The Gastropack Access System as a Model to Access Gastroenterology Services for Gastroscopy Appropriateness in Patients with Upper Gastrointestinal Symptoms: A Comparison with the Open Access System.

Esophagogastroduodenoscopy (EGD) appropriateness in Open-Access System (OAS) is a relevant issue. The Gastropack Access System (GAS) is a new system to access gastroenterological services, based on the partnership between Gastroenterologists and GPs. This study aims to evaluate if GAS is superior to OAS in terms of EGDS appropriateness. Secondarily, we evaluated the diagnostic yield of EGDS according to ASGE guidelines. The GAS was developed in an area of Bologna where General Practitioners (GPs) could decide to directly prescribe EGDS through OAS or referring to GAS, where EGDS can be scheduled after contact between GPs and specialists sharing a patient's clinical information. Between 2016 and 2019, 2179 cases (M:F = 861:1318, median age 61, IQR 47.72) were referred to GAS and 1467 patients (65%) had a prescription for EGDS; conversely, 874 EGDS were prescribed through OAS (M:F = 383:491; median age 58 yrs, IQR 45.68). Indication was appropriate in 92% in GAS (1312/1424) versus 71% in OAS (618/874), p < 0.001. The rate of clinically significant endoscopic findings (CSEF) was significantly higher in GAS (49% vs. 34.8%, p < 0.001). Adherence to ASGE guidelines was not related to CSEF; however, surveillance for pre-malignant conditions was independently related to CSEF. All neoplasm were observed in appropriate EGD. GAS is an innovative method showing extremely high rates of appropriateness. ASGE guidelines confirmed their validity for cancer detection, but their performance for the detection of other conditions needs to be refined.

Assessment of small intestinal bacterial overgrowth and methane production in patients on chronic proton-pump inhibitor treatment: prevalence and role of rifaximin in its management in primary care.

BACKGROUND: Although proton pump inhibitor (PPI) drugs have considered able to induce small intestinal bacterial overgrowth (SIBO), no data are so far available from primary care (PC). We assessed the prevalence of SIBO and methane (CH4) production consequent to chronic PPI therapy using Lactulose Breath Test (LBT). Secondary aim was to explore the possible role of rifaximin in treating PPI-induced SIBO patients. METHODS: One hundred twenty-five gastroesophageal reflux disease patients, constantly treated with PPI for at least 6 months and undergoing to LBT, were retrospectively assessed. An age-matched control population (control) of 100 patients, which had not used PPI in the last 6 months, was also enrolled. In the PPI group, SIBO positive patients and CH4 producers were treated with rifaximin 1200 mg/daily for 14 days and re-checked with LBT one month after the end of treatment. The area under the curve (AUC) before and after treatment was also calculated for both SIBO positive patients and CH4 producers. RESULTS: In the PPI group, SIBO prevalence was significantly higher vs. controls (38/125 [30.4%] vs. 27/100 [27%], P<0.05). 77/125 (61.6%) PPI patients were found to be CH4 producers vs. 21/100 (21%) controls (P<0.05). Among SIBO patients in the PPI group, 34 (89.4%) were also CH4 producers vs. 17/27 (63%) controls (P<0.05). After treatment, LBT resulted negative in 15/22 SIBO patients (68.1%) (P<0.05) and in 18/34 CH4 producers (52.9%) (P<0.05). At the AUC analysis, an overall reduction of 54.2% for H2 in SIBO patients and of 47.7% for CH4 was assessed after rifaximin treatment (P<0.05). CONCLUSIONS: Our data showed that chronic use of PPI could be able to increase the prevalence of SIBO and to shift the intestinal microbial composition towards a CH4-producing flora. rifaximin could represent a useful therapeutical option for PPI-induced SIBO and for modulating CH4-producing flora.

