Use Of Placebo Treatments Research Articles

190 Placebo – to use or not to use? Survey on the use of placebo treatments

Patients´ and healthcare professionals´ attitudes to deceptive and open-label placebo treatments in clinical practice were evaluated by means of an anonymous survey.The overall attitude to deceptive placebo treatments was favourable amongst the 310 neurological patients and 100 medical patients/healthy participants taking part in the survey. The 90 healthcare pro- fessionals and 140 patients with a functional neurological disorder were more conservative, with equal numbers being in favour and against.An even more crucial factor is the considerable percentage being strongly opposed to deceptive placebo– 16% of neurological patients and 30% of patients with a functional neurological disorder.The majority of healthcare professionals had never used deceptive placebo, with an even smaller pro- portion ever having used open-label placebo. There was marked scepticism with regards to open-label placebo in all groups, with the general underlying belief that open-label placebo is fairly ineffectiveThe prohibition of deceptive placebo use in the UK seems to be in line with general concerns and oppo- sition to placebo. Future studies will show if the negative attitude to open-label placebo is justified or if this ethically viable option deserves more consideration.The survey is ongoing (to take part, visit https://is.gd/hcp_placebosurvey). The final numbers and conclu- sions may thus change.anne-catherine.huys.15@ucl.ac.uk

'External timing' of placebo analgesia in an experimental model of sustained pain.

Research on placebo analgesia commonly focuses on the impact of information about direction (i.e., increase or decrease of pain) and magnitude of the expected analgesic effect, whereas temporal aspects of expectations have received little attention so far. In a recent study, using short-lasting, low-intensity stimuli, we demonstrated that placebo analgesia onset is influenced by temporal information. Here, we investigate whether the same effect of temporal suggestions can be found in longer lasting, high-intensity pain in a Cold Pressor Test (CPT). Fifty-three healthy volunteers were allocated to one of three groups. Participants were informed that the application of an (inert-)cream would reduce pain after 5min (P5) or 30min (P30). The third group was informed that the cream only had hydrating properties (NE). All participants completed the CPT at baseline and 10 (Test 10) and 35min (Test 35) following cream application. Percentage change in exposure time (pain tolerance) from baseline to Test 10 (Δ10) and to Test 35 (Δ35) and changes in heart rate (HR) during CPT were compared between the three groups. Δ10 was greater in P5 than in NE and P30, indicating that analgesia was only present in the group that was expecting an early onset of analgesia. Δ35 was greater in P5 and P30 compared to NE, reflecting a delayed onset of analgesia in P30 and maintained analgesia in P5. HR differences between groups were not significant. Our data suggest that 'externally timing' of placebo analgesia may be possible for prolonged types of pain. Research on placebo effects mainly focuses on the influence of information about direction (i.e., increase or decrease of pain) and magnitude (i.e., strong or weak) of the expected effect but ignores temporal aspects of expectations. In our study in healthy volunteers, the reported onset of placebo analgesia followed the temporal information provided. Such 'external timing' effects could not only aid the clinical use of placebo treatment (e.g., in open-label placebos) but also support the efficacy of active drugs.

Are open-Label Placebos Ethical? Informed Consent and Ethical Equivocations.

The doctor-patient relationship is built on an implicit covenant of trust, yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebears, physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion that the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect and such effects necessarily involve a binary distinction between autonomy and beneficence. In this article we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically.

The development and assessment of biological treatments for children.

The development of biological agents with specific immunological targets has revolutionized the treatment of a wide variety of paediatric diseases where traditional immunosuppressive agents have been partly ineffective or intolerable. The increasing requirement for pharmaceutical companies to undertake paediatric studies has provided impetus for studies of biologics in children. The assessment of biological agents in children to date has largely relied upon randomized controlled trials using a withdrawal design, rather than a parallel study design. This approach has been largely used due to ethical concerns, including use of placebo treatments in children with active chronic disease, and justified on the basis that treatments have usually already undergone robust assessment in related adult conditions. However, this study design limits the reliability of the data and can confuse the interpretation of safety results. Careful ongoing monitoring of safety and efficacy in real-world practice through national and international biologics registries and robust reporting systems is crucial. The most commonly used biological agents in children target tumour necrosis factor-α, interleukin-1, interleukin-6 and cytotoxic lymphocyte-associated antigen-4. These agents are most frequently used in paediatric rheumatic diseases. This review discusses the development and assessment of biologics within paediatric rheumatology with reference to the lessons learned from use in other subspecialties.

Patients’ attitudes about the use of placebo treatments: telephone survey

Objective To examine the attitudes of US patients about the use of placebo treatments in medical care.Design One time telephone surveys.Setting Northern California.Participants 853 members of Kaiser Permanente Northern California,...

A role for placebo therapy in psychogenic movement disorders

Psychogenic movement disorders (PMDs) mimic known movement disorders but are not attributed to an underlying neurological pathology and are generally thought to have a psychological origin. Owing to the lack of a clear pathology, patients often experience multiple referrals, frequent office visits, and numerous--often fruitless--technically sophisticated tests and interventions. No standard of care exists for PMDs, and affected patients can experience debilitating symptoms for a lifetime. Some physicians advocate the use of placebo treatment for patients with PMDs, and placebo therapy can have beneficial neurophysiological effects. Innovative research will be necessary to develop effective therapeutics for psychogenic disorders and to make recommendations for future clinician training and health care policy. This Perspectives article aims to trigger international dialogue focusing on the diagnosis and treatment of patients with PMDs, and to reframe and deepen discussion of placebo prescribing for PMDs and beyond.

Placebo Treatments in Clinical Practice: Results of National Survey

Use of placebo treatments in clinical practice is ethically controversial. Opponents argue that using placebos entails deception and therefore violates

Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists

Objective To describe the attitudes and behaviours regarding placebo treatments, defined as a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment...

Use of placebos in clinical trials involving children and adolescents.

Medications are commonly prescribed to treat child and adolescent psychiatric disorders, despite limited research about the safety and efficacy of their use in this population (1). The lack of data on medication treatment creates a dilemma for the physician. Added to this dilemma are pressures on the physician to treat patients quickly and with the least costly intervention, a circumstance that is often interpreted to mean that medication should be prescribed early in the treatment process. Clearly, additional data are needed to improve our database on the safety and efficacy of psychopharmacologic agents for children and adolescents and to serve as a rational guide for clinical treatment. At the same time, controversy has developed about the use of placebos in psychopharmacological clinical trials involving children and adolescents as subjects. Some investigators have proposed that the use of placebo treatment is unnecessary and unethical, serving only to deprive subjects of active treatment; a version of this position has been outlined by Rothman and Michels (2). In fact, some have proposed that it would be preferable to use an active placebo, that is, a medication or a medication dosage thought to be ineffective in the treatment of the study condition. Unfortunately, child and adolescent psychiatric disorders are not well understood, particularly because of the lack of data on the course and the outcome of these disorders. As such, it is impossible to predict changes in symptoms for individuals or groups of individuals within any sample, much as is the case in research on adult psychiatric disorders (3). Therefore, without a placebo control within the study, researchers have no basis for judging whether a given study medication was associated with improvement or worsening of symptoms. Furthermore, subjects in child and adolescent trials often have a high rate of response to placebo. This paper summarizes the findings of two recent studies—one part of a controlled trial and the other a naturalistic study. The findings highlight the need for clinicians to exercise caution in prescribing medication early in the course of assessment and emphasize the need for placebo in clinical trials.

The Continued Use of Placebo-Controlled Clinical Trials in the Study of Peptic Ulcer Disease: A Sponsor Perspective

Investigators and institutional reviews boards who/which have participated in recent controlled gastroenterology clinical research studies assessing new therapies for peptic ulcer disease have questioned the continued use of a placebo-control when efficacious therapies for peptic ulcer disease are currently available. As the sponsor of such studies, Glaxo is of the opinion that the use of placebo-controlled clinical research studies is appropriate in certain situations. In choosing between the use of an active comparator or placebo-controlled trial Glaxo recommends an assessment of the severity of the disease and the morbidity associated with use of placebo treatment. It further recommends the need to assess the efficacy of placebo therapy to establish the baseline remission rate for the disease. Glaxo suggests an assessment of the safety data for the new chemical entity under investigation, and if such data are lacking, minimize patient risk employing suggested study designs that maximize patient utiliza...