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Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy  Julie Wang, MD, Stacie M. Jones,

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Presentation on theme: "Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy  Julie Wang, MD, Stacie M. Jones,"— Presentation transcript:

1 Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy  Julie Wang, MD, Stacie M. Jones, MD, Jacqueline A. Pongracic, MD, Ying Song, MD, Nan Yang, PhD, Scott H. Sicherer, MD, Melanie M. Makhija, MD, Rachel G. Robison, MD, Erin Moshier, MS, James Godbold, PhD, Hugh A. Sampson, MD, Xiu-Min Li, MD  Journal of Allergy and Clinical Immunology  Volume 136, Issue 4, Pages e1 (October 2015) DOI: /j.jaci Copyright © 2015 American Academy of Allergy, Asthma & Immunology Terms and Conditions

2 Fig 1 Consort flow chart for this randomized, double-blind, placebo-controlled trial. After screening and baseline DBPCFCs with 2 g of protein, subjects were randomized to receive FAHF-2 or placebo (2:1), 10 tablets 3 times a day, for 6 months. After 6 months of treatment, a DBPCFC with 5 g of protein was performed to assess for the effect of the study medication. Subjects who demonstrated an improvement in tolerance (amount of food allergen that could be consumed without dose-limiting symptoms) as defined for the primary end point returned for a DBPCFC 3 months off therapy to assess for sustained effect. OFC, Oral food challenge. Journal of Allergy and Clinical Immunology  , e1DOI: ( /j.jaci ) Copyright © 2015 American Academy of Allergy, Asthma & Immunology Terms and Conditions

3 Fig 2 Cumulative tolerated dose at oral food challenge (OFC) at baseline and after the 6-month treatment period comparing the active- and placebo-treated groups. The mean cumulative dose tolerated by the active group at baseline was 266.2 mg (95% CI,  mg), and at 6 months, the dose was 369.2 mg (95% CI,  mg). The mean cumulative dose tolerated by the placebo group at baseline was 352.5 mg (95% CI,  mg), and at 6 months, the dose was  mg (95% CI,  mg). Journal of Allergy and Clinical Immunology  , e1DOI: ( /j.jaci ) Copyright © 2015 American Academy of Allergy, Asthma & Immunology Terms and Conditions

4 Fig 3 FAHF-2 suppressed IL-5 and increased IL-10 levels in vitro. A, PBMCs (4 × 105) from subjects (n = 12) were obtained at the baseline visit and cultured in AIM-V media alone, with relevant allergen (200 μg/mL) or allergen plus FAHF-2 (125 or 250 μg/mL). After a 3-day culture, culture supernatants were harvested, and IL-5, IFN-γ, and IL-10 levels were measured by means of ELISA. Cell viability was determined by using trypan blue dye exclusion. B, IL-5, IL-10, and IFN-γ production from PBMCs obtained at baseline with or without FAHF-2 in vitro culture (n = 53). Cultures were conducted as described in Fig 3, A. Data are shown as means ± SEMs and analyzed by using a left-censored, log-normal, repeated-measures tobit model. *P < .05, allergen versus allergen plus FAHF-2; ∗∗P < .01; and ∗∗∗P < .001. Journal of Allergy and Clinical Immunology  , e1DOI: ( /j.jaci ) Copyright © 2015 American Academy of Allergy, Asthma & Immunology Terms and Conditions

5 Fig 4 FAHF-2 increased numbers of Treg cells in vitro. PBMCs from subjects obtained at baseline were cultured as described in Fig 2. After a 3-day culture, numbers of CD4+CD25+FoxP3+ Treg cells were determined by means of flow cytometry. Data were analyzed by using FlowJo software. A, Dot plots are representative of an individual subject. B, Bar graph showing data for 10 subjects. Data are shown as means ± SEMs and analyzed by using a mixed model with a random intercept on natural log-transformed Treg cell percentages in Fig 3, B. *P < .05, allergen versus allergen plus FAHF-2. Journal of Allergy and Clinical Immunology  , e1DOI: ( /j.jaci ) Copyright © 2015 American Academy of Allergy, Asthma & Immunology Terms and Conditions


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