Introduction Patients require an accurate knowledge about placebos and their possible effects to ensure consent for placebo-controlled clinical trials is adequately informed. However, few previous studies have explored patients’ baseline levels of understanding and knowledge about placebos. The present online survey aimed to assess knowledge about placebos among patients with a history of back pain. Design A 15-item questionnaire was constructed to measure knowledge about placebos. Additional questions assessed sociodemographic characteristics, duration and severity of back pain, and previous experience of (...) receiving placebos. Setting Participants recruited from community settings completed the study online. Results 210 participants completed the questionnaire. 86.7% had back pain in the past 6 months, 44.3% currently had back pain. 4.3% had received a placebo intervention as part of a clinical trial and 68.1% had previously read or heard information about placebos. Overall knowledge of placebos was high, with participants on average answering 12.07 of 15 questions about placebos correctly. However, few participants correctly answered questions about the nocebo effect and the impact of the colour of a placebo pill. Conclusions The findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side effects. (shrink)

Complementary and alternative medicine research presents unique problems for research ethics committees which must be considered in some detail. Applying conventional research techniques to CAM raises a number of issues which ethics committees may find challenging. CAM is widely available and this will have a substantial effect on any proposed research strategy as so many individuals will have pre-existing opinions about these treatments. Whilst many complementary therapies may eventually be ‘validated’ by appropriate clinical trial methodologies other research methods could be (...) more appropriate in the early stages of a research strategy, particularly in view of the widespread availability in both the public and private sectors. Safety, efficacy, cost-effectiveness and patient preference also need evaluation; and these cannot be adequately assessed through double blind randomised placebo controlled trials. If the research question is clear, then thoughtful and often innovative evaluative processes can be designed to answer the socially and clinically relevant issues posed by this area of medicine. There are a number of agencies and organizations available to offer advice to ethics committees in this newly emerging field of CAM research including CAM Strategy Research and Development, the Foundation for Integrated Health and the Research Council for Complementary Medicine. (shrink)

Both spiritual experiences and mindfulness as a psychological variable have been identified as components of wellbeing and health. As there is uncertainty about their relationship, we have investigated the impact of spiritual experiences and mindfulness as well as their interaction on distress in chronically ill patients. The unidimensional Daily Spiritual Experiences Scale, the multidimensional Exceptional Experiences Questionnaire, the Freiburg Mindfulness Inventory, and the Brief Symptom Inventory were administered to 109 chronically ill patients. Fifty-eight patients reported regular and frequent spiritual or (...) contemplative practice from different traditions over an average of 14.7 years. Patients with regular spiritual practice reported more positive spiritual experiences, were more mindful and less distressed. A stepwise linear regression analysis revealed that the EEQ subscale “negative spiritual experiences” was the most important single predictor for psychological distress. In contrast, both the EEQ subscale “positive spiritual experiences” as well as the DSES that also captures positives daily encounters with a transcendental realm or entity did not account for a significant amount of variance in distress. Further analysis of the regression model, confirmed that NSE was still the largest predictor for distress and that mindfulness and the interaction between mindfulness and NSE were the most important buffers protecting individuals from distress. Thus, mindfulness seems not only to be a clinically important protective factor for buffering generic distress, but particularly for distress derived from NSEs. This suggests that in addition to directly facilitating well-being and health by means of positive spiritual experiences, at least some form of regular spiritual or meditative techniques seem to endow an individual with a certain degree of resilience against negative spiritual experiences that is likely a consequence of increased mindfulness. If these findings are vindicated by further studies, spiritual experiences should not be conceived and measured as univariate but rather multivariate constructs. (shrink)

Scientism is a philosophy which purports to define what the world ‘really is’. It adopts what the philosopher Thomas Nagel called ‘an epistemological criterion of reality’, defining what is real as that which can be discovered by certain quite specific methods of investigation. As a consequence all features of experience not revealed by those methods are deemed ‘subjective’ in a way that suggests they are either not real, or lie beyond the scope of meaningful rational inquiry. This devalues capacities that (...) (we argue) are in fact essential components of good reasoning and virtuous practice. Ultimately, the implications of scientism for statements of value undermine value-judgements essential for science itself to have a sound basis. Scientism has implications, therefore, for ontology, epistemology and also for which claims we can assert as objective truths about the world. Adopting scientism as a world view will have consequences for reasoning and decision-making in clinical and other contexts. We analyse the implications of this approach and conclude that we need to reject scientism if we are to avoid stifling virtuous practice and to develop richer conceptions of human reasoning. (shrink)