Archive for the ‘Clinical Trials / Drug Trials’ Category
March 10, 2010
A new randomized trial shows that on average, three months after receiving a series of 10 massage sessions, patients had half the symptoms of anxiety. This improvement resembles that previously reported with psychotherapy, medications, or both. But the trial, published in the journal Depression and Anxiety, also found massage to be no more effective than simple relaxation in a room alone with soft, soothing music. “We were surprised to find that the benefits of massage were no greater than those of the same number of sessions of ‘thermotherapy’ or listening to relaxing music,” said Karen J. Sherman, PhD, MPH, a senior investigator at Group Health Research Institute. “This suggests that the benefits of massage may be due to a generalized relaxation response.” Massage therapy is among the most popular complementary and alternative medical (CAM) treatments for anxiety, she added. But this is the first rigorous trial to assess how effective massage is for patients with generalized anxiety disorder. The trial randomly assigned 68 Group Health patients with generalized anxiety disorder to 10 one-hour sessions in pleasant, relaxing environments, each presided over by a licensed massage therapists who delivered either massage or one of two control treatments: * Relaxation therapy: breathing deeply while lying down * Thermotherapy: having arms and legs wrapped intermittently with heating pads and warm towels All three treatments were provided while lying down on a massage table in a softly lighted room with quiet music. All participants received a handout on practicing deep breathing daily at home. Unlike the two control treatments, massage was specifically designed to enhance the function of the parasympathetic nervous system and relieve symptoms of anxiety including muscle tension. Using a standard rating scale in interviews, the researchers asked the patients about the psychological and physical effects of their anxiety right after the 12-week treatment period ended and three months later, Dr. Sherman said. All three of the groups reported that their symptoms of anxiety had decreased by about 40 percent by the end of treatment – and by about 50 percent three months later. In addition to the decline in anxiety, the patients also reported fewer symptoms of depression and less worry and disability. The research team detected no differences among the three groups; but the trial did not include a control group that got no treatment at all. “Treatment in a relaxing room is much less expensive than the other treatments (massage or thermotherapy), so it might be the most cost-effective option for people with generalized anxiety disorder who want to try a relaxation-oriented complementary medicine therapy,” Dr. Sherman said.
March 04, 2010
Filed Under (Clinical Trials / Drug Trials, Neurology / Neuroscience, Parkinson's Disease, Psychology/psychiatry) by Aashi
Scientists are beginning to find out why people with Parkinson’s disease often feel socially awkward. Parkinson’s patients find it harder to recognize expressions of emotion in other people’s faces and voices, report two studies published by the American Psychological Association. One of the studies raises questions about how deep brain stimulation, the best available treatment for patients who no longer respond to medication, more strongly affects the recognition of fear and sadness. A neurodegenerative disorder, Parkinson’s causes tremors, stiffness and balance problems, as well as fairly frequent depression and dementia. In the March issue of Neuropsychology, Heather Gray, PhD, and Linda Tickle-Degnen, PhD, report that people with Parkinson’s disease, compared with matched controls, often have difficulty discerning how others are feeling. Their meta-analysis of 34 different studies using data from 1,295 participants shows a robust link between Parkinson’s and specific deficits in recognizing emotions, especially negative emotions, across different types of stimuli and tasks. The meta-analysis, conducted at Harvard Medical School and Tufts University, found that patients typically had some degree of problem identifying emotion from faces and voices. Further clarification is provided in a second study that showed that deep-brain stimulation, compared with medication, caused a consistently large deficit in the recognition of fear and sadness two key facial expressions that, when understood, aid survival. That study is published in the January issue of Neuropsychology. Researchers led by Julie Péron, PhD, at the Centre Hospitalier Universitaire de Rennes in France, compared the ability of people with Parkinson’s in three different groups to recognize facial emotions: 24 advanced patients implanted with deep-brain stimulators after they didn’t respond or were sensitive to oral levodopa (the usual drug for the disease); 20 advanced patients given apomorphine hydrochloride by injection or infusion pump while they waited an implant; and 30 healthy controls. Researchers tested all participants using standard photographs of facial expression before and three months after they were treated. Before implantation of the stimulators, all participants read facial expressions equally well. Patients in the surgical group were implanted with stimulators, electrical devices that prod the brain’s subthalamic nucleus, a small, lens-shaped structure, to normalize the nerve signals that control movement. This nucleus is part of the