Author Interviews, Gastrointestinal Disease, Lancet, Surgical Research / 27.07.2016

MedicalResearch.com Interview with: Mr Steven Brown MBChB, BMedSci, FRCS, MD Reader in Surgery Honorary Secretary to the ACPGBI Consultant colorectal surgeon University of Sheffield, UK MedicalResearch.com: What is the background for this study? Response: Haemorrhoids are common. One in 4 of us will at some time have symptoms that can be directly attributed to piles. Whilst most symptoms will settle spontaneously or with improvement to our lifestyle, there remains a large group of patients who require intervention to reduce symptomatology. Numerous interventions exist ranging from relatively minor office therapy to procedures that may take several weeks to recover from. Haemorrhoidal artery ligation (HAL) is one of the more recent surgical operations for haemorrhoidal therapy. It has been introduced certainly into the UK associated with a significant element of media hype purporting ‘painless surgery for piles’. Substantial subsequent medical literature has also suggested an efficacy rivaling other more invasive procedures. Too good to be true? Perhaps. Several systematic reviews have highlighted the lack of good quality data as evidence for the advantages of the technique. A well designed randomized controlled trial was required. The existing literature on  haemorrhoidal artery ligation at the time of the trial suggested the procedure was most effective for less symptomatic haemorrhoids (those that are associated with bleeding and/or minor prolapse; grade II or mild III piles). These type of haemorrhoids also tend to be the most common requiring intervention. The most frequently used alternative procedure for these grade of haemorrhoids in the UK is rubber band ligation (RBL), a simple office therapy not requiring anaesthetic. Hence participants with this grade of haemorrhoids were chosen as the participants with RBL as the comparator. Multiple outcomes were investigated but a patient reported outcome measure of recurrence was chosen as the primary outcome. (more…)
Author Interviews, Depression, Lancet / 23.07.2016

MedicalResearch.com Interview with: Professor David A. Richards, PhD Professor of Mental Health Services Research and NIHR Senior Investigator University of Exeter Medical School University of Exeter St Luke's Campus Exeter United Kingdom MedicalResearch.com: What is the background for this study? Response: Depression is a common mental health disorder affecting around 350 million people worldwide. Untreated depression is expected to cost the global economy US$5.36 trillion between 2011 and 2030. Many patients request psychological therapy, but the best-evidenced therapy—cognitive behavioural therapy (CBT)—is complex and costly. A simpler therapy—behavioural activation (BA)—might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression. (more…)
Author Interviews, Brigham & Women's - Harvard, Lancet, Weight Research / 15.07.2016

MedicalResearch.com Interview with: Dr. Shilpa Bhupathiraju, PhD Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: We wanted to investigate the association between body mass index (BMI) and mortality across major global regions. In doing so, we wanted to take into account important methodological limitations which plagued prior reports of BMI and mortality. One such limitation is reverse causality where a low body weight is the result of an underlying illness rather than the cause. Another major problem is confounding due to smoking where smokers have lower body weights than non-smokers but have much higher mortality rates. Therefore, to obtain an unbiased association between BMI and mortality, our primary pre-specified analysis was restricted to never smokers and those who had no existing chronic diseases at the start of the study. In this group, we found that those with a BMI of 22.5-<25 kg/m2 (considered a healthy weight range) had the lowest mortality risk during the time they were followed. The risk of mortality increased significantly with excess body weight. A BMI of 25-<27.5 kg/m2 (in the overweight range) was associated with a 7% higher risk of premature death; BMI of 27.5-<30 kg/m2 (also in the overweight range) was associated with a 20% higher risk; a BMI of 30.0-<35.0 kg/m2 was associated with a 45% higher risk; a BMI of 35.0-<40.0 kg/m2 was associated with a 94% higher risk; and a BMI of 40.0-<60.0 kg/m2 was associated with a nearly 3-fold risk. In general, we found that the association of excess body weight with mortality was greater in younger than older people and in men than women. Most importantly, the associations were broadly consistent in the major global regions we examined, including Europe, North America, Australia and New Zealand, East Asia, and South Asia. (more…)
Author Interviews, Depression, Lancet, Pediatrics / 10.06.2016

