Publications by authors named "Andrew Renwick"

35 Publications

The potential developmental neurotoxicity of calcium cyclamate in CD rats.

Food Chem Toxicol 2021 Jul 30;153:112236. Epub 2021 Apr 30.

The Coca-Cola Company, GA, USA.

The developmental neurotoxicity of calcium cyclamate was evaluated in Sprague Dawley [Crl:CD(SD)] rats, administered in drinking water, in comparison to a concurrent control group (water) and a positive control group given propylthiouracil (PTU). Calcium cyclamate was administered to F0 females for 4 weeks prior to pairing, throughout mating, gestation and lactation and to F1 offspring from weaning to 12 weeks of age, PTU was administered by gavage to F0 females from Day 6 of gestation up to Day 20 of lactation. Target calcium cyclamate doses were 0, 250, 500 and 1,000 mg/kg bw/day, while the PTU dose was 0.5 mg/kg bw/day. No treatment-related effects of cyclamate were observed in either the F0 or F1 generations on reproductive performance or neurobehavioral development. In comparison, PTU exposure resulted in developmental delays, memory impairment and a number of neuropathological and morphometric outcomes. The results from the unique developmental neurotoxicity study design, corroborate the absence of hyperactivity and any other neurotoxic effects following cyclamate administration at levels up to 878 mg/kg bw/day in F0 females and 784 mg/kg bw/day in F1 animals. This demonstrates the suitability of PTU as a positive control and confirms the safe use of cyclamate as a no-calorie sweetener.
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http://dx.doi.org/10.1016/j.fct.2021.112236DOI Listing
July 2021

Re: Bacteriological study in perianal abscess is not useful and not cost-effective.

ANZ J Surg 2017 05;87(5):420-421

Department of General Surgery, Royal Alexandra Hospital, Paisley, UK.

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http://dx.doi.org/10.1111/ans.13878DOI Listing
May 2017

Analysis of lesion localisation at colonoscopy: outcomes from a multi-centre U.K. study.

Surg Endosc 2017 07 8;31(7):2959-2967. Epub 2016 Nov 8.

Department of Surgery, Royal Alexandra Hospital, Corsebar Road, Paisley, PA2 9PN, Scotland, UK.

Background: Colonoscopy is currently the gold standard for detection of colorectal lesions, but may be limited in anatomically localising lesions. This audit aimed to determine the accuracy of colonoscopy lesion localisation, any subsequent changes in surgical management and any potentially influencing factors.

Methods: Patients undergoing colonoscopy prior to elective curative surgery for colorectal lesion/s were included from 8 registered U.K. sites (2012-2014). Three sets of data were recorded: patient factors (age, sex, BMI, screener vs. symptomatic, previous abdominal surgery); colonoscopy factors (caecal intubation, scope guide used, colonoscopist accreditation) and imaging modality. Lesion localisation was standardised with intra-operative location taken as the gold standard. Changes to surgical management were recorded.

Results: 364 cases were included; majority of lesions were colonic, solitary, malignant and in symptomatic referrals. 82% patients had their lesion/s correctly located at colonoscopy. Pre-operative CT visualised lesion/s in only 73% of cases with a reduction in screening patients (64 vs. 77%; p = 0.008). 5.2% incorrectly located cases at colonoscopy underwent altered surgical management, including conversion to open. Univariate analysis found colonoscopy accreditation, scope guide use, incomplete colonoscopy and previous abdominal surgery significantly influenced lesion localisation. On multi-variate analysis, caecal intubation and scope guide use remained significant (HR 0.35, 0.20-0.60 95% CI and 0.47; 0.25-0.88, respectively).

Conclusion: Lesion localisation at colonoscopy is incorrect in 18% of cases leading to potentially significant surgical management alterations. As part of accreditation, colonoscopists need lesion localisation training and awareness of when inaccuracies can occur.
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http://dx.doi.org/10.1007/s00464-016-5313-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5487844PMC
July 2017

A Letter to the Editor.

Ann Surg 2018 02;267(2):e39

Department of General Surgery, Royal Alexandra Hospital, Paisley, Greater Glasgow and Clyde NHS Trust, Glasgow, Scotland, UK.

