Clinical Trials in Integrative Therapies
Section snippets
Overview of Clinical Trials
Clinical trials are a set of procedures or processes in research performed to collect safety and efficacy data about an intervention.7, 8 Clinical trials are the cornerstone of evidence-based medicine and, despite some limitations,8 are the best accepted evidence of efficacy. There are three phases of human clinical trials (phase IV trials will not be addressed). Phase I trials are often first in human trials, designed to test the safety and maximum tolerated dose of a therapy. They are most
Strategies for Success
Unique challenges related to studying mind-body interventions (as opposed to natural products) include the expertise and education or competency required by the intervener (whether provider or patient [self] delivered), and whether all components are being delivered or received as intended (intervention fidelity). When designing and reporting on mind-body interventions, investigators should consider the expertise, training, and/or certification necessary for the personnel who are providing the
Conclusion
Appropriate innovative strategies and methodology for studying various integrative therapies exist and have been demonstrated in some studies as discussed above. When studying natural products, clinical researchers would benefit from partnering with basic scientists to understand preclinical data related to the substance(s) of interest. Phase II studies to evaluate dose effects, adverse events, time to benefit, and using a placebo control to account for placebo and nocebo effects, would go a
Debra L. Barton, RN, PhD, AOCN®, FAAN: Associate Professor, Oncology, Mayo Clinic Cancer Center, Rochester, MN.
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2018, Australian Critical CareCitation Excerpt :Moreover, the evidence suggests improvements in sleep quality, patient satisfaction with care and cost of care as domains that merit further investigation. The evaluation of integrative therapy approaches through the standard randomised trial design can have many shortcomings due to inherent differences in the philosophy and pace of such modalities compared to standard care.38 For example, mind–body techniques, such as GI, require engagement of the whole self, ideally both of the participants and of the interveners.
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Debra L. Barton, RN, PhD, AOCN®, FAAN: Associate Professor, Oncology, Mayo Clinic Cancer Center, Rochester, MN.
Deirdre R. Pachman, MD: Department of Medicine, Mayo Clinic, Rochester, MN.