basal ganglia system, which is thought to integrate movement, cognition and emotion. Three months after treatment, only the patients with stimulators not the drug-treated patients or the healthy controls were significantly worse at recognizing fear and sadness. Patients with stimulators confused those expressions with others, such as surprise, or even no emotion. Medicated patients and healthy controls were either accurate about fear and sadness or occasionally mistook them for other negative emotions, such as disgust. “Having Parkinson’s predisposes an individual to errors in emotion recognition,” said Gray. “The research in France, along with previous studies, indicates that deep-brain stimulation produces an even more severe deficit.” Why would treating a movement disorder affect the perception of emotions? Implants affect a part of the brain that reaches across functions, so the authors suggested that the same electrical stimulation that calms over-excited motor activity may also somehow inhibit emotional processing. Although the impact of Parkinson’s and deep-brain stimulation varies by patient, it’s important to understand. “The first step is to educate patients and their close associates about the potential for emotion recognition difficulties, so they can learn to manage some of the social consequences, such as misunderstanding and frustration,” said Gray and Tickle-Degnen. The next step might be training in emotion recognition, which they said has shown promise.
March 04, 2010
This study shows that cognitive behavioural therapy (CBT) is effective in dealing with patients suffering from lupus and high levels of daily stress as it significantly reduces the incidence of psychological disorders associated with lupus and improves and maintains patients’ QOL, despite there being no significant reduction in the disease activity index. A study that is published in the current issue of Psychotherapy and Psychosomatics by a group of Spanish investigators addresses the role of cognitive behavioral treatment in systemic lupus erythematosus. Chronic stress worsens the quality of life (QOL) of lupus patients by affecting their physical and psychological status. The effectiveness of a cognitive-behavioural intervention in a group of patients with lupus and high levels of daily stress was investigated. Forty-five patients with lupus and high levels of daily stress were randomly assigned to a control group (CG) or a therapy group (TG); they received cognitive behavioural therapy (CBT) which consisted of ten consecutive weekly sessions. The following variables were evaluated at baseline and at 3, 9 and 15 months: (1) stress, anxiety, depression, (2) Systemic Lupus Erythematosus Disease Activity Index, somatic symptoms, number of flares, (3) anti-nDNA antibodies, complement fractions C3 and C4 and (4) QOL. A multivariate analysis of repeated measures and various analyses of variance were carried out. The investigators found a significant reduction in the level of depression, anxiety and daily stress in the TG compared to the CG and a significant improvement in QOL and somatic symptoms in the TG throughout the entire follow-up period. They did not find any significant changes in the immunological parameters. CBT is effective in dealing with patients suffering from lupus and high levels of daily stress as it significantly reduces the incidence of psychological disorders associated with lupus and improves and maintains patients’ QOL, despite there being no significant reduction in the disease activity index.
March 02, 2010
Filed Under (Clinical Trials / Drug Trials, Neurology / Neuroscience, Stroke, Women's Health / Gynecology) by Aashi
New research shows women who don’t receive a clot-busting drug after a stroke fare worse than men who are not treated. The study is published in the March 2, 2010, print issue of Neurology®, the medical journal of the American Academy of Neurology. “Women need to be treated for stroke as soon as possible,” said study author Michael D. Hill, MD, MSc, FRCPC, with the University of Calgary in Alberta, Canada. “We found that women who weren’t treated had a worse quality of life after stroke than men. However, the good news is that women who were treated responded just as well as men to the treatment.” For the study, scientists examined information from a stroke database on 2,113 people who had experienced a stroke. Of those, 232 were treated with the clot-busting drug known as tissue plasminogen activator (tPA) and 44 percent were women. Men and women were separately placed in groups based on whether they received tPA within three hours after their stroke. After six months, the people were interviewed by phone about their ability to function and quality of life. The study found that women who did not receive the clot-busting drug were 12 percent less likely than men to have a good outcome six months later, or 58 percent of the women compared to 70 percent of men. However, women who were treated with these medications fared about the same as men who took the clot-buster drug. “There could be many reasons why women who weren’t treated with the clot-busting drug fared worse than men, including biological reasons,” said Hill. “One social reason may be that more than 30 percent of women were widowed compared to seven percent of men at the time of stroke, and therefore did not have a spouse who could act as a caregiver. Also, post-stroke depression is more common in women than in men, which slows down recovery.”
