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. In addition, the scientific literature has been enriched over the years through clinical studies that have assessed the bioavailability and efficacy of bioactive components, and investigated their mechanisms of action. Based on existing recognized models which aim to classify research according to the level of scientific evidence, Synadiet developed a three-grade model (A, B or C) for assessing plants health claims. In this paper, the applicability of the model is illustrated through an example for which a Grade B health claim attesting the possible contribution of red clover isoflavones to the improvement of blood lipid levels in postmenopausal women has been attributed. The model appears able to be easily extrapolated to claims pertaining to other plants. If adopted by consensus at European level, this model could initiate the implementation of a positive list of health claims on plant preparations.

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. Stool frequency and consistency were improved in both placebo and synbiotic-treated volunteers while the synbiotic treatment significantly decreased the number of days with abdominal discomfort. Synbiotic treatment had no impact on mood dimensions, quality of life scores or the overall composition of the gut microbiota (16S rRNA gene sequencing of DNA extracted from stool). Importantly, plasma proinflammatory cytokines (interleukin (IL)-6, IL-8, IL-17a and interferon-gamma (IFNγ)) were significantly lower after 30 days of synbiotic supplementation. This effect appears to be independent of the gut barrier function. This study demonstrates that a combination of B. animalis lactis and the well-known prebiotic FOS could be a promising synbiotic strategy to decrease inflammatory status with improvement of gut disorders in middle-aged people.

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. This study assessed the feasibility and efficacy of a new intervention model using an individualized educational approach. METHODS: We conducted a randomized, single-blind controlled trial to assess a novel intervention: the "Developmental and Sequenced One-to-One Intervention (DS1-EI)". In DS1-EI, trained teachers worked one-to-one with each child in a small classroom setting, offering 10 h per week of the intervention. The focus was on encouraging spontaneous communication, promoting skills through play with peers, supporting positive interactions, and developmental and sequenced learning. We enrolled 5- to 9-year-old children with ASD and ID across 11 French child care institutions for children with co-occurring ASD and ID. Participants were matched in dyads by developmental quotient and randomized to the treatment-as-usual (TAU) group or the DS1-EI group. Independent raters blindly assessed the primary variables: The Childhood Autism Rating scale (CARS) and the Psychoeducational Profile, third edition (PEP-3). The secondary variables included the Vineland Adaptive Behavior Scale II (VABS-II) and the Clinical Global Assessment Scale (CGAS). Here we perform interim analyses at 24 months. RESULTS: At baseline, 72 participants were randomized. Nine patients (5 in the DS1-EI group and 4 in the TAU group) dropped out of the study. Using linear mixed models, both intent-to-treat (ITT) and per-protocol (PP) analyses at the 12-, 18- and 24-month outcomes showed no significant group nor group-by-time interaction effects. However, we found significant improvements in most primary and secondary variables over time in both groups. CONCLUSIONS: The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months. However, the low dropout rate shows that DS1-EI is feasible, and well accepted. As the study is still ongoing, we need to wait for data at 36 months to ensure whether DS1-EI could be recommended. TRIAL REGISTRATION: ANSM130282B-31 (April 16, 2013) and ACTRN12616000592448. Registered 6 May 2016, retrospectively registered, http://www.anzctr.org.au/.

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. RESULTS: Forty-two women were included in the cranberry + propolis group, and 43 women were in the placebo group. The mean age was 53 ± 18 years, with 6.2 ± 3.6 cystitis episodes in the previous year, with no differences between the 2 groups. The mean number of infections was lower in the propolis + cranberry group (respectively, 2.3 ± 1.8 vs. 3.1 ± 1.8). The total number of cystitis episodes in the first 3 months was lower in the propolis + cranberry group (0.7 ± 1.1 vs. 1.3 ± 1.1, p = 0.0257) after adjusting for water consumption. The mean time to onset of the first urinary tract infection (UTI) was also significantly longer in the propolis + cranberry group (69.9 ± 45.8 days vs. 43.3 ± 45.9, p = 0.0258). Tolerance to the treatments was good and comparable in both groups. CONCLUSIONS: We demonstrate for the first time that cranberry and propolis supplementation significantly reduces the incidence of UTIs during the first 3 months and delays the onset of an episode of cystitis.