Italian guidelines for the management of irritable bowel syndrome: Joint Consensus from the Italian Societies of: Gastroenterology and Endoscopy (SIGE), Neurogastroenterology and Motility (SINGEM), Hospital Gastroenterologists and Endoscopists (AIGO), Digestive Endoscopy (SIED), General Medicine (SIMG), Gastroenterology, Hepatology and Pediatric Nutrition (SIGENP) and Pediatrics (SIP).

The irritable bowel syndrome (IBS) is a chronic disorder of gut-brain interaction. IBS is still associated with areas of uncertainties, especially regarding the optimal diagnostic work-up and the more appropriate management. Experts from 7 Italian Societies conducted a Delphi consensus with literature summary and voting process on 27 statements. Recommendations and quality of evidence were evaluated using the grading of recommendations, assessment, development, and evaluation (GRADE) criteria. Consensus was defined as >80% agreement and reached for all statements. In terms of diagnosis, the consensus supports a positive diagnostic strategy with a symptom-based approach, including the psychological comorbidities assessment and the exclusion of alarm symptoms, together with the digital rectal examination, full blood count, C-reactive protein, serology for coeliac disease, and fecal calprotectin assessment. Colonoscopy should be recommended in patients with alarm features. Regarding treatment, the consensus strongly supports a dietary approach for patients with IBS, the use of soluble fiber, secretagogues, tricyclic antidepressants, psychologically directed therapies and, only in specific IBS subtypes, rifaximin. A conditional recommendation was achieved for probiotics, polyethylene glycol, antispasmodics, selective serotonin reuptake inhibitors and, only in specific IBS subtypes, 5-HT3 antagonists, 5-HT4 agonists, bile acid sequestrants.

Italian guidelines for the management of irritable bowel syndrome Joint Consensus from the Italian Societies of: Gastroenterology and Endoscopy (SIGE), Neurogastroenterology and Motility (SINGEM), Hospital Gastroenterologists and Endoscopists (AIGO), Digestive Endoscopy (SIED), General Medicine (SIMG), Gastroenterology, Hepatology and Pediatric Nutrition (SIGENP) and Pediatrics (SIP)

The irritable bowel syndrome (IBS) is a chronic disorder of gut-brain interaction. IBS is still associated with areas of uncertainties, especially regarding the optimal diagnostic work-up and the more appropriate management. Experts from 7 Italian Societies conducted a Delphi consensus with literature summary and voting process on 27 statements. Recommendations and quality of evidence were evaluated using the grading of recommendations, assessment, development, and evaluation (GRADE) criteria. Consensus was defined as >80% agreement and reached for all statements. In terms of diagnosis, the consensus supports a positive diagnostic strategy with a symptom-based approach, including the psychological comorbidities assessment and the exclusion of alarm symptoms, together with the digital rectal examination, full blood count, C-reactive protein, serology for coeliac disease, and fecal calprotectin assessment. Colonoscopy should be recommended in patients with alarm features. Regarding treatment, the consensus strongly supports a dietary approach for patients with IBS, the use of soluble fiber, secretagogues, tricyclic antidepressants, psychologically directed therapies and, only in specific IBS subtypes, rifaximin. A conditional recommendation was achieved for probiotics, polyethylene glycol, antispasmodics, selective serotonin reuptake inhibitors and, only in specific IBS subtypes, 5-HT3 antagonists, 5-HT4 agonists, bile acid sequestrants

Translational Gap between Guidelines and Clinical Medicine: The Viewpoint of Italian General Practitioners in the Management of IBS.

