Alimentary Pharmacology & Therapeutics (ALIMENT PHARM THER)

Publications in this journal

• Article: Long-term oral mesalazine adherence and the risk of disease flare in ulcerative colitis: nationwide 10-year retrospective cohort from the veterans affairs healthcare system.

  Khan N, Abbas AM, Bazzano LA, Koleva YN, Krousel-Wood M
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  ABSTRACT: BACKGROUND: Adherence is a major factor in determining disease activity in ulcerative colitis (UC). There are limited data on long-term nationwide adherence levels among patients with UC. AIM: To evaluate the long-term adherence levels to oral mesalazine (mesalamine) in the Veterans Affairs (VA) healthcare system, to determine the impact of non-adherence on the risk of flares, and to evaluate the different pharmacy data-based adherence indicators. METHODS: Nationwide data were obtained from the VA for the period 2001-2011. UC patients who started mesalazine maintenance during the inclusion period were included. Level of adherence was assessed using three different indicators: medication possession ratio (MPR), continuous single-interval medication availability (CSA) and continuous multiple-interval medication gaps (CMG). Cox regression modelling was used to predict disease flares and assess the predictive value of each adherence indicator. RESULTS: We included 13 062 patients into the analysis with median follow-up time of 6.1 years. Percentage of patients with high adherence was 47%, 43%, 31% as identified by CSA, MPR and CMG respectively. Low adherers had a significant increase in the risk of flares compared with high adherers (Hazard ratio: 2.8, 1.7 and 1.8, P < 0.001 for CSA, MPR and CMG, respectively). Compared with other adherence indicators, CSA offered the best trend in predicting disease flares. CONCLUSIONS: Long-term high-adherence level was lower than previously reported. Adherence was a significant factor in predicting disease flares. Pharmacy adherence indicators may be useful to healthcare providers in identifying patients at high risk of exacerbations.
  Alimentary Pharmacology & Therapeutics 08/2012;
• Article: Letter: endoscopic monitoring and treatment step-up in post-operative Crohn's disease

  Takayuki Yamamoto
  Alimentary Pharmacology & Therapeutics 01/2012; 35(9):1111.
• Article: 124. Gubergrits N., Malecka-Panas E., Lehman GA., Vasileva G., Shen Y., Sander-Struckmeier, Caras S. Whitcomb DC. A 6 month,open-label clinical trial of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery.Aliment.Pharmacol Ther, 2011,

  Gubergrits N, Malecka-Panas E, Lehman GA, Vasileva G, Shen Y, Sander-Struckmeier, Caras S. Whitcomb DC
  Alimentary Pharmacology & Therapeutics 01/2011;
• Article: Meta-analysis: antioxidant supplements for liver diseases - the Cochrane Hepato-Biliary Group

  Bjelakovic G, Gluud LL, Nikolova D, Bjelakovic M, Nagorni A, Gluud C
  Alimentary Pharmacology & Therapeutics 01/2010; 32(3):356-367.
• Article: Barriers to physician adherence to nonsteroidal anti-inflammatory drug guidelines: a qualitative study.

  J M Cavazos, A D Naik, A Woofter, N S Abraham
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  ABSTRACT: Despite wide availability of physician guidelines for safer use of nonsteroidal anti-inflammatory drugs (NSAIDs) and widespread use of these drugs in the US, NSAID prescribing guidelines have been only modestly effective. To identify and describe comprehensively barriers to provider adherence to NSAID prescribing guidelines. We conducted interviews with 25 physicians, seeking to identify the major influences explaining physician non-adherence to guidelines. Interviews were standardized and structured probes were used for clarification and detail. All interviews were audio-taped and transcribed. Three independent investigators analysed the transcripts, using the constant-comparative method of qualitative analysis. Our analysis identified six dominant physician barriers explaining non-adherence to established NSAID prescribing guidelines. These included (i) lack of familiarity with guidelines, (ii) perceived limited validity of guidelines, (iii) limited applicability of guidelines among specific patients, (iv) clinical inertia, (v) influences of prior anecdotal experiences and (vi) medical heuristics. A heterogeneous set of influences are barriers to physician adherence to NSAID prescribing guidelines. Suggested measures for improving guideline-concordant prescribing should focus on measures to improve physician education and confidence in guidelines, implementation of physician/pharmacist co-management strategies and expansion of guideline scope.
  Alimentary Pharmacology & Therapeutics 10/2008; 28(6):789-98.
• Article: A comparative study of standard vs. high definition colonoscopy for adenoma and hyperplastic polyp detection with optimized withdrawal technique.

