Publications by authors named "François-André Allaert"

72 Publications

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

Sci Rep 2021 Jan 29;11(1):2627. Epub 2021 Jan 29.

Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Avenue E. Mounier, Box B1.73.11, 1200, Brussels, Belgium.

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.
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http://dx.doi.org/10.1038/s41598-020-80947-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7846804PMC
January 2021

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.

BMC Pediatr 2020 05 29;20(1):263. Epub 2020 May 29.

Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France.

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/.
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http://dx.doi.org/10.1186/s12887-020-02156-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7260851PMC
May 2020

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.

Urol Int 2019 22;103(1):41-48. Epub 2019 May 22.

CEN Nutriment, Impasse Françoise Dolto, Dijon, France.

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.
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http://dx.doi.org/10.1159/000496695DOI Listing
February 2020

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

Adv Ther 2019 06 2;36(6):1291-1303. Epub 2019 May 2.

Department of Endocrinology, Diabetology and Metabolic Diseases, CHU Dijon, Dijon, France.

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.
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http://dx.doi.org/10.1007/s12325-019-00957-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824455PMC
June 2019

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

Panminerva Med 2019 Dec 15;61(4):449-456. Epub 2019 Jan 15.

Department of Rehabilitation, Sud Ile-de-France Hospital, Melun, France.

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.
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http://dx.doi.org/10.23736/S0031-0808.18.03592-9DOI Listing
December 2019

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

Eur J Vasc Endovasc Surg 2019 07 19;58(1):96-103. Epub 2018 Oct 19.

Société Française de Phlébologie (SFP), Paris, France; Chaire d'évaluation médicale BSB Cenbiotech, Dijon, France.

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.
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http://dx.doi.org/10.1016/j.ejvs.2018.09.011DOI Listing
July 2019

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.

Panminerva Med 2018 Dec 28;60(4):161-169. Epub 2018 Jun 28.

Department of Rehabilitation, University Hospital, Saint-Etienne, France.

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.
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http://dx.doi.org/10.23736/S0031-0808.18.03491-2DOI Listing
December 2018

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.

BMC Psychiatry 2018 06 28;18(1):215. Epub 2018 Jun 28.

Amadéite SAS Pôle biotechnologique du Haut du Bois, 56580, Bréhan, France.

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.
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http://dx.doi.org/10.1186/s12888-018-1784-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6027788PMC
June 2018

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

Panminerva Med 2018 Sep 17;60(3):92-100. Epub 2018 Apr 17.

Medical Evaluation, Burgundy School of Business, Dijon, France -

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.
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http://dx.doi.org/10.23736/S0031-0808.18.03447-XDOI Listing
September 2018

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

Phlebology 2019 Feb 7;34(1):25-31. Epub 2018 Mar 7.

4 Vascular medicine, Caen, France.

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.
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http://dx.doi.org/10.1177/0268355518762824DOI Listing
February 2019

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

Panminerva Med 2018 Jun 6;60(2):52-59. Epub 2018 Mar 6.

Crossject, Dijon, France.

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.
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http://dx.doi.org/10.23736/S0031-0808.18.03423-7DOI Listing
June 2018

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

Hosp Pract (1995) 2018 Feb 20;46(1):30-36. Epub 2017 Dec 20.

c Chaire d'Évaluation Médicale , Cenbiotech et BSB , Dijon , 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.
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http://dx.doi.org/10.1080/21548331.2018.1418139DOI Listing
February 2018

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

Minerva Cardioangiol 2017 Dec 31;65(6):563-576. Epub 2017 Aug 31.

Health Claim Medical Evaluation Chair BSB, Dijon, France -

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.
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http://dx.doi.org/10.23736/S0026-4725.17.04451-6DOI Listing
December 2017

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

Nutrients 2017 Aug 22;9(8). Epub 2017 Aug 22.

CAPS, U1093 INSERM, Université de Bourgogne-Franche-Comté, Faculté des Sciences du Sport, F-21000 Dijon, France.

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%, < 0.05). The maximal perceived exertion was reached later with polyphenols (+12.8% ± 6.8%, < 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.
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http://dx.doi.org/10.3390/nu9080917DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5579710PMC
August 2017

Allergic rhinitis increases the risk of driving accidents.

J Allergy Clin Immunol 2017 08 9;140(2):614-616. Epub 2017 Mar 9.