Irritable bowel syndrome (IBS) guidelines are generally developed by experts, with the possibility of a translational gap in clinical medicine. The aim of our study was to assess an Italian group of general practitioners (GPs) for their awareness and use of criteria for the diagnosis and management of IBS. For this purpose, a survey was carried out involving 235 GPs, divided into two groups according to their years of activity: 65 "junior general practitioners" (JGPs) (≤10 years) and 170 "senior general practitioners" (SGPs) (>10 years). JGPs were more familiar with the Rome IV Criteria and Bristol Scale than SGPs. Abdominal pain, bowel movement frequency and bloating were the symptoms most frequently used to make a diagnosis. The most probable causes of IBS were reported to be abnormal gastrointestinal motility and psychological triggers. SGPs reported more frequently than JGPs that challenging management and patient's request were motivations for a gastroenterological consultation. The practice of clinical medicine is still far from the guidelines provided by the specialists. Abdominal pain related to defecation and changes in bowel frequency are considered to be the more important symptoms for IBS diagnosis, but most GPs, both JGPs and SGPs, like to consider abdominal bloating as another useful symptom. Involving both gastroenterologists and GPs in developing shared guidelines would be highly desirable in order to improve IBS management strategies in everyday clinical practice.

Elimination of Dietary Triggers Is Successful in Treating Symptoms of Gastroesophageal Reflux Disease.

BACKGROUND: The relationship between aliments and pathophysiological abnormalities leading to gastroesophageal reflux disease (GERD) symptoms elicitation is unclear. Nevertheless, patients often report symptoms after ingestion of specific foods. AIMS: To identify in primary care setting the presence of foods able to trigger GERD symptoms, and evaluate whether a consequent specific food elimination diet may result in clinical improvement. METHODS: Diagnosis of GERD and quantification of reflux symptoms were done according to GERD-Q questionnaire (positive when > 8). During clinical data collection, patients were asked to report aliments associated with their symptoms. Also, a precompiled list of additional foods was administered to them. Then, patients were requested to eliminate the specific foods identified, and to come back for follow-up visit after 2 weeks when GERD-Q questionnaire and clinical data collection were repeated. RESULTS: One-hundred GERD (mean GERD-Q score 11.6) patients (54 females, mean age 48.7 years) were enrolled. Eighty-five patients reported at least one triggering food, mostly spicy foods (62%), chocolate (55%), pizza (55%), tomato (52%), and fried foods (52%). At follow-up visit, the diagnosis of GERD was confirmed in only 55 patients, and the mean GERD-Q score decreased to 8.9. Heartburn reporting decreased from 93 to 44% of patients, while regurgitation decreased from 72 to 28%. About half of the patients agreed to continue with only dietary recommendations. CONCLUSIONS: Most patients with GERD can identify at least one food triggering their symptoms. An approach based on abstention from identified food may be effective in the short term.

Appropriateness in prescribing PPIs: A position paper of the Italian Society of Gastroenterology (SIGE) - Study section "Digestive Diseases in Primary Care".

The introduction of proton pump inhibitors (PPIs) into clinical practice about thirty years ago has greatly improved our therapeutic approach to acid-related diseases for their well-recognized efficacy and safety. Despite the well-defined indications, however, the use of PPIs continues to grow every year in both western and eastern countries and this phenomenon poses serious queries that include the onset of potential adverse effects and the increase in health care costs. The major reason explaining this worrying market expansion is the inappropriate use of PPIs. In order to re-establish a correct use of these effective drugs in daily clinical practice, the Italian Society of Gastroenterology (SIGE), nominated a panel of experts who reviewed the available clinical literature and produced a series of updated position statements on the use of PPIs in clinical practice.

Use of proton pump inhibitors in general practice.

