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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
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.
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.
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Shanghai, Shanghai Municipality, China
Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
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.
Time frame: Week 6
Total efficacy (Adequate relief responder)
Differences in Adequate relief responder between groups
Time frame: Week 12, 18 and 24
Symptom severity score (SSS)
Differences in the mean changes of SSS score from baseline between groups
Time frame: 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.
Time frame: Week 6, 12, 18 and 24
Bristol stool form scale (BSS)
Differences in the mean changes of BSS score from baseline between groups
Time frame: 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
Time frame: Week 6
hospital anxiety and depression score (HADS)
Differences in the mean changes of HADS score from baseline between groups
Time frame: Week 6
Self-rating anxiety scale (SAS)
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Differences in the mean changes of SAS score from baseline between groups
Time frame: Week 6
Self-rating Depression Scale (SDS)
Differences in the mean changes of SDS score from baseline between groups
Time frame: Week 6
Diarrhea frequency per day
Differences in the mean changes of Diarrhea frequency per day from baseline between groups
Time frame: Week 6, 12, 18 and 24
Urgency of defecation
Differences in the mean changes of Urgency of defecation from baseline
Time frame: 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
Time frame: Week 6, 12, 18 and 24