MedicalResearch.com Interview with: Andrea Cipriani, MD PhD Associate Professor Department of Psychiatry University of Oxford Warneford Hospital Oxford UK MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Cipriani: Major depressive disorder is common in young people, with a prevalence of about 3% in school-age children (aged 6–12 years) and 6% in adolescents (aged 13–18 years). Compared with adults, children and adolescents with major depressive disorder are still underdiagnosed and undertreated, possibly because they tend to present with rather undifferentiated depressive symptoms—eg, irritability, aggressive behaviours, and school refusal. Consequences of depressive episodes in these patients include serious impairments in social functioning, and suicidal ideation and attempts. Our analysis represents the most comprehensive synthesis of data for currently available pharmacological treatments for children and adolescents with acute major depressive disorder (5620 participants, recruited in 34 trials). Among all antidepressants, we found that only fluoxetine was significantly better than placebo. According to our results, fluoxetine should be considered the best evidence-based option among antidepressants when a pharmacological treatment is indicated for children and adolescents with moderate to severe depression. Other antidepressants do not seem to be suitable as routine treatment options. (more…)
Author Interviews, Heart Disease, Lancet, Mediterranean Diet, Weight Research / 07.06.2016

MedicalResearch.com Interview with: Dr Ramon Estruch, MD PhD Senior Consultant in the Internal Medicine Department of the Hospital Clinic Barcelona MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Estruch: Although weight stability requires a balance between calories consumed and calories expended, it seems that calories from vegetable fats have different effects that calories from animals on adiposity. Thus, an increase of dietary fat intake (mainly extra virgin olive oil or nuts) achieved naturally in the setting of Mediterranean diet does not promote weight gain or increase in adiposity parameters such as waist circumference. (more…)
Author Interviews, Cancer Research, Cost of Health Care, Global Health, Lancet / 26.05.2016

MedicalResearch.com Interview with: Dr Mahiben Maruthappu MD Senior Fellow to the CEO,NHS England Imperial College London, UK MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Maruthappu: There are over 8 million deaths due to cancer every year. At the same time, there are around 40 million unemployed people across the OECD, 7 million more than before the recent economic crisis. As a result, understanding how economic changes affect cancer survival, given the economic climate, is crucial. (more…)
Author Interviews, Lancet, OBGYNE, Schizophrenia, Smoking / 25.05.2016

MedicalResearch.com Interview with: Alan S. Brown, M.D., M.P.H. Professor of Psychiatry and Epidemiology Columbia University Medical Center Director, Program in Birth Cohort Studies, Division of Epidemiology New York State Psychiatric Institute MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Brown: Smoking during pregnancy is a risk factor for several pregnancy-related outcomes including low birthweight and preterm birth. Evidence for a link with schizophrenia is scant. We analyzed a maternal biomarker of smoking called cotinine, a nicotine metabolite, in mothers of nearly 1,000 schizophrenia cases and 1,000 controls in a national birth cohort in Finland. We found that heavy smoking in pregnancy was related to a 38% increase in schizophrenia risk in offspring and that as cotinine levels increased even in the more moderate smokers risk of schizophrenia also increased. (more…)
AHA Journals, Author Interviews, Blood Pressure - Hypertension, Lancet, Salt-Sodium / 22.05.2016

