Peanut allergy (PNA) is one of the major causes of fatal and near fatal food induced-anaphylactic reactions and at this time there is no definitive therapy. The need to develop treatments for PNA and other food allergies is urgent and challenging. Traditional Chinese Medicine, one of the oldest medical practices in the world, has benefited patients for thousands of years in China and herbal medicines have been suggested as potential herbal interventions for treating allergic disorders. Previous studies showed that Food Allergy Herbal Formula (FAHF)-I blocked systemic anaphylactic symptoms and histamine release, reduced mast cell degranulation, PN-specific serum IgE and Th2 cytokine secretion, and had no toxic effects on liver or kidney functions in a murine model of PNA, all of which could be of benefit to peanut allergic patients. Thus, the overall goals of this project are to further investigate Chinese herbal medicine for treating food allergy and to explore the mechanisms of its effects by pursuing three specific aims. Studies in Aim # 1 will minimize the number of herbs in FAHF-1 (11 herbs) in order to generate a simplified formula (sFHAF) to increase ease of standardization and safety profiles of the herbal product. One newly developed sFAHF (FAHF-2) containing 9 herbs shows therapeutic efficacy equivalent to that of FAHF-1 in the mouse model of PNA. Further reduction in the number of herbs in FAHF-2 will be carried out based upon preliminary data on the effects of the individual herbs in FAHF-2 to determine if sFAHF containing 1 to 3 herbs will have therapeutic effects comparable to FAHF-2. If a simplified formula is equivalent, more rigorous standardization methods will be performed to effectively monitor the quality of herbal product, as well as safety assessment.
Aim#2 will determine the effects of sFHAF tested in Aim#1 on murine T cells including Th1, Th2 and Th3 cells and on human T cells and basophils from peanut allergic patients.
In Aim #3, Phase I and II clinical studies will be initiated to evaluate the safety and efficacy of the sFHAF in human PNA. These clinical studies will be double blind, randomized, placebo controlled and multiple dose trials in peanut allergic patients. Accomplishing these aims will be of fundamental importance in validating the possible clinical usefulness of Chinese herbal medicine in PNA, and understanding the mechanisms of actions. These studies may lead to a novel approach for treating PNA, and other IgE mediated food allergies.
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