Michael S. SAENGER MD
Sean MACKEY MD, PhD, CPE
Barbara L. KORNBLAU JD, OTR/L, CPE
Kevin L. ZACHAROFF MD, FACIP, FACPE, FAAP
Dr. Zacharoff sketches the background history of Prescription Drug Monitoring Programs, and offers an assessment of how well they are performing and how they can be improved. Watch the segment for recommendations on what you need to know to successfully engage these tools in your prescribing practice.
- Increasing Placebo Response Tied to Higher Failure Rate of US-Based Trials
Results of a new study accepted for publication in the journal Pain suggest that high, and increasing, rates of placebo response may be contributing to the escalating failure rate in clinical trials of drugs intended to control neuropathic pain. An interesting finding of the study is that the increase in placebo responses appears to be confined to trials conducted in the US. The study, conducted by researchers at McGill University, Montreal, examines 84 clinical trials conducted worldwide since 1990. The team found that pain reduction reported by patients in the placebo group increased to an average of 30% reduction in pain levels over the period. In examining aspects of the clinical trials that might explain the noted changes over time, the study found that in the US—but not outside the US—trials became longer and larger. Other possible factors, according to the authors, could be the existence of direct-to-consumer drug advertising in the US (New Zealand is the only other country in the world that allows this), the greater spread of for-profit “contract research organizations” in the US, and perhaps greater exposure to the placebo concept in popular media in this country. The effect, they note, is to elevate the failure rate of US based trials, as it becomes harder to differentiate response rates between the trial drug and placebo. Click here to access articles discussing placebos. Read a news story about the study findings, with link to the journal article, here.
- Advanced Bone Metastases Patients and a Proposed Palliative Care Service Model
A poster presentation scheduled for tomorrow at the 2015 Palliative Care in Oncology Symposium in Boston will detail recommendations for a new service model pairing radiation oncology with palliative care. Since its 2013 implementation at Mount Sinai Medical Center, New York, the approach has resulted in improved outcomes for patients, caregivers, and the health delivery system, according to a preliminary study of efficacy to be delivered by Mount Sinai researchers. The improvements include shorter duration of radiation treatments, fewer unfinished radiation treatments, and shorter hospital stays, with no diminution in reported pain relief. The researchers examined charts of patients with advanced cancer who received palliative radiation therapy for painful bone metastases. The study included 175 patients treated before the new service started and 161 treated after the new service was established. The team concluded that judicious use of shorter and more efficient radiation treatments within the new service model led to patients spending fewer days hospitalized. This is important, according to the authors, because of the importance that most patients ascribe to being able to spend more time outside of the hospital, particularly as they near the end of life. The support from palliative care services allowed patients and families to manage symptoms at home. Click here to access the painweek.org library of information about palliative care. Read a news story about the study findings here.
- Results of New Long Term Study Suggests Further Investigation is Warranted
A research team led by Mark Ware, MBBS, MRCP, MS, at McGill University Health Centre (MUHC) in Montreal, has published results of a multicenter study of the safety of medical cannabis when used by patients with chronic noncancer pain. The study results, appearing online in The Journal of Pain, conclude that chronic pain patients who used cannabis daily for one year, when carefully monitored, had no increase in serious adverse events compared to pain patients who did not use cannabis. The authors assert that their work will serve as a benchmark study on cannabis side effects when used for pain management. The study compared 215 patients with chronic noncancer pain who were either current or former users of medical cannabis to 216 controls—patients with chronic pain but who did not use cannabis—recruited from 7 clinics across Canada. The cannabis users received a quality-controlled, closely monitored dose of herbal cannabis (2.5 mg per day of product containing 12.5% THC). The researchers found no difference in risk of significant adverse effects between the groups. Based on the study findings, the researchers conclude that quality-controlled herbal cannabis, when used by cannabis-experienced patients as part of a monitored treatment program over one year, appears to have a reasonable safety profile, but that longer term monitoring for functional outcomes is needed. The study abstract, with link to the full journal article, may be read here.
- Tinnitus: Understanding Malfunctioning Neural Mechanisms
A research team from Georgetown University Medical Center and Germany’s Technische Universität München reports the identification of a shared brain malady that is a causal factor in tinnitus and in chronic pain that persists long after an initial injury. Identification of the neural mechanism is described as a first step in the development of effective therapies for these conditions. The research is detailed in this month’s edition of Trends in Cognitive Sciences. In both tinnitus and postinjury pain, the brain has been reorganized in response to an injury in its sensory apparatus, according to the authors. The neural mechanisms that normally “gate” or control noise and pain signals can become dysfunctional, leading to a chronic perception of these sensations. The brain regions responsible for these errant sensations are the nucleus accumbens, the reward and learning center, and several areas that serve “executive” or administrative roles—the ventromedial prefrontal cortex and the anterior cingulate cortex. These areas also affect the experience of various comorbidities such as depression and anxiety. But because these systems rely on transmission of dopamine and serotonin between neurons, drugs that modulate dopamine may help restore sensory gating, according to the researchers. Read a press release from Georgetown University Medical Center on the findings here. The journal abstract and full article may be read here.
Department of Public Health and Community Medicine
Tufts Medical Center