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

This study has been terminated.
(Unable to recruit sufficient numbers of patinets in the time available)
Sponsor:
Collaborator:
Barts & The London NHS Trust
Information provided by (Responsible Party):
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT00553163
First received: November 2, 2007
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

There is increasing evidence that worsening of ulcerative colitis (UC) can be provoked by psychological stresses. 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: 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). Further more, in earlier work by others, hypnosis has 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 now plan to undertake 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 shall ask 66 patients who agree to participate in the trial to stop their azathioprine. They will then 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 the numbers of patients in each group who develop relapse of their UC after 6 months and after a year. We shall diagnose relapse from patients' own diaries recording diarrhoea and bleeding, and by sigmoidoscopy. As part of these studies, we shall also do particular blood tests and take specimens from the lining of the rectum during the sigmoidoscopy to assess by special laboratory testing how hypnotherapy might be working to reduce inflammation in the bowel.

It is hoped that this clinical trial will identify a new drug-free way of reducing the chances of relapse in patients with UC. It should also shed further light on the ways in which the brain can affect the function of the inflamed bowel


Condition Intervention
Ulcerative Colitis
Behavioral: Gut focussed hypnotherapy
Behavioral: Controlled educational sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Relapse: The proportion of patients suffering a relapse will be compared between the two treatment groups, and is the primary outcome parameter of this study. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sigmoidoscopy and assessment of mucosal inflammatory response. Psychological status Systemic measures of inflammation and stress Rectal mucosal inflammation Inflammatory Bowel Disease Questionnaire (IBDQ) and Faecal calprotectin [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: October 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Gut-focussed hypnotherapy (GFH).
Behavioral: Gut focussed hypnotherapy
Gut focussed hypnotherapy
Sham Comparator: B
n/a
Behavioral: Controlled educational sessions
Controlled educational sessions

Detailed Description:

SCIENTIFIC ABSTRACT There is increasing evidence that 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: 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 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 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 has 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 now plan to undertake a study of 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 then 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, tumour necrosis factor (TNFα), IL13 and histamine at 0, 1 month and 1 year to assess how hypnotherapy might reduce mucosal inflammation.

It is hoped that this clinical trial will identify a new drug-free way of reducing the chances 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.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inactive UC
  • Age 16-75 years
  • Minimum 1 year on Azathioprine or Mercaptopurine.
  • Simple Colitis Activity Index (SCCAI) score <3
  • Baron's sigmoidoscopic score <2 .
  • In remission for at least 3 months
  • No change to other maintenance therapy (including 5ASA) for at least 4 months

Exclusion Criteria:

  • Use of prednisolone orally or topically, or of topical 5ASA for at least 3 months Antibiotics, warfarin, anti-diarrhoeal drugs, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin > 75 mg/day
  • Herbal remedies
  • Alcohol or drug abuse
  • Pregnancy or breast feeding
  • Female of child-bearing age not taking adequate contraception
  • Participation in another drug trial in the previous three months
  • Serious liver, renal, cardiac, respiratory, endocrine, neurological or psychiatric illness
  • Already use relaxation techniques or computerized feedback
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553163

Locations
United Kingdom
Barts and The Royal London NHS Trust/Queen Mary University London/
London, United Kingdom, E1 1BB
Guy's and St Thomas' NHS Trust
London, United Kingdom, SE1 7EH
University College Hospital London
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
Queen Mary University of London
Barts & The London NHS Trust
Investigators
Principal Investigator: David S Rampton, MAFRCP DPhil Barts and the London/Queen Mary School of Medicine and Dentistry, London.
Principal Investigator: Anton Emmanuel, MBBS MD FRCP University College London Hospital, London
Principal Investigator: Louise Langmead, MBBS MD MRCP Univesity College London Hospital , London
Principal Investigator: Jeremy D Sanderson, MBBSFRCP MD Guy's and St Thomas'NHS Trust/King's College London
  More Information

Publications:
Shetty A, Kalantzis C, Polymeros D, Vega R, Abraham S, Forbes A. Hypnotherapy for inflammatory bowel disease- a randomised, placebo-controlled trial. Gut 2004;53:A226
Mawdsley JE, Jenkins D, Macey MG, Rampton DS. Natural Killer cells are increased by psychological stress and decreased by hypnotherapy in ulcerative colitis. Gut 2005; 54 (Suppl II): A23
Mawdsley JE, Jenkins D, Macey MG, Rampton DS. Hypnotherapy decreases rectal mucosal release of substance P, histamine and IL-13 in patients with active UC. Gut 2006; 55 (Suppl II): A75
Emmanuel AV, Storrie JB, Butcher L et al. Is targeting locus of control a desirable outcome of biofeedback in functional constipation ? Gut 2007;56, suppl 11:A63.
Rampton DS, Shanahan S. Fast facts: Inflammatory Bowel Disease. Health Press, 2nd ed, 2006.
Mawdsley JE, Rampton DS. Serum IL-13 concentrations are raised in active ulcerative colitis and correlate with disease activity and mucosal inflammation. Gut 2005; 54 (Suppl IV): A165

Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT00553163     History of Changes
Other Study ID Numbers: BMRP proposal no IBD 0213
Study First Received: November 2, 2007
Last Updated: November 7, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen Mary University of London:
Hypnotherapy
Prevention of relapse
ulcerative colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014