ACG clinical guideline: diagnosis and management of Barrett's esophagus

Barrett's esophagus (BE) is among the most common conditions encountered by the gastroenterologist. In this document, the American College of Gastroenterology updates its guidance for the best practices in caring for these patients. These guidelines continue to endorse screening of high-risk patients for BE; however, routine screening is limited to men with reflux symptoms and multiple other risk factors. Acknowledging recent data on the low risk of malignant progression in patients with nondysplastic BE, endoscopic surveillance intervals are attenuated in this population; patients with nondysplastic BE should undergo endoscopic surveillance no more frequently than every 3-5 years. Neither routine use of biomarker panels nor advanced endoscopic imaging techniques (beyond high-definition endoscopy) is recommended at this time. Endoscopic ablative therapy is recommended for patients with BE and high-grade dysplasia, as well as T1a esophageal adenocarcinoma. Based on recent level 1 evidence, endoscopic ablative therapy is also recommended for patients with BE and low-grade dysplasia, although endoscopic surveillance continues to be an acceptable alternative. Given the relatively common recurrence of BE after ablation, we suggest postablation endoscopic surveillance intervals. Although many of the recommendations provided are based on weak evidence or expert opinion, this document provides a pragmatic framework for the care of the patient with BE.(AU)

Systematic review with meta-analysis: the risk of gastrointestinal haemorrhage post-polypectomy in patients receiving anti-platelet, anti-coagulant and/or thienopyridine medications.

BACKGROUND: For patients undergoing colonoscopy with polypectomy, current guidelines recommend temporary cessation of blood-thinning medications. The data regarding periprocedural management of these medications are sparse. AIM: To perform a systematic review and meta-analysis to determine the risk of post-polypectomy bleeding (PPB) in patients taking anti-platelet, anti-coagulant and/or thienopyridine medications. METHODS: We searched Pubmed, Scopus, Web of Science, Biosis and Proceedings First from 1970 to 2015. PPB was defined as overt haemorrhage or drop in haemoglobin of at least 2 g/dL. RESULTS: Of 1490 articles identified, we included 3 papers and 1 abstract with patients on aspirin and/or NSAIDs, 1 paper on warfarin, 2 abstracts on clopidogrel, and 2 papers on clopidogrel plus aspirin and/or NSAIDs. While the rate of immediate PPB on aspirin and/or NSAIDs was not increased (OR = 1.1, 95% CI 0.7-1.9, P = 0.7), the risk of delayed PPB was increased (OR = 1.7, 95% CI 1.0-2.4, P = 0.0009, I(2)  = 60%) but rendered non-significant with elimination of a small study. There was an elevated risk of delayed PPB on clopidogrel (OR = 9.7, 95% CI 3.1-30.8, P = 0.0, I(2)  = 0). There was an increased risk of delayed PPB in patients on clopidogrel + aspirin and/or NSAIDs (OR = 3.4, 95% CI 1.3-8.8, P = 0.01, I(2)  = 0). Based on a single study on warfarin, the PPB rate was elevated. There were no data regarding PPB and usage of the newer anti-coagulant agents. CONCLUSIONS: Usage of aspirin or NSAIDs does not increase risk of post-polypectomy bleeding. Clopidogrel and warfarin should be discontinued in the periprocedural period to prevent the occurrence of post-polypectomy bleeding.

Prevalence of graft versus host disease and cytomegalovirus infection in patients post-haematopoietic cell transplantation presenting with gastrointestinal symptoms.