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. Medication adherence was assessed by measuring the medication possession ratio and diabetes control by collecting HbA1c values. Levels of patient treatment self-management and disease knowledge were assessed using self-questionnaires. RESULTS: Three hundred seventy-seven patients were analyzed. The medication possession ratio, already very high at baseline in the intervention (94.8%) and control (92.3%) groups, did not vary significantly after 6 months with no difference between the two groups. Significant decreases in HbA1c were observed in both groups at 6 months (p < 0.001) and 12 months (p < 0.01), with significantly greater changes from baseline in the intervention group than in the control group at 6 months (- 0.5% vs. - 0.2%, p = 0.0047) and 12 months (- 0.6% vs. - 0.2%, p = 0.0057). Patients in the intervention group showed greater improvement in their ability to self-manage treatment (+ 4.86 vs. + 1.58, p = 0.0014) and in the extent of their knowledge about diabetes (+ 0.6 vs. + 0.2, p < 0.01) at 6 months versus baseline compared with the control group. CONCLUSION: Tailored information provided by the pharmacist to patients with type 2 diabetes did not significantly improve the already high adherence rates, but was associated with a significant decrease in HbA1c and an improvement of patient knowledge about diabetes. TRIAL REGISTRATION: ISRCTN33776525. FUNDING: MSD France.

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. It corresponds to a prevalence of 3.3% [1.4, 5.1] which is significantly lower than those recorded in the PERSE Study: 11.8% [10.8; 12.8] P<0.0001. The ulcer incidence study was conducted on 71 patients hospitalized on a bed with an Ascalis Optimo® support because of their high risk of pressure ulcers. When taking into account all pressure ulcers' stages and locations, 6 patients had a pressure ulcer corresponding to an incidence of 8.5% [3.2; 17.5]. When taking into account, only stages 2 to 4 as generally done in literature, 2 patients had a pressure ulcer i.e. an incidence of 2.8% [0.0; 6.7]. CONCLUSIONS: The significant decrease of the prevalence of pressure ulcer in the rehabilitation departments where Ascalis Optimo® were available when compared to the current prevalence observed in rehabilitation services and moreover the results of the study of pressure ulcer incidence in patients bedridden on Ascalis Optimo®, shows the benefit provided to patients in terms of pressure ulcers prevention.

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. RESULTS: The initial questionnaire was reduced from 22 to 5 questions rated from 0 to 4. The internal consistency and its external validity are good, and the ROC analysis shows that values > 3 correspond to poor compliance with a sensitivity of 88.1% and a specificity of 63.1%. CONCLUSION: The adherence score is valid for the detection of patients poorly compliant to the wearing of elastic compression. Its small number of questions makes it a suitable for a screening in everyday practice.

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. They completed a specially designed venous symptoms questionnaire. Duplex ultrasound of the included limbs was performed with the patient standing to detect reflux in the GSV and to measure the GSV inner diameter at mid-thigh. RESULTS: Between January and March 2015, 35 physicians examined 1245 patients (2450 limbs after excluding 40 limbs): 77% were female, mean age 52 ± 14; 69% of the patients had venous symptoms in one or both legs. The most frequent symptoms were feeling of heaviness, feeling of swelling and aching. Predominant CEAP clinical classes were C2 (38% of limbs) and C1 (35%). In case of GSV reflux (40% of limbs), the average diameter was 5.6 ± 2 mm and the distribution was 62% < 6 mm, 30% between 6 and 8 mm, and 8% > 8 mm. The study showed a clear association between clinical class and GSV diameter (the higher the clinical class, the larger the diameter; p < .0001), between venous symptoms and diameter (the larger the diameter, the higher the intensity of symptoms, p < .0001 for overall discomfort) and between proximal extent of reflux and diameter (the more proximal the extent of reflux, the larger the diameter, p < .0001). CONCLUSION: The DIAGRAVES study demonstrated that in France for patients consulting with CVDs, more than half of the incompetent GSVs had a diameter < 6 mm, while large diameters were relatively infrequent. This should be kept in mind when considering management strategies in patients with CVDs.

