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Abstract Background The effect of thiopurine immunomodulators on health-related quality of life (HRQoL) in patients with inflammatory bowel disease (IBD) has been controversial. The aims were to evaluate the HRQoL in patients with IBD treated with thiopurines and assess the short- and long-term impacts of the treatment on HRQoL. Methods Ninety-two consecutive patients who started treatment with thiopurines were prospectively included. Evaluation of HRQoL was performed at months 0, 6, and 12 using two questionnaires, the Short-Form Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ). Results Baseline score of IBDQ was 4,6, range (2,31-6,84), with an impairment of the five dimensions of HRQoL compared with inactive patients. Results obtained in 8 dimensions of SF-36 showed worse HRQoL than Spanish general population. At 6 months patients had a significant improvement in overall IBDQ score -5,8 (1,58 -6,97)- and also in all IBDQ dimensions. All the 8 dimensions of SF-36 obtained a significant improvement. At twelve months score of IBDQ was 6,1, range (2,7-6,98), with improvement in all dimensions compared with baseline and 6 months. SF-36 showed a similar significant improvement in all subscales. Conclusions Thiopurine immunomodulators alone or with other treatments have a positive and long lasting impact on HRQoL of IBD patients.

Background: The effect of thiopurine immunomodulators on health-related quality of life (HRQoL) in patients with inflammatory bowel disease (IBD) has been controversial. The aims were to evaluate the HRQoL in patients with IBD treated with thiopurines and assess the short- and long-term impacts of the treatment on HRQoL.Methods: Ninety-two consecutive patients who started treatment with thiopurines were prospectively included. Evaluation of HRQoL was performed at months 0, 6, and 12 using two questionnaires, the Short-Form Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ).Results: Baseline score of IBDQ was 4,6, range (2,31-6,84), with an impairment of the five dimensions of HRQoL compared with inactive patients. Results obtained in 8 dimensions of SF-36 showed worse HRQoL than Spanish general population. At 6 months patients had a significant improvement in overall IBDQ score -5,8 (1,58 -6,97)- and also in all IBDQ dimensions. All the 8 dimensions of SF-36 obtained a significant improvement. At twelve months score of IBDQ was 6,1, range (2,7-6,98), with improvement in all dimensions compared with baseline and 6 months. SF-36 showed a similar significant improvement in all subscales.Conclusions: Thiopurine immunomodulators alone or with other treatments have a positive and long lasting impact on HRQoL of IBD patients. [ABSTRACT FROM AUTHOR]

The rise in food intolerances and celiac disease, along with advanced diagnostic techniques, has prompted health professionals to seek effective and economical testing methods. This study evaluates combining genetic tests with routine carbohydrate-absorption breath tests to classify patients with chronic gastrointestinal disorders into therapeutic groups, enhancing dietary management and improving gut health and quality of life. Forty-nine patients with suspected carbohydrate intolerance underwent genetic testing for lactase non-persistence, hereditary fructose intolerance, and celiac disease risk. Simultaneously, breath tests assessed lactose and fructose absorption. The lactase non-persistence genotype appeared in 36.7% of cases, with one hereditary fructose-intolerance case in a heterozygous condition. Celiac disease risk markers (HLA-DQ2/8 haplotypes) were found in 49.0% of the population. Secondary lactose and/or fructose malabsorption was present in 67.3% of patients, with 66.1% of lactase non-persistence individuals showing secondary lactose malabsorption. Fructose malabsorption was prevalent in 45.8% of patients at risk for celiac disease. Two main treatment groups were defined based on genetic results, indicating primary and irreversible gastrointestinal disorder causes, followed by a sub-classification using breath test results. Genetic testing is a valuable tool for designing dietary management plans, avoiding unnecessary diet restrictions, and reducing recovery times.

Background: Retrospective studies have suggested that long-term use of opioids can cause esophageal motility dysfunction. A recent clinical entity known as opioid-induced esophageal dysfunction (OIED) has been postulated. There is no data from prospective studies assessing the incidence of opioid-induced effects on the esophagus., Aim: Evaluate the incidence of OIED during chronic opioid therapy., Methods: From February 2017 to August 2018, all patients seen in the Pain Unit of the hospital, who started opioid treatment for chronic non-neoplastic pain and who did not present esophageal symptoms previously, were included. The presence of esophageal symptoms was assessed using the Eckardt score after 3 months and 1 year since the start of the study. In February 2021, the clinical records of all included patients were reviewed to assess whether esophageal symptoms were present and whether opioid therapy was continued. In patients presenting with esophageal symptoms, an endoscopy was performed and, if normal, a high-resolution esophageal manometry was performed. For a confidence level of 95%, a 4% margin of error and an estimated prevalence of 4%, a sample size of 92 patients was calculated., Results: 100 patients were included and followed while taking opioids, for a median of 31 months with a range between 4 and 48 months. Three women presented with dysphagia during the first 3 months of treatment, being diagnosed with esophagogastric junction outflow obstruction; type II and type III achalasia. The cumulative incidence of OIED was 3%; 95%-CI: 0-6%., Conclusions: Chronic opioid therapy in patients with chronic non-neoplastic pain is associated with symptomatic esophageal dysfunction., (Copyright © 2022 Elsevier España, S.L.U. All rights reserved.)

Opioids have become the most widely prescribed analgesics in Western countries. Opioid-induced bowel dysfunction is a widely known adverse effect, with constipation the most common manifestation. Most of the opioid-related effects occur in the stomach, small intestine, and colon and have been widely studied. However, the effects related to esophageal motility are less known. Recently published retrospective studies have suggested that long-term use of opioids can cause esophageal motility dysfunction, reflecting symptoms similar to motility disorders, such as achalasia and functional esophagogastric junction outflow obstruction. The most common manometric findings, as reported in the literature, for patients with opioid-induced dysphagia undergoing long-term therapy with these drugs are impaired lower esophageal sphincter relaxation, high amplitude/velocity, and simultaneous esophageal waves, higher integrated relaxation pressure, lower distal latency, and the esophageal contractility can be normal, hypercontractile, or premature. Based on these studies, a new clinical entity known as opioid-induced esophageal dysfunction has been postulated. For these patients, the diagnostic method of choice is high-resolution manometry, although other causes should be ruled out through endoscopy or Computed Tomography (CT). The best therapeutic option for these patients is withdrawal of the opioid; however, this is not always possible, and other options need to be investigated, such as pneumatic dilation and botulinum toxin injection, considering the risks versus the benefits.