Salt-SodiumMedicalResearch.com Interview with: Prof Andrew Mente PhD Clinical Epidemiology and Biostatistics, McMaster University Hamilton, Canada MedicalResearch.com Editor's Note:  Dr. Mente discusses his Lancet publication regarding salt intake below.  Dr. Mente's findings are disputed by the American Heart Association (AHA).  A statement from the AHA follows Dr. Mente's comments. MedicalResearch.com: What is the background for this study? What are the main findings? Prof. Mente: Several prospective cohort studies have recently reported that both too little and too much sodium intake is associated with cardiovascular disease or mortality. Whether these associations vary between those individuals with and without high blood pressure (hypertension) is unknown. We found that low sodium intake (below 3 g/day), compared to average intake (3 to 6 g/day), is associated with more cardiovascular events and mortality, both in those with high blood pressure and in those without high blood pressure. So following the guidelines would put you at increased risk, compared to consuming an sodium at the population average level, regardless of whether you have high blood pressure or normal blood pressure. High sodium intake (above 6 g/day) compared to average intake, was associated with harm, but only in people with high blood pressure (no association in people without high blood pressure). (more…)
Author Interviews, Clots - Coagulation, Lancet / 07.05.2016

MedicalResearch.com Interview with: Riyaz Bashir MD, FACC, RVT Professor of Medicine Director, Vascular and Endovascular Medicine Department of Medicine Division of Cardiovascular Diseases Temple University Hospital Philadelphia, PA 19140 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Bashir: The use of compression stockings in the prevention of post thrombotic syndrome following an episode of deep vein thrombosis is common in clinical practice. However, the evidence to suggest its efficacy has been put into question by the recent publication of the SOX trial. Since this was the largest randomized controlled trial to date addressing this issue, it has led to clinicians questioning whether compression stockings should be used at all in these patients. The main finding of this meta-analysis was that in patients with deep venous thrombosis, use of elastic compression stockings does not significantly reduce the development of post thrombotic syndrome. However the current body of evidence is limited and we believe at present it is too early to give up on the use of this therapy, which may benefit many subgroups of patients. (more…)
Alzheimer's - Dementia, Author Interviews, Depression, Lancet / 02.05.2016

MedicalResearch.com Interview with: Saira Saeed Mirza, MD, PhD Department of Epidemiology Erasmus MC, Rotterdam MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Mirza: Depressive symptoms appearing in late-life have been extensively studied for their relationship with dementia. They not only very frequently occur in demented patients, but also predict dementia. In this context, depressive symptoms have largely been assessed at a single time point only. However, depression is a disorder which remits and relapses, and symptoms do not remain same over the years. Given this pattern of disease progression, it is more important to study the course of depression over time in relation to long-term health outcomes such as dementia, rather than assessing it at a single time-point, which will neglect the course of depression. This is important as people follow different courses of depression, and different courses of depression might carry different risks of dementia. When we studied the course of depressive symptoms over 11 years in community dwelling older adults in Rotterdam, and the subsequent risks of dementia, we observed that only those who had increasing or worsening depressive symptoms were at a higher risk of dementia. In this group of people, about one in five persons developed dementia. Interestingly, people suffering from high depressive symptoms at a single time point were not at a higher dementia risk than those without depressive symptoms. (more…)
Author Interviews, Biomarkers, Lancet, Pulmonary Disease / 25.04.2016

MedicalResearch.com Interview with: Danny McBryan, MD Vice president, Clinical Development & Medical Affairs, Respiratory Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this study? What are the main findings? Dr. MvBryan: The new post-hoc analysis from the WISDOM study shows a routine blood test could help identify the small minority of patients with severe or very severe COPD who may benefit from the addition of inhaled corticosteroids (ICS). This post-hoc analysis was recently published online in The Lancet Respiratory Medicine. For 80 percent of patients in the WISDOM study, the use of ICS on top of SPIRIVA HANDIHALER (a long-acting muscarinic antagonist – LAMA) and salmeterol (a long-acting beta-agonist – LABA) had no additional benefit in reducing the risk of exacerbations, compared to SPIRIVA HANDIHALER and the LABA without ICS. The post-hoc analysis shows that these patients can be easily identified by measuring the level of white blood cells, called eosinophils. Patients with levels lower than 4 percent (300 cells/µL) were associated with a lack of response to ICS. The WISDOM study evaluated stepwise withdrawal of inhaled corticosteroids (ICS) in severe to very severe COPD patients with a history of exacerbation. WISDOM was a 12-month, double-blind, parallel-group, active-controlled study in which all patients received triple therapy (tiotropium 18 μg once daily, salmeterol 50 μg twice daily and fluticasone 500 μg twice daily) for a six-week run-in period. Patients were randomized 1:1 to continue triple therapy or stepwise withdrawal of ICS over 12 weeks (dose reduction every six weeks). The WISDOM data show that in patients with severe to very severe COPD, the risk of moderate/severe exacerbations during one year of follow-up was non-inferior between those patients who continued on inhaled corticosteroids and those where ICS therapy was withdrawn in a stepwise manner. (more…)
Author Interviews, Infections, Lancet / 23.04.2016

