ABSTRACT
Abstract The aim of this study was to assess the hepatotoxicity cases described in the literature, attributed to the consumption of Herbalife(r) products, and to determine whether a causal relationship exists between the reported cases of liver injury and the use of these products. A literature search was performed on the PubMed, LILACS and PAHO databases. Seven publications reporting a total of 53 cases of hepatotoxicity linked to the use of Herbalife(r) products were retrieved. All of the studies lacked sufficient information to some degree, whether related to patients' history, concomitant use of medication and/or other compounds (including alcohol), observations on interrupted use (dechallenge), results found with markers, viral serology and autoantibodies or observations concerning re-exposure to the products. In addition to these items, the lack of clear information on the type of products evaluated and their respective composition is an important factor to be considered. Furthermore, data quality was also questionable due to the presence of confounding factors, absence of proper exclusion of alternative explanations, and the use of questionable methods for attributing causality. Hence, an association between hepatotoxicity and consumption of these products cannot be proven based on the data collected and rigorous scientific analysis.
resumo Este estudo teve como objetivo avaliar os casos de hepatotoxicidade descritos em literatura, atribuídos ao consumo de produtos Herbalife(r), e verificar se é possível ou não estabelecer uma relação de causalidade entre eles. Realizou-se levantamento bibliográfico nas bases de dados PubMed, LILACS e PAHO e foram encontrados 7 manuscritos reportando 53 casos de hepatotoxicidade, relacionados ao uso de produtos Herbalife. Observou-se que todos trazem, de alguma forma, quantidade insuficiente de informações em relação ao histórico dos pacientes, ao uso concomitante de medicamentos e/ou outros compostos (incluindo álcool), às observações após a interrupção do uso (dechallenge), aos resultados referentes a marcadores e sorologia virais e autoanticorpos e às observações quanto à reexposição aos produtos. Some-se a estes fatos a falta de identificação clara e comprovada do tipo de produto envolvido, assim como sua composição. Além disso, a qualidade dos dados também é questionável devido à presença de variáveis de confundimento, ausência de exclusão adequada de explicações alternativas e ao uso de métodos discutíveis de atribuição de causalidade. Desta forma, a associação entre hepatotoxicidade e o consumo destes produtos não pode ser comprovada, após observar o conjunto dos dados coletados, utilizando-se rigor técnico-cientifico.
Subject(s)
Humans , Liver Failure , Dietary Supplements/adverse effects , Diet, Food, and NutritionABSTRACT
Las hierbas y otros productos de origen botánico, han sido utilizados por siglos en diversas culturas con fines medicinales y dietéticos. Contrario a la creencia de ser productos naturales y seguros, su potencial hepatotóxico es reconocido en diversos estudios a nivel mundial, lo que constituye un problema de salud que amerita mayor atención. La prevalencia reportada de hepatotoxicidad asociada a productos botánicos es variable y depende de diversos factores como población estudiada, período y diseño del estudio. Se han reportado un total de 60 productos a base de hierbas con fines medicinales y dietéticos, que pueden causar lesión hepática; sin embargo, el mecanismo fisiopatológico no está completamente dilucidado. Su cuadro clínico y características histológicas, no difieren de la lesión hepática asociada a medicamentos y la mayoría de los pacientes tienen un patrón de lesión hepatocelular. El diagnóstico se hace por exclusión, representando un desafío clínico importante, por lo que resulta fundamental la sospecha clínica y el diagnóstico diferencial de otras patologías agudas y crónicas. De allí que las investigaciones futuras están orientadas a mejorar los métodos diagnóstico existentes e introducir nuevas tecnologías toxicológicas, genéticas e inmunológicas. El manejo es complejo y representa un reto para el especialista puesto que no existe antídoto; el manejo se basa en suspender el uso del producto y en el tratamiento sintomático que disminuya la progresión a la falla hepática aguda fulminante.
Herbs and other botanicals have been used in different cultures with medicinal and dietary purposes for centuries. Contrary to the belief of being natural and safe products, their hepatotoxic potential is recognized in several studies worldwide, and represent a health problem that deserves greater attention. The reported prevalence of hepatotoxicity associated with botanicals is variable and depends on various factors such as population, period and design of the study. There have been reports of a total of 60 products with herbal medicinal and dietary purposes, which may cause liver damage; however, the pathophysiological mechanisms involved are not fully elucidated. Their clinical and histological features, not unlike liver injury associated with drugs in most patients, have a pattern of hepatocellular injury. Diagnosis is by exclusion, and represents a clinical challenge. It is essential the clinical suspicion and the differential diagnosis with other acute and chronic conditions. Hence, future researches are aimed at improving existing diagnostic methods and introducing new toxicological, genetic and immunological technologies. Treatment is complex and presents a challenge for the specialist, as there are no antidotes. Management based on the discontinued use of the product and in the symptomatic treatment, decreases the progression to an acute fulminant hepatic failure.
Subject(s)
Humans , Plants, Medicinal/adverse effects , Plant Preparations/adverse effects , Chemical and Drug Induced Liver Injury/etiology , Plants, Medicinal/chemistry , Prevalence , Dietary Supplements/adverse effects , Chemical and Drug Induced Liver Injury/diagnosis , Chemical and Drug Induced Liver Injury/epidemiology , Phytotherapy/adverse effects , Medicine, Traditional/adverse effectsABSTRACT
The intake of nutritional supplements among people who aim for weight loss has increased all over the world given the fact it is easily acquired without the need of a medical prescription.The goal of this study was to research the presence of toxicity due to the intake of Herbalife protein supplements and shakes in an animal model. Twenty-one male Wistar rats were divided in three groups: control, shake and protein. The shake and protein groups received 100 mg/kg/day of the supplement whereas the control group received 0.5 mg/kg/day of water. Supplementation regimen lasted two months and after this period laboratory exams and histological analysis were performed in order to evaluate hepatic lesions. The groups showed no differences in values of GGT, alkaline phosphatase, AST, ALT, cholesterol, HDL or triglycerides. All the toxicity reports related to Herbalife supplements are over longer periods of time of intake than the period established in this model. There are no reports on how the response of rats to this kind of supplementation works. The mechanism of hepatotoxicity in humans suggests an immune-mediated reaction. The presented model could not show the expected toxicity, it is reasonable to conclude that there is a direct relation between hepatic lesions in humans and the intake of Herbalife supplements.