Concentration/meditation as a novel means to limit inflammation: a randomized controlled pilot study

Auto-immune diseases are characterized by an inappropriate inflammatory
response against tissues in the body and represent a major health care burden.
Pro-inflammatory cytokines such as TNF-α, IL-6 and IL-1β play a central role in
the pathophysiology of many auto-immune diseases. Innovative therapies aimed at
limiting pro-inflammatory cytokine production in a more physiological manner
are warranted. In previous research conducted in an individual known as *the
iceman*, we found that, through a autodidact concentration/meditation
technique, he appears to mount a controlled stress response, characterized by
activation of the sympathetic nervous system and enhanced production of
cortisol, both of which are known to result in immunosuppression. In
accordance, while practicing this concentration/meditation technique, the
inflammatory response during human endotoxemia (lipopolysaccharide [LPS]
administration) was remarkably low in this individual. Therefore, this
technique could provide a novel means of controlling the inflammatory response.
However, the aforementioned results were obtained in just one subject, and
hence can not serve as scientific evidence for the effectiveness of the
concentration/meditation technique. The iceman claims that he can teach this
technique to other subjects within a relatively short time frame.

Therefore, in the present study we wish to investigate the effect of
concentration/meditation on autonomic nervous system activity and the
inflammatory response during experimental human endotoxemia in a controlled
manner, by comparing a group of subjects that are trained by *the iceman* and
practice the concentration/meditation technique with a group of subjects which
do not.

The main objective of the study is to determine the effect of practicing the
iceman*s concentration/meditation technique on the inflammatory response during
human endotoxemia (lipopolysaccharide [LPS] administration in healthy
volunteers).

Secondary objectives are
1. To determine the effects of concentration/meditation on the stress response
and autonomic nervous system activity.
2. To determine the effects of the concentration/meditation technique on blood
gas parameters.

Parallel randomized controlled pilot study in healthy male volunteers during
experimental endotoxemia.

Concentration/meditation for 3 hours starting 30 minutes before LPS
administration. To master the concentration/meditation technique, a group of
subjects (concentration/meditation training group, n=18) will be trained by the
iceman in the concentration/meditation technique. Of these 18 subjects, a group
of 12 subjects will be randomly selected; these 12 subjects comprise the
*concentration/meditation group*. 12 other subjects which are not trained
comprise the *control group*. Subjects of both the concentration/meditation
group and the control group (total n=24) participate in the human endotoxemia
trial (administration of an intravenous bolus [2 ng/kg] of LPS derived from E
coli O:113), during which the concentration/meditation group will practice the
concentration/meditation technique.

All subjects will visit the hospital for a screening visit in which a medical
interview and physical examination will be carried out (30 minutes). The
concentration/meditation training group will be trained by the iceman and his
team for approximately 10 days (including self study at home). The iceman and
his team have trained over 500 subjects (including more than 30 patients with
varying illnesses), and no side effects have ever occurred. The control group
will receive no training or self-study assignments. The subjects that
participate in the human endotoxemia trial will be admitted to the hospital on
the endotoxemia experiment day (10 hours). During the endotoxemia experiment
day, volunteers will receive an arterial line that will be placed under local
anaesthesia. Furthermore, a venous cannula will be placed for the
administration of fluids and LPS. The administration of LPS induces flu-like
symptoms for approximately 4-6 hrs. This model of systemic inflammation has
been applied for many years in thousands of subjects in various research
centres in the world. LPS administration is considered safe and no long-term
effects have ever been documented. At the Radboud University Medical Centre,
over 280 volunteers have received more than 350 injections of LPS. Therefore,
there is sufficient experience with this model at this centre. In total,
approximately 350 ml blood will be drawn during the study, which is comparable
to previous human endotoxemia studies and has never resulted in adverse events.
Subjects may not benefit directly from participation to the study, although
mastering the iceman*s techniques is considered a benefit by many. A subject
fee is provided.