MedicalResearch.com Interview with: Prof Jean-Pierre Allain Principal Investigator, Department of Haematology University of Cambridge, Cambridge Blood Centre Cambridge UK MedicalResearch.com: What is the background for this study? What are the main findings? Prof. Allain: In sub-Saharan Africa (SSA), 70% of the transfusions are in the form of  whole blood units (generally 1 or 2). Lack of resources limit the safety measures to donor questionnaire, viral/bacterial testing (HIV, HCV, HBV and Syphilis). Other measures used in rich countries i.e. nucleic acid testing, filtration, bacterial culture etc. are not done because of cost. Pathogen reduction would be an effective way to overcome these issues as it is able to inactivate viruses, bacteria, parasites and nucleated cells in one go, provided it is applied to whole blood and affordable. The study consisted in assessing the efficacy of such a method (Mirasol using riboflavin and UV illumination) taking inactivation of plasmodium as major endpoint of a randomised controlled clinical trial called AIMS (African Investigation of Mirasol System). (more…)
Author Interviews, Biomarkers, Lancet, Pulmonary Disease / 14.04.2016

MedicalResearch.com Interview with: Dr Henrik Watz MD Pulmonary Research Institute at Lung Clinic Grosshansdorf Airway Research Center North, German Center for Lung Research Grosshansdorf, Germany Medical Research: What is the background for this study? What are the main findings? Dr Watz : While bronchodilators are the mainstay therapy for all patients with COPD some patients benefit from the addition of inhaled corticosteroids in case of frequent exacerbations. So far only little data exist that help clinicians to better characterize those patients that may benefit from the continuation of inhaled corticosteroids on top of dual bronchodilation with a LABA and a LAMA. Post-hoc analyses of the WISDOM dataset suggest that those patients, who have blood eosinophil counts of 4 % or greater or 300 eosinophils per µL or more have less exacerbations, when inhaled corticosteroids are continued compared to patients, in whom inhaled corticosteroids are withdrawn. Patients with less than 4 % eosinophils or less than 300 eosinophils in peripheral blood, who represent 80 % of the study population in WISDOM, did not benefit from a continuation of inhaled corticosteroids. (more…)
Author Interviews, Chemotherapy, Lancet, Leukemia / 13.04.2016

MedicalResearch.com Interview with: Prof Jeffrey H Lipton, PhD, MD, FRCPC Princess Margaret Cancer Centre Toronto, ON Canada MedicalResearch.com: What is the background and purpose for this study? Dr. Lipton: Ponatinib is a third generation tyrosine kinase inhibitor that has been shown to be extremely effective in treating patients with chronic myeloid leukemia resistant to other drugs.  Because of this, it was decided to look at it in newly diagnosed patients in a randomized study against imatinib.  The study was terminated prematurely because of evidence of vascular toxicity that became evident in the phase 1 and 2 studies of ponatinib in previously treated patients with resistant disease.   (more…)
Author Interviews, Heart Disease, Lancet / 05.04.2016

