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International audience; OBJECTIVE: The objective of this study was to evaluate the proportion of therapeutics that have proven their efficacy on patient-important outcomes with a high quality of evidence among Cochrane systematic reviews (SRs). METHODS: We surveyed a random sample of 400 SRs’ abstracts published between September 2012 and December 2015, which compared therapeutic interventions with at least a placebo or no intervention control. The primary endpoint was the proportion of SRs with a statistically significant efficacy on a patient-important outcome and with a high quality of evidence. RESULTS: Among the 400 abstracts surveyed, 32 (8%) found efficacy on a patient-important outcome with a high quality of evidence. Half of the 400 SRs (50.2%) evaluated a pharmacological intervention and 12% of these found efficacy of the intervention on a patient-important outcome with a reported high quality of evidence. CONCLUSION: Based on an analysis of 400 abstracts of SRs from the Cochrane Collaboration, we found that there is a low number of therapeutic interventions which have proven their efficacy on patient-important outcomes with a high quality of evidence.

International audience; Evidence-based medicine is the cornerstone of shared-decision making in healthcare today. The public deserves clear, transparent and trust-worthy information on drug efficacy. Yet today, many drugs are prescribed and used without solid evidence of efficacy. Clinical trials and randomized clinical trials (RCTs) are the best method to evaluate drug efficacy and side effects. In a shared medical decision-making approach, general practitioners need drug assessment to be based on patient-important outcomes. The aim of project Rebuild the Evidence Base (REB) is to bridge the gap between the data needed in clinical practice and the data available from clinical research. The drugs will be assessed on clinical patient important outcomes and for a population. Using the Cochrane tools, we propose to analyse for each population and outcome : 1) a meta-analysis based on RCTs with a low risk of bias overall ; 2) an evaluate of results of confirmatory RCTs; 3) a statistical analysis of heterrogeneity between RCTs, and 4) an analysis of publication bias. Depending on the results of these analyses, the evidence will be categorised in 4 different levels: firm evidence, evidence (to be confirmed), signal or absence of evidence. Project REB proposes a method for reading and interpreting randomized clinical trials and their meta-analysis to produce quality data for general practitioners to focus on benefit-risk assessment in the interest of patients. If this data does not exist, it could enable clinical research to better its aim.

Purpose Blood pressure (BP) is measured at almost every general practitioner (GP) consultation in the region of Auvergne, France. A 2018 qualitative study shows that GPs measure BP to satisfy patients, whereas patients declare themselves indifferent to the absence of the measurement. The objective was to validate the results of a qualitative study, to quantitatively assess patient satisfaction when BP is not measured, and to study the factors associated with the degree of patient satisfaction. Methods This was a quantitative observational study conducted using self-questionnaires among patients in medical practices in Auvergne. Results Four hundred and ninety-two questionnaires were evaluated in 20 medical practices. Sixty percent of patients had indifferent or favorable feelings in the absence of BP measurement. In bivariate analysis, young age, male sex, absence of pathology, and low frequency of visits were associated with indifferent or favorable feelings in the absence of BP measurement. In multivariable analysis, a history of hypertension and psychiatric history were associated with unfavorable feelings. The intraclass correlation coefficient for practice-related variability was 5.6%. Patients’ susceptibility to having particularly favorable or unfavorable feelings could be related to their GP (physician effect). Conclusion The hypothesis put forward in the qualitative study is confirmed: the majority of patients are in favor of or indifferent to the absence of BP measurement in general practice. General practice could be more efficient by measuring BP less frequently and better.

