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)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- IBS Symptom Severity Score
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 16 to 60 years with symptoms of irritable bowel syndrome that fulfill the Rome III criteria
排除标准
- •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
研究组 & 干预措施
mebeverine + no website
Mebeverine 135mg tds for 6 weeks
干预措施: mebeverine (Drug)
mebeverine + no website
Mebeverine 135mg tds for 6 weeks
干预措施: No website (Behavioral)
methylcellulose + no website
methylcellulose 3 tablets twice a day for 6 weeks
干预措施: methylcellulose (Drug)
methylcellulose + no website
methylcellulose 3 tablets twice a day for 6 weeks
干预措施: No website (Behavioral)
placebo + no website
placebo tablets
干预措施: placebo (Drug)
placebo + no website
placebo tablets
干预措施: No website (Behavioral)
mebeverine + CBT website minimal support
mebeverine 135mg tds and access to website
干预措施: mebeverine (Drug)
mebeverine + CBT website minimal support
mebeverine 135mg tds and access to website
干预措施: CBT website with minimal support (Behavioral)
methylcellulose + CBT website
methylellulose 3 tablets twice a day and access to website
干预措施: methylcellulose (Drug)
methylcellulose + CBT website
methylellulose 3 tablets twice a day and access to website
干预措施: CBT website with minimal support (Behavioral)
placebo + CBT website minimal support
placebo tablets and access to website
干预措施: placebo (Drug)
placebo + CBT website minimal support
placebo tablets and access to website
干预措施: CBT website with minimal support (Behavioral)
mebeverine + CBT website with support
mebeverine 135mg tds and access to website with nurse support session
干预措施: mebeverine (Drug)
mebeverine + CBT website with support
mebeverine 135mg tds and access to website with nurse support session
干预措施: CBT website with support (Behavioral)
methylcellulose + CBT website support
methylcellulose 3 tablets twice a day and access to website with nurse support
干预措施: methylcellulose (Drug)
methylcellulose + CBT website support
methylcellulose 3 tablets twice a day and access to website with nurse support
干预措施: CBT website with support (Behavioral)
placebo + CBT website with support
placebo tablets and access to website with nurse support
干预措施: placebo (Drug)
placebo + CBT website with support
placebo tablets and access to website with nurse support
干预措施: CBT website with support (Behavioral)
结局指标
主要结局
IBS Symptom Severity Score
时间窗: Baseline, 6 and 12 weeks
IBS QOL
时间窗: Baseline, 6 and 12 weeks
Quality of life
次要结局
- HADs(Baseline, 6 and 12 weeks)
- Enablement(6 and 12 weeks)
- Subjects Global Assessment of relief(6 weeks and 12 weeks)
研究者
Hazel Everitt
Principal Investigator
University of Southampton
