Trial of Lixisenatide in Early Parkinson's Disease.

BACKGROUND: Lixisenatide, a glucagon-like peptide-1 receptor agonist used for the treatment of diabetes, has shown neuroprotective properties in a mouse model of Parkinson's disease. METHODS: In this phase 2, double-blind, randomized, placebo-controlled trial, we assessed the effect of lixisenatide on the progression of motor disability in persons with Parkinson's disease. Participants in whom Parkinson's disease was diagnosed less than 3 years earlier, who were receiving a stable dose of medications to treat symptoms, and who did not have motor complications were randomly assigned in a 1:1 ratio to daily subcutaneous lixisenatide or placebo for 12 months, followed by a 2-month washout period. The primary end point was the change from baseline in scores on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (range, 0 to 132, with higher scores indicating greater motor disability), which was assessed in patients in the on-medication state at 12 months. Secondary end points included other MDS-UPDRS subscores at 6, 12, and 14 months and doses of levodopa equivalent. RESULTS: A total of 156 persons were enrolled, with 78 assigned to each group. MDS-UPDRS part III scores at baseline were approximately 15 in both groups. At 12 months, scores on the MDS-UPDRS part III had changed by -0.04 points (indicating improvement) in the lixisenatide group and 3.04 points (indicating worsening disability) in the placebo group (difference, 3.08; 95% confidence interval, 0.86 to 5.30; P = 0.007). At 14 months, after a 2-month washout period, the mean MDS-UPDRS motor scores in the off-medication state were 17.7 (95% CI, 15.7 to 19.7) with lixisenatide and 20.6 (95% CI, 18.5 to 22.8) with placebo. Other results relative to the secondary end points did not differ substantially between the groups. Nausea occurred in 46% of participants receiving lixisenatide, and vomiting occurred in 13%. CONCLUSIONS: In participants with early Parkinson's disease, lixisenatide therapy resulted in less progression of motor disability than placebo at 12 months in a phase 2 trial but was associated with gastrointestinal side effects. Longer and larger trials are needed to determine the effects and safety of lixisenatide in persons with Parkinson's disease. (Funded by the French Ministry of Health and others; LIXIPARK ClinicalTrials.gov number, NCT03439943.).

A Pluridisciplinary Tracheostomy Weaning Protocol for Brain-Injured Patients, Outside of the Intensive Care Unit and Without Instrumental Assessment: Results of Pilot Study.

Concurrently to the recent development of percutaneous tracheostomy techniques in the intensive care unit (ICU), the amount of tracheostomized brain-injured patients has increased. Despites its advantages, tracheostomy may represent an obstacle to their orientation towards conventional hospitalization or rehabilitation services. To date, there is no recommendation for tracheostomy weaning outside of the ICU. We created a pluridisciplinary tracheostomy weaning protocol relying on standardized criteria but adapted to each patient's characteristics and that does not require instrumental assessment. It was tested in a prospective, single-centre, non-randomized cohort study. Inclusion criteria were age > 18 years, hospitalized for an acquired brain injury (ABI), tracheostomized during an ICU stay, and weaned from mechanical ventilation. The exclusion criterion was severe malnutrition. Decannulation failure was defined as recannulation within 96 h after decannulation. Thirty tracheostomized ABI patients from our neurosurgery department were successively and exhaustively included after ICU discharge. Twenty-six patients were decannulated (decannulation rate, 90%). None of them were recannulated (success rate, 100%). Two patients never reached the decannulation stage. Two patients died during the procedure. Mean tracheostomy weaning duration (inclusion to decannulation) was 7.6 (standard deviation [SD]: 4.6) days and mean total tracheostomy time (insertion to decannulation) was 42.5 (SD: 24.8) days. Our results demonstrate that our protocol might be able to determine without instrumental assessment which patient can be successfully decannulated. Therefore, it may be used safely outside ICU or a specialized unit. Moreover, our tracheostomy weaning duration is very short as compared to the current literature.

Heparin consumption and inflammatory response according to the coating of cardiopulmonary bypass circuits in cardiac surgery: A retrospective analysis.

