[Gastro-oesophageal reflux disease-update 2021]. / Gastroösophageale Refluxkrankheit ­ Update 2021.

Gastro-oesophageal reflux disease (GORD), a highly prevalent disease, is defined by troublesome symptoms and/or oesophageal lesions caused by reflux of gastric content. A diagnostic gold standard does not exist. A reliable diagnosis may be difficult in individual cases. Patients' history, endoscopic findings and pH-impedance monitoring contribute to the evaluation of gastro-oesophageal reflux and its consequences. High-resolution manometry may add important information on the pathophysiology of the disease and may help to rule out motility disorders as the leading cause of the symptoms. Proton pump inhibitors (PPI) are the drugs of first choice. In patients with insufficient PPI response, optimization of PPI therapy and/or combination with drugs having another mechanism of action are the available options. If PPIs are not sufficiently effective, not tolerated, or not wished antireflux procedures may be offered in specialized centers taking pathophysiological data into account.

[Gastroenterological diseases as triggers of chest pain]. / Gastroenterologische Erkrankungen als Auslöser von Thoraxschmerz.

BACKGROUND: Non-cardiac chest pain is very common and gastroenterological diseases are one of the most important causes. The frequency distribution of the underlying causes depends on the sector of the healthcare system in which it is ascertained. In individual cases it must always be taken into consideration that detection of coronary heart disease, for example, does not exclude another origin of chest pain. OBJECTIVE: This article provides a systematic review of gastroenterological diseases that can cause chest pain. Furthermore, a management algorithm was developed. MATERIAL AND METHODS: This article is based on a selective search of the literature. RESULTS AND DISCUSSION: The most frequent cause is gastroesophageal reflux disease, which is also known as reflux-chest pain syndrome. If there are no clinical alarm signals, treatment is carried out with a proton pump inhibitor either as a diagnostic test or as a probatory therapy. If this initial management does not lead to satisfactory symptom control, extended diagnostics are indicated. In individual cases this concerns the detection or exclusion of a reflux disease, of motility disorders and structural damage to the esophagus as well as diseases of the upper abdominal organs, which can evoke chest pain. After exclusion of these morphologically and/or functionally defined diseases, a so-called functional chest pain is present. The essential mechanisms are altered pain processing, esophageal hypersensitivity and mental comorbidities. The treatment of functional chest pain often proves to be difficult.

[Diagnostic and therapeutic management of helicobacter pylori: a survey among German gastroenterologists in private practice]. / Diagnostisches und therapeutisches Management der Helicobacter-pylori-Infektion: eine Umfrage unter niedergelassener Gastroenterologen in Deutschland.

Purpose: The acceptance and realization of clinical guidelines in daily routine practice is unknown. The aim of this study was to evaluate the behaviour of private gastroenterologists in Germany with respect to the diagnostic and therapeutic management of H. pylori infection in times of increasing antibiotic resistance. Methods: Between 12/2014 and 02/2015 a standardized questionnaire with 19 multiple choice questions were sent to 1507 private gastroenterologists in Germany. The data were electronically captured and analyzed using SurveyMonkey. Results: The response rate was 36 % (540 questionnaires). 65 % of responders prescribe first line therapy by themselves and mainly use standard triple therapies. In patients with intolerance to penicillin, 81 % prescribe Italian triple therapy and 19 % prescribe bismuth quadruple therapy. Risk factors for primary clarithromycin resistance (migrational background, previous macrolide exposure) are routinely assessed by only a minority of responders (22 % and 17 %, respectively). Forty-one percent of responders perform eradication control by themselves mainly using a 13C urea breath test (54 %). In second line therapy, 42 % are prescribing bismuth quadruple therapy and 24 % fluoroquinolone triple therapy. After second line therapy, 58 % of responders are performing eradication control by themselves. Of those, 70 % always take biopsies for antibiotic susceptibility testing. Conclusions: The results of our survey suggest that most private gastroenterologists in Germany adhere to current guidelines for H. pylori management; however, some relevant deviations seem to exist. Our data might be useful for further developments of clinical guidelines and their communication among the medical community.

[S2k-guideline Helicobacter pylori and gastroduodenal ulcer disease]. / S2k-Leitlinie Helicobacter pylori und gastroduodenale Ulkuskrankheit.

In the line "bismuth-containing quadruple therapy" of Table 7 (p 342), in the column "dosage" incorrectly at the three antibiotics respectively 1-1-1-1. The correct is: 3-3-3-3.

[Barrett's esophagus]. / Barrett-Ösophagus.

