MedicalResearch.com Interview with:Robert W. Levenson, Ph.D.
Professor, Department of Psychology
Director, Institute of Personality
and Social Research (IPSR)
University of California
Berkeley, CA
MedicalResearch.com: What is the background for this study?Dr. Levenson: This study comes from a 20-year longitudinal study of Bay Area married couples that we began in the late 1980s. The main purpose of the study was to understand the emotional qualities of successful marriages. Couples came to our laboratory every five years so that we could get a snapshot of the way they interacted with each. We also measured their psychological and physical health. This new paper connects the emotional behaviors we observed when couples discussed a problem in their marriage at the start of the study with the kinds of illnesses they developed over the ensuing decades.
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MedicalResearch.com Interview with:
Richard M. Mangano, PhD
Chief Scientific Officer at Relmada Therapeutics
Dr. Mangano has extensive experience leading global R&D programs in both large and small pharmaceutical companies including positions in discovery and clinical research at Hoffmann-La Roche, Lederle Laboratories, Wyeth Research and Adolor Corporation. He served as acting Therapeutic Area Director for Neuroscience at Wyeth before joining Adolor as Vice President of Clinical Research and Development. Dr. Mangano’s expertise includes multiple IND/CTC submissions and NDA/MAA approvals in psychiatry, neurology and gastrointestinal therapeutic areas. Dr. Mangano is also an adjunct professor in the Department of Pharmacology and Physiology at the Drexel University School of Medicine. He lectures in the Drug Discovery and Development Program and in the Psychiatry Department’s Resident Training Program. He has authored 30 peer reviewed publications and over 120 abstracts and presentations. Dr. Mangano holds a B.S degree in Chemistry from Iona College and a PhD degree in Biochemistry from Fordham University. Prior to joining the pharmaceutical industry, he was a research faculty member of the Maryland Psychiatric Research Institute at the University of Maryland School of Medicine.Dr. Mangano discusses the opioid addiction and the development of abuse-resistant medications.MedicalResearch.com: What is the background for the development of abuse-resistant medications? How extensive is the problem of opioid addiction?
Dr. Mangano: Recognizing the growing incidence of opioid abuse, misuse, and overdose in the United States, pharmaceutical companies, with the guidance of the FDA, are developing products that can mitigate abuse, while recognizing the importance of maintaining the availability of opioid analgesics for the millions of patients in this country who suffer from pain.
Approximately two million people in the U.S. are addicted to opioids. The market for products that treat opioid dependence has grown significantly due to the rapidly escalating problem of prescription opioid misuse and abuse, a recent resurgence of heroin use, and the growing number of physicians treating opioid dependence.
One of our product candidates, REL-1028 (BuTab), is a proprietary formulation of buprenorphine designed to treat both opioid addiction and moderate to severe chronic pain. Although there is the potential for addiction to buprenorphine, the risk is lower because it is a “partial agonist” of the mu opioid receptor compared with “full agonist” opioids like heroin, morphine, oxycodone, and hydrocodone. As a result, products containing buprenorphine, such as BuTab, should have reduced risk of abuse and physical dependence and would be controlled in Schedule III of the Controlled Substances Act (as opposed to the more restrictive Schedule II). We are also considering a formulation that would include an opioid antagonist that would not interfere with analgesia when taken orally as prescribed but would block the action of buprenorphine if it were to be inhaled or injected.
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MedicalResearch.com Interview with:
Dominik Mischkowski, co-author of the study
Former Ph.D. student at Ohio State
Now at the National Institutes of Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Mischkowski: We tested in two double blind experiments whether the popular physical painkiller acetaminophen reduces empathy for the pain of other people. In the first experiment (N=80), participants completed measures of empathy (i.e., perceived pain and personal distress) while reading hypothetical about the physical and social mishaps of other people. We found that acetaminophen reduced empathy for pain in these scenarios. In Study 2 (N=114), we replicated and extending these findings, showing that acetaminophen also decreased empathy (i.e., perceived pain, personal distress, and empathic concern) for another study participant experiencing ostracism or painful noise blasts. Furthermore, noise unpleasantness accounted for the effect of acetaminophen on empathy for noise pain.
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MedicalResearch.com Interview with:
Hui-Lin Pan, MD, PhD
Helen T. Hawkins Distinguished Professor
and Deputy Division Head for Research
Division of Anesthesiology and Critical Care, Unit 110
The University of Texas MD Anderson Cancer Center
Houston, TX
MedicalResearch.com: What is the background for this study?
