Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome

Study on the Mechanism of Moxibustion Effect on Treating Diarrhea-predominant Irritable Bowel Syndrome

To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel syndrome and evaluation by Magnetic Resonance Imaging (MRI), Event related potential (ERP).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Device: moxibustion; Device: Sham moxibustion

Detailed Description

1. A randomized controlled trial
2. Moxibustion treatment, sham control
3. To observe the safety and efficacy of moxibustion treatment versus placebo control
4. Evaluation by intestinal microbial structural and diversity changes using 16S rDNA sequencing
5. Evaluation by structural MRI and resting state-functional MRI
6. Evaluation by ERP

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Institute of Acupuncture, Moxibustion and Meridian
    • Shanghai, Shanghai, China, 200082
      • Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine
    • Shanghai, Shanghai, China, 200437
      • Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diarrhea-predominant IBS patients who met the Rome III diagnostic criteria;
2. Age 18-65 years old, male or female;
3. Volunteered for the trial, signed the informed consent

Exclusion Criteria:

1. Intestinal organic disease;
2. Constipation-predominant IBS;
3. Alternating diarrhea and constipation IBS;
4. Unstructured IBS;
5. At the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;
6. Combined liver, kidney, heart or mental disease patients;
7. Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moxibustion group; Receiving moxibustion treatment	Device: moxibustion; Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral). using mild-warm moxibustion，the surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.
Sham Comparator: Sham moxibustion group; Receiving sham moxibustion.	Device: Sham moxibustion; Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral); using sham mild-warm moxibustion，the surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total efficacy (Adequate relief responder)	The ratio of the number of responders and the total number of participants in each group. Adequate relief responder is the participant who considered effective treatment in the self-assessment.	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total efficacy (Adequate relief responder)	Differences in Adequate relief responder between groups	Week 12, 18 and 24
Symptom severity score (SSS)	Differences in the mean changes of SSS score from baseline between groups	Week 6, 12, 18 and 24
The proportion of responder to SSS	The differences of the proportion of responders between groups. Defined the SSS score decreased more than 50 points from baseline as responder.	Week 6, 12, 18 and 24
Bristol stool form scale (BSS)	Differences in the mean changes of BSS score from baseline between groups	Week 6, 12, 18 and 24
Quality of life questionnaire (IBS-QOL)	Differences in the mean changes of IBS-QOL score from baseline between groups	Week 6
hospital anxiety and depression score (HADS)	Differences in the mean changes of HADS score from baseline between groups	Week 6
Self-rating anxiety scale (SAS)	Differences in the mean changes of SAS score from baseline between groups	Week 6
Self-rating Depression Scale (SDS)	Differences in the mean changes of SDS score from baseline between groups	Week 6
Diarrhea frequency per day	Differences in the mean changes of Diarrhea frequency per day from baseline between groups	Week 6, 12, 18 and 24
Urgency of defecation	Differences in the mean changes of Urgency of defecation from baseline	Week 6, 12, 18 and 24
Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)	Eg.moxibustion related burns, blistering, etc	Week 6, 12, 18 and 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain structures （gray matter, white matter）MRI		Week 6
resting-state functional MRI	Analysis with methods of regional homogeneity，ALFF/fALFF，functional connectivity.	Week 6
Magnetic Resonance Spectroscopy (MRS)	The ratio of glutamate complex (Glx) peak area and creatine ratio (Cr) of the cingulate cortex and insula.	Week 6
Event-related potentials (ERP)	Measurement of brain resting state energy atlas and the amplitude changes of each major components during the task and latency.	Week 6
Intestinal microbiota changes	Fecal microbial structural and diversity changes	Week 6
Brain-gut microbiota interaction	Multiple regression analysis to establish the association between intestinal microbiota and brain	Week 6

Collaborators and Investigators

• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Investigators: Study Chair: Huangan Wu, MD,PhD, Shanghai University of TCM

Publications and helpful links

General Publications

• Bao C, Wu L, Shi Y, Shi Z, Jin X, Shen J, Li J, Hu Z, Chen J, Zeng X, Zhang W, Ma Z, Weng Z, Li J, Liu H, Wu H. Long-term effect of moxibustion on irritable bowel syndrome with diarrhea: a randomized clinical trial. Therap Adv Gastroenterol. 2022 Feb 23;15:17562848221075131. doi: 10.1177/17562848221075131. eCollection 2022.
• Bao C, Zhang J, Liu J, Liu H, Wu L, Shi Y, Li J, Hu Z, Dong Y, Wang S, Zeng X, Wu H. Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Oct 24;16(1):408. doi: 10.1186/s12906-016-1386-4.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: April 17, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; irritable bowel syndrome; moxibustion
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: ZYS2015-01