  J E East, M Stavrindis, S Thomas-Gibson, T Guenther, P P Tekkis, B P Saunders
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  ABSTRACT: Colonoscopy has a known miss rate for polyps and adenomas. High definition (HD) colonoscopes may allow detection of subtle mucosal change, potentially aiding detection of adenomas and hyperplastic polyps. To compare detection rates between HD and standard definition (SD) colonoscopy. Prospective, cohort study with optimized withdrawal technique (withdrawal time >6 min, antispasmodic, position changes, re-examining flexures and folds). One hundred and thirty patients attending for routine colonoscopy were examined with either SD (n = 72) or HD (n = 58) colonoscopes. Groups were well matched. Sixty per cent of patients had at least one adenoma detected with SD vs. 71% with HD, P = 0.20, relative risk (benefit) 1.32 (95% CI 0.85-2.04). Eighty-eight adenomas (mean +/- standard deviation 1.2 +/- 1.4) were detected using SD vs. 93 (1.6 +/- 1.5) with HD, P = 0.12; however more nonflat, diminutive (<6 mm) adenomas were detected with HD, P = 0.03. Twenty-three proximal hyperplastic polyps (0.32 +/- 0.58) were detected with SD vs. 31 (0.53 +/- 0.86) with HD, P = 0.35. Overall prevalence of proximal large (>9 mm) hyperplastic polyps was 7% (0.09 +/- 0.36). High definition did not lead to a significant increase in adenoma or hyperplastic polyp detection, but may help where comprehensive lesion detection is paramount. High detection rates appear possible with either SD or HD, when using an optimized withdrawal technique.
  Alimentary Pharmacology & Therapeutics 10/2008; 28(6):768-76.
• Article: Long-term outcome of using allopurinol co-therapy as a strategy for overcoming thiopurine hepatotoxicity in treating inflammatory bowel disease.

  A Ansari, T Elliott, B Baburajan, P Mayhead, J O'Donohue, P Chocair, J Sanderson, J Duley
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  ABSTRACT: Hepatotoxicity results in the withdrawal of thiopurines drugs, azathioprine (AZA) and mercaptopurine (MP), in up to 10% of patients with inflammatory bowel disease. Our group previously demonstrated that allopurinol with AZA/ciclosporin/steroid 'triple therapy' improved renal graft survival. To confirm the hypothesis that allopurinol may alleviate thiopurine hepatotoxicity by similar mechanisms as proposed in our renal study. Unselected patients with acute thiopurine hepatotoxicity were offered allopurinol co-therapy with low-dose AZA or MP. The starting AZA/MP dose was determined by thiopurine methyltransferase (TPMT) activity (two patients were intermediate TPMT); then this dose was reduced to 25% for allopurinol co-therapy. Response to treatment was assessed by clinical severity indices, endoscopy and blood tests. Of 11 patients (three Crohn's disease, eight ulcerative colitis) treated, nine (82%) remain in long-term remission (median 42 months) with normal liver tests. One patient also successfully bypassed flu-like symptoms. Two stopped: one nausea, one abnormal liver function (stealosis on biopsy). Leucopenia occurred in two cases and resolved with minor dose reductions. Allopurinol co-therapy with low-dose AZA/MP can alleviate thiopurine hepatotoxicity. It appears safe and effective for long-term use, but requires monitoring for myelotoxicity. Assessing the TPMT activity helps tailor the AZA/MP doses.
  Alimentary Pharmacology & Therapeutics 10/2008; 28(6):734-41.
• Article: Sustained modulation of intestinal bacteria by exclusive enteral nutrition used to treat children with Crohn's disease.

