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Alain Gérard,1 François Liard,2 Anne Crochard,3 Sylvia Goni,3 Bruno Millet41Rue des Marronniers’ Psychiatry Clinic, Paris; 2General Practice, Saint Epain, 3Medical Affairs Department, Laboratoire Lundbeck SAS, Issy-Les-Moulineaux, 4Psychiatry Department, Guillaume Regner University Hospital, University of Rennes 1, Rennes, FranceBackground: 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.Methods: 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.Results: 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.Conclusion: Patients consulting for anxiety or mood disorders report significant disability, which can be effectively reduced by antidepressant treatment.Keywords: depression, anxiety disorder, antidepressant, disability

This study investigates diversity among ophiolite‐bearing sediments that were exploited for pottery production in Bronze Age Crete (c.3000–1200 bc). The focus is on loose and consolidated formations of Upper Tertiary to Quaternary ages that contain some detrital products of Mesozoic ophiolitic source rocks. A literature review, geological fieldwork, sediment sampling and petrographic analysis are combined to identify the origin, the geographical distribution and the stratigraphic position of these ophiolitic sediments, and to assess regional diversity in their mineralogy and texture. The results provide insights into current archaeological problems regarding the provenance and production of ophiolite‐bearing pottery in Bronze Age Crete. [ABSTRACT FROM AUTHOR]

Abstract Background 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. Methods 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. Results 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 (p = 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 (p = 0.02). On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049). There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11) or D14 (p = 0.08). Tolerance and safety were good and comparable in both groups. Conclusion 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. Trial registration ISRCTN62203233.

Abstract: For the next decade, COPD will become the third cause of mortality in the world. COPD is mainly due to cigarette smoking and presents different levels of severity according to people, probably linked to environmental and genetic factors, which are not well documented. Recent publications pointed out bacterial bronchial colonization and exacerbations of infectious origin as worsening factors through a pro-inflammatory effect and oxidative stress. This should lead to a comprehensive review of anti-infectious prevention tools and to discuss the role of prophylactic antibiotherapy and antioxidants. [Copyright &y& Elsevier]

Nausea is a common feeling felt by the subject as a state likely to evolve into vomiting. However a lot of nausea is maintained without being followed by vomiting. Nausea can be isolated or accompanied by a clinical picture. Some situations are often accompanied by nausea like dizziness, migraines, transport sickness, pregnancy, acute or chronic digestive disorders or anxious state. Outside of a know pathological context, there must be an etiologic investigation. When they are accompanied by vomiting and general signs - especially a fever - nausea must first eliminate a potentially serious disease (intracranial hypertension, meningitis, occlusion…). Nausea resounds on the patient's quality of life, they can decrease concentration and professional activities. Many patients do not treat nausea and use rest and waiting for the resolution of symptoms. In the absence of signs of gravity taking a treatment without a medical prescription can be considered (recommendation ANSM 2008) especially for recurrent crisis whose cause can be precisely identified. They are many pharmacological substances with antinausea effects. If the etiological approach is essential and sometimes sufficient, symptomatic relief can be helped by some agents with less intense nausea and shorter duration especially by using of antihistaminics, anticholinergic agents and derivatives of phenothiazines., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

Recent drug crises have highlighted the complexity, benefits and risks of medication communication. The difficulty of this communication is due to the diversity of the sources of information and the target audience, the credibility of spokespersons, the difficulty to communicate on scientific uncertainties and the precautionary principle, which is influenced by variable perceptions and tolerances of the risk. Globally, there is a lack of training in risk management with a tendency of modern society to refuse even the slightest risk. Communication on medications is subject to regulatory or legal requirements, often uses tools and messages that are not adapted to the target audience and is often based on a poor knowledge of communication techniques. In order to improve this situation, the available information must be coordinated by reinforcing the unique medication information website and by coordinating communication between authorities by means of a single spokesperson. A particular effort must be made in the field of training in the proper use and risk of medications for both the general population and patients but also for healthcare professionals, by setting up a unified academic on-line teaching platform for continuing medical education on medications and their proper use., (© 2014 Société Française de Pharmacologie et de Thérapeutique.)

