Explore the vast range of titles available.

Observational studies report reduced colorectal cancer in regular aspirin consumers. Randomised controlled trials have shown reduced risk of adenomas but none have employed prevention of colorectal cancer as a primary endpoint. The CAPP2 trial aimed to investigate the antineoplastic effects of aspirin and a resistant starch in carriers of Lynch syndrome, the major form of hereditary colorectal cancer; we now report long-term follow-up of participants randomly assigned to aspirin or placebo. In the CAPP2 randomised trial, carriers of Lynch syndrome were randomly assigned in a two-by-two factorial design to 600 mg aspirin or aspirin placebo or 30 g resistant starch or starch placebo, for up to 4 years. Randomisation was in blocks of 16 with provision for optional single-agent randomisation and extended postintervention double-blind follow-up; participants and investigators were masked to treatment allocation. The primary endpoint was development of colorectal cancer. Analysis was by intention to treat and per protocol. This trial is registered, ISRCTN59521990. 861 participants were randomly assigned to aspirin or aspirin placebo. At a mean follow-up of 55·7 months, 48 participants had developed 53 primary colorectal cancers (18 of 427 randomly assigned to aspirin, 30 of 434 to aspirin placebo). Intention-to-treat analysis of time to first colorectal cancer showed a hazard ratio (HR) of 0·63 (95% CI 0·35–1·13, p=0·12). Poisson regression taking account of multiple primary events gave an incidence rate ratio (IRR) of 0·56 (95% CI 0·32–0·99, p=0·05). For participants completing 2 years of intervention (258 aspirin, 250 aspirin placebo), per-protocol analysis yielded an HR of 0·41 (0·19–0·86, p=0·02) and an IRR of 0·37 (0·18–0·78, p=0·008). No data for adverse events were available postintervention; during the intervention, adverse events did not differ between aspirin and placebo groups. 600 mg aspirin per day for a mean of 25 months substantially reduced cancer incidence after 55·7 months in carriers of hereditary colorectal cancer. Further studies are needed to establish the optimum dose and duration of aspirin treatment. European Union; Cancer Research UK; Bayer Corporation; National Starch and Chemical Co; UK Medical Research Council; Newcastle Hospitals trustees; Cancer Council of Victoria Australia; THRIPP South Africa; The Finnish Cancer Foundation; SIAK Switzerland; Bayer Pharma.

To evaluate the safety and effectiveness of an absorbable modified polymer starch powder hemostat (AMP-SPH) compared with standard care to control hemostasis when used in adult subjects during open or laparoscopic gynecological procedures for both benign and malignant diseases. Methods: Prospective, multi-center, randomized, and interventional phase IV study conducted on consecutive patients, aged ≥18 years, who underwent an open or laparoscopic gynecological procedure between November 2015 and July 2017 in a third-level Hospital. Study participants were randomly assigned (1:1) to receive either treatment with an AMP-SPH (AMP group) or usual standard care (SC group). The hemostatic treatment administered to the SC group was at the investigator's discretion. The primary effectiveness endpoint of the study was the achievement of hemostasis (yes/no) within 10 minutes. Results: Ninety patients, 44 (48.9%) in the AMP group and 46 (51.1%) in the SC group were included in the analysis. the AMP group, 97.7% (43/44) of patients achieved hemostasis as compared to the 93.5% (43/46) of subjects in the SC group (mean difference: 4.2%; 95%CI: -4.1% to 12.6%; p = .337). The time required to achieve hemostasis was lower in the AMP group (1.91 ± 1.15 minutes) than in the SC group (2.28 ± 2.09 minutes), although not significant (p = .309). A higher proportion of patients in the SC group (17.9%) was observed to require blood products compared to those in the AMP group (4.8%).A total of 29 adverse events (AEs) (24 non-serious and 5 serious AEs) were reported, 12 AEs in the AMP group and 17 in the SC group. According to the results of this study, AMP-SPH was not inferior to standard care in the control of bleeding for patients undergoing gynecology procedures and the cessation of bleeding was trending to be faster with the use of AMP-SPH than with standard methods. ClinicalTrials.gov NCT02835391.

