Document Detail


Safety, tolerability, and immunologic effects of a food allergy herbal formula in food allergic individuals: a randomized, double-blinded, placebo-controlled, dose escalation, phase 1 study.
MedLine Citation:
PMID:  20642207     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Food allergy is a common and serious health problem. A new herbal product, called food allergy herbal formula 2 (FAHF-2), has been demonstrated to have a high safety profile and potent long-term efficacy in a murine model of peanut-induced anaphylaxis.
OBJECTIVE: To evaluate the safety and tolerability of FAHF-2 in patients with food allergy.
METHODS: In this randomized, double-blinded, placebo-controlled, dose escalation, phase 1 trial, patients received 1 of 3 doses of FAHF-2 or placebo: 2.2 g (4 tablets), 3.3 g (6 tablets), or 6.6 g (12 tablets) 3 times a day for 7 days. Four active and 2 placebo patients were treated at each dose level. Vital signs, physical examination results, laboratory data, pulmonary function test results, and electrocardiogram data were monitored. Immunomodulatory studies were also performed.
RESULTS: Nineteen food allergic participants were included in the study. Two patients (1 in the FAHF-2 group and 1 in the placebo group) reported mild gastrointestinal symptoms. One patient withdrew from the study because of an allergic reaction that was unlikely related to the study medication. No significant differences were found in vital signs, physical examination results, laboratory data, pulmonary function test results, and electrocardiogram data obtained before and after treatment visits. Significantly decreased interleukin (IL) 5 levels were found in the active treatment group after 7 days. In vitro studies of peripheral blood mononuclear cells cultured with FAHF-2 also demonstrated a significant decrease in IL-5 and an increase in culture supernatant interferon gamma and IL-10 levels.
CONCLUSIONS: FAHF-2 appeared to be safe and well tolerated in patients with food allergy.
Authors:
Julie Wang; Sangita P Patil; Nan Yang; Jimmy Ko; Joohee Lee; Sally Noone; Hugh A Sampson; Xiu-Min Li
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology     Volume:  105     ISSN:  1081-1206     ISO Abbreviation:  Ann. Allergy Asthma Immunol.     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-07-20     Completed Date:  2010-09-01     Revised Date:  2014-09-08    
Medline Journal Info:
Nlm Unique ID:  9503580     Medline TA:  Ann Allergy Asthma Immunol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  75-84     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00602160
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Cells, Cultured
Child
Chromatography, High Pressure Liquid
Cytokines / biosynthesis*,  genetics,  secretion
Drug Dosage Calculations
Drug Evaluation
Electrocardiography / drug effects
Female
Food Hypersensitivity / blood,  diagnosis,  drug therapy*,  immunology*,  physiopathology
Humans
Immunoglobulin E / blood
Immunomodulation
Leukocytes, Mononuclear / drug effects*,  immunology,  metabolism,  pathology
Male
Middle Aged
Plant Extracts / pharmacology*
Respiratory Function Tests
Skin Tests
Grant Support
ID/Acronym/Agency:
1R01AT001495-01A1/AT/NCCAM NIH HHS; K23 AI083883/AI/NIAID NIH HHS; K23 AI083883-02/AI/NIAID NIH HHS; R01 AT001495-02/AT/NCCAM NIH HHS; R01 AT001495-03/AT/NCCAM NIH HHS; R01 AT001495-04/AT/NCCAM NIH HHS
Chemical
Reg. No./Substance:
0/Cytokines; 0/Food Allergy Herbal Formula-2; 0/Plant Extracts; 37341-29-0/Immunoglobulin E
Comments/Corrections

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