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http://dx.doi.org/10.1097/SLA.0000000000002052DOI Listing
February 2018

Biological fate of low-calorie sweeteners.

Nutr Rev 2016 11;74(11):670-689

B.A. Magnuson is with Health Science Consultants, Inc, Mississauga, Ontario, Canada. M.C. Carakostas is with MC Scientific Consulting, LLC, Dataw Island, South Carolina, USA. N.H. Moore is with Veritox, Inc, Redmond, Washington, USA. S.P. Poulos is with the Calorie Control Council, Atlanta, Georgia, USA. A.G. Renwick is with the Faculty of Medicine, University of Southampton, Southampton, United Kingdom.

With continued efforts to find solutions to rising rates of obesity and diabetes, there is increased interest in the potential health benefits of the use of low- and no-calorie sweeteners (LNCSs). Concerns about safety often deter the use of LNCSs as a tool in helping control caloric intake, even though the safety of LNCS use has been affirmed by regulatory agencies worldwide. In many cases, an understanding of the biological fate of the different LNSCs can help health professionals to address safety concerns. The objectives of this review are to compare the similarities and differences in the chemistry, regulatory status, and biological fate (including absorption, distribution, metabolism, and excretion) of the commonly used LNCSs: acesulfame potassium, aspartame, saccharin, stevia leaf extract (steviol glycoside), and sucralose. Understanding the biological fate of the different LNCSs is helpful in evaluating whether reports of biological effects in animal studies or in humans are indicative of possible safety concerns. Illustrations of the usefulness of this information to address questions about LNCSs include discussion of systemic exposure to LNCSs, the use of sweetener combinations, and the potential for effects of LNCSs on the gut microflora.
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http://dx.doi.org/10.1093/nutrit/nuw032DOI Listing
November 2016

Chemical-specific adjustment factors (inter-species toxicokinetics) to establish the ADI for steviol glycosides.

Regul Toxicol Pharmacol 2016 Aug 13;79:91-102. Epub 2016 May 13.

ToxStrategies, Inc., 2 Reeve Crt #200, St. Helena Island, SC, 29920, USA.

The acceptable daily intake (ADI) of commercially available steviol glycosides is currently 0-4 mg/kg body weight (bw)/day, based on application of a 100-fold uncertainty factor to a no-observed-adverse-effect-level value from a chronic rat study. Within the 100-fold uncertainty factor is a 10-fold uncertainty factor to account for inter-species differences in toxicokinetics (4-fold) and toxicodynamics (2.5-fold). Single dose pharmacokinetics of stevioside were studied in rats (40 and 1000 mg/kg bw) and in male human subjects (40 mg/kg bw) to generate a chemical-specific, inter-species toxicokinetic adjustment factor. Tmax values for steviol were at ∼8 and ∼20 h after administration in rats and humans, respectively. Peak concentrations of steviol were similar in rats and humans, while steviol glucuronide concentrations were significantly higher in humans. Glucuronidation in rats was not saturated over the dose range 40-1000 mg/kg bw. The AUC0-last for steviol was approximately 2.8-fold greater in humans compared to rats. Chemical-specific adjustment factors for extrapolating toxicokinetics from rat to human of 1 and 2.8 were established based on Cmax and AUC0-last data respectively. Because these factors are lower than the default value of 4.0, a higher ADI for steviol glycosides of between 6 and 16 mg/kg bw/d is justified.
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http://dx.doi.org/10.1016/j.yrtph.2016.05.017DOI Listing
August 2016

Early experience of a virtual journal club.

Clin Teach 2015 Dec 27;12(6):389-93. Epub 2015 May 27.

Department of General Surgery, Royal Alexandra Hospital, Paisley, UK.

Background: Traditional journal club models based on didactic presentation sessions followed by group discussion have many limitations. To overcome some of these shortcomings, a virtual journal club (VJC) using social media and e-mail was developed. The aim of this study was to report the initial experience of this novel multimodal e-learning platform to facilitate journal club discussion and promote the development of critical appraisal skills.

Methods: Journal articles were discussed monthly via e-mail and social media. After a 3-week period of discussion, all comments were collated and group-generated critical appraisal summaries were fed back to participants. In addition, letters to the journal editors based on the group appraisal were submitted. A questionnaire survey to evaluate the VJC concept was also conducted.

