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.
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.
Wang
Julie
J
Division of Pediatric Allergy and Immunology, Mount Sinai School of Medicine, New York, New York 10029-6574, USA. julie.wang@mssm.edu
Patil
Sangita P
SP
Yang
Nan
N
Ko
Jimmy
J
Lee
Joohee
J
Noone
Sally
S
Sampson
Hugh A
HA
Li
Xiu-Min
XM
D000293:Adolescent; D000328:Adult; D002478:Cells, Cultured; D002648:Child; D002851:Chromatography, High Pressure Liquid; D016207:Cytokines / Q000096:biosynthesis* / Q000235:genetics / Q000378:metabolism; D054796:Drug Dosage Calculations; D004341:Drug Evaluation; D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D005512:Food Hypersensitivity / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology* / Q000503:physiopathology; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D056747:Immunomodulation; D007963:Leukocytes, Mononuclear / Q000187:drug effects* / Q000276:immunology / Q000378:metabolism / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000494:pharmacology*; D012129:Respiratory Function Tests; D012882:Skin Tests
D016207:Cytokines; C497376:Food Allergy Herbal Formula-2; D010936:Plant Extracts; D007073:Immunoglobulin E