Background Home blood pressure monitoring (HBPM) could improve blood pressure control through therapeutic adherence. The main objective of this study was to determine the link between HBPM used by hypertensive patients treated in primary care and their medication adherence. Methods Cross-sectional comparative study conducted in the Auvergne region from June to November 2016. Patients were recruited by general practitioners (GPs) selected at random. Adherence was evaluated according to the Girerd score. Results From a sample of eighty-two GPs including 1026 patients, 45% of patients reported owning an HBPM device. Among these, 18% knew the rule of 3 (3 measurements in the morning and 3 in the evening for 3 days) recommended by the French State Health Authority. There was no difference in adherence between patients using HBPM and those who did not. Patients with HBPM using the rule of 3 reported better adherence than patients without the device (p = 0.06), and those who did not perform self-measurements according to the rule of 3 (p = 0.01). Patients who used HBPM according to the rule of 3 were older (p = 0.006) and less smokers (p = 0.001) than the others. Their GPs were more often GP teachers (p p = 0.001). Conclusion The statistical link between medication adherence and HBPM for patients who apply the rule of 3, emphasizes the importance of the GP educating the patient on the proper use of HBPM.

Aims To assess the methodological quality of the systematic reviews of the literature for Good Practice Guidelines (GPGs) for treatment of type 2 diabetes (T2D). Methods The GPGs on treatment of T2D from May 2012 onwards were searched on PubMed, the Guidelines International Network, the National Guidelines Clearing House and the Infobanque des guides de pratique clinique. Quality of the GPGs was assessed by means of grading of levels of evidence, strength of recommendations, statements pertaining to systematic reviews, description of their methods, search for Randomized Controlled Trials meta-analyses, and citations from three meta-analyses which contested the strategy of intensive glycemic control and metformin as first-line treatment. Results Fiflty-two GPGs were included; half of them had and applied a system of grading and strength of recommendation and 58% stated they had carried out a systematic review. Only one GPG cited the three meta-analyses. Three quarters of the GPGs failed to detail their bibliographic research methods. Conclusion The GPGs for treatment of T2D were of poor quality and their methodological rigor was insufficient. Even though the meta-analyses had a higher level of evidence, they were seldom cited.

Angiotensin-converting enzyme (ACE) inhibitors are part of first-line treatment for reduced ejection fraction heart failure (HFrEF). The aim was to assess the benefits and adverse effects of ACE inhibitors in HFrEF with a focus on important patient outcomes. A systematic review of double-blind randomized clinical trials (RCTs) and comparison of ACE inhibitors versus placebo, in HFrEF patients published in French or English. Searches were undertaken of Medline, Cochrane Central, and Embase. The primary outcomes were all-cause mortality and adverse events. From 636 articles analysed, 11 were included (13,882 patients). For all-cause mortality (5 RCTs, 9277 patients), the number needed to treat (NNT) to avoid one death at 6 months was 50 (33–107). The NNT to prevent one death at 12 months (6 RCTs, 13,016 patients) was 63 (35–314). Under the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the evidence was of moderate quality. The number needed to harm was 12 (10–15) for cough, 20 (14–31) for hypotension, 23 (17–36) for dizziness, 31 (23–47) for hyperkalaemia, and 49 (30–121) for increased creatinine levels. The quality of evidence was moderate for these criteria except for cough (low quality of evidence). This review focuses on clinical elements necessary in a shared decision-making process. In practice, general practitioners will be able to use these data to discuss ACE inhibitor treatment with HFrEF patients. This study was registered in the PROSPERO registry under the reference number CRD42018096930.

BackgroundPremature ejaculation (PE) is the most common sexual dysfunction in males. A previous qualitative study identified six communication strategies described by GPs to tackle this topic during consultations.AimTo determine whether these six strategies are more effective than usual care for promoting discussion about PE between patients and their GPs.Design and settingCluster randomised controlled trial, stratified in four French regions, with an intervention group (GPs who received a training session on the six communication strategies) and a control group (routine medical care). Participants were males aged 18–80 years consulting for a sexual, urogenital, or psychological reason.MethodThe efficacy of the training session in communication skills, compared with usual care, was evaluated by determining the percentage of patients who discussed PE with their GP (primary outcome). The percentage of enrolled patients with PE was calculated using a cut-off score >9 of the premature ejaculation diagnostic tool (PEDT) completed by the enrolled patients at Week 4 after the consultation. The quality-of-life changes were evaluated as the SF-12 scale score difference between baseline and Week 4 post-consultation.ResultsIn total, 130 patients were included by 32 GPs (n= 16 in the intervention andn= 16 in the control group). The percentage of patients who discussed PE was higher in the intervention group than in the control group (42.0% versus 4.9%, absolute difference = 37.1%; 95% confidence intervals [CI] = 24% to 50%,PConclusionTraining GPs in communication strategies about PE improves its detection.

