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Program in Placebo Studies

For many years, the placebo effect was considered to be no more than a nuisance variable that needed to be controlled in clinical trials. Only recently have researchers redefined it as the key to understanding the healing that arises from medical ritual, the context of treatment, the patient-provider relationship and the power of imagination, hope and expectation.

Although our biomedical health care system often considers these dimensions of care as secondary to the administration of pharmaceuticals and procedures, the emerging field of placebo studies is producing scientific evidence that these more humanistic elements of medicine may fundamentally contribute to the improvement of patient care.

Over the past ten years an informal network of researchers at Harvard Medical School has taken a leading role in establishing the field of placebo studies. In July 2011, the Department of General Medicine and Primary Care invited these researchers to create the world's first interdisciplinary center for placebo research. The Harvard-wide Program in Placebo Studies and the Therapeutic Encounter (PiPS) hosted at Beth Israel Deaconess Medical Center pursues placebo studies through interdisciplinary, translational research initiatives that bridge the basic, clinical and social sciences, as well as the humanities.

PiPS draws its faculty from across Harvard Medical School's teaching hospitals and the Faculty of Arts and Sciences at Harvard University.  The PiPS advisory board includes Fabrizio Benedetti, MD, of the University of Turin, Italy; Tor Wager, PhD, of the University of Colorado; Emeran Mayer, MD, of UCLA; and Pradrag Petrovic, MD, of the Karolinska Institute, Sweden.

PiPS is led by the following members of the Harvard faculty:
Ted Kaptchuk, Director
Irving Kirsch, PhD, Associate Director
Anthony Lembo, MD, Director of Clinical Research
Randy Gollub, MD, Director of Neuroscientific Research
Anne Harrington, PhD, Director of Initiatives in the Humanities
John Kelley, PhD, Director of Psychological Research
Roger B. Davis, ScD, Director of Statistics (BIDMC)
Efi Kokkoutou, MD, PhD, Director of Molecular Biological Research

One of the primary motivations for creating PiPS was to provide an environment in which young researchers could develop careers in placebo studies. As a result, a significant portion of our resources are dedicated to providing post-doctoral fellowships and opportunities for mentorship and collaboration between fellows and senior researchers. PiPS participates in a Harvard-wide BIDMC NIH T-32 fellowship program.

Just as evidence-based scientific research drives the progress of medical therapy, so too evidence-based research is needed to guide and enhance the art of medicine. Traditionally, the art of medicine has been understood as a humanistic orientation sequestered from medical science and technology. Research on the placebo response provides a fruitful opportunity for developing rigorous knowledge that can bridge this gap in the service of patient care.

Until PiPS researchers began contributing to the field of placebo studies, there had been comparatively little patient-centered research aimed at harnessing placebo responses in the treatment of common illnesses. PiPS has addressed this gap by creating a comprehensive agenda for placebo research that targets high-priority clinical challenges and their underlying biological, psychosocial and cultural mechanisms.

•  Irritable Bowel Syndrome (IBS) studies investigating whether placebo effects are dose dependent and how they can best be utilized in clinical practice.
•  Asthma physiological experiments delineating the malleability of placebo responses.
•  Chronic pain studies comparing two types of placebo interventions - sham needles versus placebo pills -- for pain relief.
•  Depression studies investigating novel uses of placebo effects.

• Performing neuroimaging studies clarifying the brain mechanisms of placebo analgesia.
• Investigating the neurobiology of physicians while they treat patients.
• Elucidating genetic signatures of the placebo response.

Our research in the SOCIAL SCIENCES includes:
• Examining how patients' and practitioners' psychological profiles influence their response to placebo.
• Investigating patients' cultural narratives while receiving placebo treatment.
• Analyzing social-demographic variables associated with placebo responses.

Our research in the HUMANITIES AND BIOETHICS includes:
• Ethical analyses surrounding the use of placebos in research and clinical practice.
• Philosophic and theoretical papers that contribute new hypotheses and insights about the
 relationship between the mind and the body.
• Historical analyses of the history of placebo effects and placebo controls.

• Analyses of bias and potential distortions in scientific research, including placebo research.
• Analyses of potential limitations of the reliability of single-methodology studies.
• Investigations into more efficient methods for detecting drug-placebo differences in clinical trials.
• Studies comparing the outcomes of clinical trials with and without "placebo run in" periods.

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