Findings: After eight cycles of the VJC, the mean trainee participation rate was 29.6 per cent (range 21.1-42.1%). Senior trainees (≥4 years of postgraduate experience) were more likely to participate than more junior trainees (75.0 versus 21.1%; p = 0.005). The majority of participants thought that the VJC was educationally valuable, easy to participate in, helpful in keeping up to date with recent papers and useful in developing critical appraisal skills. Barriers to participation were lack of time, motivation and lack of experience in critical appraisal. In addition, the group-generated critical appraisal summaries derived from VJC discussions led to eight published 'letters to the editor'. Traditional journal club models based on didactic presentation sessions followed by group discussion have many limitations

Conclusion: This novel VJC model is a feasible and popular method of delivering a journal club in the postgraduate setting.
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http://dx.doi.org/10.1111/tct.12357DOI Listing
December 2015

Re: risk factors for umbilical trocar site incisional hernia in laparoscopic cholecystectomy: a prospective 3-year follow-up study.

Am J Surg 2015 Feb 29;209(2):424-5. Epub 2014 Jul 29.

Department of General Surgery, Royal Alexandra Hospital, Corsebar Road, Paisley, Scotland PA2 9PN, UK.

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http://dx.doi.org/10.1016/j.amjsurg.2014.02.016DOI Listing
February 2015

Surgical Ward Round Quality and Impact on Variable Patient Outcomes.

Ann Surg 2015 Dec;262(6):e105

Department of General Surgery Royal Alexandra Hospital Paisley, Scotland, United Kingdom.

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http://dx.doi.org/10.1097/SLA.0000000000000779DOI Listing
December 2015

Salmonellosis as a differential diagnosis.

BMJ Case Rep 2012 Nov 9;2012. Epub 2012 Nov 9.

Department of General Surgery, Royal Alexandra Hospital, Paisley, UK.

With a low incidence of Salmonella infection, salmonellosis is an uncommon problem in Scotland. It occurs in both immune-compromised and immune-competent patients. We present two cases of salmonellosis in immune-competent patients who had had a history of gastroenteritis. Diagnosis was delayed in one patient; however, both patients received appropriate treatment and made good recovery following their respective illnesses. Apart from acting as a reminder to consider salmonellosis as a differential diagnosis when managing patients with infective process, the cases also highlight the importance of concise history taking, and the importance of cultures-and-sensitivities in managing infectious cases.
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http://dx.doi.org/10.1136/bcr-2012-007219DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4544314PMC
November 2012

A proposal for an upper limit of leucine safe intake in healthy adults.

J Nutr 2012 Dec 24;142(12):2249S-2250S. Epub 2012 Oct 24.

Clinical Chemistry Laboratory, Cochin and Hôtel-Dieu Hospitals, AP-HP, Paris, France.

Based on recent research, an upper limit of safe intake (ULSI) for leucine is proposed for healthy adults: 0.53 g/(kg·d). Because leucine has been used as a dietary supplement for many years in people practicing exercise and sport, further study with long-term exposure to leucine in this specific subpopulation should be performed to eventually adjust the ULSI.
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http://dx.doi.org/10.3945/jn.112.160853DOI Listing
December 2012

Sweet-taste receptors, low-energy sweeteners, glucose absorption and insulin release.

Br J Nutr 2010 Nov 12;104(10):1415-20. Epub 2010 Jul 12.

School of Medicine, University of Southampton, Southampton SO17 1BJ, UK.

