Randomised controlled trials that test for non-inferiority of the experimental arm are performed when a new treatment is compared with an established standard of care. Instead of being required to have superior clinical efficacy, the new treatment might be preferred for its improved safety, convenience, or reduced cost. These trials are increasingly prevalent because highly efficacious standard-of-care treatments have been established for many diseases, making demonstration of superiority against standard-of-care implausible and placebo controlled trials without any active comparators unethical to perform.1,2
A basic weakness of non-inferiority trials, compared with superiority trials, is that poor conduct of the trial or deviations from the protocol could result in false rejection of the null hypothesis that the experimental treatment is inferior. Most trials report that some participants do not adhere to their allocated treatment. Intention-to-treat analysis estimates the treatment effect accounting for this real world adherence pattern by comparing outcomes between groups of participants defined by their allocated treatment; it measures the effect of allocating a treatment on participant outcomes, instead of the actual effect of treatment (often called an effectiveness trial). If the primary research interest is the causal effect of assigning treatments, then this estimate is likely to be the most relevant. In other situations, the question of primary interest is the causal effect of the treatment itself. Because many patterns of non-adherence result in reduced observed differences between the comparison arms, there is a risk that relying on the intention-to-treat analysis to conclude non-inferiority will lead to the adoption of treatments which, when taken, lead to worse outcomes.Read More
A recent study published in The International Journal of Social Psychiatry analyzes how psychiatrists in the UK understand psychosis. Through interviews, the authors found several prominent “positions” on psychosis. They discovered three dominant positions—a biomedical understanding, a critical perspective focused on social context, and an ambivalent stance. The authors, Therese O’Donoghue and Jon Crossley from the Department of Neuroscience at the University of Leicester, also note several key themes discussed by psychiatrists, such as orthodox medical training, power hierarchies in the field, and the need for psychiatrists to appear invulnerable.
“Recently, there has been support from several influential figures in the field for a broader perspective on psychosis. Jim van Os argued that what are currently regarded as mental illnesses are better framed as vulnerabilities, as they are seldom ‘cured.’ They critiqued the evidence-based symptom reduction model which dominates service organizations because of its disconnection from the needs of patients,” O’Donoghue and Crossley write.
Separately, the prominent psychiatrist Sir Robin Murray publicly stated that he regretted ignoring social factors throughout his research career, and called for more research on environmental factors and epigenetics. He cautioned that those still clinging to a Kraepelinian model were refusing to accept the evidence base to the detriment of their patients.”
This week we present the second part of our podcast to join in the events for World Benzodiazepine Awareness Day 2020 (W-BAD). In part one, we interviewed Angela Peacock and talked about her experiences of taking and coming off benzodiazepines and also her involvement in the film Medicating Normal, which had a special screening and panel discussion on July the 11th at 1:00 PM EST.
And before we go on, I just wanted to say that these podcasts would not be possible without the efforts of W-BAD lead operations volunteer Nicole Lamberson, who goes above and beyond to make these interviews possible. Later in this episode, we will hear from Baylissa Frederick, who is a therapeutic coach and psychotherapist with over two decades’ experience working with clients affected by prescribed drug injury. But before we chat with Baylissa, I’m delighted to get the chance to talk with clinical pharmacologist Dr. Jim Wright.
Jim is Emeritus Professor in the Departments of Anesthesiology, Pharmacology, and Therapeutics in Medicine at the University of British Columbia. Jim obtained his MD from the University of Alberta in 1968, and his PhD in pharmacology from McGill University in 1976. He is a practicing specialist in internal medicine and clinical pharmacology. He is also Editor in Chief of the Therapeutics Letter and he sits on the editorial boards of PLoS One and the Cochrane Library. Dr. Wright’s research focuses on issues relating to the appropriate use of prescription drugs, clinical pharmacology, clinical trials, systematic review, meta-analysis, and knowledge translation.Read More
A paper published recently in the journal Research Involvement and Engagement overviews the current state of service user involvement in mental health research and practice in the UK. Peter Beresford, the author of the paper and self-described “writer, researcher, educator, activist, and (long term mental health) service user,” draws on his wide range of personal and professional experiences to summarize 40 years of public and service user involvement.