  S T Leach, H M Mitchell, W R Eng, L Zhang, A S Day
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  ABSTRACT: The use of exclusive enteral nutrition to treat paediatric Crohn's disease (CD) is widely accepted, although the precise mechanism(s) of action remains speculative. To investigate the changes to key intestinal bacterial groups of Eubacteria, Bacteroides, Clostridium coccoides, Clostridium leptum and Bifidobacteria, during and after exclusive enteral nutrition treatment for CD in paediatric patients and correlate these changes to disease activity and intestinal inflammation. Stool was collected from six children at diagnosis of CD, during exclusive enteral nutrition and 4 months post-therapy, and from seven healthy control children. The diversity of bacteria was assessed by polymerase chain reaction-denaturing gradient gel electrophoresis with changes to bacterial diversity measured by Bray-Curtis similarity, intestinal inflammation assessed by faecal S100A12 and the disease activity assessed by PCDAI. A significantly greater change in intestinal bacterial composition was seen with exclusive enteral nutrition treatment compared with controls. Further, the intestinal bacteria remained altered 4 months following exclusive enteral nutrition completion. Changes in the composition of Bacteroides were associated with reduced disease activity and inflammation. Exclusive enteral nutrition reduces bacterial diversity and initiates a sustained modulation of all predominant intestinal bacterial groups. Exclusive enteral nutrition may reduce inflammation through modulating intestinal Bacteroides species. The implications of these results for exclusive enteral nutrition therapy and CD pathogenesis should now be the subject of further investigation.
  Alimentary Pharmacology & Therapeutics 10/2008; 28(6):724-33.
• Article: Efficacy and safety of antiviral therapy in patients with Crohn's disease and chronic hepatitis C.

  T M Scherzer, K Staufer, G Novacek, P Steindl-Munda, S Schumacher, H Hofer, P Ferenci, H Vogelsang
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  ABSTRACT: Efficacy and safety of antiviral combination therapy in patients with Crohn's disease (CD) and chronic hepatitis C (CHC) is presently not established and consequently CHC is rarely treated in CD patients. To analyse the efficacy and tolerability of antiviral interferon/ribavirin therapy in patients with CHC and CD. Eleven HCV-infected CD patients received either 3 x 1.5 microg/kg/week interferon-alpha-2b or 180 microg/week peginterferon-alpha-2a (PEGASYS; Roche, Basel, Switzerland) as monotherapy (n = 1) or in combination with 800-1200 mg/day ribavirin (COPEGUS; Roche) (n = 10) for 24-54 weeks according to HCV-genotype and initial response respectively. Eight patients were under CD-specific therapy. Five (46%) patients (HCV-1: a = 3; HCV-2: n = 0; HCV-3: n = 1; unknown: n = 1) achieved a sustained virological response, three (27%) patients relapsed, three (27%) were nonresponders (all GT 1b). At baseline, the Harvey--Bradshaw Index was 0 (0-8) [median (range)], increased on antiviral therapy to 4 (1-15) (P = 0.005) and decreased to baseline level 0 (0-6) after 6-month follow-up. This preliminary experience demonstrates that treatment of CHC in patients with CD is comparable to the treatment of CHC in those without CD. However, gastrointestinal symptoms may be temporarily exacerbated and haemopoietic growth factors may be required.
  Alimentary Pharmacology & Therapeutics 10/2008; 28(6):742-8.
• Article: Clinical trial: a multicentre, randomized, double-blind, placebo-controlled, dose-finding, phase II study of subcutaneous interferon-beta-la in moderately active ulcerative colitis.

  C Pena-Rossi, S Schreiber, G Golubovic, A Mertz-Nielsen, J Panes, D Rachmilewitz, M J Shieh, V I Simanenkov, D Stanton, H Graffner
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  ABSTRACT: Ulcerative colitis (UC) pathophysiology is characterized by an imbalance between pro- and anti-inflammatory cytokines. Interferon (IFN)-beta-1a has potent immunoregulatory properties, including stimulation of host defence mechanisms and thus represents a potential treatment. To extend pilot data and identify a suitable dose of IFN-beta-1a to achieve endoscopically confirmed remission (ECR) in patients with moderately active UC and to evaluate safety. In this multicentre, double-blind, placebo-controlled trial, adults with moderately active UC were randomized to IFN-beta-1a 44 or 66 microg, or placebo, subcutaneously three times weekly for 8 weeks, with a 4-week follow-up. Endoscopically-confirmed remission was observed in 23.4% [95% confidence interval (CI): 13.8-35.7] of placebo patients, 29.2% (95% CI: 18.6-41.8) of the IFN-beta-la 44 microg group and 20.0% (950% CI: 11.1-31.8) of the 66 microg group (P = 0.45). Improvements with IFN-beta-1a 44 microg were greater than with placebo for most secondary efficacy outcomes, although significance was not achieved. Placebo response rates were higher than expected from previous trials. Adverse events were similar to the known safety profile of IFN treatment. Interferon-beta-1a was generally well tolerated at the doses tested, but a significant therapeutic benefit in patients with UC was not observed.
  Alimentary Pharmacology & Therapeutics 10/2008; 28(6):758-67.
• Article: Meta-analysis: zinc supplementation for acute gastroenteritis in children.