Antispasmodics like phloroglucinol are commonly used to alleviate pain. Various authorities recommend the use of this drug for conditions such as dysmenorrhoea, threatened abortion or labour pains. The goal was to carry out a systematic review analysing the existing data concerning the efficacy of phloroglucinol to treat pain in obstetrical or gynaecologic cases. The protocol was registered in Prospero (CRD 42018094065). The keywords “phloroglucinol” and “randomised controlled trials” were used to search Medline, Embase and the Cochrane Library. We selected randomised, controlled against placebo trials testing the effect of phloroglucinol on gynaecologic or obstetrical pain either as a primary or secondary endpoint. We excluded trials exploring pain caused by intestinal, renal, metabolic or other causes and trials that were not available for critical review in either English or French. A quantitative synthesis (meta-analysis) was planned if the included trials were sufficiently homogenous. If this were not the case, a descriptive synthesis would be presented. Twelve trials identified studied the effect of phloroglucinol in gynaecologic or obstetrical conditions. Only two trials corresponded to the inclusion criteria of this review, one of which was not available for critical review. Phloroglucinol is not well evaluated in this field. Whether for labour pains, abortion pains or benign gynaecologic pains, the results found are insufficient to promote the use of this drug in these indications.

International audience; BACKGROUND:Guidelines for type 2 diabetes (T2D) recommend reducing HbA1c through lifestyle interventions and glucose-lowering drugs (metformin, then combination with dipeptidyl peptidase-4 inhibitors [DPP-4Is] among other glucose-lowering drugs). However, no double-blind randomized clinical trial (RCT) compared with placebo has so far demonstrated that DDP-4Is reduce micro- and macrovascular complications in T2D. Moreover, the safety of DPP-4Is (with increased heart failure and acute pancreatitis) remains controversial.METHODS:A systematic review of the literature (PubMed, Cochrane Library Central Register of Controlled Trials [CENTRAL] and https://clinicaltrials.gov), including all RCTs vs placebo published up to May 2015 and the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), published June 2015, was performed. Primary endpoints were all-cause mortality and death from cardiovascular causes; secondary endpoints were macrovascular and microvascular events. Safety endpoints were acute pancreatitis, pancreatic cancer, serious adverse events and severe hypoglycaemia.RESULTS:A total of 36 double-blind RCTs were included, allowing analyses of 54,664 patients. There were no significant differences in all-cause mortality (RR=1.03, 95% confidence interval [CI]=0.95-1.12), cardiovascular mortality (RR=1.02, 95% CI=0.92-1.12), myocardial infarction (RR=0.98, 95% CI=0.89-1.08), strokes (RR=1.02, 95% CI=0.88-1.17), renal failure (RR=1.06, 95% CI=0.88-1.27), severe hypoglycaemia (RR=1.14, 95% CI=0.95-1.36) and pancreatic cancer (RR=0.54, 95% CI=0.28-1.04) with the use of DPP-4Is. However, DDP-4Is were associated with an increased risk of heart failure (RR=1.13, 95% CI=1.01-1.26) and of acute pancreatitis (RR=1.57, 95% CI=1.03-2.39).CONCLUSION:There is no significant evidence of short-term efficacy of DPP-4Is on either morbidity/mortality or macro-/microvascular complications in T2D. However, there are warning signs concerning heart failure and acute pancreatitis. This suggests a great need for additional relevant studies in future.

