Effect of neuromuscular electrical stimulation on exercise capacity in patients with severe chronic obstructive pulmonary disease: A randomised controlled trial.

OBJECTIVE: To compare strengthening by neuromuscular electrical stimulation versus cycle ergometer training during a pulmonary rehabilitation program, in patients with severe to very severe chronic obstructive pulmonary disease. DESIGN: A prospective randomized controlled study. SETTING: Two inpatient pulmonary rehabilitation centers. SUBJECTS: Patients with severe to very severe chronic obstructive pulmonary disease and multidimensional index to predict risk of death ≥5, were randomly assigned to receive neuromuscular electrical stimulation or cycle ergometer training during pulmonary rehabilitation. MAIN MEASURES: The primary endpoint was the change in exercise capacity using 1-min sit-to-stand test Secondary endpoints were the changes in exercise capacity using 6-min walk test, quadriceps strength, quality of life and dyspnea. RESULTS: 102 patients were included. After 3 weeks, 47 patients in the neuromuscular electrical stimulation group, and 45 in the cycle ergometer training group were able to be analyzed. No significant difference was seen in the evolution of exercise capacity using 1-min sit-to-stand test (3.3 ± 3.8 and 2.6 ± 4.1) and 6-min walk test (37.8 ± 58.4 and 33.1 ± 46.7), in the evolution of quadriceps strength and endurance (9.2 ± 12.9 and 6.6 ± 16.1; 9.0 ± 13.2 and 6.2 ± 17.0), in the evolution of quality of life (St George's Respiratory Questionnaire: -11.3 ± 11.7 and -8.1 ± 11.6; COPD Assessment Test: -5.7 ± 7.1 and -4.7 ± 7.0), or in the evolution of dyspnea using Dyspnea 12 (-5.5 ± 10.2 and -5.9 ± 8.5) except using modified medical research council scale (95% confidence interval: 0.48 [0.05; 0.91], p = 0.027). CONCLUSION: We found no significant difference between the two programs on exercise capacity, quadriceps strength and quality of life.

Efficacy and Tolerability of Phototherapy With Light-Emitting Diodes for Sensitive Skin: A Pilot Study.

Sensitive skin (SS) syndrome is defined by the occurrence of unpleasant sensations in response to stimuli that should normally not induce such sensations. It affects ~50% of women and 40% of men and can impact the quality of life. There is no consensus on therapeutic management. Phototherapy by light-emitting diodes (LEDs) is increasingly being used in dermatology for various inflammatory skin disorders with significant reduction in SS-10 and good tolerability. A Korean study suggested its efficacy in alleviating SS symptoms associated with other facial diseases. Our objective is to obtain preliminary data on the efficacy of phototherapy with LEDs for alleviating SS symptoms and increasing tolerance in subjects with SS that is not associated with other facial skin disorders. This monocentric pilot study included 30 subjects with SS who had a Sensitive Scale-10 score ≥40. The treatment consisted of red LED light exposure twice a week until significant reduction in SS-10 with a maximal treatment length of 8 weeks. The primary outcome was defined by a 60% decrease in the SS-10 score compared to the baseline. Results: Thirty subjects were included; 83% were women, and the mean age was 28.9 years. Two participants were considered lost to follow-up. The cheeks (90%) and the nose (70%) were the most frequently involved parts of the face. Cold, heat, temperature variation, water and sun were the most frequent triggering factors. Twenty-eight subjects (93.3%, 95% CI 77.9 to 99.2%) achieved the primary outcome. Significant reduction in SS-10 was achieved in 77% of subjects in six sessions or fewer. The mean (SD) SS-10 scores were 54.7 (12.1) at inclusion, 14.4 (6.0) at the last session and 13.9 (7.5) 2 months after the last session, suggesting that the benefits persist for a few weeks. Two side effects were reported: both were allergic reactions to the nickel contained in the protective goggles. This pilot study had a small sample size and no control group. LEDs were effective in treating SS in all 28 subjects who completed the study in accordance with the protocol, and the benefits persisted for 2 months after the last LED therapy session.

Trends in sodium valproate prescriptions among children aged 0 to 14 years between 2010 and 2016: A study based on the French National Health Insurance Database.

PURPOSE: After a huge campaign of information on the teratogenic risk of sodium valproate (VPA) having taken place in France we aimed to evaluate the trend of its prescriptions in young epileptic girls. METHOD: Using the French National Health Insurance Database we searched for patients aged 0-14 years being supplied an antiepileptic drug (AED) between 2010 and 2016. RESULTS: 113,362 children received at least one AED, 61,259 boys and 52,103 girls. Compared to 2010-2014 years, VPA was less prescribed in 2016 as first AED (29% vs 37.3% respectively). The difference between the two periods was greater for girls (-41%) than for boys (-12%). CONCLUSION: The changing trend of VPA as first AED prescribed, particularly in girls, reflects published evidence in terms of safety.

Risk of suicide attempt associated with isotretinoin: a nationwide cohort and nested case-time-control study.

