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Xiu-Min Li, MD, Mount Sinai School of Medicine, New York, NY
Therapeutic effect of Chinese herbal medicine on food allergy, 2001-
The first clinical trial for this experimental therapy, known as Food Allergy Herbal Formula 2 (FAHF-2), began in December 2007 and was successfully concluded in 2010 (see artcle below). Dr. Li and her colleague, Hugh Sampson, MD, developed FAHF-2, which contains nine herbs used in traditional Chinese medicine. The therapy may prevent anaphylactic reactions to peanut, tree nuts, fish, shellfish, and sesame.
This clinical trial, which involved 19 participants aged 12 to 45, was an FDA Phase I study, which tests a therapy in a small group of patients to determine whether or not it is safe and well-tolerated. Drs. Li and Sampson expect to initiate a Phase II study, which will evaluate FAHF-2’s effectiveness. The final step before FDA approval would be a successful Phase III trial, which would test for effectiveness and side effects in patients at multiple medical centers. The researchers also will consider marketing FAHF-2 as an over-the-counter supplement while the approval process continues. This decision would depend on two key factors: whether or not the immunological findings in humans mirror the results previously found in animal studies; and whether or not most of the participants tolerate significant amounts of allergenic food after undergoing an oral food challenge.