Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

Chengdu University of Traditional Chinese Medicine

Status: Unknown

Conditions: Irritable Bowel Syndrome

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04276961

2019YFC1709004

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Acupuncture plus usual care

Experimental group

Description:

Acupuncture will be given on the basis of usual care. A total of 12 sessions of acupuncture will be given over a period of 4 weeks.

Treatment:

Other: Acupuncture

Sham acupuncture plus usual care

Sham Comparator group

Description:

Sham acupuncture refers to acupuncture at sham points. Sham acupuncture will be given on the basis of usual care. A total of 12 sessions of sham acupuncture will be given over a period of 4 weeks.

Treatment:

Other: Acupuncture