The efficacy of a whole foods, plant-based dietary lifestyle intervention for the treatment of peripheral neuropathic pain in leprosy: a randomized control trial protocol.

Introduction: 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. Objectives: (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. Methods: 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. Expected impact: 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.

A review of nutrition in neuropathic pain of leprosy.

Leprosy is a neglected tropical disease (NTD) that continues to burden low- and middle-income countries (LMICs), despite being eliminated as a public health concern by the World Health Organization (WHO) in 2000. The causative agents, Mycobacterium leprae and Mycobacterium lepromatosis, affect nearly 200,000 individuals globally each year, with over 19,000 new cases detected in the Americas in 2020 alone. Canada has experienced an increasing incidence of leprosy, due to rising levels of travel and migration from endemic areas, reaching over 37,000 individuals with leprosy by the end of 2020. Patients experience a spectrum of signs and symptoms including hypopigmented cutaneous macules alongside peripheral neuropathy including peripheral neuropathic pain (PNP) and disabling sensory neuropathies. Despite the development of effective and curative therapeutics via multidrug therapy (MDT), many barriers to treatment adherence and effective immunological control of the pathogen challenge the care of patients with leprosy. Socioeconomic barriers, such as disability-related social stigma and often undiagnosed nutritional deficiencies, have resulted in heightened disease severity. PNP therapeutics are associated with significant side effects and remain ineffective as the majority of individuals will not experience a greater than 30% reduction of symptoms. Nutrient supplementation is known to be instrumental in reducing host oxidative stress, strengthening the immune system and mitigating comorbidities. Likewise, dietary lifestyle interventions known to be physiologically beneficial have recently emerged as powerful tools conferring neuroprotective effects, potentially mitigating PNP severity. However, a significant knowledge gap concerning the effect of adequate nutrition on host immunological control of leprosy and PNP severity exists. Further evaluation of this relationship will provide key insight into the pathogenesis of leprosy, strengthening the current body of literature.

Ofloxacin-Containing Multidrug Therapy in Ambulatory Leprosy Patients: A Case Series.

BACKGROUND: Standard dapsone and clofazimine-containing multidrug therapy (MDT) for leprosy is limited by drug tolerability, which poses treatment adherence barriers. Although ofloxacin-based regimens are promising alternatives, current efficacy and safety data are limited, particularly outside of endemic areas. We evaluated treatment outcomes in patients with leprosy receiving ofloxacin-containing MDT (OMDT) at our center. METHODS: We performed a retrospective chart review of patients treated for leprosy at our center over an 8-year period (2011-2019). Primary outcomes evaluated were clinical cure rate, occurrence of leprosy reactions, antibiotic-related adverse events, and treatment adherence. Analyses were descriptive; however, data were stratified by age, sex, spectrum of disease, region of origin, and treatment regimen, and odds ratios were reported to assess associations with adverse outcomes. RESULTS: Over the enrolment period, 26 patients were treated with OMDT (n = 19 multibacillary, n = 7 paucibacillary), and none were treated with clofazimine-based standard MDT. At the time of analysis, 23 patients (88%) had completed their course of treatment, and all were clinically cured, while 3 (12%) were still on treatment. Eighteen patients (69%) experienced either ENL (n = 7, 27%), type 1 reactions (n = 7, 27%), or both (n = 4, 15%). No patients stopped ofloxacin due to adverse drug effects, and there were no cases of allergic hypersensitivity, tendinopathy or rupture, or C. difficile colitis. CONCLUSIONS: We demonstrate a high cure rate and tolerability of OMDT in this small case series over an 8-year period, suggesting its viability as an alternative to standard clofazimine-containing MDT.

Case Report: A Case of Type 1 Leprosy Reaction and Dapsone Hypersensitivity Syndrome Complicating the Clinical Course of Multibacillary Leprosy.

Type 1 reactions, characterized by increasing lesion erythema, pain, and nerve damage, commonly complicate leprosy. Dapsone hypersensitivity syndrome (DHS) is a potentially fatal reaction occurring 6-8 weeks into dapsone therapy. We present a case of intercurrent Type 1 reaction and DHS in a multibacillary leprosy patient recently started on multidrug treatment.