Background The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial aimed to determine whether a pragmatic education intervention in general practice could improve the quality of life of patients with chronic heart failure (CHF) compared with routine care. Results This cluster randomised controlled clinical trial included 241 patients with CHF attending 54 general practitioners (GPs) in France and involved 19 months of follow-up. The GPs in the Intervention Group were trained during a 2-day interactive workshop to provide a patient education programme. The mean age of the patients was 74 years (±10.5), 62 % were men and their mean left-ventricular ejection fraction was 49.3 % (± 14.3). At the end of the follow-up period, the mean Minnesota Living with Heart Failure Questionnaire scores in the Intervention and Control Groups were 33.4 (± 22.1) versus 27.2 (± 23.3; P = 0.74, intra-cluster coefficient [ICC] = 0.11). At the end of the follow-up period, the 36-Item Short Form Health Survey (mental health and physical health) scores in the Intervention and Control Groups were 58 (± 22.1) versus 58.7 (± 23.9; P = 0.58, ICC = 0.01) and 52.8 (± 23.8) versus 51.6 (± 25.5; P = 0.57, ICC = 0.01), respectively. Conclusions Patient education delivered by GPs to elderly patients with stable heart failure in the ETIC programme did not achieve an improvement in their quality of life compared with routine care. Further research on improving the quality of life and clinical outcomes of elderly patients with CHF in primary care is necessary. Trial registration The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial is a cluster randomised controlled trial registered with ClinicalTrials.gov (Registration Number: NCT01065142) and the French Drug Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé; Registration Number: 2009-A01142-55). Electronic supplementary material The online version of this article (doi:10.1186/s12875-016-0473-4) contains supplementary material, which is available to authorized users.

Background Chronic heart failure, is increasing due to the aging population and improvements in heart disease detection and management. The prevalence is estimated at ~10% of the French general practice patient population over 59 years old. The primary objective of this study is to improve the quality of life for heart failure patients though a complex intervention involving patient and general practitioner (GP) education in primary care. Methods A randomised, cluster controlled trial, stratified over 4 areas of the Auvergne region in France comparing intervention and control groups. The inclusion criteria are: patients older than 50 years with New York Heart Association (NYHA) stage I, II, or III heart failure, with reduced ejection fraction or with preserved ejection fraction. Heart failure should be confirmed by the patient’s cardiologist according to the European Society of Cardiology guidelines criteria. The exclusion criteria include: severe cognitive disorders, living in an institution, participating in another clinical trial, having NYHA stage IV heart failure, or a lack of French language skills. The complex intervention consists of training at the GP practice with an interactive 2-day workshop to provide a patient’s education programme. GPs are trained to perform case management, lifestyle counselling and motivational interviewing, to educate patients on the main topics including clinical alarm signs, physical activity, diet and cardiovascular risk factors. The patients’ education sessions are scheduled at 1, 4, 7, 10, 13 and 19 months following the start of the trial. The primary outcome to be assessed is the impact on the quality of life as determined using two questionnaires: the Minnesota Living with Heart Failure Questionnaire and SF-36. To detect a difference in the mean quality of life at 19 months, we anticipate studying a minimum of 400 patients from 80 GPs. Discussion This trial will provide insight into the effectiveness of a complex intervention to educate patients with heart failure including a 2-day GP workshop and patients’ education programme in the setting of a GP consultation to improve the quality of life in patients with chronic heart failure. This complex intervention tool could be used during initial and further medical training. Trial registration ETIC is a cluster-randomised, controlled trial registered on ClinicalTrials.gov [NCT01065142, 2010, Feb 8] and the French drug agency [Agence Nationale de Sécurité du Médicament et des produits de santé; registration number: 2009-A01142-55, on March 5th, 2010]. Electronic supplementary material The online version of this article (doi:10.1186/s12875-014-0208-3) contains supplementary material, which is available to authorized users.

