褪黑素治疗神经性疼痛：一项双盲随机对照试验方案

Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial.

作者信息

Gilron Ian, Tu Dongsheng, Holden Ronald R, Moulin Dwight E, Duggan Scott, Milev Roumen

机构信息

Department of Anesthesiology & Perioperative Medicine, Queen's University, Kingston, ON, Canada.

Department of Psychology, Queen's University, Kingston, ON, Canada.

出版信息

JMIR Res Protoc. 2022 Sep 28;11(9):e40025. doi: 10.2196/40025.

DOI:10.2196/40025

PMID:36170003

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9557986/

Abstract

BACKGROUND

Neuropathic pain (NP), a complication of several conditions (eg, diabetic neuropathy and varicella zoster), is a common challenging problem, and there is a growing need to develop safe and effective nonopioid treatments. Sleep disturbance is commonly associated with NP because pain intensity in NP conditions is often worse at night. The pineal hormone melatonin has been shown to reduce pain in both preclinical and clinical settings, in addition to multiple trials demonstrating efficacy for primary insomnia and delayed sleep phase syndrome.

OBJECTIVE

We propose to conduct a clinical trial to evaluate the efficacy and safety of melatonin for NP.

METHODS

Using a double-blind, placebo-controlled, crossover design, 30 adults with NP will be randomly allocated to one of two sequences of treatment with melatonin and placebo. During each of the two treatment periods, participants will take capsules containing melatonin or placebo for 4 weeks, followed by a 7-day washout period. The primary outcome will be mean daily pain intensity (scored 0-10) at maximally tolerated doses (MTDs) during each period. Secondary outcomes, assessed at MTDs, will include global improvement, adverse events, mood, and quality of life.

RESULTS

This trial was registered in the International Standard Randomized Controlled Trial registry May 4, 2022 (ISRCTN #16215617), attained conditional ethics approval May 9, 2022 (Queen's University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board protocol number ANAE-387-22), and recruitment is set to start August 2022.

CONCLUSIONS

This trial will provide rigorous evidence comparing the efficacy of melatonin to that of placebo in the treatment of NP.

TRIAL REGISTRATION

ISRCTN Registry 16215617; https://www.isrctn.com/ISRCTN16215617.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40025.

摘要

背景

神经性疼痛（NP）是多种病症（如糖尿病性神经病变和水痘带状疱疹）的并发症，是一个常见的具有挑战性的问题，并且开发安全有效的非阿片类治疗方法的需求日益增长。睡眠障碍通常与NP相关，因为NP患者的疼痛强度在夜间往往更严重。松果体激素褪黑素已被证明在临床前和临床环境中均能减轻疼痛，此外多项试验表明其对原发性失眠和睡眠相位延迟综合征有效。

目的

我们提议进行一项临床试验，以评估褪黑素治疗NP的疗效和安全性。

方法

采用双盲、安慰剂对照、交叉设计，30名患有NP的成年人将被随机分配到褪黑素和安慰剂两种治疗顺序之一。在两个治疗期的每个期间，参与者将服用含褪黑素或安慰剂的胶囊4周，随后是7天的洗脱期。主要结局将是每个期间最大耐受剂量（MTD）下的平均每日疼痛强度（评分0 - 10）。在MTD下评估的次要结局将包括整体改善情况、不良事件、情绪和生活质量。