BACKGROUND: There is lack of consensus regarding whether both upper and lower endoscopic examinations are required for diagnosis of gastrointestinal acute graft versus host disease (GI-AGVHD). AIM: To evaluate the impact of endoscopic procedures on the diagnosis of GI-AGVHD. METHODS: We performed a retrospective case-control study of recipients of allogeneic haematopoetic cell transplant (HCT) from 2000 to 2011, who presented with GI symptoms between 20 and 125 days post-HCT. GI-AGVHD status was based on the National Institutes of Health (NIH) clinical grading system. RESULTS: One hundred and twenty-nine clinical GI-AGVHD cases and 184 controls underwent endoscopic examinations. Diarrhoea was present in 73% of cases and 38% of controls (P < 0.0001); 99% of patients with nausea ± vomiting and diarrhoea underwent bidirectional endoscopy. Histology had a sensitivity of 92% and specificity of 91% compared to the clinical criteria. The sensitivity for GI-AGVHD was 80% or greater when upper endoscopy (EGD) was performed with either sigmoidoscopy or colonoscopy, or if lower endoscopic examinations were performed alone. The sensitivity of EGD alone was only 48% (P = 0.003). Sensitivity was highest with biopsy of the terminal ileum (79%), followed by the ascending (74%), transverse/descending (73%) and sigmoid colons (69%). Diagnostic yield for cytomegalovirus (CMV) infection was equivalent for biopsies from both upper and lower GI tracts. Patients found to have concurrent GI-AGVHD and CMV infection (N = 18) had a poorer overall prognosis. CONCLUSION: In patients post-HCT with GI symptoms, sigmoidoscopy alone had equivalent diagnostic yield for GI-AGVHD and CMV infection, compared with the addition of EGD or performance of full colonoscopy.

Control of intra-oesophageal pH in patients with Barrett's oesophagus on omeprazole-sodium bicarbonate therapy.

BACKGROUND: Approximately 30-40% of patients with Barrett's oesophagus (BE) patients manifest abnormal oesophageal pH profiles despite proton pump inhibitor (PPI) therapy. AIM: To determine control of oesophageal reflux using Bravo pH monitoring in patients BE on omeprazole-sodium bicarbonate oral suspension powder (Ome-NaBic) 40 mg twice daily. METHODS: Initial pH monitoring off PPI for 1 week was performed. All patients underwent repeat pH testing on Ome-NaBic administered before breakfast and at bedtime after 21-28 days of therapy depending upon the prior PPI therapy. The goal was to enroll 30 subjects, however, the trial was terminated prematurely when the sponsor lost financing due to a change in business strategy. RESULTS: A total of 88 patients responded to the study invitation, 27 patients signed informed consent, and 21 patients underwent pH testing of PPI. A total of 15 patients completed the protocol (13 men, 2 women). Demographic information for patients completing at least one Bravo study included a mean (±s.d.) age 62 ± 9 years; body mass index 31 ± 8 kg/m(2) (range 23-48); mean BE length of 2.6 ± 2 cm; 9 (43%) patients with long segment BE. All (100%) patients demonstrated normalisation of supine pH on both days of Ome-NaBic therapy. One patient (6%) demonstrated abnormal upright reflux on the second day of monitoring on Ome-NaBic therapy; all the other patients demonstrated normal pH scores on therapy. CONCLUSIONS: Administration of twice daily Ome-NaBic demonstrated control of nocturnal oesophageal reflux in 100% of patients with Barrett's oesophagus, and complete control of oesophageal pH during 97% of the 24-h recording periods.

Variation of health-care resource utilization according to GERD-associated complications.

Complications associated with gastroesophageal reflux disease (GERD) can include esophageal stricture, Barrett's esophagus, gastrointestinal hemorrhage, and extraesophageal symptoms. The impact of GERD-associated complications on health-care utilization deserves further evaluation. We identified commercial enrollees 18-75 years old with claims for GERD (International Classification of Diseases, Ninth Revision, Clinical Modification Codes: 530.81 or 530.11) and subsequent usage of proton pump inhibitors from 01/01/05 to 06/30/09. The initial GERD diagnosis date was designated as the index date, and patients were studied for 6 months preindex and postindex. Eligible patients were subsequently stratified based on medical claims for GERD-associated complications as follows: stage A (GERD diagnosis, no other symptoms), stage B (GERD + extraesophageal symptoms), stage C (GERD + Barrett's esophagus), stage D (GERD + esophageal stricture), and stage E (GERD + iron-deficiency anemia or acute upper gastrointestinal hemorrhage). Patient characteristics, health-care utilization, and costs were compared between stage A and each stage with complicated GERD (B-D). Of the 174,597 patients who were eligible for analysis, 74% were classified as stage A, 20% stage B, 1% stage C, 2% stage D, and 3% stage E. Relative to stage A, patients in stages C, D, and E were significantly more likely to visit a gastroenterologist (13% vs. 68%, 71%, and 38%, respectively) and had higher rates of esophageal ulcers (0.3% vs. 8%, 5%, and 3%, respectively) and Nissen fundoplication (0.05% vs. 0.6%, 0.3%, and 0.2%, respectively). Six-month GERD-related costs ranged from $615/patient (stage A) to $1714/patient (stage D); all-cause costs ranged from $4195/patient (stage A) to $11,340/patient (stage E). Compared with stage A, all other cohorts had significantly higher all-cause and GERD-related costs (P < 0.0001 for all comparisons). While patients with more severe GERD represented a relatively small portion of the GERD cohort, they demonstrated significantly greater health-care costs and overall utilization than patients with uncomplicated GERD.