MedicalResearch.com Interview with: Dr Henning Kelbæk MD Department of Cardiology Roskilde Hospital,Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Kelbæk : In some patients with large acute myocardial infarcts, stent implantation has been connected with an increased risk of downstream embolization of thrombus material and disturbances in flow impairing the prognosis of the patients. In accordance, previous smaller studies have shown a benefit in angiographic and other parameters in patients having their stent implanted several hours after the artery was opened, allowing the infarct-related lesion to ’cool down’ and residual thrombus to dissolve under antithrombotic treatment, whereas larger randomised trials focusing on clinical data have been missing. Our trial demonstrates, a bit surprisingly, that delaying or deferring stent implantation does not improve the clinical outcome of these patients.  (more…)
Addiction, Author Interviews, Cocaine, Lancet / 30.03.2016

MedicalResearch.com Interview with: Mascha Nuijten MSc Researcher/ PhD candidate Brijder Research (PARC) The Hague The Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: Crack-cocaine dependence is a complex disorder, for which no proven effective pharmacotherapy is yet available. Prior to our study, sustained-release dexamfetamine was found to be a promising treatment for cocaine dependence in several studies, but no studies so far had shown a convincing benefit in terms of substantial cocaine use reductions. Therefore, we investigated the efficacy of sustained-release (SR) dexamphetamine in a robust dose of 60 mg/day in chronic crack-cocaine dependent patients. We found that the number of days of cocaine use decreased with almost 40% in the dexamfetamine group, compared with 9% in the matched placebo group. In addition, the number of cocaine self-administrations on days that patients used crack-cocaine decreased with 43% in the dexamfetamine group and with 7% in the placebo group. Thus, SR dexamfetamine both contributed to cocaine abstinence and to cocaine use reductions. (more…)
Author Interviews, Breast Cancer, Lancet / 18.03.2016

MedicalResearch.com Interview with: Professor Jack Cuzick, PhD, FMedSci, FRCP(hon) Director, Wolfson Institute of Preventive Medicine and Head, Centre for Cancer Prevention Queen Mary University of London. MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Cuzick: Ductal carcinoma in situ (DCIS) is a very early form of breast cancer, where cancer cells are present in milk ducts, but have not spread to the surrounding breast tissue. It is estimated that approximately a fifth of all screen-detected breast cancers are DCIS, with around 4,800 people diagnosed with DCIS in the UK each year. Our IBIS-II DCIS trial looked at 2,980 postmenopausal women with DCIS in 14 countries, who were either given anastrozole or tamoxifen for five years after surgery. The two groups had a similar number of cases of the disease recurring, whether they took tamoxifen or anastrozole. Those who took anastrozole had an 11 per cent lower rate of recurrence of DCIS or invasive cancer than those who took tamoxifen, but this difference was not significant. The similar NSABP B-35  trial found a 29% reduction with anastrozole and the combined analysis of the two trials indicated a significant 21% reduction. The key difference between the two groups were in the side effects of the medication. Women who took anastrozole experienced fewer womb and ovarian cancers and non melanoma skin cancers, and fewer deep vein thromboses and gynecological issues, compared with those who took tamoxifen. However more fractures and musculoskeletal side effects were seen among those receiving anastrozole. (more…)
Author Interviews, Lancet, OBGYNE / 11.03.2016

MedicalResearch.com Interview with: Charles J. Lockwood, MD Member of of the March of Dimes Board of Trustees Dean at Morsani College of Medicine Senior Vice President, USF Health and Professor of Obstetrics & Gynecology, and Public Health The University of South Florida  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Lockwood: There remain questions about the utility of vaginal progesterone therapy in asymptomatic women with singleton gestations at risk for preterm birth. The OPPTIMUM study investigators conducted a double-blind, randomized, placebo-controlled trial of vaginal progesterone delivered via a pessary releasing 200 mg per day (n=618) vs. placebo (n=610) from around 22 to 34 weeks gestation among women at high risk for prematurity on the basis of a characteristic history and/or the presence of cervicovaginal fetal fibronectin or a cervical length less than 25 mm in length on transvaginal ultrasound.  The primary endpoints were fetal death or preterm birth before 34 weeks (obstetrical outcome), or a composite of neonatal mortality or morbidities (neonatal outcome).  The authors found that progesterone had no significant impact on either primary endpoint, with an adjusted OR of 0·86, 95% CI: 0·61-1·22 for obstetrical outcomes and an OR of 0·62, 95% CI:0·38-1·03 for neonatal outcomes. (more…)
Author Interviews, Gastrointestinal Disease, Lancet, Microbiome, Pediatrics / 09.03.2016

