Are Sham Acupuncture Interventions More Effective than (Other) Placebos? A Re-Analysis of Data from the Cochrane Review on Placebo Effects

Background and Objective: A recent Cochrane review on placebo interventions for all kinds of conditions found that `physical placebos' (which included sham acupuncture) were associated with larger effects over no-treatment control groups than `pharmacological placebos'. We re-analyzed the data from this review to investigate whether effects associated with sham acupuncture differed from those of other `physical placebos'. Methods: All trials included in the Cochrane review as investigating `physical placebos' were classified as investigating either (sham) acupuncture or other physical placebos. The latter group was further subclassified into groups of similar interventions. Data from the Cochrane review were re-entered into the RevMan 5 software for meta-analysis. The primary analysis was a random-effects analysis of trials reporting continuous outcomes of trials that used either sham acupuncture or other physical placebos. Results: Out of a total of 61 trials which reported a continuous outcome measure, 19 compared sham acupuncture and 42 compared other physical placebos with a no-treatment control group. The trials re-analyzed were highly heterogeneous regarding patients, interventions and outcomes measured. The pooled standardized mean difference was -0.41 (95% confidence interval -0.56, -0.24) between sham acupuncture and no treatment and -0.26 (95% CI -0.37, -0.15) between other physical placebos and no treatment (p value for subgroup differences = 0.007). Significant differences were also observed between subgroups of other physical placebos. Conclusion: Due to the heterogeneity of the trials included and the indirect comparison our results must be interpreted with caution. Still, they suggest that sham acupuncture interventions might, on average, be associated with larger effects than pharmacological and other physical placebos

Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos

BackgroundPlacebo groups are used in randomised clinical trials (RCTs) to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects.Methods and FindingsWe conducted a content analysis of 45 Participant Information Leaflets (PILs) using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database). Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%), but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50:50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001) and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001) or adverse effects (4 vs. 39, p<001). 8 PILs (18%) explicitly stated that the placebo treatment was either undesirable or ineffective.ConclusionsPILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled trials

Relieving pain using dose-extending placebos

Placebos are often used by clinicians, usually deceptively and with little rationale or evidence of benefit, making their use ethically problematic. In contrast with their typical current use, a provocative line of research suggests that placebos can be intentionally exploited to extend analgesic therapeutic effects. Is it possible to extend the effects of drug treatments by interspersing placebos? We reviewed a database of placebo studies, searching for studies that indicate that placebos given after repeated administration of active treatments acquire medication-like effects. We found a total of 22studies in both animals and humans hinting of evidence that placebos may work as a sort of dose extender of active painkillers. Wherever effective in relieving clinical pain, such placebo use would offer several advantages. First, extending the effects of a painkiller through the use of placebos may reduce total drug intake and side effects. Second, dose-extending placebos may decrease patient dependence. Third, using placebos along with active medication, for part of the course of treatment, should limit dose escalation and lower costs. Importantly, provided that nondisclosure is pre-authorized in the informed consent process and that robust evidence indicates therapeutic benefit comparable to that of standard full-dose therapeutic regimens, introducing dose-extending placebos into the clinical arsenal should be considered. This novel prospect of placebo use has the potential to change our general thinking about painkiller treatments, the typical regimens of painkiller applications, and the ways in which treatments are evaluated

Prescribing Placebos

The use of placebos in medicine is an area of ethical questioning, but we often do not consider the effect of placebos on daily life. One’s preconceptions on the outcomes of exercise physically affect health. Studies show being aware of the advantages of exercise is beneficial to aspects of health such as blood pressure, blood glucose levels, and depression. This article analyzes how the placebo effect applies to exercise and how it can be taken advantage of to improve health outcomes

Strengthening the ethical assessment of placebo-controlled surgical trials : three proposals