AIM: To evaluate the characteristics of the prescription of the proton pump inhibitor drugs (PPI) and the adherence to the indications of the guidelines regulating the reimbursement limitations set forth by the Italian Drug Agency. METHODS: Thirty general practitioners (GP) participated in the study, providing data on more than 40000 patients in total. The population was divided into non occasional users of PPI drugs (PPI users) and non-users (PPI non-users) based on evidence of a prescription of at least 3 packs of PPIs in the last 90 d before analysis. The data provided allowed an assessment of compliance with the requirements of eligibility for PPI reimbursement according to the Italian Drug Agency rules, in order to obtain subpopulations which complied or not with the rules. RESULTS: Six thousand three hundred and twenty-two patients were found to be PPI users, accounting for 14.9% of the patient population. PPI users were more frequently female, older and more frequently diagnosed with gastroesophageal reflux disease, gastric or duodenal ulcers, arthropathy, heart disease and cancer than the rest of the population. PPI users had more frequently received prescriptions for non-steroidal ant-inflammatory drugs (NSAIDS), acetylsalicylic acid (ASA), oral anticoagulant therapy (OAT) and systemic steroids. PPI reimbursement resulted applicable to 69.3% of the PPI users, but a potential for reimbursement of PPI prescriptions was identified in the non PPI users for the treatment of peptic or reflux disease (8.5%) and for the protection of gastric damage caused by NSAIDS (6.1%). Patients who are potentially eligible for reimbursement are older, diagnosed with arthropathy and heart disease more frequently and most commonly receive NSAID and ASA prescriptions compared with PPI users who do not satisfy eligibility requirements. Patients in whom it was not possible to identify conditions related to prescription suitability were more frequently associated with use of OAT. CONCLUSION: A substantial number of patients who apparently do not meet prescription suitability conditions can be identified, but among non PPI users on the contrary, it is possible to identify an equal number of patients for whom prescription would be suitable. Poor suitability can be identified in the population receiving OAT. Thus, there is scope for decreasing inappropriate use of PPI drugs by adhering to certain criteria and by involving all interested parties.

Nickel sensitization in patients with gastro-esophageal reflux disease.

BACKGROUND: Gastro-esophageal reflux disease (GERD) leads to frequent medical visits, and available therapies fail in up to 40% of patients. Food allergies may be involved in GERD pathogenesis; however, allergens other than food have received little attention. Nickel allergy is common in the general population and some high-nickel foods are associated with GERD. However, the potential relationship between nickel allergy and GERD remains unaddressed. AIM: This study aimed to evaluate the prevalence of nickel sensitization in patients with and without GERD and to compare clinical and demographic features. METHODS: This prospective, multicenter study included 210 adult GERD patients and 140 patients without GERD who presented at the general practitioner. All GERD patients had undergone treatment with proton pump inhibitors and upper digestive endoscopy within the previous five years. Demographic and clinical data were collected by questionnaire and patients underwent a nickel patch allergy test. RESULTS: Patients with and without GERD presented similar characteristics, with the exception of nickel sensitization, which was significantly more prevalent among GERD patients than controls (39.5% vs. 16.4%; p = 0.001). Nickel-positive GERD patients were more frequently female (90.4% vs. 65.4%, p = 0.003) and asthmatic (18.1% vs. 4.7%; p = 0.038), compared to nickel-negative GERD patients. At six-month follow-up, most of the patients, with or without nickel sensitization, reported improved symptoms without differences in drug prescription. CONCLUSION: Nickel sensitization is particularly prevalent in GERD patients seen in general practice. Whether allergies other than food allergy play a role in GERD remains to be elucidated.

Association between coeliac disease and psoriasis: Italian primary care multicentre study.

BACKGROUND: Studies assessing the association between coeliac disease (CD) and psoriasis show conflicting results. OBJECTIVE: To assess in the primary care setting the prevalence of CD in patients with psoriasis and the response to a gluten-free diet (GFD) in subjects with psoriasis and CD. METHODS: We enrolled 218 patients with psoriasis and 264 controls. Coeliac screening was carried out in all subjects (Eurospital, Trieste, Italy). In subjects with a positive serology, the diagnosis of CD was confirmed histologically. RESULTS: Nine (4.1%) psoriatic patients had positive anti-tissue transglutaminase antibodies compared to only 1 among controls (0.4%, p < 0.05; OR 2.03, 95% CI 1.42-90.11). The diagnosis of CD was confirmed histologically in all 10 subjects. At 6 months GFD was associated with a great improvement of skin lesions in 7 out of 8 patients with psoriasis. CONCLUSION: Our multicentre primary care study showed an high prevalence of CD in psoriasis and an improvement of skin lesions in CD under GFD.