Aims: This French study was set up to collect perceptions of general practitioners (GPs), cardiologists and patients on anticoagulation therapy with vitamin K antagonists (VKA) in the management of thromboembolic risk in atrial fibrillation (AF)., Method: This is a prospective survey conducted in France, between July 1 and August 7 2011, on a sample defined to obtain a sufficient number of patient files of 133 physicians, divided into 65 cardiologists and 68 GPs., Results: Three hundred and ninety-four patients on VKA and 130 patients not receiving VKA were included in this study. For more than one in three patients, AF was diagnosed incidentally in a medical consultation for another reason. In addition, 15% and 23% of diagnoses of FA were performed after hospitalization for stroke or TIA by cardiologists and GPs, respectively. According to the patient, the doctor contacted first is a GP (52% for the GP vs. 35.5% for the cardiologist), but they state that the diagnosis was made mainly by a cardiologist (63% for the cardiologist vs. 27% for the GP). In 78% of cases, cardiologists are initial prescribers. A CHADS2 score of 0 was found in 23% of patients not receiving VKA and in 11% of patients on VKA. A CHADS2 score superior or equal to 2 is significantly more frequently found in patients with paroxysmal AF. Concerning the monitoring of the patient, GPs ensure mainly monitoring of INR. In terms of compliance, according to doctors, their patients systematically take their treatment in 91% of cases. However, by interviewing patients, 60% of non-compliant patients are considered compliant by their physician., Conclusion: This study has achieved an overview of anticoagulation treatment in AF, in France. The initiation is mainly ensured by the cardiologist and the monitoring by the GP. Assessments between cardiologists and GPs are relatively similar, however, it appears that anticoagulation treatment is under-prescribed for the patients at risk., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Following the Mediator crisis and the passage of the Health and Safety Law of December 2011, off-label prescriptions are a real concern shared by all those involved in healthcare system. Off-label, in the strictest sense of the term, is defined as all prescriptions that do not correspond to the summary of product characteristics (SPC), particularly those that fail to comply with the indications and dosage regimens defined by the marketing authorization (MA) for clear safety reasons. There are various rasons for off-label prescriptions, both conscious and unconscious. They are intended to respond to unmet medical needs, the needs of poorly studied populations or not studied at all in trials, but in relation to whom it is reasonable to extrapolate that MA would be given (common-sense prescriptions) and, additionally, to urgent public health needs (such as baclofen, pregnant women, and HIV drugs). All these prescriptions would deserve to be studied for a potential MA. However, there are off-label prescriptions that need to be restricted or even penalized in the case of compassionate prescriptions or unjustified prescriptions or prescriptions not based on any scientific grounds. Off-label prescriptions are not easy to track down because if the prescriber has to write "off-label" on his prescription, then clearly, in practice, he will only do so in exceptional cases. Neither the pharmacists who dispense the drug nor the Social Security that reimburses it, have access to the diagnosis (or targeted indication). Thus, in order to identify the off-label prescription, we must be able to cross reference the available databases (such as pharmacovigilance database, medicalized information system program [programme de médicalisation des systèmes d'information, PMSI], hospital drug formularies, general sample of beneficiaries [échantillon généraliste de bénéficiaires, EGB] or national inter-regional Health Insurance Information System [système national d'informations inter-régions d'Assurance maladie, SNIIRAM], sales data, and data from market surveys). The shared computerized patient file may resolve this problem. The temporary use recommendation (TUR) proposed by the Drug Safety Law will only partially deal with this problem for recently marketed molecules. This temporary and exceptional mechanism will authorize a recognized off-label prescription, which may be reimbursed and monitored for 3 years. These TURs will only concern a small portion of "off-label" drugs having yet a positive risk/benefit ratio (conditional MA) but this is far from matching with majority of off-label prescriptions. As such, and in order to improve the use of drugs, it is important to propose a control system for all "off-label" prescriptions with a dedicated committee: the "off-label" committee which would determine the frame of the "off-label" prescriptions., (© 2013 Société Française de Pharmacologie et de Thérapeutique.)