Dr. Hui-Lin Pan: Chronic nerve pain caused by damage to the peripheral nerve is a debilitating health problem and remains very difficult to treat. Sensory neurons in the spinal cord are normally inhibited by inhibitory neurotransmitters (GABA and glycine) to regulate transmission of painful information. A major feature of nerve injury-induced chronic pain is reduced spinal cord inhibition, resulting from diminished activity of a chloride transporter called KCC2. In this study, we investigated whether increasing KCC2 expression at the spinal level using a lentiviral vector can restore KCC2 activity, thereby reducing chronic nerve pain.
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MedicalResearch.com Interview with:
Zoher Ghogawala MD FACS
Department of Neurosurgery
Lahey Hospital and Medical Center
Burlington, MA 01805MedicalResearch.com: What is the background for this study?
Dr. Ghogawala: There is enormous practice variation around the utilization of lumbar spinal fusion in the United States and across the world. In the United States, lumbar spinal fusion utilization has increased to 465,000 hospital-based procedures in 2011 according to a report from the AHRQ (published in 2014). Spinal fusion accounts now for the highest aggregate hospital cost (12.8 billion dollars in 2011) of any surgical procedure performed in US hospitals. What is problematic is that there are no top tier studies that address the question of whether or not adding a lumbar spinal fusion when performing a simple decompression is necessary or helpful. The question is whether we perform too many fusions in the United States.
The SLIP study is the first class I study that demonstrates that the addition of a lumbar fusion when performing a lumbar laminectomy to decompress spinal nerves improves health-related quality of life for patients suffering from low back pain and sciatica from lumbar stenosis with spondylolisthesis - a very common cause of low back pain caused by nerve compression associated with one spinal bone being slightly out of alignment.MedicalResearch.com: What are the main findings?
Dr. Ghogawala:
1) Adding a lumbar fusion when performing a lumbar laminectomy results in superior health-related quality of life at 2,3, and 4 years after surgery.
2) Patients with fusion obtained durable results but 14% required re-operation for problems adjacent to their fusion over the 4 year study period.
3) Lumbar laminectomy alone provided good results for 70% of patients. There was less blood loss and faster recovery for these patients. On the other hand, the outcomes were less durable. One in three patients who underwent a lumbar laminectomy alone required re-operation within 4 years because their back became unstable. These patients underwent fusion and their health-related quality of life improved.
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MedicalResearch.com Interview with:
Wendy King, PhD
Associate Professor of Epidemiology
Epidemiology Data Center, Room 105
University of Pittsburgh
Pittsburgh, PA 15213
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. King: Severe obesity is associated with significant joint pain and impaired physical function, such as difficulty bending, lifting carrying and walking. Excess weight can lead to joint damage and accompanying pain, resulting in activity restriction and walking limitations. Obesity can also contribute to pain and physical limitations through factors such as impaired cardiorespiratory function, systematic inflammation, reduced flexibility, low strength per body mass, and depression. Previous studies have reported significant improvements in mean values of bodily and joint specific pain, physical function, and walking capacity in the first 3-12 months following RYGB or LAGB. However, very few studies have examined the variability in response to surgery or reported on longer-term follow-up of these procedures.
My colleagues and I followed 2,221 patients participating in the Longitudinal Assessment of Bariatric Surgery-2, a large NIH-funded prospective study of adults with severe obesity undergoing weight-loss surgery at one of 10 hospitals across the U.S. Through three years of follow-up, approximately 50 to 70 % of patients who underwent bariatric surgery reported clinically important improvements in bodily pain, physical function and usual walking speed. About three-quarters of the participants with symptoms indicative of osteoarthritis before surgery experienced improvements in knee and hip pain and function. In addition, over half of participants who had a mobility deficit prior to surgery did not post-surgery. Several baseline characteristics such as younger age, male sex, higher household income, lower body mass index, fewer depressive symptoms and no history of diabetes or venous edema with ulcerations, were associated with a higher chance of improvement in pain and physical function following surgery. In addition, pre- to post-surgery reductions in weight and depressive symptoms, and remission of diabetes and venous edema with ulcerations were associated with pre- to post-surgery improvements. Thus, our findings reinforce results from shorter-term studies by addressing the durability or response and expand our understanding of the variability in response, and what factors are related to chance of improvement.
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MedicalResearch.com Interview with:
Shawn Bugden B.Sc. (Pharm), M.Sc., Pharm.D.
