Asunto(s)
Arachis/inmunología , Técnicas y Procedimientos Diagnósticos/normas , Glycine max/inmunología , Isotretinoína/uso terapéutico , Hipersensibilidad al Cacahuete/tratamiento farmacológico , Anafilaxia/inmunología , Anafilaxia/prevención & control , Antígenos de Plantas/inmunología , Arachis/efectos adversos , Bases de Datos Factuales , Fármacos Dermatológicos/administración & dosificación , Fármacos Dermatológicos/uso terapéutico , Humanos , Inmunoglobulina E/inmunología , Isotretinoína/administración & dosificación , Monitoreo Fisiológico/métodos , Hipersensibilidad a la Nuez/tratamiento farmacológico , Hipersensibilidad a la Nuez/inmunología , Hipersensibilidad a la Nuez/prevención & control , Hipersensibilidad al Cacahuete/inmunología , Aceite de Soja/metabolismo , Glycine max/efectos adversosRESUMEN
BACKGROUND: Food Allergy Herbal Formula-2 (FAHF-2) is a 9-herb formula based on traditional Chinese medicine that blocks peanut-induced anaphylaxis in a murine model. In phase I studies FAHF-2 was found to be safe and well tolerated. OBJECTIVE: We sought to evaluate the safety and effectiveness of FAHF-2 as a treatment for food allergy. METHODS: In this double-blind, randomized, placebo-controlled study 68 subjects aged 12 to 45 years with allergies to peanut, tree nut, sesame, fish, and/or shellfish, which were confirmed by baseline double-blind, placebo-controlled oral food challenges (DBPCFCs), received FAHF-2 (n = 46) or placebo (n = 22). After 6 months of therapy, subjects underwent DBPCFCs. For those who demonstrated increases in the eliciting dose, a repeat DBPCFC was performed 3 months after stopping therapy. RESULTS: Treatment was well tolerated, with no serious adverse events. By using intent-to-treat analysis, the placebo group had a higher eliciting dose and cumulative dose (P = .05) at the end-of-treatment DBPCFC. There was no difference in the requirement for epinephrine to treat reactions (P = .55). There were no significant differences in allergen-specific IgE and IgG4 levels, cytokine production by PBMCs, or basophil activation between the active and placebo groups. In vitro immunologic studies performed on subjects' baseline PBMCs incubated with FAHF-2 and food allergen produced significantly less IL-5, greater IL-10 levels, and increased numbers of regulatory T cells than untreated cells. Notably, 44% of subjects had poor drug adherence for at least one third of the study period. CONCLUSION: FAHF-2 is a safe herbal medication for subjects with food allergy and shows favorable in vitro immunomodulatory effects; however, efficacy for improving tolerance to food allergens is not demonstrated at the dose and duration used.
Asunto(s)
Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Hipersensibilidad a los Alimentos/tratamiento farmacológico , Medicina Tradicional China , Extractos Vegetales/uso terapéutico , Administración Oral , Adolescente , Adulto , Alérgenos/inmunología , Anafilaxia/etiología , Anafilaxia/prevención & control , Arachis/inmunología , Células Cultivadas , Niño , Método Doble Ciego , Femenino , Humanos , Inmunización , Interleucina-10/metabolismo , Interleucina-5/metabolismo , Leucocitos Mononucleares/inmunología , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Hipersensibilidad a la Nuez/complicaciones , Hipersensibilidad a la Nuez/tratamiento farmacológico , Placebos , Extractos Vegetales/efectos adversos , Hipersensibilidad a los Mariscos/tratamiento farmacológico , Linfocitos T Reguladores/inmunología , Resultado del Tratamiento , Estados Unidos , Adulto JovenRESUMEN
Three crucial areas of the management of anaphylaxis due to food allergy are discussed: making a diagnosis, deciding who needs a self-injectable adrenaline device and spotting the novel allergen. Managing children and teenagers with anaphylaxis is challenging due to the lack of available evidence that specific addresses these issue. The available evidence is presented and discussed.