Details

Autor(en) / Beteiligte

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

Titel

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

Ist Teil von

• Journal of allergy and clinical immunology, 2015-10, Vol.136 (4), p.962-970.e1

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2015

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.