Burgundy University, Dijon, France. Electronic address:

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http://dx.doi.org/10.1016/j.jaci.2017.01.037DOI Listing
August 2017

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

Minerva Pediatr 2018 Apr 17;70(2):117-126. Epub 2017 Feb 17.

Pharmacie du Vallon, Sainte Foy-Lès-Lyon, 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.
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http://dx.doi.org/10.23736/S0026-4946.17.04752-1DOI Listing
April 2018

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

BMC Med Inform Decis Mak 2017 01 17;17(1):10. Epub 2017 Jan 17.

Biostatistics and Bioinformatics (DIM), University Hospital, Dijon, France; Bourgogne Franche-Comté University, Dijon, France.

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.
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http://dx.doi.org/10.1186/s12911-017-0408-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5240253PMC
January 2017

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

Phlebology 2017 Aug 4;32(7):443-447. Epub 2016 Oct 4.

2 Biostatistics and Bioinformatics (DIM) and INSERM, CIC 1432, University Hospital, Dijon, France.

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.
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http://dx.doi.org/10.1177/0268355516653005DOI Listing
August 2017

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

Vasa 2016 Nov 6;45(6):491-495. Epub 2016 Sep 6.

1 Selurl Philangio, Grenoble, France.

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. We addressed the question whether oedema is already present in the morning in patients suffering of primary varicose veins without trophic changes.

Patients And Methods: In total, 101 patients with primary varicose veins (C2 and/or C3 stage of the CEAP classification) and 122 controls were enrolled as they appeared in our centre. The consultation time was no later than 6 hours after the patient had woken up. Oedema was detected by pitting test and ultrasound.

Results: The mean consultation time lapse was 3.7 ± 1.2 hours after waking-up. Oedema was more frequent in the group of primary varicose veins without trophic changes (36 % compared to 14 % in the control group; p < 0.01). Oedema was mainly detected by ultrasound and far less so by the pitting test.

Conclusions: Patients with varicose veins have morning oedema more frequently than patients without varicosis and at a higher rate than in epidemiological studies.
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http://dx.doi.org/10.1024/0301-1526/a000576DOI Listing
November 2016

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

PLoS One 2016 7;11(7):e0158567. Epub 2016 Jul 7.

Nutritional Epidemiology, Nutrition and Health Research Center, Mexican National Institute of Public Health, Cuernavaca, Morelos, México.

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. The objective of our study was to develop and validate such an instrument in urban, low socioeconomic, adult Mexican population.

Methods: To construct the Water Ingestion-Related Wellbeing Instrument (WIRWI), a qualitative study in which wellbeing related to everyday practices and experiences in water consumption were investigated. To validate the WIRWI a formal, five-process procedure was used. Face and content validation were addressed, consistency was assessed by exploratory and confirmatory psychometric factor analyses, repeatability, reproducibility and concurrent validity were assessed by conducting correlation tests with other measures of wellbeing such as a quality of life instrument, the SF-36, and objective parameters such as urine osmolality, 24-hour urine total volume and others.

Results: The final WIRWI is composed of 17 items assessing physical and mental dimensions. Items were selected based on their content and face validity. Exploratory and confirmatory factor analyses yielded Cronbach's alpha of 0.87 and 0.86, respectively. The final confirmatory factor analysis demonstrated that the model estimates were satisfactory for the constructs. Statistically significant correlations with the SF-36, total liquid consumption and simple water consumption were observed.

Conclusion: The resulting WIRWI is a reliable tool for assessing wellbeing associated with consumption of plain water in Mexican adults and could be useful for similar groups.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0158567PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4936734PMC
July 2017

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

Phlebology 2017 May 11;32(4):234-240. Epub 2016 Apr 11.

6 Chaire d'Evaluation Médicale Ceren ESC & Cenbiotech/dim CHU du, Dijon, France.

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.
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http://dx.doi.org/10.1177/0268355516642659DOI Listing
May 2017

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

Phlebology 2016 Jul 5;31(6):390-6. Epub 2015 Mar 5.

Service de Biostatistique et d'Informatique Medicale (DIM), Centre Hospitalier Universitaire, Dijon Cedex, France INSERM U866, Universite de Bourgogne, Dijon, France.

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. Since 2010-2011 it is possible to differentiate the reason for hospital admission from the pathologies which secondly occurred. Any stay with the ICD-10 codes selected was considered as a hospital-occurred thrombosis unless it was the principal diagnosis of the first medical unit summary. To eliminate outpatient consultations or in day care, stays of <48 h were excluded.