Erythema Nodosum Leprosum Triggered by Antecedent Influenza Vaccine and Respiratory Tract Infection: A Case Report.

We present a patient with new-onset erythema nodosum leprosum months after successful treatment of her mid-borderline leprosy, which was likely triggered by a combination of antecedent influenza vaccination and upper respiratory tract infection.

Evaluation of safety tool for ambulatory leprosy patients at risk of adverse outcome.

BACKGROUND: Leprosy is a potentially debilitating disease of the skin and nerves that requires a complex management approach consisting of laboratory monitoring, screening for factors that will adversely affect outcome with corticosteroids, engagement of allied health services, and prolonged follow-up. Given the complexities of leprosy management, a safety tool was developed and implemented in the Tropical Disease Unit at Toronto General Hospital. Our objective was to evaluate the utility of the tool using a retrospective chart review. METHODS: We reviewed the charts of patients with leprosy treated over a 3.5-year period: up to 3 years prior to tool implementation, and 6-months following implementation. Pre-determined outcomes of interest included: loss to follow-up; monitoring of laboratory parameters; allied health services engagement; baseline ophthalmologic assessment; and risk mitigation interventions. RESULTS: Of 17 patients enrolled, 8 were treated pre-implementation, and 9 post-implementation. Five (29.4%) pre-implementation patients were lost to follow-up compared to none post-implementation (p = 0.009). One (12.5%) pre-implementation patient was sent for baseline ophthalmologic assessment versus 8 (88.9%) post-implementation (p = 0.0034). Only post-implementation patients received referrals for occupational therapy and social work, with 77.8% (n = 7) receiving occupational therapy (p = 0.0023) and 33.3% (n = 3) social work (p = 0.2059). Laboratory parameters such as hemoglobin, hepatic transaminases, and methemoglobin were routinely monitored for patients on dapsone irrespective of tool implementation. CONCLUSIONS: Implementation of a leprosy-specific safety tool has established a user-friendly method for systemizing all elements of care, and ensuring the involvement of allied health services necessary for optimizing health outcomes.

Leprosy in Nonimmigrant Canadian Man without Travel outside North America, 2014.

In Canada, Hansen disease (leprosy) is rare and not considered in diagnoses for nonimmigrant patients. We report Mycobacterium leprae infection in a Canadian man whose sole travel was to Florida, USA. The M. leprae isolate was identified as armadillo-associated genotype 3I-2-v1. Travelers to the southern United States should avoid contact with armadillos.

Clinical Pearls: Leprosy Reactions.

Leprosy reactions are acute inflammatory episodes that occur in the setting of Mycobacterium leprae infection. Precipitants of reactions can be pharmacologic and nonpharmacologic. Both type 1 and type 2 reactions typically occur before and during leprosy treatment but may also occur after treatment has been completed. Reactions cause morbidity due to nerve damage, and prompt corticosteroid therapy is warranted to minimize nerve damage due to reactions.

Leprosy in Toronto: an analysis of 184 imported cases.

BACKGROUND: Leprosy is a rare but serious mycobacterial infection. Immigration from areas where the disease is endemic has resulted in the importation of leprosy into countries where it is not endemic and where physicians and health care workers have little or no experience in diagnosis and therapy. In this study we characterized leprosy patients seen in a tropical disease unit that manages most of the reported leprosy cases in Canada. METHODS: We reviewed the clinical records of all 184 leprosy patients who were referred to the Tropical Disease Unit at Toronto General Hospital between 1979 and 2002 and abstracted demographic and clinical information. RESULTS: Patients were more likely to be male (122 or 66.3%) and of Indian (44 or 23.9%), Filipino (49 or 26.6%) or Vietnamese (37 or 20.1%) origin. Patients experienced symptoms for a mean of 4.8 years before referral to the Tropical Disease Unit. Most had no family history of leprosy (152/172 or 88.4%). Most patients presented with either borderline tuberculoid (80 or 43.5%) or borderline lepromatous (37 or 20.1%) disease. On average, patients presented with 5.8 skin lesions. Upper- and lower-extremity nerve dysfunction was common at presentation, with up to one-third of patients demonstrating either sensory or motor loss. A significantly greater lag time to presentation was observed in patients who emigrated from low-prevalence regions (p < 0.001). INTERPRETATION: Leprosy is a chronic infectious disease that is associated with serious morbidity if left untreated. Leprosy is uncommon in developed countries, but it is important for physicians to have a high index of suspicion when a foreign-born patient presents with chronic dermatitis and peripheral nerve involvement.

