Association between type 2 diabetes and depressive symptoms after a 1-year follow-up in an older adult Mediterranean population.

OBJECTIVES: To examine the cross-sectional association between baseline depressive symptoms and the presence of type 2 diabetes (T2D), and its association with glycated hemoglobin (HbA1c) and other metabolic variables, and the prospective association of depressive symptoms and HbA1c after 1 year of follow-up. METHODS: n = 6224 Mediterranean older adults with overweight/obesity and metabolic syndrome (48% females, mean age 64.9 ± 4.9 years) were evaluated in the framework of the PREDIMED-Plus study cohort. Depressive symptoms were assessed using the Beck Depression Inventory-II and HbA1c was used to measure metabolic control. RESULTS: The presence of T2D increased the likelihood of higher levels of depressive symptoms (χ2 = 15.84, p = 0.001). Polynomial contrast revealed a positive linear relationship (χ2 = 13.49, p = 0.001), the higher the depressive symptoms levels, the higher the prevalence of T2D. Longitudinal analyses showed that the higher baseline depressive symptoms levels, the higher the likelihood of being within the HbA1c ≥ 7% at 1-year level (Wald-χ2 = 24.06, df = 3, p < .001, for the full adjusted model). Additionally, depressive levels at baseline and duration of T2D predicted higher HbA1c and body mass index, and lower physical activity and adherence to Mediterranean Diet at 1 year of follow-up. CONCLUSIONS: This study supports an association between T2D and the severity of depressive symptoms, suggesting a worse metabolic control from mild severity levels in the short-medium term, influenced by lifestyle habits related to diabetes care. Screening for depressive symptoms and a multidisciplinary integrative therapeutic approach should be ensured in patients with T2D.

Halo effect of a Mediterranean-lifestyle weight-loss intervention on untreated family members' weight and physical activity: a prospective study.

OBJECTIVES: Obesity is subject to strong family clustering. The relatives of participants in weight-loss interventions may also modify their lifestyle and lose weight. The aim of this study was to examine the presence and magnitude of a halo effect in untreated family members of participants enrolled in a randomized, multi-component, lifestyle intervention. METHODS: A total of 148 untreated adult family members of participants in an intensive weight-loss lifestyle intervention (the PREDIMED-Plus study) were included. Changes at 1 and 2 years in body weight, physical activity, and adherence to a traditional Mediterranean diet (MedDiet) were measured. Generalized linear mixed models were used to assess whether the change differed between family members of the intervention group compared to the control. RESULTS: Untreated family members from the intervention group displayed a greater weight loss than those from the control after 1 and 2 years: adjusted 2-year weight change difference between groups was -3.98 (SE 1.10) kg (p < 0.001). There was a halo effect with regard to adherence to the MedDiet at one year which was sustained at two years: 2-year adjusted difference in MedDiet score change +3.25 (SE 0.46) (p < 0.001). In contrast, no halo effect was observed with regard to physical activity, as the untreated family members did not substantially modify their physical activity levels in either group, and the adjusted difference at two years between the 2 groups was -272 (SE 624) METs.min/week (p = 0.665). CONCLUSIONS: In the first prospective study to assess the influence on untreated family members of a diet and physical activity weight-loss intervention, we found evidence of a halo effect in relatives on weight loss and improvement in adherence to a MedDiet, but not on physical activity. The expansion of MedDiet changes from individuals involved in a weight-loss intervention to their family members can be a facilitator for obesity prevention.

Polypharmacy is a risk factor for hospital admission due to a fall: evidence from the English Longitudinal Study of Ageing.

BACKGROUND: Falls amongst older people are common; however, around 40% of falls could be preventable. Medications are known to increase the risk of falls in older adults. The debate about reducing the number of prescribed medications remains controversial, and more evidence is needed to understand the relationship between polypharmacy and fall-related hospital admissions. We examined the effect of polypharmacy on hospitalization due to a fall, using a large nationally representative sample of older adults. METHODS: Data from the English Longitudinal Study of Ageing (ELSA) were used. We included 6220 participants aged 50+ with valid data collected between 2012 and 2018.The main outcome measure was hospital admission due to a fall. Polypharmacy -the number of long-term prescription drugs- was the main exposure coded as: no medications, 1-4 medications, 5-9 medications (polypharmacy) and 10+ medications (heightened polypharmacy). Competing-risk regression analysis was used (with death as a potential competing risk), adjusted for common confounders, including multi-morbidity and fall risk-increasing drugs. RESULTS: The prevalence of people admitted to hospital due to a fall increased according to the number of medications taken, from 1.5% of falls for people reporting no medications, to 4.7% of falls among those taking 1-4 medications, 7.9% of falls among those with polypharmacy and 14.8% among those reporting heightened polypharmacy. Fully adjusted SHRs for hospitalization due to a fall among people who reported taking 1-4 medications, polypharmacy and heightened polypharmacy were 1.79 (1.18; 2.71), 1.75 (1.04; 2.95), and 3.19 (1.61; 6.32) respectively, compared with people who were not taking medications. CONCLUSIONS: The risk of hospitalization due to a fall increased with polypharmacy. It is suggested that prescriptions in older people should be revised on a regular basis, and that the number of medications prescribed be kept to a minimum, in order to reduce the risk of fall-related hospital admissions.

