New bismuth-containing quadruple therapy in patients infected with Helicobacter pylori: A first Italian experience in clinical practice.

BACKGROUND: Rising antibiotic resistance requires the evaluation of new and effective therapies. AIMS: To test the efficacy and safety of the new bismuth-containing quadruple therapy in patients infected with Helicobacter pylori. MATERIAL AND METHODS: Consecutive H. pylori-positive dyspeptic patients were enrolled, either naïve or with previous failure treatment. Patients were treated with Pylera® (three-in-one capsules containing bismuth subcitrate potassium 140 mg, metronidazole 125 mg, and tetracycline 125 mg) three capsules q.i.d. plus omeprazole 20 mg or esomeprazole 40 mg b.i.d. for 10 days. Eradication was confirmed using an urea breath test (at least 30 days after the end of treatment). Efficacy was assessed by UBT and safety by means of treatment-emergent adverse events. RESULTS: One hundred and thirty-one patients were included in the study: 42% of patients were naïve, and 58%, with previous failure treatment. H. pylori eradication was achieved in 124 patients (94.7%, 95% confidence intervals (CIs) 89.3-97.8) in ITT population. In the PP population, the percentage was 97.6% (95%, CIs 93.3-99.2). No difference in eradication rate was found either between naïve and previously treated patients (92.7% vs 96.0%, P=.383), or smoking and nonsmoking ones, or in patients taking omeprazole or esomeprazole. Treatment-emergent adverse events occurred in 35 patients (26.7%, 95% CIs 19.9-34.9). They were mild in all cases except in four, who discontinued the study due to diarrhea (three patients) and diffuse urticarial rush (one patient). CONCLUSIONS: Pylera® achieved a remarkable eradication rate in clinical practice, irrespective if it was used as first treatment or as a rescue therapy. Treatment-emergent adverse events were uncommon generally mild.

The Management of Patients With Diverticulosis and Diverticular Disease in Primary Care: An Online Survey Among Italian General Pratictioners.

GOALS: To investigate the current opinion of Italian general practitioners (GPs) on the management of patients with diverticular disease (DD) of the colon. BACKGROUND: The management of DD remains a point of debate, and guidelines are not uniform in their advice. STUDY: A web-based survey was conducted among Italian GPs. Twelve questions were aimed at the diagnosis, treatment, and management options for diverticulosis and symptomatic DD. RESULTS: In total, 245 surveys were filled out. A high-fiber diet was prescribed widely in diverticulosis (44%), together with advice to allow seeds (30%). Rifaximin (26%) and probiotics (25%) were the most frequently prescribed drugs in this population. Colonoscopy was the most prescribed instrumental tool in the diagnosis (77%) and follow-up (21%) of symptomatic uncomplicated diverticular disease patients. Rifaximin, probiotics, and mesalazine were the most frequently prescribed drugs in symptomatic uncomplicated diverticular disease patients (82.8, 59.5%, and 36.3%, respectively). Finally, 77% of the Italian GPs prescribed laboratory exams in the follow-up of these patients. The vast majority of the Italian GPs (83%) managed suspected acute diverticulitis at home, and did not consider two episodes of acute diverticulitis as a strict surgical indication (86%). Rifaximin, probiotics, and mesalazine were the most frequently prescribed drugs to prevent recurrence of the disease (42.5%, 28.2%, and 12.4%, respectively). Finally, 87% of the Italian GPs prescribed laboratory examinations in the follow-up of these patients. CONCLUSIONS: This survey shows that the current management of DD in primary care by Italian GPs is not fully in line with current guidelines and more recent literature data.

Predictive value of the Diverticular Inflammation and Complication Assessment (DICA) endoscopic classification on the outcome of diverticular disease of the colon: An international study.

BACKGROUND: Diverticular Inflammation and Complication Assessment (DICA) endoscopic classification has been recently developed for patients suffering from diverticulosis and diverticular disease. AIMS: We assessed retrospectively the predictive value of DICA in patients for whom endoscopic data and clinical follow-up were available. METHODS: For each patient, we recorded: age, severity of DICA, presence of abdominal pain, C-reactive protein and faecal calprotectin test (if available) at the time of diagnosis; months of follow-up; therapy taken during the follow-up to maintain remission (if any); occurrence/recurrence of diverticulitis; need of surgery. RESULTS: We enrolled 1651 patients (793 M, 858 F, mean age 66.6 ± 11.1 years): 939 (56.9%) patients were classified as DICA 1, 501 (30.3%) patients as DICA 2 and 211 (12.8%) patients as DICA 3. The median follow-up was 24 (9-38) months. Acute diverticulitis (AD) occurred/recurred in 263 (15.9%) patients; surgery was necessary in 57 (21.7%) cases. DICA was the only factor significantly associated to the occurrence/recurrence of diverticulitis and surgery either at univariate (χ(2 )= 405.029; p < 0.0001) or multivariate analysis (hazard ratio = 4.319, 95% confidence interval (CI) 3.639-5.126; p < 0.0001). Only in DICA 2 patients was therapy effective for prevention of AD occurrence/recurrence with a hazard ratio (95% CI) of 0.598 (0.391-0.914) (p = 0.006, log rank test). Mesalazine-based therapies reduced the risk of AD occurrence/recurrence and needs of surgery with a hazard ratio (95% CI) of 0.2103 (0.122-0.364) and 0.459 (0.258-0.818), respectively. CONCLUSIONS: DICA classification is a valid parameter to predict the risk of diverticulitis occurrence/recurrence in patients suffering from diverticular disease of the colon.

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.