INTRODUCTION: There are several types of surface treatments (coatings) aimed at improving the biocompatibility of cardiopulmonary bypass (CPB) circuit. Some coatings appear to require higher doses of heparin to maintain anticoagulation goals, and some of them might induce postoperative coagulopathy. In this study, we compared the amount of heparin required, postoperative bleeding, and inflammatory response according to three types of coatings. METHOD: We retrospectively included 300 consecutive adult patients who underwent cardiac surgery with CPB and received one of three coatings (Phisio®, Trillium®, and Xcoating™). Our primary objective was to compare, according to coating, the amount of heparin required to maintain an ACT > 400s during CPB. Our secondary objectives were to compare postoperative bleeding for 48 h and CRP rate. RESULTS: Baseline characteristics were comparable between groups except for age and preoperative CRP. We did not find a significant difference between the 3 coatings regarding the amount of heparin reinjected. However, we found less postoperative bleeding with the Xcoating™ circuit compared to the Phisio® circuit (-149 mL [-289; -26.5]; p = 0.02) and a lower elevation of CRP with the Phisio® circuit (2.8 times higher than preoperative CRP) compared to Trillium® (4.9 times higher) and Xcoating™ (6.4 times higher); p < 10-3. CONCLUSION: The choice of coating did not influence the amount of heparin required during CPB; however, the post-CPB inflammatory syndrome may be impacted by this choice.

Evolution of body composition following successful kidney transplantation is strongly influenced by physical activity: results of the CORPOS study.

BACKGROUND: Weight gain (mainly gain of fat mass) occurs quickly after successful kidney transplantation and is associated with metabolic complications (alterations of glycaemic control, hyperlipidaemia). Determinants of weight gain are multifactorial and are mainly related to the transplant procedure itself (glucocorticoid use, increased appetite). In the modern era of transplantation, one challenge is to limit these metabolic alterations by promoting gain of muscle mass rather than fat mass. This prospective study was performed to assess determinants of fat mass, fat-free mass and body cell mass changes after kidney transplantation with a focus on physical activity and nutritional behaviour before and after transplantation. METHODS: Patients were included at the time of listing for deceased donor kidney transplantation. Body composition was determined using dual X-ray absorptiometry and bioimpedance spectroscopy to assess fat mass, fat-free mass and body cell mass (= fat-free mass - extracellular water) at the time of inclusion, 12 months later, and 1, 6, 12 and 24 months after transplantation. Recall dietary data and physical activity level were also collected. RESULTS: Eighty patients were included between 2007 and 2010. Sixty-five had a complete 24-month follow-up after kidney transplantation. Fat mass, fat-free mass and body cell mass decreased during the waiting period and early after kidney transplantation. The nadirs of body cell mass and fat-free mass occurred at 1 month and the nadir for fat mass occurred at 6 months. Maximum levels of all parameters of body composition were seen at 12 months, after which body cell mass and fat-free mass decreased, while fat mass remained stable. In multivariate analysis, male recipients, higher physical activity level and lower corticosteroid dose were significantly associated with better body cell mass recovery after kidney transplantation. CONCLUSIONS: Lifestyle factors, such as physical activity level, together with low dose of corticosteroids seem to influence body composition evolution following kidney transplantation with recovery of body cell mass. Specific strategies to promote physical activity in kidney transplant recipients should be provided before and after kidney transplantation.

Randomized study of antiseptic application technique in healthy volunteers before vascular access insertion (TApAS trial).

