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

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.

• Authors: 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
• Journal: The Journal of allergy and clinical immunology (J Allergy Clin Immunol) Vol. 136 Issue 4 Pg. 962-970.e1 (Oct 2015) ISSN: 1097-6825 [Electronic] United States
• PMID: 26044855 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Chemical References

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

Topics

• Administration, Oral
• Adolescent
• Adult
• Allergens (immunology)
• Anaphylaxis (etiology, prevention & control)
• Arachis (immunology)
• Cells, Cultured
• Child
• Double-Blind Method
• Drugs, Chinese Herbal (administration & dosage, 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, drug therapy)
• Placebos
• Plant Extracts (adverse effects, therapeutic use)
• Shellfish Hypersensitivity (drug therapy)
• T-Lymphocytes, Regulatory (immunology)
• Treatment Outcome
• United States
• Young Adult