Scientific Abstract

Proposal No. IBD-0213R
Principal Investigator:  David S. Rampton, DPhil
Applicant Organization:  Queen Mary and Westfield College, University of London (United Kingdom)
Project Title:  Hypnotherapy for prevention of relapse in ulcerative colitis: a randomized, single-blinded, controlled clinical trial
Period of Award:  October 1, 2007 – February 28, 2011

Relapse of ulcerative colitis (UC) can be provoked by psychological stress.  As yet, there have been no proper scientific studies to find out whether stress reduction can improve the course of UC.  Hypnotherapy is a technique by which a practitioner induces a temporary trance-like state in patients.  The practitioner uses suggestion to induce relaxation as well as beneficial modification of the way in which the patient experiences the gut working.  In previous studies in our lab funded by The Broad Foundation, we have shown that a single session of hypnosis can reduce measures of inflammation at both systemic and rectal mucosal levels.  Thus, 50min of gut-focussed hypnosis reduced serum interleukin-6 (IL6) and NK cell numbers in circulating blood, as well as rectal mucosal release of IL13, substance P and histamine.

Many patients with UC need to take the immunosuppressive, azathioprine, to keep their disease in remission.  While azathioprine is usually effective, it does carry the risk of side-effects.  We plan to study hypnotherapy to see whether it can prevent relapse of UC in patients who normally need to take azathioprine to keep their UC inactive.  To do this, we shall ask 66 patients who agree to participate in the trial to stop their azathioprine.  They will be allocated to receive either gut-focussed hypnotherapy (44 patients) or, as a control, non-emotive educational sessions (22 patients) once a month for 3 months, with intervening self-hypnosis daily in the active arm.  We shall then record relapse rates in each group after 6 months and at 1 year.  We shall diagnose relapse from patients’ diaries recording the Simple Clinical Activity Index, and by Baron score >1 at sigmoidoscopy.  We shall also measure routine blood tests (including CRP), serum IL6 and IL13 concentrations, as well as rectal mucosal release of substance P, TNFα, IL13 and histamine at 0, 1 month and 1 year to assess how hypnotherapy might reduce mucosal inflammation.

This clinical trial will test if a drug-free way with hypnosis will reduce the changes of relapse in patients with UC withdrawing from treatment with azathioprine.  It should also shed further light on the ways in which the brain affects the function of the inflamed bowel.