Background/aims: To evaluate esophageal sensitivity to acid between morbidly obese (MO) patients and non-MO controls with abnormal esophageal acid exposure., Methods: We conducted a cross-sectional study of 58 patients: 30 MO (cases) and 28 non-MO (controls). Esophageal symptoms and esophageal sensitivity to 0.1 M hydrochloric acid solution (Bernstein test) were compared between MO and non-MO patients with a prior diagnosis of abnormal esophageal acid exposure., Results: MO patients were less symptomatic than non-MO controls (14% vs 96%; odds ratio [OR], 0.006; 95% confidence interval [CI], 0.001 to 0.075; p=0.000). MO patients were more likely to present with decreased esophageal sensitivity to the instillation of acid than non-MO controls (57% vs 14%; OR, 8; 95% CI, 1.79 to 35.74; p=0.009). Subgroup analysis revealed no differences in esophageal sensitivity in MO patients with and without abnormal esophageal acid exposure (43% vs 31%; p=0.707)., Conclusions: Silent gastroesophageal reflux disease (GERD) is common among MO individuals, likely due to decreased esophageal sensitivity to acid. The absence of typical GERD symptoms in these patients may delay discovery of precancerous conditions, such as Barrett's esophagus. We believe that these patients may require a more aggressive diagnostic work-up to rule out the presence of silent GERD.

The effect of high-resolution esophageal manometry (HRM) on oxygen saturation (SaO2) and hemodynamic function has not been previously evaluated. This was a prospective study of consecutive patients referred for HRM. Demographic and clinical data were collected on all patients. The study variables included SaO2, heart rate (HR) and blood pressure (BP). SaO2 and HR were measured at baseline, during intubation, during and 5 min after HRM. BP was measured at baseline, during and after HRM. 158 (56% women) patients with a mean age of 56 (SD 15) years were included. Thirty-five (22%) were obese and 55 (35%) were overweight. Eighteen (12%) patients had a history of respiratory disease and 27 (17%) were smokers. Intubation was difficult in 22%. Exploration tolerance was poor in 17% or very poor in 6%. The average duration of the test was 9.9 (SD 2.8) minutes. Sixty-four (47%) and 59 (37%) patients had SaO2 below 95% during intubation and during HRM, respectively. Three patients had SaO2 ≤90%. Sixty-nine (44%) patients had tachycardia during intubation and 8 (5%) during HRM. The appearance of desaturation (SaO2 <95%) during intubation was associated with a lower basal SaO2; desaturation during HRM and 5 minutes after HRM was associated with a higher age, a higher BMI and a lower basal SaO2. HRM decreases SaO2 and increases heart rate primarily during the insertion of the probe, as part of the standard stress response and therefore HMR can be considered a safe procedure. However, in older and overweight patients, respiratory parameters should be monitored., (© 2017 International Society for Diseases of the Esophagus.)

Background: *N.P. and M.P. contributed equally to this study.The current prevalence of esophagitis in southern Europe is unknown. In addition, the risk factors for reflux esophagitis are not fully understood., Objective: The objective of this article is to assess the prevalence and risk factors for esophagitis in Spain., Methods: A prospective, observational, cross-sectional, multicenter study (PRESS study) was conducted among 31 gastrointestinal endoscopy units throughout Spain. A total of 1361 patients undergoing upper gastrointestinal endoscopy were enrolled. Sociodemographic, clinical and treatment data were recorded., Results: A total of 95% of patients were Caucasian and 52% were male (mean age: 53 ± 17 years). The most frequent symptoms prompting endoscopy were heartburn (40%), regurgitation (26%) and dysphagia (15%). Fifty-four percent of patients undergoing endoscopy were receiving proton pump inhibitor (PPI) treatment. Esophagitis (mainly mild-moderate) was present in 154 (12.4%) patients. The severe form was recorded in only 11 (0.8%) patients. Multivariate analysis results indicated that the likelihood of esophagitis was higher in men (OR = 1.91, 95% CI = 1.31-2.78), in patients with high GERD-Q scores (OR = 1.256, 95% CI = 1.176-1.343), weight increase (OR = 1.014, 95% CI = 1.003-1.025) and high alcohol consumption (OR = 2.49, 95% CI = 1.16-5.36)., Conclusion: Severe esophagitis is a rare finding in the Spanish population. Male gender, high GERD-Q score, weight increase and high alcohol consumption are main risk factors for its appearance.

Chronic cough (CC), or cough lasting more than 8 weeks, has attracted increased attention in recent years following advances that have changed opinions on the prevailing diagnostic and therapeutic triad in place since the 1970s. Suboptimal treatment results in two thirds of all cases, together with a new notion of CC as a peripheral and central hypersensitivity syndrome similar to chronic pain, have changed the approach to this common complaint in routine clinical practice. The peripheral receptors involved in CC are still a part of the diagnostic triad. However, both convergence of stimuli and central nervous system hypersensitivity are key factors in treatment success., (Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.)