“I have been privileged to be part of the emerging psychiatric system survivor and disabled people’s movements over that period, as well as being involved in UK government developments at a high level, and in voluntary organizations, user-led and disabled people’s organizations (ULOs and DPULOs) and activities and also international schemes, as well as initiatives in other countries,” Beresford writes.
“This has offered me close-up insights into theory, policy, and practice developments over this period as well as opportunities to be part of them. It has introduced me to many people involved in such activities as policymakers, educators, practitioners, service users, and family carers.”Read More
I have depression and anxiety. These conditions are well-controlled most of the time, but when I have a significant dip, no one makes anything easier for me unless I explain it all to them — an unpleasant effort at the best of times and beyond my ken at the worst. When my depression mushrooms, I shun visibility; I walk so close to buildings that my shoulder becomes dirty. Because my intermittent disability is invisible, in the thick of it I have often felt compelled to make myself invisible. I neither anticipate nor receive public compassion.
Such social insensitivity is endemic to the lives of people with permanent but invisible disabilities that affect their daily functioning, who are likewise deprived of outer symbols to signal their condition.Read More
A 2018 article published in Ethical Human Psychology and Psychiatry argues that there are two primary false beliefs held by academic psychiatry related to the efficacy of antidepressants. The article was written by researchers with expertise on antidepressants and suicide risk, Michael Hengartner of Zurich University in Switzerland and Martin Plöderl of Paracelsus Medical University in Salzburg, Austria.
First, they explain that physicians often attribute antidepressant effects to pharmacological action rather than placebo effects. Second, academic psychiatry maintains that physical dependence on antidepressant drugs does not exist, and therefore any withdrawal or discontinuation symptoms are benign and affect only a small minority of users. These two remain pervasive within the field of psychiatry, despite a wealth of evidence suggesting that they are untrue. Hengartner and Plöderl point to the undue influence of the pharmaceutical industry as one of the forces maintaining the popularity of these misleading beliefs about antidepressants.
“The problem is presumably less with erroneous views expressed by patients and researchers critical of psychopharmacological drugs, but rather with false beliefs held by academic psychiatry and promoted by the pharmaceutical industry,” the authors write.Read More
We’ve all likely read about the many health benefits of hiking, which shows that spending time in nature is good for you. But even if you can’t escape the city, spending time in local parks and urban green spaces can still offer a number of great health benefits. Here we will take a look at 24 scientific studies showing how green space is good for you.
In a recent commentary in Adolescent Psychiatry, psychiatrist Edmund Levin addresses conflicting positions assumed by various key opinion leaders and major organizations regarding adolescent depression screening. Levin reveals that although organizations including the American Academy of Child and Adolescent Psychiatry (AACAP) and the American Academy of Pediatrics (AAP) have promoted the idea of scaling up youth depression screening, research increasingly indicates that this approach falls short in reality.
Levin argues that screening fails to improve outcomes for teens who screen positive. Drawing from personal, clinical experience with a patient whose “severe depression” classification he links to various contextual determinants, Levin illustrates the importance of more sophisticated evaluation methods than screening alone.
“Over-diagnosis needs to be considered as a contributor to the trend of increasing percentages of youth being diagnosed and medicated for a variety of mental health conditions, including depression,” Levin writes. “The possibility of over-diagnosis is magnified if screening is developed and promoted as a marketing tool by pharmaceutical companies, which in fact may be the case of calls for the use of depression screening devices.”Read More
While welcoming international recognition of mental health, Dainius Pūras, UN Special Rapporteur on the right to physical and mental health, told the Human Rights Council on Monday that “much more is still needed”.
“The global mental health status quo should move away from the outdated ‘mad or bad’ approach which seeks to prevent behaviours deemed as ‘dangerous’ or provide treatment considered ‘medically necessary’ without consent,” he said.Read More
Published in the journal Lancet Psychiatry, the small-scale study utilized doctors’ observations of patients in British hospitals during the pandemic’s exponential phase in April. Doctors were asked to report clinical details about COVID-19 patients whose neurological and psychological complications could suggest a neurological component to the disease.Read More