This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis.
1. A randomized controlled trial. 2. Acupuncture treatment(intradermal thumbtack needle embedding), placebo control. 3. To explore the efficacy and safety of acupuncture(intradermal thumbtack needles embedding) as an adjuvant therapy for active ulcerative colitis. 4. To explore the potential relevant mechanisms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Intradermal thumbtack needle embedding at specified acupoints. Needles are embedded for up to 72 hours, replaced weekly for 12 weeks. Patients press needles 3-5 times daily to elicit deqi sensation.
Application of needle-free adhesive placebo patches at non-acupoint sites. Patches are replaced weekly for 12 weeks. Patients apply gentle pressure 3-5 times daily without deqi sensation.
Standard background therapy: Mesalazine at a stable dose (e.g., 2-4g/day) maintained throughout the 12-week study period. This provides the background treatment for both groups, allowing evaluation of the additive effect of acupuncture.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGClinical remission rate
Proportion of patients who achieve a Mayo Stool Frequency Subscore (SFS) of 0 or 1 and not increased from induction baseline, a Mayo Rectal Bleeding Subscore (RBS) of 0, and a Mayo Endoscopic Score(MES) of 0 or 1 with no friability present on endoscopy.
Time frame: Week 13-16 after randomization
Clinical response rate
Proportion of patients with a decrease from induction baseline in the mMayo score by at least 30% and at least 2 points, with either a 1-point or more decrease from induction baseline in the Mayo Rectal Bleeding Subscore (RBS) or a Mayo RBS of 0 or 1
Time frame: Week 13-16 after randomization
Endoscopic improvement rate
Proportion of patients with a Mayo Endoscopic Subscore (MES) of 0 or 1 (no friability) or an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of 0 or 1.
Time frame: Week 13-16 after randomization
Endoscopic remission (normalization) rate
Proportion of patients with a Mayo Endoscopic Subscore (MES) of 0.
Time frame: Week 13-16 after randomization
Symptomatic remission rate
Proportion of patients with a Mayo Stool Frequency Subscore (SFS) of 0 or 1 and not increased from induction baseline, and a Mayo Rectal Bleeding Subscore (RBS) of 0
Time frame: Week 12 and 24 after randomization
Symptomatic response rate
Proportion of patients with a decrease from baseline in the symptomatic Mayo score (SFS+RBS) by ≥30% and ≥1 point, plus either a ≥1-point decrease in RBS or an RBS of 0 or 1.
Time frame: Week 12 and 24 after randomization
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Number of remission-relapse episodes
Incidence of clinical recurrences(defined per STRIDE-II consensus) within 24 weeks post-randomization.
Time frame: Week 24 after randomization
Time to first relapse
Time to first relapse within 24 weeks post-randomization
Time frame: Week 24 after randomization
Use of rescue medication
Proportion of patients requiring glucocorticoids, immunosuppressants, biologics, or other rescue medications due to disease progression.
Time frame: Week 24 after randomization
Change in Nancy Histological Index score
Change from baseline in the Nancy Histological Index score, a validated scale for assessing histological disease activity in ulcerative colitis, with scores ranging from 0 (no activity) to 4 (severe activity). A higher score indicates more severe histological inflammation.
Time frame: Week 13-16 after randomization
Change in fecal calprotectin level
Change from baseline in fecal calprotectin concentration
Time frame: Baseline, Week 12, Week 24
Change in C-reactive protein level
Change from baseline in serum C-reactive protein (CRP) concentration.
Time frame: Baseline, Week 12, Week 24
Change in erythrocyte sedimentation rate
Change from baseline in erythrocyte sedimentation rate (ESR).
Time frame: Baseline, Week 12, Week 24
Change in hemoglobin level
Change from baseline in hemoglobin (Hb) concentration.
Time frame: Baseline, Week 12, Week 24
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score
Change from baseline in the total score of the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32-item questionnaire measuring quality of life in IBD patients, with total scores ranging from 32 to 224. A higher score indicates a better quality of life.
Time frame: Baseline, Week 12, Week 24
Change in Pittsburgh Sleep Quality Index (PSQI) score
Change from baseline in the global score of the Pittsburgh Sleep Quality Index (PSQI). The PSQI assesses sleep quality over a 1-month interval, with global scores ranging from 0 to 21. A higher score indicates worse sleep quality.
Time frame: Baseline, Week 12, Week 24
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score
Change from baseline in the score of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) subscale. The FACIT-Fatigue is a 13-item subscale measuring fatigue, with scores ranging from 0 to 52. A higher score indicates less fatigue (better outcome).
Time frame: Baseline, Week 12, Week 24
Change in Beck Depression Inventory-II (BDI-II) score
Change from baseline in the total score of the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item self-report inventory measuring the severity of depression, with total scores ranging from 0 to 63. A higher score indicates more severe depressive symptoms.
Time frame: Baseline, Week 12, Week 24
Change in Beck Anxiety Inventory (BAI) score
Change from baseline in the total score of the Beck Anxiety Inventory (BAI). The BAI is a 21-item self-report inventory measuring the severity of anxiety, with total scores ranging from 0 to 63. A higher score indicates more severe anxiety symptoms.
Time frame: Baseline, Week 12, Week 24
De Qi sensation on the Massachusetts General Hospital Acupuncture Sensation Scale (MASS)
Score on the Massachusetts General Hospital Acupuncture Sensation Scale (MASS), a validated instrument assessing 12 sensations associated with De Qi (e.g., soreness, numbness, distension). The total score is a weighted sum, with a higher score indicating a more pronounced De Qi experience.
Time frame: Week 12 after randomization
Change in Acupuncture Treatment Expectancy score
Change from baseline in the score of the Acupuncture Expectancy Scale (AES), a questionnaire assessing patients' belief in the potential benefit of acupuncture treatment. A higher score indicates greater treatment expectancy.
Time frame: Baseline, Week 12 after randomization
Incidence of acupuncture-related adverse events
Number and percentage of participants experiencing any acupuncture-related adverse event (e.g., local hematoma, intense pain \[VAS ≥8\], infection) or other discomfort (e.g., nausea, dizziness) following each acupuncture session, assessed over the entire treatment period.
Time frame: Throughout the 12-week treatment period
Change in abdominal symptoms severity score
Change from baseline in the severity of abdominal symptoms (including defecation urgency and abdominal pain) as assessed by a Numerical Rating Scale (NRS). The NRS is a self-report scale ranging from 0 ("no symptom") to 10 ("worst imaginable symptom"). A higher score indicates more severe symptoms.
Time frame: Week 12 after randomization
Change in Patient-Doctor Relationship Questionnaire (PDRQ-9) score
Change from baseline in the total score of the Patient-Doctor Relationship Questionnaire (PDRQ-9). The PDRQ-9 is a 9-item questionnaire assessing the quality of the patient-doctor relationship, with total scores ranging from 9 to 45. A higher score indicates a better perceived relationship.
Time frame: Baseline, Week 12 after randomization