Data and analysis scripts: Amitriptyline for the management of painful HIV-associated sensory neuropathy (HIV-SN)

<b>Citation: </b>Dinat N, Marinda E, Moch S, Rice AS, Kamerman PR. Randomized, double-blind, crossover trial of amitriptyline for analgesia in painful HIV-associated sensory neuropathy. PLoS One 10(5):e0126297. DOI:10.1371/journal.pone.0126297, PMID: 25974287<b>Repo content: </b>Data, codebooks, and analysis scripts for a randomized, double-blind, placebo-controlled, cross-over clinical trial of amitriptyline for the management of moderate to severe pain associated with HIV-associated sensory neuropathy. <b>Background and study aims: </b>The peripheral nervous system is part of the nervous system that is made up of the nerves and ganglia (group of nerve cells) outside of the brain and spinal cord (the central nervous system). It connects the central nervous system to the limbs and organs of the body. Damage to peripheral nerves, especially the long nerves of the feet and hands, is common in people infected with HIV. This damage may be caused by the virus itself, some of the antiretroviral drugs used to treat HIV/AIDS, or as a result of opportunistic infections, for example thrush, herpes and tuberculosis. The nerve damage is often painful, can have a detrimental effect on a person's quality of life and has significant socioeconomic effects. Unlike other types of peripheral neuropathy (e.g., the neuropathy that develops in people with diabetes mellitus), there are, as yet, no effective treatments for painful HIV neuropathy. Here, we want to see if amitriptyline, an antidepressant drug that has been shown to relieve pain in other types of neuropathy, can provide pain relief better than that of a placebo (a dummy pill) in patients with painful HIV neuropathy. <b>Who participated? </b>Adult HIV-infected individuals that have been diagnosed with painful HIV-associated sensory neuropathy. Participants were either be on stable antiretroviral therapy, or had never been exposed to antiretroviral therapy for HIV infection.<b>What did the study involve? </b>Ambulatory HIV-positive patients attending clinics at Chris Hani Baragwanath Hospital, Soweto, South Africa were randomly allocated to receive amitriptyline (25-150mg/day) or a placebo for six weeks. The drug/placebo dose was started at 25mg/day and increased every three days over the first two weeks of the treatment until participants achieve pain relief, intolerable side effects, or a maximum dose of 150 mg/day. The trial drug and the placebo were identical in appearance. Participants visit the study centre every three weeks to receive their medication and to record a pain score. At the end of the first six-week treatment period, participants are taken off their assigned medication for a three-week 'washout' period. After this washout period, those participants who receive amitriptyline before were now given the placebo and vice versa for another 6 weeks. Dose titration and pain assessments followed the same protocol used in the first six-week period.<b>Where was the study run from? </b>Nthabiseng HIV Clinic and the Centre for Palliative Care, Chris Hani Baragwanath Hospital, Soweto, South Africa<b>What was the study outcome? </b>Amitriptyline was not superior to placebo at relieving moderate-to-severe pain in individuals with HIV-SN.<br>

<b>引用文献：</b>Dinat N、Marinda E、Moch S、Rice AS、Kamerman PR. 阿米替林用于缓解HIV相关感觉神经病（HIV-associated sensory neuropathy, HIV-SN）疼痛的随机双盲交叉试验. PLoS One 10(5):e0126297. DOI:10.1371/journal.pone.0126297, PMID:25974287<b>数据集内容：</b>本数据集包含一项针对阿米替林治疗HIV相关感觉神经病所致中重度疼痛的随机双盲安慰剂对照交叉临床试验的原始数据、编码手册及分析脚本。<b>研究背景与目的：</b>周围神经系统（peripheral nervous system）是神经系统的组成部分，由脑和脊髓（即中枢神经系统（central nervous system））以外的神经与神经节（神经细胞集群）构成，可将中枢神经系统与躯体四肢及内脏器官相连。HIV感染者常出现周围神经损伤，尤以手足长神经受累多见。此类损伤可由HIV病毒本身、部分抗反转录病毒治疗（antiretroviral therapy）药物，或机会性感染（如鹅口疮、疱疹及结核病）引发。神经损伤常伴随剧烈疼痛，严重影响患者生活质量，并带来显著的社会经济负担。与其他类型周围神经病（如糖尿病性周围神经病）不同，目前尚无针对疼痛性HIV相关感觉神经病的有效治疗方案。本研究旨在探讨阿米替林——一种已被证实可缓解其他类型神经病疼痛的抗抑郁药物——是否较安慰剂（placebo）能更有效地减轻疼痛性HIV相关感觉神经病患者的疼痛症状。<b>研究对象：</b>经确诊患有疼痛性HIV相关感觉神经病的成年HIV感染者。受试者可接受稳定的抗反转录病毒治疗，或从未接受过HIV感染的抗反转录病毒治疗。<b>研究流程：</b>招募南非索韦托克里斯·哈尼·巴拉格万斯医院门诊就诊的HIV阳性成年患者，将其随机分配至阿米替林组（每日25-150mg）或安慰剂组，治疗周期为6周。给药剂量以每日25mg起始，在治疗前两周每3日递增一次，直至患者疼痛得到缓解、出现不可耐受的不良反应，或达到最大剂量150mg/日。试验药物与安慰剂外观完全一致。受试者每3周前往研究中心领取药物并记录疼痛评分。在首个6周治疗周期结束后，受试者需停药并接受为期3周的洗脱期。洗脱期结束后，此前接受阿米替林的受试者将转为服用安慰剂，此前服用安慰剂的受试者则转为服用阿米替林，治疗周期同样为6周。剂量滴定与疼痛评估流程与首个6周治疗周期一致。<b>研究开展地点：</b>南非索韦托克里斯·哈尼·巴拉格万斯医院恩塔比森HIV诊所与姑息治疗中心。<b>研究结果：</b>阿米替林在缓解HIV相关感觉神经病患者的中重度疼痛方面，并不优于安慰剂。