黄连木类草药制剂的不良反应:随机对照临床试验的系统回顾和荟萃分析

IF 1.9 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE
Saeid Mohseni , Narjes Gorji , Reihaneh Moeini , Zahra Meamariani , Hoda Shirafkan
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引用次数: 0

摘要

黄连木有营养和治疗用途。本系统综述和荟萃分析旨在评估黄连木属草药制剂在随机对照临床试验中的安全性。方法截至2023年8月在PubMed、Embase、Scopus、Web of Science、谷歌Scholar等数据库中检索相关关键词。使用Cochrane协作工具评估偏倚的质量和风险。使用RevMan软件报告不良事件和停药率的汇总效应大小为相对风险(RR)和95%置信区间(CI)。生成森林图以可视化每次比较的效应大小。结果共纳入26项符合条件的随机对照临床试验(RCTs)(1 851例)。最后,干预组和比较组分别报告了14例和13例不良事件,差异无统计学意义(RR: 0.99 [95% CI: 0.48, 2.05];Z: 0.01, p: 0.99)。实验组的不良反应多为轻度胃肠道事件。干预组的停药率低于对照组。但差异无统计学意义(RR: 0.81 [95% CI: 0.62, 1.05];Z: 1.61, p: 0.11)。这些发现在黄连木属和治疗适应症亚组中是一致的。结论黄连木的安全性与安慰剂、常规饮食或常规治疗相当,不良事件少,无严重不良事件。然而,考虑到高偏倚风险,如样本量小,未来有必要进行高质量、大规模、不同人口统计学的随机对照试验,以确认这些制剂的安全性和有效性,特别是对特定人群或长期使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Adverse effects of herbal preparations of Pistacia species: a systematic review and meta-analysis of randomised controlled clinical trials

Adverse effects of herbal preparations of Pistacia species: a systematic review and meta-analysis of randomised controlled clinical trials

Introduction

Pistacia species (spp.) have nutritional and therapeutic usage. This systematic review and meta-analysis aimed to assess the safety of herbal preparations of Pistacia spp. in the randomised controlled clinical trials.

Methods

Relevant keywords were searched in PubMed, Embase, Scopus, Web of Science, and Google Scholar up to August 2023. The quality and risk of bias were assessed using the Cochrane Collaboration tool. Pooled effect sizes for adverse events and withdrawal rates were reported as relative risks (RR) and 95% confidence intervals (CI) using RevMan software. Forest plots were generated to visualise effect sizes for each comparison.

Results

Twenty-six eligible randomised controlled clinical trials (RCTs) were included in the pooled analysis (1 851 subjects). Finally, 14 and 13 adverse events were reported for the intervention and comparator groups, respectively, without any significant difference (RR: 0.99 [95% CI: 0.48, 2.05]; Z: 0.01, P: 0.99). Most adverse events in the experimental groups were mild gastrointestinal events. The intervention groups reported lower withdrawal rate than the comparator groups. However, the difference was not significant (RR: 0.81 [95% CI: 0.62, 1.05]; Z: 1.61, P: 0.11). These findings were consistent across Pistacia spp. and treatment indication subgroups.

Conclusion

The safety of Pistacia spp. was comparable to that of placebo, regular diet, or conventional treatments, with few adverse events and no serious adverse events. However, given the high risk of bias, such as small sample sizes, future high-quality, large-scale RCTs with diverse demographics are necessary to confirm the safety and efficacy of these preparations especially for specific populations or long-term usage.
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来源期刊
Journal of Herbal Medicine
Journal of Herbal Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
3.90
自引率
0.00%
发文量
94
期刊介绍: The Journal of Herbal Medicine, the official journal of the National Institute of Medical Herbalists, is a peer reviewed journal which aims to serve its readers as an authoritative resource on the profession and practice of herbal medicine. The content areas of the journal reflect the interests of Medical Herbalists and other health professionals interested in the clinical and professional application of botanical medicines. The objective is to strengthen the research and educational base of herbal medicine with research papers in the form of case studies, original research articles and reviews, monographs, clinical trials and relevant in vitro studies. It also publishes policy statements, opinion pieces, book reviews, conference proceedings and profession related information such as pharmacovigilance reports providing an information source for not only the Herbal Practitioner but any Health professional with an interest in phytotherapy.
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