International audience; BACKGROUND: Cannabis is the most consumed illegal substance in France. General practitioners (GPs) are the health professionals who are most consulted by adolescents. Brief intervention (BI) is a promising care initiative for the consumption of cannabis, and could be a tool for GPs in caring for adolescents who consume cannabis. The aim of the CANABIC study is to measure the impact of a BI carried out by a GP on the consumption of cannabis by adolescents of 15 to 25 years of age. METHODS: A randomized clustered controlled trial, stratified over three areas (Auvergne, Languedoc-Roussillon, and Rhone-Alps), comparing an intervention group, which carries out the BI in consultation, and a control group, which ensures routine medical care. The main assessment criterion is the consumption of cannabis by amount of joints per month, at 12 months. The amount necessary to highlight a significant difference between the two groups of 30 % of consumption at 12 months is 250 patients (50 GPs, 5 patients per GP; risk alpha = 5 %; power = 90 %; intra-cluster correlation coefficient rho = 0.2; Hawthorne effect = 15 %; lost to follow-up rates for GPs = 10 % and for patients = 20 %). This plan is replicated for the three areas, and therefore a total of 750 patients are expected.The secondary criteria for judgment are the associated consumption of tobacco and alcohol, the perception of the consequences of consumption, and the driving of a vehicle following consumption. DISCUSSION: Research about BI for young cannabis users is underway. The aim of the CANABIC study is to validate a BI suited to adolescents who consume cannabis, which may be performed in the general practice. This would provide a tool for their treatment by a GP, which could be widely distributed during initial or further medical training.Trial registration: CANABIC is a randomized clustered trial (NCT01433692, registered 2011 Sept 12), PHRC funded: Clinical Research Hospital Program (Governmental Fund, Health Ministry). Date first patient randomized: March 2012.

Background Combined oral contraceptives (COC) increase the risk of venous thromboembolism (VTE), but the risk of recurrent VTE is not precisely determined. In this retrospective cohort study, we sought the risk factors for recurrence after a first VTE that occurred in women taking COC. Study Design Time-to-event analysis was done with Kaplan–Meier estimates. In total, 172 patients were included (43% with pulmonary embolism): 82% had no other clinical risk factor for VTE. Results Among the 160 patients who stopped anticoagulation, the cumulative incidence of recurrent VTE was 5.1% after 1 year and 14.2% after 5 years. Significant factors associated with recurrence were renewed use of COC [hazard ratio (HR)=8.2 (2.1–32.2)], antiphospholipid syndrome [HR=4.1 (1.3–12.5)] and protein C deficiency or factor II G20210A [HR=2.7 (1.1–7)]. Pure-progestin contraception [HR=1.3 (0.5–3.0)] or factor V Leiden [HR=1.3 (0.5-3.4)] did not increase recurrence. Postsurgical VTE had a lower risk of recurrence [HR=0.1 (0.0–0.9)]. Conclusion Further studies are warranted to determine whether testing for antiphospholipid syndrome, protein C deficiency or the factor II G20210A could modify the duration of anticoagulation. This study confirms the safety of pure-progestin contraception.

Contexte. L’ibuprofène est l’un des AINS les plus vendus en officine. Il peut être délivré sur ordonnance ou sur conseil du pharmacien (over the Counter, OTC). L’une de ses indications est la douleur dentaire. L'objectif de cette revue était d’évaluer l'efficacité et la sécurité de la prise d'ibuprofène dans les douleurs dentaires.Méthode. Une revue de la littérature a été faite par les 2 thésards de façon indépendante parmi des ECR issus des bases de données Medline via PubMed, Central via Cochrane et Embase. Seuls les ECR s’intéressant à des douleurs spontanées et/ou provoquées par des stimuli mécaniques et/ou thermiques et comparant l'ibuprofène per os à un placebo et/ou à une autre molécule ont été sélectionnés. La méthode d’évaluation du risque de bais revisitée de la Cochrane (ROB 2) a été appliquée à chaque étude incluse.Résultats. Les équations de recherche ont permis de recueillir 799 articles. Sur les sept études incluses et évaluées, seul un ECR présentait un risque de biais faible. Aucune méta-analyse n'a pu être réalisée. Cinq études évaluaient l’efficacité de l’ibuprofène en prémédication d’un soin endodontique comparé à une autre molécule et/ou placebo. Une étude évaluait l’efficacité analgésique de l’ibuprofène comparé à l’acéclofénac pendant 45 minutes chez des patients atteints de pulpite irréversible. Une étude s’intéressait à l’effet de l’ibuprofène après une heure sur des tests diagnostiques couramment utilisés en odontologie.Conclusion. Cette revue témoigne du peu d'études existantes à propos de l'utilisation d’ibuprofène pour des douleurs dentaires. Il apparait que l’ibuprofène entraine un soulagement durant une heure chez les patients atteints de pathologies endodontiques. Les risques inhérents à la prise d’ibuprofène étaient insuffisamment évalués.

