Huai Yisheng, Fan Qian, Dong Yiyue, Li Xu, Hu Junwei, Liu Lumin, Chen Yuelai, Yin Ping
Sleep Medicine Center, LongHua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Front Neurol. 2024 Apr 15;15:1341861. doi: 10.3389/fneur.2024.1341861. eCollection 2024.
Functional constipation (FC) is a common functional gastrointestinal disorder in clinical practice, with the prevalence of which increasing with age. With the increasing aging of the population worldwide, this problem is bound to become more prominent. Acupuncture is effective and recommended for the treatment of FC. However, little is known about how acupuncture affects the gut microbiota and inflammatory cytokines and thus improves gut function. Meanwhile, there are few high-quality clinical trials specifically focusing on acupuncture in treating FC in older people. The objective of this study is to assess the efficacy and safety of acupuncture in treating FC in older people. Additionally, the research aims to explore the mechanism of action of acupuncture in treating FC in older people by affecting intestinal microbiota and inflammation cytokines.
This study is designed as a single-center, randomized, sham-controlled clinical trial. A total of 98 eligible FC patients will be randomized in a 1:1 ratio into an acupuncture group and a sham acupuncture group. Both groups will receive 24 treatments over 8 weeks with a 12-week follow-up. The primary outcome of the study is the treatment response rate, which is the proportion of participants with ≥3 mean weekly Complete Spontaneous Bowel Movements (CSBMs) over weeks 3-8. The secondary outcomes will include the proportion of participants with ≥3 mean weekly CSBMs during other assessment periods; the percentage of patients with ≥1 increase in mean weekly CSBMs from baseline; the average changes in CSBMs; Patient Assessment of Constipation-Symptoms (PAC-SYM), Bristol Stool Scale, Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS) and weekly usage of emergency bowel medications. Adverse events will be recorded throughout the study. Data for the outcomes will be collected at Week 0 (baseline), Week 4 (the intervention period), Week 8 (the post-treatment), Week 12 (the follow-up period) and Week 20 (the follow-up period). In addition, changes in intestinal microbiota will be analyzed using 16S rRNA high-throughput detection, and the concentration of relevant inflammatory cytokines in serum will be measured by ELISA based on blood samples. The intention-to-treat analysis will be performed in this study. [https://www.chictr.org.cn/], identifier [ChiCTR2300070735].
功能性便秘（FC）是临床实践中常见的功能性胃肠疾病，其患病率随年龄增长而增加。随着全球人口老龄化加剧，这一问题势必变得更加突出。针灸治疗FC有效且被推荐。然而，关于针灸如何影响肠道微生物群和炎性细胞因子从而改善肠道功能，人们了解甚少。同时，很少有高质量的临床试验专门聚焦于针灸治疗老年人FC。本研究的目的是评估针灸治疗老年人FC的疗效和安全性。此外，该研究旨在通过影响肠道微生物群和炎症细胞因子来探索针灸治疗老年人FC的作用机制。
本研究设计为单中心、随机、假针刺对照临床试验。总共98例符合条件的FC患者将按1:1比例随机分为针灸组和假针灸组。两组均在8周内接受24次治疗，并进行12周的随访。研究的主要结局是治疗反应率，即第3至8周期间平均每周完全自主排便（CSBM）≥3次的参与者比例。次要结局将包括其他评估期间平均每周CSBM≥3次的参与者比例；平均每周CSBM较基线增加≥1次的患者百分比；CSBM的平均变化；便秘症状患者评估（PAC-SYM）、布里斯托大便分类法、便秘生活质量患者评估问卷（PAC-QOL）、自评焦虑量表（SAS）、自评抑郁量表（SDS）以及每周急救肠道药物的使用情况。在整个研究过程中记录不良事件。结局数据将在第0周（基线）、第4周（干预期）、第8周（治疗后）、第12周（随访期）和第20周（随访期）收集。此外，将使用16S rRNA高通量检测分析肠道微生物群的变化，并基于血样通过ELISA法测量血清中相关炎性细胞因子的浓度。本研究将进行意向性分析。[https://www.chictr.org.cn/]，标识符[ChiCTR2300070735]