  B Patro, D Golicki, H Szajewska
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  ABSTRACT: Uncertainty exists regarding the use of zinc in the treatment of acute gastroenteritis in children living in Europe, where zinc deficiency is rare. To review evidence for the effectiveness of zinc in treating acute gastroenteritis in children, with special emphasis on data from developed countries. MEDLINE, EMBASE, and the Cochrane Library were searched through November 2007 for randomized controlled trials (RCTs) relevant to acute gastroenteritis in children younger than 5 years of age and zinc; additional references were obtained from the reviewed articles. Eighteen RCTs (11,180 participants, mainly from developing countries) met the inclusion criteria. Use of zinc was associated with a significant reduction in diarrhoea duration (13 RCTs, 5643 infants, weighted mean difference -0.69 day, 95% CI -0.97 to -0.40) and the risk of diarrhoea lasting longer than 7 days [eight RCTs, n = 5769, relative risk (RR) 0.71, 95% CI 0.53-0.96]. No significant reduction in stool volume was observed for those receiving zinc compared with placebo (three RCTs, n = 606, standardized mean difference, -0.38, 95% CI -1.04 to 0.27). Combined data from five RCTs (n = 3156) showed that zinc significantly increased the chance of vomiting compared to the control agent (RR 1.2, 95% CI 1.05-1.4). These data confirm that zinc supplementation can be useful for treating acute gastroenteritis in children, particularly those from developing countries. However, the role of zinc supplements in treating children with acute gastroenteritis in developed countries needs further evaluation.
  Alimentary Pharmacology & Therapeutics 10/2008; 28(6):713-23.
• Article: Bleeding ectopic varices in cirrhosis: the role of transjugular intrahepatic portosystemic stent shunts.

  N Kochar, D Tripathi, N C McAvoy, H Ireland, D N Redhead, P C Hayes
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  ABSTRACT: Bleeding from ectopic varices is uncommon but can be difficult to manage. To report our experience of the use of transjugular intrahepatic portosystemic stent shunts (TIPSS) in the management of uncontrolled bleeding from ectopic varices. A retrospective study of patients who had TIPSS for bleeding ectopic varices. Patients were selected from a dedicated data base. Over 14 years, of 750 TIPSS insertions, 28 patients had TIPSS for bleeding ectopic varices (Child-Pugh score: 8.8 +/- 1.8). Varices were rectal (12), stomal (8), duodenal (4) and at other sites (4). Concomitant variceal embolization was performed in five. Portal pressure gradient fell from 18.2 +/- 6.4 to 7.2 +/- 3.5 mmHg. TIPSS achieved haemostasis in six of nine patients who presented with active bleeding. Five patients rebled from ectopic varices. This was related to shunt dysfunction in two and responded to shunt interventions. Three patients rebled despite a functional shunt. Of these, thrombin controlled bleeding in one. Eight patients developed hepatic encephalopathy post-TIPSS. Transjugular intrahepatic portosystemic stent shunt is a safe and effective treatment for bleeding ectopic varices. Rebleeding from ectopic varices related to shunt dysfunction responds to shunt intervention. A significant proportion of patients have rebleeding despite a patent shunt, when other adjunctive measures like thrombin injection may be tried.
  Alimentary Pharmacology & Therapeutics 09/2008; 28(3):294-303.
• Article: Low-dose aspirin reduces the gene expression of gastrokine-1 in the antral mucosa of healthy subjects.

