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

Julie Wang, Stacie M. Jones, Jacqueline A. Pongracic, Ying Song, Nan Yang, Scott H. Sicherer, Melanie M. Makhija, Rachel G. Robison, Erin Moshier, James Godbold, Hugh A. Sampson, Xiu Min Li*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

43 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)962-970.e1
JournalJournal of Allergy and Clinical Immunology
Volume136
Issue number4
DOIs
StatePublished - Oct 2015

Keywords

  • Chinese herbal therapy
  • Food Allergy Herbal Formula-2
  • Food allergy
  • peanut allergy

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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