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This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum acupuncture | Experimental | Participants receive intradermal thumbtack needle embedding at four fixed acupoints (bilateral BL25 and ST36) and one optional pair selected from ST25 (for damp-heat), BL20 (for spleen deficiency/dampness), BL23 (for spleen-kidney yang deficiency), or SP6 (for liver depression/spleen deficiency) based on TCM pattern diagnosis. Needles are embedded for up to 72 hours; patients press them 3-5 times daily to elicit deqi sensation. Needles are replaced weekly for 12 weeks. All participants concurrently receive standard mesalazine therapy. |
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| sham acupuncture | Sham Comparator | Participants receive sham acupuncture using needle-free adhesive placebo patches (identical in appearance to verum needles) applied at two fixed pairs of non-acupoints (4 points total), away from true meridians or acupoints. Patients are instructed to apply gentle pressure to the patch sites 3-5 times daily , without eliciting deqi sensation. Patches are replaced weekly for 12 consecutive weeks. All participants concurrently receive standard mesalazine therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical 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. | Week 13-16 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 13-16 after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhou Pu | Contact | 02783663625 | tongjihlunli@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Qin | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
IPD after de-identification can be shared on individual request to the principal investigator at yuqin@tjh.tjmu.edu.cn
IPD and supporting information will be available after the publication of the primary outcomes
Data requests from qualified researchers for the purpose of replicating analyses or conducting secondary analyses will be considered. Requestors must submit a research proposal outlining the scientific purpose and analysis plan to the principal investigator via the contact email. Approval will be granted based on scientific merit, feasibility, and adherence to data use agreements.
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
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Participants are randomly assigned to one of two parallel groups in a 1:1 ratio.
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|
| Sham acupuncture | Device | 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. |
|
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| Mesalazine | Drug | 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. |
|
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| 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. |
| Week 13-16 after randomization |
| Endoscopic remission (normalization) rate | Proportion of patients with a Mayo Endoscopic Subscore (MES) of 0. | 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 | 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. | Week 12 and 24 after randomization |
| Number of remission-relapse episodes | Incidence of clinical recurrences(defined per STRIDE-II consensus) within 24 weeks post-randomization. | Week 24 after randomization |
| Time to first relapse | Time to first relapse within 24 weeks post-randomization | Week 24 after randomization |
| Use of rescue medication | Proportion of patients requiring glucocorticoids, immunosuppressants, biologics, or other rescue medications due to disease progression. | 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 3 (severe activity). A higher score indicates more severe histological inflammation. | Week 13-16 after randomization |
| Change in fecal calprotectin level | Change from baseline in fecal calprotectin concentration | Baseline, Week 12, Week 24 |
| Change in C-reactive protein level | Change from baseline in serum C-reactive protein (CRP) concentration. | Baseline, Week 12, Week 24 |
| Change in erythrocyte sedimentation rate | Change from baseline in erythrocyte sedimentation rate (ESR). | Baseline, Week 12, Week 24 |
| Change in hemoglobin level | Change from baseline in hemoglobin (Hb) concentration. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | Week 24 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. | Baseline, Week 12, Week 24 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001565 |
| Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |