Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial

<p>Abstract</p> <p>Background</p> <p>Medical management of GERD mainly uses proton pump inhibitors. Alginates also have proven efficacy. The aim of this trial was to compare short-term efficacy of an alginate (Gaviscon^®, 4 × 10 mL/day) and omeprazole (20 mg/day) on GERD symptoms in general practice.</p> <p>Methods</p> <p>A 14-day multicentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon^®(4 × 10 mL/day) and omeprazole (20 mg/day) in patients with 2-6 day heartburn episodes weekly without alarm signals. The primary outcome was the mean time to onset of the first 24-h heartburn-free period after initial dosing. Secondary outcomes were the proportion of patients without heartburn by D7, pain relief by D7, and reduction in pain intensity by D7 and D14.</p> <p>Results</p> <p>278 patients were recruited; 120 were included in the Gaviscon^®group and 121 in the omeprazole group for the per protocol non-inferiority analysis. The mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 (± 2.2) days for Gaviscon^®and 2.0 (± 2.3) days for omeprazole (<it>p </it>= 0.93); mean intergroup difference was 0.01 ± 1.55 days (95% CI = -0.41 to 0.43): i.e., less than the lower limit of the 95% CI of -0.5 days predetermined to demonstrate non-inferiority. The mean number of heartburn-free days by D7 was significantly greater in the omeprazole group: 3.7 ± 2.3 days vs. 3.1 ± 2.1 (<it>p </it>= 0.02). On D7, overall quality of pain relief was slightly in favour of omeprazole (<it>p </it>= 0.049). There was no significant difference in the reduction in pain intensity between groups by D7 (<it>p = </it>0.11) or D14 (<it>p = </it>0.08). Tolerance and safety were good and comparable in both groups.</p> <p>Conclusion</p> <p>Gaviscon^®was non-inferior to omeprazole in achieving a 24-h heartburn-free period in moderate episodic heartburn, and is a relevant effective alternative treatment in moderate GERD in primary care.</p> <p>Trial registration</p> <p><a href="http://www.controlled-trials.com/ISRCTN62203233">ISRCTN62203233</a>.</p

Les fossés : caractéristiques et dynamiques de remplissage

International audienc

Les fossés : caractéristiques et dynamiques de remplissage

International audienc

Les fossés : caractéristiques et dynamiques de remplissage

International audienc

Étude comparative de la survenue d'effets indésirables suite à l'administration de collyres anti-allergiques sans ou avec conservateur

Objectif : Le but de cette étude était d'évaluer la survenue d'effets indésirables après administration de collyres anti-allergiques dont le principe actif est le cromoglycate de sodium, l'acide N-acétyl-aspartyl-glutamique ou les antihistaminiques H1 (anti-H1) chez des patients souffrant de conjonctivite allergique. Ces collyres se présentent sous une forme sans conservateur ou avec conservateur, il s'agit alors essentiellement du chlorure de benzalkonium. Méthodes : Etude prospective, ouverte, non randomisée, portant sur 3 090 patients inclus par 507 médecins généralistes de toutes les régions de France. Les données recueillies concernaient les effets indésirables ressentis après administration du collyre, ainsi que les caractéristiques des patients et de leur pathologie allergique. Résultats : Les patients atteints de conjonctivites allergiques souffraient de manière concomitante de rhinite dans 60 % des cas et d'asthme dans 15 % des cas ; dans 70 % des cas, un facteur déclenchant (pollen, poussière, animal ...) était identifié. Deux groupes de patients ont été constitués en fonction du collyre prescrit : sans conservateur (n = 2 712) et avec conservateur (n = 121). La proportion de patients présentant au moins un effet indésirable était de 24 % avec un collyre sans conservateur et 89 % avec un collyre avec conservateur (p < 0,001). L'effet indésirable le plus souvent rapporté était la survenue de picotements ou de brûlures (respectivement 10,4 % et 47,1 % pour des collyres sans et avec conservateur, p < 0,001). L'observance des collyres anti-allergiques sans conservateur était significativement supérieure à celle des collyres avec conservateur. En effet, le nombre moyen d'instillations par jour était supérieur dans le sous-groupe sans conservateur par rapport au sous-groupe avec conservateur (respectivement 3,5 et 2,9 instillations par jour ; p < 0,001) et le nombre d'oublis était inférieur dans le sous-groupe sans conservateur (3,6 versus 4,2 ; p = 0,01). Conclusion : La prescription de collyre sans conservateur permet une réduction significative des effets indésirables oculaires et une meilleure adhésion du patient à son médicament anti-allergique

Les fossés : caractéristiques et dynamiques de remplissage

International audienc

Les fossés : caractéristiques et dynamiques de remplissage

International audienc

Assessment of diabetes screening by general practitioners in France: the EPIDIA Study.: diabetes screening in France

AIM: To audit Type 2 diabetes screening in general practice in France and to determine the frequency of undiagnosed diabetes in patients at high risk, after systematic screening and diagnosis. METHODS: For this study, 288 general practitioners volunteered to include all consecutive non-diabetic patients aged or= 7.0 mmol/l. RESULTS: There were 5950 patients included. The most frequent diabetes risk factors were: age >or= 40 years, 92%; overweight [body mass index (BMI) >or= 27 kg/m2], 59%; treated hypertension, 48%; treated dyslipidaemia, 37%; family history of diabetes, 24%. Of these subjects at high risk for diabetes, 88% had a FPG measurement in their medical record (75% measured during the preceding 12 months). In the 1499 patients in whom FPG was measured, diabetes was diagnosed in 40 patients (2.7% 95% CI 1.9-3.5) and 22% had impaired fasting glucose (IFG). Thus, the frequency of undiagnosed diabetes in the 5950 high-risk patients was 0.67% (0.46-0.88). CONCLUSION: Screening for diabetes by general practitioners in France appears to be adequate and undiagnosed diabetes is rare in patients with risk factors for diabetes, at least in those consulting the general practitioners studied

Disability in patients consulting for anxiety or mood disorders in primary care: response to antidepressant treatment.

The primary objective of this prospective observational study was to evaluate changes in self-reported disability in patients with anxiety or mood disorders 3 months after initiating antidepressant treatment. This study included 8396 patients consulting 2433 general practitioners in France for a major mood episode, generalized anxiety disorder, social anxiety disorder, panic disorder, or obsessive-compulsive disorder. Treatment was initiated with the antidepressant that the physician considered appropriate. Patients were evaluated with the Sheehan Disability Scale (SDS), Hospital Anxiety and Depression Scale, and Clinical Global Impression-Severity (CGI-S) at baseline and after 6 and 12 weeks. At 12 weeks, 6617 patients (78.8%) were evaluable. At inclusion, the mean SDS subscores were 6.5 ± 2.2 on the work/school activities dimension, 6.8 ± 1.9 on the social activities dimension, and 6.5 ± 2.0 on the family life dimension. At the 12-week follow-up visit, the mean change in score on these three dimensions was -3.9 ± 2.6, -4.2 ± 2.5, and -4.0 ± 2.5, respectively. At the 12-week follow-up visit, 90.0% of patients were responders (defined as patients whose SDS dimension scores decreased by at least one point) on the work/school SDS subscores; 92.8% were responders on the social life SDS subscores, and 91.1% were responders on family life/home responsibilities SDS subscores. Functional remission (defined as an SDS subscore of 0 at study end) rates were 18.0% for the work/school dimension, 16.8% for the social activities dimension, and 19.5% for the family life dimension. Using a cutoff of ≤2, remission rates were 56.8%, 55.0%, and 58.0%, respectively. Improvements in self-rated disability were correlated with improvements in symptoms measured with clinician-rated CGI-S. Patients consulting for anxiety or mood disorders report significant disability, which can be effectively reduced by antidepressant treatment