Background: The growing demand for colonoscopies and inappropriate colonoscopies have become a significant problem for health care., Objectives: To assess the appropriateness of colonoscopies and to analyze the association with some clinical and organizational factors. To compare the results of the European Panel of Appropriateness of Gastrointestinal Endoscopy (EPAGE) and the EPAGE-II criteria., Design: Cross-sectional study., Setting: Endoscopy unit of a teaching hospital in Spain., Patients: Patients referred for colonoscopy, excluding urgent, therapeutic indications, and poor cleansing., Main Outcome Measurements: Appropriateness of colonoscopies according to the EPAGE criteria., Results: From 749 colonoscopies, 619 were included. Most patients were referred by gastroenterologists (66.1%) in an outpatient setting (80.6%). Hematochezia was the most frequent indication (31.5%) followed by colorectal cancer-related indications (27.3%); a clinically relevant diagnosis was established in 41%. Inappropriate use was higher with EPAGE (27.0%) than EPAGE-II (17.4%) criteria. Surveillance after colonic polypectomy and uncomplicated lower abdominal pain were the indications exhibiting higher inadequacy. Inappropriate use was less with older age, in hospitalized patients, with referrals from internal medicine, and in colonoscopies with clinically relevant diagnoses. Agreement between EPAGE and EPAGE-II was fair (weighted κ = 0.31) but improved to moderate (simple κ = 0.60) after grouping appropriate and uncertain levels., Limitations: The appropriateness criteria are based on panel opinions. Some patients (12%) could not be evaluated with the EPAGE criteria., Conclusions: Our study identifies substantial colonoscopy overuse, especially in tumor disease surveillance. The EPAGE-II criteria decrease the inappropriate rate and the possibility of overlooking potentially severe lesions., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Epidemiological studies have shown a greater prevalence of irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) among first-degree relatives of patients diagnosed of these diseases. However, it is not known whether relatives of patients with IBD have a greater prevalence of IBS than the general population., Aims: To analyse the prevalence of IBS among first-degree relatives by consanguinity (parents, siblings and offspring) and affinity (spouses) of patients with IBD., Materials and Methods: A prevalence study was conducted identifying 490 relatives of 91 patients with IBD. Of these, 404 met inclusion criteria; and 360 (response rate: 89.1%) answered the questionnaires. Subjects were invited to participate in the study through index cases (patients with IBD). The following variables were collected: age, sex, history of digestive diseases, kinship and cohabitation with the index case. The relatives completed a questionnaire to identify those who met Rome I and Rome II criteria for IBS., Results: The overall prevalence of IBS among the first-degree relatives of patients with IBD was 49.4% and 10% according to Rome I and Rome II criteria respectively. IBS prevalence was higher in first-degree blood relatives than in spouses of patients (Rome I: 53.1% vs 29.1%, p=0.001; Rome II: 10.8% vs 5.4%, NS). No differences were found in IBS prevalence depending on whether relatives were living with the index case or not., Conclusion: IBS prevalence in first-degree relatives of patients with IBD is elevated. It is significantly greater in blood relatives, which suggests involvement of genetic and psychological factors rather than environmental factors., (Copyright © 2011 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.)

Background: Heartburn is frequently reported by patients with achalasia before treatment. However, the esophageal sensitivity to acid as a possible mediator of this symptom has not been previously evaluated., Aim: To evaluate the prevalence of gastroesophageal reflux symptoms and the esophageal sensitivity to acid perfusion in patients with untreated achalasia., Methods: Forty patients with achalasia were prospectively evaluated. Forty-three patients with gastroesophageal reflux disease comprised the control group (ten of them with Barrett's esophagus). Symptoms were evaluated by a structured clinical questionnaire. Objective assessment was performed by ambulatory 24-h esophageal pH monitoring and endoscopy. Esophageal sensitivity to acid was evaluated by esophageal perfusion of ClH 0.1 N., Results: Fifteen (37%) of the 40 patients with achalasia presented heartburn, but only four of them had esophagitis and/or abnormal esophageal pH recording. Eight patients had abnormal pH recording. Three patients had esophagitis. The esophagus was sensitive to acid in seven (17%) patients with achalasia, three of them with heartburn and one with abnormal pH recording. In the control group, 40 of 43 (93%) presented heartburn. Acid perfusion was positive in 32 (74%). Sensitivity to acid was lower in patients with achalasia than in those with gastroesophageal reflux disease with or without Barrett's esophagus., Conclusions: The prevalence of heartburn in patients with achalasia is high, although its association with objective indicators of gastroesophageal reflux disease is weak. Patients with achalasia have lower esophageal sensitivity to acid than patients with GERD, suggesting that heartburn is does not arise from this condition.

Background: Gastroesophageal reflux disease (GERD) has a major impact at the primary care level and there is a need to evaluate whether the diagnosis and therapeutic management of GERD in Europe needs to be improved., Methods: This project was designed to test the hypothesis that a new primary care management strategy would improve outcomes for patients with GERD, compared with usual care, in Europe. The analysis pools five separate cluster-randomized studies conducted in Austria, Italy, Norway, Spain and Sweden. These studies used a strategy based on the self-administered GerdQ questionnaire to stratify adult patients with symptoms of heartburn or regurgitation according to the frequency and impact of symptoms. A score of ≥8 indicates a high probability of suffering GERD. Patients with a GerdQ impact score ≤2 were treated with generic proton-pump inhibitors according to local guidance, and patients with an impact score ≥3 were treated with esomeprazole 40 mg once daily., Results: In total, 2400 patients were enrolled across the five studies. The protocols were modified by individual countries according to their local guidelines/requirements. In Norway, the new management strategy was compared with traditional routine endoscopy and 24-hour pH-metry, and encompassed proton-pump inhibitor reimbursement restrictions. Outcome measures differed by country, but included control of GERD symptoms, self-rated health status and work productivity, treatment changes, specialist referrals and physician adherence. GERD-related use of healthcare resources was also evaluated., Conclusion: The pooled analysis will determine whether a locally adapted primary care management strategy for GERD, using GerdQ as a patient-tailored diagnostic and therapeutic evaluation tool, is beneficial compared with usual care across five countries with different standard approaches to GERD management and control.

Aim: Upper oesophageal pH monitoring may play a significant role in the study of extra-oesophageal GERD, but limited normal data are available to date. Our aim was to develop a large series of normal values of proximal oesophageal acidification., Methods: 155 healthy volunteers (74 male) participated in a multi-centre national study including oesophageal manometry and 24 hours oesophageal pH monitoring using two electrodes individually located 5 cm above the LOS and 3 cm below the UOS., Results: 130 participants with normal manometry completed all the study. Twelve of them were excluded for inadequate pH tests. Twenty-seven subjects had abnormal conventional pH. The remaining 91 subjects (37 M; 18-72 yrs age range) formed the reference group for normality. At the level of the upper oesophagus, the 95th percentile of the total number of reflux events was 30, after eliminating the meal periods 22, and after eliminating also the pseudo-reflux events 18. Duration of the longest episodes was 5, 4 and 4 min, respectively (3.5 min in upright and 0.5 min in supine). The upper limit for the percentage of acid exposure time was 1.35, 1.05 and 0.95%, respectively. No reflux events were recorded in the upper oesophagus in 8 cases., Conclusion: This is the largest series of normal values of proximal oesophageal reflux that confirm the existence of acid reflux at that level in healthy subjects, in small quantity and unrelated to age or gender. Our data support the convenience of excluding pseudo-reflux events and meal periods from analysis.