The present review explores the interactions between sweeteners and enteroendocrine cells, and consequences for glucose absorption and insulin release. A combination of in vitro, in situ, molecular biology and clinical studies has formed the basis of our knowledge about the taste receptor proteins in the glucose-sensing enteroendocrine cells and the secretion of incretins by these cells. Low-energy (intense) sweeteners have been used as tools to define the role of intestinal sweet-taste receptors in glucose absorption. Recent studies using animal and human cell lines and knockout mice have shown that low-energy sweeteners can stimulate intestinal enteroendocrine cells to release glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. These studies have given rise to major speculations that the ingestion of food and beverages containing low-energy sweeteners may act via these intestinal mechanisms to increase obesity and the metabolic syndrome due to a loss of equilibrium between taste receptor activation, nutrient assimilation and appetite. However, data from numerous publications on the effects of low-energy sweeteners on appetite, insulin and glucose levels, food intake and body weight have shown that there is no consistent evidence that low-energy sweeteners increase appetite or subsequent food intake, cause insulin release or affect blood pressure in normal subjects. Thus, the data from extensive in vivo studies in human subjects show that low-energy sweeteners do not have any of the adverse effects predicted by in vitro, in situ or knockout studies in animals.
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http://dx.doi.org/10.1017/S0007114510002540DOI Listing
November 2010

Using urinary solubility data to estimate the level of safety concern of low levels of melamine (MEL) and cyanuric acid (CYA) present simultaneously in infant formulas.

Regul Toxicol Pharmacol 2010 Jul-Aug;57(2-3):247-55. Epub 2010 Mar 15.

Nestlé Research Center, Lausanne, Switzerland.

Melamine (MEL) and cyanuric acid (CYA) may occur simultaneously in milk products. There is no health based guidance value for the mixture of MEL+CYA. Limited toxicological data indicate that MEL+CYA toxicity occurs at levels lower than the toxic doses of the single compounds. The key adverse effect of MEL+CYA is the formation of crystals in the urinary tract, which is dependent on the solubility of the MEL+CYA complex. Urinary concentrations resulting from oral doses of MEL+CYA and MEL alone have been calculated from published data from animal studies. A human exposure scenario assuming consumption of infant formula contaminated at a level of 1 ppm of MEL and CYA each (2 ppm of MEL+CYA) was also analyzed. Margins of more than two orders or magnitude were observed between estimated urine concentrations known to be without detectable effects in rats and calculated human urine concentrations. Because the hazard is related to the physico-chemical characteristics of the mixture, there would be a negligible concern associated with crystal formation if the urinary concentration of the complex is within the solubility range. The solubility of MEL+CYA was higher in urine than in water. A strong pH-dependency was observed with the lowest solubility found at pH 5-5.5. The calculated human urinary concentration was about 30 times less than the solubility limit for MEL+CYA in adult human urine. Altogether, these data provide preliminary evidence suggesting that the presence of 1 ppm of MEL and CYA each in infant formula is unlikely to be of significant health concern.
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http://dx.doi.org/10.1016/j.yrtph.2010.03.002DOI Listing
September 2010

Application of the Margin of Exposure (MOE) approach to substances in food that are genotoxic and carcinogenic.

Food Chem Toxicol 2010 Jan;48 Suppl 1:S2-24

Food Standards Agency, UK.

This paper presents the work of an expert group established by the International Life Sciences Institute - European branch (ILSI Europe) to follow up the recommendations of an international conference on "Risk Assessment of Compounds that are both Genotoxic and Carcinogenic: New Approaches". Twelve genotoxic and carcinogenic chemicals that can be present in food were selected for calculation of a Margin of Exposure (MOE) between a point of departure on the dose-response for oral carcinogenicity in animal studies and estimates of human dietary exposure. The MOE can be used to support prioritisation of risk management action and, if the MOE is very large, on communication of a low level of human health concern. Depending on the approaches taken in determining the point of departure and the estimation of exposure, it is possible to derive very different values for the MOE. It is therefore essential that the selection of the cancer endpoint and mathematical treatment of the data are clearly described and justified if the results of the MOE approach are to be trusted and of value to risk managers. An outline framework for calculating an MOE is proposed in order to help to ensure transparency in the results.
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http://dx.doi.org/10.1016/j.fct.2009.11.003DOI Listing
January 2010

Application of the margin of exposure (MoE) approach to substances in food that are genotoxic and carcinogenic - example: 1-methylcyclopropene and its impurities (1-chloro-2-methylpropene and 3-chloro-2-methylpropene).

Food Chem Toxicol 2010 Jan 26;48 Suppl 1:S81-8. Epub 2009 Sep 26.

University of Southampton, UK.

