Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial
NCT ID: NCT00553163
Last Updated: 2019-06-28
Study Results
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
26 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-10-31
Study Completion Date
2010-04-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Ulcerative Colitis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Investigators
Study Groups
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Gut-focussed hypnotherapy (GFH).
Gut-focussed hypnotherapy (GFH).
Group Type
ACTIVE_COMPARATOR
Gut focussed hypnotherapy
Intervention Type
BEHAVIORAL
Gut focussed hypnotherapy
Educational sessions
Regular sessions to learn about UC from research nurse
Group Type
SHAM_COMPARATOR
Control educational sessions
Intervention Type
BEHAVIORAL
Control educational sessions
Interventions
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Gut focussed hypnotherapy
Gut focussed hypnotherapy
Intervention Type
BEHAVIORAL
Control educational sessions
Control educational sessions
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
16 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Barts & The London NHS Trust
OTHER
Sponsor Role
collaborator
Queen Mary University of London
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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David S Rampton, MAFRCP DPhil
Role: PRINCIPAL_INVESTIGATOR
Barts and the London/Queen Mary School of Medicine and Dentistry, London.
Anton Emmanuel, MBBS MD FRCP
Role: PRINCIPAL_INVESTIGATOR
University College London Hospital, London
Louise Langmead, MBBS MD MRCP
Role: PRINCIPAL_INVESTIGATOR
Univesity College London Hospital , London
Jeremy D Sanderson, MBBSFRCP MD
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas'NHS Trust/King's College London
Locations
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Barts and The Royal London NHS Trust/Queen Mary University London/
London, , United Kingdom
Site Status
University College Hospital London
London, , United Kingdom
Site Status
Guy's and St Thomas' NHS Trust
London, , United Kingdom
Site Status
Countries
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United Kingdom
References
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Reference Type
DERIVED
Other Identifiers
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BMRP proposal no IBD 0213
Identifier Type: -
Identifier Source: org_study_id
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