CONTEXTE Les inhibiteurs de pompe à protons, largement utilisés depuis plus d’une trentaine d’années pour diminuer la quantité d’acide produite par l’estomac, sont souvent délicats à faire stopper par les patients. Il est probable que le rebond d’acidité gastrique soit une de ces difficultés.OBJECTIF L’objectif principal était d’évaluer le rebond d’acidité gastrique après arrêt d’un traitement par IPP, ses conditions d’apparition et son impact clinique. L’objectif secondaire était d’évaluer les méthodes permettant l’arrêt des IPP malgré cet effet rebond.MÉTHODE Nous avons réalisé une revue systématique de la littérature de tous les articles publiés entre 1980 et avril 2022 sur différentes bases de données Web et sélectionné les études de cas sans distinction selon leur design ou les critères de mesure.RÉSULTATS Nous avons retenu 12 études. Sur celles-ci 6 confirmaient l’existence d’un effet rebond. Après analyse des données de ces études nous avons pu identifier un délai nécessaire de 4 semaines de traitement par IPP pour permettre l’apparition d’un effet rebond à l’arrêt du traitement. Le rebond d’acidité semble être possible quelles que soient les molécules utilisées. De plus la colonisation par H. pylori semble être un élément protecteur contre l’effet rebond. Il apparait également qu’il existe une concordance entre le rebond constaté au niveau biologique et les symptômes cliniques décrits par les patients. Les méthodes de préventions du rebond d’acidité sont encore moyennement efficaces et leur développement nécessite la réalisation de nouvelles études. Un protocole d’arrêt progressif du traitement associé à l’éducation thérapeutique pourrait être une piste prometteuse.CONCLUSION Il existe bien un rebond d’acidité gastrique après un traitement quotidien d’au moins 4 semaines par IPP, apparaissant en une dizaine de jours après l’arrêt et perdurant jusqu’à plusieurs mois.

