Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial

Обзор

The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.

Подробное описание

Acupuncture has been proven to be an effective and safe treatment for CD. In this trial, based on previous studies, which mainly treated CD from the perspective of spleen and stomach tonification, we explored the therapeutic effect of acupuncture in treating CD from the perspective of tonifying the Shaoyang pivot mechanism to enhance the therapeutic effect.Brain-gut axis dysfunction is one of the important pathogenic mechanisms of CD. This trial attempted to explore the therapeutic targets and efficacy mechanisms of acupuncture to enhance CD by analysing brain-gut axis multi-pathway indicators.

Вмешательства

• Другое "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group
  Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV12 and bilateral ST36 and GB41 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, GB41, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV4 and bilateral SP6 and GB34 were selected
• Другое "Nourishing spleen and kidney with warmth" Acupuncture Group
  Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3 and LI11 were selected for acupuncture and CV12 and bilateral ST36 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, SP4, KI3 and LI11 were selected for acupuncture and CV4 and bilateral SP6 were selected for moxibustion. These two groups are alterna

Первичные конечные точки

• The proportion of recurrences [Срок оценки: Week 52]

Вторичные конечные точки (12)

• Number of recurrences [Срок оценки: Week 52]
• Time of recurrences [Срок оценки: Week 52]
• Crohn's disease activity index （CDAI）score [Срок оценки: Week 0, 6, 12, 24, 36 and 52]
• Patient Reported Outcome （PRO2） [Срок оценки: Week 0, 6, 12, 24, 36 and 52]
• First laboratory tests [Срок оценки: Week 0, 6, 12, 24, 36 and 52]
• Second laboratory tests [Срок оценки: Week 0, 6, 12, 24, 36 and 52]
• Third laboratory tests [Срок оценки: Week 0, 6, 12, 24, 36 and 52]
• Inflammatory bowel disease questionnaire (IBDQ) [Срок оценки: Week 0, 12, 24, 36 and 52]
• Hospital anxiety and depression scale (HADS) [Срок оценки: Week 0, 12, 24, 36 and 52]
• The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [Срок оценки: Week 0, 12, 24, 36 and 52]
• Colonoscopy or small bowel MR evaluation [Срок оценки: Week 0 and 52]
• Expectation of acupuncture treatment [Срок оценки: Week 0]

Критерии участия

Критерии включения

• patients with clinical diagnosis consistent with CD;
• aged 16-75;
• patients in remission (CDAI < 150 and CRP < 5mg/l, or Faecal calprotectin < 50μg/g, or no ulcer under endoscopy);
• patients with frequent disease recurrences (≥2) in the past years;
• patients were not taking medication or were only taking one or more of the following drugs: \[mesalazine (≤4g/d), prednisone (≤15mg/d), azathioprine (≤1mg/kg/d)\] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-TNF-α, IL-12p40, α4β7);
• those who have never experienced acupuncture;
• patients signing informed consent.

Критерии исключения

• patients who are recently pregnant or in pregnancy or lactation;
• patients with serious organic diseases;
• patients diagnosed as psychosis;
• patients who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
• severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
• there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
• patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
• there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Research Institute of Acupuncture and Meridian — Шанхай

Публикации

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Идентификаторы

NCT: NCT06553053 · ZYS2024-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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