We report three cases of primary renal tumors occurring on post-transplant kidneys, after a delay of 4, 8 and 12 years respectively following transplantation in a population of 1134 post kidney transplant followed at our institution. All three tumors underwent early detection because of the yearly ultrasound evaluation recommended for all post kidney transplant patients. The diagnosis was suggested by CT in all three cases but confirmed by preoperative percutaneous biopsy in two cases. The final pathology results confirmed two cases of clear cell renal carcinomas and one case of oncocytoma. Tumorectomy was undertaken for all three patients with successful results in two cases and return to hemodialysis in the third patient with a 4 cm tumor with mass effect on the collecting system.

Treatment of hepatitis C in renal transplant recipients remains a controversial issue, as interferon therapy has been associated with a high risk of rejection and poor efficacy. We report here the use of pegylated interferon-alpha, alone or in combination with ribavirin, in renal transplant recipients with chronic hepatitis C. Eight renal transplant recipients with chronic hepatitis C were recruited. The mean delay between renal transplantation and antiviral therapy was 198.8 months. Sustained virological response was observed in four of out eight patients. Three patients with sustained virological response were genotype 2, one was genotype 1; fibrosis stages were F1 for one patient, F2 for 2, F3 for one. At baseline, renal dysfunction was moderate in seven patients and severe in one patient. No patient experienced rejection episodes during or after pegylated interferon-alpha therapy. One patient developed haemolytic uraemic syndrome, which eventually resulted in graft loss and return to dialysis. In conclusion, for renal transplant recipients treated with pegylated interferon-alpha-based therapy, we observed a low risk of renal dysfunction, acceptable tolerance and significant virological efficacy. This is therefore the first study to suggest that pegylated interferon-alpha could be proposed late after transplantation to renal transplant recipients.

Gastroesophageal reflux disease (GERD) is defined as a pathologic condition that develops when reflux of stomach contents produce annoying symptoms and/or complications. According to whether esophagitis is present, GERD is classified as being erosive and non-erosive. Functional pyrosis is defined by the presence of retrosternal burning for at least 6 months in the absence of structural or metabolic alterations, GERD, or motor disorders that could cause the symptoms. Currently, functional pyrosis does not include patients with an acid-sensitive esophagus or those who improve with antisecretory drugs, which differentiates this entity from non-erosive GERD. GERD has usually been identified with acid reflux. However, the availability of new diagnostic methods such as Bilitec and, especially, impedance monitoring has revealed that acid, weakly acidic and gas reflux is able to produce distressing symptoms and complications in some patients.

Alterations in the physiological mechanism of swallowing involve several anatomical structures performing complex and coordinated activities. These alterations can be secondary to various pathological conditions with highly varied causes. Consequently, the approach to patients with swallowing disorders represents a diagnostic challenge. The first difficulty arises in establishing a diagnosis of the syndrome, in which the presence of dysphagia is often the key symptom. The second difficulty lies in identifying the alteration: distinguishing between those affecting the oral and pharyngeal phases and those affecting the pharyngeal phase is clinically important since the etiology and diagnostic strategy will differ. Whenever possible, treatment should be etiological and should aim to restore the swallowing mechanism. Alternative routes for nutrition are sometimes required, either because etiological treatment is lacking or to avoid complications.

Purpose: The aim of this study was to perform a psychometric evaluation of the Fecal Incontinence Quality of Life Scale in the Spanish language., Methods: Eleven hospitals in Spain participated in the study, which included 118 patients with active fecal incontinence. All the patients filled out a questionnaire on the severity of their incontinence, a general questionnaire of health (Medical Outcomes Survey Short Form), and a Spanish translation of the Fecal Incontinence Quality of Life Scale (Cuestionario de Calidad de Vida de Incontinencia Anal), which consists of 29 items in four domains: lifestyle, behavior, depression, and embarrassment. On a second visit, patients repeated the Fecal Incontinence Quality of Life Scale. For each domain, an evaluation was made of temporal reliability, internal reliability, the convergent validity with the generic questionnaire of health, and the discriminant validity correlating the domains of Cuestionario de Calidad de Vida de Incontinencia Anal with the severity of fecal incontinence., Results: For cultural adaptation, the answer alternatives for 14 items were modified. A total of 111 patients (94 percent) completed the study adequately. Temporal reliability (test-retest) was good for all domains except for embarrassment, which showed significant differences (P < 0.02). Internal reliability was good/excellent for all domains (Cronbach alpha >0.80, between 0.84 and 0.96). The four domains of Cuestionario de Calidad de Vida de Incontinencia Anal significantly correlated with the domains of the generic questionnaire on health (P < 0.01) and with the scale of severity of fecal incontinence (P < 0.001). All domains of Cuestionario de Calidad de Vida de Incontinencia Anal correlated negatively with the need to wear pads (P < 0.01) and with the presence of complete fecal incontinence., Conclusions: The Cuestionario de Calidad de Vida de Incontinencia Anal incorporates sufficient requirements of reliability and validity to be applied to patients with fecal incontinence.

Objective: To evaluate the prevalence of gastroesophageal reflux disease (GERD) in severely obese patients and the association between symptoms and objective data of GERD in this population., Research Methods and Procedures: A total of 158 consecutive severely obese patients (BMI > or = 40 kg/m(2)) were prospectively evaluated. Symptoms were evaluated by a structured clinical questionnaire. Objective assessment was made by ambulatory 24-hour esophageal pH monitoring and endoscopy. GERD was defined by the presence of symptoms or complications (esophagitis). The clinical criterion defining GERD was the presence of at least two episodes of heartburn per week., Results: The mean age of the 138 patients subjected to complete study was 42.6 +/- 10.2 years, with a BMI of 50.1 +/- 6.9 kg/m(2) (range, 40.6 to 69.4 kg/m(2)); 78% were women. The prevalence of GERD evaluated by symptoms and/or esophagitis was 33.3% (46/138). Clinical criteria of GERD were present in 31/138 cases (22.5%), and 26 (18.8%) had esophagitis. In 69/138 patients (50%), pHmetry was abnormal. Fifty-three patients with esophagitis and/or abnormal pHmetry were asymptomatic. The sensitivity of heartburn as a diagnostic criterion of GERD in patients with severe obesity was 29.3%, with a specificity of 85.7%. No significant association was observed between severe obesity grade and the prevalence of symptoms and/or objective data., Discussion: Asymptomatic gastroesophageal reflux (abnormal esophageal acid exposure and/or reflux esophagitis) is more common than symptomatic gastroesophageal reflux in severely obese patients. Increased BMI is not associated with a greater prevalence of GERD in these patients.

