■尽管通过世卫组织批准的多药疗法(MDT)有效治疗了麻风病,患者仍然患有衰弱的神经性后遗症,包括周围神经性疼痛(PNP),并继续发展并发病因(如糖尿病),和进行性现有的神经病变随着时间的推移。寻求改善生理和代谢健康的策略,包括那些减少全身性炎症和增强对神经毒性因子的免疫反应性的物质,可能会影响潜在的神经病变病因.一个完整的食品植物为基础的饮食(WFPBD)已被证明是有效的治疗神经性疼痛由于糖尿病,限制严重程度和相关症状学。糖尿病仍然是麻风病的重要后遗症,高达50%的患者需要皮质类固醇的反应,可能发展为生化糖尿病。由于营养干预可能会调节麻风病和糖尿病,对这些关系的具体探索仍然是相关的。
■(1)为了证明WFPBD生活方式干预的效果,关于麻风病的神经性疼痛变量;(2)通过评估耐受性和副作用来了解饮食在治疗麻风病慢性后遗症中的意义。
■预期,随机化,控制,单盲,描述了多中心介入试验。每周一小时的饮食咨询会议推广WFPBD强调蔬菜,水果,全谷物,坚果,和豆类,省略动物产品,并将实施在六个月内限制脂肪摄入量。参与者将是70名年龄和性别匹配的人,他们经历了活跃或治疗的“治愈”麻风病和PNP,随机分为干预组或对照组。主要结果测量包括通过视觉模拟量表进行的疗效,主观问卷和客观定量感官测试,以及安全,耐受性,WFPBD对麻风病PNP的危害。本研究将在所有参与研究中心的研究伦理委员会(REB)批准后启动。在研究开始之前,审判将在ClinicalTrials.gov注册。
■据推测,WFPBD将减轻PNP的进展和严重程度,并有可能减少与标准皮质类固醇治疗麻风病反应相关的不良事件,从而降低疾病的严重程度。通过检测WFPBDs对麻风病PNP的影响,我们希望阐明有助于加强这种被忽视的热带病治疗管理的数据。
UNASSIGNED: Despite effective treatment of leprosy via WHO-approved multi-drug therapy (MDT), patients still suffer from debilitating neuropathic sequelae, including peripheral neuropathic pain (PNP), and continue to develop intercurrent etiologies (such as diabetes), and progressive existing neuropathy over time. Strategies seeking to improve physiological and metabolic wellness, including those that reduce systemic inflammation and enhance immune responsiveness to neurotoxic factors may influence underlying neuropathic etiologies. A whole food plant-based diet (WFPBD) has been shown to be effective in the management of neuropathic pain due to diabetes, limiting severity and relevant symptomology. Diabetes remains a significant sequela of leprosy, as up to 50% of patients in reaction requiring corticosteroids, may develop a biochemical diabetes. As nutritional interventions may modulate both leprosy and diabetes, a specific exploration of these relationships remains relevant.
UNASSIGNED: (1) To demonstrate the effect of a WFPBD lifestyle intervention, on neuropathic pain variables in leprosy; and (2) To contextualize the significance of diet in the treatment of chronic sequelae in leprosy by evaluating tolerability and side effect profile.
UNASSIGNED: A prospective, randomized, controlled, single-blind, multicentre interventional trial is described. Weekly one-hour dietary counseling sessions promoting a WFPBD emphasizing vegetables, fruits, whole-grains, nuts, and legumes, omitting animal products, and limiting fat intake over a six-month duration will be implemented. Participants will be 70 age and sex-matched individuals experiencing active or treated \"cured\" leprosy and PNP, randomized to either intervention or control groups. Primary outcome measures include efficacy via visual analog scale, subjective questionnaire and objective quantitative sensory testing, as well as safety, tolerability, and harms of a WFPBD on PNP in leprosy. This study will be initiated after Research Ethics Board (REB) approval at all participating sites, and in advance of study initiation, the trial will be registered at ClinicalTrials.gov.
UNASSIGNED: It is hypothesized that WFPBDs will mitigate progression and severity of PNP and potentially reduce the adverse events related to standard corticosteroid treatment of leprosy reactions, thereby reducing disease severity. By examining the effects of WFPBDs on PNP in leprosy, we hope to illuminate data that will lead to the enhanced therapeutic management of this neglected tropical disease.