Results: The results pertain to the 78,838,983 hospitalizations in France from 2005 to 2011 and on the 18,683,603 hospital stays in 2010-2011. The incidence of hospital stays came to 860,343 (1.09%) for venous thromboembolism, with 428,261 (0.543%) for deep vein thrombosis without pulmonary embolism and 432,082 (0.548%) for pulmonary embolism. It corresponds to an incidence of 189 per 100,000 inhabitants. Out of 100 hospital stays involving venous thromboembolism, for 40.3% venous thromboembolism was the cause of hospitalization whereas 59.7% can be considered to have occurred during hospital stay. These distributions are of 25.6 and 74.4% for deep vein thrombosis, respectively, 53.8 and 46.2% for pulmonary embolism.

Conclusion: The high proportion of hospital-occurred venous thromboembolism is an alarming situation that should question the quality of prevention and/or its effectiveness.
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http://dx.doi.org/10.1177/0268355515575592DOI Listing
July 2016

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

Homeopathy 2014 Oct 10;103(4):239-49. Epub 2014 Jun 10.

Laboratoires Boiron, Sainte Foy-lès-Lyon, France.

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. Patients (≥12-years) with early symptoms of ILI or ENT disorders (<36 h duration) who received treatment were included. Socio-demographic data, symptom severity and disease impact on daily activities and sleep were recorded at inclusion. Symptom evolution and patient satisfaction were assessed after 3 days of treatment.

Results: 573 patients (mean age: 42.5 ± 16.2 years; 61.9% female) were recruited by 133 pharmacies. Two-thirds of patients (63.2%) visited the pharmacy early (<24 h) after symptom onset. The most common symptoms were runny nose (56.4%), sore throat (54.6%) and cough (49.0%). Patients were given 2.6 ± 1.2 medications; 98.4% of patients received allopathic (usually paracetamol, 33.5%) and 25.3% homeopathic (Oscillococcinum, 56.6%) treatment, usually combined with allopathy. Compliance was good and 77.2% of patients continued treatment for 3 days. Most symptoms improved significantly after 3 days and quality of life was enhanced. 85.9% of patients were satisfied with the advice received.

Conclusions: Seeking a pharmacist's advice for the management of ILI and ENT disorders has several public health benefits. The clinical improvement and high patient satisfaction observed validate the role of the pharmacist as a health professional of first resort.
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http://dx.doi.org/10.1016/j.homp.2014.04.001DOI Listing
October 2014

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

J Int Soc Sports Nutr 2014 11;11:36. Epub 2014 Jul 11.

Chair of Medical Evaluation ESC, Dijon, France ; CEN Nutriment, Dijon, France.

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. Participants were randomly assigned to the Placebo (PLA), Soluble Milk Protein (SMP, with fast digestion rate) or Micellar Casein (MC, with slow digestion rate) group. During the 10-week training period, participants were instructed to take 30 g of the placebo or protein twice a day, or three times on training days. Tests were performed on quadriceps muscles at inclusion (PRE), after 4 weeks (MID) and after 10 weeks (POST) of training. They included muscle endurance (maximum number of repetitions during leg extensions using 70% of the individual maximal load), fatigue (decrease in muscle power after the endurance test), strength, power and muscle thickness.

Results: Muscle fatigue was significantly lower (P < 0.05) in the SMP group at MID and POST (-326.8 ± 114.1 W and -296.6 ± 130.1 W, respectively) as compared with PLA (-439.2 ± 153.9 W and -479.2 ± 138.1 W, respectively) and MC (-415.1 ± 165.1 W and -413.7 ± 139.4 W, respectively). Increases in maximal muscle power, strength, endurance and thickness were not statistically different between groups.

Conclusions: The present study demonstrated that protein composition has a large influence on muscular performance after prolonged resistance training. More specifically, as compared with placebo or micellar casein, soluble milk protein (fast digestible) appeared to significantly reduce muscle fatigue induced by intense resistance exercise.
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http://dx.doi.org/10.1186/1550-2783-11-36DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107592PMC
July 2014

Compression versus inner sole for venous patients with foot static disorders: a prospective trial comparing symptoms and quality of life.

Phlebology 2015 Feb 27;30(1):32-8. Epub 2013 Sep 27.

Chaire d'Evaluation Médicale, Ceren ESC & Cenbiotech, Dijon, France.