Development of a refractory gastro-oesophageal reflux score using an administrative claims database.

BACKGROUND: Approximately one-third of gastro-oesophageal reflux disease (GERD) patients demonstrate refractory symptoms following treatment with proton pump inhibitor (PPI) therapy. AIM: To develop a refractory GERD score that can be applied to predict patients' healthcare utilisation. METHODS: We enrolled adults (≥18 years) with a diagnosis of GERD. Refractory GERD was evaluated on an 8-point scale where 1 point was given for each of the following criteria: doubling, addition, or switching of GERD medication dose, receipt of a GERD-related endoscopic procedure or surgery, or ≥3 GERD-related outpatient visits. Refractory GERD was defined as the presence of two or more points. RESULTS: A total of 135,139 GERD patients (44% male) were analysed with a mean (±s.d.) age of 52.9 ± 15 years. The mean overall refractory GERD score was 1.12 ± 1.2 (range 0-8 on an 8-point scale); 31% of patients had refractory GERD with a mean score of 2.56 ± 0.82. Among patients with refractory GERD, 31% doubled their GERD medication, 28% added a new GERD medication, 60% switched GERD medications, 54% had a GERD-related procedure and 1% had a GERD-related surgery. Patients with refractory GERD were more likely to be female (59% vs. 55%, P < 0.001) and had a higher co-morbidity score (0.78 vs. 0.56, P < 0.001). The overall mean costs for refractory patients during the study period were significantly higher compared with treatment-responsive patients ($18,088 ± $36,220 vs. $11,044 ± $22,955, P < 0.001). CONCLUSIONS: Refractory GERD was present in approximately one-third of the GERD patients. We created a GERD refractory score that could define need for increased anti-reflux therapy and predict higher healthcare resource utilisation.

The inaccuracy of ICD-9-CM Code 530.2 for identifying patients with Barrett's esophagus.

Barrett's esophagus (BE) is a chronic complication associated with gastroesophageal reflux disease. The ICD-9-CM code used for BE, 530.2, is also used for patients with 'ulcer of the esophagus.' We aimed to determine if the ICD-9-CM code of 530.2 is reliable for identifying cases of Barrett's esophagus within databases for research purposes. We reviewed the records of all patients assigned code 530.2 at two university medical center hospitals and a veterans' administration hospital over a cumulative 16-year period. Billing records provided information about where the code was assigned, whether it was a major or minor diagnosis, and if the code was assigned on multiple occasions for each patient. Histology and endoscopy records were reviewed to confirm the diagnosis of Barrett's esophagus. Among 435 patients with code 530.2 in their records, 354 (82%) had an esophageal biopsy reported and 393 (90%) had an endoscopy report available for review. Only 182 (42%) had specialized intestinal metaplasia documented in a biopsy from an area of salmon-colored mucosa arising above the esophagogastric junction (51% of those with histology available). There were 288 patients (66%) with an endoscopic diagnosis of Barrett's esophagus (73% of those with an endoscopy reported). Variables associated with documented specialized intestinal metaplasia were age > or = 60 (OR 2.3; 95% CI 1.4-3.7), multiple assignments of 530.2 (OR 3.2; 95% CI 2.0-5.0), and assignment of 530.2 in a gastrointestinal (GI) clinic or an endoscopy unit (OR 3.5; 95% CI 2.0-6.3). The positive predictive value of the code being assigned in a GI location was 48% (95% CI 43-54%). Therefore, ICD-9-CM code of 530.2 is not specific for the diagnosis of Barrett's esophagus. The usage of code 530.2 in a GI setting was not sufficiently predictive of BE to be reliable for rigorous epidemiological studies.