Clinical features of constipation in general practice in Italy.

BACKGROUND: Definition and diagnosis of constipation remain challenging, partly due to different perceptions of the disease by doctors and patients. AIM: To evaluate prevalence and features of constipation among individuals seen in general practice, by comparing different diagnostic instruments. METHODS: Standardized questionnaires and the Bristol stool form scale were distributed to all subjects attending 10 general practitioners for any reason in a 2-week period. The questionnaires investigated constipation defined according to: (1) self-perception (yes/no); (2) a visual analogue scale; (3) Rome III Criteria. RESULTS: The prevalence of constipation in 1306 subjects (790 female, 516 male) resulted: (1) 34% self-reported; (2) 28% by visual analogue scale; (3) 24% by Rome Criteria. Constipation was more frequent in females. A high frequency of symptoms of obstructed defecations was observed with differences among patients with self-reported constipation with or without Bristol stool type 1-2. CONCLUSIONS: Prevalence of constipation among individuals attending their GP ranges between 24 and 34%, according to the different definitions adopted. Symptoms of obstructed defecations are frequent. The combination of self-evaluation and the Bristol stool type scale is potentially useful to identify subgroups of patients with different clinical features in general practice.

A survey of pharmacological and nonpharmacological treatment of functional gastrointestinal disorders.

BACKGROUND: Treatment of functional gastrointestinal disorders (FGIDs) is based on symptoms relieve by conventional drugs, but increasingly complementary and alternative medicine (CAM) is used. OBJECTIVE: This survey aimed to investigate the current treatments used by FGIDs patients. METHODS: A total of 25 Italian gastroenterologists interviewed outpatients on gastrointestinal symptoms and treatments (pharmacological, CAM, diet/dietary supplements) used during the last year to relieve FGIDs. Consecutive adults with FGIDs according to Rome III were included. RESULTS: Of the 199 patients, 81% used conventional drugs, 64.3% diet/dietary supplements, and 48.7% CAM. Conventional drugs, diet/dietary supplements, or CAM as exclusive treatment were used by 24.6, 6, and 2.5% of patients, respectively. Two-thirds used more than one treatment: 34.7% conventional drugs, CAM, and diet/dietary supplements, 17.1% conventional drugs and diet/dietary supplements, 10.1% diet and CAM, and 5% conventional drugs and CAM. Benefits and adverse effects were similar for conventional drugs and nonpharmacological treatments. Males (OR 2.4) without lower GI symptoms (OR 5.4) used more frequently exclusive pharmacological treatment of FGIDs. CONCLUSIONS: Conventional drugs are the preferred treatment for FGID. CAM and dietary modifications are more likely used as an adjunct to rather than instead of conventional drugs. Adverse effects occurred in all treatments.

A validation study of the Italian Short-Form Leeds Dyspepsia Questionnaire.

Assessment of symptoms should be one of the main outcome measures in dyspepsia clinical trials. This requires a reliable, valid and responsive questionnaire that measures the frequency and severity of dyspeptic symptoms. The Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) has been proven to fulfil these criteria in its original version in the English language. The aim of the study was to assess the internal consistency, reliability, validity and responsiveness of the Italian version of the SF-LDQ in primary and secondary care. Unselected primary and secondary care patients completed the Italian version of the SF-LDQ. Test-retest reliability was assessed after 2 days. Validity was measured by comparison with diagnosis made by physicians. Responsiveness was determined before and after treatment for endoscopically proven disease. The SF-LDQ was administered to 311 patients in primary care and 179 in secondary care patients. Internal consistency, as judged by the Cronbach's α, was 0.90. Pearson's correlation coefficient for test-retest reliability was 0.92. The SF-LDQ had a sensitivity of 80% and a specificity of 82%. A highly significant response to change was also observed (p = 0.001). The Italian SF-LDQ is a reliable, valid and responsive self-completed outcome measure for quantifying the frequency and severity of dyspeptic symptoms.