BACKGROUND: In France about 32% of hospitalized patients have a vascular access placement. However, a common complication associated with these is catheter-related bloodstream infection (CRBI) due to the introduction of microorganisms from the skin during catheter insertion. There is no consensus on the best way to clean the skin prior to catheter insertion, which could be a key element of CRBI prevention. The two techniques most commonly used to apply antiseptic to the skin are the concentric circle and back-and-forth techniques, but these have not been compared in clinical trials. Hence, this study conducted this comparison. METHODS: This single-center, non-comparative, randomized, matched pilot study investigated the levels of cutaneous microorganisms before and after antiseptic application using both techniques in a population of healthy French volunteers. The two application methods were used on each participant's arms at the elbow fold, with randomization for the application side (right or left). Quantification of cutaneous microorganisms was performed in a blinded manner with regard to the technique used. FINDINGS: From April 8 to July 17, 2019, 132 healthy volunteers participated in the study. For the whole study population, the mean initial colonization level was 2.68 log10 colony forming units (CFU)/mL (SD 0.82) before the back-and-forth technique, and 2.66 log10 CFU/mL (SD 0.85) before the concentric circle technique. The mean differences in number of microorganisms between the initial sample and the final sample were 2.45 log10 CFU/mL (95% CI: 2.29 to 2.61) for the back-and-forth technique and 2.43 log10 CFU/mL (95% CI: 2.27 to 2.59) for the concentric circle technique. The mean difference in reduction in microorganisms between the back-and-forth technique and the concentric circle technique was 0.02 log10 CFU/mL (95% CI: -0.11 to 0.15). INTERPRETATION: There was no clinically difference in reduction of microorganisms between the concentric circle and back-and-forth techniques at the bend of the healthy volunteer's elbow, after the 30 s of drying of the antiseptic. These findings have a significant impact on time required to achieve antiseptic application before catheter insertion because there is yet no argument to justify application for 30 s, because a single concentric circle pass was much faster with similar results. Future studies should investigate the impact of skin application technique on the prevention of infectious risk associated with catheter insertion on admission to health care facilities (conventional, outpatient, or emergency) and throughout the period of stay in a health care facility.

Nasal high-frequency percussive ventilation vs nasal continuous positive airway pressure in newborn infants respiratory distress: A cross over clinical trial.

OBJECTIVE: To determine if nasal high-frequency percussive ventilation (nHFPV) to manage neonatal respiratory distress decreases the regional cerebral oxygen saturation (rScO2 ) compared to nasal continous positive airway pressure (nCPAP). STUDY DESIGN: A prospective, randomized, monocentric, open-label, noninferiority crossover trial. Newborns of gestational age (GA) ≥ 33 weeks exhibiting persistent respiratory distress after 10 minutes of life were treated with nHFPV and nCPAP, in succession and in random order. The primary endpoint was the mean rScO2 , as revealed by near-infrared spectroscopy (NIRS). RESULTS: Forty-nine newborns were randomized; the mean GA and birth weight was 36.4 ± 1.9 weeks and 2718 ± 497 g. The mean rScO2 difference during the last 5 minutes of each ventilation mode (nHFPV minus nCPAP) was -0.7 ± 5.4% (95% confidence interval (CI) -2.25; 0.95%). CONCLUSION: In our study on newborns of GA ≥33 weeks treated for respiratory distress, cerebral oxygenation via nHFPV was not inferior to nCPAP.

Double-blind, randomized controlled trial of therapeutic plasma exchanges vs sham exchanges in moderate-to-severe relapses of multiple sclerosis.

INTRODUCTION: No randomized controlled clinical trial of therapeutic plasma exchanges (TPE) has yet been performed for moderate-to-severe relapses of multiple sclerosis (MS). OBJECTIVE: To compare TPE to sham-TPE in patients with a recent steroid-resistant moderate-to-severe MS relapse. METHODS: Patients presenting with an MS relapse of less than 2 months without improvement and 15 days after a course of steroids were randomized. Specific criteria were used for each relapse type to define moderate-to-severe disability. The primary endpoint was the proportion of patients with at least a moderate improvement based on objective and functional evaluation after 1 month. RESULTS: Thirty-eight patients were randomized. The intention-to-treat analysis included 14 patients in the TPE group and 17 in the Sham-TPE group. The proportion of patients with at least moderate improvement at 1 month did not differ between the groups (P = .72), although 57.1% of the TPE group had full recovery compared with 17.6% of the sham group. Considering optic neuritis (ON), a significant difference in the proportion of different levels of improvement was observed in favor of the TPE group (P = .04). The combined Kurtzke's functional systems scores were significantly more improved in the TPE group than in the sham-TPE group at months 1 (P < .01), 3 (P < .05), and 6 (P < .05). No major side effects were observed. CONCLUSIONS: A significant difference between TPE and Sham-TPE at the primary endpoint was only observed in patients with ON. Neurological function improved significantly more often in the TPE group than in the sham-TPE group.

