Usefulness of Pep-Test for Laryngo-Pharyngeal Reflux: A Pilot Study in Primary Care.

BACKGROUND: Gastroesophageal reflux disease is a digestive disorder characterized by nausea, regurgitation, and heartburn. Gastroesophageal reflux is the primary cause of laryngeal symptoms, especially chronic posterior laryngitis. The best diagnostic test for this disease is esophageal impedance-pH monitoring; however, it is poorly employed owing to its high cost and invasiveness. Salivary pepsin measured using a lateral flow device (Pep-test) has been suggested as an indirect marker of laryngopharyngeal reflux (LPR). The present study tested the reliability of Pep-test in diagnosing LPR in uninvestigated primary care attenders presenting with chronic laryngeal symptoms, and evaluated the raw pepsin concentration in patients with LPR. METHODS: A multicenter, non-interventional pilot study was conducted on 86 suspected patients with LPR and 59 asymptomatic subjects as controls in three Italian primary care settings. A reflux symptom index questionnaire was used to differentiate patients with LPR (score >13) from controls (score <5). Two saliva samples were collected, and comparisons between the groups were performed using two-sided statistical tests, according to variable distributions. RESULTS: There was no statistical difference in the salivary pepsin positivity between LPR patients and controls, whereas the pepsin intensity value was higher in controls than in LPR patients. CONCLUSION: A high prevalence of pepsin positivity was observed in asymptomatic controls. Pepsin measurement should not be considered as a diagnostic test for LPR in primary care patients.

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.

Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia.

BACKGROUND: One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study. METHODS/DESIGN: The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time. This project is a prospective, multicentre, randomized, parallel-group, superiority trial that follow patients over a period of 12 months. Withdrawal from allocated treatment within 3 months is the primary outcome. DISCUSSION: The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole rather than with haloperidol, provides physicians with a solid evidence base to be directly applied in the routine care of patients with schizophrenia.