Does body mass index differ between patients with Barrett's oesophagus and patients with chronic gastro-oesophageal reflux disease?

BACKGROUND: Obesity has been demonstrated to be a risk factor for the development of gastro-oesophageal reflux disease (GERD). AIM: To perform a prospective cohort study to determine whether there was a difference in body mass index (BMI) between patients with GERD and patients with Barrett's oesophagus (BE). METHODS: We prospectively enrolled patients undergoing endoscopic evaluation for GERD and collected information regarding BMI, tobacco and/or alcohol use, and family history of GERD. Patients with non-erosive reflux disease underwent confirmatory 24-h pH testing. RESULTS: Seven hundred and fifty one patients with GERD (mean +/- s.d. age of 55.4 +/- 14.2 years, 74% male) entered the study, and BE was present in 165 (22%, 90% male, 79% Caucasian) patients. The mean GERD symptom duration was 10.3 +/- 0.4 years (range 1-62 years) with a mean body mass index of 27.8 +/- 0.2 kg/m(2) (range 15-55) Compared with patients having GERD alone, patients with BE were more likely to be older (P = 0.001), male (P < 0.001), current or prior tobacco users (P = 0.002), and with greater duration of GERD symptoms (P < 0.001). There was no significant difference in the BMI for patients with and without BE. CONCLUSIONS: While obesity is a risk factor for both GERD and BMI, patients with BE did not demonstrate increased BMI compared with patients having chronic GERD.

Control of intra-oesophageal and intra-gastric pH with proton pump inhibitors in patients with Barrett's oesophagus.

BACKGROUND: A significant percentage of patients with Barrett's oesophagus (BE) will continue to manifest abnormal intra-oesophageal pH profiles regardless of proton pump inhibitor (PPI) therapy. AIMS: We conducted a prospective study in order to determine whether a change in PPI therapy would alter intra-oesophageal and intra-gastric acid suppression in BE patients. PATIENTS: Seventeen Helicobacter pylori-negative BE patients (16 males, 1 female; mean+/-S.D. age, 63.5+/-13.2). METHODS: Twenty-four-hour pH monitoring was performed on omeprazole or lansoprazole, followed by repeat pH monitoring on rabeprazole at a dose titrated for symptom relief. Patients completed validated symptom and health-related quality-of-life (HRQL) surveys while on and off therapy. RESULTS: Ten (59%) of the 17 patients had abnormal baseline intra-oesophageal pH profiles. Oesophageal pH monitoring values on rabeprazole were abnormal in five out of five (100%) of the omeprazole cohort and three out of five (60%) of the lansoprazole cohort that had abnormal pH profiles on initial testing. Intra-gastric pH control was inadequate in BE patients on all PPIs; the mean percentage time with intra-gastric pH below 4.0 was 46% on omeprazole, 71% on lansoprazole and 51% on rabeprazole (p=0.25). All of the patients demonstrated the phenomenon of nocturnal acid breakthrough while undergoing PPI therapy. CONCLUSIONS: Change in PPI therapy did not alter intra-oesophageal or intra-gastric control in patients with BE.

A prospective study of oesophageal 24-h ambulatory pH monitoring in patients with functional dyspepsia.