Femtosecond laser-assisted versus phacoemulsification cataract surgery (FEMCAT): a multicentre participant-masked randomised superiority and cost-effectiveness trial.

BACKGROUND: Cataract surgery is one of the most common operations in health care. Femtosecond laser-assisted cataract surgery (FLACS) enables more precise ocular incisions and lens fragmentation than does phacoemulsification cataract surgery (PCS). We hypothesised that FLACS might improve outcomes in cataract surgery compared with PCS despite having higher costs. METHODS: We did a participant-masked randomised superiority clinical trial comparing FLACS and PCS in two parallel groups (permuted block randomisation stratified on centres via a centralised web-based application, allocation ratio 1:1, block size of 2 or 4 for unilateral cases and 2 or 6 for bilateral cases). Five French University Hospitals enrolled consecutive patients aged 22 years or older who were eligible for unilateral or bilateral cataract surgery. Participants, outcome assessors, and technicians carrying out examinations were masked to the surgical treatment allocation until the last follow-up visit and a sham laser procedure was set up for participants randomly assigned to the PCS arm. The primary clinical endpoint was the success rate of surgery, defined as a composite of four outcomes at a 3-month postoperative visit: absence of severe perioperative complication, a best-corrected visual acuity (BCVA) of 0·0 LogMAR (logarithm of the minimum angle of resolution) or better, an absolute refractive error of 0·75 dioptres or less, and unchanged postoperative corneal astigmatism power (≤0·5 dioptres) and axis (≤20°). The primary economic endpoint was the incremental cost per additional patient who had treatment success at 3 months. Primary outcomes were assessed in all randomly assigned patients who met all eligibility criteria (missing data considered as failure). We used mixed logistic regression models or mixed linear regression models for statistical comparisons, adjusted on centres and whether cataract surgery was bilateral or unilateral. The study is registered with ClinicalTrials.gov, NCT01982006. FINDINGS: Of the 907 patients (1476 eyes) randomly assigned between Oct 9, 2013, and Oct 30, 2015, 870 (704 eyes in FLACS group and 685 eyes in the PCS group) were analysed. We identified no significant difference in the success rate of surgery between the FLACS and PCS groups (FLACS: 41·1% [289 eyes]; PCS: 43·6% [299 eyes]); adjusted odds ratio 0·85, 95% CI 0·64-1·12, p=0·250). The incremental cost-effectiveness ratio was €10 703 saved per additional patient who had treatment success with PCS compared with FLACS. We observed no severe adverse events during the femtosecond laser procedure, and most of the complications in the FLACS group related to the primary outcome measures occurred during the phacoemulsification phase or postoperatively. INTERPRETATION: Despite its advanced technology, femtosecond laser was not superior to phacoemulsification in cataract surgery and, with higher costs, did not provide an additional benefit over phacoemulsification for patients or health-care systems. FUNDING: French Ministry of Social Affairs and Health.

No Improvement of Hepatitis B Vaccination Response in Patients Dialysed with a Polymethylmethacrylate Membrane Compared to High-Flux Polysulfone: Results of the HEPADIAL Study.