The chlorinated impurities of 1-methylcyclopropene possess weak mutagenicity and are carcinogenic in rodent bioassays. Dose-response modelling of the data for 1-chloro-2-methylpropene gave a BMDL10 for nasal carcinomas in male rats of 11 mg/kg-bw/day (after correction for the 5 days/week dosage schedule). No human exposure data are available and theoretical estimates had to be used to calculate the MoE. The MoEs ranged from 40,000 to 100,000,000 depending on the assumptions used in the exposure estimation.
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http://dx.doi.org/10.1016/j.fct.2009.09.024DOI Listing
January 2010

Application of the margin of exposure (MOE) approach to substances in food that are genotoxic and carcinogenic. Example: leucomalachite green.

Food Chem Toxicol 2010 Jan 26;48 Suppl 1:S75-80. Epub 2009 Sep 26.

University of Southampton, UK.

Leucomalachite green (LMG) is mutagenic and produces DNA-adducts in vivo, and is carcinogenic in rodent bioassays. Dose-response modelling of the data for hepatocellular adenomas and carcinomas in female mice gave a BMDL10 of 20 mg/kg-bw/day. Limited data are available on the concentrations present in fish for human consumption. Human exposure estimates assumed that all consumed fish is contaminated with LMG. The calculated MoEs were 4,000,000 and 400,000 respectively for average and high exposure estimates.
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http://dx.doi.org/10.1016/j.fct.2009.09.025DOI Listing
January 2010

The importance of tumor stage and relative survival analysis for the association between sex and survival after resection of colorectal cancer.

Ann Surg 2009 Mar;249(3):402-8

Department of Colorectal Surgery, Concord Hospital and The Discipline of Surgery, The University of Sydney, Sydney, New South Wales, Australia.

Objective: The aim of this study was to determine whether the previously noted poorer survival of men after resection of colorectal cancer varied among clinicopathological tumor stages.

Summary Background Data: The question of whether sex is independently associated with prognosis after resection of colorectal cancer has been examined in numerous studies over the past 2 decades, but with conflicting results.

Methods: Data on 3,301 patients were drawn from a comprehensive, prospective hospital registry of all resections for colorectal cancer performed between January 1971 and December 2005. Statistical analysis employed Kaplan Meier estimation and relative survival analysis to adjust for differential male/female life expectancy in the general population.

Results: The relative survival of males was significantly less than that of females (P = 0.004) only in stage B. This was not accounted for by other negative pathology features and cause of death did not differ significantly between males and females. However, men with stage B tumor were more likely than women to experience postoperative morbidity, particularly a respiratory complication or a surgical complication requiring urgent reoperation. The sex difference in relative survival persisted among patients who had either a respiratory complication or an urgent reoperation (P = 0.003) but disappeared among those who had neither (P = 0.193).

Conclusion: The poorer survival of men with stage B tumor was attributable to their greater postoperative morbidity which led to the earlier death of some due to causes unrelated to their colorectal cancer.
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http://dx.doi.org/10.1097/SLA.0b013e31819a0469DOI Listing
March 2009

The 7th workshop on the assessment of adequate intake of dietary amino acids: summary of general discussion.

J Nutr 2008 Oct;138(10):2050S-2205S

Ajinomoto Co., Inc., Quality Assurance and External Scientific Affairs Department, 104-8315 Tokyo, Japan.

Extensive discussion sessions were held at the end of each of the 2 d of the workshop. Through the course of the workshop, it became clear that there were different opinions on how to use uncertainty factors to obtain upper levels of intake from no observed adverse effect levels of a particular nutrient and that the selection of an appropriate uncertainty factor would be rather arbitrary. Much of the discussion centered around the potential for using metabolic limits, expressed as the level of intake at which the major pathway of metabolism may approach saturation and at which the amino acid is metabolized by alternative pathways, as a measurable early or surrogate marker for amino acid excess and possible toxicity. After extensive discussion on various conditions that would need to be satisfied for metabolic limits to be used as markers of excessive intake of amino acids, there was a general consensus that methods such as measuring oxidation limits are an attractive approach that merit future investigation. It was noted that there are many data on the clinical use of glutamine, whereas data for proline are very scarce. There was recognition that regardless of the available data, there is regulatory pressure for setting upper levels of intake for amino acids and that much more data are required.
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http://dx.doi.org/10.1093/jn/138.10.2050SDOI Listing
October 2008

Rebuttal to letter to the editor. Dr. Qin (Volume 51, 2008).