BACKGROUND: The diagnostic utility of 24-h oesophageal ambulatory pH monitoring in patients with functional dyspepsia has not been well established. AIMS: We performed a prospective study of oesophageal pH monitoring in patients with functional dyspepsia in order to assess whether a positive pH test might predict response to proton pump inhibitor therapy in a subset of functional dyspepsia patients. PATIENTS: Forty Helicobacter pylori-negative functional dyspepsia patients (35 males and 5 females, mean age (+/-S.E.M.) of 54+/-2.4 years) with predominantly unspecified dyspepsia subtype and normal distal oesophageal biopsies. METHODS: All subjects were randomised in a double-blind fashion to either omeprazole 20 mg/day or placebo daily for four weeks after 24-h pH monitoring. RESULTS: Twenty-four-hour pH monitoring was abnormal in 9 of the 21 patients (43%) in the omeprazole group and 5/19 (26%) of the placebo group (p=NS). Patients who reported symptomatic improvement on the Gastrointestinal Symptom Rating Scale were no more likely to have abnormal scores on pH monitoring than patients who did not have symptomatic response. CONCLUSIONS: Although approximately one-third of functional dyspepsia patients will have abnormal profiles on 24-h ambulatory oesophageal pH monitoring, an abnormal score does not appear to predict response to proton pump inhibitor therapy in patients with unspecified functional dyspepsia.

Oesophageal and gastric pH profiles in patients with gastro-oesophageal reflux disease and Barrett's oesophagus treated with proton pump inhibitors.

BACKGROUND: Acid plays a significant role in the development of gastro-oesophageal reflux symptoms and tissue damage. It is generally assumed that acid suppressive therapy with proton pump inhibitors improves or eliminates symptoms of gastro-oesophageal reflux disease by normalizing intra-oesophageal pH. However, the degree of acid suppression induced by proton pump inhibitor therapy in patients with gastro-oesophageal reflux disease and/or Barrett's oesophagus has not been adequately studied. AIM: To assess the efficacy of proton pump inhibitors in normalizing intra-oesophageal and intra-gastric pH in patients with gastro-oesophageal reflux disease with and without Barrett's oesophagus who have been rendered symptom-free by acid-suppressive therapy. METHODS: Patients with gastro-oesophageal reflux disease and Barrett's oesophagus were prospectively evaluated by dual sensor 24-h pH monitoring while receiving proton pump inhibitor therapy for complete control of gastro-oesophageal reflux disease symptoms. Analyses and comparisons of intra-oesophageal and intra-gastric pH profiles on therapy were then made. RESULTS: One hundred and ten patients, 98 men and 12 women, with gastro-oesophageal reflux disease (n = 62) and/or Barrett's oesophagus (n = 48), were studied. All tolerated proton pump inhibitors well and were asymptomatic at the time of the study. Thirty-six (58%) patients with gastro-oesophageal reflux disease and 24 (50%) patients with Barrett's oesophagus (P = 0.4) normalized their intra-oesophageal pH profiles on proton pump inhibitors. Compared with patients with gastro-oesophageal reflux disease, patients with Barrett's oesophagus were more likely to have higher degree of pathologic acid reflux despite proton pump inhibitor therapy (DeMeester score 50.5 +/- 8.2 vs. 31.4 +/- 4.6, P = 0.03) and exhibited less intra-gastric acid suppression (% total pH < 4.0: 53.9 +/- 2.7 vs. 39.9 +/- 2.6, P = 0.0004), particularly supine (% pH < 4.0: 62.1 +/- 3.4 vs. 44.8 +/- 3.4, P = 0.0006). CONCLUSIONS: Gastro-oesophageal reflux disease patients with or without Barrett's oesophagus continue to exhibit pathologic gastro-oesophageal reflux disease and low intra-gastric pH despite proton pump inhibitor therapy that accomplishes complete reflux symptom control. Further, intra-oesophageal and intra-gastric pH control is significantly more difficult to achieve in patients with Barrett's oesophagus. These findings may have significant therapeutic implications.

Efficacy of esomeprazole in controlling reflux symptoms, intraesophageal, and intragastric pH in patients with Barrett's esophagus.

