A Graded Approach for Evaluating Health Claims about Plant-Based Food Supplements: Application of a Case Study Methodology.

The implementation of REGULATION (EC) No 1924/2006 has led to the formation of a list of health claims that can be used in food supplements (EU 432/2012). However, such supplements are often composed of plant preparations with claims omitted from this list. The peculiarity of plants is related to their long history of use, that could allow claims based on traditionally recognized health effects.

Improvement of gastrointestinal discomfort and inflammatory status by a synbiotic in middle-aged adults: a double-blind randomized placebo-controlled trial.

Several studies suggest that microbial alterations (dysbiosis) are intimately linked to chronic inflammation occurring upon aging. The aim of this study was to investigate the potential interest of a synbiotic approach (co-administration of a probiotic bacteria and a prebiotic dietary fibre) to improve gastrointestinal wellness and inflammatory markers in middle-aged people. Middle-aged subjects were randomized to take synbiotic (Bifidobacterium animalis lactis and fructo-oligosaccharides (FOS)) or placebo for 30 days.

Developmental and sequenced one-to-one educational intervention (DS1-EI) for autism spectrum disorder and intellectual disability: a two-year interim report of a randomized single-blind multicenter controlled trial.

Background: Children with autism spectrum disorder (ASD) and moderate to severe intellectual disability (ID) face many challenges. There is little evidence-based research into educational settings for children with ID and ASD and in France. Little is known about how this unserved population could benefit from intervention and education.

A Multicenter, Randomized, Placebo-Controlled Study Evaluating the Efficacy of a Combination of Propolis and Cranberry (Vaccinium macrocarpon) (DUAB®) in Preventing Low Urinary Tract Infection Recurrence in Women Complaining of Recurrent Cystitis.

Objectives: The purpose of the study was to compare the efficacy of a product containing cranberry and propolis (DUAB) to placebo for reducing frequency of cystitis in women with recurrent acute cystitis.

Method: A multicenter, placebo-controlled, randomized study of women aged >18 years with at least 4 episodes of cystitis in the previous 12 months was performed. The number of cystitis episodes over a 6-month follow-up was the primary end point.

Impact of a Community Pharmacist-Delivered Information Program on the Follow-up of Type-2 Diabetic Patients: A Cluster Randomized Controlled Study.

Introduction: Low-quality communication between patients and care providers and limited patient knowledge of the disease and the therapy are important factors associated with poor glycemic control in patients with type 2 diabetes. We conducted a multicenter study to determine whether structured and tailored information delivered by pharmacists to type 2 diabetic patients could improve patient treatment adherence, hemoglobin A1c (HbA1c) levels and knowledge about diabetes.

Methods: One hundred seventy-four pharmacies were randomized to deliver an educational program on diet, drug treatment, disease and complications during three 30-min interviews over a 6-month period, or to provide no intervention, to type 2 diabetic patients treated with oral antidiabetic agents.

Efficacy of a motorized air support to prevent pressure ulcers in at-risk patients hospitalized in rehabilitation departments: incidence and prevalence studies.

Background: The main objective was to assess the reduction of the pressure ulcers prevalence which could be obtained if Ascalis Optimo® mattresses were made available ad libitum in rehabilitation services (RS) by comparison to prevalence as observed in the national PERSE study (historical control) in similar departments using a variety of prevention aids.

Methods: This cross-sectional prevalence study was combined with a prospective study of the incidence of pressure ulcer occurrence in the high-risk target population whose beds were systematically equipped with the studied support.

Results: The prevalence study shows that 12 of the 369 patients presented pressure ulcers which occurred when Ascalis Optimo® was used.

Great Saphenous Vein Diameters in Phlebological Practice in France: A Report of the DIAGRAVES Study by the French Society of Phlebology.

Objective: The aim was to evaluate the distribution of the diameter of the great saphenous vein (GSV) at mid-thigh level and to investigate its association with clinical class, symptoms, and proximal extent of reflux.

Methods: Vascular physicians, members of the French Society of Phlebology, were invited to participate in a consecutive observational study in patients presenting with symptoms and/or signs of uni- or bilateral chronic venous disorders (CVDs) in previously untreated limbs (clinical class of the CEAP classification C0s - C6). Patients were included between January and March 2015.