  G Martin, T Wex, G Treiber, P Malfertheiner, G Nardone
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  ABSTRACT: Gastrokine 1 (GKN1), one of the most abundant transcripts in normal stomach, is down-regulated by Helicobacter pylori infection. Aspirin (ASA), which is often used for secondary prevention of cardiovascular events, can damage gastric-duodenal mucosa within 1 or 2 h of ingestion. To study the gastric mucosal expression of GKN1 during acute low-dose ASA consumption. Ten H. pylori-negative human volunteers took 100 mg ASA per day for 1 week, and underwent multiple upper GI endoscopies. GKN1 expression was analysed in antral and corpus mucosa by quantitative reverse-transcriptase polymerase chain reaction, western blot and immunohistochemistry (IHC). Gastric mucosal damage was detected endoscopically and histologically. Gastrokine 1 was similarly expressed in both antral and corpus mucosa. The use of low-dose ASA led to a significant decrease (3.07 a.u. vs. 0.23 a.u., P < 0.001) in antrum at day 7, while GKN1 transcript levels in corpus mucosa were slightly elevated (twofold, P < 0.005). Western blot and IHC confirmed these changes at the protein level. Furthermore, IHC revealed a vesicular staining pattern in the cytoplasm for GKN1 that was confirmed by transfected human gastric adenocarcinoma cell line expressing GKN1. Our data demonstrated that low-dose ASA downregulates GKN1 expression specifically in antral mucosa.
  Alimentary Pharmacology & Therapeutics 09/2008; 28(6):782-8.
• Article: Neural and psychological predictors of treatment response in irritable bowel syndrome patients with a 5-HT3 receptor antagonist: a pilot study.

  J M Jarcho, L Chang, M Berman, B Suyenobu, B D Naliboff, M D Lieberman, V Z Ameen, M A Mandelkern, E A Mayer
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  ABSTRACT: Symptom improvement in irritable bowel syndrome (IBS) treatment trials varies widely, with only 50-70% of patients qualifying as responders. Factors predicting treatment responsiveness are not known, although we have demonstrated that symptom improvement with the 5-HT3R antagonist alosetron is correlated with reduced amygdala activity. To determine whether neural activity during rectal discomfort or psychological distress predicts symptom improvement following treatment with alosetron. Basal psychological distress and neural activity (15O PET) during uncomfortable rectal stimulation were measured in 17 nonconstipated IBS patients who then received 3 weeks of alosetron treatment. Greater symptom improvement was predicted by less activity in bilateral orbitofrontal cortex (OFC) and medial temporal gyrus during pre-treatment scans. Lower levels of interpersonal sensitivity predicted greater symptom improvement and were positively related to activity in left OFC. Connectivity analysis revealed a positive relationship between activity in the left OFC and right amygdala. Irritable bowel disease symptom improvement with 5-HT3R antagonist alosetron is related to pre-treatment reactivity of the left OFC, which may be partially captured by subjective measures of interpersonal sensitivity. The left OFC may fail to modulate amygdala response to visceral stimulation, thereby diminishing effectiveness of treatment. Psychological factors and their neurobiological correlates are plausible predictors of IBS treatment outcome.
  Alimentary Pharmacology & Therapeutics 09/2008; 28(3):344-52.
• Article: Clinical trial: alvimopan for the management of post-operative ileus after abdominal surgery: results of an international randomized, double-blind, multicentre, placebo-controlled clinical study.

  M W Büchler, C M Seiler, J R T Monson, Y Flamant, M W Thompson-Fawcett, M M Byrne, E R Mortensen, J F B Altman, R Williamson
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  ABSTRACT: Post-operative ileus (POI) affects most patients undergoing abdominal surgery. To evaluate the effect of alvimopan, a peripherally acting mu-opioid receptor antagonist, on POI by negating the impact of opioids on gastrointestinal (GI) motility without affecting analgesia in patients outside North America. Adult subjects undergoing open abdominal surgery (n = 911) randomly received oral alvimopan 6 or 12 mg, or placebo, 2 h before, and twice daily following surgery. Opioids were administered as intravenous patient-controlled analgesia (PCA) or bolus injection. Time to recovery of GI function was assessed principally using composite endpoints in subjects undergoing bowel resection (n = 738). A nonsignificant reduction in mean time to tolerate solid food and either first flatus or bowel movement (primary endpoint) was observed for both alvimopan 6 and 12 mg; 8.5 h (95% CI: 0.9, 16.0) and 4.8 h (95% CI: -3.2, 12.8), respectively. However, an exploratory post hoc analysis showed that alvimopan was more effective in the PCA (n = 317) group than in the non-PCA (n = 318) group. Alvimopan was well tolerated and did not reverse analgesia. Although the significant clinical effect of alvimopan on reducing POI observed in previous trials was not reproduced, this trial suggests potential benefit in bowel resection patients who received PCA.
  Alimentary Pharmacology & Therapeutics 09/2008; 28(3):312-25.
• Article: Clinical trial: percutaneous acetic acid injection vs. percutaneous ethanol injection for small hepatocellular carcinoma--a long-term follow-up study.

