Clinical trial NCT04276961: Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome
Official title: Acupuncture in Addition to Usual Care for the Treatment of Refractory Irritable Bowel Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
First posted: 2020-02-19
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of participants with adequate relief of global IBS symptoms
timeFrame: 4 weeks after randomization (week 4)
Secondary outcomes:
measure: IBS symptom severity scale
timeFrame: Baseline (week 0), week 2, 4, 6, 8
measure: Weekly bowel movements
timeFrame: Baseline (week 0), week 2, 4, 6, 8
measure: Work and Social Adjustment Scale
timeFrame: Baseline (week 0), week 2, 4, 6, 8
measure: Irritable Bowel Syndrome Quality of Life Instrument
timeFrame: Baseline (week 0), week12, and month12
measure: Bristol Stool Form Scale
timeFrame: Baseline, weeks 2, 4, 6 and 8.
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: Baseline, weeks 2, 4.
measure: Self-Rating Depression Scale (SDS)
timeFrame: Baseline, weeks 2, 4.
Other outcomes:
measure: Proportion of participants with adverse events
timeFrame: Week 4 and 12
Locations:
city: Chengdu
country: China
facility: Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: Beijing University of Chinese Medicine
name: Zhi-Gang Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao J, Chen M, Wang X, Ye K, Shi S, Li H, Wang J, Chen X, Ni J, Wei Q, Shi Y, Hu Y, Sun J, Li D, Liu S, Li Z, Zheng H, Yu SG. Efficacy of acupuncture in refractory irritable bowel syndrome: study protocol for a randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e045655. doi: 10.1136/bmjopen-2020-045655.