Production of trimethylamine-N-oxide (TMAO), a biomarker of CVD risk, is dependent on intestinal microbiota, but little is known of dietary conditions promoting changes in gut microbial communities. Resistant starches (RS) alter the human microbiota. We sought to determine whether diets varying in RS and carbohydrate (CHO) content affect plasma TMAO levels. We also assessed postprandial glucose and insulin responses and plasma lipid changes to diets high and low in RS. In a cross-over trial, fifty-two men and women consumed a 2-week baseline diet (41 percentage of energy (%E) CHO, 40 % fat, 19 % protein), followed by 2-week high- and low-RS diets separated by 2-week washouts. RS diets were assigned at random within the context of higher (51–53 %E) v. lower CHO (39–40 %E) intake. Measurements were obtained in the fasting state and, for glucose and insulin, during a meal test matching the composition of the assigned diet. With lower CHO intake, plasma TMAO, carnitine, betaine and γ-butyrobetaine concentrations were higher after the high- v. low-RS diet (P<0·01 each). These metabolites were not differentially affected by high v. low RS when CHO intake was high. Although the high-RS meal reduced postprandial insulin and glucose responses when CHO intake was low (P<0·01 each), RS did not affect fasting lipids, lipoproteins, glucose or insulin irrespective of dietary CHO content. In conclusion, a lower-CHO diet high in RS was associated with higher plasma TMAO levels. These findings, together with the absence of change in fasting lipids, suggest that short-term high-RS diets do not improve markers of cardiometabolic health.

Hydroxyethyl starch (HES) [corrected] is widely used for fluid resuscitation in intensive care units (ICUs), but its safety and efficacy have not been established in patients with severe sepsis. In this multicenter, parallel-group, blinded trial, we randomly assigned patients with severe sepsis to fluid resuscitation in the ICU with either 6% HES 130/0.42 (Tetraspan) or Ringer's acetate at a dose of up to 33 ml per kilogram of ideal body weight per day. The primary outcome measure was either death or end-stage kidney failure (dependence on dialysis) at 90 days after randomization. Of the 804 patients who underwent randomization, 798 were included in the modified intention-to-treat population. The two intervention groups had similar baseline characteristics. At 90 days after randomization, 201 of 398 patients (51%) assigned to HES 130/0.42 had died, as compared with 172 of 400 patients (43%) assigned to Ringer's acetate (relative risk, 1.17; 95% confidence interval [CI], 1.01 to 1.36; P=0.03); 1 patient in each group had end-stage kidney failure. In the 90-day period, 87 patients (22%) assigned to HES 130/0.42 were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer's acetate (relative risk, 1.35; 95% CI, 1.01 to 1.80; P=0.04), and 38 patients (10%) and 25 patients (6%), respectively, had severe bleeding (relative risk, 1.52; 95% CI, 0.94 to 2.48; P=0.09). The results were supported by multivariate analyses, with adjustment for known risk factors for death or acute kidney injury at baseline. Patients with severe sepsis assigned to fluid resuscitation with HES 130/0.42 had an increased risk of death at day 90 and were more likely to require renal-replacement therapy, as compared with those receiving Ringer's acetate. (Funded by the Danish Research Council and others; 6S ClinicalTrials.gov number, NCT00962156.).

This trial tested the influence of aspirin or resistant starch on the incidence of colorectal cancer or colonic adenomas in patients with the Lynch syndrome (hereditary nonpolyposis colon cancer). Neither intervention influenced the incidence of colorectal neoplasms in the Lynch syndrome. Neither aspirin or resistant starch influenced the incidence of colorectal neoplasms in the Lynch syndrome. The regular use of aspirin or aspirin-like agents is associated with a moderate reduction in the risk of colonic polyps and colorectal cancer. 1 – 4 Randomized trials of high-fiber diets have not shown a reduction in the risk of adenomas or colorectal cancer, 5 but none have investigated the effects of resistant starch. There is epidemiologic evidence of a negative correlation between colon cancer and starch intake. 6 Resistant starches escape digestion in the upper gut; colonic fermentation yields short-chain fatty acids, including butyrate, which has antineoplastic properties. 7 In carcinogen-treated rats, resistant starch reduces the development of intestinal tumors 8 , 9 and the production . . .