Associate Professor
College of Pharmacy, Faculty of Health Sciences
University of Manitoba
Winnipeg, Manitoba, Canada
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Bugden: Fentanyl is 100 times more potent than morphine. While there has been a great deal of attention to fentanyl deaths associated with substance abuse, our study focused on the safety of fentanyl use in standard medical practice. Fentanyl is most commonly prescribed as a transdermal (skin) patch that delivers the medication over 3 days. The product monograph and numerous safety warnings (FDA, Health Canada…) make it clear that fentanyl patches should not be used unless the patient has had considerable previous opioid exposure (more than 60mg morphine per day for more than 1 week). Failure to heed these warnings may result in opioid overdose, respiratory depression and death.
This study examined over 11 000 first prescriptions for fentanyl patches over a 12-year period to determine if patients had received adequate exposure to opioids. Overall 74.1% of first prescriptions were filled by patients who had not received adequate prior opioid exposure. An improvement was seen over the study period but even at the end of the study, 50% of prescriptions would be classed as unsafe. More than a quarter (26.3%) of fentanyl prescriptions were given to patients who were completely opioid naïve and had no exposure to opioids of any kind in the previous 60 days. Older adults, who may be more sensitive to the effects of fentanyl overdose, were more likely to receive unsafe prescriptions than younger adults.
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MedicalResearch.com Interview with:
Dr. Daniel C. Cherkin PhD
Senior Investigator
Group Health Research Institute
Seattle, WA
MedicalResearch.com: What is the background for this study?
Dr. Cherkin: Chronic low back pain is a widespread, costly, and potentially disabling problem. It’s the most common cause of pain of any kind. It affects eight in 10 Americans at some point in their lives. In recent years, the United States has been spending more on back pain treatments—but unfortunately with worse results in how much pain bothers people and interferes with their lives. Group Health is addressing the problem in several ways, including this innovative research.
MedicalResearch.com: What are the main findings?
Dr. Cherkin: In a randomized controlled trial involving more than 300 patients at Group Health, we found that training in a kind of mindfulness meditation—mindfulness-based stress reduction (MBSR)—led to meaningful improvements in functioning and chronic low back pain at six months and one year. MBSR, which is becoming increasingly popular and available in the United States, involves training in observing, acknowledging, and accepting thoughts and feelings including pain. The training also includes some easy yoga poses to help participants become more aware of their bodies. Results with mindfulness-based stress reduction were significantly better than with usual care (whatever patients would be doing for their back pain if they weren’t in the study, including medications and physical therapy—but not mindfulness meditation or cognitive behavioral therapy). And results with mindfulness-based stress reduction were very similar to those with cognitive behavioral therapy (CBT). CBT includes education about chronic pain, relationships between thoughts and emotional and physical reactions, instruction and practice in changing dysfunctional thoughts, setting and working towards behavioral goals, relaxation skills, activity pacing, and pain coping strategies. Prior studies had already proven that CBT helped adults of various ages with back pain.
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MedicalResearch.com Interview with:Eric Sun, MD/PhD
Instructor
Department of Anesthesiology, Perioperative and Pain Medicine
Stanford University
MedicalResearch.com: What is the background for this study? Dr. Sun: Epidural steroid injections are frequently used to treat chronic low back pain. While previous studies have shown they are effective at improving symptoms, whether they reduce spending is unknown. These concerns are particularly salient because insurers are worried that epidural steroid injections are being overused.
MedicalResearch.com: What are the main findings?Dr. Sun: Overall, we find that epidural steroid injections were associated with decreases in spending ranging from five to fifteen percent, depending on the specific indication. These differences were largely driven by decreases in outpatient spending (e.g., spending on outpatient physician visits).
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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.
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MedicalResearch.com Interview with:
Matthew S. Robbins, MD, FAHS
Associate Professor of Clinical Neurology, Albert Einstein College of Medicine
Chief of Neurology, Jack D. Weiler Hospital
Montefiore Medical Center
Director of Inpatient Services, Montefiore Headache Center
Associate Program Director, Neurology Residency
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Robbins: It is now well-established that having a history of migraine increases the risk of having vascular and obstetrical complications for pregnant women. What is not known is if having active migraine during pregnancy would increase complications later on in that very same pregnancy. Having severe migraine attacks during pregnancy may indicate particularly severe and active disease. We evaluated pregnant women who presented to the hospital setting with acute, severe migraine attacks, and then reviewed their records for what happened during the same pregnancy when they delivered. We found that compared to local and national rates, pregnant women with severe migraine attacks presenting to the hospital have increased rates of preeclampsia, preterm delivery, and low birthweight. This risk was particularly elevated in pregnant women age 35 years or older.
