title: Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Pediatric Allergy and Immunology, Mount Sinai School of Medicine, New York, NY 10029-6574, USA.
authors.forename: Sangita P
authors.initials: SP
authors.lastname: Patil
authors.forename: Julie
authors.initials: J
authors.lastname: Wang
authors.forename: Ying
authors.initials: Y
authors.lastname: Song
authors.forename: Sally
authors.initials: S
authors.lastname: Noone
authors.forename: Nan
authors.initials: N
authors.lastname: Yang
authors.forename: Sylvan
authors.initials: S
authors.lastname: Wallenstein
authors.forename: Hugh A
authors.initials: HA
authors.lastname: Sampson
authors.forename: Xiu-Min
authors.initials: XM
authors.lastname: Li
mesh_terms: D000293:Adolescent; D000328:Adult; D015549:Basophil Degranulation Test; D001491:Basophils / Q000187:drug effects* / Q000276:immunology; D002469:Cell Separation; D002648:Child; D002851:Chromatography, High Pressure Liquid; D005260:Female; D005434:Flow Cytometry; D005512:Food Hypersensitivity / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use*; D012882:Skin Tests; D055815:Young Adult
chemical_list: C497376:Food Allergy Herbal Formula-2; D010936:Plant Extracts