title: 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.
  
  
  CONCLUSIONS
  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.affiliation: Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: julie.wang@mssm.edu.
authors.forename: Julie
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Pediatrics, Division of Allergy and Immunology, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
authors.forename: Stacie M
authors.initials: SM
authors.lastname: Jones
authors.affiliation: Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
authors.forename: Jacqueline A
authors.initials: JA
authors.lastname: Pongracic
authors.affiliation: Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Ying
authors.initials: Y
authors.lastname: Song
authors.affiliation: Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Nan
authors.initials: N
authors.lastname: Yang
authors.affiliation: Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Scott H
authors.initials: SH
authors.lastname: Sicherer
authors.affiliation: Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
authors.forename: Melanie M
authors.initials: MM
authors.lastname: Makhija
authors.affiliation: Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
authors.forename: Rachel G
authors.initials: RG
authors.lastname: Robison
authors.affiliation: Department of Preventive Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Erin
authors.initials: E
authors.lastname: Moshier
authors.affiliation: Department of Preventive Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: James
authors.initials: J
authors.lastname: Godbold
authors.affiliation: Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Hugh A
authors.initials: HA
authors.lastname: Sampson
authors.affiliation: Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: xiu-min.li@mssm.edu.
authors.forename: Xiu-Min
authors.initials: XM
authors.lastname: Li
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000276:immunology; D000707:Anaphylaxis / Q000209:etiology / Q000517:prevention & control; D010367:Arachis / Q000276:immunology; D002478:Cells, Cultured; D002648:Child; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D005512:Food Hypersensitivity / Q000188:drug therapy*; D006801:Humans; D007114:Immunization; D016753:Interleukin-10 / Q000378:metabolism; D015848:Interleukin-5 / Q000378:metabolism; D007963:Leukocytes, Mononuclear / Q000276:immunology; D008297:Male; D055118:Medication Adherence; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D021184:Nut Hypersensitivity / Q000150:complications / Q000188:drug therapy; D010919:Placebos; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D000067208:Shellfish Hypersensitivity / Q000188:drug therapy; D050378:T-Lymphocytes, Regulatory / Q000276:immunology; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000485:Allergens; D004365:Drugs, Chinese Herbal; C497376:Food Allergy Herbal Formula-2; D015848:Interleukin-5; D010919:Placebos; D010936:Plant Extracts; D016753:Interleukin-10
keywords: Chinese herbal therapy; Food Allergy Herbal Formula-2; Food allergy; peanut allergy