[Nausea: Current view]. / Les nausées : données actuelles.

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.

Information and communication on risks related to medications and proper use of medications for healthcare professionals and the general public: precautionary principle, risk management, communication during and in the absence of crisis situations.

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.

Off-label prescriptions: how to identify them, frame them, announce them and monitor them in practice?

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.

[Atrial fibrillation and anticoagulation: general practitioner, cardiologist and patient's points of view]. / Fibrillation atriale et traitement anticoagulant: point de vue du médecin généraliste, du cardiologue et du patient.

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.

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

BACKGROUND: 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.

Herpes zoster: family history and psychological stress-case-control study.

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.

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

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.

[Comparison of platelet monitoring in patients receiving thromboprophylaxis with fondaparinux or a low molecular weight heparin. The Ariane study]. / Étude Ariane : comparaison de la surveillance plaquettaire chez des patients recevant une thromboprophylaxie par fondaparinux ou HBPM.

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.

Implementation of guidelines for allergic rhinitis in specialist practices. A randomized pragmatic controlled trial.

BACKGROUND: Guidelines for allergic rhinitis are more effective than free-treatment choice in the control of seasonal allergic rhinitis. OBJECTIVE: To validate the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines in the treatment of intermittent and persistent allergic rhinitis induced by pollens. DESIGN: A multicenter, open-label, parallel, pragmatic randomized study compared two therapeutic strategies during a 2-week treatment course. In the first strategy ('guidelines group'), 417 patients were treated according to ARIA with ebastine as oral antihistamine. In the second strategy ('free-choice treatment group'), investigators had a free choice for the treatment of 422 patients. MAIN OUTCOME MEASURES: Quality of life measured using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), work productivity and daily symptom medication scores. RESULTS: 94.2% patients returned the baseline visit questionnaires and 88.6% returned the posttreatment period questionnaires. RQLQ scores were similar in the two groups at baseline. After treatment, there were improvements in the overall score and in all domains in both treatment groups. According to pragmatic methodology, the improvements show that the guidelines group (-1.70 +/- 1.20) is more effective than the free-choice treatment group (-1.52 +/- 1.22) with a gamma risk of 2%. Individual RQLQ scores, work productivity, and daily symptom scores were significantly improved in the guidelines group by comparison to the free-choice treatment group. CONCLUSION: A treatment based on ARIA guidelines offers patients a significant improvement in comparison to the use of a nonstandardized treatment regimen.

[Improving care for depressed patients: what is added by GP's meetings?]. / Amélioration de la prise en charge des patients déprimés. L'apport de tables rondes de médecins généralistes.

PURPOSE: To show what French GP's have to say about their management of depressed patients, and how to improve it. METHODS: GP's forum discussions, as peer groups, controlled by an independent moderator and recorded by another, both Gp's. Reports have been synthesised through a list of items, until saturation. RESULTS: 83 reports have been analysed. The most important difficulties were about diagnosis of depression (patient's denial, multiplicity of complaints, polypathology), about treatment (bad acceptability of antidepressants, difficulties to access to a psychotherapy) and about care organisation (exchange between GP's and psychiatrists are difficult and unusual). DISCUSSION: Questions about quality of GP's care to depressed patients come from populations which differ from GP's patients. CONCLUSION: The specificity of primary care exercise should be taken into account to elaborate recommendations and to evaluate quality of care.

[Management of urinary tract infections in women. Epidemiologic survey of 7916 women in general practice]. / Les infections urinaires de la femme en médecine générale. Résultats d'un observatoire réalisé auprès de 7916 patientes.

OBJECTIVE: To evaluate the management of urinary tract infections in women by general practitioners and compare it with official French guidelines. METHODS: This survey enrolled 1587 general practitioners in France and 7916 adult women. Exclusion criteria for patients included: pregnancy, diabetes, neurogenic bladder, or urinary catheters. During the visit at which the diagnosis was made, physicians completed a questionnaire that included diagnostic and management details, in particular, prescription of further examinations. RESULTS: According to the French guidelines, 37% of women had an upper or complicated urinary tract infection, although one third of the complicated infections were so defined only by the patient's age (>65 years). Additional testing was prescribed for 36% of the women with acute uncomplicated cystitis. CONCLUSION: This study shows that the management of urinary tract infections in women does not comply with current guidelines, especially in cases of acute uncomplicated cystitis. The use of age alone as a complicating factor should be reconsidered.

Effects of training on general practitioners' management of pain in osteoarthritis: a randomized multicenter study.

OBJECTIVE: To evaluate the effects of a short interactive training program for general practitioners (GP) on pain management in patients with osteoarthritis (OA). METHODS: A multicenter, parallel-group study. GP were randomized to receive training on relationships and communication, pain evaluation, prescription, and negotiation of a patient contract or to a control group receiving a presentation about obtaining consent in trials. Outcomes were patient assessments of pain and functional ability. We invited 1500 GP to take part in the study. Those who volunteered to receive the training recruited outpatients from May 2001 to April 2002. Patients participating in the evaluation of the effects of the general practitioners' training had lower limb OA and pain on motion [> or = 40 mm on a visual analog scale (VAS)] and had indications for treatment with acetaminophen. The primary endpoint: sum of patient pain relief based on the daily VAS self-evaluation during the 2 weeks of the trial. RESULTS: In total, 180 GP (84 trained, 96 nontrained) enrolled 842 patients (414 and 428, respectively). Mean baseline VAS pain was 63 +/- 14 mm. Patients in the trained-GP group had better overall pain relief (316 +/- 290 mm/day vs 265 +/- 243 mm; p < 0.0001), greater improvement in Lequesne and WOMAC scores (p < 0.0001), and better overall perception of treatment (p = 0.002). Acetaminophen use was slightly higher in the trained group; however, the difference in pain relief remained statistically significant (p = 0.0003) after adjustment for this difference. CONCLUSION: This is the first study to demonstrate a positive effect of physician training on patients with a painful condition.

