Data_Sheet_3_Microbial Profiles of Patients With Antipsychotic-Related Constipation Treated With Electroacupuncture.XLSX

Antipsychotic-related constipation (APRC) is one of the most common side effects of taking antipsychotic medication. APRC can seriously impact patient quality of life and is potentially fatal, though the efficacy of current APRC treatments is low for most patients. In this study, we conducted a controlled, pilot randomized, sham-electroacupuncture (SEA) study to assess the efficacy of electroacupuncture (EA) in patients with APRC. We used 16S rRNA gene sequencing to assess the microbial profiles of these patients and analyze how EA treatments affected their bacteria.
Methods: We treated 133 APRC patients with randomly assigned EA treatments or SEA treatments for 4 consecutive weeks, fully evaluating the patients 8 weeks after treatment. The participants, outcome assessors, and statistics were all blind to the EA and SEA treatments. Outcomes assessed included changes in spontaneous bowel movements (SBMs) and the frequency of rescue measures. We detected assessed the microbial diversity of stool specimens both before and after EA treatment using 16S rRNA gene sequencing.
Results: Both EA and SEA treatments reduced the need for constipation rescue measures and did not have serious side effects. EA treatments were better than SEA treatments at increasing SBMs and reducing rescue measures. The diversity of gut microbiota changed after EA treatment. LEfSe analysis indicated changes in the genus (belonging to phylum Proteobacteria) of gut microbiota in patients following EA treatment.
Conclusions: This study found that EA treatment is effective and safe for patients with APRC, and could be associated with changes in their microbial profiles. Further study, with larger sample sizes, is needed to explore the efficacy of EA intervention as a clinical treatment for APRC.
Trial Registration: ChiCTR, ChiCTR-ONC-17010842, http://www.chictr.org.cn/showproj.aspx?proj=18420.

抗精神病药物相关性便秘（Antipsychotic-related constipation, APRC）是服用抗精神病药物最常见的不良反应之一。APRC可严重损害患者的生活质量，甚至可危及生命，尽管当前针对APRC的治疗方案对多数患者的疗效欠佳。
本研究设计并开展了一项随机对照先导假电针（sham-electroacupuncture, SEA）试验，旨在评估电针（electroacupuncture, EA）对APRC患者的治疗效应。我们采用16S rRNA基因测序技术对受试者的肠道微生物组谱进行解析，探究电针治疗对患者肠道菌群的调控作用。

方法：本研究共纳入133名APRC患者，按随机分配原则分为两组，分别接受连续4周的电针或假电针治疗，并于治疗结束后8周完成全面随访评估。本研究采用三盲设计：受试者、结局评估者及统计分析人员均对分组干预措施不知情。本次研究的评估结局包括自发排便次数（spontaneous bowel movements, SBMs）的变化情况，以及解救性治疗措施的使用频率。我们分别于电针治疗前后采集粪便标本，通过16S rRNA基因测序检测并分析患者的肠道菌群多样性。

结果：电针与假电针治疗均能降低便秘解救治疗的使用需求，且未引发严重不良事件。相较于假电针治疗，电针治疗在提升自发排便次数、减少解救性治疗使用方面的疗效更为显著。电针干预后，患者的肠道菌群多样性发生显著改变。线性判别分析效应大小（Linear Discriminant Analysis Effect Size, LEfSe）分析显示，接受电针治疗的患者肠道菌群中隶属于变形菌门（Proteobacteria）的菌属丰度出现明显变化。

结论：本研究结果表明，电针治疗用于APRC患者安全有效，其治疗效应可能与患者肠道微生物组谱的改变密切相关。未来需开展更大样本量的临床研究，进一步探索电针干预作为APRC临床治疗手段的应用价值。

试验注册：中国临床试验注册中心（ChiCTR），注册号ChiCTR-ONC-17010842，注册链接：http://www.chictr.org.cn/showproj.aspx?proj=18420。