Barrett's esophagus is an endoscopically visible metaplasia of the columnar epithelium in the esophagus with histological detection of a specialized intestinal metaplasia. The circumferential and longitudinal extent are described endoscopically using the Prague classification. Barrett's esophagus mostly occurs as the result of gastroesophageal reflux disease. The risk of developing esophageal adenocarcinoma is increased but the absolute risk is low with 0.10-0.15 % per year. According to guideline recommendations, screening for Barrett's esophagus as well as endoscopic and biopsy surveillance should be limited to high risk groups. On detection of intraepithelial neoplasia (IEN) endoscopic therapy is indicated, whereby a second opinion must be obtained from a specialized pathologist for low-grade IEN. The influence of proton pump inhibitors on the progression to carcinoma is controversially discussed and a preventive anti-reflux operation is not indicated.

Management of reflux esophagitis: does the choice of proton pump inhibitor matter?

BACKGROUND: Proton pump inhibitors (PPIs) are the treatment of choice for reflux esophagitis (RE). The effectiveness of PPIs throughout RE management, from healing to maintenance, has not been fully studied. AIM: To compare esomeprazole with lansoprazole or pantoprazole for RE management using a management model. METHODS: Data from six studies comparing esomeprazole with lansoprazole or pantoprazole for healing (4-8 weeks) or maintenance of healing (6 months) of RE were incorporated into hypothetical management models to determine the proportion of patients in endoscopic remission after sequential healing and maintenance therapy, assuming that patients received the same PPI throughout. The number needed to treat (NNT) to achieve one more patient in remission with esomeprazole vs. other PPIs was estimated. The hypothetical model was validated using results from the EXPO study, which compared esomeprazole with pantoprazole for RE healing and maintenance. RESULTS: Overall, esomeprazole 40 mg produced higher rates of healing (life-table estimates) than lansoprazole 30 mg (82.4-92.6% vs. 77.5-88.8%; p < 0.01) or pantoprazole 40 mg (95.5% vs. 92.0%; p < 0.001) and higher rates of endoscopic and symptomatic remission at 6 months than lansoprazole (83.0-84.8% vs. 74.0-75.9%; p < 0.001; life-table estimates) or pantoprazole (70.9% vs. 59.6%; p < 0.0001; observed rates). In the hypothetical management model, the NNT for esomeprazole was 9 vs. lansoprazole and 8 vs. pantoprazole. The actual NNT for esomeprazole vs. pantoprazole in the EXPO study was 9 (95% confidence interval: 6; 16). CONCLUSIONS: In this management model, esomeprazole was more effective than either lansoprazole or pantoprazole for maintaining remission after sequential healing and 6 months' maintenance therapy for RE.

Endoscopic procedures in patients under clopidogrel or dual antiplatelet therapy: a survey among German gastroenterologists and current guidelines.

BACKGROUND: Because of the higher risk of bleeding, guidelines recommend cessation of clopidogrel seven days prior to high-risk endoscopic procedures. However, premature cessation of clopidogrel may lead to catastrophic cardiovascular sequelae due to stent thrombosis. We aimed to assess the current clinical practice among German gastroenterologists regarding endoscopic procedures in patients under clopidogrel/dual antiplatelet therapy. METHODS: A 10-item questionnaire on endoscopic procedures in patients under clopidogrel/dual antiplatelet therapy was sent by e-mail to all 220 members of the ALGK. RESULTS: 73 (33 %) chief gastroenterologists returned completed questionnaires, 35 (48 %) of whom conduct high-volume endoscopic units performing more than 4000 procedures per annum. 62 (85 %) endoscopic units perform endoscopic biopsies under clopidogrel alone, while just in 30 (41 %) departments biopsies are carried out under dual antiplatelet therapy. In 36 (49 %) GI-units endoscopic polypectomy under clopidogrel monotherapy is performed, in contrast to only 4 (5.5 %) in the case of combined antiplatelet therapy. However, in emergency situations more than 60 % of all participants do perform endoscopic sphincterotomy in patients under clopidogrel/dual antiplatelet therapy. Percutaneous endoscopic gastrostomy is carried out in 32 endoscopic units (44 %) under clopidogrel monotherapy, but only in 4 (5.5 %) under dual antiplatelet therapy. CONCLUSION: Current guidelines on endoscopic procedures in patients under clopidogrel/dual antiplatelet therapy are mainly based on expert opinion and therefore, backed by only weak evidence. Our survey shows that in this setting the clinical decision making takes place on an individual basis, as there are no data to support the recommendations of the present guidelines.