Regul Toxicol Pharmacol 2008 Dec 7;52(3):352. Epub 2008 Aug 7.

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http://dx.doi.org/10.1016/j.yrtph.2008.07.007DOI Listing
December 2008

Minimising the population risk of micronutrient deficiency and over-consumption: a new approach using selenium as an example.

Eur J Nutr 2008 Feb 14;47(1):17-25. Epub 2008 Jan 14.

School of Medicine, University of Southampton, Southampton, SO16 7PX, UK.

Background: At the present time the recommended daily intake or allowance (RDA) and the safe upper level (UL) of intake of micronutrients are given as single values. The recommended daily intake is considered to cover the requirements of 97.5% of the population while the safe upper level is a value for the whole population. These values provide only limited guidance to risk managers.

Aim Of The Study And Methods: A method has been developed recently which models the relationships between intake and risks of either deficiency or excess using an observed incidence for each effect and population distribution characteristics. Using this model it is possible to formulate advice to risk managers on the incidence (prevalence) of adverse effects, due to either deficiency or excess, at different levels of intake. Application of the model to the data used to derive the RDA and UL for selenium shows that it can predict the impact of changes in nutrient intake on the balance between benefit (absence of deficiency) and risk (development of toxicity).

Results And Conclusions: Application of the model has illustrated the utility of this approach, but highlighted the need for a comprehensive evaluation of the data and a critical appraisal of the validity of the relationships that are analyzed. In addition, the derived incidences will usually relate to effects with different biological or health impacts, so that the final balance between benefit and risk should be developed by a dialogue between the risk assessor and the risk manager.
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http://dx.doi.org/10.1007/s00394-007-0691-6DOI Listing
February 2008

A nonsurgical means of fecal diversion: the Zassi Bowel Management System.

Dis Colon Rectum 2007 Jul;50(7):1017-22

Colorectal Unit, University of Sydney, Concord Hospital, Hospital Road, Concord, Sydney, New South Wales, 2137, Australia.

Purpose: Patients with perineal burns and immobile hospitalized patients with severe excoriation from incontinence caused by excessive diarrhea pose difficult management problems, frequently requiring stoma formation. The Zassi Bowel Management System (Zassi Medical Evolutions, Fernandina Beach, Florida) multichannel intrarectal catheter was evaluated for its safety and its ability to divert feces away from perineal skin to allow wound and skin healing.

Methods: A prospective cohort study was conducted on inpatients from the Burns and Geriatric Units. Patients with previous rectal disease were excluded. Perineal skin and wound healing was measured before and after tube insertion by using the perianal disease activity index score. Data regarding patient comfort, wound contamination, dressing changes, bed linen changes, and adverse events were collected. Proctoscopy was performed before and after tube insertion.

Results: Twenty-two tubes were inserted in 20 patients (7 perineal burns, 13 severe perineal excoriations). Mean perianal disease activity index scores reduced from 14 to 6.4 (P<0.0001) after tube insertion. Mean dressing changes reduced from 3.3 to 1.5 times per day (P<0.01), and mean bed linen changes in the incontinent patients reduced from 9.3 to 1.2 times per day (P<0.0001). Mean duration of rectal intubation was 14 days. Proctoscopy after tube removal was normal in all cases. One patient developed a superficial ulcer on the buttock from retention strapping.

Conclusions: The Zassi Bowel Management System tube allows diversion of feces away from the perineum for wound healing. It is safe, effective, and may help avoid stoma formation.
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http://dx.doi.org/10.1007/s10350-006-0882-xDOI Listing
July 2007

The 5th workshop on the assessment of adequate intake of dietary amino acids: general discussion 2.

J Nutr 2006 06;136(6 Suppl):1755S-1757S

CanTox Health Sciences International, Missisauga, Ontario 15N 2X7, Canada.

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http://dx.doi.org/10.1093/jn/136.6.1755SDOI Listing
June 2006

The intake of intense sweeteners - an update review.