BACKGROUND: An altered immune response and decreased vaccine response are observed in patients with chronic renal failure. A preliminary study of 15 non-immunised patients, despite appropriate previous hepatitis B vaccination, showed a 60% seroconversion rate after 3 months of dialysis with a polymethylmethacrylate (PMMA) membrane. This response was associated with circulating soluble CD40 (CD40s) decrease, a natural inhibitor of the humoral immune response. The aim of the study is to confirm these results in a randomised study. METHODS: We conducted a multicentre randomised intention-to-treat superiority clinical trial comparing polysulfone and a PMMA membrane in 2 parallel patient groups. The primary end point was the vaccine response rate, as defined by an anti-HBs antibodies titre of >10 IU/L, 1 month after the last vaccination with a double dose of Engerix B20®, performed at weeks 12, 16, 20, and 36. RESULTS: Twenty-five patients were randomised and included in an intention-to-treat analysis. They were dialysed on polysulfone (n = 11) or PMMA (n = 14) for 40 weeks. Fifty percent of the PMMA patients versus 54.5% of the polysulfone patients achieved seroconversion (p = 1.00). The median anti-HBs antibody titre in responders at week 40 was 496 (92-750) versus 395 (43-572) UI/mL for PMMA and polysulfone, respectively (p = 0.46). The median CD40s titre at week 12 was 306 (193-448) versus 491 (281-515) pg/mL (p = 0.21). The CD40s median variation between week 0 and week 12 was 5 (-105 to 90) versus 64 (-63 to 123) pg/mL (p = 0.55). The CD40s level at week 12 in non-responders was slightly inferior to that of the responders: median 193 (168-331) versus 413 (281-512) pg/mL (p = 0.08). CONCLUSION: We did not observe a better vaccine response with the PMMA membrane compared to high-flux polysulfone. The PMMA membrane did not decrease the CD40s more than the polysulfone membrane probably because the titre was previously low in the 2 groups.

Efficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial.

BACKGROUND: Irreversible pulpitis is a highly painful inflammatory condition of the dental pulp which represents a common dental emergency. Recommended care is partial endodontic treatment. The dental literature reports major difficulties in achieving adequate analgesia to perform this emergency treatment, especially in the case of mandibular molars. In current practice, short-course, orally administered corticotherapy is used for the management of oral pain of inflammatory origin. The efficacy of intraosseous local steroid injections for irreversible pulpitis in mandibular molars has already been demonstrated but resulted in local comorbidities. Oral administration of short-course prednisolone is simple and safe but its efficacy to manage pain caused by irreversible pulpitis has not yet been demonstrated. This trial aims to evaluate the noninferiority of short-course, orally administered corticotherapy versus partial endodontic treatment for the emergency care of irreversible pulpitis in mandibular molars. METHODS/DESIGN: This study is a noninferiority, open-label, randomized controlled clinical trial conducted at the Bordeaux University Hospital. One hundred and twenty subjects will be randomized in two 1:1 parallel arms: the intervention arm will receive one oral dose of prednisolone (1 mg/kg) during the emergency visit, followed by one morning dose each day for 3 days and the reference arm will receive partial endodontic treatment. Both groups will receive planned complete endodontic treatment 72 h after enrollment. The primary outcome is the proportion of patients with pain intensity below 5 on a Numeric Scale 24 h after the emergency visit. Secondary outcomes include comfort during care, the number of injected anesthetic cartridges when performing complete endodontic treatment, the number of antalgic drugs and the number of patients coming back for consultation after 72 h. DISCUSSION: This randomized trial will assess the ability of short-term corticotherapy to reduce pain in irreversible pulpitis as a simple and rapid alternative to partial endodontic treatment and to enable planning of endodontic treatment in optimal analgesic conditions. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02629042 . Registered on 7 December 2015. (Version n°1.1 28 July 2015).

To Drain or Not to Drain Infraperitoneal Anastomosis After Rectal Excision for Cancer: The GRECCAR 5 Randomized Trial.