Impact of S3 training courses "Sedation and Emergency Management in Endoscopy for Endoscopy Nurses and Assisting Personnel" on the process and structure quality in gastroenterological endoscopy in practices and clinics - results of a nationwide survey.

INTRODUCTION: After the S3 Guideline Sedation in Gastrointestinal Endoscopy was published, a training curriculum for a three-day course for endoscopy nurses was developed. The aim of this study was to investigate what effect the course participation had on the daily routine process and structure quality by implementing a German-wide survey in gastroenterology practices and clinics. METHODS: A questionnaire with a total of 44 individual questions on personnel, space, and equipment structure, sedation, peri- and post-interventional monitoring, as well as discharge and complication management in endoscopy departments was sent to a total of 2113 course participants (1056 Institutions). They had completed the seminar between December 2008/January 2009 and June 2010. RESULTS: The response rate was 21.2 % (224 /1056). Fifty-four percent were from clinic endoscopy departments, 46 % from practices. Overall, some form of structural change occurred in 86.8 % of the clinics and in 84.5 % of the practices. New staff was hired in 28.1 % of the clinics and 12.6 % of the practices. Rosters were changed in 11.6 % of the clinics and 7.8 % of the practices. Almost all issues improved after course participation. However, they did not reach statistic significance with the exception of the availability of peri-interventional ECG-monitoring in practices. The "performance of sedation in threesomes" increased in clinics by more than 20 % and in practices by more than 15 %. The use of the ASA-classification to assess risk increased significantly in clinics (before 24 %, after 50 %) as well as practices (before 40 %, after 60 %) by more than 20 % (p = 0.0007 and p = 0.0385, respectively). The documentation of the discharge status (e. g. using checklists) more than doubled in clinics (before 19 %, after 41.3 %) and practices (before 17.5 %, after 38.8 %) after course completion. CONCLUSION: The only nationwide endoscopy nurses' survey on structure and process quality in endoscopy so far, shows that since the publication of the S3 guideline in 2008 numerous processes and structures have improved with respect to patient safety.

[How safe is sedation in gastrointestinal endoscopy? A multicentre analysis of 388,404 endoscopies and analysis of data from prospective registries of complications managed by members of the Working Group of Leading Hospital Gastroenterologists (ALGK)]. / Wie sicher ist die Sedierung in der gastrointestinalen Endoskopie? Eine multizentrische Auswertung von 388 404 Endoskopien und Auswertung der Daten aus prospektiv geführten Komplikationsregistern von Mitgliedern der Arbeitsgemeinschaft leitender Gastroenterologen im Krankenhaus (ALGK).

BACKGROUND: Gastrointestinal endoscopies are increasingly being carried out with sedation. All of the drugs used for sedation are associated with a certain risk of complications. Data currently available on sedation-associated morbidity and mortality rates are limited and in most cases have substantial methodological limitations. The aim of this study was to record severe sedation-associated complications in a large number of gastrointestinal endoscopies. METHODS: Data on severe sedation-associated complications were collected on a multicentre basis from prospectively recorded registries of complications in the participating hospitals (median documentation period 27 months, range 9 - 129 months). RESULTS: Data for 388,404 endoscopies from 15 departments were included in the study. Severe sedation-associated complications occurred in 57 patients (0.01 %). Forty-one percent of the complications and 50 % of all complications with a fatal outcome (10/20 patients) occurred during emergency endoscopies. In addition, it was found that 95 % of the complications and 100 % of all fatal complications affected patients in ASA class ≥ 3. CONCLUSIONS: Including nearly 400,000 endoscopies, this study represents the largest prospective, multicenter record of the complications of sedation worldwide. The analysis shows that sedation is carried out safely in gastrointestinal endoscopy. The morbidity and mortality rates are much lower than previously reported in the literature in similar groups of patients. Risk factors for the occurrence of serious complications include emergency examinations and patients in ASA class ≥ 3.

[Efficacy and safety of OTC omeprazole]. / Wirksamkeit und Sicherheit von Omeprazol in der Selbstmedikation. Ergebnisse einer apothekenbasierten nicht-interventionellen Beobachtungsstudie bei Patienten mit Refluxbeschwerden.