Background: oral osmotic laxatives are among the first-line treatments for functional constipation. Within the framework of the REB (Rebuilding the Evidence Base) project, the evaluation of the benefit-risk balance of oral osmotic laxatives in the treatment of functional constipation was relevant.Objective: the objective of this study was to analyze the efficacy and safety of oral osmotic laxatives in the treatment of functional constipation in pediatric and adult populations.Method: a systematic review was performed using the main databases (Cochrane, Embase and PubMed) by collecting randomized clinical trials comparing oral osmotic laxatives against placebo and oral osmotic laxatives against each other. The primary endpoints were based on treatment efficacy as well as treatment tolerability. Results from studies with risk of bias were not included.Results: from 1668 articles, 24 were selected. A meta-analysis was performed with the articles with a low risk of bias. Other data that could not be included in the meta-analysis were described in the results section. The main results showed that osmotic laxatives were effective and well tolerated in both adults and children. Between the different osmotic laxatives, PEG 4000 was superior to PEG 3350 in both adults and children, with a demonstrated dose effect in adults. It was more effective than lactulose in pediatrics. No significant difference was observed between lactulose and sorbitol. There were very few adverse effects, all of which were mild and not severe, confirming that osmotic laxatives are the laxatives to use in first-line treatment of functional constipation.Conclusion: osmotic laxatives are effective and safe treatments for the treatment of functional constipation in adults and children. PEG 4000 is the osmotic laxative that appears to be the most effective.; Contexte : les laxatifs osmotiques oraux font partie des traitements de première intention de la constipation fonctionnelle. Dans le cadre du projet REB (Reconstruire l’Evidence Base), l’évaluation de la balance bénéfices risques des laxatifs osmotiques oraux dans le traitement de la constipation fonctionnelle était pertinente.Objectif : l’objectif de cette étude était d’analyser l’efficacité et la tolérance des laxatifs osmotiques oraux dans le traitement de la constipation fonctionnelle en populations pédiatrique et adulte.Méthode : une revue systématique a été réalisée à l’aide des principales bases de données (Cochrane, Embase et PubMed) en recueillant les essais cliniques randomisés comparant les laxatifs osmotiques oraux contre placebo et les laxatifs osmotiques oraux entre eux. Les critères de jugements principaux étaient basés sur l’efficacité du traitement ainsi que la tolérance des traitements. Les résultats des études avec risques de biais n’ont pas été retenus.Résultats : parmi 1668 articles, 24 ont été sélectionnés. Une méta-analyse a été réalisée avec les articles avec un risque de biais faible. Les autres données qui ne pouvaient pas être incluses dans la méta-analyse ont été décrites dans la partie résultat. Les principaux résultats montraient que les laxatifs osmotiques étaient efficaces et avec une bonne tolérance chez l’adulte comme chez l’enfant. Entre les différents laxatifs osmotiques, il existait une supériorité du PEG 4000 par rapport au PEG 3350 chez l’adulte comme chez l’enfant avec un effet-dose démontré chez l’adulte. Il était plus efficace que le Lactulose en pédiatrie. Aucune différence significative n’a été observée entre le Lactulose et le Sorbitol. Il existait peu d'effets indésirables, tous étant légers et non sévères, ce qui confirmait que les laxatifs osmotiques étaient les laxatifs à utiliser en première intention dans le traitement de la constipation fonctionnelle.Conclusion : les laxatifs osmotiques sont des traitements efficaces et avec une bonne sécurité pour le traitement de la constipation fonctionnelle chez l’adulte et chez l’enfant. Le PEG 4000 est le laxatif osmotique qui paraît le plus efficace.

Introduction :Les vomissements aigus sont un motif fréquent de consultation en médecine ambulatoire et à ce titre, plus de 10 millions de boites ont été remboursées en 2017 soit 13 millions d’euros. Dans le projet REB porté par le Collège National des Généralistes Enseignants, une évaluation desbénéfices et des risques des antiémétiques a été réalisée.Méthode :Une revue de la littérature a été réalisée indépendamment par deux investigateurs jusqu’au 22 mars 2018 à partir des bases de données Medline, Cochrane, Embase et Clinical Trials.Les critères d’inclusion étaient :- Vomissements aigus chez les adultes et les enfants quelques soient leurs étiologies exceptées en chimiothérapie, radiothérapie, post-chirurgie, au cours de la grossesse et pour le mal des transports ;- Essais cliniques contrôlés et randomisés ;- Publication en langue française ou anglaise ;- Comparaison des antiémétiques versus placebo ou autre molécule.Pour les bénéfices, les effets sur la sévérité des nausées et la fréquence des vomissements étaient évalués. Pour les risques, les effets secondaires étaient évalués.Le protocole est enregistré dans le registre PROSPERO sous le numéro CRD42018091878.Résultats :Nous avons retenu 24 articles parmi les 1 704 trouvés à partir de la recherche électronique. L’ensemble des études ont été réalisées aux urgences. La plupart (83%) évaluait les sétrons, 29% le métoclopramide. La voie administration était à 50% intraveineuse et 38% par voie orale. Lamajorité concernait l’enfant (67%) et la gastro-entérite aigüe (67%). Le bénéfice global sur les vomissements (variables binaires et continues), exprimé en SMD (Standardized Mean Difference), était faible à 0,25 (IC95 = 0,16 – 0,33, p < 0,01). Sur les critères de jugement binaires (arrêt desvomissements, succès de réhydratation, non hospitalisation), le RR était de 1,24 (IC95 = 1,11 – 1,39, p < 0,01, I2 = 79,7%), le NNT 5 pour l’ondansétron, seule valeur significative. Sur les critères de jugement continus (score de nausées exprimé en échelle visuelle analogique) le SMD global était de 0,83 (IC95 = 0,30-1,36, p < 0,01, I2 = 92,1%). Les risques (effets secondaires) étaient rapportés seulement dans 40% des études et de manière non exhaustive avec notamment l’akathisie, la sédation et les céphalées.Conclusion :Il semble que les antiémétiques aient une efficacité limitée par rapport au placebo et que leurs risques soient insuffisamment évalués. La place de l’ondansétron est à discuter dans ces indications en médecine ambulatoire. Cette étude remet en question la pertinence de la prescription des antiémétiques dans les vomissements aigus, l’évolution étant spontanément favorable en l’absence de traitement.