Barrett's esophagus is a metaplastic condition associated with gastroesophageal reflux disease and an increased risk for adenocarcinoma. Acid plays a significant role in the development and progression of Barrett's esophagus and high dose proton pump inhibitor (PPI) therapy is often needed. The aim of this study is to assess the efficacy of esomeprazole, a new potent PPI, on symptom relief and intraesophageal and intragastric acid suppression in patients with Barrett's esophagus (BE). Patients were evaluated by standardized questionnaires and dual sensor 24-h pH monitoring while receiving esomeprazole at a dose (40-80 mg/day) needed for control of symptoms. Analyses of intraesophageal and intragastric pH profiles were then made. Thirteen patients, mostly men, were studied. All tolerated esomeprazole (40-80 mg/day) with good symptom control. Sixty-two percent of patients with BE had abnormal intraesophageal pH profiles despite adequate symptom control on esomeprazole which was associated with significant breakthrough of intraesophageal acid control, particularly at night. Low nocturnal intragastric pH correlated highly with nocturnal intraesophageal acid reflux (P = 0.004) and there was a relative failure of nocturnal intragastric acid control with esomeprazole. A high percentage of patients with BE continue to exhibit pathologic GERD and low intragastric pH despite esomeprazole for reflux symptom control. For an antisecretory treatment aimed at chemoprevention of esophageal adenocarcinoma to be effective, higher PPI dosing confirmed by pH monitoring may be necessary.

A prospective randomized trial comparing a virtual reality simulator to bedside teaching for training in sigmoidoscopy.

BACKGROUND AND STUDY AIMS: Clinical investigation using endoscopy simulators is now possible due to recent advances in virtual reality technology. A prospective randomized trial was conducted to compare the exclusive use of a virtual reality endoscopy simulator with bedside teaching for training in sigmoidoscopy. MATERIALS AND METHODS: Internal medicine residents were randomly assigned to training exclusively using a virtual reality simulator (group 1) or via bedside teaching (group 2). Residents were then observed performing five sigmoidoscopic procedures in asymptomatic patients referred for colorectal cancer screening. Endoscopic examinations were evaluated for procedure duration, completion, ability to perform retroflexion, and level of patient comfort/discomfort. Each examination was scored from 1 (inability to insert the endoscope beyond the rectum) to 5 (able to complete the entire examination independently in less than 20 min). RESULTS: Sixty-six sigmoidoscopic examinations were completed by nine residents in group 1 (simulator-trained group) and seven residents in group 2 (traditional teaching group). Participants in group 1 had more difficulty with initial endoscope insertion and negotiation of the rectosigmoid junction (mean score +/- SEM 2.9 +/- 0.2) than those in group 2 (3.8 +/- 0.2) ( P < 0.001). The splenic flexure was reached independently in 10 of 34 examinations (29 %) in group 1, compared with 23 of 32 examinations (72 %) in group 2 ( P = 0.001). Retroflexion was successfully performed by 19 of 34 (56 %) in group 1 compared to 27 of 32 (84 %) in group 2 ( P = 0.02). The average procedure time, patient satisfaction, and discomfort associated with the procedure did not differ statistically between the two groups. CONCLUSIONS: The use of a state-of-the-art virtual reality-based endoscopy simulator is inferior to traditional bedside teaching techniques when used exclusively for training medical residents to perform sigmoidoscopy.

Use of a simple symptom questionnaire to predict Barrett's esophagus in patients with symptoms of gastroesophageal reflux.

OBJECTIVE: Accurately predicting Barrett's esophagus (BE) in patients with gastroesophageal reflux disease (GERD) is difficult. Using logistic regression analysis of symptom questionnaire scores we created a model to predict the presence of BE. METHODS: We conducted a logistic regression analysis of symptom data collected prospectively on 517 GERD patients and created a prediction model based on patient gender, age, ethnicity, and symptom severity. RESULTS: There were 337 (65%) males and 180 (35%) females, of whom 99 (19%) had Barrett's esophagus (BE). Multiple logistic regression analysis was performed to determine the predictive ability of gender, age, and ethnicity along with symptoms of heartburn, nocturnal pain, odynophagia, presence of belching, dysphagia, relief of symptoms with food, and nausea. The only significant predictors (at the 0.05 level) were male gender, heartburn, nocturnal pain, and odynophagia (all with positive effects on the presence of BE) and dysphagia (which had a negative effect). A nomogram was produced to show the effect of a given predictor on the probability of having BE in the context of the effects of the other predictors, and to estimate the probability of having BE for a given individual. The mean score (+/-SD) for the BE patients in our sample was 397.4+/-46.2 with a range of 292-530. For the patients without BE, the mean score (+/-SD) was 351.3+/-60.3 with a range of 190 - 528 (p < 0.001). If screening for BE is performed at a score of 375 or more, our model would have a specificity of 63% with a sensitivity of 77% (95% CI 61-86% given the 63% specificity). CONCLUSIONS: By asking seven questions about symptom severity, clinicians may be able to assign a probability to the presence of BE, and thus, determine the need for endoscopy in GERD patients.