Leprosy: a primer for Canadian physicians.

Leprosy is a rare but serious infectious disease caused by Mycobacterium leprae. While global prevalence of the disease is decreasing, increasing rates of immigration from countries where leprosy is endemic have led to the recognition of this illness in North America. Classically, leprosy presents as hypopigmented cutaneous macules along with sensory and motor peripheral neuropathies, although the clinical manifestations vary along a disease spectrum. In addition to primary infection, patients may undergo a "reaction," an acute inflammatory response to the mycobacterium, which leads to pain and erythema of skin lesions and dangerous neuritis. Reactions can occur at any time during the course of leprosy, but they tend to be precipitated by treatment. They are a significant cause of impaired quality of life due to marked nerve damage and thus warrant prompt intervention. Although leprosy may have a protracted onset and be difficult to recognize, cure is achievable with appropriate multidrug therapy. Because untreated leprosy can result in permanent, irreversible nerve damage and secondary transmission, early diagnosis and treatment are essential to minimize morbidity.

Leprosy in Toronto: an analysis of 184 imported cases

BACKGROUND: Leprosy is a rare but serious mycobacterial infection. Immigration from areas where the disease is endemic has resulted in the importation of leprosy into countries where it is not endemic and where physicians and health care workers have little or no experience in diagnosis and therapy. In this study we characterized leprosy patients seen in a tropical disease unit that manages most of the reported leprosy cases in Canada. METHODS: We reviewed the clinical records of all 184 leprosy patients who were referred to the Tropical Disease Unit at Toronto General Hospital between 1979 and 2002 and abstracted demographic and clinical information. RESULTS: Patients were more likely to be male (122 or 66.3%) and of Indian (44 or 23.9%), Filipino (49 or 26.6%) or Vietnamese (37 or 20.1%) origin. Patients experienced symptoms for a mean of 4.8 years before referral to the Tropical Disease Unit. Most had no family history of leprosy (152/172 or 88.4%). Most patients presented with either borderline tuberculoid (80 or 43.5%) or borderline lepromatous (37 or 20.1%) disease. On average, patients presented with 5.8 skin lesions. Upper- and lower-extremity nerve dysfunction was common at presentation, with up to one-third of patients demonstrating either sensory or motor loss. A significantly greater lag time to presentation was observed in patients who emigrated from low-prevalence regions (p < 0.001). INTERPRETATION: Leprosy is a chronic infectious disease that is associated with serious morbidity if left untreated. Leprosy is uncommon in developed countries, but it is important for physicians to have a high index of suspicion when a foreign-born patient presents with chronic dermatitis and peripheral nerve involvement.

Leprosy: a primer for Canadian physicians

Leprosy is a rare but serious infectious disease caused by Mycobacterium leprae. While global prevalence of the disease is decreasing, increasing rates of immigration from countries where leprosy is endemic have led to the recognition of this illness in North America. Classically, leprosy presents as hypopigmented cutaneous macules along with sensory and motor peripheral neuropathies, although the clinical manifestations vary along a disease spectrum. In addition to primary infection, patients may undergo a [quot ]reaction,[quot ] an acute inflammatory response to the mycobacterium, which leads to pain and erythema of skin lesions and dangerous neuritis. Reactions can occur at any time during the course of leprosy, but they tend to be precipitated by treatment. They are a significant cause of impaired quality of life due to marked nerve damage and thus warrant prompt intervention. Although leprosy may have a protracted onset and be difficult to recognize, cure is achievable with appropriate multidrug therapy. Because untreated leprosy can result in permanent, irreversible nerve damage and secondary transmission, early diagnosis and treatment are essential to minimize morbidity.