January 20, 2010
Filed Under (Clinical Trials / Drug Trials, Parkinson's Disease, Rehabilitation / Physical Therapy) by Aashi
Treadmill training can be used to help people with Parkinson’s disease achieve better walking movements, say researchers. In a systematic review of the evidence, Cochrane Researchers concluded treadmill training could be used to improve specific gait parameters in Parkinson’s patients. Gait hypokinesia, characterised by slowness of movement, is one of the main movement disorders that affects Parkinson’s patients and can have a major impact on quality of life. More recently, health professionals have started incorporating exercise into treatment regimes as a useful complement to traditional drug therapies. Training on treadmills is one option that may help to improve movement. The researchers analysed data from eight trials including 203 patients for the review, published in The Cochrane Library. They compared treadmill training versus no treadmill training, using effects on walking speed, stride length, number of steps per minute (cadence) and walking distance to measure improvement in gait. Treadmill training had a positive impact on each of these measurements, apart from cadence. “Treadmill training appears to be a safe and effective way of improving gait in patients with Parkinson’s disease,” said lead researcher Jan Mehrholz, of the Wissenschaftliches Institut in Kreischa, Germany. “Crucially, we saw very few adverse effects or drop outs in patients given this type of rehabilitation therapy.” However, the researchers say the findings must be treated with care as they are based on a limited number of small trials. “There is still a need for larger trials to establish if treadmill training can be safely used as a routine therapy for Parkinson’s patients,” said Merhholz. “We also need to answer basic questions about how long the benefits last and what a good training programme should consist of. For instance, how often and how long should patients train for?”
January 20, 2010
Filed Under (Clinical Trials / Drug Trials, HIV / AIDS) by Aashi
Intensive home-based nursing in HIV/AIDS patients significantly improves self-reported knowledge of HIV, awareness of medications, and self-reported adherence to medication programmes, according to a new Cochrane Systematic Review. One home-based care trial included in the review also significantly impacted on HIV stigma, worry, and physical functioning. It did not, however, help improve depressive symptoms, mood, general health, and overall functioning. These conclusions are interesting, but more research is needed to understand the impact of home-based care in developing countries and on important disease outcomes, say the researchers. The study represents the first systematic review of the impact of home care in HIV/AIDS. As a disease that affects 33 million people, HIV/AIDS puts a huge strain on health systems, particularly in developing countries. Therefore, in countries where health services are overstretched, home-based care is offered to HIV patients as an alternative to hospital care. Home-based care can include counselling, medical management, exercise, and spiritual support to try to improve patients’ quality of life in familiar surroundings, while reducing costs and pressure on hospital beds. Researchers examined data from 13 studies, two of which were ongoing. The researchers report that home-based care has positive impacts on some aspects of patient wellbeing but little effect on others. Patients said that home care improved their knowledge of the disease, and of HIV medications, and helped them adhere to medication programmes. It also reduced worry and improved physical functions of patients, but had little effect on depression, general health, or indicators of disease progression such as CD4 counts. Importantly, few studies considered the effects of home-based care in developing countries or on important disease outcomes. “Further large studies are needed to evaluate the effects of home-based care in developing countries, where HIV and AIDS take the biggest toll,” said Young. “And there should be a greater focus on how home-based care impacts on progression to full blown AIDS and death from the disease.” “This study is a useful addition to the literature because of the wide range of home care options considered. However, there is no doubt that the evidence base for home-based care in HIV needs further development.”