Proton pump inhibitors and their drug interactions: an evidence-based approach.

The proton pump inhibitors (PPIs) are the most effective antisecretory agents used to treat acid-related disorders. As such, they are frequently prescribed for patients who are concurrently using other medications. PPIs may interact with other drugs through numerous mechanisms. The most important include competitive inhibition of hepatic cytochrome P (CYP) 450 enzymes involved in drug metabolism, and alteration of the absorption of other drugs via changes in gastric pH levels. Poor metabolizers, who lack CYP2C19, may be particularly predisposed to drug interactions. Although the potential for drug interactions is high, few clinically significant interactions have been reported for the PPIs. Nevertheless, caution is indicated when certain drugs are co-prescribed with these agents. The incidence of clinically significant drug interactions increases proportionately with the number of drugs taken and with the age of the patient. The drug interaction with the greatest clinical importance is the reduction in benzodiazepine clearance by omeprazole.

Is colorectal cancer screening necessary in the preoperative assessment of inguinal herniorrhaphy? A case-control study.

OBJECTIVES: The question of whether patients presenting for inguinal hernia repair require pre-operative assessment for colon cancer has remained unanswered. A case-control study is necessary to assess whether the prevalence of premalignant or malignant colonic lesions is higher in patients presenting with inguinal hernia compared to the general population. METHODS: Between 1990-2000, 614 inguinal herniorrhaphies were performed at the Veterans Affairs Palo Alto Health Care System (VAPAHCS). We retrospectively studied the 149 (24%) patients from this group with no prior history of colonic polyps, malignancy, or gastrointestinal bleeding who had flexible sigmoidoscopy or colonoscopy performed during the peri-operative period. Comparison was made to 149 controls undergoing colonoscopy or sigmoidoscopy during the same time period for colon cancer (CRC) screening. RESULTS: The mean (+/-SEM) patient age was 67 +/- 0.7 (range 31-92) yr in the hernia patients and 66 +/- 0.8 (range 46-93) in the control group (p = 0.7). Eighty-two of the inguinal hernia patients had screening procedures performed preoperatively with a mean time (+/-SEM) of 1.4 +/- 0.14 yr, while endoscopy was performed in the post-operative period for the remaining 67 patients (average time 2.7 +/- 0.2 yr, p < 0.001). More patients underwent colonoscopy in the control group compared to the hernia cohort (p = 0.004). Seven (5%) patients in the hernia group were found to have colorectal cancer compared to six (4%) in the control group (p = 0.8). CONCLUSIONS: This study does not support previously published findings that patients with inguinal hernias are more likely to have premalignant colonic lesions. Patients with inguinal hernias should undergo screening for colon cancer at the same rate as the general population.

Palliative care in inflammatory bowel disease: an evidence-based approach.

The management of the patient with inflammatory bowel disease (IBD) is challenging for both the physician and the patient. IBD imposes both a physical and emotional burden on patients' lives. Palliative care is important for IBD patients because it focuses on improving quality of life. While palliative care does not change the natural history of the disease, it provides relief from pain and other distressing symptoms. This article focuses on various aspects of care for IBD patients including pain control, management of oral and skin ulcerations, stomal problems in IBD patients, control of nausea and vomiting, management of chronic diarrhea and pruritus ani, evaluation of anemia, treatment of steroid-related bone disease, and treatment of psychological problems associated with IBD. Each of these areas is reviewed using an evidence-based approach. Evidence in category A refers to evidence from clinical trials that are randomized and well controlled. Category B Evidence refers to evidence from cohort or case-controlled studies. Category C is evidence from case reports or flawed clinical trials. Evidence from category D is limited to the clinical experience of the authors. Evidence labelled as category E refers to situations where there is insufficient evidence available to form an opinion. Algorithms for management of pain and nausea in IBD patients are presented.

