Acupuncture in Addition to Usual Care for the Treatment of Refractory Irritable Bowel Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- The proportion of participants with adequate relief of global IBS symptoms
研究概览
简要总结
The trial aims to examine the efficacy and safety of acupuncture in the treatment of refractory irritable bowel syndrome (IBS). The investigators will include 170 participants to receive acupuncture plus usual care or sham acupuncture plus usual care. Twelve sessions of acupuncture will be delivered to participants over a period of 4 weeks. The primary outcome is defined as proportion of participants with adequate relief of global IBS symptoms at week 8, which is defined as >50% reduction in IBS-SSS scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-70 years (either sex);
- •Fulfilled Rome IV criteria for IBS;
- •Patients with normal occult blood in stool in recent one month;
- •The age is above 50, the results of colonoscopy are normal in near year;
- •Symptoms are present for ≥12 months;
- •There is an absence of response to a minimum of 6 weeks of dietary intervention or advice;
- •There is an absence of response to an adequate dose of at least one conventional pharmacological agent tried for a minimum of 6 weeks;
- •Signed the written informed consent form.
排除标准
- •Previous colonoscopy, meal barium fluoroscopy, abdominal ultrasound and other examinations found severe intestinal organic lesions (including but not limited to ulcerative colitis, familial multiple intestinal polyps, colorectal cancer patients);
- •The presence of one or more of the following warning symptoms: unexplained rectal bleeding, a positive faecal occult blood test result; anaemia, abdominal mass, ascites, fever, and emaciation;
- •The presence of other severe medical conditions, such as cardiovascular disease, endocrine disorders, hepatic dysfunction, renal diseases, and cognitive disorders that can affect the outcome assessment results;
- •Unconscious, unable to express subjective symptoms of discomfort and clearly diagnosed severe mental disorders;
- •An unstable psychological state or accompanying psychological disorders (SDS>56);
- •With pregnancy or lactation;
- •Accepting acupuncture treatment in the last 3 months;
- •Difficulties in attending the trial, such as fear of acupuncture.
结局指标
主要结局
The proportion of participants with adequate relief of global IBS symptoms
时间窗: 4 weeks after randomization (week 4)
Adequate relief of global IBS symptoms will be defined as a \>50% reduction in the IBS symptom severity scale (IBS-SSS).
次要结局
- IBS symptom severity scale(Baseline (week 0), week 2, 4, 6, 8)
- Self-Rating Depression Scale (SDS)(Baseline, weeks 2, 4.)
- Weekly bowel movements(Baseline (week 0), week 2, 4, 6, 8)
- Irritable Bowel Syndrome Quality of Life Instrument(Baseline (week 0), week12, and month12)
- Self-Rating Anxiety Scale (SAS)(Baseline, weeks 2, 4.)
- Bristol Stool Form Scale(Baseline, weeks 2, 4, 6 and 8.)
- Work and Social Adjustment Scale(Baseline (week 0), week 2, 4, 6, 8)
研究者
zheng hui
Clinical Professor
Chengdu University of Traditional Chinese Medicine