Meal patterns across ten European countries - results from the European Prospective Investigation into Cancer and Nutrition (EPIC) calibration study.

OBJECTIVE: To characterize meal patterns across ten European countries participating in the European Prospective Investigation into Cancer and Nutrition (EPIC) calibration study. DESIGN: Cross-sectional study utilizing dietary data collected through a standardized 24 h diet recall during 1995-2000. Eleven predefined intake occasions across a 24 h period were assessed during the interview. In the present descriptive report, meal patterns were analysed in terms of daily number of intake occasions, the proportion reporting each intake occasion and the energy contributions from each intake occasion. SETTING: Twenty-seven centres across ten European countries. SUBJECTS: Women (64 %) and men (36 %) aged 35-74 years (n 36 020). RESULTS: Pronounced differences in meal patterns emerged both across centres within the same country and across different countries, with a trend for fewer intake occasions per day in Mediterranean countries compared with central and northern Europe. Differences were also found for daily energy intake provided by lunch, with 38-43 % for women and 41-45 % for men within Mediterranean countries compared with 16-27 % for women and 20-26 % for men in central and northern European countries. Likewise, a south-north gradient was found for daily energy intake from snacks, with 13-20 % (women) and 10-17 % (men) in Mediterranean countries compared with 24-34 % (women) and 23-35 % (men) in central/northern Europe. CONCLUSIONS: We found distinct differences in meal patterns with marked diversity for intake frequency and lunch and snack consumption between Mediterranean and central/northern European countries. Monitoring of meal patterns across various cultures and populations could provide critical context to the research efforts to characterize relationships between dietary intake and health.

Adherence to Mediterranean diet reduces the risk of metabolic syndrome: a 6-year prospective study.

BACKGROUND AND AIMS: Benefits of Mediterranean diet on MetS risk have been suggested, but overall prospective evidence in the general population is limited. For the first time, the prospective association of adherence to Mediterranean diet with the 6-y risk of MetS and its components was evaluated in a large cohort in Europe. METHODS AND RESULTS: Subjects included were participants from the Supplémentation en Vitamines et Minéraux AntioXydants (SU.VI.MAX) study. Adherence to Mediterranean diet was assessed using traditional Mediterranean diet score (MDS), an updated Mediterranean score (MED) and Mediterranean style-dietary pattern score (MSDPS) calculated from at least three 24-h records. In 3232 subjects, the association between Mediterranean diet scores and 6-y risk of MetS was evaluated. The association between Mediterranean scores and MetS components was also estimated. A lower risk of MetS was observed with increasing MED score (P-trend = 0.001) and MDS (P-trend = 0.03) in multivariate models. The adjusted odds ratios (95% Confidence Interval) for MetS risk were 0.47 (0.32-0.69) and 0.50 (0.32-0.77) in subjects in the highest versus lowest tertile of MED score and MDS, respectively. The MED score was inversely associated with waist circumference, systolic blood pressure and triglycerides, and directly associated with HDL-cholesterol. The MDS was negatively associated with waist circumference and triglycerides, and MSDPS was positively associated with HDL-cholesterol. CONCLUSIONS: All Mediterranean diet scores were associated in a potentially beneficial direction with components of MetS or MetS incidence. Our findings support that individuals should be encouraged to follow a Mediterranean dietary pattern for reduction of MetS risk.

Association between dietary scores and 13-year weight change and obesity risk in a French prospective cohort.

