Evidence map›Paper›PMID 26044855›Full record

Trial reportThe Journal of allergy and clinical immunology2015

Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy.

Julie Wang, Stacie M Jones, Jacqueline A Pongracic, Ying Song, Nan Yang, Scott H Sicherer, Melanie M Makhija, Rachel G Robison, Erin Moshier, James Godbold and 2 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of allergy and clinical immunology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 pooled it
5.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 87 citations in OpenAlex.

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  6. Traditional Chinese Medicine for Pediatric Allergic Diseases.Current allergy and asthma reports · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Julie WangJaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: julie.wang@mssm.edu.
Stacie M JonesDepartment of Pediatrics, Division of Allergy and Immunology, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
Jacqueline A PongracicAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
Ying SongJaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
Nan YangJaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
Scott H SichererJaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
Melanie M MakhijaAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
Rachel G RobisonAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
Erin MoshierDepartment of Preventive Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.
James GodboldDepartment of Preventive Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.
Hugh A SampsonJaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
Xiu-Min LiJaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: xiu-min.li@mssm.edu.
Icahn School of Medicine at Mount Sinai · USLurie Children's Hospital · USArkansas Children's Hospital · US

Funding

MULTIDISCIPLINARY CLINICAL AND TRANSLATIONAL SCIENCE (MCTS) PROGRAM (UL1)UL1RR025741 · NCRR · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GREENLAND, PHILIP · 2008 to 2011
$24.7M
Mount Sinai Institutes for Clinical and Translational SciencesUL1TR000067 · NCATS · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI SAMPSON, HUGH A · 2012 to 2014
$16.5M
Multidisciplinary Clinical and Translational Science (MCTS) Program (UL1)UL1TR000150 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LLOYD-JONES, DONALD M · 2012 to 2013
$10.1M
Arkansas Center for Clinical and Translational ResearchUL1TR000039 · NCATS · UNIV OF ARKANSAS FOR MED SCIS · PI BECK, CORNELIA MARIE, JAMES, LAURA P · 2012 to 2014
$10.0M
Effect of Chinese herbal medicine on food allergyR01AT001495 · NCCIH · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI LI, XIU-MIN · 2004 to 2010
$3.0M
Immunological response to Chinese herbal medicine in food allergyK23AI083883 · NIAID · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI WANG, JULIE · 2009 to 2013
$646k
NCATS NIH HHS TR000039NCATS NIH HHS UL1 TR000039NCATS NIH HHS UL1 TR000067NCATS NIH HHS UL1TR000067NCATS NIH HHS UL1 TR000150NCATS NIH HHS UL1TR000150NCCIH NIH HHS 1R01AT001495-01A1NCCIH NIH HHS 2R01 AT001495-05A1NCCIH NIH HHS R01 AT001495NCRR NIH HHS UL1 RR025741NCRR NIH HHS UL1RR025741NIAID NIH HHS K23 AI083883
6 · The paper itself

Abstract

backgroundFood Allergy Herbal Formula-2 (FAHF-2) is a 9-herb formula based on traditional Chinese medicine that blocks peanut-induced anaphylaxis in a murine model. In phase I studies FAHF-2 was found to be safe and well tolerated.

objectiveWe sought to evaluate the safety and effectiveness of FAHF-2 as a treatment for food allergy.

methodsIn this double-blind, randomized, placebo-controlled study 68 subjects aged 12 to 45 years with allergies to peanut, tree nut, sesame, fish, and/or shellfish, which were confirmed by baseline double-blind, placebo-controlled oral food challenges (DBPCFCs), received FAHF-2 (n = 46) or placebo (n = 22). After 6 months of therapy, subjects underwent DBPCFCs. For those who demonstrated increases in the eliciting dose, a repeat DBPCFC was performed 3 months after stopping therapy.

resultsTreatment was well tolerated, with no serious adverse events. By using intent-to-treat analysis, the placebo group had a higher eliciting dose and cumulative dose (P = .05) at the end-of-treatment DBPCFC. There was no difference in the requirement for epinephrine to treat reactions (P = .55). There were no significant differences in allergen-specific IgE and IgG4 levels, cytokine production by PBMCs, or basophil activation between the active and placebo groups. In vitro immunologic studies performed on subjects' baseline PBMCs incubated with FAHF-2 and food allergen produced significantly less IL-5, greater IL-10 levels, and increased numbers of regulatory T cells than untreated cells. Notably, 44% of subjects had poor drug adherence for at least one third of the study period.

conclusionFAHF-2 is a safe herbal medication for subjects with food allergy and shows favorable in vitro immunomodulatory effects; however, efficacy for improving tolerance to food allergens is not demonstrated at the dose and duration used.

Indexed as

Medicine, Chinese TraditionalAdministration, OralAdolescentAdultAllergensAnaphylaxisArachisCells, CulturedChildDouble-Blind MethodDrugs, Chinese HerbalFemaleFood HypersensitivityHumansImmunizationInterleukin-10AllergensDrugs, Chinese HerbalFood Allergy Herbal Formula-2Interleukin-10Interleukin-5PlacebosPlant ExtractsChinese herbal therapyFood allergyFood Allergy Herbal Formula-2peanut allergy

Identifiers

PMID26044855
PMCPMC4600418
OpenAlexW2106413482

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.