Ulcer and bleeding complications and their relationship with dyspeptic symptoms in NSAIDs users: a transversal multicenter study.

OBJECTIVES: To evaluate the prevalence of lesions and digestive complications secondary to the use of non-steroidal anti-inflammatory drugs (NSAIDs), the clinical profile seen for digestive complaints and the relation with the endoscopic findings. METHODS: Prospective, multicentric, open study, evaluating consecutively 1231 patients, divided as follows: group I - NSAID and group II - non-NSAID. All patients answered questionnaire to evaluate the onset, the type of clinical complaint, the use of medication and possible complications associated to digestive bleeding. RESULTS. A total of 1213 patients were evaluated. Among them, 65% were female and 13.1% were smokers; 15.6% mentioned they ingested alcoholic beverages. The main signs and symptoms reported were epigastralgy and pyrosis (67% and 62%, respectively). The upper gastrointestinal (UGI) endoscopy was normal in 3.9% in group I and in 10.7% in group II (p < 0.001). Patient who do not use NSAID will be 2.5 times more likely to have normal UGI endoscopy (p = 0.001). The presence of erosive or ulcer lesions in the stomach and duodenum was more frequent in group I. The incidence of lesions in the stomach when compared to the duodenum is observed (erosions: 49.12% vs. 13.60%, p = 0.001; ulcers: 14.04% vs. 11.84%, p = 0.05). The risk of digestive bleeding is 12 times higher (6.14% vs. 0.51%) in those who used NSAIDs, and the stomach is the site in which bleeding occurs more frequently. Conclusions. The frequency of gastric ulcer, duodenal ulcer and digestive bleeding was higher in patients who used NSAIDs. There was no connection found between endoscopic findings and dyspeptic symptoms.

BRAZILIAN CLINICAL GUIDELINE FOR THE THERAPEUTIC MANAGEMENT OF GASTROESOPHAGEAL REFLUX DISEASE (BRAZILIAN FEDERATION OF GASTROENTEROLOGY, FBG).

BACKGROUND: Gastroesophageal Reflux Disease (GERD) is a prevalent condition in Brazil, affecting 12% to 20% of the urban population, with significant implications for patient quality of life and potential for complications. OBJECTIVE: This paper focuses on the recent update of the Brazilian guidelines for GERD, a necessary revision due to advancements in knowledge and practice since the last publication over a decade ago. The update pays particular attention to the role and safety of proton pump inhibitors (PPIs), acknowledging the growing concerns about their long-term use, adverse events, and overprescription. METHODS: The methodology of the guideline update involved an extensive literature review in multiple languages (English, French, Italian, Spanish, and Portuguese), drawing from major databases such as Medline, Embase, and SciELO-Lilacs. RESULTS: This comprehensive approach resulted in a carefully curated selection of studies, systematic reviews, and meta-analyses, specifically focusing on PPIs and other therapeutic strategies for GERD. The updated guidelines are presented in a user-friendly question-and-answer format, adhering to the PICO system (Population, Intervention, Comparison, Outcomes) for clarity and ease of interpretation. The recommendations are supported by robust scientific evidence and expert opinions, enhancing their practical applicability in clinical settings. To ensure the reliability and clarity of the recommendations, the GRADE system (Grading of Recommendations Assessment, Development, and Evaluation) was employed. This system categorizes the strength of recommendations as strong, weak, or conditional and classifies evidence quality as high, moderate, low, or very low. These classifications provide insight into the confidence level of each recommendation and the likelihood of future research impacting these guidelines. CONCLUSION: The primary aim of these updated guidelines is to offer practical, evidence-based advice for the management of GERD in Brazil, ensuring that healthcare professionals are equipped with the latest knowledge and tools to deliver optimal patient care. BACKGROUND: •Gastrointestinal specialists rely heavily on guidelines to manage digestive pathologies effectively. The Brazilian clinical guideline for therapeutic management of gastroesophageal reflux disease (GERD) is an invaluable tool for these specialists. BACKGROUND: •It critically analyzes practical aspects of therapy through 12 questions covering a wide range of topics, from behavioral measures to surgical and endoscopic indications. BACKGROUND: •The recommendations in this guideline are justified using the GRADE system (Grading of Recommendations Assessment, Development, and Evaluation), and experienced experts provide comments and suggestions at the end of each question.

Association of a probiotic to a Helicobacter pylori eradication regimen does not increase efficacy or decreases the adverse effects of the treatment: a prospective, randomized, double-blind, placebo-controlled study.

