Proton-pump inhibitors adverse effects: a review of the evidence and position statement by the Sociedad Española de Patología Digestiva

Introduction: In the last few years a significant number of papers have related the use of proton-pump inhibitors (PPIs) to potential serious adverse effects that have resulted in social unrest. Objective: The goal of this paper was to provide a literature review for the development of an institutional position statement by Sociedad Española de Patología Digestiva (SEPD) regarding the safety of long-term PPI use. Material and methods: A comprehensive review of the literature was performed to draw conclusions based on a critical assessment of the following: a) current PPI indications; b) vitamin B12 deficiency and neurological disorders; c) magnesium deficiency; d) bone fractures; e) enteric infection and pneumonia; f) interactions with thienopyridine derivatives; e) complications in cirrhotic patients. Results: Current PPI indications have remained unchanged for years now, and are well established. A general screening of vitamin B12 levels is not recommended for all patients on a PPI; however, it does seem necessary that magnesium levels be measured at therapy onset, and then monitored in subjects on other drugs that may induce hypomagnesemia. A higher risk for bone fractures is present, even though causality cannot be concluded for this association. The association between PPIs and infection with Clostridium difficile is mild to moderate, and the risk for pneumonia is low. In patients with cardiovascular risk receiving thienopyridines derivatives it is prudent to adequately consider gastrointestinal and cardiovascular risks, given the absence of definitive evidence regardin potential drug-drug interactions; if gastrointestinal risk is found to be moderate or high, effective prevention should be in place with a PPI. PPIs should be cautiously indicated in patients with decompensated cirrhosis. Conclusions: PPIs are safe drugs whose benefits outweigh their potential side effects both short-term and long-term, provided their indication, dosage, and duration are appropriate.

Soporte nutricional perioperatorio en los pacientes programados para cirugía digestiva en el Hospital Mateu Orfila (Maó-Menorca)

La desnutrición se asocia con elevadas tasas de morbimortalidad postoperatoria. En este estudio piloto se ha evaluado la efectividad de un programa de apoyo nutricional perioperatorio a pacientes que iban a someterse a cirugía programada de cirugía mayor digestiva. Se administró de forma perioperatoria la formula enteral hipercalorica/hiperproteica (Fresubin® protein energy drink) al grupo de pacientes con riesgo nutricional/desnutrición (RN/DN). Con el objeto de valorar la efectividad de la intervención nutricional preoperatoria, se ha comparado los resultados respecto a un grupo control retrospectivo. Entre los dos grupos con RN/DN se encontraron diferencias estadísticamente significativas en incidencia de vómitos, infección herida, hiperglucemia, exitus hospitalario, estancia hospitalaria, estancia en UCI y administración de NPT. Se ha demostrado una mejor evolución tras la cirugía en el grupo de pacientes con RN/DS que han sido suplementados de forma preoperatoria con una fórmula de nutrición enteral.

Sensitivity and specificity of the Gastrointestinal Short Form Questionnaire in diagnosis of gastroesophageal reflux disease

Introduction: Gastrointestinal Short Form Questionnaire (GSFQ) is a questionnaire for gastroesophageal reflux disease (GERD) diagnosis, with a version in Spanish language, not yet compared to an objective test. Aims: To establish GSFQ diagnostic performance against 24-hour pH monitoring carried out in two tertiary care hospitals. Methods: Consecutive adult patients with typical GERD symptoms (heartburn, regurgitation) referred for pH monitoring fulfilled the GSFQ (score range 0-30, proportional to probability of GERD). Diagnosis of GERD was established when acid exposure time in distal esophagus was superior to 4.5% or symptom association probability was greater than 95%. Receiver-operator characteristic (ROC) curves were calculated and best cut-off score determined, with corresponding sensitivity, specificity and likelihood ratios (LR) (95% confidence interval for each). Results: One hundred and fifty-two patients were included (59.9% women, age 47.9 ± 13.9; 97.4% heartburn; 71.3% regurgitation). pH monitoring was abnormal in 65.8%. Mean GSFQ score was 11.2 ± 6. Area under ROC was 56.5% (47.0-65.9%). Optimal cut-off score was 13 or greater: sensitivity 40% (30.3-50.3%), specificity 71.2% (56.9-82.9%), positive LR 1.39 (0.85-2.26) and negative LR 0.84 (0.67-1.07). Exclusion of questions 1 and 3 of the original GSFQ, easily interpreted as referred to dyspepsia and not GERD, improved only marginally the diagnostic performance: AUROC 59.1%. Conclusion: The GSFQ does not predict results of pH monitoring in patients with typical symptoms in a tertiary care setting.

Health-related quality of life and determinant factors in celiac disease: a population-based analysis of adult patients in Spain

Background: Celiac disease (CD) has a negative impact on the health-related quality of life (HRQL) of affected patients. Although HRQL and its determinants have been examined in Spanish CD patients specifically recruited in hospital settings, these aspects of CD have not been assessed among the general Spanish population. Methods: An observational, cross-sectional study of a non-randomized, representative sample of adult celiac patients throughout all of Spain's Autonomous Regions. Subjects were recruited through celiac patient associations. A Spanish version of the self-administered Celiac Disease-Quality of Life (CD-QOL) questionnaire was used. Determinant factors of HRQL were assessed with the aid of multivariate analysis to control for confounding factors. Results: We analyzed the responses provided by 1,230 patients, 1,092 (89.2%) of whom were women. The overall mean value for the CD-QOL index was 56.3 ± 18.27 points. The dimension that obtained the most points was dysphoria, with 81.3 ± 19.56 points, followed by limitations with 52.3 ± 23.43 points; health problems, with 51.6 ± 26.08 points, and inadequate treatment, with 36.1 ± 21.18 points. Patient age and sex, along with time to diagnosis, and length of time on a gluten-free diet were all independent determinant factors of certain dimensions of HRQL: women aged 31 to 40 expressed poorer HRQL while time to diagnosis and length of time on a gluten-free diet were determinant factors for better HRQL scores. Conclusions: The HRQL level of adult Spanish celiac subjects is moderate, improving with the length of time patients remain on a gluten-free diet.

