Clinical trial NCT00553163: Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial
Official title: Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Hypnotherapy
Prevention of relapse
ulcerative colitis
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Barts & The London NHS Trust
First posted: 2007-11-04
Enrollment: 26
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Relapse at 1 Year
timeFrame: 1 year
Secondary outcomes:
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 13
timeFrame: 13 weeks
measure: Hospital Anxiety and Depression Score-Anxiety, (HADSA) at Week 13
timeFrame: 13 weeks
measure: Hospital Anxiety and Depression Score-Depression (HADSD)
timeFrame: 13 weeks
measure: Perceived Stress Questionnaire-Recent (PSQ-R)
timeFrame: 13 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts and The Royal London NHS Trust/Queen Mary University London/
city: London
country: United Kingdom
facility: University College Hospital London
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Trust
Study officials:
affiliation: Barts and the London/Queen Mary School of Medicine and Dentistry, London.
name: David S Rampton, MAFRCP DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London Hospital, London
name: Anton Emmanuel, MBBS MD FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Univesity College London Hospital , London
name: Louise Langmead, MBBS MD MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Guy's and St Thomas'NHS Trust/King's College London
name: Jeremy D Sanderson, MBBSFRCP MD
role: PRINCIPAL_INVESTIGATOR
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