OBJECTIVE: To assess the effect of pelvic drainage after rectal surgery for cancer. BACKGROUND: Pelvic sepsis is one of the major complications after rectal excision for rectal cancer. Although many studies have confirmed infectiveness of drainage after colectomy, there is still a controversy after rectal surgery. METHODS: This multicenter randomized trial with 2 parallel arms (drain vs no drain) was performed between 2011 and 2014. Primary endpoint was postoperative pelvic sepsis within 30 postoperative days, including anastomotic leakage, pelvic abscess, and peritonitis. Secondary endpoints were overall morbidity and mortality, rate of reoperation, length of hospital stay, and rate of stoma closure at 6 months. RESULTS: A total of 494 patients were randomized, 25 did not meet the criteria and 469 were analyzed: 236 with drain and 233 without. The anastomotic height was 3.5 ±â€Š1.9 cm from the anal verge. The rate of pelvic sepsis was 17.1% (80/469) and was similar between drain and no drain: 16.1% versus 18.0% (P = 0.58). There was no difference of surgical morbidity (18.7% vs 25.3%; P = 0.83), rate of reoperation (16.6% vs 21.0%; P = 0.22), length of hospital stay (12.2 vs 12.2; P = 0.99) and rate of stoma closure (80.1% vs 77.3%; P = 0.53) between groups. Absence of colonic pouch was the only independent factor of pelvic sepsis (odds ratio = 1.757; 95% confidence interval 1.078-2.864; P = 0.024). CONCLUSIONS: This randomized trial suggests that the use of a pelvic drain after rectal excision for rectal cancer did not confer any benefit to the patient.

One-Year Mortality in Older Patients with Cancer: Development and External Validation of an MNA-Based Prognostic Score.

PURPOSE: The MNA (Mini Nutritional Assessment) is known as a prognosis factor in older population. We analyzed the prognostic value for one-year mortality of MNA items in older patients with cancer treated with chemotherapy as the basis of a simplified prognostic score. METHODS: The prospective derivation cohort included 606 patients older than 70 years with an indication of chemotherapy for cancers. The endpoint to predict was one-year mortality. The 18 items of the Full MNA, age, gender, weight loss, cancer origin, TNM, performance status and lymphocyte count were considered to construct the prognostic model. MNA items were analyzed with a backward step-by-step multivariate logistic regression and other items were added in a forward step-by-step regression. External validation was performed on an independent cohort of 229 patients. RESULTS: At one year 266 deaths had occurred. Decreased dietary intake (p = 0.0002), decreased protein-rich food intake (p = 0.025), 3 or more prescribed drugs (p = 0.023), calf circumference <31 cm (p = 0.0002), tumor origin (p<0.0001), metastatic status (p = 0.0007) and lymphocyte count <1500/mm3 (0.029) were found to be associated with 1-year mortality in the final model and were used to construct a prognostic score. The area under curve (AUC) of the score was 0.793, which was higher than the Full MNA AUC (0.706). The AUC of the score in validation cohort (229 subjects, 137 deaths) was 0.698. CONCLUSION: Key predictors of one-year mortality included cancer cachexia clinical features, comorbidities, the origin and the advanced status of the tumor. The prognostic value of this model combining a subset of MNA items and cancer related items was better than the full MNA, thus providing a simple score to predict 1-year mortality in older patients with an indication of chemotherapy.

Nutritional advice in older patients at risk of malnutrition during treatment for chemotherapy: a two-year randomized controlled trial.

OBJECTIVE: We tested the effect of dietary advice dedicated to increase intake in older patients at risk for malnutrition during chemotherapy, versus usual care, on one-year mortality. METHOD: We conducted a multicentre, open-label interventional, stratified (centre), parallel randomised controlled trial, with a 1∶1 ratio, with two-year follow-up. Patients were aged 70 years or older treated with chemotherapy for solid tumour and at risk of malnutrition (MNA, Mini Nutritional Assessment 17-23.5). Intervention consisted of diet counselling with the aim of achieving an energy intake of 30 kCal/kg body weight/d and 1.2 g protein/kg/d, by face-to-face discussion targeting the main nutritional symptoms, compared to usual care. Interviews were performed 6 times during the chemotherapy sessions for 3 to 6 months. The primary endpoint was 1-year mortality and secondary endpoints were 2-year mortality, toxicities and chemotherapy outcomes. RESULTS: Between April 2007 and March 2010 we randomised 341 patients and 336 were analysed: mean (standard deviation) age of 78.0 y (4·9), 51.2% male, mean MNA 20.2 (2.1). Distribution of cancer types was similar in the two groups; the most frequent were colon (22.4%), lymphoma (14.9%), lung (10.4%), and pancreas (17.0%). Both groups increased their dietary intake, but to a larger extent with intervention (p<0.01). At the second visit, the energy target was achieved in 57 (40.4%) patients and the protein target in 66 (46.8%) with the intervention compared respectively to 13 (13.5%) and 20 (20.8%) in the controls. Death occurred during the first year in 143 patients (42.56%), without difference according to the intervention (p = 0.79). No difference in nutritional status changes was found. Response to chemotherapy was also similar between the groups. CONCLUSION: Early dietary counselling was efficient in increasing intake but had no beneficial effect on mortality or secondary outcomes. Cancer cachexia antianabolism may explain this lack of effect. TRIAL REGISTRATION: ClinicalTrials.gov NCT00459589.