Prevention of pressure ulcers with a motorized air support in at-risk patients hospitalized in rehabilitation departments APAM + an observational prevalence study with historical control and incidence study.

Background: The main study was a cross-sectional multicenter study of the prevalence of pressure ulcers in rehabilitation services (RS) where Axtair Automorpho® Plus mattresses were made available ad libitum. The primary objective was to enable comparison with prevalence as observed in the national PERSE study (historical control) in similar departments using a variety of prevention aids.

Methods: This cross-sectional prevalence study was combined with a prospective study of the incidence of pressure ulcer occurrence in the high-risk target population whose beds were systematically equipped with the studied support.

A randomized controlled double-blind clinical trial comparing versus placebo the effect of an edible algal extract (Ulva Lactuca) on the component of depression in healthy volunteers with anhedonia.

Background: The effects of the seaweed extract were evaluated on the animal model equivalent of depression compared with a control group treated with the carrier (spring water) and a reference group treated with Imipramine and showed significative effect. This clinical trial was intended to confirm in humans the potential efficacy identified in animals. The primary objective was to compare against a placebo the effect of Ulva L.

Clinical study on the efficacy, acceptance, and safety of hearing aids in patients with mild to moderate presbyacusis.

Background: The primary objective of this trial was to demonstrate the effect of wearing a Hearing aid (HA) on improvement of hearing and comprehension in everyday life situations.

Methods: This single-center phase IV open-label clinical trial was carried out on men or women 40 years old or more, presenting mild or moderate first-degree presbyacusis. Presbyacusis was diagnosed by performance of pure-tone audiometry in silence.

Design and evaluation of the psychometric properties of a self-questionnaire on patient adherence to wearing elastic compression stockings.

Background: Patients' adherence to elastic compression stockings is difficult to evaluate, and therefore we create a short self-questionnaire and validate its psychometric properties.

Methods: We reduce the questions with Varimed rotation analysis, evaluate its internal consistency using Cronbach's alpha test and its external validity by comparison to electronic thermic captors. Receiver operating characteristic (ROC) analysis was used to determine a threshold and determine its sensitivity and specificity.

Human factors study of ZENEO® (needle-free autoinjector) and comparison of different user instruction formats.

Background: ZENEO® (Crossject, Dijon France) is a novel prefilled, disposable needle-free auto-injector (AI) device under development for drug deliverer in a variety of routine-use or emergency situations. At present, reported user experience and patient preferences are limited. To determine what impact different forms of user instructions may have on successful use of the ZENEO® device.

Prevalence, characteristics and risk factors of pressure ulcers in public and private hospitals care units and nursing homes in France.

Objective: The aim of this study conducted in 2014 was to describe the prevalence of pressure ulcers in different types of French hospital unit at the national level to compare them with data from the 1994 and 2004 study.

Methods: This cross-sectional study was conducted over a single day. All care units were invited to participate by drawing lots stratified by region in successive waves until 1,200 agreements were obtained.

Effect of NaCl + Chitosan 3% vs. NaCl on high blood pressure parameters of healthy volunteers with prehypertension.

Background: Because of the impressive increase in the risk of cardiovascular complications associated with levels of BP previously considered to be normal, the JNC 7 report has introduced a new classification that includes the term "prehypertension" for those with blood pressures (BPs) ranging from 120-139 mmHg systolic and/or 80-89 mmHg diastolic. In the framework of a salt reduction as recommended by health authorities, this trial evaluates if the use of Symbiosal® reduces more prehypertension than standard table marine salt (NaCl).

Methods: Study design: monocenter, randomized, double blind, controlled trial comparing the marine salt NaCl + Chitosan 3% according a specific patent Symbiosal and the standard table marine salt NaCl.

An Acute Dose of Specific Grape and Apple Polyphenols Improves Endurance Performance: A Randomized, Crossover, Double-Blind versus Placebo Controlled Study.

Polyphenols are thought to be an interesting ergogenic aid for exercise and recovery. However, most studies regarding the effects of polyphenols investigated several days of supplementations. The present work aimed to study the effects of an acute intake of grape and apple polyphenols on the capacity to maintain intense exercise, here named endurance performance.

Observational study on the dispensing of cough syrups to children with acute cough by community pharmacists in France.

