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大麻素与安慰剂或不干预治疗疼痛的比较:一项系统评价、荟萃分析和试验序贯分析的方案

Cannabinoids versus placebo or no intervention for pain: protocol for a systematic review with meta-analysis and trial sequential analysis.

作者信息

Barakji Jehad Ahmad, Korang Steven Kwasi, Feinberg Joshua, Maagard Mathias, Gluud Christian, Mathiesen Ole, Jakobsen Janus Christian

机构信息

Copenhagen Trial Unit, Rigshospitalet, Department 7812, Center for Clinical Intervention Research, Copenhagen, Denmark

Copenhagen Trial Unit, Rigshospitalet, Department 7812, Center for Clinical Intervention Research, Copenhagen, Denmark.

出版信息

BMJ Open. 2019 Oct 31;9(10):e031574. doi: 10.1136/bmjopen-2019-031574.

Abstract

INTRODUCTION

Pain is a frequent clinical symptom with significant impact on the patient's well-being. Therefore, adequate pain management is of utmost importance. While cannabinoids have become a more popular alternative to traditional types of pain medication among patients, the quality of evidence supporting the use of cannabinoids has been questioned. The beneficial and harmful effects of cannabinoids in patients with pain is unknown. Accordingly, we aim to assess the efficacy, tolerability and safety of cannabinoids (herbal, plant-derived extracts and synthetic) compared with placebo or no intervention for any type of pain.

METHODS AND ANALYSES

We will conduct a systematic review of randomised clinical trials with meta-analysis and Trial Sequential Analysis to assess the beneficial and harmful effects of cannabinoids in any dose, formulation and duration. We will accept placebo or no treatment as control interventions. We will include participants with any type of pain (acute and chronic pain, cancer-related pain, headache, neuropathic pain or any other types of pain). We will systematically search The Cochrane Library, MEDLINE, Embase, Science Citation Index and BIOSIS for relevant literature. We will follow the recommendations by Cochrane and the Preferred Reporting Items for Systematic Review and Meta-Analysis statement. The risk of systematic errors (bias) and random errors (play of chance) will be assessed. The overall certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.

ETHICS AND DISSEMINATION

Ethical approval is not a requirement since no primary data will be collected. The findings of this systematic review will be submitted for peer-reviewed publication and disseminated in national and international conferences.

DISCUSSION

Although cannabinoids are now being used to manage different pain conditions, the evidence for the clinical effects are unclear. The present review will systematically assess the current evidence for the benefits and harms of cannabinoids to inform practice and future research.

摘要

引言

疼痛是一种常见的临床症状,对患者的健康有重大影响。因此,充分的疼痛管理至关重要。虽然大麻素已成为患者中比传统止痛药更受欢迎的替代品,但支持使用大麻素的证据质量受到质疑。大麻素对疼痛患者的有益和有害影响尚不清楚。因此,我们旨在评估大麻素(草药、植物提取物和合成物)与安慰剂或无干预措施相比,对任何类型疼痛的疗效、耐受性和安全性。

方法与分析

我们将对随机临床试验进行系统评价,并进行荟萃分析和试验序贯分析,以评估任何剂量、剂型和疗程的大麻素的有益和有害影响。我们将接受安慰剂或无治疗作为对照干预措施。我们将纳入患有任何类型疼痛(急性和慢性疼痛、癌症相关疼痛、头痛、神经性疼痛或任何其他类型疼痛)的参与者。我们将系统检索考克兰图书馆、MEDLINE、Embase、科学引文索引和生物学文摘数据库中的相关文献。我们将遵循考克兰和系统评价与荟萃分析优先报告项目声明的建议。将评估系统误差(偏倚)和随机误差(机遇的作用)的风险。将使用推荐分级评估、制定和评价方法评估证据的总体确定性。

伦理与传播

由于不收集原始数据,因此无需伦理批准。本系统评价的结果将提交同行评审发表,并在国内和国际会议上传播。

讨论

尽管目前大麻素被用于管理不同的疼痛状况,但其临床效果的证据尚不清楚。本综述将系统评估目前关于大麻素利弊的证据,为实践和未来研究提供信息。

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