The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.
Acupuncture has been proven to be an effective and safe treatment for CD. In this trial, based on previous studies, which mainly treated CD from the perspective of spleen and stomach tonification, we explored the therapeutic effect of acupuncture in treating CD from the perspective of tonifying the Shaoyang pivot mechanism to enhance the therapeutic effect.Brain-gut axis dysfunction is one of the important pathogenic mechanisms of CD. This trial attempted to explore the therapeutic targets and efficacy mechanisms of acupuncture to enhance CD by analysing brain-gut axis multi-pathway indicators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
106
Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV12 and bilateral ST36 and GB41 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, GB41, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV4 and bilateral SP6 and GB34 were selected for moxibustion. These two groups are alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes.
Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3 and LI11 were selected for acupuncture and CV12 and bilateral ST36 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, SP4, KI3 and LI11 were selected for acupuncture and CV4 and bilateral SP6 were selected for moxibustion. These two groups are alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes.
Shanghai Research Institute of Acupuncture and Meridian
Shanghai, China
RECRUITINGThe proportion of recurrences
Defined as CDAI \> 150 and increase ≥ 70 points, or emergency, hospitalization and surgical events due to worsening of CD conditions, or need to adjust drug to control disease condition.
Time frame: Week 52
Number of recurrences
Total number of recurrences. The median number will be counted for both groups.
Time frame: Week 52
Time of recurrences
Time to first recurrence will be counted for both groups.
Time frame: Week 52
Crohn's disease activity index (CDAI)score
The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.
Time frame: Week 0, 6, 12, 24, 36 and 52
Patient Reported Outcome (PRO2)
The outcome is measured by level of abdominal pain (visual analogue scale, VAS) and number of diarrhoea in the past week.
Time frame: Week 0, 6, 12, 24, 36 and 52
First laboratory tests
serum C-reactive protein (CRP)
Time frame: Week 0, 6, 12, 24, 36 and 52
Second laboratory tests
erythrocyte sedimentation rate (ESR)
Time frame: Week 0, 6, 12, 24, 36 and 52
Third laboratory tests
platelet count (PLT)
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Time frame: Week 0, 6, 12, 24, 36 and 52
Inflammatory bowel disease questionnaire (IBDQ)
The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.
Time frame: Week 0, 12, 24, 36 and 52
Hospital anxiety and depression scale (HADS)
The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Time frame: Week 0, 12, 24, 36 and 52
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52.
Time frame: Week 0, 12, 24, 36 and 52
Colonoscopy or small bowel MR evaluation
measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score)
Time frame: Week 0 and 52
Expectation of acupuncture treatment
measured by acupuncture treatment effectiveness expectation questionnaire
Time frame: Week 0
Blind questionnaire
measured by patients guessing their grouping
Time frame: Week 6 and 12