BACKGROUND: The treatment for the eradication of Helicobacter pylori (H. pylori) is complex; full effectiveness is rarely achieved and it has many adverse effects. In developing countries, increased resistance to antibiotics and its cost make eradication more difficult. Probiotics can reduce adverse effects and improve the infection treatment efficacy.If the first-line therapy fails a second-line treatment using tetracycline, furazolidone and proton-pump inhibitors has been effective and low cost in Brazil; however it implies in a lot of adverse effects. The aim of this study was to minimize the adverse effects and increase the eradication rate applying the association of a probiotic compound to second-line therapy regimen. METHODS: Patients with peptic ulcer or functional dyspepsia infected by H. pylori were randomized to treatment with the furazolidone, tetracycline and lansoprazole regimen, twice a day for 7 days. In a double-blind study, patients received placebo or a probiotic compound (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum and Streptococcus faecium) in capsules, twice a day for 30 days. A symptom questionnaire was administered in day zero, after completion of antibiotic therapy, after the probiotic use and eight weeks after the end of the treatment. Upper digestive endoscopy, histological assessment, rapid urease test and breath test were performed before and eight weeks after eradication treatment. RESULTS: One hundred and seven patients were enrolled: 21 men with active probiotic and 19 with placebo plus 34 women with active probiotic and 33 with placebo comprising a total of 55 patients with active probiotic and 52 with placebo. Fifty-one patients had peptic ulcer and 56 were diagnosed as functional dyspepsia. The per-protocol eradication rate with active probiotic was 89.8% and with placebo, 85.1% (p=0.49); per intention to treat, 81.8% and 79.6%, respectively (p=0.53). The rate of adverse effects at 7 days with the active probiotic was 59.3% and 71.2% with placebo (p=0.20). At 30 days, it was 44.9% and 60.4%, respectively (p=0.08). CONCLUSIONS: The use of this probiotic compound compared to placebo in the proposed regimen in Brazilian patients with peptic ulcer or functional dyspepsia showed no significant difference in efficacy or adverse effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN04714018.

Potassium-competitive acid blockers, a new therapeutic class, and their role in acid-related diseases: a narrative review.

Introduction: A new therapeutic class, potassium-competitive acid blockers (P-CABs), has emerged in Brazil to promote a superior antisecretory effect addressing the unmet needs related to acid-related disease management. Vonoprazan fumarate showed a good safety profile and was approved by the Brazilian regulatory agency - ANVISA. Aim: This narrative review was conducted to review the general concepts regarding P-CABs, focussing on vonoprazan fumarate. Material and methods: A literature search was conducted through April-May 2021 using official databases with a combination of MeSH controlled vocabulary and text words. The authors selected articles that described pivotal and novel insights about P-CABs and vonoprazan fumarate. Results: Vonoprazan is a drug of the P-CABs class newly approved for the management of acid-related diseases in Brazil. P-CABs achieve rapid, potent, and prolonged acid suppression (including night-time) and promise to address some unmet clinical needs in GERD. Furthermore, considering the difficulties encountered in attaining effective symptomatic control - particularly at night - using currently available PPIs, this new drug class is promising. Conclusions: This review brings important information about vonoprazan, a new therapeutic option in Brazil, which may be considered as a valuable tool for managing acid-related diseases.

SAFETY OF LONG-TERM PROTON PUMP INHIBITORS: FACTS AND MYTHS.

BACKGROUND: Proton pump inhibitors (PPIs) are one of the most prescribed drugs in the world. Frequent use and long-term maintenance of these drugs drew the attention of researchers for sporadic adverse effects reports. OBJECTIVE: The purpose of this narrative review is to discuss appropriate data and causality related to these adverse events and PPIs. METHODS: A narrative review was conducted by systematizing information about safety and adverse events on PPIs from 2015 to 2020. A structured search on Pubmed was performed to identify systematic reviews and meta-analysis investigating the following situations: a) gastric cancer; b) micronutrients deficiency; c) acid rebound; d) infections; e) fractures; f) dementia; g) kidney disease; and h) sudden death and cardiovascular changes. RESULTS: Recent studies have potentially associated PPIs with some adverse events as osteoporosis-related fractures. There are also reports of intestinal infections, including Clostridium difficile, besides poor vitamins absorption and minerals such as vitamin B12, magnesium, and iron. Furthermore, there are some dementia, pneumonia, kidney disease, myocardial infarction, and stroke reports. For kidney diseases, studies consistently suggest that the use of PPI may be associated with an increased risk of adverse kidney events, especially in the elderly, with long-term PPI use and pre-existing kidney disease. Another additional question is whether chronic PPI use would also lead to the onset of gastric cancer. The abrupt discontinuation of PPIs is also related to increased gastric acid production above pre-PPI treatment levels; this phenomenon is called acid rebound. CONCLUSION: The key to mitigate adverse effects is the rational use of PPIs at the lowest effective dose and in the shortest possible duration. Although these adverse effects have a potential clinical impact, their causal association is still subject to validation.

Vonoprazan in the management of gastric/peptic ulcers: a systematic review of safety data.

Introduction: Although potassium-competitive acid blockers (P-CABs) prompted safety concerns when first developed, they ultimately proved to have a favourable safety profile. Aim: To assess the safety of vonoprazan in the management of gastroesophageal reflux disease (GERD), peptic ulcers, or gastroduodenal mucosal lesions induced by chronic use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs). Material and methods: From March to June 2021, a literature search was conducted using Medline via PubMed, Cochrane library, Lilacs, SciELO, and Centre for Reviews and Dissemination (CRD) electronic databases. After applying the eligibility criteria, 10 studies were included in this review. Of these 10 articles, vonoprazan was used as initial therapy in 6 and as maintenance therapy in 4. Adverse event rates were similar for vonoprazan and proton-pump inhibitors (PPIs). Conclusions: Our findings suggest that vonoprazan is a safe option for the management of erosive oesophagitis, gastric/peptic ulcers, or peptic ulcers induced by chronic use of aspirin or NSAIDs.

Vonoprazan in the management of erosive oesophagitis and peptic ulcer-induced medication: a systematic review.