Objective There is no pharmacological treatment for oropharyngeal dysphagia (OD). The aim of this study was to compare the therapeutic effect of stimulation of oropharyngeal transient receptor potential vanilloid type 1 (TRPV1) with that of thickeners in older patients with OD. Design A clinical videofluoroscopic non-randomised study was performed to assess the signs of safety and efficacy of swallow and the swallow response in (1) 33 patients with OD (75.94±1.88 years) while swallowing 5, 10 and 20 ml of liquid (20.4 mPa.s), nectar (274.4 mPa.s), and pudding (3930 mPa.s) boluses; (2) 33 patients with OD (73.94±2.23 years) while swallowing 5, 10 and 20 ml nectar boluses, and two series of nectar boluses with 150 μM capsaicinoids and (3) 8 older controls (76.88±1.51 years) while swallowing 5, 10 and 20 ml nectar boluses. Results Increasing bolus viscosity reduced the prevalence of laryngeal penetrations by 72.03% (p<0.05), increased pharyngeal residue by 41.37% (p<0.05), delayed the upper esophageal sphincter opening time and the larynx movement and did not affect the laryngeal vestibule closure time and maximal hyoid displacement. Treatment with capsaicinoids reduced both, penetrations by 50.% (p<0.05) and pharyngeal residue by 50.% (p<0.05), and shortened the time of laryngeal vestibule closure (p<0.001), upper esophageal sphincter opening (p<0.05) and maximal hyoid and laryngeal displacement. Conclusion Stimulation of TRPV1 by capsaicinoids strongly improved safety and efficacy of swallow and shortened the swallow response in older patients with OD. Stimulation of TRPV1 might become a pharmacologic strategy to treat OD.

Observational studies report that higher intake of dietary fibre (a heterogeneous mix including non-starch polysaccharides and resistant starches) is associated with reduced risk of colorectal cancer, but no randomised trials with prevention of colorectal cancer as a primary endpoint have been done. We assessed the effect of resistant starch on the incidence of colorectal cancer. In the CAPP2 study, individuals with Lynch syndrome were randomly assigned in a two-by-two factorial design to receive 600 mg aspirin or aspirin placebo or 30 g resistant starch or starch placebo, for up to 4 years. Randomisation was done with a block size of 16. Post-intervention, patients entered into double-blind follow-up; participants and investigators were masked to treatment allocation. The primary endpoint for this analysis was development of colorectal cancer in participants randomly assigned to resistant starch or resistant-starch placebo with both intention-to-treat and per-protocol analyses. This study is registered, ISRCTN 59521990. 463 patients were randomly assigned to receive resistant starch and 455 to receive resistant-starch placebo. At a median follow-up 52·7 months (IQR 28·9–78·4), 53 participants developed 61 primary colorectal cancers (27 of 463 participants randomly assigned to resistant starch, 26 of 455 participants assigned to resistant-starch placebo). Intention-to-treat analysis of time to first colorectal cancer showed a hazard ratio (HR) of 1·40 (95% CI 0·78–2·56; p=0·26) and Poisson regression accounting for multiple primary events gave an incidence rate ratio (IRR) of 1·15 (95% CI 0·66–2·00; p=0·61). For those completing 2 years of intervention, per-protocol analysis yielded a HR of 1·09 (0·55–2·19, p=0·80) and an IRR of 0·98 (0·51–1·88, p=0·95). No information on adverse events was gathered during post-intervention follow-up. Resistant starch had no detectable effect on cancer development in carriers of hereditary colorectal cancer. Dietary supplementation with resistant starch does not emulate the apparently protective effect of diets rich in dietary fibre against colorectal cancer. European Union, Cancer Research UK, Bayer Corporation, National Starch and Chemical Co, UK Medical Research Council, Newcastle Hospitals Trustees, Cancer Council of Victoria Australia, THRIPP South Africa, The Finnish Cancer Foundation, SIAK Switzerland, and Bayer Pharma.

Optimal glucose control and fluid resuscitation in patients with septic shock remain a challenge. In this study involving more than 500 patients, the potential benefit of maintaining euglycemia through intensive insulin therapy and optimal fluid resuscitation with either pentastarch or Ringer's lactate was assessed. There was no benefit in the intensive-therapy group with respect to either 28-day survival or organ function; there was more severe hypoglycemia in the intensive-therapy group and more acute renal failure in the pentastarch group. The potential benefit of maintaining euglycemia through intensive insulin therapy and optimal fluid resuscitation was assessed. There was no benefit in the intensive-therapy group with respect to either 28-day survival or organ function. In a study by Van den Berghe et al. involving critically ill surgical patients, intensive insulin therapy to maintain euglycemia (glucose level, 80 to 110 mg per deciliter [4.4 to 6.1 mmol per liter]) lowered in-hospital mortality from 10.9% to 7.2%, mostly by reducing deaths from multiple organ failure with a proven septic focus. 1 This beneficial effect occurred predominantly in cardiac surgical patients who received high glucose challenges immediately after surgery (8 to 12 g of glucose intravenously per hour) and was associated with an unusually high rate of death (5.1%) among controls. Furthermore, in a follow-up study by Van . . .

