Management of Irritable Bowel Syndrome in Primary Care (MIBS Trial)

Sponsor

Hazel Everitt (Other)

Overall Status

Completed

CT.gov ID

NCT00934973

Collaborator

National Institute for Health Research, United Kingdom (Other)

135

Enrollment

Location

Arms

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aims:

To pilot an randomized, controlled trial (RCT) to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and of the patient CBT based self-management website.
To assess the level of support needed for patients using the patient CBT based self-management website for IBS (i.e., initial 30 minute telephone support session with a nurse and email support or not).

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Drug: mebeverine Drug: methylcellulose Drug: placebo Behavioral: CBT website with support Behavioral: No website Behavioral: CBT website with minimal support	Phase 4

Detailed Description

Background:

Irritable bowel syndrome (IBS) affects 10-22% of the United Kingdom (UK) population, with National Health Service (NHS) costs over £200 million a year. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current general practitioner (GP) treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms.

A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: NHS costs 2005 of nearly £10 million for mebeverine and over £8 million for fiber-based bulking agents.

Cognitive behavioral therapy (CBT) and self-management can be helpful, but poor availability in the NHS restricts its use. Development of web-based CBT could increase access without increased costs.

Plan of Investigation:

135 patients aged 16-60 years with IBS symptoms fulfilling the Rome III criteria, recruited via GP practices, will be randomised to: mebeverine, methylcellulose or placebo for 6 weeks and to the CBT based website with a nurse telephone session and email support, website with minimal support, or no website, thus creating 9 groups.

Outcomes: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks. An intention to treat analysis will be undertaken by analysis of covariance (ANCOVA) for a factorial trial.

Potential Impact:

Development of a web-based self-management CBT program for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. CBT has been shown to be of benefit for IBS but it's availability is limited due to the high cost and therapist time required for face-to-face CBT. A website can be accessed at a time and place convenient to the patient and the CBT program undertaken at a pace determined by patient needs. The website could be used as a long term support for self-management.

Determining the effectiveness of commonly used drug treatments will help patients and doctors in making informed treatment decisions regarding the drug management of IBS symptoms, enabling better targeting of treatment to those who may benefit.

Study Design

Study Type:

Interventional

Actual Enrollment :

135 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Management of Irritable Bowel Syndrome in Primary Care: Feasibility Randomised Controlled Trial of Mebeverine, Methylcellulose, Placebo and a Patient Self-management Cognitive Behavioural Therapy Website. (MIBS Trial)

Actual Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: mebeverine + no website Mebeverine 135mg tds for 6 weeks	Drug: mebeverine overencapsulated mebeverine 135 mg tds for 6 weeks Behavioral: No website No CBT website
Active Comparator: methylcellulose + no website methylcellulose 3 tablets twice a day for 6 weeks	Drug: methylcellulose overencapsulated methylcellulose 3 tablets bd for 6 weeks Behavioral: No website No CBT website
Placebo Comparator: placebo + no website placebo tablets	Drug: placebo overencapsulated placebo tablets 1 tds for 6 weeks Behavioral: No website No CBT website
Active Comparator: mebeverine + CBT website minimal support mebeverine 135mg tds and access to website	Drug: mebeverine overencapsulated mebeverine 135 mg tds for 6 weeks Behavioral: CBT website with minimal support
Active Comparator: methylcellulose + CBT website methylellulose 3 tablets twice a day and access to website	Drug: methylcellulose overencapsulated methylcellulose 3 tablets bd for 6 weeks Behavioral: CBT website with minimal support
Placebo Comparator: placebo + CBT website minimal support placebo tablets and access to website	Drug: placebo overencapsulated placebo tablets 1 tds for 6 weeks Behavioral: CBT website with minimal support
Active Comparator: mebeverine + CBT website with support mebeverine 135mg tds and access to website with nurse support session	Drug: mebeverine overencapsulated mebeverine 135 mg tds for 6 weeks Behavioral: CBT website with support cognitive behavioral therapy with nurse telephone session and email support
Active Comparator: methylcellulose + CBT website support methylcellulose 3 tablets twice a day and access to website with nurse support	Drug: methylcellulose overencapsulated methylcellulose 3 tablets bd for 6 weeks Behavioral: CBT website with support cognitive behavioral therapy with nurse telephone session and email support
Placebo Comparator: placebo + CBT website with support placebo tablets and access to website with nurse support	Drug: placebo overencapsulated placebo tablets 1 tds for 6 weeks Behavioral: CBT website with support cognitive behavioral therapy with nurse telephone session and email support

Outcome Measures

Primary Outcome Measures

IBS Symptom Severity Score [Baseline, 6 and 12 weeks]
IBS QOL [Baseline, 6 and 12 weeks]
Quality of life

Secondary Outcome Measures

Subjects Global Assessment of relief [6 weeks and 12 weeks]
Subjects global assessment of relief
Enablement [6 and 12 weeks]
Assessment of Enablement
HADs [Baseline, 6 and 12 weeks]
Hospital Anxiety and Depression Score

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients aged 16 to 60 years with symptoms of irritable bowel syndrome that fulfill the Rome III criteria

Exclusion Criteria:

Atypical symptoms (unexplained weight loss, rectal bleeding)
Diagnosis of inflammatory bowel disease, coeliac disease or peptic ulcer disease
Pregnant or breast feeding
Currently taking or allergy to mebeverine or methylcellulose