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MedicalResearch.com Interview with:
Adam T. Hirsh PhD
Assistant Professor, Psychology
Indiana University
Indianapolis, INMedical Research: What is the background for this study? What are the main findings?
Dr. Hirsh: Pain is highly prevalent and is a major cause of disability. How patients cope with pain affects how much pain they feel and how much that pain interferes with their lives. Compared to White individuals, Black individuals experience greater pain across a number of clinical conditions, as well as in response to experimentally-delivered stimuli. These race differences may be due to differences in pain-related coping. We conducted a meta-analysis of clinical and experimental studies (including 2,719 Black and 3,770 White adults) to quantify race differences in the overall use of pain coping strategies as well as specific coping strategies. The results indicated that, compared to White individuals, Black individuals used pain coping strategies more frequently overall. In particular, Black individuals more frequently used strategies that involved praying and catastrophizing, whereas White individuals more frequently used strategies that involved task persistence. These results suggest that Black individuals use coping strategies more frequently, specifically strategies associated with poorer pain outcomes.
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MedicalResearch.com Interview with:
Jeffrey F. Scherrer, PhD
Associate Professor
Research Director
Department of Family and Community Medicine
Saint Louis University School of Medicine
St. Louis, MO 63104Medical Research: What is the background for this study? What are the main findings?
Dr. Scherrer: We initiated a series of studies on chronic opioid use and risk of depression about 3 years ago and obtained an NIH R21 to study prescription opioid use and risk of new onset depression, depression recurrence and transition to treatment resistant depression. The rationale comes partly from clinical observations of the research team (I am not a clinician, just a epidemiologist). We also observed the large field demonstrating patients with depression are more likely to get opioids for pain, take them longer and develop abuse. We wanted to switch the direction of effect to determine if the reverse exists. After publishing two papers demonstrating longer use of opioid was associated with increasing risk of depression, our next step was to look at recurrence among patients with a recent history of depression.
Medical Research: What should clinicians and patients take away from your report?Dr. Scherrer: Our main recommendation is clinicians should repeatedly screen patients for depression. While screening at time of starting opioids is common, repeated screening is worth consideration. Patients with depression who may experience temporary euphoria should not expect opioids to cure depression and they may increase risk for worsening mood and or recurrence after long term use.
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MedicalResearch.com Interview with:
Souvik Sen, MD, MS, MPH, FAHA
Professor and Chair, Neurology Department,
South Carolina Smart State Endowed Stroke Chair
University of South Carolina School of MedicineMedical Research: What was the catalyst for conducting this study examining the association between migraine with aura and ischemic stroke subtypes?
Dr. Souvik Sen: South Carolina, North Carolina, and Georgia are located in the “buckle” of the stroke belt, with one of the highest stroke related death rates in the country. An unfortunate trend is that younger patients are having strokes leading to death and disability. As a part of the workup for young stroke we are interested in migraine with aura and the type of stroke associated with this condition.
Medical Research: What did you conclude as a result of the findings and how did they compare with your expectations at the beginning of the study?(more…)
MedicalResearch.com Interview with:
Dr. Vincent Martin, MD
Professor of Internal Medicine
University of Cincinnati College of Medicine
Cincinnati OH
Medical Research: What is the background for this study? What are the main findings?Dr. Martin: Past studies have found that the perimenopause is associated with an increased prevalence of migraine headache, but there have been no studies to determine if the frequency of migraine attacks is increased during this time period. In our study we reported that high frequency headache (≥10 days per month with headache) was increased by 62% during perimenopause (irregular menstrual cycles) as compared to premenopause (regular menstrual cycles). We later divided the perimenopause into early and late stages. During the early perimenopause women experience irregular menstrual bleeding while during the late perimenopause women begin skipping menstrual periods for 2-11 months. Of the two stages the late perimenopause in particular had the greatest likelihood for high frequency headache increasing its risk by 86%. This could suggest that low estrogen and progesterone levels, which occur when menstrual periods are skipped, might account for the increased probability of headache attacks in women with migraine.
The common belief in the medical field is that migraine attacks improve in women during menopause. To the contrary we found that high frequency migraine increased by 76% during menopause compared to premenopause. This indicates that a subgroup of women with frequent headaches tend to worsen with menopause. The increased probability of high frequency headache appeared to be secondary to an increased intake of pain medications occurring during this time period, which could result in “rebound headaches”. Rebound headaches occur from overuse of pain medications.