Objective: To prospectively compare the improvement in quality of life and symptoms achieved when using two treatments-medical compression stockings and inner sole-in subjects with symptomatic chronic venous disease in the presence of foot static disorders.

Materials And Methods: This prospective study included 24 patients with a symptomatic chronic venous disease associated with foot static disorders. The basic CEAP was used to classify the patients. The venous symptoms were recorded using a 10-point visual analog scale and scored using a customized questionnaire. Patient-reported quality of life data were acquired using a CIVIC questionnaire. A standardized measurement of the Djian-Annonier angle was used to quantify the foot static disorders. We compared the use of the following two treatments: medical compression stockings (18 mm of Hg) and inner sole. For this comparison, we used a crossover technique over 4 successive weeks.

Results: One male and 23 female patients were included in this study. We found significant improvement in quality of life scores when only medical compression stockings were used (p < 0.005), only inner sole were used (p < 0.01) and also when both treatments were used together (p < 0.001), compared with no treatment. This was mainly observed for the somatic component of CIVIC. The symptoms of pain, heaviness, swollen feeling, and cramps were significantly improved by the two treatments, whether given separately (p < 0.001) or together (p < 0.0001). No additive effect of the treatments was observed.

Conclusion: This study suggests that a number of leg symptoms occurring in varicose veins patients are not likely to have a venous origin. They are frequently related to a foot static disorder, which is responsible for postural changes. This study also strongly demonstrates the need for correction of the foot static disorder if such a disorder is present in any patient with chronic venous disease. The use of the inner sole will improve the symptoms and also the quality of life with an efficiency that is almost equal to that provided by the medical compression stockings and the combined use of both treatments is recommended.
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http://dx.doi.org/10.1177/0268355513505508DOI Listing
February 2015

Effectiveness of homeopathic medicine associated with allopathic medicine in the outpatient management of influenza-like illnesses or ear, nose, and throat disorders by pharmacists.

J Manag Care Pharm 2013 Oct;19(8):631-41

Laboratoires Boiron, 20, rue de la Liberation, F-69110 Sainte-Foy-les-Lyon, France.

Background: Pharmacists play an increasing role in advising on treatment for minor illnesses such as influenza-like illness (ILI) or ear, nose, and throat (ENT) disorders. However, the profile of patients consulting pharmacists with these illnesses, the types of over-the-counter (OTC) medicines recommended by pharmacists, and the effectiveness of these treatments have not been studied.

Objectives: To describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines for ILI or ENT disorders by pharmacists in France and to investigate the effectiveness of these treatments.

Methods: A prospective, observational, multicenter study was carried out in randomly selected pharmacies across the 8 IDREM medical regions of France. Pharmacies that agreed to participate recruited male or female patients who responded to the following inclusion criteria: age ≥ 12 years presenting with the first symptoms of an ILI or ENT disorder that were 
present for less than 36 hours prior to the pharmacy visit. All medicines recorded in the study were recommended by the pharmacists. The following data were recorded at inclusion and after 3 days of treatment: the intensity of 13 symptoms, global symptom score, and disease impact on daily activities and sleep. Two groups of patients were compared: those recommended allopathic medicine only (AT group) and those recommended homeopathic medicine with or without allopathic medicine (HAT group). The number and severity of symptoms, change in global symptom score, and disease impact on daily activities and sleep were compared in the 2 treatment groups after 3 days of treatment. Independent predictors of recommendations for homeopathic medicine were identified by multi-
factorial logistic regression analysis.

Results: A total of 242 pharmacies out of 4,809 (5.0%) contacted agreed to participate in the study, and 133 (2.8%) included at least 1 patient; 573 patients were analyzed (mean age: 42.5 ± 16.2 years; 61.9% female). Of these, 428 received allopathic medicines only (74.7%; AT group), and 145 (25.3%) received homeopathic medicines (HAT group) alone (9/145, 1.6%) or associated with allopathy (136/145, 23.7%). At inclusion, HAT patients were significantly younger (39.6 ± 14.8 vs. 43.4 ± 16.1 years; P  less than  0.05), had a higher mean number of symptoms (5.2 ± 2.5 vs. 4.4 ± 2.5; P  less than  0.01), and more severe symptoms (mean global symptom score: 24.3 ± 5.5 vs. 22.3 ± 5.8; P = 0.0019) than AT patients. After 3 days, the improvement in symptoms and disease impact on daily activities and sleep was comparable in both groups of patients.

