Dose-Effect Response in Acupuncture for Functional Constipation

Официальное название

Response Characteristics of the Dose-Effect Relationship in Acupuncture Treatment for Functional Constipation: A Randomized Controlled Study

Обзор

This is a single-center, randomized, parallel-group trial evaluating the dose-response relationship of two experimental interventions: manual acupuncture and electroacupuncture for functional constipation. A total of 72 participants with functional constipation (Rome IV criteria) will be randomly assigned in a 1:1 ratio to either the manual acupuncture group or the electroacupuncture group. Both groups receive acupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37) points, 30 minutes per session, three times per week for 12 weeks. The electroacupuncture group additionally receives electrical stimulation (continuous wave, 10 Hz, 0.5-4 mA). The primary outcome is the responder rate at week 12, defined as the percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week. Secondary outcomes include changes in gut microbiota, brain functional connectivity measured by multimodal MRI and fNIRS, and scales. The study aims to clarify the dose-response characteristics of different acupuncture modalities and their underlying biological mechanisms.

Вмешательства

• Другое Manual Acupuncture
  Acupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37). Participant lies supine and rests for 5 minutes before treatment. After routine disinfection, the acupuncturist inserts needles vertically to a certain depth, followed by mild lifting, thrusting, and twisting for 10 seconds at each acupoint to induce deqi. Needles are retained for 30 minutes. After removal, needle holes are pressed to prevent bleeding. Treatment frequency: three sessions per week for 12 weeks.
• Устройство Electroacupuncture
  Acupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37). Participant lies supine and rests for 5 minutes before treatment. After routine disinfection, the acupuncturist inserts needles vertically to a certain depth, followed by mild lifting, thrusting, and twisting for 10 seconds at each acupoint to induce deqi. Then needles are connected to an electroacupuncture device (Hwato SDZ-III, Suzhou Medical Products Factory, China). Two pairs of electrodes are attached: one pair to bilateral Tians

Первичные конечные точки

• Responder Rate at Week 12 [Срок оценки: Week 12]

Вторичные конечные точки (9)

• Responder Rate at Week 16 [Срок оценки: Week 16]
• Changes in Blood Flow Measured by DCS [Срок оценки: Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16]
• Changes in Gut Microbiota [Срок оценки: Baseline, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved]
• Changes in Brain Function [Срок оценки: Baseline, after deqi, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved]
• Changes in Cortical Activity Measured by fNIRS [Срок оценки: Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16]
• Acupuncture Expectancy Scale [Срок оценки: Baseline]
• Patient Assessment of Constipation Quality of Life [Срок оценки: Baseline, weeks 2, 4, 6, 8, 10, 12, 16]
• Generalized Anxiety Disorder 7-item Scale [Срок оценки: Baseline, weeks 2, 4, 6, 8, 10, 12, 16]
• Patient Health Questionnaire-9 [Срок оценки: Baseline, weeks 2, 4, 6, 8, 10, 12, 16]

Критерии участия

Критерии включения

• Meet Rome IV diagnostic criteria for functional constipation
• Symptoms present for ≥6 months, meeting diagnostic criteria in the last 3 months
• Mean weekly complete spontaneous bowel movements (CSBMs) ≤2 during 14-day baseline period
• Age 18-75 years
• No use of constipation medications for at least 2 weeks prior to treatment (except rescue medication)
• No acupuncture treatment for constipation in the past 3 months
• Not currently participating in another clinical trial
• Willing and able to provide written informed consent

Критерии исключения

• Constipation secondary to other causes (IBS, organic diseases, medications, endocrine disorders, metabolic disorders, neurological disorders, or gastrointestinal surgery)
• Loose or watery stools (Bristol type 6 or 7) >1 time during baseline without laxative use
• History of pelvic floor dysfunction
• Use of probiotics, fiber supplements, or laxatives within 2 weeks prior to treatment (2-week washout required)
• Severe hemorrhoids or anal fissures
• Severe or uncontrolled heart, liver, or kidney disease; abdominal aortic aneurysm; hepatosplenomegaly; cognitive impairment; or psychiatric disorders
• Dependence on opioids or anticholinergic drugs
• Red flags: unexplained weight loss >10% in 3 months, hematochezia or positive fecal occult blood, family history of colon cancer (first-degree relative diagnosed <50 years), anemia (Hb <110 g/L), or elevated inflammatory markers
• Contraindications to acupuncture: coagulation disorders or use of anticoagulants
• Pregnancy or breastfeeding
• Unable to comply with follow-up or contraindications to MRI (e.g., cardiac pacemaker, non-titanium aneurysm clips, metallic implants, claustrophobia)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07506122 · TJ-IRB202603096

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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