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. RESULTS: On the day of the prevalence study, 18 of the 456 patients presented pressure ulcers which occurred during the period when Axtair Automorpho® Plus supports were made available to the departments. This corresponds to a prevalence of 3.9% [2.4, 6.2] which is significantly lower than those recorded in the PERSE study: 11.8% [10.8; 12.8] p <0.0001. The ulcer incidence study covers 57 patients who were hospitalized on a bed with an Axtair Automorpho® Plus support because of their risk of contracting pressure ulcers. One pressure ulcer occurred in 3 patients and 3 pressure ulcers occurred in another patient, i.e. 4 out of 57 corresponding to an incidence of 7.0% [2.0; 17.0]. CONCLUSIONS: The results of the pressure ulcer prevalence study in rehabilitation departments where Axtair Automorpho® Plus supports were available as well as results of the study of pressure ulcer incidence in patients bedridden on Axtair Automorpho® Plus, confirm the expected benefit provided to patients in terms of prevention.

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.L extract in healthy volunteers whose anhedonia was characterized by a component of depression. METHODS: Single-centre double-blind randomized placebo-controlled clinical trial on parallel arms of two groups of 45 subjects. The study could include men or women aged 18 to 65 years with anhedonia characterized by a Snaith Hamilton Pleasure Scale score (SHAPS) of ≥5 and feeling low morale for at least four weeks characterized by a component of depression evaluated on the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR). Evaluation criteria: QIDS-SR; Patient Global Improvement Impression (PGII) and Clinical Global Improvement Impression (CGII). RESULTS: 86 subjects were included in the trial: 42 in the placebo group and 44 Ulva group. At D84, QIDS-SR significantly decreased more in the Ulva.L.L. group than in the placebo group (p: 0.0389). This difference is essentially linked to an improvement of the sleep disorders (p: 0.0219), of the psychomotor consequences (p: 0.002) and of the nutrition behaviour (p: 0.0694). 90.1% have the feeling of being improved in the Ulva group vs 72.5% in the placebo group (p: 0.0114) and in parallel 90.9% of the practitioners have the feeling that the subject has improved vs 70.8% (p: 0.0214). CONCLUSION: This double-blind randomized placebo-controlled trial shows that daily intake for three months of a water-soluble extract of Ulva L.L. continues to significantly improve the component of depression of subjects presenting anhedonia compared with a placebo. TRIAL REGISTRATION: Trial retrospectively registred on ClinicalTrial.gov under ID: NCT03545399 Date: 05/22/2018.

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. The main criterion was the comparison of the Glasgow Hearing Aid Benefit Profile (GHABP) before wearing HA and after a month of use and the secondary one was audiometric parameters. RESULTS: Forty-seven patients (mean age 60.0±6.9 years) were included in the study. After 4 weeks, when wearing HA, no significant difficulty remains in the patients when they watch television (GHABP situation 1) or when they have a conversation without background noise (GHABP situation 2). To have a conversation in a busy street or a shop GHABP (situation 3) 4.4% of patients still have great difficulty, as are 2.2% of them when participating in a group conversation (GHABP situation 4). The GHABP score of residual disability for the whole of the 4 situations of difficulty is 1.3±0.5, translating into no or only slight residual disability, in very significant amelioration of 1.3±0.7 points (P<0.0001), or 46.4% compared to the initial value. Audiometric parameters were also significantly improved. CONCLUSIONS: This study has allowed us to highlight from a clinical as well as an audiometric perspective the safety, effectiveness, as well as the important benefit of Sonalto® pre-set hearing aids on the improvement of hearing in patients presenting incipient presbyacusis.