Authors:
Andrew G Renwick

Food Addit Contam 2006 Apr;23(4):327-38

School of Medicine, University of Southampton, Southampton, UK.

Studies on the intakes of intense sweeteners in different countries published since the author's previous review in 1999 indicate that the average and 95th percentile intakes of acesulfame-K, aspartame, cyclamate and saccharin by adults are below the relevant acceptable daily intake (ADI) values. Fewer data are available for the newer sweeteners, sucralose and alitame, and because they are recent introductions to the market very low intakes were reported in those countries where they were available at the time of the intake study. Overall there has not been a significant change in the intakes of sweeteners in recent years. The only data indicating that the intake of an intense sweetener could exceed its ADI value were the 95th percentile intakes of cyclamate in children, particularly those with diabetes. This sub-group was identified as having high intakes of cyclamate in 1999, and recent studies have not generated reliable intake data to address this possibility.
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http://dx.doi.org/10.1080/02652030500442532DOI Listing
April 2006

The Fourth Workshop on the Assessment of Adequate Intake of Dietary Amino Acids: general discussion of session 3 and overall workshop discussion.

J Nutr 2005 06;135(6 Suppl):1602S-6S

School of Medicine, University of Southampton, Bassett Crescent East, UK.

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http://dx.doi.org/10.1093/jn/135.6.1602SDOI Listing
June 2005

Molecular approaches to the identification of biomarkers of exposure and effect--report of an expert meeting organized by COST Action B15. November 28, 2003.

Toxicol Lett 2005 Apr 8;156(2):227-40. Epub 2005 Jan 8.

Federal Institute for Risk Assessment, P.O. Box 330013, 14191 Berlin, Germany.

In the past, the term biomarker has been used with several meanings when used in human and environmental toxicology as compared to pharmaceutical development. However, with the advent of molecular approaches and their application in the field of drug development and toxicology, the concept of biomarkers has to be newly defined. In the meeting, the experts found consent in defining the term and described the application of biomarkers in toxicology, drug development and clinical diagnostics. Molecular approaches to biomarker identification and selection lead to a large amount of data. Hence, the statistical analysis is challenging and special statistical problems have to be solved in biomarker characterization, of particular interest are attempts aiming at class discovery and prediction. Reliability and biological relevance are to be demonstrated for biomarkers of exposure and effect which is also true for biomarkers of susceptibility. It is envisaged that the application of biomarkers will expand from current use in pre-clinical toxicology to the risk characterization and risk assessment of chemicals and from early clinical phases of drug development to later phases and even into daily clinical use in diagnostics and disease classification.
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http://dx.doi.org/10.1016/j.toxlet.2004.11.016DOI Listing
April 2005

Establishing the upper end of the range of adequate and safe intakes for amino acids: a toxicologist's viewpoint.

Authors:
Andrew G Renwick

J Nutr 2004 06;134(6 Suppl):1617S-1624S; discussion 1630S-1632S, 1667S-1672S

Clinical Pharmacology Group, Allergy and Inflammatory Sciences Research Division, School of Medicine, University of Southampton, Southampton, UK SO16 7PX.

The safety assessment of high intake levels of individual amino acids cannot be based on data from nutritional studies with proteins. Routine toxicity tests designed to investigate a wide range of possible effects should be undertaken for hazard identification and characterization using studies selected to mirror the predicted pattern and duration of human exposure. The approach used to establish an acceptable daily intake level for additives and pesticides, based on defining a "no observed adverse effect" level in the experimental study and dividing by uncertainty factors that allow for species differences and human variability, has a long history of use for foreign compounds and would provide a suitable basis for determining health-based guidance values for single amino acids. The usual default uncertainty factors for toxicokinetics and toxicodynamics should be replaced by compound-specific values if suitable data are available. In addition, the usual uncertainty factors should be modified to more relevant default values based on species differences and human variability in the biodisposition of amino acids in general or of groups of metabolically interrelated amino acids. There would be no significant health concerns if the human intake levels were below a health-based guidance value developed using this approach. A population-distribution approach could be used to define the magnitude of any risk at intake levels above the guidance value.
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http://dx.doi.org/10.1093/jn/134.6.1617SDOI Listing
June 2004
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