Efficacy and Safety of Two-step Acupuncture Therapy for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- change from baseline in the PRO2 score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding will be maintained for participants, outcome assessors, and statisticians to prevent bias in evaluation. However, the practitioner administering the intervention will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
change from baseline in the PRO2 score
时间窗: Week 8 after randomization
Data on daily bowel movements and rectal bleeding will be summarized from the stool diaries. The PRO2 score, assessed at weeks 4, 8, 12, 16, 20, 24, 28, and 32, comprises the Stool Frequency (SF) and Rectal Bleeding (RB) subscales of the Mayo score. The SF subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). The RB subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). The primary outcome is the change from baseline in the PRO2 score at week 8.
次要结局
- The proportion of patients achieving a ≥ 50% reduction in PRO2 score at weeks 4, 8, 12, 16, 20, 24, 28, and 32.(Weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.)
- The proportion of patients with a PRO2 score of 0(At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.)
- Changes from baseline in weekly average U-NRS scores(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(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(At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.)
- Changes from baseline in IBDQ-32 scores(At weeks 4, 8, 12, 20, and 32 after randomization.)
- Changes from baseline in WPAI-IBD scores(At weeks 4, 8, 20, and 32 after randomization.)
- Changes from baseline in PSQI scores(At weeks 8, 20, and 32 after randomization.)
- Changes from baseline in HADS scores(At weeks 8, 20, and 32 after randomization.)
- PGIC(At weeks 4, 8, 20, and 32 after randomization.)
- Changes from baseline in the PRO2 score(Weeks 4, 12, 16, 20, 24, 28, and 32 after randomization)
研究者
He Chen
Researcher, Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences