Helicobacter pylori infection is very common in the Spanish population and represents the main cause of chronic gastritis, peptic ulcer, and gastric cancer. The last iteration of Spanish consensus guidelines on H. pylori infection was conducted in 2016. Recent changes in therapeutic schemes along with increasing supporting evidence were key for developing the V Spanish Consensus Conference (May 2021). Fourteen experts performed a systematic review of the scientific evidence and developed a series of recommendations that were subjected to an anonymous Delphi process of iterative voting. Scientific evidence and the strength of the recommendation were classified using GRADE guidelines. An eradication therapy, when prescribed empirically, is considered acceptable when it reliably achieves, or preferably surpass, 90% cure rates. Currently, only quadruple therapies (with or without bismuth) and generally lasting 14 days, accomplish this goal in first- and second-line therapies. A non-bismuth quadruple concomitant regimen (proton pump inhibitor, clarithromycin, amoxicillin, and metronidazole) or a quadruple bismuth-based combination (proton pump inhibitor, bismuth, tetracycline, and metronidazole), are recommended as first-line regimens. Rescue therapies after eradication failure and management of H. pylori infection in peptic ulcer disease were also reviewed.

New guidelines for the limits of elemental impurities in drug products were introduced by the International Council for Harmonization in 2014. While the guidelines define a limit for each element, the complete quantification of the 24 elements included is, in fact, unnecessary. An accurate \"pass/fail\" test to determine whether the threshold was exceeded or not could be valuable in this context. In this study, a screening procedure using the features of high-resolution continuum source graphite furnace atomic absorption spectrometry for the evaluation of 12 elements in three different drugs was developed. The three-dimensional absorbance spectrum including time and wavelength in the vicinity of the main line of the element allows for a pass/fail decision related to the presence or absence of the element in the sample. Additionally, the bi-dimensional absorbance-wavelength spectrum defines the elements captured in the window when additional peaks are seen in the spectrum. The analysis of the selected drugs included sample digestion, the definition of pyrolysis and atomization temperatures, determination of the limit of detection and other validation parameters for each element. The evaluation of the spectra, both three- and bi-dimensional, revealed that only three elements, Cr, Ni, and Cu, were present in the samples in amounts above the LOD and therefore \"fail\" in the test. Nevertheless, they were quantified, and the analysis revealed that their levels were below the permitted daily exposure, which are at least 6 times higher than the LOD of the selected elements. Operating in a routine mode, the proposed method is a good option for the evaluation of elemental impurities in drug active ingredients or drug final products.

Helicobacter pylori approximately infect 50% of Spanish population and causes chronic gastritis, peptic ulcer and gastric cancer. Until now, three consensus meetings on H.pylori infection had been performed in Spain (the last in 2012). The changes in the treatment schemes, and the increasing available evidence, have justified organizing the IVSpanish Consensus Conference (March 2016), focused on the treatment of this infection. Nineteen experts participated, who performed a systematic review of the scientific evidence and developed a series of recommendation that were subjected to an anonymous Delphi process of iterative voting. Scientific evidence and the strength of the recommendation were classified using GRADE guidelines. As starting point, this consensus increased the minimum acceptable efficacy of recommended treatments that should reach, or preferably surpass, the 90% cure rate when prescribed empirically. Therefore, only quadruple therapies (with or without bismuth), and generally lasting 14 days, are recommended both for first and second line treatments. Non-bismuth quadruple concomitant regimen, including a proton pump inhibitor, clarithromycin, amoxicillin and metronidazole, is recommended as first line. In the present consensus, other first line alternatives and rescue treatments are also reviewed and recommended.

BACKGROUND: The Portuguese National Health Directorate has issued clinical practice guidelines on prescription of anti-inflammatory drugs, acid suppressive therapy, and antiplatelets. However, their effectiveness in changing actual practice is unknown.
METHODS: The study will compare the effectiveness of educational outreach visits regarding the improvement of compliance with clinical guidelines in primary care against usual dissemination strategies. A cost-benefit analysis will also be conducted. We will carry out a parallel, open, superiority, randomized trial directed to primary care physicians. Physicians will be recruited and allocated at a cluster-level (primary care unit) by minimization. Data will be analyzed at the physician level. Primary care units will be eligible if they use electronic prescribing and have at least four physicians willing to participate. Physicians in intervention units will be offered individual educational outreach visits (one for each guideline) at their workplace during a six-month period. Physicians in the control group will be offered a single unrelated group training session. Primary outcomes will be the proportion of cyclooxygenase-2 inhibitors prescribed in the anti-inflammatory class, and the proportion of omeprazole in the proton pump inhibitors class at 18 months post-intervention. Prescription data will be collected from the regional pharmacy claims database. We estimated a sample size of 110 physicians in each group, corresponding to 19 clusters with a mean size of 6 physicians. Outcome collection and data analysis will be blinded to allocation, but due to the nature of the intervention, physicians and detailers cannot be blinded.
CONCLUSIONS: This trial will attempt to address unresolved issues in the literature, namely, long term persistence of effect, the importance of sequential visits in an outreach program, and cost issues. If successful, this trial may be the cornerstone for deploying large scale educational outreach programs within the Portuguese National Health Service.
BACKGROUND: ClinicalTrials.gov number NCT01984034.

OBJECTIVE: To test the Genval recommendations and the usefulness of a short trial of proton pump inhibitor (PPI) in the initial management and maintenance treatment of gastroesophageal reflux disease (GERD) patients.
METHODS: Five hundred and seventy seven patients with heartburn were recruited. After completing a psychometric tool to assess quality of life (PGWBI) and a previously validated GERD symptom questionnaire (QUID), patients were grouped into those with esophagitis (EE, n = 306) or without mucosal damage (NERD, n = 271) according to endoscopy results. The study started with a 2-wk period of high dose omeprazole (omeprazole test); patients responding to this PPI test entered an acute phase (3 mo) of treatment with any PPI at the standard dose. Finally, those patients with a favorable response to the standard PPI dose were maintained on a half PPI dose for a further 3-mo period.
RESULTS: The test was positive in 519 (89.9%) patients, with a greater response in EE patients (96.4%) compared with NERD patients (82.6%) (P = 0.011). Both the percentage of completely asymptomatic patients, at 3 and 6 mo, and the reduction in heartburn intensity were significantly higher in the EE compared with NERD patients (P < 0.01). Finally, the mean PGWBI score was significantly decreased before and increased after therapy in both subgroups when compared with the mean value in a reference Italian population.
CONCLUSIONS: Our study confirms the validity of the Genval guidelines in the management of GERD patients. In addition, we observed that the overall response to PPI therapy is lower in NERD compared to EE patients.

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The aim of this article is to introduce Lithuanian clinical practice guidelines for the management of laryngopharyngeal form of gastroesophageal reflux disease for standardization of the diagnosis and treatment of the disease and prevention of its complications. Composed guidelines provide recommendations for primary care physicians as well as otorhinolaryngologists and gastroenterologists for the management of adults with uncomplicated laryngopharyngeal form of gastroesophageal reflux disease. Committee composed of experts from Lithuanian Otorhinolaryngological and Gastroenterological Societies developed guidelines based on a comprehensive review of the evidence-based literature related to laryngopharyngeal form of gastroesophageal reflux disease and guidelines of other countries. The guidelines provide description of each medicine groups with emphasis on proton pump inhibitors as the most effective drugs for the treatment of laryngopharyngeal form of gastroesophageal reflux disease. Indications for empirical treatment with proton pump inhibitors are described, as well as duration of treatment, doses, optimal regimen of use, and assessment of treatment efficacy. The therapy should begin with the application of proton pump inhibitors twice daily, before meal for three months. Combined therapy for nonresponders is described. Algorithm for stopping the medication is recommended. These recommendations may provide an efficient and economical approach to the management of this problem.

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Gastroesophageal reflux disease (GERD) has evolved from a scarcely reported, little understood disease process just a century ago to a now highly prevalent disease with up to 25% of the population complaining of symptoms of reflux. Throughout history attempts have been made to delineate the esophagus and related pathologies, but it has not been until relatively recently that enough has been understood about its screening, diagnosis and treatment to make a substantial impact on sufferers. Although the use of antacids and thereafter histamine 2 receptor antagonists dramatically improved the management of GERD, it was the advent of the proton pump inhibitor (PPI) class of drugs that revolutionized medical care. Although the relationship of hiatus hernia to reflux was well accepted, the modest results of open fundoplication fell into further disregard given the efficacy of PPIs. The PPIs are currently the most effective form of therapy and are equivalent on a milligram for milligram basis. While currently no novel drugs or devices are of proven efficacy for GERD, the development of an acid-suppressive agent of equal efficiency to a PPI but with a more rapid onset of action and a greater duration of effectiveness would be of particular clinical utility for the future.