Introduction: Vonoprazan has been found to promote a better antisecretory effect addressing acid-related diseases' unmet needs. Aim: To assess if vonoprazan effectively treats patients diagnosed with gastroesophageal reflux disease esophagitis or with peptic ulcers induced by chronic use of aspirin or non-steroidal anti-inflammatory drugs. Material and methods: A literature search was conducted (April/2021) using Medline via PubMed, Cochrane library, Lilacs, Scielo, and Centre for Reviews and Dissemination electronic databases. Results: We retrieved 55 titles. Of these, 13 met the eligibility criteria and were included in this review. Of these 13 articles, 4 were prospective cohort studies, 1 was a follow-up analysis of a preceding prospective study, 1 was a retrospective cohort study, and 6 were randomized clinical trials. Conclusions: Our findings suggest that vonoprazan was effective and non-inferior to proton pump inhibitors in healing and maintaining healed reflux oesophagitis, leading to faster symptom relief. Vonoprazan may also be considered for preventing aspirin- or non-steroidal anti-inflammatory drug-related peptic ulcer recurrence.

IMPACT OF HEARTBURN AND REGURGITATION ON INDIVIDUALS' WELL-BEING IN THE GENERAL POPULATION: A BRAZILIAN NATIONAL SURVEY.

BACKGROUND: Heartburn and acid regurgitation are typical symptoms usually associated with gastroesophageal reflux disease (GERD). GERD is one of the gastrointestinal diagnosis with higher prevalence worldwide, significantly impairing patients' quality of life. OBJECTIVE: The objective of this study was to analyze the impact of GERD-related symptoms in the Brazilian urban population. METHODS: National telephone survey with community-dwelling Brazilian individuals. Self-reported prevalence and frequency of symptoms (heartburn / regurgitation) were assessed. Individuals rated the impact of symptoms in their general well-being using a numeric scale from 1 to 10 (1 = no impact; 10 = very intense, preventing the person to eat and perform daily routine activities). Descriptive and bivariate statistical analyses were performed. RESULTS: The final sample was comprised of 1,773 subjects, 935 (52.7%) females, an average of 40 years old. The prevalence of heartburn and regurgitation in the past 6 months was 26.2% (n=466) and 11.0% (n=196), respectively. Women presented higher prevalence (heartburn n=266, 28.5% and regurgitation n=119, 12.7%) than men (n=200, 23.1% and n=78, 8.9%, respectively) (P<0.05). Heartburn in the past week was reported by 175 individuals (9.8%), while regurgitation episodes by 67 (3.8%). Absence of impact of the symptom in the overall well-being was observed for 82 subjects (17.6%) with heartburn and 18 individuals (9.2%) with regurgitation. Very intense impact was reported by 46 subjects (9.8%) with heartburn and 41 (20.9%) with regurgitation. Women's well-being was more affected than men's (mean score 5.45 vs 4.71, P<0.05). CONCLUSION: Heartburn and regurgitation were frequent symptoms, women with higher prevalence. These symptoms led to a substantial impact on individuals' well-being, women being more affected.

BRAZILIAN PHYSICIANS' PRACTICES ON THE MANAGEMENT OF SYMPTOMS SUGGESTING GASTROESOPHAGEAL REFLUX DISEASE: A MULTIDISCIPLINARY SURVEY.

BACKGROUND: Clinical guidelines are available to steer decisions regarding diagnosis, management and treatment of gastrointestinal disorders. Despite this, variations in physician's practices regarding gastroesophageal reflux disease (GERD) symptoms are well described in the literature. OBJECTIVE: To describe practices of physicians from different specialties on the management of patients with typical symptoms of GERD (heartburn and regurgitation) in a Brazilian sample. METHODS: National online survey enrolling a sample of general practitioners, gastroenterologists, cardiologists and otolaryngologists. The survey was conducted from August 6th to September 12th, 2018. Subjects answered a structured questionnaire addressing variables regarding physicians' profile (age, sex, specialty, practice setting, years in practice, type of medical expense reimbursement), their patients characteristics and prescribing behaviors. RESULTS: The final weighted sample was comprised of 400 physicians, 64% male, with an average of 15 years of experience. Physicians' estimates of gastroesophageal symptoms prevalence among their pool of patients was 37.6% for the total sample, reaching 70.3% among gastroenterologists. The medical specialty with lower average percentage of patients presenting gastroesophageal symptoms was otolaryngology (24.5%). Physicians reported that they request ancillary tests for 64.5% of patients with GERD typical symptoms. The most common diagnostic test was endoscopy (69.4%), followed by video nasolaryngoscopy (16.6%). The percentage of patient to whom endoscopy is performed was significantly higher among gastroenterologists and general practitioners as compared to otolaryngologists and cardiologists, while video nasolaryngoscopy is markedly more frequent among otolaryngologists. In terms of therapeutic options, the most frequently reported strategy was lifestyle modifications followed by proton pump inhibitors. CONCLUSION: Overall patients' profile and patterns of GERD diagnosis and management seem different between gastroenterologists, general practitioners, otolaryngologists, and cardiologists. Clinical guidelines should address this variability and include other medical specialties besides gastroenterologists in their scope.

NORMAL VALUES OF ESOPHAGEAL HIGH-RESOLUTION MANOMETRY: A BRAZILIAN MULTICENTER STUDY.