The nonstenotic, nonfistulizing (or inflammatory) pattern of Crohn's disease appears to be unstable in time and may evolve toward either the stenotic or the fistulizing pattern. We aimed to assess the course of the inflammatory disease and its relation to certain clinical characteristics. After a mean follow-up of 93 months, we evaluated 73 patients with an inflammatory pattern. The behavior trend and its relation to disease location, initial treatment, and need for corticosteroids, immunosuppressors, and surgical resection were analyzed. In 64% of the patients the inflammatory pattern did not change, while in 14 and 22% it evolved toward a stenotic and a fistulizing pattern, respectively. This change was mainly determined by the appearance of perianal disease (75%). The mean time to behavior evolution was 67 months. Most patients required corticosteroids (92%). Need for immunosuppressors (48%) and surgical resection (30%) was significantly greater (P < 0.05) among patients with a change in pattern than in those with persistent inflammatory disease. The inflammatory pattern of CD remains stable in about half of patients. The course of this pattern is not indolent, however, since the needs for immunosuppression and surgical resection during follow-up are considerable.

Introduction: Crohn's disease shows periods of exacerbation and remission. Corticosteroids are the most frequently used drugs in exacerbations of disease activity. The objective of this study is to determine which clinical and laboratory parameters are associated with the therapeutic decision to administer corticosteroids during the course of the disease., Material and Method: Two-hundred seven consecutive visits made by 62 patients with Crohn's disease were selected from a database. Data from visits in which corticosteroid administration was initiated (n = 65) were compared with those from visits in which this decision was not made (n = 142). Univariate and multivariate (logistic regression) analyses were performed. The results are expressed as odds ratio (OR) with 95% confidence interval (95% CI)., Results: In the univariate analysis statistically significant differences were found between groups in localization, maintenance treatment, Crohn's Disease Activity Index (CDAI) score, the presence of abdominal pain, mass, perianal disease, extraintestinal manifestations and all laboratory parameters (leukocytes, platelets, fibrinogen, erythrocyte sedimentation rate, C-reactive protein). In the multivariate analysis (with corticosteroid administration as the dependent variable) a statistically significant positive association was found between the decision to administer corticosteroids and mild (OR = 31.9; 95% CI, 6.6-154.1), moderate or severe (OR = 49.7; 95% CI, 6.1-401.3) CDAI, ileocolic localization (OR = 4.8; 95% CI, 1-22.1) and the presence of perianal disease (OR = 7.4; 95% CI, 1.5-35.9), while a negative association was found with maintenance treatment with immunosuppressant drugs (OR = 0.05; 95% CI, 0.30-0.008). The laboratory variables positively associated with corticosteroid administration were C-reactive protein and leukocyte count., Conclusion: The variable with greatest predictive value for corticosteroid prescription is the CDAI score, although other clinical and laboratory variables not included in this index are also associated with corticosteroid administration. There is a negative association between the use of immunosuppressive drugs and corticosteroid prescription.

Acalculous biliary pain has been related to gallbladder dysfunction that produces a gallbladder emptying defect-a condition which favours the development of lithiasis. It is therefore probable that microlithiasis is present in patients with gallbladder dysfunction. The aims of this study were to measure gallbladder emptying and investigate bile abnormalities in patients with acalculous biliary pain. In 92 consecutive patients, gallbladder emptying was assessed by quantitative cholescintigraphy (abnormal ejection fraction < or =40%). In 64 patients, a microscopic study was performed on duodenal bile, defining abnormality as the presence of cholesterol crystals in any amount and/or calcium bilirubinate granules and/or microspheroliths at a rate of >10 per slide. The ejection fraction was abnormal in 45 patients (49%) (median 25.1%, range 6.8-39.3%) and normal in the remaining 47 cases (median 71.3%, range 41.0-96.1%). Bile was abnormal in 32 of 64 patients (50%), the most frequent finding being calcium bilirubinate granules. In the patients with bile abnormalities, abnormal ejection fraction was more frequent (20 of 32) and the median ejection fraction was lower (30.9%, range 12.0-94.1%) than in the patients with normal bile (16 of 32 with an abnormal ejection fraction; median ejection fraction 50.7%, range 6.8-96.1%). Abnormal bile was frequent (55.5%) in patients with reduced ejection fraction, but was not uncommon in patients with normal ejection fraction (33.3%). Fewer patients showed no alteration (25%). It is concluded that in most patients, acalculous biliary pain coexists with gallbladder dysfunction or abnormal bile, the combination of both alterations being common.

Background and Aim: Helicobacter pylori is the major cause of peptic ulcer disease, but the proportion of H. pylori-negative peptic ulcers seems to be increasing in developed countries. We investigated the frequency of H. pylori-negative peptic ulcer without intake of nonsteroidal anti-inflammatory drugs (NSAIDs) in a Mediterranean European country., Materials and Methods: We prospectively collected consecutive patients with an endoscopically verified active peptic ulcer over 6 months from different areas of Spain. Helicobacter pylori infection was assessed by rapid urease test and histologic examination (corpus and antral biopsies). A (13)C-urea breath test was performed if H. pylori was not detected with the invasive test. Patients were considered H. pylori-negative if all three tests were negative. NSAID use was determined by structured data collection., Results: Of 754 consecutive peptic ulcer patients, 16 (2.1%) were H. pylori-negative and had not used NSAIDs before the diagnosis. Of the 472 patients who had duodenal ulcers, 95.7% (n = 452) were H. pylori-positive and only 1.69% (n = 8) were negative for both H. pylori infection and NSAID use; 193 patients had benign gastric ulcers and 87% (n = 168) of them were infected by H. pylori (p <.001 vs. duodenal ulcers). NSAID intake was more frequent in gastric ulcer patients (52.8%) than in duodenal ulcer patients (25.4%; p <.001). Consequently, the frequency of H. pylori-negative gastric ulcer in patients not using NSAID was 4.1% (n = 8)., Conclusion: Peptic ulcer disease is still highly associated with H. pylori infection in southern Europe, and only 1.6% of all duodenal ulcers and 4.1% of all gastric ulcers were not associated with either H. pylori infection or NSAID use.