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. METHODS: We conducted a human factors study on 134 healthy volunteers. On enrolment, subjects were provided with different instructive training material; a device quick guide plus either use of a dummy training device, an illustrated leaflet, or a demonstration video. After 6 weeks, subjects returned and performed an unaided simulated injection, and compliance with specific steps necessary for successful use, and avoidance of actions that interfere with appropriate use was recorded by an investigator. RESULTS: Most subjects (93.3%) successfully performed a simulated injection without major errors (regardless of type of educational instructions), and the great majority (97.5%) reported no difficulty in a range of objective measures of important necessary steps. Compliance with necessary steps and avoidance of detrimental actions was greater in those subjects with prior access to a demonstration video or provided with an illustrated patient leaflet. Prior experience with a dummy training device provided little if any benefit. User satisfaction with the device was high. CONCLUSIONS: The results show that the ZENEO® device can be effectively used with a conventional suite of printed user instructions. Use of a demonstration video provides additional value, whereas use of a dummy training device had limited value.

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. Lots were drawn for towns with more than 10,000 inhabitants. All public- and private-sector hospital facilities in each town drawn by lot were invited to participate in the survey. RESULTS: 776 hospital services throughout France took part and accommodated 21,538 patients: 12,752 women (59.2%) and 8,786 men (40.8%). Of these patients, 1,753 (8.1%; IC95% = 7.7; 8.5) had pressure ulcers. The pressure-ulcer rate was 7.8% (IC95% = [7.3; 8.3] (n = 997)) for hospitalized women and 8.6% (IC95% = [8.0; 9.2] (n = 756)) for men (p = 0.0381). The 8.1% level reported in 2014 therefore points to a reduction in pressure-ulcer prevalence; 8.6% in 1994 and 8.9% in 2004. CONCLUSIONS: The actions performed daily by healthcare professionals to prevent pressure ulcers, supported by research and training programs, including those by PERSE, are having a real impact over time.

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. Children who were proposed a cough syrup by a pharmacist were recruited. Questionnaires were completed by the pharmacists and/or parents at inclusion and by the parents after 5 days of treatment. RESULTS: Four hundred fourteen children were included (mean age: 6.0±2.9 years); 45.9% had a dry and 43.3% a productive cough. 30.4% were proposed an allopathic antitussive syrup, 28.3% an allopathic expectorant syrup and 23.7% a homeopathic syrup. Children with a dry cough were more likely to be given an allopathic antitussive (55.2%) or homeopathic (28.2%) syrup. Children with a productive cough or cough of several days duration were more likely to be given an allopathic expectorant syrup (70.1%). Cough disappearance was more frequent with homeopathic syrups compared to allopathic expectorants (P=0.002), or allopathic antitussives (P=0.042). Adverse events were most common with allopathic antitussive syrups (18.7%) (P<0.001). Two-thirds of parents were satisfied with the treatment their child received. CONCLUSIONS: Pharmacists play an important role in the management of acute cough in children. Homeopathic cough syrups may have an interest in terms of public health.

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. The study has been conducted in 2 parallel arms design: every subject received, according to the randomization Symbiosal or NaCl. STUDY OBJECTIVES: The main objective of this clinical trial was to demonstrate a higher reduction of systolic BP (SBP) with Symbiosal than with NaCl in the framework of a table salt reduction to a maximum of 3 g per day in prehypertensive patients RESULTS: Twenty-two subjects were included in the Symbiosal group and 19 in the NaCl group according randomization. The two groups have the same salt consumption: a daily intake of respectively 2.2±1.1 g/day vs. 2.5±1.2 g/day (P=0.3621). The SBP was measured by the investigators at D0 and D56. It significantly (P<0.0001) decreased more in the Symbiosal group from 133.8±5.7 mmHg to 126.1±6.5 mmHg which correspond to a reduction of 7.7±5.9 mmHg while it slightly increased in the group NaCl from 136.6±10.3 mmHg to 140.4±8.3 mmHg which corresponds to an increase of 3.7±6 mmHg (main criteria). The proportion of subjects whose SBP was under 130 mmHg strongly and significantly more important in the Symbiosal group =77.3% vs. 10.5% in the NaCl group (P<0.0001). CONCLUSIONS: This controlled randomized double-blind trial comparing Symbiosal to standard salt in the framework of a salt reduction demonstrate the efficiency of Symbiosal to prevent hypertension by controlling the BP rising in subject presenting prehypertensive status which is the target population of that food supplement.