Background: Several studies have reported risk factors for herpes zoster (HZ), but their results remain controversial and difficult to compare because of their limitations regarding sampling and design., Objectives: This study was aimed to determine risk factors in ambulatory patients aged 50 years or more, by consulting general practitioners (GPs) in France., Study Design: A prospective, national, matched case-control study was conducted. It involved 121 GPs who recruited 250 cases of HZ and 500 controls (matched by age and sex), aged 50 years and older, between April 2009 and September 2010. GP and patient questionnaires explored the following risk factors: family history of HZ, comorbidities, depression, anxiety, negative life events, physical trauma, alcohol and tobacco consumption, level of education, and various protective factors (such as exposure to children). Odds ratios were estimated using conditional logistic regression., Results: In multivariate adjusted analysis, a family history of HZ (OR 3.69, 95% CI 1.81-7.51), a HAD depressive score≥8 (OR 4.15, 95% CI 1.88-9.16), and a recent negative life event (OR 3.40, 95% CI 1.67-6.93) were all significantly associated with HZ., Conclusions: This case-control study conducted in ambulatory patients in general practice reinforced the hypothesis that, in addition to the age-related decline in VZV-specific T-cell-mediated immunity, depression negative life event and familiar history of zoster increase the risk of occurrence of herpes zoster. In people with familiar history, this risk could be prevented by vaccination., (Copyright © 2012 Elsevier B.V. All rights reserved.)

Objective: To describe and compare the conditions of use of fondaparinux and low molecular weight heparin (LMWH) in the prevention of venous thromboembolism in routine general practice with a focus on platelet monitoring., Method: This was an observational and pharmaco-epidemiological survey, performed in France in general practice in adult patients receiving thromboprophylaxis with fondaparinux or a LMWH. The study collected data on medical conditions justifying thromboprophylaxis, reasons for platelet monitoring and type of prescription., Results: Four hundred and seventy general practioners included 837 analysable patients (450 treated with fondaparinux and 387 with LMWH). In the fondaparinux group, the mean age was 61.5±17.3 and 259 (57.6 %) patients were women. In the LMWH group, the mean age was 61.7±17.8 and 205 (53.0 %) patients were women. The reasons of prescribing were: bedridden related to a severe acute medical illness in 255 (56.7 %) patients with fondaparinux and 244 (63.1 %) with LMWH, and reduction of mobility associated with trauma without fracture respectively in 121 (26.9 %) and 85 (22.0 %) of patients. Associated risk factors were varicose veins, obesity and a history of thrombosis. Platelet monitoring was prescribed in 168 (37.6 %) patients treated with fondaparinux. In this group, these prescription were considered "appropriate" in 94 (20.9 %) patients, of whom 76 (16.9 %) were monitored for screening purposes, and "not appropriate" in 67 (14.9 %) patients, because prescribed to monitor thrombo-prophylaxis. In the LMWH group, a platelet count was prescribed in 370 (96.1 %) patients, of whom 312 (81.0 %) receiving a prescription only in order to monitor thromboprophylaxis., Discussion: The results provided in the Ariane study were coherent with literature data (Etape and Depart studies). In comparison with the CNAM study, which evaluated prescription practices for LMWH in thromboprophylaxis in France in 1999, and which reported a global rate of platelet monitoring of 70.0 %, the rate reported in the Ariane study (81.0 %) seems to represent an improvement in the practice standards. Since 2009, Afssaps does not recommend a systematic monitoring with LMWH at acute or prophylactic dose, outside a post surgical context or in case of pre-treatment with unfractionated heparin., Conclusion: The Ariane study provides important information on platelet monitoring in patients treated with fondaparinux or LMWH, and also on thromboprohylaxis in general practice., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)