On-demand therapy is effective for maintaining symptoms control in nonerosive gastroesophageal reflux disease (GERD). Our aim was to assess the clinical effectiveness of on-demand therapy with a proton pump inhibitor (PPI) in mild GERD (nonerosive and low-grade esophagitis), its impact on health-related quality of life (HRQoL), and the degree of patient satisfaction. Fifty-five patients (17 with nonerosive GERD and 38 with low-grade esophagitis) were treated with rabeprazole, 20 mg/day. The healed patients started on-demand therapy. We evaluated symptoms (clinical questionnaire), HRQoL (SF-36 questionnaire), and patient satisfaction (visual analogue scale). Of the 55 patients included, 51 started on-demand therapy for 6 months. Symptom control (heartburn

Our aims were to describe clinical characteristics of patients with chronic posterior laryngitis and to predict the response to omeprazole therapy. Ninety-one patients with posterior laryngitis were evaluated by a questionnaire, esophageal manometry and pH recording, and endoscopy. Patients were treated with omeprazole, 20 mg twice daily for 3 months. Therapy was continued another 3 months if necessary. Clinical manifestations of reflux occurred in 84 (92%) patients, abnormal acid reflux in 53 (65%) cases, and esophagitis in 6 of 50 (12%). After 3 months of therapy significant improvement occurred in 30 of 70 patients (41%). Continuing therapy for 3 more months increased the response to 65% (45 of 69 cases). Response to therapy was associated with lower age and lower duration of laryngeal symptoms, but a consistent prediction of the response could not be made. In conclusion, patients with posterior laryngitis frequently present with manifestations of gastroesophageal reflux. Response to therapy can not be predicted with certainty.

Background: Cardiomyotomy, often associated with an antireflux technique, is effective in the management of achalasia, although gastroesophageal reflux (GER) may occur after the procedure. Patient-centered measures, ie, health-related quality of life (HRQoL) and satisfaction, should be included in the evaluation of the patients., Methods: A study was made of the incidence of GER (symptoms, upper endoscopy and 24-hour pH monitoring), HRQoL (Short Form-36 Health Survey), and satisfaction after open-access cardiomyotomy and 180-degree anterior fundoplication in 28 consecutive patients, with a minimum postoperative follow-up of 12 months., Results: Mean age was 45 years (range 15 to 80) and 68% were female. In 8 subjects (all with heartburn) GER morbidity was present (4 with esophagitis and 4 with positive pH study), and 6 patients required proton pump inhibitors. Short Form-36 scores after surgery were similar to those found in the general population. Patient satisfaction was high and was more related to the absence of dysphagia than to the presence of GER symptoms., Conclusions: Gastroesophageal reflux is relatively frequent after cardiomyotomy and partial fundoplication, although the efficacy of proton pump inhibitor treatment minimizes its clinical significance.

Unlabelled: Dynamic cholescintigraphy (DCG) is a valid technique for evaluating gallbladder emptying. Cholecystokinin (CCK) as a slow infusion is recommended as a contraction stimulus. The normal ejection fraction (EF) has been shown to be reproducible, although the reproducibility of abnormal results has not been investigated. The aims of the present study were to standardize the CCK administration method (phase 1), obtain EF normality values (phase 2), and evaluate the reproducibility of abnormal results in patients with clinically suspected gallbladder dysfunction (phase 3)., Methods: Phase 1 included 40 healthy volunteers divided into 4 groups (n = 10) and subjected to intravenous CCK infusion according to 4 different regimens (0.25, 0.30, 0.40, and 0.60 Ivy dog units [IDU]/kg). Phase 2 comprised 33 healthy volunteers for determining DCG normality values, and phase 3 evaluated the reproducibility of abnormal results in 44 patients having clinical manifestations compatible with gallbladder dysfunction and showing an abnormal EF in a previous study., Results: The most effective CCK infusion regimen was 0.40 IDU/kg (3.07 ng/kg) over 20 min, because it afforded the least variability and a high EF. When this regimen was applied to the healthy population, the EF was found to be 74.2% +/- 17.1% (mean +/- SD); the inferior normality limit was estimated to be 40%. Abnormal results were recorded in 77% (95% confidence interval, 62%-89%) of the patients. When the 2 DCG studies of phase 3 were compared, the EF correlation coefficient between them was 0.439 (P = 0.003)., Conclusion: Slow CCK infusion is the best regimen for stimulating gallbladder contraction; an EF of less than 40% is estimated to represent abnormality. The abnormal results for the EF in patients with clinically suspected gallbladder dysfunction proved to be reproducible.

Congenital oesophageal stenosis is a very rare disease that commonly occurs in infancy with male predominance. This report describes a highly unusual case of congenital oesophageal stenosis extended throughout the length of the oesophagus, without webs or tracheobronchial remnants in the oesophageal wall, with normal oesophageal motility and normal endosonography in an adult female.

