Ulcerative Colitis Clinical Trial
Official title:
Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial
There is increasing evidence that worsening of ulcerative colitis (UC) can be provoked by
psychological stresses. When this protocol was devised, there had 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: while
they are in this state, 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, we have shown that a single 50 minute session of hypnosis can
reduce special indicators of inflammation both in the blood-stream and in the lining of the
lower bowel (rectum). Furthermore, in earlier work by others, hypnosis had been shown to be
effective in the treatment of patients with irritable bowel syndrome, duodenal ulcer and
indigestion unassociated with ulcers.
Many patients with UC need to take the immunosuppressive drug, azathioprine, in addition to a
5ASA drug, to keep their disease under control. While azathioprine is usually effective in
maintaining remission of UC, it does require regular drug checks and carries the risk of
possible side-effects. We undertook a study of hypnotherapy to see whether it can prevent
relapse (worsening) of UC in patients who normally need to take azathioprine to keep their UC
inactive. To do this, we planned to ask 66 patients who agreed to participate in the trial to
stop their azathioprine. They were then to 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. The
numbers of patients in each group who developed relapse of their UC in a year were recorded.
We diagnosed relapse from patients' diaries recording diarrhoea and bleeding, and by
sigmoidoscopy.
It was hoped that this clinical trial would identify a new drug-free way of reducing the
chances of relapse in patients with UC.
SCIENTIFIC ABSTRACT There is increasing evidence that relapse of ulcerative colitis (UC) can
be provoked by psychological stress. When this study was planned, there were 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: while they are in this state, 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, we had shown that a single session of hypnosis can
reduce measures of inflammation at both systemic and rectal mucosal levels. Thus, 50 min of
gut-focussed hypnosis reduced serum interleukin-6 (IL6) and non-killer (NK) cell numbers in
circulating blood, as well as rectal mucosal release of interleukin-13 (IL13), substance P
and histamine. Furthermore, in earlier work by others, hypnosis had been shown to be
effective in the treatment of patients with irritable bowel syndrome, duodenal ulcer and
indigestion unassociated with ulcers.
Many patients with UC need to take the immunosuppressive, azathioprine, in addition to a
5ASA, to keep their disease in remission. While azathioprine is usually effective in
maintaining remission of UC, it does require regular drug checks and carries the risk of
possible side-effects. We undertook a study of hypnotherapy to see whether it could prevent
relapse of UC in patients who normally need to take azathioprine to keep their UC inactive.
To do this, we planned to ask 66 patients who agreed to participate in the trial to stop
their azathioprine. They were then to 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 then
recorded relapse rates in each group at 1 year. We diagnosed relapse from patients' diaries
recording the Simple Clinical Activity Index, and by Baron score >1 at sigmoidoscopy.
It was hoped that this clinical trial would identify a new drug-free way of reducing the
chances of relapse in patients with UC withdrawing from treatment with azathioprine.
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