Effect of chronic cortical stimulation on chronic severe tinnitus: a prospective randomized double-blind cross-over trial and long-term follow up.

BACKGROUND: Chronic severe tinnitus can be greatly detrimental to quality of life. Some authors have reported benefit of repetitive transcranial magnetic stimulation, others of electrical cortical stimulation by stimulating the Heschl's gyrus or secondary auditory areas. OBJECTIVE: To evaluate the efficacy of chronic electrical epidural stimulation of the auditory cortex on severe and disabling tinnitus. METHOD: In this double-blind randomized cross-over, patients with chronic (at least 2 years), severe (Strukturierte Tinnitus-Interview, STI score > 19), unilateral or strongly lateralized tinnitus were included. After open-phase stimulation for 4 months, patients were randomized into 2 groups for double-blind stimulation with cross-over between significant and non-significant phases and wash-out in between. Each of the 3 phases was 2 weeks in duration. Patients were chronically stimulated and followed if not explanted. A decrease of STI score >35% was considered as clinically significant. RESULTS: None of the 9 patients included achieved significant improvement during the double-blind phase. Four were explanted, 2 owing to lack of effect, one for breast cancer under the stimulator, and another for psychiatric decompensation. Five are still stimulated. Three felt slight to great subjective effectiveness, the remaining 2 reported benefits and still requested stimulation. CONCLUSIONS: This study did not find an objective efficiency of chronic cortical stimulation for severe and resistant tinnitus. The discordance between the results in double-blind and open evaluations could be related to a placebo effect of surgery, but may also be explained by a poorly defined target, a too short randomized phase, or inappropriate outcome measures. Clinical trial reference: NCT00486577.

Body composition in 98 patients awaiting kidney transplantation.

OBJECTIVE: Recent data suggest that the nutritional status of patients who are on the waiting list for kidney transplantation, influence outcomes after renal transplantation. Body composition (BC) analysis is rarely included in pretransplant evaluation. The aim of this study was to determine how alteration of the BC of these patients could influence pretransplant and post-transplant care. METHODS: We compared the BC of French patients on a waiting list for kidney transplantation to a sex- and age-matched healthy, European control population. Patients were included when listed for kidney grafting in a prospective longitudinal study (CORPOS). Biological nutritional parameters, fat free mass (FFM) and fat mass (FM) estimated by dual-energy x-ray absorptiometry (DXA) were assessed on the day of wait-list registration. FFM and FM index (FFMi - FMi) are the ratio of FFM and FM to height squared. Results are expressed as median (range). These indexes were compared with previous study values used as a normal range in nutritional assessment and clinical practice. RESULTS: The study included 28 women and 70 men aged 25.3 to 65.9 y. Body mass index ranged from 16.8 kg/m² to 39.4 kg/m². Compared with controls, FMi was higher in women (10.6 kg/m² [3.7-18.6 kg/m²]) than in men (8.1 kg/m² [3.5-13.3 kg/m²] in M) and FFMi was lower in women (14.3 kg/m² [11.8-21.4 kg/m²]) than in men (17.9 kg/m² [13.9-24.2 kg/m²]) (P < 0.01), reflecting an abnormal distribution of body compartments. All biological parameters were within the normal range. CONCLUSION: BC abnormalities, which can only be detected with the use of DXA, are present in patients on a kidney transplantation waiting list. Detection of these abnormalities could influence the post-transplantation survey in order to prevent the frequent risk for developing metabolic complications after the procedure.