MedicalResearch.com Interview with: Phillip I. Tarr, MD Melvin E. Carnahan MD Professor of Pediatrics Director, Pediatric Division of Gastroenterolgy and Nutrition Washington University in St Louis School of Medicine St Louis, MO 63110, USA MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Tarr: There is a longstanding belief that gut bacteria are relevant to the developing necrotising enterocolitis (NEC). We have established dysbiosis in the gut before NEC occurs, suggesting this ecological perturbation might be causal.

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Author Interviews, Cannabis, Lancet, Mental Health Research / 08.03.2016

MedicalResearch.com Interview with: Dr Sagnik Bhattacharyya Reader in Translational Neuroscience and Psychiatry Institute of Psychiatry, Psychology & Neuroscience, KCL Consultant Psychiatrist, Early Intervention Pathway Director, Maudsley Early Intervention in Dual Diagnosis clinic Psychosis Clinical Academic Group, South London & Maudsley NHS Foundation Trust King’s Health Partners  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Bhattacharyya: Cannabis is the most commonly used illicit drug in the world and its use has been linked to the onset of psychotic disorders such as schizophrenia. Whilst a lot of research has investigated the association between cannabis use and the development of psychosis, there is less clarity regarding the consequences of continued cannabis use in those with an established psychotic disorder. We therefore pooled together all available evidence from studies that specifically looked at the effects of cannabis use on outcome following the onset of psychosis. Based on data from more than 16000 patients with a first episode or more established psychosis, our results show that continued cannabis use is consistently associated with poor outcome in the form of more relapses (as indexed by psychiatric hospitalisation), longer hospitalisations and increased positive symptoms. However, outcomes were not as bad if cannabis use was discontinued following the onset of psychosis. (more…)
Author Interviews, Chemotherapy, Lancet / 08.03.2016

MedicalResearch.com Interview with: Dr Christina H Ruhlmann PhD Department of Oncology Odense University Hospital, Denmark  MedicalResearch.com: What is the background for this study? Response: The background for the GAND-emesis study is the result of a phase II study in patients with gynecological cancer receiving fractionated radiotherapy and concomitant weekly cisplatin 40 mg/m2. In that study, patients received weekly antiemetic prophylaxis with palonosetron and prednisolone, and we found that 57% of patients were continuously free from emesis (sustained no emesis) during 5 weeks of treatment. We hypothesized that the addition of a NK1 receptor antagonist could increase the number of patients with sustained no emesis, and we therefore planned the GAND-emesis study: a multinational, randomised, placebo-controlled, double-blind study that has recently been published. MedicalResearch.com: What are the main findings? Response: In the GAND-emesis study we compared efficacy of weekly antiemetic prophylaxis with fosaprepitant, palonosetron, and dexamethasone to placebo, palonosetron, and dexamethasone during 5 weeks of radiotherapy and concomitant weekly cisplatin 40 mg/m2 for cervical cancer. The primary endpoint was sustained no emesis during 5 weeks of treatment (competing risk analysis). We found that the proportion of patients with sustained no emesis was 48.7% for the placebo group compared with 65.7% for the fosaprepitant group, and the treatments were well tolerated. To our knowledge, this is the first study to investigate the efficacy of a NK1 receptor antagonist during 5 weeks of chemoradiotherapy. (more…)
Author Interviews, Dengue, Lancet, OBGYNE / 07.03.2016

