Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2022-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Acupuncture plus usual care

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Acupuncture will be given for a total of 12 session over 4 weeks. Acupuncture at acupoints Tianshu (ST25), Shangjuxu (ST37), Zusanli (ST36), and Neiguan (PC6) bilaterally will be given.

Sham acupuncture plus usual care

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.

Group Type SHAM_COMPARATOR

Acupuncture

Intervention Type OTHER

Acupuncture will be given for a total of 12 session over 4 weeks. Acupuncture at acupoints Tianshu (ST25), Shangjuxu (ST37), Zusanli (ST36), and Neiguan (PC6) bilaterally will be given.

Interventions

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Acupuncture

Acupuncture will be given for a total of 12 session over 4 weeks. Acupuncture at acupoints Tianshu (ST25), Shangjuxu (ST37), Zusanli (ST36), and Neiguan (PC6) bilaterally will be given.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No