January 19, 2010
A randomised controlled trial of fish oil given intravenously to patients in intensive care has found that it improves gas exchange, reduces inflammatory chemicals and results in a shorter length of hospital stay. Researchers writing in BioMed Central’s open access journal Critical Care investigated the effects of including fish oil in the normal nutrient solution for patients with sepsis, finding a significant series of benefits. Philip Calder, from the University of Southampton, UK, worked with a team of researchers to carry out the study in 23 patients with systemic inflammatory response syndrome or sepsis in the Hospital Padre Américo, Portugal. He said, “Recently there has been increased interest in the fat and oil component of vein-delivered nutrition, with the realization that it not only supplies energy and essential building blocks, but may also provide bioactive fatty acids. Traditional solutions use soybean oil, which does not contain the omega-3 fatty acids contained in fish oil that act to reduce inflammatory responses. In fact, soybean oil is rich in omega-6 acids that may actually promote inflammation in an excessive or unbalanced supply”. Calder and his colleagues found that the 13 patients in the fish oil group had lower levels of inflammatory agents in their blood, were able to achieve better lung function and left hospital earlier than the 10 patients who received traditional nutrition. According to Calder, “This is the first study of this particular fish oil solution in septic patients in the ICU. The positive results are important since they indicate that the use of such an emulsion in this group of patients will improve clinical outcomes, in comparison with the standard mix”.
January 16, 2010
Filed Under (Clinical Trials / Drug Trials, Psychology/psychiatry) by Aashi
Have you ever accidentally pulled your headphone socket out while listening to music? What happens when the music stops? Psychologists believe that our brains continuously predict what is going to happen next in a piece of music. So, when the music stops, your brain may still have expectations about what should happen next. A new paper published in NeuroImage predicts that these expectations should be different for people with different musical experience and sheds light on the brain mechanisms involved. Research by Marcus Pearce Geraint Wiggins, Joydeep Bhattacharya and their colleagues at Goldsmiths, University of London has shown that expectations are likely to be based on learning through experience with music. Music has a grammar, which, like language, consists of rules that specify which notes can follow which other notes in a piece of music. According to Pearce: “the question is whether the rules are hard-wired into the auditory system or learned through experience of listening to music and recording, unconsciously, which notes tend to follow others.” The researchers asked 40 people to listen to hymn melodies (without lyrics) and state how expected or unexpected they found particular notes. They simulated a human mind listening to music with two computational models. The first model uses hard-wired rules to predict the next note in a melody. The second model learns through experience of real music which notes tend to follow others, statistically speaking, and uses this knowledge to predict the next note. The results showed that the statistical model predicts the listeners’ expectations better than the rule-based model. It also turned out that expectations were higher for musicians than for non-musicians and for familiar melodies which also suggests that experience has a strong effect on musical predictions. In a second experiment, the researchers examined the brain waves of a further 20 people while they listened to the same hymn melodies. Although in this experiment the participants were not explicitly informed about the locations of the expected and unexpected notes, their brain waves in responses to these notes differed markedly. Typically, the timing and location of the brain wave patterns in response to unexpected notes suggested that they stimulate responses that synchronise different brain areas associated with processing emotion and movement. On these results, Bhattacharya commented, “… as if music indeed ‘moves’ us!” These findings may help scientists to understand why we listen to music. “It is thought that composers deliberately confirm and violate listeners’ expectations in order to communicate emotion and aesthetic meaning,” said Pearce. Understanding how the brain generates expectations could illuminate our experience of emotion and meaning when we listen to music.