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MedicalResearch.com Interview with:
Carolyn Ee, MBBS
Department of General Practice
University of Melbourne
Carlton, Victoria, Australia
Medical Research: What is the background for this study? What are the main findings?
Response: Hot flushes affect up to 90% of women during the menopause and beyond, and women are turning to complementary therapies. Our randomised sham-controlled trial found no difference between real and sham acupuncture (given with a blunt needle) for hot flushes, with both groups improving by around 40% at the end of treatment.
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More on Mental Health Research on MedicalResearch.comMedicalResearch.com Interview with:
Dr Mia Tova Minen
Department of Neurology
NYU Langone Medical Center
New York, NY 10016
Medical Research: What is the background for this study? What are the main findings?
Dr. Minen: Migraine affects 12% of adults in the United States, and is thus a very common condition. There are effective treatments for migraine patients, but we also know that if patients and their doctors do not consider the psychiatric disorders that can co-occur with migraine, migraines can worsen, a term called migraine chronification. Thus, we felt that it was important to discuss the various psychiatric disorders associated with migraine, the screening tools available to assess for them, and various treatment considerations for patients with migraine and psychiatric conditions.
We also discussed potential explanations for the relationship between migraine and these psychiatric conditions.
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More on Gastroenterology on MedicalResearch.com
MedicalResearch.com Interview with:
Prof. Guy Boeckxstaens
Translational Research in GastroIntestinal Disorders
KU Leuven, Belgium
Medical Research: What is the background for this study? What are the main findings?
Prof. Boeckxstaens: Patients with IBS have increased abdominal pain for which no efficient therapy is available, mainly as the underlying cause is unclear. In our study, we checked the hypothesis that pain receptors (in particular TRPV1) in the gut wall of IBS patients are more sensitive (sensitized) than those of control subjects. Based on previous work, we focused on histamine, mainly as we had indications that mast cells releasing histamine may be involved in IBS. Interestingly, we noticed that neurons in rectal biopsies were indeed more sensitive to capsaicin, a substance of which we know it selectively acts on the pain receptors of interest. We could demonstrate that histamine sensitizes TRPV1 via interaction with its histamine 1 receptor (H1R). We next showed that treatment with a H1R blocker was able to prevent TRPV1 sensitization. Based on this observation, we decided to start a pilot study evaluating the effect of a H1R blocker, ebastine, in patients suffering from IBS. This study showed that 12 weeks treatment with ebastine indeed improved abdominal symptoms, in particular pain.
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MedicalResearch.com Interview with:
Daniel Steffens, Ph.D.
The George Institute for Global Health
The University of Sydney
Medical Research: What is the background for this study?
Dr. Steffens: Back pain is a leading cause of disease burden globally. At present, a variety of interventions, such as getting a mattress that can help with back pain, exercise, education, back belts and shoe insoles, are commonly prescribed to prevent an episode of low back pain. Guidelines lack clear recommendations for prevention of low back pain and the effectiveness of the range of possible prevention strategies for low back pain is not clear. Our study aimed to investigate the effectiveness of these interventions for prevention of low back pain.
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MedicalResearch.com Interview with:
Marc R. Larochelle, MD, MPH
Assistant Professor of Medicine
Boston Medical Center
Boston, MAMedical Research: What is the background for this study? What are the main findings?Dr. Larochelle: More than 16 thousand people in the United States die from prescription opioid overdose each year. However, morbidity extends well beyond fatal overdose - nearly half a million emergency department visits each year are related to prescription opioid-related harms. Emergency department visits for misuse of opioids represent an opportunity to identify and intervene on opioid use disorders, particularly for patients who receive prescriptions for opioids to treat pain. We examined a cohort of nearly 3000 commercially insured individuals prescribed opioids for chronic pain who were treated for a nonfatal opioid overdose in an emergency department or inpatient setting. We were interested in examining rates of continued prescribing after the overdose and the association of that prescribing with risk of repeated overdose. We found that 91% of individuals received another prescription for opioids after the overdose. Those continuing to receive opioids at high dosages were twice as likely as those whose opioids were discontinued to experience repeated overdose.
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MedicalResearch.com Interview with:
Michael D. April, MD, DPhil
Department of Emergency Medicine
San Antonio Uniformed Services Health Education Consortium
San Antonio, TXMedical Research: What is the background for this study? What are the main findings?