[Results from the observational study EPIGRAM: management of excess weight in general practice and follow-up of patients treated with orlistat]. / Résultats de l'étude observationnelle EPIGRam: prise en charge de l'obésité et du surpoids en médecine générale, suivi de la cohorte traitée par l'orlistat.

The EPIGRAM pharmacoepidemiological study was conducted in general practitioners (GPs) prescribing orlistat (Xenical) in order to describe, under real clinical conditions, the management of obese or overweight patients, as well as a 1-year follow-up of a patient cohort treated with orlistat. A total of 714 GPs participated in this study and recruited a total of 6801 patients. Forty percent were treated with orlistat, 76% were women and 63% presented with a comorbidity. With a mean body mass index of 33.1+/-5.1 kg/m2, 85% of the patients treated with orlistat were in agreement with the indications of this drug. Comparison of patients treated and not treated with orlistat did not allow identification of any key factor able to predict prescription of the treatment. Patients treated with orlistat on inclusion and reviewed at least once by their doctor were followed up for an average of 11 months and a maximum of 23 months. Between 64% and 77% of patients stopped treatment with orlistat during the follow-up period. The treatment cost was the main reason for definitive treatment discontinuation for more than 50% of the patients. The average weight loss was 5% and 9% after 3 and 12 months of treatment, respectively.

[A comparative study of the ocular tolerance after administration of anti-allergic eye drops with or without a preservative]. / Etude comparative de la survenue d'effets indésirables suite à l'administration de collyres anti-allergiques sans ou avec conservateur.

AIM: The aim of the study was to evaluate the occurrence of ocular adverse effects observed after administration of anti-allergic eye drops with and without a preservative in patients with allergic conjunctivitis. METHODS: A total of 3090 patients with allergic conjunctivitis and treated with anti-allergic eye drops were included in an open nonrandomised prospective study by 507 general practitioners located throughout France. The symptoms of discomfort and pain experienced during instillations as well as the characteristics of the patients and of their allergic pathology were recorded. RESULTS: Two groups of patients (eyedrops without preservative [n = 2712] and with preservative [n = 121]) were identified. Sixty percent and 15% of the cases of allergic conjunctivitis were associated with rhinitis and asthma, respectively, and for 70% of the occurrences, an identifiable factor (pollen, dusts, animals etc.) was responsible for the appearance of the symptoms. Compliance was significantly higher for anti-allergic eye drops without preservative than for those with a preservative (average number of instillations 3.5 vs 2.9/day, p < 0.001; number of instillations omitted 3.6 vs 4.2, p = 0.01). The proportion of patients experiencing at least one adverse drug reaction was 24% for eye drops with no preservative and 89% for eye drops with a preservative (p < 0.001). The most frequently notified symptom was a sensation of prickling and burning (10% and 47%, respectively, for eye drops with no preservative and eye drops with a preservative; p < 0.001). CONCLUSION: The prescription of eye drops with no preservative allows a significant decrease in ocular adverse drug reactions and a greater acceptance by the patient regarding his/her anti-allergic treatment.

[Methodology and quality control in EPIGRAM, a pharmacoepidemiological study of obesity in general practice]. / EPIGRAM, etude pharmacoépidémiologique de l'obésité: méthodologie et critères de qualité.

The EPIGRAM pharmacoepidemiological study was conducted in general practitioners prescribing orlistat (Xenical) in order to describe, under real clinical conditions, the management of obese or overweight patients. A 1-year follow-up of a patient cohort treated with orlistat was also conducted. Quality criteria specific to the study were defined to ensure the scientific validity of the results; these criteria mainly involved the following items: independent scientific committee, sampling investigator's recruitment, study organisation and quality control of the collected data. On-site control visits of a sample of 13% of participating GPs revealed that 75% of the controlled data were documented in a source file of which 85% were consistent with the source data. Only 1% of the 130 000 controlled data (data were controlled only on visits for which information was available) gave rise to correction requests. Of the patients treated with orlistat on inclusion, 17% were lost to follow-up by their GP and 25% were contacted directly at the end of the study.

[Mucoregulators in acute bronchitis syndromes: focus on use by general practitioners and data from the literature]. / Les mucorégulateurs dans les syndromes bronchiques aigus: point sur les pratiques en médecine générale et les données de la littérature.

Antibiotics have long been used in the initial treatment of acute bronchitis (AB) and acute exacerbations of chronic bronchitis (AECB). However, their lack of value in AB has been clearly demonstrated and antibiotic therapy is justified in only a few cases of AECB. In parallel, although the value of mucoregulators in these diseases is still debated, their prescription remains important in general practice. In this context, our aim was to determine the prescribing behaviour of general practitioners (GPs) with regard to these drugs, as well as the beliefs of GPs concerning the place of mucoregulators in the treatment of AB in children and adult smokers, as well as in patients with non-obstructive AECB. A survey was carried out in 370 GPs, who were presented with three standardised and computerised medical cases: (i) rhinopharyngitis + AB in a child; (ii) AB in an adult smoker without a previous medical history; and (iii) a patient with non-obstructive AECB. The results showed that mucoregulators are frequently prescribed by GPs for children and adults with AB, or in AECB. This high prescribing rate is due to the belief of the GPs that these drugs are effective and well tolerated, which is confirmed by the literature. Their use avoids the frequent and unjustified prescription of antibiotics in situations where they are not recommended but where the patients request drug therapy.