BACKGROUND: The high-resolution manometry has been a significant advance in esophageal diagnostics. There are different types of catheter and systems devices to capture esophageal pressures that generate variable data related to Chicago Classification (CC) and consequently influence normal values results. There are not normative data for the 24-channel water-perfused high-resolution manometry system most used in Brazil with healthy volunteers in supine posture. OBJECTIVE: To determine manometric esophageal normative values for a 24-channel water-perfused high-resolution manometry catheter in supine posture using healthy volunteers according to CC 3.0 parameters. METHODS: A total of 92 volunteers with no gastrointestinal symptoms or medications affecting GI motility underwent esophageal high-resolution manometry by standard protocol. Age, gender and manometry parameters analyzed using Alacer software were collected. The median, range, and 5th and 95th percentiles (where applicable) were obtained for all high-resolution manometry metrics. Normal value percentiles were defined as 95th integrated relaxation pressure, 5th-100th distal contractile integral, and 5th distal latency. RESULTS: The mean age was 40.5±13.2 years. Our normative metrics were integrated relaxation pressure <16 mmHg and distal contractile integral (708-4111 mmHg.cm.s) distal latency was <6 s and peristaltic break size (>4 cm). For EGJ-CI the range 5th-95th was 21.7-86.9 mmHg.cm.s. CONCLUSION: This is the first report of normative data for the 24-channel water-perfused system in supine posture. It revealed higher integrated relaxation pressure and distal latency duration which suggest the need to change CC 3.0 cutoffs for this system. It is observed that there is a tendency that DCI >7000 mmHg.cm.s may represent the lower limit of hypercontractility, and when <700 mmHg.cm.s (<5% percentile) interpreted as ineffective esophageal motility or failcontraction. Also compared to Chicago 3.0, higher integrated relaxation pressure and duration of distal latency were found. We emphasize that these data must be confirmed by future studies.

HISTORICAL PERSPECTIVE OF GASTROESOPHAGEAL REFLUX DISEASE CLINICAL TREATMENT.

BACKGROUND: Gastroesophageal reflux disease (GERD) is one of the most prevalent gastrointestinal diseases. GERD generates significant impairment in patients' quality of life and it is associated to relevant medical resources utilization. A better understanding of GERD pathophysiology in the past five decades has favored the evolution of therapeutic strategies from non-drug interventions and antacids to more efficacious and safer alternatives. OBJECTIVE: To summarize data about the historical evolution of GERD management in Brazil, focusing on medical therapy and addressing evidence on efficacy and safety of drug classes currently recommended. METHODS: A narrative review was conducted by systematizing information about discoveries on GERD pathophysiology. We also addressed efficacy and safety of medications currently used to reduce symptoms and improve endoscopic healing of esophageal lesions. A structured search on Pubmed was performed to identify systematic reviews and meta-analysis investigating GERD outcomes positively impacted by proton pump inhibitors (PPIs), the first choice of pharmacotherapy for the disease. RESULTS: The chronological development of therapeutic measures for GERD in Brazil evolved from lifestyle interventions with relative poor effect on symptoms related to esophageal acid exposure, particularly heartburn, to effective and safe pharmacological interventions such as histamine H2-receptor antagonists and PPIs. In the present days, some drug classes play a minor role in disease management, namely prokinetics and antacids, due to their reduced efficacy and relevant safety concerns (particularly with prokinetics). The main challenge for prescribers and researchers seems to be finding long-acting acid suppressants strategies able to ameliorate patients' symptoms and quality of life, thereafter, reducing medical resource consumption. The dual delayed-release PPI dexlansoprazole seems to respond for some of the limitations other PPIs have. CONCLUSION: Recognizing the historical evolution of GERD management can help care providers to better understand therapeutic options for their patients, as well as focus on unmet needs that deserve further attention. PPIs are still the first choice therapy, with good evidence in favor of their efficacy, despite some safety concerns. However, as with any medical intervention, it is recommended to prescribe PPIs for patients with clear indication, using adequate dosing and monitoring for adverse events.

Diretriz brasileira de conduta terapêutica na doença do refluxo gastroesofágico (Federação Brasileira de Gastroenterologia, FBG) / Brazilian clinical guideline for the therapeutic management of gastroesophageal reflux disease (brazilian federation of gastroenterology, fbg)

ABSTRACT Background: Gastroesophageal Reflux Disease (GERD) is a prevalent condition in Brazil, affecting 12% to 20% of the urban population, with significant implications for patient quality of life and potential for complications. Objective: This paper focuses on the recent update of the Brazilian guidelines for GERD, a necessary revision due to advancements in knowledge and practice since the last publication over a decade ago. The update pays particular attention to the role and safety of proton pump inhibitors (PPIs), acknowledging the growing concerns about their long-term use, adverse events, and overprescription. Methods: The methodology of the guideline update involved an extensive literature review in multiple languages (English, French, Italian, Spanish, and Portuguese), drawing from major databases such as Medline, Embase, and SciELO-Lilacs. Results: This comprehensive approach resulted in a carefully curated selection of studies, systematic reviews, and meta-analyses, specifically focusing on PPIs and other therapeutic strategies for GERD. The updated guidelines are presented in a user-friendly question-and-answer format, adhering to the PICO system (Population, Intervention, Comparison, Outcomes) for clarity and ease of interpretation. The recommendations are supported by robust scientific evidence and expert opinions, enhancing their practical applicability in clinical settings. To ensure the reliability and clarity of the recommendations, the GRADE system (Grading of Recommendations Assessment, Development, and Evaluation) was employed. This system categorizes the strength of recommendations as strong, weak, or conditional and classifies evidence quality as high, moderate, low, or very low. These classifications provide insight into the confidence level of each recommendation and the likelihood of future research impacting these guidelines. Conclusion: The primary aim of these updated guidelines is to offer practical, evidence-based advice for the management of GERD in Brazil, ensuring that healthcare professionals are equipped with the latest knowledge and tools to deliver optimal patient care.

