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In postoperative pain following the extraction of the third molar (Levine et al., 1981; Levine and Gordon, 1984), a hidden intravenous injection of 6–8 mg morphine corresponded to an open intravenous injection of saline solution in full view of the patient (placebo). In other words, telling the patient that a painkiller was being injected (with …
Continue reading "Open Administration of Placebos Greatly Increases Effectiveness"
In recent years, the placebo effect has been a topic of considerable interest both in the scientific and the clinical community. In this time, the placebo effect has evolved from being considered a nuisance in clinical and pharmacological research to becoming a neurobiological phenomenon worthy of scientific investigation in its own right. Recent research shows that placebo effects are genuine psychobiological events attributable to the overall therapeutic context and that these effects can be robust in both laboratory and clinical settings. These psychosocially induced biochemical changes in a patient's brain and body may, in turn, affect the course of a disease and the response to therapy. Here we summarize and discuss the current insights into placebo mechanisms and discuss the potentially widespread implications for research and clinical practice. Even though a systematic knowledge of placebo effects across the lifespan is lacking, we aim at highlighting specific aspects related to the care of elderly patients and those suffering from neurodegenerative diseases.
Behavior analysts have shown that a single-subject experimental design (SSED) is a useful tool for identifying the effectiveness of specific therapeutic techniques, whereas researchers outside applied behavior analysis (ABA) maintain that randomized placebo-controlled trials (RPCT) provide the most definitive test of efficacy. In this paper, the possible benefits that could result from supporting SSED studies by placebo control groups are discussed. However, the use of placebo groups in psychotherapy research arouses considerable controversy and many researchers argue against it. The main aim of this paper is to clarify theoretical and methodological problems associated with using placebo groups in psychotherapy research and to demonstrate that these problems can be solved if the assumptions on which they are based are reformulated. The article also discusses ethical issues about the use of placebo groups in research on the effectiveness of psychotherapy.
This “Dodo bird verdict” (DBV) — everybody has won — has been applied to a long-time and never-ending debate about which psychotherapy approach is more effective in treating patients in need of psychotherapy (1), psychodynamic psychotherapy (PDPT), cognitive-behavioral psychotherapy (CBT), or one of the many other therapy modalities that exist in between and beyond and claim to be the best for all and everybody. Psychotherapists of all colors and proveniences have a clear answer to this question: Mine is the best because I believe it in and I am good at it…... The empirical side of this competition tells a different story. Whenever different psychotherapies were tested in clinical trials against another therapy of the same or different kind or against another control condition (see below), the effects of one therapy was not that much different from another therapy. Meta-analyses of today (2) confirm what Rosenzweig described in the classical DBV paper 80 years ago (1): All psychotherapies operate with similar assumptions, implement similar means, and generate similar results, based on what has been called “common factors” that are immanent to all psychotherapy traditions.
But when you look at the distribution of genuine placebo publications in our database (3) (Figure) it was not before the late 1950's when placebo research started to slowly grow, and two milestone papers mark the beginning of it: Henry Beecher’s ever-since-cited paper, “The Powerful Placebo,” of 1955 (4), and Stewart Wolf’s almost completely forgotten, “The Pharmacology of Placebos,” of 1959 (5)
When Lee D. Park, M.D. and Uno Covi, M.D. from the Department of Psychiatry at Johns Hopkins University School of Medicine in Baltimore, MD, back in the 1960s, gave their depressed patients placebos, they did exactly this — told them that the pill did not contain an active pharmacological agent (at that time, likely a classical tricyclic antidepressant), but was a placebo. They were surprised to see that it did work (1): 14 of their 15 patients reported improved symptoms a week later, and no difference was found between those that had believed they were taking the placebo and those that had — upon questioning — believed they had received a real drug.
For many years, placebos have been conceptualized by their inert content and their use as controls in clinical trials and treatments in clinical practice. Recent research demonstrates that placebo effects are genuine psychobiological phenomenon attributable to the overall therapeutic context, and that placebo effects can be robust in both laboratory and clinical settings. Evidence has …
Continue reading "Placebo Effects: Biological, Clinical and Ethical Advances"
Background: Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether open-label placebo (non-deceptive and non- concealed administration) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome (IBS). Findings: Open-label placebo produced significantly higher mean (6SD) global improvement scores (IBS-GIS) at both 11- day midpoint (5.261.0 vs. 4.061.1, p,.001) and at 21-day endpoint (5.061.5 vs. 3.961.3, p = .002). Significant results were also observed at both time points for reduced symptom severity (IBS-SSS, p = .008 and p = .03) and adequate relief (IBS-AR, p=.02 and p=.03); and a trend favoring open-label placebo was observed for quality of life (IBS-QoL) at the 21-day endpoint (p = .08). Conclusion: Placebos administered without deception may be an effective treatment for IBS. Further research is warranted in IBS, and perhaps other conditions, to elucidate whether physicians can benefit patients using placebos consistent with informed consent.
Randomized placebo-controlled trials are recognized as the gold-standard of evidence-based medicine but when it comes to psychotherapy research all that g litters is not gold. Translation of this standard from medicine to clinical psychology is fraught with difficulties. While a wealth of robust evidence shows that psychotherapy is effective for a range of mental health conditions the use of placebo controls to assess the effectiveness of specific psychological interventions faces serious conceptual and methodological challenges (Gaab et al., 2018). In this Opinion article we identify two under-appreciated placebo-related problems which substantially risk the validity of clinical trials in psychotherapy. The first is a common misconception about the nature of placebos; the second is the problem of double-blinding. We review current solutions and future prospects for the gold-standard in psychotherapy research.