Grading health claims by weight of evidence would make for a better-informed public.

In the European Regulation 1924/2006 and especially its first recital, the evaluation of health claims (HC) by European Food Safety Agency (EFSA) was introduced so as "to ensure a high level of consumer protection, [and] give the consumer the necessary information to make choices in full knowledge of the facts…". Now, with 10 years of hindsight since the Regulation was adopted, it can be asked whether EFSA HC process of evaluation that led to a marginal number of accepted claims is consistent with this objective, not just for protecting consumers but for allowing them to decide freely and make informed choices. The aim of this paper was to demonstrate that the inclusion of a ranking of the weight of evidence in the assessment of EFSA's scientific substantiation of HC would allow consumers to benefit from the very high standard of scientific evaluation performed by EFSA. The definition of standards of proof is a generalized practice and rests on the principle that evaluations of health practices should be understood in terms of descriptions ranging from formal proof from high-power double-blind placebo-controlled studies to rankings based on the consensus views of experts or even agreement among professionals. Grading of weight of evidence - not of scientific expertise - is pervasive in all the recommendations or consensus meetings of health authorities or learned societies. This approach would stimulate research and product innovation as industrials would see a positive return on investment.

Efficacy of Ruscus extract, HMC and vitamin C, constituents of Cyclo 3 fort®, on improving individual venous symptoms and edema: a systematic review and meta-analysis of randomized double-blind placebo-controlled trials.

INTRODUCTION: Venoactive drugs (VADs) are considered an important component of the medical (conservative) treatment of chronic venous disorders (CVDs). However, the efficacy of certain VADs on one or more individual leg symptoms may have not been extensively studied to justify a high level or grade of recommendation in guidelines on CVD. The aim of the present systematic review and meta-analysis was to study the effectiveness of VADs containing Ruscus across the spectrum of defined venous symptoms. EVIDENCE ACQUISITION: On November 14 2016, a literature search of the databases MEDLINE and Scopus was performed, supplemented by hand searching, to identify randomized double-blind placebo-controlled trials on Ruscus extracts in patients with CVD. EVIDENCE SYNTHESIS: The main outcome measures were the effects of Ruscus on individual symptoms and leg edema, which were expressed as risk ratio (RR) or standardized mean difference (SMD) with 95% confidence interval (CI). Trial quality of evidence was graded using the GRADE system. We identified 10 trials, mostly with low risk of bias, on 719 patients. On qualitative analysis, Ruscus significantly improved seven defined leg symptoms, including pain, heaviness, fatigue, feeling of swelling, cramps, itching and paresthesia compared to placebo. On quantitative analysis, Ruscus compared with placebo, assessed as a categorical variable, reduced leg pain (RR=0.35, P=0.01, number needed to treat [NNT] 5, with no heterogeneity), heaviness (RR=0.26, P<0.00001, NNT=2.4, with a small amount of heterogeneity), feeling of swelling (RR=0.53, P<0.0001, NNT=4, with considerable heterogeneity, minimized after sensitivity analysis), paresthesia (RR=0.27, P<0.0001, NNT=1.8), global symptoms (RR=0.54, P<0.00001, NNT=4.3) and the total number of venous symptoms (RR 0.41, P=0.002). Similarly, Ruscus compared to placebo, assessed as a continuous variable reduced pain (SMD=-0.80, 95% CI: -1.21 to -0.39), heaviness (SMD=-1.23, 95% CI: -1.60 to -0.86), fatigue (SMD -1.16, 95% CI: -1.71 to -0.61), feeling of swelling (SMD=-2.27, 95% CI: -3.83 to -0.70), and paresthesia (SMD=-0.86, 95% CI: -1.51 to -0.21). Regarding objective assessments of leg edema, the use of Ruscus compared with placebo reduced ankle circumference (SMD=-0.74, 95% CI: -1.01 to -0.47) and leg or foot volume (SMD=-0.61, 95% CI: -0.91 to -0.31). The existing evidence, where sufficient, was mostly of high quality. CONCLUSIONS: Based on high quality evidence, Ruscus extracts are highly effective in reducing symptoms and edema of patients with CVD.

The place of Ruscus extract, hesperidin methyl chalcone, and vitamin C in the management of chronic venous disease.

