Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial

Summary

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.

Conditions

• Ulcerative Colitis

Interventions

BEHAVIORAL

Gut focussed hypnotherapy

Gut focussed hypnotherapy

BEHAVIORAL

Control educational sessions

Control educational sessions

Sponsors & Collaborators

• Barts & The London NHS Trust

  collaborator OTHER

• Queen Mary University of London

  lead OTHER

Principal Investigators

• David S Rampton, MAFRCP DPhil · Barts and the London/Queen Mary School of Medicine and Dentistry, London.

• Anton Emmanuel, MBBS MD FRCP · University College London Hospital, London

• Louise Langmead, MBBS MD MRCP · Univesity College London Hospital , London

• Jeremy D Sanderson, MBBSFRCP MD · Guy's and St Thomas'NHS Trust/King's College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2010-04-30

Completion

2010-04-30

Countries

• United Kingdom

Study Locations