Dr. April: Anesthesia research studies have found that nasal inhalation of isopropyl
alcohol has efficacy in treating nausea among post-operative patients. We
sought to study this agent among Emergency Department patients with nausea or
vomiting. We found that patients randomized to inhale isopropyl alcohol had
improved self-reported nausea scores compared to patients randomized to inhale
saline (placebo).
MedicalEditor's note: Do Not Do This Without Medical Supervision!(more…)
MedicalResearch.com Interview with:
Dr Emmanuel Boselli, MD, PhD
Anesthesiology and Intensive Care
University Claude Bernard Lyon I
University of Lyon
Lyon, France
Medical Research: What is the background for this study? What are the main findings?Dr. Boselli: We hypothesized that the use of conversational hypnosis in patients undergoing regional anesthesia procedures for ambulatory upper limb surgery might provide better comfort than the use of oral premedication during the regional anesthesia procedure. We assessed the subjective effect of conversational hypnosis on a patient self-reported comfort scale ranging from 0 (no comfort) to 10 (maximal comfort), and the objective effect was assessed using the Analgesia/Nociception Index (ANI), a 0-100 index derived from heart rate variability reflecting the relative parasympathetic tone. In our study of 100 patients undergoing hand surgery in two different centers, 50 had conversational hypnosis while being given regional anesthesia (Saint-Grégoire hospital), and 50 were given of oral hydroxyzine 30 minutes to an hour before the regional anesthesia procedure (Lyon hospital). Patients having hypnosis measured an average ANI of 51 before and 78 after hypnosis, whereas those who had premedication averaged 63 before and 70 after. The average comfort scale of those who had received hypnosis was 6.7 before and 9.3 after, while patients who had medication averaged 7.8 before and 8.3 after. The main finding of this study is that conversational hypnosis induced greater increase in comfort scales and ANI values than oral premedication.
Medical Research: What is conversational hypnosis? What does it consist of?Dr. Boselli: Conversational hypnosis consists of matching the patient's behavioral communication patterns, reflective listening, avoiding any negative suggestion (e.g. "Keep calm and quiet" instead of "Please don't move!") and focalizing the patient's attention on something else than the regional anesthesia procedure, such as the ultrasound machine screen.
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MedicalResearch.com Interview with:
Richard L. Rauck, M.D.
Director of Carolinas Pain Institute
Winston Salem, NC
Medical Research: How large is the problem of chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate?Dr. Rauck: Chronic pain affects more than 100 million Americans - more than diabetes, heart disease and cancer combined. It is the most common cause of long-term disability, costing the U.S. billions of dollars annually in medical costs and lost wages and productivity. Medical Research: What are the main medical conditions associated with this type of pain?Dr. Rauck: A National Institute of Health Statistics survey indicated that low back pain is the most common cause of chronic pain (27%), followed by severe headache or migraine pain (15%), neck pain (15%) and facial ache or pain (4%).
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MedicalResearch.com Interview with:
Benjamin W. Friedman MD, MS
Department of Emergency Medicine
Montefiore Medical Center
Albert Einstein College of Medicine
Bronx, New York
Medical Research: What is the background for this study? What are the main findings?
Dr. Friedman: Low back pain is responsible for 2.4% of visits to emergency departments resulting in 2.7 million visits annually. Pain outcomes for these patients are generally poor. One week after an ED visit in an unselected low back pain population, 70% of patients report persistent back-pain related functional impairment and 69% report analgesic use. Three months later, 48% report functional impairment and 46% report persistent analgesic use. Treatment of Low back pain with multiple concurrent medications is common in the ED setting. Data from a national sample show that emergency physicians often prescribe NSAIDs, skeletal muscle relaxants, and opioids in combination—26% of patients receive a NSAID combined with a skeletal muscle relaxant and 26% also receive an NSAID combined with an opioid. Sixteen percent of patients receive all three classes of medication. Several clinical trials have compared combination therapy with NSAIDS + skeletal muscle relaxants to monotherapy with just one of these agents. These trials have reported heterogeneous results. The combination of opioids + NSAIDS has not been well evaluated in patients with acute low back pain. Given the poor pain and functional outcomes that persist beyond an ED visit for musculoskeletal LBP and the heterogeneity in clinical care, we conducted a randomized comparative efficacy study with the following objective. To compare pain and functional outcomes one week and three months after ED discharge among patients randomized to a ten day course of:
1) naproxen + placebo
2) naproxen + cyclobenzaprine or
3) naproxen + oxycodone/acetaminophen.
