine tumors, 2 cases of LMNH and 1 MANEC tumor. In our study group there were 24 patients (16.22%) with VEOPC. Family history of pancreatic neoplasia (33.3% vs 1.03%, p=0.0004) and alcohol consumption (42.86% vs 5.41%, p=0.01) were significantly more prevalent in young patients. Pain, as primary symptom, was reported at higher rates in patients with VEOPC (60% vs 22.94%, p=0.006). Tumors were more frequently located in the head of the pancreas in younger patients (56.52%) and in the body of the pancreas in older patients (52.07%, p=0.02). There was no significant difference in therapy or death rate during follow-up period between the two study groups, although patients diagnosed under 45 years were more frequently subjected to a radical resection (33.3% vs 22.69%). Conclusions: Our study has identified alcohol consumption and family history of pancreatic neoplasia as risk factors for VEOPC. Pain is the primary symptom at diagnosis in young patients with PDAC. In our cohort, therapeutic options do not differ significantly in PDAC patients with age of onset.

Surgical Treatment of a Mucinous Cystic Neoplasm in a Young Female Patient - A Case Report.

The major challenge in the evaluation of pancreatic cystic neoplasms is identifying lesions with malignant potential or signs of malignancy. Overall, the risk of malignancy in incidentally detected pancreatic cysts is low. Pancreatic cystic neoplasms with malignant potential are: serous cystic tumors (SCTs), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs) and solid pseudopapillary neoplasms (SPNs). The risk for developing malignancy is very low for SCTs, moderate to high in MCNs, solid pseudopapillary tumors and some IPMNs (up to 70 percent for main-duct IPMNs). We present a thirty-five years old female patient, without risk factors for the occurrence of pancreatic cancer was diagnosed via clinical examination and crosssectional imaging of the abdomen with a 7 cm cystic lesion located in the pancreatic body and tail, in the context of gastric outlet obstruction and upper abdominal pain with no improvement following conservative treatment. A distal pancreatectomy was thus performed, with favorable postoperative outcome. The histopathology examination described a non-invasive mucinous cystic neoplasm with low grade dysplasia. Many pancreatic cysts can be followed with surveillance imaging, through an algorithm which combines CT scan, MRI or endoscopic ultrasound. The decision to recommend surgery should take into account factors such as the patient's age and general health, the malignant risk of the specific lesion, potential complications and the suspicion for malignancy.

The Orientation of Gastric Biopsy Samples Improves the Inter-observer Agreement of the OLGA Staging System.

BACKGROUND AND AIMS: Evaluation of severity and extension of gastric atrophy and intestinal metaplasia is recommended to identify subjects with a high risk for gastric cancer. The inter-observer agreement for the assessment of gastric atrophy is reported to be low. The aim of the study was to evaluate the inter-observer agreement for the assessment of severity and extension of gastric atrophy using oriented and unoriented gastric biopsy samples. Furthermore, the quality of biopsy specimens in oriented and unoriented samples was analyzed. METHODS: A total of 35 subjects with dyspeptic symptoms addressed for gastrointestinal endoscopy that agreed to enter the study were prospectively enrolled. The OLGA/OLGIM gastric biopsies protocol was used. From each subject two sets of biopsies were obtained (four from the antrum, two oriented and two unoriented, two from the gastric incisure, one oriented and one unoriented, four from the gastric body, two oriented and two unoriented). The orientation of the biopsy samples was completed using nitrocellulose filters (Endokit®, BioOptica, Milan, Italy). The samples were blindly examined by two experienced pathologists. Inter-observer agreement was evaluated using kappa statistic for inter-rater agreement. The quality of histopathology specimens taking into account the identification of lamina propria was analyzed in oriented vs. unoriented samples. The samples with detectable lamina propria mucosae were defined as good quality specimens. Categorical data was analyzed using chi-square test and a two-sided p value <0.05 was considered statistically significant. RESULTS: A total of 350 biopsy samples were analyzed (175 oriented / 175 unoriented). The kappa index values for oriented/unoriented OLGA 0/I/II/III and IV stages have been 0.62/0.13, 0.70/0.20, 0.61/0.06, 0.62/0.46, and 0.77/0.50, respectively. For OLGIM 0/I/II/III stages the kappa index values for oriented/unoriented samples were 0.83/0.83, 0.88/0.89, 0.70/0.88 and 0.83/1, respectively. No case of OLGIM IV stage was found in the present case series. Good quality histopathology specimens were described in 95.43% of the oriented biopsy samples, and in 89.14% of the unoriented biopsy samples, respectively (p=0.0275). CONCLUSION: The orientation of gastric biopsies specimens improves the inter-observer agreement for the assessment of gastric atrophy.

