Placebos in practice.
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SUBMITTER: Spiegel D
PROVIDER: S-EPMC524090 | biostudies-literature | 2004 Oct
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND: The placebo and the placebo effect are often investigated in the context of clinical trials. Little data exist on the use of placebos in the course of routine health care. OBJECTIVE: The aim of this study is to describe a group of academic physicians' use of placebos and their knowledge, attitudes, and beliefs about placebos and the placebo effect. DESIGN: A 16-question anonymous web-based survey of physicians from Internal Medicine departments of 3 Chicago-area medical schools was used. RESULTS: There were 231/466 (50%) physicians who responded; of these, 45% reported they had used a placebo in clinical practice. The most common reasons for placebo use were to calm the patient and as supplemental treatment. Physicians did not widely agree on the definition of a placebo and had a variety of explanations for its mechanism of action. Ninety-six percent of the respondents believed that placebos can have therapeutic effects, and up to 40% of the physicians reported that placebos could benefit patients physiologically for certain health problems. Only 12% of the respondents said that placebo use in routine medical care should be categorically prohibited. Regarding "placebo-like" treatment, 48% of respondents reported giving at least 1 type of treatment in a situation where there was no evidence of clinical efficacy. CONCLUSION: Nearly half of the respondents use placebos in clinical practice and most believe in the mind-body connection. The results of this study, based on retrospective self-reported behavior, are subject to recall bias and may not be representative of American physicians.
| S-EPMC2173915 | biostudies-other
Project description:Although placebos have long been considered a nuisance in clinical research, today they represent an active and productive field of research and, because of the involvement of many mechanisms, the study of the placebo effect can actually be viewed as a melting pot of concepts and ideas for neuroscience. Indeed, there exists not a single but many placebo effects, with different mechanisms and in different systems, medical conditions, and therapeutic interventions. For example, brain mechanisms of expectation, anxiety, and reward are all involved, as well as a variety of learning phenomena, such as Pavlovian conditioning, cognitive, and social learning. There is also some experimental evidence of different genetic variants in placebo responsiveness. The most productive models to better understand the neurobiology of the placebo effect are pain and Parkinson's disease. In these medical conditions, the neural networks that are involved have been identified: that is, the opioidergic-cholecystokinergic-dopaminergic modulatory network in pain and part of the basal ganglia circuitry in Parkinson's disease. Important clinical implications emerge from these recent advances in placebo research. First, as the placebo effect is basically a psychosocial context effect, these data indicate that different social stimuli, such as words and rituals of the therapeutic act, may change the chemistry and circuitry of the patient's brain. Second, the mechanisms that are activated by placebos are the same as those activated by drugs, which suggests a cognitive/affective interference with drug action. Third, if prefrontal functioning is impaired, placebo responses are reduced or totally lacking, as occurs in dementia of the Alzheimer's type.
| S-EPMC3055515 | biostudies-literature
Project description:ObjectivesTo better understand which theoretically plausible placebogenic techniques might be acceptable in UK primary care.DesignA qualitative study using nominal group technique and thematic analysis. Participants took part in audio-recorded face-to-face nominal groups in which the researcher presented six scenarios describing the application in primary care of theoretically plausible placebogenic techniques: (1) Withholding side effects information, (2) Monitoring, (3) General practitioner (GP) endorsement, (4) Idealised consultation, (5) Deceptive placebo pills and (6) Open-label placebo pills. Participants voted on whether they thought each scenario was acceptable in practice and discussed their reasoning. Votes were tallied and discussions transcribed verbatim.SettingPrimary care in England.Participants21 GPs in four nominal groups and 20 'expert patients' in five nominal groups.ResultsParticipants found it hard to decide which practices were acceptable and spoke about needing to weigh potential symptomatic benefits against the potential harms of lost trust eroding the therapeutic relationship. Primary care patients and doctors felt it was acceptable to harness placebo effects in practice by patient self-monitoring (scenario 2), by the GP expressing a strongly positive belief in a therapy (scenario 3) and by conducting patient-centred, empathic consultations (scenario 4). Deceptive placebogenic practices (scenarios 1 and 5) were unacceptable to most groups. Patient and GP groups expressed a diverse range of opinions about open-label placebo pills.ConclusionsAttempts to harness placebo effects in UK primary care are more likely to be accepted and implemented if they focus on enhancing positive patient-centred communication and empathic relationships. Using placebos deceptively is likely to be unacceptable to both GPs and patients. Open-label placebos also do not have clear support; they might be acceptable to some doctors and patients in very limited circumstances-but further evidence, clear information and guidance would be needed.
| S-EPMC7044897 | biostudies-literature
Project description:Clinical trials use placebos with the assumption that they are inert, thus all placebos are considered to be equal. Here we show that this assumption is wrong and that different placebo procedures are associated to different therapeutic rituals which, in turn, trigger different mechanisms and produce different therapeutic outcomes. We studied high altitude, or hypobaric hypoxia, headache, in which two different placebos were administered. The first was placebo oxygen inhaled through a mask, whereas the second was placebo aspirin swallowed with a pill. Both placebos were given after a conditioning procedure, whereby either real oxygen or real aspirin was administered for three consecutive sessions to reduce headache pain. We found that after real oxygen conditioning, placebo oxygen induced pain relief along with a reduction in ventilation, blood alkalosis and salivary prostaglandin (PG)E2, yet without any increase in blood oxygen saturation (SO2). By contrast, after real aspirin conditioning, placebo aspirin induced pain relief through the inhibition of all the products of cyclooxygenase, that is, PGD2, PGE2, PGF2, PGI2, thromboxane (TX)A2, without affecting ventilation and blood alkalosis. Therefore, two different placebos, associated to two different therapeutic rituals, used two different pathways to reduce headache pain. The analgesic effect following placebo oxygen was superior to placebo aspirin. These findings show that different placebos may use different mechanisms to reduce high altitude headache, depending on the therapeutic ritual and the route of administration. In clinical trials, placebos and outcome measures should be selected very carefully in order not to incur in wrong interpretations.
| S-EPMC4633056 | biostudies-literature
Project description:Practice Programmatic Submission
| PRJEB26575 | ENA
Project description:Phase 1 preventive HIV vaccine trials are often designed as randomized, double-blind studies with the inclusion of placebo recipients. Careful consideration is needed to determine when the inclusion of placebo recipients is highly advantageous and when it is optional for achieving the study objectives of assessing vaccine safety, tolerability and immunogenicity. The inclusion of placebo recipients is generally important to form a reference group that ensures fair evaluation and interpretation of subjective study endpoints, or endpoints whose levels may change due to exposures besides vaccination. In some settings, however, placebo recipients are less important because other data sources and tools are available to achieve the study objectives.
| S-EPMC4554766 | biostudies-literature
Project description:This study investigated the efficacy of an open-label placebo (OLP) treatment for menopausal hot flushes. Women with at least five moderate or severe hot flushes per day were allocated to receive four weeks of OLP for twice a day or no-treatment. Intention-to-treat analyses included n = 100 women. In comparison to no-treatment, OLP reduced the log-transformed hot flush composite score (frequency × intensity) (mean difference in change: - 0.32, 95% CI [- 0.43; - 0.21], p < 0.001, Cohen's d = 0.86), hot flush frequency (- 1.12 [- 1.81; - 0.43], p = 0.02, Cohen's d = 0.51), and improved overall menopause-related quality of life (- 2.53 [- 4.17; - 0.89], p = 0.02, Cohen's d = 0.49). Twelve (24%) (vs. three [6%]) patients had 50% lesser hot flushes. Problem rating of hot flushes and subdomains of quality of life did not improve. After four weeks, the OLP group was further divided via randomization to continue or discontinue the treatment. Benefits were maintained at week 8 (log-transformed score: - 0.04 [- 0.06; 0.14], p = 0.45). There was no difference between taking placebos for 8 or 4 weeks (log-transformed score: 0.04 [- 0.17; 0.25], p = 0.73). Results indicate that open-label placebos may be an effective, safe alternative for menopausal hot flushes.
| S-EPMC7674475 | biostudies-literature
Project description: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).Two-group, randomized, controlled three week trial (August 2009-April 2010) conducted at a single academic center, involving 80 primarily female (70%) patients, mean age 47 ± 18 with IBS diagnosed by Rome III criteria and with a score ? 150 on the IBS Symptom Severity Scale (IBS-SSS). Patients were randomized to either open-label placebo pills presented as "placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes" or no-treatment controls with the same quality of interaction with providers. The primary outcome was IBS Global Improvement Scale (IBS-GIS). Secondary measures were IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR) and IBS Quality of Life (IBS-QoL).Open-label placebo produced significantly higher mean (±SD) global improvement scores (IBS-GIS) at both 11-day midpoint (5.2 ± 1.0 vs. 4.0 ± 1.1, p<.001) and at 21-day endpoint (5.0 ± 1.5 vs. 3.9 ± 1.3, 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).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.ClinicalTrials.gov NCT01010191.
| S-EPMC3008733 | biostudies-literature
Project description:ObjectiveTo provide the first quantitative data on the use of the term "placebo" in the 19th century.DesignComputer search of BMJ's archival database from January 1840 (the first issue) through December 1899 for uses of the words "placebo(s)." Grounded theory was used to categorise the implications of uses of the term.Results71 citations contained the term "placebo(s)." Of these, 22 (31%) used the term to mean "no effect" or as a general pejorative term, 18 (25%) portrayed placebo treatment as permitting the unfolding of the natural history (the normal waxing and waning of illness), 14 (20%) described placebo as important to satisfy patients, 7 (10%) described it as fulfilling a physician's performance role, 3 (4%) described its use to buy time, 3 (4%) described its use for financial gain, 2 (3%) used it in a manner similar to a placebo control, and only one implied that placebo could have a clinical effect. Only one citation mentioned telling the patient about his placebo treatment.ConclusionNineteenth century physicians had diverse a priori assumptions about placebos. These findings remind us that contemporary medicine needs to use rigorous science to separate fact from its own beliefs concerning the "provision of care." As in previous generations, ethical issues concerning placebos continue to challenge medicine.
| S-EPMC3525309 | biostudies-literature