MedicalResearch.com Interview with: Mrs Enny S Paixão London School of Hygiene & Tropical Medicine London UK  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dengue is a vector borne disease endemic in more than 100 countries (mainly in South America and southeast Asia) and is spreading to new areas, with outbreaks of increasing magnitude and severity. It is estimated that each year, 390 million people are infected with dengue and 96 million develop clinical symptoms. Despite of the importance of this disease, the effects of disease during pregnancy on fetal outcomes remain unclear. Using the published scientific literature, we investigated the risk of stillbirth, miscarriage, preterm birth, and low birth weight for women who had dengue infection during pregnancy. This study showed some evidence that dengue infection alone, in the absence of clinical symptoms, does not affect the outcome of pregnancy, but also that clinical dengue during pregnancy seems to increase the frequency of stillbirth, prematurity, and low birthweight. (more…)
Author Interviews, Lancet, Neurological Disorders, Pain Research / 07.03.2016

MedicalResearch.com Interview with: Nadine Attal, MD PhD Professeur associée de l'UVSQ INSERM U 987 et CETD CHU Ambroise Paré 92100 Boulogne-Billancourt MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Attal: The background for this study is based on the findings of experimental studies in animals and healthy subjects indicating that botulinum toxin type A  (BTX-A) may have analgesic activity independent of its effect on muscle tone. BTX-A has been reported to have analgesic effects against peripheral neuropathic pain in prior trials, but the quality of the evidence was generally low, as it was derived mostly from small pilot studies and no study has evaluated the relevance of repeated administrations for the treatment of NP. Furthermore, the clinical profiles of the patients responding to BTX-A have not been fully characterized. MedicalResearch.com: What should clinicians and patients take away from your report? Dr. Attal: They should take away that two repeated subcutaneous administrations of botulinum toxin type A are effective in peripheral  neuropathic pain but mostly in patients with allodynia and/or limited thermal deficits. BTX-A also appears to be particularly effective on paroxysmal pain (ie electric shock like pain). Finally, the efficacy of a second administration of BTX-A is enhanced over the first injection. (more…)
Author Interviews, Cancer Research, Lancet, Leukemia, OBGYNE, Pediatrics / 04.03.2016

MedicalResearch.com Interview with: Erin Marcotte, Ph.D. Assistant Professor Division of Epidemiology and Clinical Research Department of Pediatrics University of Minnesota MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Marcotte: Recently there have been several studies that indicate a higher risk of immune-related disorders, such as type-I diabetes, asthma, and allergies, among children born by cesarean delivery. Our analysis used pooled data from 13 independent studies of childhood leukemia that were conducted in 9 different countries. We used data on over 33,000 children to investigate the relationship between birth by cesarean delivery and risk of childhood leukemia. We did not find an association between cesarean delivery overall and childhood leukemia. However, when we looked at emergency cesarean deliveries and pre-labor (planned) cesarean deliveries separately, we found a 23% increase in risk of acute lymphoblastic leukemia among children born by pre-labor cesarean delivery. (more…)
Author Interviews, Breast Cancer, Chemotherapy, Lancet / 04.03.2016

MedicalResearch.com Interview with: Massimo Cristofanilli, MD, FACP Professor of Medicine Associate Director of Translational Research and Precision Medicine Department of Medicine-Hematology and Oncology Robert H Lurie Comprehensive Cancer Center Feinberg School of Medicine Chicago, IL 60611  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Cristofanilli: The majority of breast cancer are estrogen-receptor positive and therefore candidate for treatment with endocrine therapy in the adjuvant and advanced settings. The most significant issue in the management of estrogen-receptor positive metastatic breast cancer is the development of drug resistance. Very few effective options are available for patients that demonstrate progression of disease while on standard endocrine therapy, particularly in premenopausal women and/or women that have even progressed on chemotherapy. The study demonstrated that the combination of fulvestrant with palbociclib, a novel inhibitor of CDK4/6 kinases, significantly improve response to treatment and delays disease progression with minimal toxicity.  (more…)
Author Interviews, Lancet / 01.03.2016

