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

J Allergy Clin Immunol. 2015 Oct;136(4):962-970.e1. doi: 10.1016/j.jaci.2015.04.029. Epub 2015 Jun 1.


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.

Trial registration: NCT00602160.

Keywords: Chinese herbal therapy; Food Allergy Herbal Formula-2; Food allergy; peanut allergy.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Allergens / immunology
  • Anaphylaxis / etiology
  • Anaphylaxis / prevention & control
  • Arachis / immunology
  • Cells, Cultured
  • Child
  • Double-Blind Method
  • Drugs, Chinese Herbal / administration & dosage*
  • Drugs, Chinese Herbal / adverse effects*
  • Female
  • Food Hypersensitivity / drug therapy*
  • Humans
  • Immunization
  • Interleukin-10 / metabolism
  • Interleukin-5 / metabolism
  • Leukocytes, Mononuclear / immunology
  • Male
  • Medication Adherence
  • Medicine, Chinese Traditional*
  • Middle Aged
  • Nut Hypersensitivity / complications
  • Nut Hypersensitivity / drug therapy
  • Placebos
  • Plant Extracts / adverse effects
  • Plant Extracts / therapeutic use*
  • Shellfish Hypersensitivity / drug therapy
  • T-Lymphocytes, Regulatory / immunology
  • Treatment Outcome
  • United States
  • Young Adult


  • Allergens
  • Drugs, Chinese Herbal
  • Food Allergy Herbal Formula-2
  • Interleukin-5
  • Placebos
  • Plant Extracts
  • Interleukin-10

Associated data