BACKGROUND: Isotretinoin is the only effective treatment for severe acne. An isotretinoin-related suicide risk is still debated and under scrutiny by regulatory agencies. Our objectives were: to assess the risk of suicide attempt before, during and after isotretinoin treatment; to detect any potential triggering effect of isotretinoin initiation on suicide attempt. METHODS: We implemented a cohort and nested case-time-control study of subjects treated with oral isotretinoin (course or initiation) aged 10-50 years, using the Nationwide French Health Insurance data (2009-2016). The main outcome was hospitalized suicide attempt. Standardized incidence ratios for hospitalized suicide attempts were calculated before, during and after isotretinoin treatment. The number of isotretinoin initiations was compared in risk and control periods of 2 months using a case-time-control analysis. RESULTS: In all, 443 814 patients (median age 20.0 years; interquartile range 17.0-27.0 years) were exposed to isotretinoin, amounting to 244 154 person-years, with a marked seasonality for treatment initiation. Compared with the French general population, the occurrence of suicide attempts under isotretinoin treatment was markedly lower, with a standardized incidence ratio of 0.6 [95% confidence interval (CI) = 0.53-0.67]; the same applied, to a lesser extent, before and after isotretinoin treatment. In the case-time-control analysis, among cases of suicide attempt, 108 and 127 isotretinoin initiations were observed in the risk and control periods respectively (i.e. 0-2 months and 2-4 months before the date of suicide attempt). The comparison with the 1199 and 1253 initiations observed among matched controls in the same two periods yielded a case-time-control odds ratio of 0.89 (95% CI = 0.68-1.16). A sensitivity analysis using three-month periods and a complementary analysis adding completed suicides for case definition showed consistent results. CONCLUSION: Compared with the general population, a lower risk of suicide attempt was observed among patients exposed to isotretinoin and there was no evidence for a triggering effect of isotretinoin initiation on suicide attempt. A selection of patients at lower risk for suicidal behaviour and appropriate treatment management could explain these findings. Risk management plans should therefore be maintained.

Use of 5α-reductase inhibitors for benign prostate hypertrophy and risk of high grade prostate cancer: a French population-based study.

OBJECTIVE: To assess the association between 5α-reductase inhibitor (5-ARI) use and high grade (Gleason score 8-10) prostate cancer. PATIENTS AND METHODS: We conducted a population-based nested matched case-control study using the French national health insurance database linked to data from all pathology laboratories in Brittany, France. Among 74 596 patients with ≥1 drug reimbursement for symptomatic benign prostate hypertrophy (BPH) between 1 January 2010 and 31 December 2011, 767 incident prostate cancer cases between 1 January 2012 and 31 December 2013 were matched according to age and delay between the first observed delivery of drug for BPH (5-ARIs, α-blockers or phytotherapy) and diagnostic date of the case to five control patients, using an incidence density sampling design. RESULTS: A total of 963 patients (153 cases, 810 controls) had been exposed to 5-ARIs. A significant heterogeneity (P = 0.005) was detected across cancer grades when estimating the association between prostate cancer and long-term (≥2 years) 5-ARI use vs no 5-ARI exposure: adjusted conditional odds ratio 1.76 (95% confidence interval [CI] 0.97-3.21) for Gleason score ≥8 and 0.64 (95% CI 0.44-0.93) for Gleason score < 8. CONCLUSION: Our results indicate an increased risk of high grade and a decreased risk of low grade prostate cancer associated with 5-ARI use. Patients treated for >2 years with 5-ARIs should be informed about the increased risk of development of high grade disease.

Rationale and design of the CANARI study: a case-control study investigating the association between prostate cancer and 5-alpha-reductase inhibitors for symptomatic benign prostate hypertrophy by linking SNIIRAM and pathology laboratories in a specific region in France.

Benign prostate hypertrophy (BPH) could be associated with low urinary symptoms requiring medical treatment: 5-alpha-reductase inhibitors (5-ARI) or ɑ-blockers. Two clinical trials investigating 5-ARI use in prostate cancer (PCa) primary prevention highlighted a potential safety signal with an increased risk of high-grade PCa. Later observational studies failed to show similar results but have some limits. This paper focuses on describing the protocol of the CANARI study and its feasibility, as regards the matching process of two pseudo-anonymous databases. The study concerned patients living in the Brittany region (France) between 2010 and 2013. We designed a case-control study nested within a cohort of men treated by medical drugs licensed for symptomatic BPH between 2010 and 2011. Cases were patients with incident PCa diagnosed between 2012 and 2013 identified through French Health database (SNIIRAM). Gleason score was searched through Brittany pathology laboratories. Controls were patients without PCa diagnosis. Local pathology laboratories database was constituted in Brittany, gathering Gleason scores. No unique identification number is available in France; linkage of SNIIRAM and Brittany pathology laboratories database was made by deterministic matching. We matched 859 cases to Gleason grading (119 had Gleason score ≥8 and 740 had Gleason <8); around 22% of cases received 5-ARI and 78% α-blockers or phytotherapy. The CANARI study investigated in a population of men treated for BPH the risk of PCa with 5-ARI, according to Gleason grade thanks to SNIIRAM database enriched by local pathological results.