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MedicalResearch.com Interview with:
Julie M. Fritz, PT, PhD, FAPTA
Professor, Department of Physical Therapy
Associate Dean for Research, College of Health
University of Utah
Salt Lake City, UT 84106
Medical Research: What is the background for this study? What are the main findings?
Dr. Fritz: Low back pain affects up to 80% of adults at some point in their lives and back pain is among the most common reasons why someone visits their primary care provider. Despite how common back pain is, the health care system does a surprisingly poor job of managing patients with the condition. There are many things that can happen at the initial primary care visit for back pain that are unhelpful or may even delay recovery such as ordering an MRI or prescribing opioids. Most practice guidelines recommend that primary care providers avoid ordering an MRI or opioid pain medication, reassure the patient that they will begin to feel better quickly and then wait a few weeks before considering referral to physical therapy. Others have suggested that earlier use of physical therapy may be more beneficial to patients. We conducted this study to compare early physical therapy with a wait-and-see approach.
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MedicalResearch.com Interview with: Alexander Egeberg, MD
Department of Cardiology
Herlev and Gentofte Hospital
Hellerup, Denmark
Medical Research: What is the background for this study? What are the main findings?
Dr. Egeberg: Psoriasis is a common chronic skin disease, with a strong inflammatory component. Within the last decade, our understanding of psoriasis have advanced significantly, and psoriasis is now widely regarded as a systemic disease, where the skin is a direct marker of disease activity. The inflammatory pathways in psoriasis have also been implicated in several central nervous system diseases such as depression, uveitis, and multiple sclerosis. Moreover, pain generation and sensitization can occur as a result of the pro-inflammatory mediators which are upregulated in psoriasis.
In the present study, we investigated the association between psoriasis and psoriatic arthritis, and the risk of new-onset migraine. The main finding was a psoriasis-severity dependent increased risk of new-onset migraine, and patients with severe skin psoriasis, and psoriatic arthritis appeared to have the highest risk.
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MedicalResearch.com Interview with:
Prof. Dr. Holger Lode
Clinical Immunology, Pediatrics
University of Greifswald, Greifswald
Medical Research: What is the background for this study?
Response: Neuroblastoma is a cancer in childhood with one of the highest death rates. Standard treatment is already very intensive. It includes chemotherapy, surgery, radiation, high dose chemotherapy followed by autologous stem cell transplantation. However, the progress made in improving survival rates is still poor.
The use of an immune-modulatory treatment with a neuroblastoma specific monoclonal antibody ch14.18 (100 mg/m2 /cycle) in combination with cytokines and 13cis retinoic acid (13 cis RA) has shown benefit for patients with this disease [1]. This antibody targets ganglioside GD2 abundantly expressed on neuroblastoma with limited to no expression on healthy tissue. Low expression of GD2 on pain fibers is associated with an on-target side effect of the treatment, which is the induction of neuropathic pain. Approval of ch14.18 (dinutuximab) for the treatment of children with neuroblastoma has been provided by FDA.
In Europe, ch14.18 was not available for a long time. There were several reasons why the antibody in the US could not be given to children in Europe. Therefore a new development of this side of the Atlantic was initiated following the remanufacturing of the antibody in CHO cells [2] (dinutuximab beta) and was made available within clinical trials of the SIOPEN group. The SIOPEN group is a network of leading European pediatric oncology centers to improve outcome for children with neuroblastoma (http://www.siopen.org), similar to the COG (children`s oncology group in the USA; https://www.childrensoncologygroup.org).
Following the recloning procedure, ch14.18/CHO was first evaluated for safety in a Phase I study [3], which confirmed the tolerability and showed activity at a dosing regimen of 20 mg/m2 given by 8 hour infusions on 5 consecutive days. Dinutuximab beta is further developed by Apeiron Biologics.
The current way to apply 100 mg /m2 / cycle is by 4 short term infusions of 25 mg/m2/day each over 8 hrs on 4 consecutive days. The entire treatment consists of 5 cycles. The drawback is that STI is associated with a high amount of intravenous morphine required to make this treatment tolerable for patients. Also the rate of inflammatory side effects observed is substantial.
Clinical observation indicates that if patients treated by STI suffer from pain despite analgesic treatments, a decrease in speed of antibody infusion improves this on target toxicity. Therefore, we hypothesized that significant prolongation of the time of antibody infusion will improve tolerability of that treatment, but at the same time maintains clinical activity and efficacy in high risk neuroblastoma patients.
