To observe the clinical effect of acupuncture on quiescent Crohn's disease
To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion.
Patients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. Same Hwato acupuncture device was used to blind the subjects, but do not puncturing into the skin and do not have the deqi sensation. The surface temperature of acupoints was maintained at 37℃± 1℃ for moxibustion.
Shanghai Research Institute of Acupuncture and Meridian
Shanghai, China
The proportion of clinical relapse rates
Defined as a CDAI score of \>150 with an increase of ≥70 points from baseline, or the need for CD surgery, or new CD medications.
Time frame: Week 48
Time of first relapse
Difference in time to first relapse between groups during the trial.
Time frame: Week 48
Number of relapses
Difference in the number of relapses between groups during the trial.
Time frame: Week 48
Moderate to severe clinical relapse rate
Defined as CDAI score ≥ 220; Differences in moderate to severe clinical recurrence rates between groups during the trial.
Time frame: Week 48
The mean change of CDAI from baseline
Difference in the mean change of CDAI from baseline between groups
Time frame: Week 12, 24, 36 and 48
The mean change of serum CRP level from baseline
Difference in the mean change of serum CRP level from baseline between groups
Time frame: Week 12, 24, 36 and 48
The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ)
Quality of life assessment for Crohn's disease. The score ranges from 32 to 224, and the higher the score, the better the outcome.
Time frame: Week 12 and 24
The mean change of the Hospital anxiety and depression scale (HADS)
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Psychological factors (Anxiety and depression) assessment for CD. The score ranges from 0 to 21, and the higher the score, the worse the outcome.
Time frame: Week 12 and 24
The mean change of Crohn's disease endoscopic index of severity (CDEIS)
Intestinal inflammation performance. The score ranges from 0 to 44, and the higher the score, the worse the outcome.
Time frame: Week 48