BACKGROUND/OBJECTIVES: The relationship between diet quality and development of obesity is complex and unresolved. The aim of this study was to assess and compare the predictive value of six different dietary scores on both relative weight change and the risk of obesity after 13 years of follow-up in adults aged 45 years and older. SUBJECTS/METHODS: Six scores reflecting adherence to different nutritional recommendations (the French Programme National Nutrition Santé-Guideline Score (PNNS-GS), the Dietary Guidelines for Americans Index (DGAI), the Diet Quality Index-International (DQI-I), the Mediterranean Diet Scale (MDS), the relative Mediterranean Diet Score (rMED) and the Mediterranean Style Dietary Pattern Score (MSDPS)) were estimated in 3151 participants in the French SU.VI.MAX (SUpplémentation en VItamines et Minéraux AntioXydants) study. Associations of dietary scores with 13-year weight change were assessed through multivariate linear regression models, and obesity risk was analyzed with logistic regression, providing odds ratios (OR) and 95% confidence intervals (CI). RESULTS: Except for the MSDPS, higher scores, that is, better adherence to nutritional guidelines or to a Mediterranean diet, were associated with lower weight gain in men (all P-value for trend <0.05). In addition, among men, ORs for becoming obese after 13 years associated with a 1 s.d. increase in dietary scores ranged from 0.63, 95% CI: 0.51, 0.78 for DGAI to 0.72, 95% CI: 0.59, 0.88 for MDS. These associations were weaker or not statistically significant in women. CONCLUSION: Overall, the six dietary scores predicted obesity risk equally well. Among French adults, strong adherence to dietary guidelines appears to be protective with regard to weight gain and obesity, especially in men.

Protein intake, calcium balance and health consequences.

High-protein (HP) diets exert a hypercalciuric effect at constant levels of calcium intake, even though the effect may depend on the nature of the dietary protein. Lower urinary pH is also consistently observed for subjects consuming HP diets. The combination of these two effects was suspected to be associated with a dietary environment favorable for demineralization of the skeleton. However, increased calcium excretion due to HP diet does not seem to be linked to impaired calcium balance. In contrast, some data indicate that HP intakes induce an increase of intestinal calcium absorption. Moreover, no clinical data support the hypothesis of a detrimental effect of HP diet on bone health, except in a context of inadequate calcium supply. In addition, HP intake promotes bone growth and retards bone loss and low-protein diet is associated with higher risk of hip fractures. The increase of acid and calcium excretion due to HP diet is also accused of constituting a favorable environment for kidney stones and renal diseases. However, in healthy subjects, no damaging effect of HP diets on kidney has been found in either observational or interventional studies and it seems that HP diets might be deleterious only in patients with preexisting metabolic renal dysfunction. Thus, HP diet does not seem to lead to calcium bone loss, and the role of protein seems to be complex and probably dependent on other dietary factors and the presence of other nutrients in the diet.

Estimating food intakes in Australia: validation of the Commonwealth Scientific and Industrial Research Organisation (CSIRO) food frequency questionnaire against weighed dietary intakes.

BACKGROUND: There is a dearth of knowledge about the foods that Australian adults eat and a need for a flexible, easy-to-use tool that can estimate usual dietary intakes. The present study was to validate a commonly used Australian Commonwealth Scientific and Industrial Research Organisation (CSIRO) food-frequency questionnaire (C-FFQ) against two 4-day weighed food records (WFR), as the reference method. METHODS: The C-FFQ, as the test item, was administrated before the WFR. Two 4-day WFR were administrated 4 weeks apart. Under-reporting was established using specific cut-off limits and estimated basal metabolic rate. Seventy-four women, aged 31-60 years, were enrolled from a free-living community setting. RESULTS: After exclusion for under-reporting, the final sample comprised 62 individuals. Correlations between protein intake from the WFR and urinary urea were significant. Overall agreement between FFQ and WFR was shown by 'levels of agreement' (LOA) and least products regressions. There was presence of fixed and proportional bias for almost half the nutrients, including energy, protein, fat and carbohydrates. For most of the nutrients that did not present bias, the LOA were 50-200%. Agreement was demonstrated for percentage dietary energy protein and fat; carbohydrate; and absolute amounts of thiamine, riboflavin, magnesium and iron. However, relative intake agreement was fair to moderate, with approximately 70% of (selected) nutrients exact or within +/-1 quintile difference. CONCLUSION: The C-FFQ is reasonable at measuring percentage energy from macronutrients and some micronutrients, and comprises a valuable tool for ranking intakes by quintiles; however, it is poor at measuring many absolute nutrient intakes relative to WFR.

[Translational research and Cancer Plan]. / Recherche translationnelle et plan Cancer.