RESUMO Contexto: A doença do refluxo gastroesofágico (DRGE) é uma condição prevalente no Brasil, afetando 12% a 20% da população urbana, com implicações significativas na qualidade de vida dos pacientes e potencial para complicações. Objetivo: Este artigo foca na recente atualização das diretrizes brasileiras para a DRGE, uma revisão necessária devido aos avanços no conhecimento e na prática desde a última publicação há mais de uma década. A atualização presta atenção especial ao papel e à segurança dos inibidores da bomba de prótons (IBPs), reconhecendo as crescentes preocupações sobre seu uso a longo prazo, eventos adversos e prescrição excessiva. Métodos: A metodologia da atualização das diretrizes envolveu uma extensa revisão da literatura em múltiplos idiomas (inglês, francês, italiano, espanhol e português), com dados de importantes bases de dados como Medline, Embase e SciELO-Lilacs. Resultados: Esta abordagem abrangente resultou em uma seleção cuidadosamente curada de estudos, revisões sistemáticas e meta-análises, focando especificamente em IBPs e outras estratégias terapêuticas para a DRGE. As diretrizes atualizadas são apresentadas em um formato de perguntas e respostas de fácil utilização, aderindo ao sistema PICO (População, Intervenção, Comparação, Resultados) para clareza e facilidade de interpretação. As recomendações são apoiadas por evidências científicas robustas e opiniões de especialistas, aumentando sua aplicabilidade prática em ambientes clínicos. Para garantir a confiabilidade e clareza das recomendações, foi empregado o sistema Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Este sistema categoriza a força das recomendações como forte, fraca ou condicional e classifica a qualidade da evidência como alta, moderada, baixa ou muito baixa. Essas classificações fornecem insights sobre o nível de confiança de cada recomendação e a probabilidade de pesquisas futuras impactarem nessas diretrizes. Conclusão: O objetivo principal destas diretrizes atualizadas é oferecer conselhos práticos e baseados em evidências para o manejo da DRGE no Brasil, garantindo que os profissionais de saúde estejam equipados com os conhecimentos e ferramentas mais recentes para proporcionar um cuidado ótimo ao paciente.

IVTH BRAZILIAN CONSENSUS CONFERENCE ON HELICOBACTER PYLORI INFECTION.

Significant progress has been obtained since the III Brazilian Consensus Conference on H. pylori infection held in 2012, in Bento Gonçalves, Brazil, and justify a fourth meeting to establish updated guidelines on the current management of H. pylori infection. Therefore, the Núcleo Brasileiro para Estudo do Helicobacter pylori e Microbiota (NBEHPM), association linked to Brazilian Federation of Gastroenterology (FBG) held its fourth meeting again in Bento Gonçalves, RS, Brazil, on August 25-27, 2017. Twenty-six delegates, including gastroenterologists, endoscopists, and pathologists from the five regions of Brazil as well as one international guest from the United States, participated in the meeting. The participants were invited based on their knowledge and contribution to the study of H. pylori infection. The meeting sought to review different aspects of treatment for infection; establish a correlation between infection, dyspepsia, intestinal microbiota changes, and other disorders with a special emphasis on gastric cancer; and reassess the epidemiological and diagnostic aspects of H. pylori infection. Participants were allocated into four groups as follows: 1) Epidemiology and Diagnosis, 2) Dyspepsia, intestinal microbiota and other afections, 3) Gastric Cancer, and, 4) Treatment. Before the consensus meeting, participants received a topic to be discussed and prepared a document containing a recent literature review and statements that should be discussed and eventually modified during the face-to-face meeting. All statements were evaluated in two rounds of voting. Initially, each participant discussed the document and statements with his group for possible modifications and voting. Subsequently, during a second voting in a plenary session in the presence of all participants, the statements were voted upon and eventually modified. The participants could vote using five alternatives: 1) strongly agree; 2) partially agree; 3) undecided; 4) disagree; and 5) strongly disagree. The adopted consensus index was that 80% of the participants responded that they strongly or partially agreed with each statement. The recommendations reported are intended to provide the most current and relevant evidences to management of H. pylori infection in adult population in Brazil.