Subtotal parathyroidectomy versus total parathyroidectomy with autotransplant in secondary hyperparathyroidism ­ a single-centre prospective cohort of 43 patients.

INTRODUCTION: The need for parathyroidectomy remains high in the group of patients on long-term dialysis with medically refractory secondary hyperparathyroidism (sHPT). We aim to compare the results after subtotal parathyroidectomies (sPtx) and total parathyroidectomies with autotransplant (tPtx + AT) performed for sHPT at a single referral centre. MATERIAL AND METHODS: This prospective study comparatively analysed sPtx and tPtx + AT performed in our department between February 2010 and December 2014. We followed-up both surgical techniques, with respect to the main clinical symptoms, laboratory data, mortality, and recurrent disease. RESULTS: Forty-three patients on whom we performed 26 sPtx and 19 tPtx + AT were entered in the study. There were no statistically significant differences between groups as far as demographic and preoperative clinical data are concerned. We did not encounter postoperative mortality in either of the groups. The follow-up period was significantly longer for the sPtx group (p = 0.04). The immediate postoperative serum calcium levels were significantly lower in the tPtx + AT group (p = 0.009). Definitive hypoparathyroidism was encountered in two patients in the sPtx group (8.3%) and in one from the tPtx + AT group (5.26%). Four patients from the sPtx group (16.6%) and three from the tPtx + AT group (15.78%) died during the follow-up due to causes unrelated to parathyroidectomy. Overall we had two recurrences in the sPtx group and none in the tPtx + AT group (p = 0.57). CONCLUSIONS: In our opinion both techniques have comparable results concerning the clinical and laboratory outcomes and rates of postoperative hypoparathyroidism, at least in short- and medium-term follow-up.

XRCC1 Arg194TRp and Arg399Gln Polymorphisms and Risk of Non-Hodgkin Lymphoma in a Romanian Population.

XRCC1 polymorphisms may alter the individual's capacity to repair DNA damages and may increase the risk for developing different types of cancer, including Non-Hodgkin Lymphoma (NHL). The purpose of our study was to investigate the association between XRCC1 Arg194Trp and Arg399Gln polymorphisms and risk of NHL, in a case-control study consisted of 81 patients with NHL and 113 healthy controls. The polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) methods were performed to determine the XRCC1 genotypes. A statistically significant association was observed between the XRCC1 Arg194Trp polymorphism and risk of NHL (p < 0.0001, OR = 7.01, 95% CI = 2.488-19.753) in both male and female. We found no association between NHL and control groups with respect to XRCC1 Arg399Gln polymorphism (p = 0.4867, OR = 1.346, 95% CI = 0.5822-3.111). Also, we did not find differences between the XRCC1 polymorphisms and NHL risk taking into account the IPI score, ECOG performance status, Ann Arbor stage and the treatment outcome (p > 0.05, for all comparisons). Our results suggested an increased risk for NHL regarding the XRCC1 Arg194Trp polymorphism in a Romania population, while XRCC1 Arg399Gln polymorphism is not associated with NHL. Further work is needed to validate these results on a larger sample study.