The French Cancer Plan 2003-2007 has made translational research central to its research programme, to ensure the care-research continuum and the quickest application possible for the most recent discoveries, for the patients' benefit. This is a new field of research, still little-known or ill-understood. A working group, composed of physicians and researchers from academic research and industrial research, sought to define translational research in cancerology and define the issues at stake in it. Translational research needs to develop in close connection with the patients in order to enable a bi-directional flow of knowledge from cognitive research toward medical applications and from observations made on patients toward cognitive research. Placed under the aegis of the French National Cancer Institute and Leem Research, the group has put forth a strategy for implementing translational research in cancerology in France to make it attractive, competitive and efficient and to foster the development of public-private partnerships.

[Methodology and long-term follow-up of drug induced side effects in children (cancer, leukemia, AIDS, growth hormone)]. / Méthodologie et pratique du suivi à long terme des effets indésirables des médicaments chez l'enfant (cancers, leucémies, SIDA, hormones de croissance).

Long-term follow up for medicines used in children is necessary in some therapeutic areas. Long-term effects (e.g. in cancer) may be detected many years after the treatment period. Growth, development and maturation specific to children can make these effects particularly harmful. The development plan of a paediatric drug should include, long term follow up on the basis of pharmacological-toxicological and safety data. These aspects should be taken into account when modifying the protocol (lower dosage, withdrawal of some associations etc). The follow up period may be very long, as in cancer (e.g. second tumour after treatment for cancer). A cohort is the best choice for this follow up, but other alternatives may be useful, including a specific follow-up Unit. Long-term follow-up is nevertheless difficult and expensive, manpower-dependent and the risk of failure is great especially in the teenage years.

[Drug effects in elderly subjects: from the pharmacologic target to the risk-benefit. Round Table #5 of the 16th National Clinical Pharmacology Workshop]. / Les effets des médicaments chez les sujets âgés: de la cible pharmacologique au bénéfice/risque.

In addition to being a fast-growing subpopulation, the elderly also receive large quantities of medication and are particularly exposed to iatrogenic effects. In France, 8.6 per cent of hospitalizations of patients over the age of 70 are due to an adverse event. This workshop comprising pharmaceutical companies, pharmacologists, geriatricians and health authorities aimed to make propositions for improving drug research in the elderly in order to prevent iatrogenic drug reactions by encouraging more rigorous application of existing guidelines. In addition to information extrapolated from clinical trials conducted on young or healthy people, it is imperative to include in clinical trials a sufficient number of elderly patients and to take into consideration specific criteria such as multiple medication regimens, concomitant diseases, cognitive impairment and motor disturbances. The assessment of drugs used in the elderly must be based on a specific and validated geriatrics scale and in some cases (postmarketing studies) may be based on specific trials (those called 'conducted in the real world').

[How to improve drug development and utilization in pediatrics]. / Comment mieux développer et utiliser les médicaments en pédiatrie?

Insufficient drug evaluation in children and the lack of adapted pharmaceutical formulations explain the importance of unlicensed and off-label prescriptions. As a consequence a regulation proposed in the USA by the Food and Drug Administration, requiring manufactures to assess the safety and effectiveness of new drugs in paediatric patients, has recently been adopted. Appropriate means to facilitate drug evaluation in children are now necessary in terms of recruitment and methodology. A ten-centre American Pediatric Pharmacology Research Unit network has been created and is being financed by the National Institute of Health. A similar trend is evolving in Europe. Appropriate drug utilization in children requires adequate formulations, administration devices and information as well as improved knowledge on the long-term potential consequences of drug use during growth and maturation.

Safety profile of 3 months' therapy with alfuzosin in 13,389 patients suffering from benign prostatic hypertrophy.

The safety profile of alfuzosin, a selective alpha 1-adrenergic antagonist, was assessed in a total of 13,389 patients (mean age 66.9 +/- 8.5 years) with symptomatic benign prostatic hypertrophy in two open, noncontrolled, multicentre, post-marketing surveillance studies, both conducted in France. Alfuzosin was prescribed at the recommended dose of 2.5 mg t.i.d., according to the current labelling recommendations, for a 3-month period. Clinical safety was assessed using spontaneous reporting of adverse events leading to discontinuation of treatment. Overall, 89.7% of the patients completed the treatment period. Drop outs were recorded in 10.3% of patients: 3.7% for intolerance; 1.5% for resolution of urinary symptoms; 2.1% for lack of efficacy, and 3.0% for loss to follow-up, noncompliance, and miscellaneous reasons. Two thirds of the adverse events leading to discontinuation were vasodilatory and occurred in 2.7% of the patients: vertigo/dizziness (1.4%); malaise (0.6%); hypotension (0.4%), and headache (0.4%). Other adverse events (predominantly gastrointestinal disorders) were recorded in < 1.2% of the patients. Three quarters of the adverse events occurred during the first week of therapy. As expected, adverse events were more frequent in the elderly (aged over 75 years) and in patients taking cardiovascular drugs or with concomitant cardiovascular disease. Overall, alfuzosin was very well tolerated and the adverse event profile was consistent with the cumulative experience of the drug. No unexpected or serious adverse events considered to be related to alfuzosin were recorded. Particular care must be taken when prescribing for very elderly patients and/or those with concomitant cardiovascular disease for which they are receiving therapy.