BACKGROUND: Heartburn and acid regurgitation--cardinal symptoms of gastro-esophageal reflux disease (GERD)--rank among the most frequent gastrointestinal disorders. The high degree of suffering often requires a fast and effective symptom relief. Proton pump inhibitors (PPI) are the medication of choice for all manifestations of GERD. Since 2009 the PPI omeprazole is available for OTC-treatment (over the counter). The aim of this pharmacoepidemiologic observational study was to document efficacy and safety of omeprazole under daily-life conditions of self-medication. 2718 patients who had bought the omeprazole product Antra in the pharmacy for treatment of heartburn or acid regurgitation participated in this prospective non-interventional study. RESULTS: A large part of patients benefited from the PPI-treatment with fast and long lasting symptom relief: 44% of patients already experienced improvement of their symptoms within two to four hours, 71% of patients were completely symptom-free after the OTC treatment (max. 14 days). Overall the PPI was very well tolerated. Adverse events were rare (2.4%) and in accordance with previous experiences. 94% of patients indicated that in case of need they would take the product again. 40% of 178 patients who had been followed-up over a period of three months remained completely symptom-free. CONCLUSION: The efficacy and safety of omeprazole known from clinical trials are confirmed for OTC-treatment under daily-life conditions by the results of this non-interventional study.

[Current value of quinolones in Helicobacter pylori therapy]. / Aktueller Stellenwert von Fluorchinolonen in der Helicobacter-pylori-Therapie.

Eradication rates in first-line Helicobacter pylori therapy have been declining over the last decades, mainly due to increasing resistance against the recommended antibiotics clarithromycin and metronidazole. Thus, there is a need to evaluate novel regimens and substances to offer effective alternative treatment strategies. New generation quinolones, like levofloxacin and moxifloxacin, exhibit a broad-spectrum activity against various Gram-positive and Gram-negative strains and are mostly well tolerated. Based on a large number of studies, quinolones have been introduced in second-line and rescue treatment and are recommended for these indications in current guidelines. Various studies have investigated alternative strategies for first-line treatment including quinolone-based regimens. In the context of increasing resistance rates of Helicobacter pylori against quinolones some risks and benefits have to be considered when using quinolones as a first-line strategy. Besides numerous studies investigating levofloxacin and moxifloxacin there are some promising results for the new substance sitafloxacin, which might overcome primary resistance of Helicobacter pylori against conventional quinolones.

[The ABC's of medical statistics. Reading and understanding clinical trials]. / Das ABC der medizinischen Statistik. Klinische Studien lesen und verstehen.

Clinical trials test hypotheses that are accepted or rejected according to a predetermined probability of error (level of significance). Significance does not however mean relevance. Good parameters of relevance are absolute risk reduction and based on this the calculation of the number of patients who need to be treated for one additional patient to benefit. The randomized controlled trial is the gold standard for comparative evaluation of effects. In the ideal scenario it is designed so that a difference established by statistical methods becomes probable. In non-inferiority studies care should be taken that no equivalence is shown but rather that the difference is not greater than a predefined margin of error for differences. Meta-analyses of studies with similar endpoints have the potential to improve the level of evidence. Since the findings of meta-analyses depend on the studies included, critical assessment of the results is essential.

[The ABC's of medical statistics. Reading and understanding clinical trials]. / Das ABC der medizinischen Statistik. Klinische Studien lesen und verstehen.

Clinical trials test hypotheses that are accepted or rejected according to a predetermined probability of error (level of significance). Significance does not however mean relevance. Good parameters of relevance are absolute risk reduction and based on this the calculation of the number of patients who need to be treated for one additional patient to benefit. The randomized controlled trial is the gold standard for comparative evaluation of effects. In the ideal scenario it is designed so that a difference established by statistical methods becomes probable. In non-inferiority studies care should be taken that no equivalence is shown but rather that the difference is not greater than a predefined margin of error for differences. Meta-analyses of studies with similar endpoints have the potential to improve the level of evidence. Since the findings of meta-analyses depend on the studies included, critical assessment of the results is essential.

S3-guideline "helicobacter pylori and gastroduodenal ulcer disease" of the German society for digestive and metabolic diseases (DGVS) in cooperation with the German society for hygiene and microbiology, society for pediatric gastroenterology and nutrition e. V., German society for rheumatology, AWMF-registration-no. 021 / 001.

This guideline updates a prior consensus recommendation of the German Society for Digestive and Metabolic Diseases (DGVS) from 1996. It was developed by an interdisciplinary cooperation with representatives of the German Society for Hygiene and Microbiology, the Society for Pediatric Gastroenterology and Nutrition (GPGE), and the German Society for Rheumatology. The guideline is methodologically based on recommendations of the Association of the Scientific Medical Societies in Germany (AWMF) for providing a systematic evidence-based S 3 level consensus guideline and has also implemented grading criteria according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) process. Clinical applicability of study results as well as specifics for Germany in terms of epidemiology, antibiotic resistance status, diagnostics, and therapy were taken into account.