TAILIEUCHUNG - Alterations in Brain and Immune Function Produced by Mindfulness Meditation

Since biomarkers of safety and efficacy are becoming tools in drug development, it is necessary to determine whether these biomarkers can qualify for applications in clinical trials. Qualification is defined as “a conclusion that the biomarker data submitted support use of the biomarker in drug discovery, drug development or post approval studies and where appropriate, in regulatory decision making” (ICH E-16). A definition of validation was proposed during the workshop. Validation would refer to "establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a biomarker that. | Alterations in Brain and Immune Function Produced by Mindfulness Meditation Richard J. Davidson PhD Jon Kabat-Zinn PhD Jessica Schumacher ms Melissa Rosenkranz ba Daniel Muller MD PhD Saki F. Santorelli EdD Ferris Urbanowski ma Anne Harrington PhD Katherine Bonus ma and John F. Sheridan PhD Objective The underlying changes in biological processes that are associated with reported changes in mental and physical health in response to meditation have not been systematically explored. We performed a randomized controlled study on the effects on brain and immune function of a well-known and widely used 8-week clinical training program in mindfulness meditation applied in a work environment with healthy employees. Methods We measured brain electrical activity before and immediately after and then 4 months after an 8-week training program in mindfulness meditation. Twenty-five subjects were tested in the meditation group. a wait-list control group N 16 was tested at the same points in time as the meditators. At the end of the 8-week period subjects in both groups were vaccinated with influenza vaccine. Results We report for the first time significant increases in left-sided anterior activation a pattern previously associated with positive affect in the meditators compared with the nonmeditators. We also found significant increases in antibody titers to influenza vaccine among subjects in the meditation compared with those in the wait-list control group. Finally the magnitude of increase in left-sided activation predicted the magnitude of antibody titer rise to the vaccine. Conclusions These findings demonstrate that a short program in mindfulness meditation produces demonstrable effects on brain and immune function. These findings suggest that meditation may change brain and immune function in positive ways and underscore the need for additional research. Key words meditation mindfulness EEG immune function brain asymmetry influenza vaccine HIV human immunodeficiency .

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