January 16, 2010
Filed Under (Clinical Trials / Drug Trials, Diabetes) by Aashi
A new evidence review suggests that using a pump to deliver insulin continuously instead of taking three or more daily injections might result in better control of blood sugar for people with type 1 diabetes. “The findings of this review tell us that both continuous subcutaneous insulin infusion and multiple injections correct blood glucose levels. However, [continuous infusion] may be better for reducing harmful fluctuations in blood glucose,” said lead author Marie Misso, Ph.D. Type 1 diabetes which used to be known as juvenile diabetes results when the pancreas is not able to secrete enough insulin, causing the levels of glucose (or sugar) in the blood to rise. Chronically high blood glucose can lead to heart attacks, circulation problems and blindness. Low levels can lead to unconsciousness and even death. Type 1 diabetes is one of the most common chronic diseases of childhood. Most people with the condition control their glucose by injecting themselves with insulin three or more times per day. Others choose to use a pump, which gives continual, smaller doses of insulin without the discomfort of injections. “There are numerous studies that evaluate these treatments, but most are of poor quality,” said Misso, a research fellow at the Monash Institute of Health Services Research in Clayton, Australia. “So there has been uncertainty about which treatment is best for maintaining consistent levels of blood glucose and reducing harmful fluctuations.” In the new review, Misso and colleagues analyzed the results of 23 studies that assigned 976 adults and children to one of the two interventions randomly. Researchers looked at measures such as levels of hemoglobin A1c (or HbA1c), a widely used marker for assessing long-term glucose control. They also looked at the incidence of both high and low blood glucose. The review appears in the latest issue of The Cochrane Library, a publication of the Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic. While participants using the insulin pump had significantly lower HbA1c levels than those using multiple daily injections, no differences existed between the two for non-severe low blood glucose levels. However, there appeared to be a reduction in severe incidents of low blood glucose among those using the pump. “Good evidence is now available to support the use of continuous subcutaneous insulin infusion in the appropriate patient. It is essential to consider adverse events, late complications of diabetes, mortality and cost when deciding whether [a pump] is appropriate for the patient,” Misso said. For people who likely have to deal with their condition for the rest of their lives, convenience is another consideration that comes into play. The advantages of using the insulin pump include being able to avoid possibly painful injections several times a day. In addition, pumps administer the medication without the user having to find a private place to give the injection. The downside to pump use includes having to wear it like a pager or cell phone throughout the day, concerns about protecting the tubing that goes into the body although wireless pumps have recently come on the market and worries about breaking the pump during rough play or exposure to water. Ramin Alemzadeh, M.D., director of the Diabetes Program at the Children’s Hospital of Wisconsin in Milwaukee, cautioned that although the researchers reported pumps might improve glucose control overall, pediatric patients should not expect major changes in the longer-term control of blood glucose. “In our experience, we don’t see a significant overall blood glucose improvement beyond six months or one year of treatment in most children and adolescents. Initially, the patient’s HbA1c levels improve, but after a while levels begin to rise and are not significantly different from where they started,” Alemzadeh said. “A patient’s diabetes management starts with them and their family. How well they do is independent of which method of insulin administration they use.”
January 14, 2010
Filed Under (Clinical Trials / Drug Trials, Depression, Mental Health, Sleep / Sleep Disorders) by Aashi
Wives of soldiers deployed to Iraq and Afghanistan are more likely to be diagnosed with depression, anxiety, sleep disorders and other mental health conditions than women whose husbands are not deployed, according to a new study by researchers at the University of North Carolina at Chapel Hill and the Uniformed Services University of the Health Sciences. The study, published Jan. 14, 2010, in The New England Journal of Medicine, examined medical records of the wives of active duty U.S. Army personnel, comparing those whose husbands were serving abroad with those whose husbands were not deployed. “This study confirms what many people have long suspected,” said Alyssa Mansfield, Ph.D., the study’s lead author, who conducted the research as a doctoral student at the UNC Gillings School of Global Public Health and is now a research epidemiologist at RTI International. “It provides compelling evidence that Army spouses are feeling the impact of recent deployments to Iraq and Afghanistan. The result is more depression, more stress, more sleepless nights.” Understanding the scope of the problem can help the U.S. military better plan mental health prevention and treatment programs for the families of active duty personnel, she said. The study also may provide insight into families’ long-term medical needs. The researchers examined medical records of more than 250,000 female spouses of active duty Army personnel for outpatient care received between 2003 and 2006. About 31 percent of the wives’ husbands were not deployed during that period, while about 34 percent were overseas for between one and 11 months and 35 percent were deployed for longer. Although the three groups were similar in size, the study found almost 3,500 more diagnoses of mental health conditions among wives of soldiers deployed for less than a year, compared to the group of wives of non-deployed soldiers. Also, there were more than 5,300 additional diagnoses among wives of soldiers deployed for a year or longer. Depression, anxiety, sleep disorders and acute stress reaction and adjustment disorders were the most commonly diagnosed conditions among both groups. Spouses of deployed military personal naturally fear for their loved ones’ safety, Mansfield said. But they also often face challenges maintaining a household, coping as a single parent and dealing with the marital strain that comes with being apart for an uncertain amount of time. “The majority of active duty soldiers are married, so we need to pay attention to the needs of their families, both short and long term,” Mansfield said. “These findings should help the military medical system better plan mental health programs not only for treatment, but also for support and prevention.” |
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