Aims: Although the results of dynamic ultrasonography (DUS) are similar to those of dynamic cholescintigraphy (DCS) in the study of gallbladder function, the methodology required for this technique is laborious and sometimes complex. The aim of this study was to investigate the reliability of a simple method of DUS to evaluate gallbladder function using DCS as a reference., Patients and Methods: Gallbladder function was studied using DUS and DCS in 80 consecutive patients with clinical findings compatible with gallbladder dysfunction. For DUS the ellipsoid method was used with measurement of three gallbladder diameters (transversal, longitudinal and anteroposterior) in basal conditions and after applying a cholecystokinetic stimulus (meal test); gallbladder emptying of less than 50% was considered abnormal. In DCS intravenous cholecystokinin (CCK) (0.40 IDU/kg in 20 minutes) was used as stimulus and an ejection fraction < or = 40% was considered abnormal., Results: In 15 patients (19%; 95% CI, 11-29%) abnormal gallbladder response was found using DUS. The ejection fraction in the entire group of patients studied was 48 26.2%. Ejection fraction was abnormal in 41 patients (51%; 95% IC, 40-63%) with a value of 25 8.5% and was normal in 39 patients (49%; 95% IC, 40-63%) with a value of 71.5 14.5%. The correlation coefficient between the values of gallbladder emptying calculated with DUS and the ejection fraction obtained with DCS was 0.199 (p = 0.079). When patients were divided according to gallbladder emptying measured by DUS and the ejection fraction obtained with DCS the concordance was very low (k = 0.065; EE = 0.085)., Conclusions: DUS performed using a simple technique lacks diagnostic value in gallbladder dysfunction when DCS is taken as a reference test

Objective: To know the type, frequency and time course for the occurrence of adverse events in our series of patients with inflammatory bowel disease treated with azathioprine or 6-mercaptopurine., Patients and Method: 92 consecutive patients were treated with azathioprine. 70 of them (55 Crohn's disease, 14 ulcerative colitis and 1 undetermined colitis) were suitable for analysis., Results: We observed 23 adverse reactions in 21 patients. Adverse events were as follows: haematological 11.4%, digestive intolerance 11.4%, infection 7.1%, and pancreatitis 2.8%. The prevalence was increased among ulcerative colitis patients (57.8 vs. 21.8%) (p = 0.02). There were no statistical differences in the prevalence of adverse events respective of the age, gender or location of disease. Digestive intolerance and pancreatitis occurred within the first 6 months of therapy, whereas haematological side effects occurred between 3 months and 4 years after therapy onset. Early occurrence (but not late occurrence) was associated with thiopurine methyltransferase (TMPT) activity levels. All infections took place between 8 months and 5 years of treatment. Azathioprine was definitively withdrawn due to side effects in 9 cases (12.8%)., Conclusions: The frequency of adverse events in our study is similar to that reported in previous studies. Azathioprine withdrawal is required in almost half of the cases because of toxicity. Frequency of side effects is increased in patients with ulcerative colitis. The variability in time course makes clinical-biological monitoring mandatory.

A high prevalence of gastroesophageal reflux disease (GER) in asthma patients has been shown in several reports from North America and Europe. However, no data from Southern Europe are available. This paper evaluates the prevalence of abnormal reflux in asthmatics, the pattern of acid reflux when present, and the relationship between asthma and GER. Eighty-one consecutive ambulatory patients with clinically stable asthma (41 women; median age 40 years, range 17-69 years) were prospectively evaluated. All patients had a thorough digestive history; baseline pulmonary function studies, including bronchoprovocation methacholine test; and ambulatory 24-hr esophageal pH monitoring. Reflux symptoms were present in 40 patients (49%). Twelve patients had abnormal GER as defined by pH testing, giving a prevalence rate of 15% (95% confidence interval 8%-24%). The presence of acid reflux was not associated with a more severe respiratory disease. Abnormal GER seems not to be a clinically significant problem in many patients with asthma in our area.

Objective: To investigate the eradication rate of Helicobacter pylori with omeprazole, amoxicillin and clarithromycin during 6 days in patients with duodenal ulcer. To compare the reliability of the analysis of the eradication with urea-13C breath test performed one month and 3 months after therapy. To evaluate the one-year reinfection rate., Patients and Methods: Prospective study including 99 patients with duodenal ulcer (65 with acute disease and 34 in maintenance treatment) infected by Helicobacter pylori (urease rapid test and urea-13C breath test positive). Patients were treated with omeprazole 20 mg, clarithromycin 500 mg and amoxicillin 1 g, b.i.d., during 6 days. The infection status was investigated 1 and 3 months after treatment by urea-13C breath test. The one-year reinfection rate was investigated using the same test., Results: Per protocol eradication rates were 76% (95%-CI: 66-84) one month and 73% (95%-CI: 63-81) 3 months after treatment. In the intention to treat analysis, eradication rates were 74% (95%-CI: 64-82) and 70% (95%-CI: 60-79), respectively. Side effects were mild and uncommon. The rate of false negative urea-13C breath test results one month after therapy with respect to 3 months was 4.2% (95%-CI: 0.8-11.7). One-year reinfection rate determined in 56 patient was absent., Conclusions: The eradication of Helicobacter pylori with triple therapy for 6 days in patients with duodenal ulcer is not satisfactory. To investigate Helicobacter pylori infection with urea-13C breath test one month after treatment overestimates the results of the eradication. One-year reinfection rate is clinically irrelevant.

The evaluation of gastric emptying by the double isotope technique involves some methodologic conditioning. Among them contamination correction or interference in the energy windows of the activity of the two isotopes used in the marking of the solids and fluids of the test food are important. The results of an experiment in which a phantom was used to evaluate the contamination between indio 111 (DTPA-Ca111In) and technecium 99m (colloid99mTc). Three test studies were posteriorly performed in healthy volunteers and 27 studies in a control group (13 males, mean age of 33 years, mean body mass index 39.02 kg/m). In these studies the contamination was corrected with the acquisition, following an initial swallow of juice marked with 111In, of activity in the windows of both isotopes. The contamination of 111In (isotope of greatest radiation energy) in the window of 99mTc was 24% in the phantom and 20%, 23% and 26% in the three initial study tests. The mean contamination in the control group was of 22% with limits of 19% to 29% and a standard deviation of 3%. Despite the comparable results, the usefulness of the individualized contamination calculation in the studies of gastric emptying with dual isotope to minimize the methodologic errors of this technique is discussed.

Objective: To develop guidelines for predicting colonic disease on the basis of clinical parameters., Experimental Design: A prospective study of the clinical data prior to colonoscopy. On the basis of the endoscopic findings, the patients were divided into three diagnostic groups: absence of significant disease, significant benign disease and malignant disease. The patient population was divided randomly into two subgroups. The clinical data from one of them was used to build a database which, using Bayes' theorem, was compared with the variables from the other subgroup to predict the diagnosis for each patient., Patients: A total of 336 patients (170 males and 166 females; mean age: 58 years; range: 15 to 87 years) were evaluated., Results: When the endoscopic findings were grouped on the basis of their clinical importance, 211 patients (63%) belonged to the group without significant disease, 60 patients (18%) had significant benign disease and 65 (19%) presented a neoplastic disease. Of the 21 variables selected for use in the database, 6 showed statistically significant differences in terms of the absence or presence of malignant disease: age, absence of previous similar episodes, weight loss, rectal bleeding, lack of improvement and the presence of a mass on digital rectal examination. The predictive model differentiated patients with neoplasm from those without malignant disease, but was not capable of identifying differences among the latter. The model was useful for assessing the risk of malignant disease for each patient., Conclusions: The predictive model obtained is a useful tool for establishing the diagnosis and the priority in the performance of colonoscopy.