Contexte : L’objectif de l’étude HEFESTOS est de développer et valider un modèle prédictif, basé sur des variables cliniques faciles à mesurer en soins primaires, pour prédire à court terme l’hospitalisation ou le décès dans une cohorte de patients insuffisants cardiaques de plus de 45 ans suivie en soins primaires pour une décompensation cardiaque. Il s’agit d’une étude européenne portée par l’Espagne. Le protocole a été approuvé par le Comité d’éthique espagnol et devait être soumis au comité d’éthique de chaque pays. L’objectif de notre thèse était de lancer l’étude pour la France. D’une part, faire les demandes d’autorisations notamment éthiques afin d’être conforme à la réglementation française. D’autre part, participer au recrutement des médecins.Matériels et méthodes : Il s’agit d’une étude non interventionnelle, prospective, multicentrique dans laquelle les patients sont suivis pendant30 jours. Les critères d’inclusion sont : être âgé de plus de 45 ans, avoir une insuffisance cardiaque connue et un diagnostic de décompensation cardiaque. La taille de l’échantillon nécessaire pour valider le modèle était de 50 patients par pays. Un consentement était demandé dans le protocole espagnol et l’étude en France avait été classée dans le cadre de la loi Jardé. Les médecins généralistes maitres de stagedes universités (MSU) recevant des internes sur le semestre de mai à octobre 2018 ont été contactés pour participer à l’étude. Les internes devaient aider les MSU à inclure et suivre les patients.Résultats : L’étude a été initialement définie comme une recherche non interventionnelle impliquant la personne humaine de catégorie 3 (RIPH 3), nécessitant un avis du comité de protection des personnes (CPP), une autorisation de la Commission Nationale Informatique et Libertés (CNIL) et une information à l’Agence Nationale de Sécurité du Médicament (ANSM). Finalement, l’étude ne rentrait pas dans le cadre de la loi Jardé. Elle impliquait seulement une évaluation éthique du CPP local, une autorisation de la CNIL avec un formulaire de non opposition. La procédure éthique a été longue et difficile : la loi Jardé venait juste d’être modifiée, ce qui rendait le parcours complexe y compris pour les référents des différentes entités (Département de Médecine Générale, CPP, CNIL…) qui n‘ont pas toujours pu guider ce parcours du fait de la nouveauté de celui-ci. Un diagramme a été établi afin de guider les chercheurs dans le cadre des études non interventionnelles. Dans le cadre de l’étude,158 médecins auvergnats ont été contactés et 61 médecins ont accepté de participer. Les inclusions sont en cours.Conclusion : Notre travail a mis en évidence les difficultés éthiques pour mettre en place une étude non interventionnelle en soins primaires en France dans le contexte du changement de la Loi Jardé. Notre travail a permis de clarifier la procédure et les interlocuteurs pour les recherches non interventionnelles en soins primaires à Clermont-Ferrand.