Background: Over-the-counter medicines may be proposed by pharmacists for children with acute cough. Study objectives were to describe the sociodemographic profile of children who were proposed a cough syrup by a pharmacist, the nature of the cough and type(s) of cough syrup proposed and to assess the evolution of the cough, tolerance and satisfaction with treatment.

Methods: Observational, prospective, longitudinal, multicentre study with 157 pharmacies in France.

The tidal waves of connected health devices with healthcare applications: consequences on privacy and care management in European healthcare systems.

Background: The market for Connected Health Devices (CHD) with healthcare applications is growing fast and should be worth several billion euros in turnover in the coming years. Their development will completely transform the organisation of our healthcare system, profoundly change the way patients are managed and revolutionizes disease prevention.

Main Body: The CHD with healthcare applications is a tidal wave that has societal impact calling into question the privacy of patients' personal and healthcare information and its protection in secure systems.

Hospital incidence and annual rates of hospitalization for venous thromboembolic disease in France and the USA.

Objective The study was designed to describe the hospital incidences and annual hospitalization rates for venous thromboembolic disease by age and sex in France and the United States on the closest possible methodological bases. Methods French statistics are from the PMSI MCO (Programme de médicalisation des système d'information de médecine, chirurgie et obstétrique (French national hospital discharge register)) national database. These are compiled for each calendar year by collating résumé de sortie anonymisé (RSA, anonymous discharge summary) files forwarded and validated by health establishments with admissions in medicine, surgery, obstetrics, and odontology.

Early morning oedema in patients with primary varicose veins without trophic changes.

Background: Chronic lower limb oedema is one of the complications of superficial or deep chronic venous disorders. It is ranked as "C3"on the CEAP classification. In epidemiological studies, the recognition of oedema is mainly based on clinical signs, and oedema is more easily detected in the second part of the day when it becomes evident.

Development and Validation of an Instrument to Evaluate Perceived Wellbeing Associated with the Ingestion of Water: The Water Ingestion-Related Wellbeing Instrument (WIRWI).

Background: Ingestion of water has been associated with general wellbeing. When water intake is insufficient, symptoms such as thirst, fatigue and impaired memory result. Currently there are no instruments to assess water consumption associated with wellbeing.

Sclerotherapy is a safe method of treatment of chronic venous disorders in older patients: A prospective and comparative study of consecutive patients.

Unlabelled: Objectives An aging population requires evaluation of methods of treatment for older patients. Our objective was to evaluate the indications, practical modalities, safety and tolerability of sclerotherapy in patients 75 years of age and older (group 1) and compare with a control group of patients 18 to74 years of age (group 2). Method This observational, multicentre, prospective and comparative study was conducted by the French Society of Phlebology.

More than one in two venous thromboembolism treated in French hospitals occurs during the hospital stays.

Objective: The objective was to describe the prevalence of venous thromboembolism, pulmonary embolism, and deep vein thrombosis among hospitalized patients and the percentages of those occurring during the hospital stays.

Methods: French DRG gave now the opportunity to investigate the frequency of venous thromboembolism occurring during the hospital stay. Statistics are issued from the national PMSI MCO databases encoded using the CIM10.

Management of the early symptoms of influenza-like illnesses and ear, nose and throat (ENT) disorders by pharmacists.

Background: Pharmacists play a key role in primary healthcare, but the characteristics of patients who consult a pharmacist directly rather than going to their general practitioner (GP) are unknown. Our aim was to describe the socio-demographic and clinical characteristics of patients who seek direct therapeutic advice from a pharmacist for influenza-like illness (ILI) or ear, nose and throat (ENT) disorders, the types of medicines dispensed and patient satisfaction with the advice received.

Methods: This prospective, observational study was carried out on a random sample of French pharmacies between November 2010 and March 2011.

Effects of soluble milk protein or casein supplementation on muscle fatigue following resistance training program: a randomized, double-blind, and placebo-controlled study.

Background: The effects of protein supplementation on muscle thickness, strength and fatigue seem largely dependent on its composition. The current study compared the effects of soluble milk protein, micellar casein, and a placebo on strength and fatigue during and after a resistance training program.

Methods: Sixty-eight physically active men participated in this randomized controlled trial and underwent 10 weeks of lower-body resistance training.