Abstract | BACKGROUND: 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.
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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)
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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
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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
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