背景:针灸治疗克罗恩病(CD)的疗效和机制尚不清楚。我们调查了它对症状的影响,肠道微生物群,和CD患者的循环炎症标志物。
方法:这48周,随机化,假控制,平行组临床试验在中国一家三级门诊进行.2015年4月至2019年11月,66例患者(平均年龄40·4岁,62%为男性,所有患者均为中国汉族),患有轻度至中度活动性CD且对药物治疗无反应,并随机平均分配到针灸组或假手术组。治疗组每周接受3次针灸治疗,共12周,随访36周。Clinicaltrials.gov:NCT02559037。
结果:在第12周,针刺组的临床缓解率(主要结果)和临床反应率明显高于假手术组。差异为42·4%(95%CI:20·1%-64·0%)和45·5%(95%CI:24·0%-66·9%),分别,两者都维持在第48周。针刺组在第12周的CD活性指数和C反应蛋白水平明显下降,并在随访36周时维持。CD内镜下的严重程度指数,组织病理学评分,针刺组48周复发率明显降低。肠道微生物群的操作分类单位数量以及prausnitzii和Roseburiafececis的相对丰度增加。血浆二胺氧化酶,脂多糖,针刺后12周,Th1/Th17相关细胞因子降低。
结论:针刺可有效诱导和维持活动性CD患者的缓解,这与肠道抗炎细菌的丰度增加有关,增强肠屏障,以及循环Th1/Th17相关细胞因子的调节。
背景:国家重点基础研究计划(2015CB554500和2009CB522900),上海新星计划(19QA1408100)。
BACKGROUND: The efficacy and mechanisms of acupuncture for Crohn\'s disease (CD) are not well understood. We investigated its effects on symptoms, intestinal microbiota, and circulating inflammatory markers in CD patients.
METHODS: This 48-week, randomized, sham controlled, parallel-group clinical trial was performed at a tertiary outpatient clinic in China. From April 2015 to November 2019, 66 patients (mean age 40·4, 62·1% were male, all were Han Chinese) with mild to moderate active CD and unresponsive to drug treatment were enrolled and randomly assigned equally to an acupuncture group or a sham group. The treatment group received 3 sessions of acupuncture plus moxibustion per week for 12 weeks and a follow-up of 36 weeks. Clinicaltrials.gov: NCT02559037.
RESULTS: At week 12, the clinical remission rate (the primary outcome) and clinical response rate of acupuncture group were significantly higher than that of sham group, with a difference of 42·4% (95% CI: 20·1%-64·0%) and 45·5% (95% CI: 24·0%-66·9%), respectively, both of which maintained at week 48. The acupuncture group had significantly lower CD activity index and C-reactive protein level at week 12, which maintained at 36-week follow-up. The CD endoscopic index of severity, histopathological score, and recurrence rate at week 48 were significantly lower in acupuncture group. The number of operational taxonomic unit of intestinal microbiota and relative abundance of Faecalibacterium prausnitzii and Roseburia faecis were increased. Plasma diamine oxidase, lipopolysaccharide, and Th1/Th17 related cytokines were decreased in 12-week after acupuncture.
CONCLUSIONS: Acupuncture was effective in inducing and maintaining remission in patients with active CD, which was associated with increased abundance of intestinal anti-inflammatory bacteria, enhanced intestinal barrier, and regulation of circulating Th1/Th17-related cytokines.
BACKGROUND: National Key Basic Research Program of China (2015CB554500 and 2009CB522900), Shanghai Rising-Star Program (19QA1408100).