Peer reviewedPublisher PD

HREC members\u27 personal values influence decision making in contentious cases

This article identifies 14 contentious issues faced by Human Research Ethics Committees (HRECs). The authors argue that HREC members will respond variably to these issues based on their own fundamental values and worldview. In particular, we propose that personal interpretations of current ethics regulations and HREC members’ attitudes to consequentialism, Kantianism, and utilitarianism in some cases affect their responses to contentious research issues. We seek to promote understanding of how personal and professional back­grounds of HREC reviewers influence their approaches to value-laden issues embedded in ethics applications. Taking the form of a literature review, our con­tribution highlights the need for further exploration of how HREC members make decisions, and what factors influence the outcomes of ethics applications

Impure placebo as an unsound concept and other problems in the paper by Howick et al. : [Comment]

Howick et al. have reported the findings of a survey that addressed the use of placebos among primary care practitioners in the United Kingdom. They adopted methodology similar to that used in previous studies performed in other countries; however, the use of this approach also means that they repeated the conceptual confusion of the previous surveys. Therefore the findings are not useful. ... The paper’s main finding “placebos are commonly used in UK primary care” is not correct. Only 0.9% of the responding general practitioners reported using pure placebos frequently. The frequency with which impure placebos are used is irrelevant because the concept is useless, as described above. Misleading a patient by administering inert substances without the explicit consent of the patient is unethical. The authors' proposal to “develop ethical and cost-effective placebos” is not possible because saving money by misleading patients is unethical. There is substantial conceptual confusion in the area of placebo and placebo-effect research, and the paper by Howick et al. does not help to reduce this confusion

Regulation with Placebo Effects

A growing scientific literature supports the existence of placebo effects from a wide range of health interventions and for a range of medical conditions. This Article reviews this literature, examines the implications for law and policy, and suggests future areas for research on placebo effects. In particular, it makes the case for altering the drug approval process to account for, if not credit, placebo effects. It recommends that evidence of placebo effects be permitted as a defense in cases alleging violations of informed consent or false advertising. Finally, it finds that tort law already has doctrines such as joint and several liability to account for placebo effects. Future research on placebo effects should focus on whether awareness of placebo effects can disable these effects and whether subjects can control their own placebo effects

Probiotic Biotherapy: Discussing its Influential Role in Oral Health

Introduction: Probiotics are widely known for their health promoting benefits, especially with its association to gastrointestinal health. For many years, most research has been focused on the prevention or treatment of gastrointestinal infections or diseases. However, recently probiotics has been a subject of investigation with its association to oral health. This review of literature is designed to analyze the effectiveness of using probiotics as a preventative and therapeutic method for oral infections/diseases such as periodontitis, dental caries, and the like. Methods: Databases such as the PubMed, and Google Scholar were utilized to find current and relevant findings for this reviewed literature. Mendeley was utilized to gather and store findings. Following keyword search items include probiotics, oral health, periodontal diseases, periodontitis, dental caries, gingivitis, halitosis, Lactobacilli, and biotherapy. Articles were narrowed down to include studies published within the last 5 years. Results: Short-term clinical studies suggest that the oral intake of probiotics show a strong inhibitory effect on the growth and biofilm formation of pathogenic strains, stimulate the immune function, and regulate the inflammatory response. Their repeated success in inhibiting harmful oral bacteria suggests that the use of probiotics holds a promising future in dentistry. Conclusion: Although still in its initial stages, the use of probiotics is being established as a living biotherapeutic designed to restore normal oral microflora in the oral cavity. More long-term clinical trials are needed to fully understand their functioning and substantiate their role in oral health.https://scholarscompass.vcu.edu/denh_student/1023/thumbnail.jp

Unethical aspects of homeopathic dentistry

In the last year there has been a great deal of public debate about homeopathy, the system of alternative medicine whose main principles are that like cures like and that potency increases relative to dilution. The House of Commons Select Committee on Science and Technology concluded in November 2009 that there is no evidence base for homeopathy, and agreed with some academic commentators that homeopathy should not be funded by the NHS. While homeopathic doctors and hospitals are quite commonplace, some might be surprised to learn that there are also many homeopathic dentists practising in the UK. This paper examines the statements made by several organisations on behalf of homeopathic dentistry and suggests that they are not entirely ethical and may be in breach of various professional guidelines