During nine years, 157 consecutive patients with achalasia have been dilated in our unit. First, the long-term effect of dilation on clinical status was evaluated. The probability of being in clinical remission eight years after first dilation was 51%. The pressure of the LES measured after dilation was highly predictive of the long-term clinical evolution. Second, a predictive model of the individual response to pneumatic dilation was developed and simplified. Therapy was effective in 80% of the patients, after one to four dilations. Younger age was the only factor significantly associated with ineffective therapy. Depending on the prognosis of the outcome calculated with the predictive model, patients were classified in groups of risk that showed a different rate of ineffective, therapy. In the simplified model, age < or = 20 years, male gender, esophageal body diameter < or = 3 cm, esophageal body basal pressure > 15 mm Hg, and pressure of the lower esophageal sphincter > 30 mm Hg were predictors of a poor response to dilation. We conclude that pneumatic dilation is an effective therapy for achalasia. A predictive model was useful to classify the patients in groups with a different risk for ineffective dilation. A simplification of this model could be used to predict the response to dilation.

The relationship between the diameter of the esophageal body and the clinical profile of the disease and response to treatment was analyzed in 151 patients with idiopathic achalasia by pneumatic dilation of the cardias. Of the 151 patients, 46 presented an esophageal diameter < or = 3 cm (group I), 78 a diameter > 3 cm up to a maximum of 5 cm (group II) and 27 presented a diameter > 5 cm (group III). The result of pneumatic dilatation of the cardias under endoscopic control was analyzed in 117 patients with a minimum follow up of one year after the last dilatation session. Of all the clinical parameters studied, significant statistical differences were only found in group III in respect to the time of symptom evolution and the presence of regurgitation. Manometric data in basal pressure of the esophageal body and in contraction wave width were lower in groups I and III, respectively. The remaining variables were similar in the three groups although group III showed a trend to older age and the frequency of pulmonary complications with lesser thoracic pain and registry of a strict pattern. Endoscopic pneumatic dilation carried out in all the cases was effective in 83% of the patients and was similar in the three study groups. The rate of complications (perforation) was also similar. The therapeutic efficacy of pneumatic dilatation was accompanied by a significant reduction in esophageal diameter. It was concluded that the increase in esophageal diameter in idiopathic achalasia is associated with chronological, clinical and functional parameters which suggest greater disease evolution but do not determine significant changes in the therapeutic response to endoscopic pneumatic dilatation.

Objective: To compare sclerotherapy with oesophageal transection in the prevention of rebleeding in patients with oesophageal varices., Design: A prospective trial., Patients: Forty-one patients with cirrhosis and variceal bleeding., Methods: After recovering from an acute episode of oesophageal variceal bleeding patients were randomized into two groups. One patient was excluded. Twenty-two patients were treated with sclerotherapy (group 1) and 18 underwent an oesophageal transection (group 2), with a shorter elapsed time from randomization to treatment in group 1. Both groups were similar with regard to clinical and biochemical features and variceal size. Failure, defined in group 1 as rebleeding or incomplete eradication after four sclerotherapy sessions, occurred in five (22.7%) patients; in group 2, rebleeding occurred in two (11.1%) patients (no statistically significant difference)., Conclusion: Although the survival rate was similar in both groups, sclerotherapy is preferable to oesophageal transection because it requires a shorter duration of hospitalization and has fewer complications.

The prevalence of gastroesophageal reflux after successful pneumatic dilatation was investigated in 30 patients with primary esophageal motor disorder. After a median follow-up period of 377 days, three patients presented symptoms of acid reflux and five patients had endoscopic esophagitis (grade I, 3 patients; grade II, one patient; and grade III, one patient). Ambulatory 24 hr. esophageal pH monitoring was positive in 20% and 30% of the patients compared to our normal values and to those from other series from the literature, respectively. The concordance between pH results and symptoms and/or endoscopic esophagitis was very low. It is concluded that 24 hr. esophageal pH monitoring is frequently abnormal after pneumatic dilatation, but its clinical significance is low, because very few patients have symptoms and/or severe esophagitis.

Differential diagnosis between idiopathic achalasia and esophageal pseudoachalasia is difficult to perform. One hundred and forty-four consecutive patients with a clinical diagnosis of primary esophageal motor disorder have been evaluated for pneumatic dilatation of the cardias. Of them, 6 (4.1%) have been finally diagnosed of esophageal pseudoachalasia with carcinoma of the cardias, although in four cases more than one biopsy procedure was needed to establish the diagnosis. The clinical data--higher age, shorter clinical history and higher weight loss--, the higher pressure of the lower esophageal sphincter and the failure of the dilatation suggested the diagnosis, but were uncertain findings. Esophageal biopsy is the only objective method to obtain a definitive diagnosis and should be performed in every patient with an esophageal motor disorder evaluated for dilatation of the cardias and, if negative, it should be repeated when malignancy is suggested by available data.

In this study we investigated the effect of selective (M1) and non-selective (M1 and M2) pharmacologic blockade of muscarinic receptors on cholecystokinin-induced gallbladder emptying. After validating the method of study, the gallbladder function was evaluated in 15 normal volunteers by quantitative biliary scintigraphy, and the effect of intravenous atropine (0.15 mg/10 kg) and pirenzepine (10 mg) was analyzed in each subject. Atropine significantly reduced the ejection period and the ejection fraction of gallbladder evacuation. Pirenzepine reduced the ejection period, but the ejection fraction remained unchanged. We conclude that the effect of cholecystokinin on gallbladder motility is mediated through muscarinic receptors. Our results suggest that M2 receptors, but not M1 receptors, are involved in this response.