Segurança dos inibidores de bomba de prótons utilizados a longo prazo: fatos e fantasias / Safety of long-term proton pump inhibitors: facts and myths

ABSTRACT Background: Proton pump inhibitors (PPIs) are one of the most prescribed drugs in the world. Frequent use and long-term maintenance of these drugs drew the attention of researchers for sporadic adverse effects reports. Objective: The purpose of this narrative review is to discuss appropriate data and causality related to these adverse events and PPIs. Methods: A narrative review was conducted by systematizing information about safety and adverse events on PPIs from 2015 to 2020. A structured search on Pubmed was performed to identify systematic reviews and meta-analysis investigating the following situations: a) gastric cancer; b) micronutrients deficiency; c) acid rebound; d) infections; e) fractures; f) dementia; g) kidney disease; and h) sudden death and cardiovascular changes. Results: Recent studies have potentially associated PPIs with some adverse events as osteoporosis-related fractures. There are also reports of intestinal infections, including Clostridium difficile, besides poor vitamins absorption and minerals such as vitamin B12, magnesium, and iron. Furthermore, there are some dementia, pneumonia, kidney disease, myocardial infarction, and stroke reports. For kidney diseases, studies consistently suggest that the use of PPI may be associated with an increased risk of adverse kidney events, especially in the elderly, with long-term PPI use and pre-existing kidney disease. Another additional question is whether chronic PPI use would also lead to the onset of gastric cancer. The abrupt discontinuation of PPIs is also related to increased gastric acid production above pre-PPI treatment levels; this phenomenon is called acid rebound. Conclusion: The key to mitigate adverse effects is the rational use of PPIs at the lowest effective dose and in the shortest possible duration. Although these adverse effects have a potential clinical impact, their causal association is still subject to validation.

RESUMO: Contexto: Os inibidores da bomba de prótons (IBPs) são um dos medicamentos mais prescritos no mundo. O uso frequente e a manutenção a longo prazo dessas drogas chamaram a atenção dos pesquisadores devido aos relatos esporádicos de efeitos adversos. Objetivo: Esta revisão narrativa tem o objetivo de discutir os dados e a causalidade relacionada a esses eventos adversos e o uso de IBPs. Métodos: Uma revisão narrativa foi conduzida através da sistematização das informações sobre segurança e eventos adversos de IBPs de 2015 a 2020. Uma busca estruturada na base de dados PubMed foi realizada visando identificar revisões sistemáticas e meta-análises investigando as situações a seguir: a) câncer gástrico; b) deficiência de microelementos; c) acidez de rebote; d) infecções; e) fraturas; f) demência; g) doença renal; e h) morte súbita e alterações cardiovasculares. Resultados: Estudos recentes têm potencialmente associado IBPs a alguns eventos adversos, como fraturas relacionadas à osteoporose. Também há relatos de infecções intestinais, incluindo Clostridium difficile, além de má absorção de vitaminas e minerais como vitamina B12, magnésio e ferro. Além disso, há alguns relatos de demência, pneumonia, doença renal, infarto do miocárdio e acidente vascular cerebral. Na doença renal, os estudos sugerem consistentemente que o uso de IBPs pode estar associado a um risco aumentado de eventos renais adversos, especialmente em idosos, com o uso de IBPs a longo prazo e doença renal preexistente. Outra questão adicional é se o uso crônico de IBPs também levaria ao aparecimento de câncer gástrico. A descontinuação abrupta de IBPs também está relacionada ao aumento da produção de ácido gástrico acima dos níveis de tratamento pré-IBPs; este fenômeno é conhecido como rebote ácido. Conclusão: A chave para mitigar esses efeitos adversos é o uso racional de IBPs na menor dose efetiva e com a menor duração possível. Embora esses efeitos adversos tenham um impacto clínico potencial, sua associação causal ainda está pendente de uma validação.

Impacto da pirose e regurgitação no bem-estar de indivíduos da população geral: um inquérito nacional brasileiro / Impact of heartburn and regurgitation on individuals' well-being in the general population: a brazilian national survey

ABSTRACT BACKGROUND: Heartburn and acid regurgitation are typical symptoms usually associated with gastroesophageal reflux disease (GERD). GERD is one of the gastrointestinal diagnosis with higher prevalence worldwide, significantly impairing patients' quality of life. OBJECTIVE: The objective of this study was to analyze the impact of GERD-related symptoms in the Brazilian urban population. METHODS: National telephone survey with community-dwelling Brazilian individuals. Self-reported prevalence and frequency of symptoms (heartburn / regurgitation) were assessed. Individuals rated the impact of symptoms in their general well-being using a numeric scale from 1 to 10 (1 = no impact; 10 = very intense, preventing the person to eat and perform daily routine activities). Descriptive and bivariate statistical analyses were performed. RESULTS: The final sample was comprised of 1,773 subjects, 935 (52.7%) females, an average of 40 years old. The prevalence of heartburn and regurgitation in the past 6 months was 26.2% (n=466) and 11.0% (n=196), respectively. Women presented higher prevalence (heartburn n=266, 28.5% and regurgitation n=119, 12.7%) than men (n=200, 23.1% and n=78, 8.9%, respectively) (P<0.05). Heartburn in the past week was reported by 175 individuals (9.8%), while regurgitation episodes by 67 (3.8%). Absence of impact of the symptom in the overall well-being was observed for 82 subjects (17.6%) with heartburn and 18 individuals (9.2%) with regurgitation. Very intense impact was reported by 46 subjects (9.8%) with heartburn and 41 (20.9%) with regurgitation. Women's well-being was more affected than men's (mean score 5.45 vs 4.71, P<0.05). CONCLUSION: Heartburn and regurgitation were frequent symptoms, women with higher prevalence. These symptoms led to a substantial impact on individuals' well-being, women being more affected.

