Acupuncture for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis

Official title

Efficacy and Safety of Two-step Acupuncture Therapy for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis

Overview

Ulcerative colitis (UC) is one of the two primary forms of inflammatory bowel disease. This condition is characterized by continuous mucosal inflammation that begins in the rectum and extends proximally throughout the colon. Common intestinal symptoms also include rectal bleeding, increased stool frequency, tenesmus, nocturnal bowel movements, and crampy abdominal pain. Acupuncture has been suggested as a potential intervention to alleviate clinical symptoms of UC. This single-center, parallel-group, two-arm, randomized, sham-controlled trial aims to evaluate the effects and safety of acupuncture for UC.

Detailed description

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by episodes of symptoms including rectal bleeding, increase stool frequency, and abdominal pain, impacting quality of life significantly. Conventional treatments often come with potential side effects and may not be sufficient. Acupuncture is increasingly recognized for its promising benefits in UC. This study aims to assess the efficacy and safety of acupuncture for symptom relief in mild to moderate UC.This single-center, parallel-arm, randomized, sham-controlled trial will involve 64 patients with UC, randomly assigned in a 1:1 ratio to either the acupuncture or sham acupuncture group. Participants will receive 20 sessions of acupuncture or sham acupuncture over eight weeks. Blinding will be applied to participants, outcome assessors, and statisticians. The primary outcome measure is the change in Patient-Reported Outcome 2 (PRO2) from baseline at week 8. Secondary outcomes include changes from baseline in the following scales: PRO2 at other time points, weekly average Numeric Rating Scale (U-NRS) for bowel urgency, weekly average NRS for abdominal pain (both associated and not associated with bowel movement), the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32), Work Productivity and Activity Impairment Questionnaire-Inflammatory Bowel Disease (WPAI-IBD), Pittsburgh Sleep Quality Index (PSQI), and Hospital Anxiety and Depression Scale (HADS). Patient Global Impression of Change (PGIC) will also be assessed as secondary outcomes. Adverse events and additional treatments will be monitored throughout the study. The modified intention-to-treat (mITT) population will include participants who complete baseline assessments and receive at least one treatment session.

Interventions

• Other Acupuncture
  Acupuncture sessions will use sterile, disposable stainless-steel needles (0.3 mm × 40 mm and 0.3 mm × 75 mm). Each session has two phases: Supine Position: * Needles (0.35 mm × 75 mm) are inserted into ST25, ST15, and SP14, reaching the abdominal muscle layer. * Needles (0.30 mm × 40 mm) are inserted into CV12, CV4, ST36, ST37, and SP6. * Electroacupuncture (EA) at ST25, SP15, and ST36 uses a continuous 5 Hz wave, 0.1 to 2.0 mA. Prone Position: * Needles are inserted into BL32, BL33, and BL
• Other Sham acupuncture
  Sterile, disposable stainless-steel needles (0.30 mm × 25 mm) will be used. After skin sterilization, needles will be inserted into the same points as the acupuncture group but to a shallow depth of 2 to 3 mm and lightly manipulated for blinding. Paired alligator clips will be attached to the same points, but the sham EA apparatus will have no current output, though it mimics the active EA apparatus in appearance and sound. Sham sessions will follow the same schedule as the acupuncture group: th

Primary outcome measures

• change from baseline in the PRO2 score [Time frame: Week 8 after randomization]

Secondary outcome measures (11)

• The proportion of patients achieving a ≥ 50% reduction in PRO2 score at weeks 4, 8, 12, 16, 20, 24, 28, and 32. [Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.]
• The proportion of patients with a PRO2 score of 0 [Time frame: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.]
• Changes from baseline in weekly average U-NRS scores [Time frame: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.]
• Changes from baseline in weekly average NRS scores for abdominal pain associated with bowel movements [Time frame: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.]
• Changes from baseline in weekly average NRS scores for abdominal pain not associated with bowel movements [Time frame: At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.]
• Changes from baseline in IBDQ-32 scores [Time frame: At weeks 4, 8, 12, 20, and 32 after randomization.]
• Changes from baseline in WPAI-IBD scores [Time frame: At weeks 4, 8, 20, and 32 after randomization.]
• Changes from baseline in PSQI scores [Time frame: At weeks 8, 20, and 32 after randomization.]
• Changes from baseline in HADS scores [Time frame: At weeks 8, 20, and 32 after randomization.]
• PGIC [Time frame: At weeks 4, 8, 20, and 32 after randomization.]
• Changes from baseline in the PRO2 score [Time frame: Weeks 4, 12, 16, 20, 24, 28, and 32 after randomization]

Eligibility criteria

Inclusion criteria

Eligible participants are those aged 18 to 70 years who meet the diagnostic criteria for mild to moderate UC, have a PRO2 score of ≥ 2 points, and provide written informed consent. Patients currently receiving oral and/or topical 5-aminosalicylic acid (such as mesalamine) may continue their treatment during the study period.

Exclusion criteria

Participants will be excluded if they meet any of the following criteria:

• Diagnosis of Crohn's disease, intestinal tuberculosis, chronic intestinal infections, or intestinal malignancies.
• Current treatment with corticosteroids, thiopurines, biologics, or oral small molecules.
• Severe skin conditions or infections.
• Presence of severe underlying medical conditions, including but not limited to cardiovascular diseases, hepatobiliary diseases, kidney diseases, hematologic disorders, autoimmune diseases, communicable diseases, severe malnutrition, or malignancies.
• Mental illness, cognitive dysfunction, or language disorders.
• Receipt of acupuncture therapy for UC within the past month.
• Substance abuse issues.
• Pregnancy, plans to become pregnant within the next year, lactation, or being within 12 months postpartum.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Chen H, Fang J, Liu S, Gao S, Shi H, Ma JZ, Shen X, Wang W, Liu Z. Efficacy and safety of two-step acupuncture therapy for symptom relief in adults with mild to moderate ulcerative colitis: rationale and design of the TSA-UC randomised controlled trial. BMJ Open. 2025 Feb 27;15(2):e094301. doi: 10.1136/bmjopen-2024-094301. PMID 40021194

Identifiers

NCT: NCT06615765 · 2024-190-KY

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