Despite continuous improvement in our knowledge and management of chronic venous disease (CVD), certain areas, such as the role of muscarinic receptors in the pathology and treatment of CVD, remain unexplored. The symposium "The place of Ruscus extract, hesperidin methyl chalcone, and vitamin C in the management of CVD", held at the Annual Meeting of the European Venous Forum on 7-9 July 2016 in London, presented an update on the pathophysiology of CVD and highlighted how the combination of Ruscus extract, hesperidin methyl chalcone, and vitamin C (Ruscus/HMC/VitC; Cyclo 3® Fort), may counteract the deleterious processes underlying CVD. The data presented during this symposium are reported here. The pathophysiology of CVD is driven by a complex process involving numerous factors, with the two key players being venous hypertension and the inflammatory response. The cascade of reactions induced by disturbed venous flow, inflammation, and tissue alterations results in the early appearance of symptoms and progressive development of clinical signs of disease. Previous studies have shown that Ruscus extract acts at three levels: on the veins, capillaries and lymphatics, and has anti-inflammatory properties. A series of recent experiments has shed new light on the mechanism of action of the combination of Ruscus/HMC/VitC. The efficacy of Ruscus/HMC/VitC in CVD is supported by clinical studies, while two meta-analyses have confirmed a significant decrease of several symptoms and ankle circumference in response to treatment with this agent, leading to the conclusion that Ruscus/HMC/VitC deserves a Grade A rating.

Effect of magnesium, probiotic, and vitamin food supplementation in healthy subjects with psychological stress and evaluation of a persistent effect after discontinuing intake.

BACKGROUND: The aim of this paper was to describe the changes in subjects' psychological stress intensity under the effect of dietary supplements of magnesium, probiotics, and vitamins after one month of intake. METHODS: Observational cohort study of subject complaining of psychological stress defined by a Perceived Stress Scale (PSS 10) score of more than 21. RESULTS: The study covered 242 healthy volunteers, 38.6±13.6-year-old, among whom 79.8% were women. Under the effect of the supplementation of magnesium, probiotics, and vitamins, the psychological stress of the subjects decreased significantly from 34.1±4.5 to 26.2±6.1 (P<0.0001), which corresponds to an average reduction of 22.7±16.0%. Fatigue decreased even more significantly from 16.8±6.4 to 8.7±6.2 (P<0.0001), which corresponds to an average reduction of 45.0%±38.1%. Analysis showed that the psychological stress level was strictly similar one month after the treatment was discontinued and therefore clearly demonstrated that the psychological benefit was maintained over time. CONCLUSIONS: Stress and fatigue are significantly reduced by the intake of a food supplement with probiotics, magnesium, vitamins, and minerals and this effect is fully maintained one month after discontinuing the food supplement intake.

Combination of Ruscus aculeatus extract, hesperidin methyl chalcone and ascorbic acid: a comprehensive review of their pharmacological and clinical effects and of the pathophysiology of chronic venous disease.

This paper focuses on Ruscus aculeatus extract (Ruscus extract) and its combination with hesperidin methyl chalcone (HMC) and ascorbic acid (AA), which have been safely and effectively used in CVD treatment for more than 50 years in some European countries. It presents the effects of that drug on veins and on venous hypertension, its effect on microcirculation and on lymphatics demonstrated by preclinical studies and the clinical evidence issued from clinical trials supporting its use to relieve the symptoms of venous disease. In addition to its venoconstrictive effect on veins, its pharmacological action is on the microcirculation impairment caused by venous hypertension that is at the heart of the pathophysiological mechanism underlying venous disease.

Pea proteins oral supplementation promotes muscle thickness gains during resistance training: a double-blind, randomized, Placebo-controlled clinical trial vs. Whey protein.

BACKGROUND: The effects of protein supplementation on muscle thickness and strength seem largely dependent on its composition. The current study aimed at comparing the impact of an oral supplementation with vegetable Pea protein (NUTRALYS®) vs. Whey protein and Placebo on biceps brachii muscle thickness and strength after a 12-week resistance training program. METHODS: One hundred and sixty one males, aged 18 to 35 years were enrolled in the study and underwent 12 weeks of resistance training on upper limb muscles. According to randomization, they were included in the Pea protein (n = 53), Whey protein (n = 54) or Placebo (n = 54) group. All had to take 25 g of the proteins or placebo twice a day during the 12-week training period. Tests were performed on biceps muscles at inclusion (D0), mid (D42) and post training (D84). Muscle thickness was evaluated using ultrasonography, and strength was measured on an isokinetic dynamometer. RESULTS: Results showed a significant time effect for biceps brachii muscle thickness (P < 0.0001). Thickness increased from 24.9 ± 3.8 mm to 26.9 ± 4.1 mm and 27.3 ± 4.4 mm at D0, D42 and D84, respectively, with only a trend toward significant differences between groups (P = 0.09). Performing a sensitivity study on the weakest participants (with regards to strength at inclusion), thickness increases were significantly different between groups (+20.2 ± 12.3%, +15.6 ± 13.5% and +8.6 ± 7.3% for Pea, Whey and Placebo, respectively; P < 0.05). Increases in thickness were significantly greater in the Pea group as compared to Placebo whereas there was no difference between Whey and the two other conditions. Muscle strength also increased with time with no statistical difference between groups. CONCLUSIONS: In addition to an appropriate training, the supplementation with pea protein promoted a greater increase of muscle thickness as compared to Placebo and especially for people starting or returning to a muscular strengthening. Since no difference was obtained between the two protein groups, vegetable pea proteins could be used as an alternative to Whey-based dietary products. TRIAL REGISTRATION: The present trial has been registered at ClinicalTrials.gov (NCT02128516).

Short-term and mid-term outcome of isolated symptomatic muscular calf vein thrombosis.

BACKGROUND: Although muscular calf vein thrombosis (MCVT) is commonly seen in everyday practice, no treatment guidelines are available. This study evaluated short-term and mid-term outcome of isolated symptomatic MCVT. METHOD: We included prospectively and consecutively all patients referred to an outpatient clinic with isolated MCVT. Clinical signs were pain or edema, or both, of the calf. Diagnosis was established with duplex ultrasound (DUS) examination. Not completely occlusive and asymptomatic MCVTs were excluded. Patients were followed up clinically and with DUS at 1, 3, and 9 months, and up to 36 months. Anticoagulant therapy at curative dosage associated with compression was prescribed for 1 month and was extended for 2 additional months in case of incomplete recanalization at 1 month or if risk factors for venous thromboembolism (VTE) were present. RESULTS: Included were 128 patients (78 women, 50 men) presenting with 131 MCVTs. Their mean age was 57.02 +/- 15.36 years (range, 20 to 87 years). Thrombus was present in the soleal veins (SoV) in 73 patients (55.7%) and in the medial gastrocnemius veins (MGV) in 58 (44.3%). Initial symptoms were isolated pain in the calf in 90 patients, isolated edema of the calf in six, and pain plus edema in 32. Anticoagulant therapy was prescribed in 53 patients (41.4%) for 1 month, in 59 (46.1%) for 3 months, and in 13 (10.2%) for >or=6 months. At baseline, nine pulmonary embolisms (7%), complicated with MCVT, were observed in six MGV patients (10.3%) and three SoV patients (4.1%; P = .18). Two nonfatal hemorrhagic events occurred. Three patients died during the follow-up after anticoagulant therapy had been discontinued. Recanalization of MCVT was considered complete at 1, 3, and 9 months in 54.8%, 84.7%, and 96% of cases, respectively, with no significant difference between the MGV and the SoV groups. Twenty-nine VTE symptomatic recurrences (PE, n = 6; DVT including MCVT, n = 23) were observed in 24 patients (18.8%), with similar figures in both thrombosis groups: none at 3 months, 11 between 3 and 9 months and 18 between 9 and 36 months. No extension of the MCVT or a recurrence of VTE was observed in patients treated with anticoagulant therapy. Twelve cases of superficial thrombophlebitis occurred during the follow-up period. CONCLUSION: This study confirms the place of MCVT in VTE disorders. Pulmonary embolism at the MCVT initial diagnosis was not rare, and mid-term follow-up (mean, 26.7 months) revealed that 18.8% of patients had at least one VTE recurrence. The treatment of acute MCVT needs to be standardized because no guidelines currently exist.

How do individuals sleep around the world? Results from a single-day survey in ten countries.

BACKGROUND AND PURPOSE: To describe between-country differences in both the prevalence and type of sleep disorders seen across the globe, and to provide information on how impaired sleep impacts daytime functioning. PATIENTS AND METHODS: The study is a large-scale, global cross-sectional survey conducted on International Sleep Well Day (March 21), 2002. A standardized questionnaire was used in 10 countries under the guidance of local survey managers. In addition, the Athens Insomnia Scale (AIS) and the Epworth Sleepiness Scale (ESS) were completed. Subjects included in the study were adults from 10 countries representing different continents with clear variations in lifestyle. RESULTS: The total number of questionnaires collected was 35,327. Overall, 24% of subjects reported that they did not sleep well. According to self-assessments using the AIS, 31.6% of subjects had 'insomnia', while another 17.5% could be considered as having 'sub-threshold insomnia'. According to ESS scores, 11.6% of subjects were found to be 'very sleepy' or 'dangerously sleepy' during the day. CONCLUSIONS: Although there seem to be important global variations in the prevalence of insomnia, its symptoms and their management, about one in four individuals do not think they sleep well. Moreover, self-reported sleep problems could be underestimated in the general population. Overall, there is a need for increased awareness of the importance of disturbed sleep and the improved detection and management of sleep disorders.