Stereoselective disposition of ibuprofen enantiomers in infants.

The pharmacokinetics of the enantiomers of ibuprofen were investigated after oral administration of a single 7.6 +/- 0.3 mg kg-1 dose of the racemate in 11 infants. Mean (+/- s.d.) half-lives were 1.6 +/- 0.5 h for S(+) and 1.5 +/- 0.5 h for R(-) and mean (+/- s.d.) AUC values were 31.5 +/- 14.3 mg l-1 h for S(+) and 36.6 +/- 13.8 mg l-1 h for R(-). Since plasma concentrations of the active S(+)-isomer were lower than those reported in adults, a higher dosage might be required in infants.

Chemonucleolysis versus surgical discectomy for sciatica secondary to lumbar disc herniation. A cost and quality-of-life evaluation.

The objective of this study was to evaluate and compare the cost and effects on quality of life [using quality-adjusted life years (QALYs)] of 2 treatments for sciatica secondary to lumbar disc herniation: chemonucleolysis and surgical discectomy. The design involved a combination of decision analysis and Rosser index, with assessment of probabilities from long term clinical series. Utility was based on patients' subjective assessment using a simplified self-administered Health Measurement Questionnaire (HMQ). 146 patients from 7 hospitals were enrolled, 2 to 3 months after chemonucleolysis or surgery. The end-points used were cost and QALYs for each intervention, every year for years 1 to 7. At the time of analysis (1990), the total cost of surgical discectomy was FF15,400, compared with FF8000 for chemonucleolysis. After 1 year, and including the costs of reoperation for failure and relapse and long term medical costs for the non-reoperated unsatisfactory results, discectomy costs were almost 40% higher than those of chemonucleolysis. Ratios remain unchanged after 7 years. QALY results reveal an additional benefit of 52 days of good health associated with chemonucleolysis.

Comparative efficacy and tolerance of ibuprofen syrup and acetaminophen syrup in children with pyrexia associated with infectious diseases and treated with antibiotics.

A double-blind, randomised, parallel group study has been done comparing the efficacy and tolerability of 7.5 mg/kg ibuprofen syrup (n = 77) and 10 mg.kg-1 acetaminophen syrup (n = 77) in 154 children (6 months to 5 years) with fever (> or = 38 degrees C) associated with infectious diseases and treated with antibiotic therapy. The area under the percentage reduction in temperature curve captured the net effect of each drug and provided the best estimate for comparison of efficacy during a defined period. Temperature evolution over time was not significantly different between the two groups. Nevertheless, the temperature reduction over the first 4 h of treatment (H0-H4) was significantly higher after ibuprofen (60%) than acetaminophen (45%). Both ibuprofen and acetaminophen were well tolerated. In conclusion, significant antipyretic activity, good tolerability and its availability as a syrup make ibuprofen an effective means of fever control in children.

[Early treatment of labiopalatine clefts. Their management and anesthetic problems]. / Traitement précoce des fentes labio-palatines. Gestion et problèmes anesthésiques.

The authors review a new therapeutic chronology for cleft lip and palate developed by R. Malek and J. Psaume. This involves very early treatment requiring orthopaedic or surgical procedures in small infants aged one to three months. These have been made possible by progress in techniques and equipment from both a surgical and orthopaedic standpoint as well as in anaesthesia. They describe the organisation of anaesthesia and analyse their results, showing that this is a simple anaesthetic, free of risk. The postoperative course is simple. The child is fed normally and is discharged on the 2nd or 3rd postoperative day.

[Facial lupus vulgaris caused by BCG]. / Lupus vulgaire de la face à B.C.G.

The authors report on an exceptional complication of BCG vaccination: a case of facial lupus vulgaris, which appeared one year after vaccination in a girl with normal cellular and humoral immunity.