Conclusions: Patients recommended homeopathic medicine by pharmacists were younger and had more severe symptoms than those recommended allopathic medicine. After 3 days of treatment, clinical improvement was comparable in both treatment groups. Pharmacists have an important role to play in the effective management of ILI and ENT disorders.
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http://dx.doi.org/10.18553/jmcp.2013.19.8.631DOI Listing
October 2013

Phlebotonic and compression stocking therapy in venous edema management: an overview of recent advances with a focus on Cyclo 3 Fort® and progressive compression stockings.

Womens Health (Lond) 2013 Jul 25;9(4):325-33. Epub 2013 Apr 25.

Clinique Universitaire de Médecine Vasculaire, CHU Michallon, Grenoble, F-38043, France.

Venous edema of the limb presents several challenges to clinicians, particularly with regard to its definition, pathophysiology and measurement, as well as those relating to its management. Compression therapy forms the cornerstone of standard care for thromboprophylaxis and management of lower limb venous and lymphatic disorders. Venoactive drugs, of plant or synthetic origin, have also been shown to be effective and safe in the management of venous edema and/or chronic venous disease-related symptoms. This article, based on a symposium held at the XXV World Congress of the International Union of Angiology on 2-5 July 2012 (Prague, Czech Republic), provides an overview of some of the recent developments in the use of phlebotonic and compression therapy in the management of patients with lower limb venous edema, with a focus on Cyclo 3 Fort(®) and progressive compression stockings.
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http://dx.doi.org/10.2217/whe.13.26DOI Listing
July 2013

Validation of a short food frequency questionnaire to evaluate nutritional lifestyles in hypercholesterolemic patients.

Ann Endocrinol (Paris) 2012 Dec 7;73(6):523-9. Epub 2012 Nov 7.

Department of Endocrinology, hôpital de la Pitié-Salpétrière, AP-HP, 47-83, boulevard de l'Hôpital, 75013 Paris, France.

Objectives: The purpose of our study was to develop and validate a short food frequency questionnaire which could assess the nutritional lifestyles of hypercholesterolemic patients consulting in daily practice.

Material And Methods: The questionnaire explores 11 nutrient categories. Hundred and thirty-one patients were recruited for the construct validity and 58 patients for the external validity in La Pitié Hospital, Paris. The reference method used was the diet history. To measure the internal consistency and to test the sensibility to change on a large scale, the questionnaire was used in an observational study conducted in Spain in 1048 moderate hypercholesterolemic patients. Psychometric analyses included construct validity, internal consistency, test-retest reliability, external validity and sensibility to change.

Results: Validation of the questionnaire indicated a good internal consistency (Cronbach Coefficient Alpha at 0.69) and test-retest reliability (intraclass correlation coefficient=0.89). The correlation between the scores of the FFQ and those of the diet history was significant with a Pearson correlation coefficient at 0.3 (P=0.029). The comparison between the ranking of the patients showed an agreement of 72% with a kappa of 0.48 [0.10; 0.69]. The sensibility to change was good with a score evolution improving one and four months after nutrition advices: 28.2% of patients ranked in group 1 at inclusion versus 61.3% (P<0.0001) at one month and 75.2% (P<0.0001) at four months.

Conclusion: In conclusion, we developed and validated a food questionnaire for hypercholesterolemic patients, which can be used as a therapeutic education tool in daily practice or in clinical research.
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http://dx.doi.org/10.1016/j.ando.2012.09.006DOI Listing
December 2012

Watermarking as a traceability standard.

Stud Health Technol Inform 2012 ;180:761-5

Inserm U650, LaTIM, GET ENST Bretagne.

The exponential increase in the number of electronic document exchanges in healthcare has considerably increased the risk of document drop-out or address errors. It may therefore be important to know to whom the information belongs and who produced it. This becomes a major concern when the document has been involved in processes leading to the choice of therapy and eventually in cases where patients seek damages for medical malpractice. Watermarking, which is the embedding of security elements, such as a digital signature, within a document, can help to ensure that a digital document is reliable. However, at the same time, questions arise about the validity of watermarking-based evidence. In this paper, beyond the technical aspects, we discuss the worldwide legal acceptability of watermarking and the need for its recognition as a standard according to technical characteristics that the CEN and ISO need to agree on.
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January 2013