Background In Asia, axillary hyperhidrosis is a frequent problem for many people, and the consequent excessive sweating can seriously affect many aspects of daily life and even lead to mental disorders. Microwave therapy is a new, non‐invasive treatment method for axillary hyperhidrosis, whose energy and long‐term effectiveness still needs to be clinically validated. Objective The aim of this study was to evaluate the clinical efficacy, safety, histological changes, and psychological status of microwave devices in the treatment of axillary hyperhidrosis and osmidrosis. Method We conducted a prospective self‐controlled study in a top‐tier Chinese hospital. After a 5/5 energy treatment session, a skin biopsy was taken to observe histological changes both before and after treatment. An iodine starch test was used to determine the sweating range. We evaluated symptoms of improved efficacy using the Hyperhidrosis Disease Severity Scale (HDSS) and assessed changes in life status with the DLQI. In the case of concurrent underarm odor, odor‐5, VAS, and Young‐Jin Park grading were used to assess odor relief. The effect of odor on psychology was assessed by using a psychological status symptom checklist (scl‐90). The study period was 1 year. Results We observed 20 patients in this study. Of those, 90% met the primary treatment endpoint of a decrease in axillary hyperhidrosis symptomatology to below grade 2 on the HDSS score (p < 0.001). Furthermore, 75% of patients achieved a treatment endpoint of at least 50% reduction in VAS (p < 0.001). 70% of patients achieved a treatment endpoint of at least 50% reduction in odor‐5 (p < 0.001). The iodine starch test showed that the region decreased 99% from the baseline to 12 months after follow‐up had ended (p < 0.001). Eight patients volunteered to undergo histological examination; their average light density of immunohistochemistry decreased from 1.04 (0.4–2.11) to 0.07 (0.04–0.46; p < 0.05). The immunohistochemical positive number for sweat glands was initially 104 (59.75–132.5) but was 41.5 (29.75–62) after the procedure. None of the patients experienced any serious adverse reactions. Conclusion The treatment demonstrated high effectiveness, safety, and short‐lived adverse reactions.

PurposeLow intake of dietary fibre is associated with the development of type 2 diabetes. Dyslipidaemia plays a key role in the pathogenesis of type 2 diabetes. Knowledge of the impact of dietary fibres on postprandial lipaemia is, however, sparse. This study aimed in subjects with metabolic syndrome to assess the impact on postprandial lipaemia and features of the metabolic syndrome of a healthy carbohydrate diet (HCD) rich in cereal fibre, arabinoxylan and resistant starch compared to a refined-carbohydrate western-style diet (WSD).MethodsNineteen subjects completed the randomised, crossover study with HCD and WCD for 4-week. Postprandial metabolism was evaluated by a meal-challenge test and insulin sensitivity was assessed by HOMA-IR and Matsuda index. Furthermore, fasting cholesterols, serum-fructosamine, circulating inflammatory markers, ambulatory blood pressure and intrahepatic lipid content were measured.ResultsWe found no diet effects on postprandial lipaemia. However, there was a significant diet × statin interaction on total cholesterol (P = 0.02) and LDL cholesterol (P = 0.002). HCD decreased total cholesterol (−0.72 mmol/l, 95% CI (−1.29; −0.14) P = 0.03) and LDL cholesterol (−0.61 mmol/l, 95% CI (−0.86; −0.36) P = 0.002) compared with WSD in subjects on but not without statin treatment. We detected no other significant diet effects.ConclusionsIn subjects with metabolic syndrome on statins a 4-week diet rich in arabinoxylan and resistant starch improved fasting LDL and total cholesterol compared to subjects not being on statins. However, we observed no diet related impact on postprandial lipaemia or features of the metabolic syndrome. The dietary fibre x statin interaction deserves further elucidation.