Controlling for non-specific effects of acupuncture in clinical trials |
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| Affiliation: | 1. Department of Internal Medicine, Diakonessenhuis Utrecht, The Netherlands;2. Department of Geriatric Medicine, Gelre Hospitals, Apeldoorn, The Netherlands;3. Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands;4. Department of Medical Oncology, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands;5. Department of Geriatric Medicine, Diakonessenhuis, Utrecht, The Netherlands;1. Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02115, USA;2. Department of Endocrinology, School Of Medicine, Pontificia Universidad Catolica De Chile, Santiago 8330074, Chile;3. Division of Endocrinology, Diabetes and Metabolism, Cedars-Sinai Medical Center, Los Angeles, CA 90048;4. Centre Investigation Clinique, Assistance Publique- Georges Pompidou; Institut National de la Sante et de la Recherche Medicale, Unite Mixte de Recherche en Sante 970, Universite Paris Descartes, Paris 75014, France;5. Cardiovascular Genetics Research Unit, University of Utah School of Medicine Salt Lake City, Utah 84112;6. Vanderbilt University Medical Center, Nashville, TN 37232;7. Channing Division of Network Medicine, Brigham and Women’s Hospital, Boston, MA 02115;8. Institute for Translational Genomics and Population Sciences and Department of Pediatrics, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA 90502;9. Research and Evaluation Branch, Kaiser Permanente of Southern California, Pasadena, CA 91188;10. Medical Genetics Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048;11. Departments of Medicine and Physiology and Biophysics, University of Southern California Keck School of Medicine, CA 90033 |
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| Abstract: | ![]()
Placebo controlled trials are used to examine the relative size of the specific effects of a therapy. When the therapy is a manual treatment like acupuncture, placebo control models are very complex due to the range of non-specific effects that can occur and issues such as blinding. This article examines ten different research models that have been used to control for placebo or other non-specific effects in clinical trials of acupuncture. Through an examination of the different non-specific effects that can occur in acupuncture therapy, it explores the relative ability of these ten models to control for the placebo and other non-specific effects. Three models are eliminated as probably unable to adequately control for these effects and therefore unable to explore the specific effects of acupuncture. The strengths and weaknesses of the remaining seven models are analyzed. Finally, methods and assessments needed to control for non-specific effects are discussed so that these seven models can be used to control for these effects and thus the models can examine the specific effects of acupuncture treatment. |
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