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. Forty-eight physically active men (31 ± 6 years) were included in this study. During the two testing sessions, volunteers completed an endurance test at a high percentage of their maximal aerobic power and time to exhaustion was measured. Respiratory and pain parameters were also monitored. The preceding evening and 1 h before testing, volunteers had to absorb either 500 mg of polyphenols or placebo according to randomization. In comparison with the placebo, the mean duration of the maximal endurance test was significantly increased with polyphenols (+9.7% ± 6.0%, p < 0.05). The maximal perceived exertion was reached later with polyphenols (+12.8% ± 6.8%, p < 0.05). Practically, the present study showed the beneficial effects of grape and apple polyphenols for athletes looking for endurance performance improvements. The specifically designed profile of polyphenols appeared to enhance the capacity to maintain intensive efforts and delay perceived exertion.

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. Rather than trying to stop the use of CHD, we must channel the wave by clearly examining the advantages versus the risks and threats to the patients, and find counter-measures for implementation. The main difficulty is channeling the wave in a way that is acceptable to CHD developers who otherwise will bypass the rules, even if they can be sued for it. Therefore, it appears necessary to implement guidelines that can be used by all developers, defining the minimum requirement for assuring the security of patient privacy and healthcare management. CONCLUSION: In European Healthcare Systems, there is an imperative need for establishing security guidelines that CHD producers could use to ensure compliance, so that patient privacy and healthcare management is safeguarded. The aim would be to implement the guidelines a posteriori rather than a priori control so as not to hamper innovation.

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. They are compared to the data issued from the US National Hospital Discharge Survey which is equivalent to the PMSI in France and uses the International Classification of Diseases-9 for encoding the data. These data were published in the Morbidity, Mortality Weekly Report of the Centre for Disease Control. Results In the US, 547,996 hospital stays involve venous thromboembolic diseases, 348,558 deep venous thrombosis (DVT), and 277,549 pulmonary embolism (PE). Of these 78,511, or 14%, include a diagnosis of both DVT and PE. The hospital incidence of venous thromboembolic disease is 1.4%, DVT 0.9%, and PE 0.7%. In France, of the 26,658,228 annual hospital stays, 273,931 include venous thromboembolic disease, 179,286 DVT, and 139,345 PE while 44,700, i.e. 16.3%, include both DVT and PE. The hospital incidence of venous thromboembolic disease is thus 1.0%, DVT 0.6%, and PE 0.5%. The overall annual hospitalization rates for venous thromboembolic disease, DVT, and PE are respectively 274, 179, and 139 per 100,000 inhabitants in France and 239, 146, and 121 per 100,000 inhabitants in the US. Conclusion Venous thromboembolic diseases occur in France and the US in 1% of all hospital stays and are responsible for an annual hospitalization rate that exceeds 200 per 100,000. The scale of these annual incidences should prompt us to question the quality of prevention put in place and/or its efficacy.

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

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. Each centre collected in 10 to 20 patients ≥75 years of age and an equal number of patients <75 years of age treated by sclerotherapy, the treatment indication, the patient's personal history, the CEAP clinical class, the type of the veins being treated, the characteristics of sclerotherapy and the complications (immediately after treatment and at one-month follow-up). Results Population: In total, 418 patients were enrolled in 15 centres: 176 patients in group 1 (mean: 79.4 years) and 242 patients in group 2 (mean: 52.7 years).CEAP clinical classes C4, C5 and C6, history of deep vein thrombosis (12.5%) and superficial vein thrombosis (11.9%), long-term anticoagulant therapy (9.1%) and antiplatelet therapy (16.5%) were more frequent in older patients.All types of veins were treated from saphenous veins to telangiectasias. Sclerotherapy features: There was no difference in concentration of the sclerosing agents. When foam sclerotherapy was used (84% of patients), the injected volume was lower in group 1. COMPLICATIONS: One vasovagal syncope occurred in group 1. One asymptomatic distal deep vein thrombosis, confined to the Medial Gastrocnemius Veins, was reported in both groups at one-month follow-up. Conclusions This study shows the feasibility and safety of sclerotherapy in older patients, with no specific complications nor need for special precautions.