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振动胶囊治疗慢性特发性便秘的疗效与安全性:一项随机对照试验的系统评价和荟萃分析

Efficacy and safety of vibrating capsule in treatment of chronic idiopathic constipation: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Haghbin Hossein, Zakirkhodjaev Nurruddinkhodja, Gangwani Manesh Kumar, Beran Azizullah, Lee-Smith Wade, Piper Michael H, Aziz Muhammad

机构信息

Division of Gastroenterology, Ascension Providence Hospital, Southfield, MI, USA.

Division of Occupational and Environmental Medicine, The University of Texas Health Science Center at Houston, Houston, TX, USA.

出版信息

Transl Gastroenterol Hepatol. 2024 Jan 16;9:8. doi: 10.21037/tgh-23-64. eCollection 2024.

Abstract

BACKGROUND

Multiple pharmacological interventions and modalities are available for managing chronic idiopathic constipation (CIC), with variable efficacy. Vibrating capsule (VC) is a device that has shown variable results in alleviating constipation by tactile stimulation of the colonic wall and inducing peristalsis. This meta-analysis is to investigate the efficacy and safety of this modality.

METHODS

Comprehensive literature search was performed through June 14th, 2023, on databases including Embase, PubMed/MEDLINE, Cochrane Central, Web of Science, Global Index Medicus, and Google Scholar. Core concepts of VC, constipation, and bowel movement were searched. The DerSimonian-Laird method and random effects model were utilized. We calculated odds ratio (OR) and mean difference (MD) for proportional and continuous variables, respectively, with 95% confidence interval (CI) and a P value of <0.05 considered statistically significant.

RESULTS

The search strategy yielded 117 articles. Four studies with 705 total patients were finalized comparing VC to placebo/sham treatment. The pooled complete spontaneous bowel movement (CSBM), defined as bowel movement without use of laxatives within the last 48 hours with sense of complete evacuation did not achieve statistical improvement with VC (MD =0.153; 95% CI: -0.218 to 0.523; P=0.422). However, spontaneous bowel movement (SBM), defined as bowel movement without use of laxatives within the last 48 hours, showed statistical improvement with VC (MD =0.159; 95% CI: 0.095 to 0.223; P<0.001). VC didn't show an increase in pooled adverse events (OR =1.431; 95% CI: 0.702 to 2.916; P=0.324).

CONCLUSIONS

The systematic review and meta-analysis suggest that VC is safe and efficacious in some outcomes, however, larger randomized controlled trials (RCTs) and real-world data are needed to establish this.

摘要

背景

有多种药物干预措施和治疗方法可用于管理慢性特发性便秘(CIC),但其疗效各不相同。振动胶囊(VC)是一种通过触觉刺激结肠壁并诱导蠕动来缓解便秘的装置,其效果不一。本荟萃分析旨在研究该治疗方法的疗效和安全性。

方法

截至2023年6月14日,对包括Embase、PubMed/MEDLINE、Cochrane Central、Web of Science、全球医学索引和谷歌学术在内的数据库进行了全面的文献检索。检索了振动胶囊、便秘和排便的核心概念。采用DerSimonian-Laird方法和随机效应模型。我们分别计算了比例变量和连续变量的比值比(OR)和均值差(MD),95%置信区间(CI),P值<0.05被认为具有统计学意义。

结果

检索策略共获得117篇文章。最终纳入4项研究,共705例患者,比较了振动胶囊与安慰剂/假治疗。将完全自主排便(CSBM)定义为在过去48小时内未使用泻药且有完全排空感的排便,振动胶囊治疗后未达到统计学上的改善(MD =0.153;95%CI:-0.218至0.523;P=0.422)。然而,将自主排便(SBM)定义为在过去48小时内未使用泻药的排便,振动胶囊治疗后有统计学上的改善(MD =0.159;95%CI:0.095至0.223;P<0.001)。振动胶囊并未显示汇总不良事件增加(OR =1.431;95%CI:0.702至2.916;P=0.324)。

结论

系统评价和荟萃分析表明,振动胶囊在某些结果方面是安全有效的,然而,需要更大规模的随机对照试验(RCT)和真实世界数据来证实这一点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d477/10838609/0da0a1229091/tgh-09-23-64-f1.jpg

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