RESUMO CONTEXTO: Pirose e regurgitação ácida são sintomas típicos usualmente relacionados à doença do refluxo gastroesofágico (DRGE). A DRGE é um dos diagnósticos gastrointestinais com maior prevalência mundial, afetando significativamente a qualidade de vida dos pacientes. OBJETIVO: Analisar o impacto de sintomas relacionados à DRGE em uma amostra da população brasileira urbana. MÉTODOS: Inquérito nacional via telefone com indivíduos brasileiros em contexto comunitário. O inquérito foi conduzido entre 6 de agosto e 12 de setembro de 2018. A prevalência autorrelatada e a frequência dos sintomas foram avaliadas. Os respondentes classificaram o impacto dos sintomas no seu bem-estar geral utilizando uma escala numérica de 1 a 10 (1 = ausência de impacto; 10 = impacto muito grave, impedindo a pessoa de comer ou realizar atividades da vida diária). Análises estatísticas descritivas e bivariadas foram conduzidas. RESULTADOS: A amostra final foi constituída por 1.773 indivíduos, 935 (52,7%) mulheres, com idade média de 40 anos. A prevalência de pirose e regurgitação nos últimos 6 meses foi de 26,2% (n=466) e 11,0% (n=196), respectivamente. Sexo feminino (pirose n=266, 28,5% e regurgitação n=119, 12,7%) apresentou prevalência mais alta do que o masculino (n=200, 23,1% e n=78, 8,9%, respectivamente) (P<0,05). Pirose na última semana foi relatada por 175 indivíduos (9,8%), enquanto episódios de regurgitação por 67 (3,8%). Ausência de impacto dos sintomas no bem-estar geral dos indivíduos foi observada para 82 respondentes (17,6%) com pirose e 18 (9,2%) daqueles com regurgitação. Impacto muito grave foi reportado por 46 (9,8%) indivíduos com pirose e 41 (20,9%) com regurgitação. Sexo feminino foi mais afetado pelos sintomas do que o masculino. CONCLUSÃO: Pirose e regurgitação foram bastante frequentes sendo o sexo feminino mais afetado. Tais sintomas levaram a impacto no bem-estar dos indivíduos, com maior prejuízo para mulheres.

Prevalence of heartburn and gastroesophageal reflux disease in the urban Brazilian population.

BACKGROUND: The epidemiological aspects of heartburn and gastroesophageal reflux disease have been object of growing interest in the last decade because of its increasing prevalence and the complications of the disease. AIMS: To evaluate the prevalence of heartburn and gastroesophageal reflux disease as well as their main characteristics in the Brazilian urban population. METHODS: A national inquire enrolling 13,959 adults was conducted in 22 Brazilian cities. The inclusion criteria were the presence of heartburn at least once a week ("heartburn group") and age greater than 16 years old. Individuals with heartburn with frequency of more than once a week were considered as having gastroesophageal reflux disease (GERD group). Factors related to the complaint were asked such as predisposing factors, habits (tobacco, alcohol and coffee intake) and body mass index. In this populational study a probabilistic model was used. RESULTS: The results are presented in absolute and relative frequency, which were ponderated estimates of the respective population figures. The global prevalence of heartburn was 11.9% (1,651 persons). Heartburn once a week was present in 4.6% (637 persons) and GERD in 7.3% (1,014 persons). The average ages of both groups were similar (men: 36.9 +/- 15.0; women: 39.6 +/- 15.1 yrs). Females were more affected in both groups. The occurrence of GERD increased with age and was more prevalent after 55 years old. The body mass index was in the normal range and similar in both groups (men: 24.7 +/- 4.6; women: 25.3 +/- 5.2 kg/m(2)). In both groups the individuals related their symptoms to food intake, fatty and spicy foods (heartburn group: 64.7%, 28.5%, 17.7%; GERD group: 55.0%, 25.9%, 11.7% respectively). In GERD group, stress (24.2%), health problems (22.3%) were more related to the symptoms than in heartburn group (20.0% and 15.0% respectively). CONCLUSIONS: The global prevalence of heartburn (11.9%) is relatively high in the Brazilian urban population, although lower than the reported figure to other countries. Heartburn and GERD have higher prevalence in women and both are related to food intake, fatty and spicy foods; GERD is more prevalent in individuals older than 35 years old.

Epidemiology of constipation in São Paulo, Brazil: a population-based study.

OBJECTIVE: Epidemiologic data on constipation in South America are limited. The main objective of this study was to assess the prevalence of self-reported symptoms of constipation in Brazil. METHODS: Telephone and personal surveys were conducted among community-dwelling adults in homes with land-based telephones in São Paulo. Data were weighted by numbers of adults, total residents, and telephones in each household. To account for potential nonresponse and noncoverage bias, results were further adjusted according to Brazilian census data. RESULTS: Among 4570 households contacted, 3050 adults (66.7%) participated. Respondents (mean [SE] age: 42.6 [2.7] years) were primarily women (53.1%). A minority of all respondents reported symptoms consistent with constipation, including a perception of incomplete voiding in 8.0%; expending efforts to defecate in 7.6%; ≤2 stools weekly in 9.0%; and hard stools in 12.7%. Prevalences of these symptoms and efforts to manage them were more frequent in women (P ≤ 0.004), but most were not significantly associated with advancing age. With increasing age, proportions of respondents with ≤2 stools per week declined (P = 0.001), whereas use of bowel enemas (P = 0.026) and digital maneuvers to disimpact stool increased (P < 0.001). Despite frequent constipation symptoms, the vast majority of respondents did not report using prescription medications, but some used natural remedies (29.5%) and/or laxatives (13.4%). CONCLUSIONS: Symptoms of constipation are prevalent in São Paulo, particularly among women. On the other hand, most survey respondents did not use medications or other remedies that manage this condition. These findings may point to an unmet gastrointestinal treatment need. Future research is needed to corroborate our findings in rural settings and to further evaluate potential predictors and consequences of constipation in South America.