Endoluminal calprotectin measurement in assessment of pouchitis and a new index of disease activity: a pilot study

Pouchitis is the most common complication following proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis (UC). To provide a standardized definition of pouchitis clinical, endoscopic and histological markers were grouped and weighted in the pouch disease activity index (PDAI). However, the delay in the assessment of the final score due to the time requested for histological analysis remains the main obstacle to the index implementation in clinical practice so that the use of modified-PDAI (mPDAI) with exclusion of histologic subscore has been proposed. We tested the ability of calprotectin measurement in the pouch endoluminal content to mimic the histologic score as defined in the PDAI, the index that we adopted as gold standard for pouchitis diagnosis. Calprotectin was measured by ELISA in the pouch endoluminal content collected during endoscopy in 40 consecutive patients with J-pouch. In each patient PDAI and mPDAI were calculated and 15% of patients were erroneously classified by mPDAI. ROC analysis of calprotectin values vs. acute histological subscore ≥ 3 identified different calprotectin cut-off values with corresponding sensitivity and specificity allowing the definition and scoring of different range of calprotectin subscores. We incorporated the calprotectin score in the mPDAI obtaining a new score that shows the same specificity as PDAI for diagnosis of pouchitis and higher sensitivity when compared with mPDAI. The use of the proposed new score, once validated in a larger series of patients, might be useful in the early management of patients with symptoms of pouchitis.

Endoscopic incision for the treatment of refractory esophageal anastomotic strictures: outcomes of 13 cases with a minimum follow-up of 12 months

Background and aim: Endoscopic incision is an alternative method for refractory esophageal strictures; however, little is known about its long-term efficacy. The aim of the study is to assess the long-term outcomes of endoscopic incision for treating refractory esophageal anastomotic strictures. Methods: Between September 2011 and September 2014, 13 patients with refractory esophageal anastomotic strictures were treated with endoscopic incision. Their clinical data were retrospectively collected to evaluate the efficacy and safety of the technique. Results: All the 13 patients underwent the procedure successfully with median operation duration of 15 minutes. A total of 27 sessions were necessary to maintain lumen patency until September 2015, and 7 patients needed retreatment. The symptoms relieved in all the cases, and the median dysphagia score decreased from 4 to 1 during a median follow-up of 24 months. The median diameter of stricture was enlarged from 4 mm to 12 mm. As a short-term effect, dysphagia symptoms improved in 100% (13/13), 84.6% (11/13) and 76.9% (10/13) of the patients one, three and six months after a single treatment. As long-term effect, the dysphagia improved in 61.5% (8/13), 63.6% (7/11) and 60% (6/10) of the patients 12, 18 and 24 months after a single treatment. Conclusions: The efficacy of endoscopic incision is favorable in the short term. However, retreatment is needed to maintain the long-term lumen patency for parts of the patients.

Endoscopic sleeve gastroplasty (the Apollo method): a new approach to obesity management

Background: Many obese patients cannot lose weight or reject conventional obesity management. Endoscopic sleeve gastroplasty (the Apollo method) is a pioneering coadjuvant, interventionist technique for the integral management of obesity. Objectives: The goals of this study were to report safety and efficacy results obtained at 6 months in patients undergoing endoscopic sleeve gastroplasty. Material and methods: A prospective study was performed in 55 patients (13 males, 42 females) who were subjected to the Apollo technique; mean age was 43.5 years (range 25-60) and mean BMI was 37.7 kg/m² (range 30-48). All received multidisciplinary follow-up for weight loss. Weight changes and presence of complications were assessed. Through the endoscope a triangular pattern suture is performed consisting of approximately 3-6 transmural (mucosa to serosa) stitches, using a cinch device to bring them nearer and form a plication. Results: A total of 6-8 plications are used to provide a tubular or sleeve-shaped restriction to the gastric cavity. No major complications developed and patients were discharged at 24 hours following the procedure. Endoscopic and radiographic follow-up at 6 months post-procedure showed a well preserved tubular form to the stomach. After 6 months patients had lost 18.9 kg and 55.3% of excess weight. Conclusions: Endoscopic sleeve gastroplasty, together with dietary and psycho-behavioral changes, is a safe, effective technique in the coadjuvant management of obese patients.

Unusual presentation of Gilbert disease with high levels of unconjugated bilirubin: report of two cases

Gilbert's syndrome is a benign condition characterized by asymptomatic sporadic episodes of jaundice, due to a mild unconjugated hyperbilirubinemia caused by a deficiency in bilirubin glucoronidation. Under certain physiologic or pathologic events, bilirubin level rises but according to literature it does not reach out more than 3 mg/dl. We report 2 cases of Gilbert's syndrome, genetically tested, which presented with bilirubin levels above 6 mg/dl without any trigger or coexisting condition. In conclusion, bilirubin levels higher than 6 mg/dl in Gilbert syndrome are rare, hemolytic and other metabolism diseases must be ruled out, and genetic testing may be necessary in some cases.