The management of patients with new onset of upper gastro-intestinal symptoms in primary care.

BACKGROUND: Data dealing with dyspepsia management in general practice are lacking, and most of the studies investigated a subset of patients with suspected peptic ulcer disease either with or without previous complaints. AIMS: To evaluate the one-year management of patients presenting new onset upper abdominal symptoms without alarming features. METHODS: 275 patients were enrolled by 63 Italian general practitioners. RESULTS: Referral to upper gastro-intestinal tract endoscopy resulted significantly higher in patients with predominant epigastric pain compared to subjects with non-painful symptoms or non-dominant symptoms. Amongst drug therapies, only prokinetics and antacids and anti-secretory therapies were prescribed differently amongst clinical subgroups. The rate and type of management and referrals resulted were not influenced by the age of patients or the use of anti-inflammatory drugs. The most frequent diagnosis at one-year follow-up was reflux oesophagitis. The absence of organic disease was less frequent in patients with dominant epigastric pain than non-painful or non-dominant symptoms. CONCLUSION: The management of these patients in primary care in Italy is mainly determined by clinical presentation, independent of age. Any judgement about appropriateness of the treatment should consider not only conventional features such as age, but the more complex individual frameworks as well.

[Practice guidelines, CME and epidemiologic research in general practice: a consistent triad?]. / Linee guida, ECM e ricerca epidemiologica in medicina generale: una triade coerente?

A multidisciplinary effort involving epidemiologists, general practitioners and specialists is critical for finding valid and feasible answers, by asking the right questions through observational and experimental studies. Clinical practice guidelines may represent a good starting point of this research process, highlighting which information needs exist in everyday practice; logically, guidelines also represent an ideal end, as a means of transferring any useful knowledge produced into practice. In between, this research process may have an added educational value and represent an active and valuable means of achieving continuing medical education credits. Consistency of the research-education-guidelines triad is discussed in this paper by describing methods and results of a practical research experience--a cohort study for evaluating prevalence, incidence, chronicity and management of digestive disorders--involving epidemiologists, gastroenterologists and thirty-five general practitioners of the Emilia-Romagna region.

Delayed Gastric Emptying in Functional Dyspepsia.

Functional dyspepsia is a complex syndrome with a poorly defined pathophysiology, resulting in uncertainties in its therapeutic approach. Abnormalities in gastrointestinal motility and sensitivity alone or combined seem to play a role in a substantial subgroup of patients. Drugs capable of prokinetic effects, such as antidopaminergics (eg, metoclopramide, domperidone, levosulpiride) and serotonin 5-HT4 receptor agonists (eg, tegaserod) can be potentially used in the treatment of dyspeptic patients. Furthermore, 5-HT4 receptor agonists do not appear to increase the gastric fundus tone which may also contribute to improved symptoms in subsets of patients. Alosetron, a 5-HT3 receptor antagonist, has been investigated mainly in irritable bowel syndrome, and the few studies performed in functional dyspepsia have provided conflicting results. Erythromycin and related derivatives, the motilides, represent another class of prokinetic compounds able to accelerate gastric emptying and potentially indicated in functional dyspepsia. The stimulatory effect on fundic tone and the occurrence of tachyphilaxis hamper the efficacy of these drugs in the long-term treatment. kappa-opioid receptor agonists might be useful for functional digestive syndromes because of their antinociceptive effects, but there are few available results and most are inconclusive. Results are also needed to prove efficacy of antidepressants (tricyclic agents and 5-HT reuptake inhibitors). Future clinical trials should be performed so that the formal structure required by good clinical practice can be adapted to detect significant effects in subgroups of patients with functional dyspepsia. Therapy should be ideally targeted to the different pathophysiologic abnormalities of these subgroups. The identification of the mechanisms leading to symptom generation should facilitate the development of newer and more effective therapeutic strategies in functional dyspepsia.