Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy

• Published in: Journal of allergy and clinical immunology Vol. 136; no. 4; pp. 962 - 970.e1
• Main Authors: Wang, Julie, Jones, Stacie M., Pongracic, Jacqueline A., Song, Ying, Yang, Nan, Sicherer, Scott H., Makhija, Melanie M., Robison, Rachel G., Moshier, Erin, Godbold, James, Sampson, Hugh A., Li, Xiu-Min
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2015; Elsevier Limited
• Subjects: Administration, Oral; Adolescent; Adult; Allergens - immunology; Allergy and Immunology; Anaphylaxis - etiology; Anaphylaxis - prevention & control; Arachis - immunology; Arachis hypogaea; Asthma; Cells, Cultured; Child; Children & youth; Chinese herbal therapy; Crustaceans; Double-Blind Method; Drug dosages; Drugs, Chinese Herbal - administration & dosage; Drugs, Chinese Herbal - adverse effects; Family medical history; FDA approval; Female; Food; Food allergies; Food allergy; Food Allergy Herbal Formula-2; Food Hypersensitivity - drug therapy; Hemophilia; Hospitals; Humans; Immunization; Interleukin-10 - metabolism; Interleukin-5 - metabolism; Laboratories; Leukocytes, Mononuclear - immunology; Male; Medication Adherence; Medicine, Chinese Traditional; Middle Aged; Nut Hypersensitivity - complications; Nut Hypersensitivity - drug therapy; peanut allergy; Placebos; Plant Extracts - adverse effects; Plant Extracts - therapeutic use; Proteins; Shellfish; Shellfish Hypersensitivity - drug therapy; T-Lymphocytes, Regulatory - immunology; Traditional Chinese medicine; Treatment Outcome; United States; Young Adult; United States; China; Food allergy; sIgE; FDA; AE; Treg; sIgG4; peanut allergy; FAHF-2; SPT; Food Allergy Herbal Formula-2; Chinese herbal therapy; OIT; FoxP3; DBPCFC; Adverse event; Skin prick test; Oral immunotherapy; Forkhead box protein 3; Allergen-specific IgG 4; Double-blind, placebo-controlled oral food challenge; Regulatory T; US Food and Drug Administration; sIgG 4; Allergen-specific IgE
• ISSN: 0091-6749; 1097-6825; 1097-6825
• DOI: 10.1016/j.jaci.2015.04.029

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. We sought to evaluate the safety and effectiveness of FAHF-2 as a treatment for food allergy. 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. 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. 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.