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MedicalResearch.com Interview with:
Monika Goyal, MD
Pediatric emergency medicine
Children’s National Hospital
Washington, DC
Medical Research: What is the background for this study? What are the main findings?
Dr. Goyal: Appendicitis is a painful surgical condition and adequate analgesia, particularly with opioids, are considered one of the mainstays of management. We found that almost half of all children diagnosed with appendicitis did not receive any analgesia. Furthermore, among the patients that did receive analgesia, there were marked racial differences with black children having lower rates of opioid medication receipt than white children, even after we took pain scores or acuity level into account.
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MedicalResearch.com Interview with:
Lynn Webster, M.D.
Vice President of Scientific Affairs
PRA Health Sciences
(lead study investigator, and former President of the American Academy of Pain Medicine)Medical Research: What is the background for this study? What are the main advantages of the buccal film?Dr. Webster: Because of its partial agonist activity and high affinity for mu-opioid receptors, buprenorphine has the potential to precipitate withdrawal in patients who are already on mu-opioid full agonists. As a result, the current practice is to taper patients who are on around-the-clock (ATC) opioid therapy to a morphine sulfate equivalent (MSE) dose before switching to buprenorphine. But tapering can result in a loss of pain control for patients. For this study, we wanted to determine if patients on around-the-clock opioid full agonist therapy could be safely transitioned to buprenorphine HCl buccal film – an opioid partial agonist administered through the buccal mucosa – without the need for an opioid taper, and without inducing opioid withdrawal or sacrificing pain control. Buprenorphine HCl buccal film is the first pain product in development to combine the efficacy of buprenorphine with this unique delivery system, which allows for efficient and convenient delivery of buprenorphine into the bloodstream.
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MedicalResearch.com Interview with:
Dr. Sebastiano Mercadante MD
Director, Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit
La Maddalena Cancer Center, Palermo, Italy
Medical Research: What is the background for this study? What are the main findings?
Dr. Mercadante: Breakthrough cancer pain (BTcP) has been defined as a transitory increase in pain intensity that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background (1). Breakthrough cancer pain is a common problem in patients with cancer and is associated with significant morbidity. In a recent report in which a pragmatic definition of breakthrough cancer pain was used (2), the prevalence of BTcP was 75% (3).
Oral morphine (OM) has been traditionally offered as a breakthrough cancer pain medication in doses of about 1/6 of the daily opioid regimen for years, although this approach has never been supported by any evidence. Different technologies have been developed to provide a rapid onset of effect with potent opioid drugs such as fentanyl (rapid onset opioids, ROOs) delivered by non-invasive routes. Fentanyl products have been shown to be significantly superior to oral opioids, but it has been suggested that the dose of fentanyl should be individually titrated in order to enable effective analgesia to be delivered while minimizing the risk of clinically significant adverse effects. The need of dose titration with rapid onset opioids has never been appropriately assessed and this statement is derived by a series of weaknesses of papers published for regulatory issues. Indeed, the only existing study comparing dose titration and proportional doses, reported that proportional doses of (Fentanyl buccal tablet) FBT are more effective and safe over dose titration method. NICE guidelines did not provide evidence for that, at least at certain time intervals after administration.
To scientifically compare rapid onset opioids and oral morphine, we used a similar approach and made a strict selection of patients, according to a more specific algorithm for a diagnosis o fbreakthrough cancer pain. Thus, patients were randomized to receive in a crossover design Fentanyl buccal tablet and oral morphine, both given in doses proportional to opioid daily doses, for the management of breakthrough cancer pain.
This comparative study has shown that, when giving the drugs for breakthrough cancer pain in doses proportional to the opioid regimen for background pain, Fentanyl was clearly superior for efficacy and rapidity in comparison with oral morphine. The analgesic effect was more intense either at 15 and 30 minutes after study medications were given. A larger number of episodes treated with Fentanyl buccal tablet presented a decrease in pain intensity of ≥33% and ≥50% in comparison with episodes treated with oral morphine, and a relevant difference in SPID30 was reported. Of interest, adverse effects commonly observed in patients receiving opioids were not severe and did not differ between the treatments, suggesting that the use of proportional doses of both drugs are safe, reflecting what is derived by the long-lasting experience with oral morphine.(more…)
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MedicalResearch.com Interview with:
Daniel Steffens, Ph.D.
The George Institute for Global Health
The University of Sydney
Medical Research: What is the background for this study?
Dr. Steffens: Back pain is a leading cause of disease burden globally. At present, a variety of interventions, such as getting a 