Práticas de médicos brasileiros no manejo de sintomas sugestivos de doença do refluxo gastroesofágico: uma avaliação multidisciplinar / Brazilian physicians' practices on the management of symptoms suggesting gastroesophageal reflux disease: a multidisciplinary survey

ABSTRACT BACKGROUND: Clinical guidelines are available to steer decisions regarding diagnosis, management and treatment of gastrointestinal disorders. Despite this, variations in physician's practices regarding gastroesophageal reflux disease (GERD) symptoms are well described in the literature. OBJECTIVE: To describe practices of physicians from different specialties on the management of patients with typical symptoms of GERD (heartburn and regurgitation) in a Brazilian sample. METHODS: National online survey enrolling a sample of general practitioners, gastroenterologists, cardiologists and otolaryngologists. The survey was conducted from August 6th to September 12th, 2018. Subjects answered a structured questionnaire addressing variables regarding physicians' profile (age, sex, specialty, practice setting, years in practice, type of medical expense reimbursement), their patients characteristics and prescribing behaviors. RESULTS: The final weighted sample was comprised of 400 physicians, 64% male, with an average of 15 years of experience. Physicians' estimates of gastroesophageal symptoms prevalence among their pool of patients was 37.6% for the total sample, reaching 70.3% among gastroenterologists. The medical specialty with lower average percentage of patients presenting gastroesophageal symptoms was otolaryngology (24.5%). Physicians reported that they request ancillary tests for 64.5% of patients with GERD typical symptoms. The most common diagnostic test was endoscopy (69.4%), followed by video nasolaryngoscopy (16.6%). The percentage of patient to whom endoscopy is performed was significantly higher among gastroenterologists and general practitioners as compared to otolaryngologists and cardiologists, while video nasolaryngoscopy is markedly more frequent among otolaryngologists. In terms of therapeutic options, the most frequently reported strategy was lifestyle modifications followed by proton pump inhibitors. CONCLUSION: Overall patients' profile and patterns of GERD diagnosis and management seem different between gastroenterologists, general practitioners, otolaryngologists, and cardiologists. Clinical guidelines should address this variability and include other medical specialties besides gastroenterologists in their scope.

RESUMO CONTEXTO: Diretrizes clínicas estão disponíveis para orientar decisões sobre diagnóstico, manejo e tratamento de desordens gastrointestinais. Apesar disso, variações nas práticas relacionadas aos sintomas de doença do refluxo gastroesofágico (DRGE) são observadas na literatura. OBJETIVO: Descrever os conhecimentos e práticas relacionados ao manejo de pacientes com sintomas típicos de DRGE (pirose e regurgitação) em uma amostra brasileira de médicos de especialistas e não especialistas. MÉTODOS: Inquérito nacional online investigando a conduta frente ao diagnóstico de DRGE em uma amostra de médicos generalistas, gastroenterologistas, cardiologistas e otorrinolaringologistas. O inquérito foi conduzido entre 6 de agosto e 12 de setembro de 2018. Os sujeitos responderam a um questionário estruturado avaliando variáveis relacionadas ao perfil dos médicos (idade, sexo, especialidade, contexto de prática, anos de experiência, tipo de reembolso de despesas médicas), características dos pacientes e comportamentos de prescrição. RESULTADOS: A amostra final ponderada foi composta por 400 médicos, 64% homens, com um tempo médio de experiência de 15 anos. A estimativa dos médicos a respeito da prevalência de sintomas gastroesofágicos entre seus pacientes foi de 37,6% para a amostra total, alcançando 70,3% entre gastroenterologistas. A especialidade médica com menor percentual de pacientes apresentando sintomas gastroesofágicos foi otorrinola­ringologia (24,5%). Os médicos requisitaram exames complementares em 64,5% dos pacientes com sintomas típicos de DRGE. O exame diagnóstico mais frequente foi endoscopia (69,4%), seguida de nasolaringoscopia (16,6%). O percentual de pacientes nos quais uma endoscopia é realizada é significativamente maior entre gastroenterologistas e médicos generalistas, quando comparado a otorrinolaringologistas e cardiologistas, enquanto nasolaringoscopia é marcadamente mais frequente entre otorrinolaringologistas. Em termos de opções terapêuticas, a estratégia mais frequentemente reportada foi modificações no estilo de vida, seguida de inibidores da bomba de prótons. CONCLUSÃO: De modo geral, o perfil de pacientes e os padrões de diagnóstico e manejo de DRGE parecem diferir entre gastroenterologistas, médicos generalistas, otorrinolaringologistas e cardiologistas. Diretrizes clínicas devem abordar esta variabilidade e incluir outras especialidades médicas além de gastroenterologistas em seu escopo.