  W L Tsai, J S Cheng, K H Lai, C P Lin, G H Lo, P I Hsu, H C Yu, C K Lin, H H Chan, W C Chen, T A Chen, W L Li, H L Liang
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  ABSTRACT: The long-term outcome of percutaneous acetic acid injection (PAI) and percutaneous ethanol injection (PEI) for treating small hepatocellular carcinoma (HCC) remains unclear. To compare the long-term outcome of PAI vs. PEI for treating small HCC. From July 1998 to July 2004, 125 patients with small HCC were enrolled. Seventy patients receiving PAI and 55 patients receiving PEI were enrolled. There were no significant differences in the clinical characteristics between the two groups. Tumour recurrence and survival rates were assessed. Mean follow-up time was 43 months. The local recurrence rate and new tumour recurrence rate were similar between the PAI and PEI groups. The PAI group had significantly better survival than the PEI group (P = 0.027). Multivariate analysis revealed that PAI was the significant factor associated with overall survival [PAI vs. PEI, RR: 0.639, 95% CI: (0.419-1.975), P = 0.038]. The treatment sessions required to achieve complete tumour necrosis were significantly fewer in the PAI group than in the PEI group (2.4 +/- 1.0 vs. 2.9 +/- 1.3, P = 0.018). Percutaneous acetic acid injection required fewer treatment sessions than PEI and provided better survival after long-term follow-up.
  Alimentary Pharmacology & Therapeutics 09/2008; 28(3):304-11.
• Article: Systematic review: primary and secondary prevention of gastrointestinal cancers with antioxidant supplements.

  G Bjelakovic, D Nikolova, R G Simonetti, C Gluud
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  ABSTRACT: The evidence on whether antioxidant supplements prevent gastrointestinal cancers is contradictory. To assess the beneficial and harmful effects of antioxidant supplements in preventing gastrointestinal cancers. Using the Cochrane Collaboration methodology, we reviewed the randomized trials comparing antioxidant supplements with placebo or no intervention on the occurrence of gastrointestinal cancers. We searched electronic databases and reference lists until October, 2007. Our outcome measures were gastrointestinal cancers, overall mortality and adverse events. Outcomes were reported as relative risks (RR) with 95% confidence intervals (CI) based on random-effects and fixed-effect models meta-analyses. We identified 20 randomized trials (211,818 participants) assessing beta-carotene, vitamin A, vitamin C, vitamin E, and selenium. The trial quality was generally high. The antioxidant supplements were without a significant effect on the occurrence of gastrointestinal cancers (RR 0.94, 95% CI 0.83-1.06, I(2) = 54.0%). The heterogeneity seemed to be explained by bias risk (low-bias risk trials RR 1.04, 95% CI 0.96-1.13 compared to high-bias risk trials RR 0.59, 95% CI 0.43-0.80, test of interaction P < 0.0005) and type of antioxidant supplement (beta-carotene potentially increasing and selenium potentially decreasing cancer risk). Antioxidant supplements had no significant effect on mortality in a random-effects model meta-analysis (RR 1.02, 95% CI 0.97-1.07, I(2) = 53.5%) but significantly increased mortality in a fixed-effect model meta-analysis (RR 1.04, 95% CI 1.02-1.07). We could not find evidence that the studied antioxidant supplements prevented gastrointestinal cancers. On the contrary, they seem to increase overall mortality.
  Alimentary Pharmacology & Therapeutics 09/2008; 28(6):689-703.