Effect and outcomes of the ASGE guidelines on the periendoscopic management of patients who take anticoagulants.

OBJECTIVE: In December 1997, the American Society of Gastrointestinal Endoscopy (ASGE) issued guidelines regarding periendoscopic management of patients who take anticoagulants. They recommended that physicians substitute heparin for warfarin in their patients who have highly thrombotic conditions (e.g., a mechanical valve in the mitral position), and who will undergo high-risk procedures (e.g., polypectomy). The purpose of this study was to assess whether patient outcomes and anticoagulant management changed after the publication of the 1997 guidelines. METHODS: We collected utilization data on all 104 patients at the Veterans Affairs Palo Alto Health Care System who were taking chronic warfarin therapy and who underwent endoscopic procedures during the study period (1996-1999). These patients underwent 99 colonoscopies, 63 upper endoscopies, and nine endoscopic retrograde cholangiopancreatographies. According to the ASGE guidelines, 18 of these patients had highly thrombotic conditions, whereas the remaining 86 patients had relatively low thrombotic conditions. We calculated their costs for intravenous or subcutaneous heparin therapy from the perspective of society. We followed-up all patients for 3 months, to determine the incidence of thrombotic and hemorrhagic outcomes. RESULTS: No patient suffered a thromboembolism or a hemorrhage; thus, the adverse-event rate (95% confidence interval) was 0% (0-3%). As recommended by the ASGE guidelines, all five (100%) patients who had highly thrombotic conditions had heparin substituted for warfarin before undergoing high-risk procedures. This strategy was also followed in 44 (27%) of the 166 procedures in other patients: 16 high-risk procedures in low-risk patients, and 28 low-risk procedures (in 20 low-thrombotic patients and in eight high-thrombotic patients). There was no significant difference between the management of any patients before and after the publication of the guidelines. The average cost per course of heparin therapy (typically 2 days intravenous heparin preprocedure, and 3 days heparin administered subcutaneously postendoscopy) was $1684. In all, 44 (90%) of 49 courses of heparin substituted for warfarin therapy were not recommended by the guidelines. CONCLUSIONS: Patients treated by the ASGE guidelines had the same 0% rate of thrombosis as patients who received periendoscopic heparin outside of the guidelines. Following the ASGE guidelines in all patients would have reduced the use of heparin therapy by 90%, for a net savings of $74,100.

Clinical and fiscal impact of lansoprazole intolerance in veterans with gastro-oesophageal reflux disease.

BACKGROUND: Omeprazole was replaced by lansoprazole as the only proton pump inhibitor on the Veterans Affairs (VA) formulary in February 1997. We aimed to assess the clinical and fiscal impact of this conversion at two VA hospitals. METHODS: We identified lansoprazole intolerant patients using pharmacy databases. We reviewed medical records to obtain data regarding reasons for lansoprazole intolerance. The costs of the formulary change and the savings to the VA were calculated. RESULTS: A total of 3833 patients required long-term proton pump inhibitor therapy; 2224 (58%) were started on lansoprazole and 1479 (39%) were converted from omeprazole to lansoprazole. The remaining 130 (3.4%) patients were never converted from omeprazole to lansoprazole. Of the 3833 patients, 325 (8.5%) currently receive omeprazole therapy; of these, 195 out of 3703 (5.3%) patients are true lansoprazole failures; 172 of these 195 patients completed the study. Most (87%) of the lansoprazole intolerant patients received prior omeprazole. Discontinuation of lansoprazole was due to poor symptom control in 69% and/or side-effects (22%) including diarrhoea (10%), abdominal pain (5%), or hives (1%). The 1-year cost of managing lansoprazole failure in 195 patients was $61 690. However, the savings to the VA during the same time period, which totalled $321 360, more than offset the costs associated with the conversion. CONCLUSIONS: Lansoprazole intolerance requiring omeprazole conversion occurred in 5% of veterans on proton pump inhibitor therapy for chronic gastro-oesophageal reflux disease (GERD) symptoms and in 10% of patients with prior omeprazole success. The VA realized substantial cost savings in association with the formulary change.