Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study - 30/11/11
Corresponding author: Xiu-Min Li, MD, Pediatric Allergy and Immunology, Mount Sinai School of Medicine, One Gustave L. Levy Place, New York, NY 10029-6574.Abstract |
Background |
Food allergy is a common and increasing health concern in westernized countries. No effective treatment is available, and accidental ingestion can be life-threatening. Food Allergy Herbal Formula-2 (FAHF-2) blocks peanut-induced anaphylaxis in a murine model of peanut-induced anaphylaxis. It was found to be safe and well tolerated in an acute phase I study of patients with food allergy.
Objective |
We sought to assess the safety of FAHF-2 in an extended phase I clinical trial and determine the potential effects on peripheral blood basophils from patients with food allergy.
Methods |
Patients in an open-label study received 3.3 g (6 tablets) of FAHF-2 three times a day for 6 months. Vital signs, physical examination results, laboratory data, pulmonary function test results, and electrocardiographic data were acquired at baseline and at 2-month intervals. During the course of the study, basophil activation and basophil and eosinophil numbers were evaluated by using CCR3/CD63 staining and flow cytometry.
Results |
Of 18 patients enrolled, 14 completed the study. No significant drug-associated differences in laboratory parameters, pulmonary function study results, or electrocardiographic findings before and after treatment were found. There was a significant reduction (P < .010) in basophil CD63 expression in response to ex vivo stimulation at month 6. There was also a trend toward a reduction in eosinophil and basophil numbers after treatment.
Conclusion |
FAHF-2 was safe and well tolerated and had an inhibitory effects on basophil numbers in an extended phase I clinical study. A controlled phase II study is warranted.
El texto completo de este artículo está disponible en PDF.Key words : Food allergy, Food Allergy Herbal Formula-2, basophil activation
Abbreviations used : AE, BAT, FAHF-2, FDA, fMLP, OIT, SHIP-2, SPT, Syk, TCM, TN
Esquema
| Supported in part by the Food Allergy Initiative, the Winston Wolkoff Integrative Medicine for Allergy and Immunology Foundation, and National Institutes of Health grant 1R01AT001495-01A1 and 2R01AT001495-05A1 awarded to X.-M. Li. J.W. is funded in part by a grant from the National Institutes of Health/National Institute of Allergy and Infectious Diseases (K23 AI083883). |
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| Disclosure of potential conflict of interest: H. A. Sampson is a consultant for Allertein Therapeutics, LLC; has received research support from the Food Allergy Initiative (FAI) and the National Institutes of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH); is a consultant and scientific advisor for the FAI; is a medical advisor for the Food Allergy & Anaphylaxis Network (FAAN); is a scientific advisor for the University of Nebraska–FARRP; and is 45% owner of Herbal Springs, LLC. X.-M. Li has a consultant for the FAI; is a shareholder of Herbal Springs, LLC; and has received research support from the FAI and NIH. The rest of the authors have declared that they have no conflict of interest. |
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| www.clinicaltrials.gov identifier: NCT00602160. |
Vol 128 - N° 6
P. 1259 - décembre 2011 Regresar al número
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