MedicalResearch.com Interview with: Theresa Wimberley PhD student National Centre for Register-based Research School of Business and Social Sciences Aarhus University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Approximately 30% of patients with schizophrenia suffer from treatment-resistant schizophrenia, i.e. they do not respond to first-line antipsychotic treatment. Identification of high-risk patients as early as possible is crucial in order to optimize treatment and improve prognosis. In a large population-based cohort of patients diagnosed with schizophrenia we found the following candidate predictors of treatment resistance:
  • younger age at diagnosis,
  • living in less urban areas,
  • paranoid schizophrenia subtype,
  • a history of psychiatric hospital admission,
  • personality disorder,
  • suicide attempt, and
  • psychotropic drug use. Additionally, as opposed to other studies using treatment-based proxies for treatment-resistant schizophrenia, this study not only considered clozapine users as treatment resistant. We extended the proxy definition to include patients eligible for clozapine, as clozapine is considered to be under-prescribed. We found similar results regardless of definition used.
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Author Interviews, Cleveland Clinic, Lancet, Multiple Sclerosis / 16.02.2016

MedicalResearch.com Interview with: Dr Jeffrey A Cohen MD Mellen Center, Neurological Institute Cleveland Clinic, Cleveland OH 44195, USA Medical Research: What is the background for this study? What are the main findings? Dr. Cohen: Fingolimod, a non-selective sphingosine 1-phosphate receptor (S1PR) modulator, was the first oral medication approved to treat relapsing multiple sclerosis.  Though generally well tolerated, fingolimod’s first dose cardiac effects and other potential adverse effects complicate its use.  Ozanimod is a selective S1PR modulator with several other potentially advantageous pharmacologic properties. The results of phase 2 RADIANCE trial were recently published.  In this trial, participants were randomized to placebo (n=88), ozanimod 0.5 mg (n=87), or ozanimod 1 mg (n=83) PO once daily for 24 weeks.  The mean cumulative number of gadolinium-enhancing lesions on monthly MRI scans at weeks 12-24, the primary endpoint, was reduced from 11.1 +/- 29.9 with placebo to 1.5 +/- 3.7 with ozanimod 0.5 mg and 1.5 +/- 3.4 with ozanimod 1 mg (both p<0.0001).  Other MRI endpoints supported the primary endpoint.  Ozanimod was well tolerated with good safety.  Importantly, the dose up-titration protocol effectively mitigated first dose cardiac effects. (more…)
Author Interviews, Epilepsy, Lancet, Pharmacology / 15.02.2016

MedicalResearch.com Interview with: Dr. Michael Privitera MD Professor of the Department of Neurology and director of the Epilepsy Center University of Cincinnati Neuroscience Institute  Medical Research: What is the background for this study? What are the main findings? Dr. Privitera: Generic substitution of medications has saved the American health care system billions of dollars per year. However, based on a series of uncontrolled studies, patients and clinicians share concerns that generic substitution of antiepileptic drugs may lead to loss of efficacy or emergence of adverse effects. To answer this question we undertook a prospective, randomized study that tested bioequivalence of two generic products of the antiepileptic drug lamotrigine. Lamotrigine was identified in several publications as a possible source of problems after generic switches. FDA studies test a single generic versus the brand name product in a single dose study in normal volunteers. We designed a study that would be most likely to show a difference between generics if one existed. We compared the two generic lamotrigine products showing the most difference in prior testing in patients with epilepsy taking the drug daily using rigorous pharmacokinetic methods. Each patient took each of the two generics for 2 four week periods. Our study showed the two generics were essentially indistinguishable and easily met bioequivalence standards. No patient had loss of seizure control or unexpected adverse effects. (more…)