Evidence map›Paper›PMID 37087097›Full record

Trial reportThe journal of allergy and clinical immunology. In practice2023

Double-Blind, Placebo-Controlled Study of E-B-FAHF-2 in Combination With Omalizumab-Facilitated Multiallergen Oral Immunotherapy.

Julie Wang, Robert A Wood, Samantha Raymond, Mayte Suárez-Fariñas, Nan Yang, Scott H Sicherer, Hugh A Sampson, Xiu-Min Li

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The journal of allergy and clinical immunology. In practice, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06103656 (Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of Chinese Herbal Therapy and Multiple Food Allergen Oral Immunotherapy), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% 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.

NCT06103656 phase2completednot on this map

Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of Chinese Herbal Therapy and Multiple Food Allergen Oral Immunotherapy

TypeinterventionalSponsorNew York Medical CollegeRan2016 to 2021Enrolled33ConditionsFood AllergyArmsDrug: Chinese Herbal Medication, Drug: Placebo, Drug: Omalizumab
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Traditional Chinese Medicine for Pediatric Allergic Diseases.Current allergy and asthma reports · 2025
    Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Omalizumab Implementation in Practice: Lessons Learned From the OUtMATCH Study.The journal of allergy and clinical immunology. In practice · 2024
    Article
  9. Review
  10. Review
  11. Review
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

8 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.
Robert A WoodDepartment of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.
Samantha RaymondDepartment of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.
Mayte Suárez-FariñasDepartment of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY; Department of Genetics and Genomics Science, Icahn School of Medicine at Mount Sinai, New York, NY.
Nan YangGeneral Nutraceutical Technology, Elmsford, NY; Department of Pathology, Microbiology and Immunology, New York Medical College, Valhalla, NY.
Scott H SichererJaffe Food Allergy Institute, 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 LiDepartment of Pathology, Microbiology and Immunology, New York Medical College, Valhalla, NY; Department of Otolaryngology, New York Medical College, Valhalla, NY.
Icahn School of Medicine at Mount Sinai · USNew York Medical College · USJohns Hopkins University · US

Funding

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
IgE Suppressing Berberine Nanomedicine for Treatment of Food AllergiesR43AI148039 · NIAID · GENERAL NUTRACEUTICAL TECHNOLOGY, LLC · PI YANG, NAN · 2019 to 2019
$225k
NCCIH NIH HHS R01 AT001495NIAID NIH HHS R43 AI148039
6 · The paper itself

Abstract

backgroundOral immunotherapy (OIT) is limited by adverse events, and most patients require continued treatment to maintain their increased threshold. Adjunctive treatments have been explored to increase the safety and efficacy of OIT.

objectiveThis study aimed to determine the safety and efficacy of enhanced, butanol purified Food Allergy Herbal Formula-2 (E-B-FAHF-2) for inducing remission in subjects undergoing omalizumab-facilitated multiallergen OIT (multi-OIT).

methodsIn this double-blind, placebo-controlled clinical trial, subjects were randomized 1:1 to receive either E-B-FAHF-2 or placebo, starting 2 months before OIT and continuing throughout OIT. All subjects received a 4-month course of omalizumab, starting 2 months before OIT through the 2-month OIT build-up phase. After 24 months of multi-OIT (maintenance dose of 1000 mg of each allergen), desensitization and remission were assessed. The primary objective was to determine if subjects in the E-B-FAHF-2 group (EOIT) were more likely than the placebo group (OIT) to develop remission to all 3 allergens treated with multi-OIT, as defined by the absence of dose-limiting symptoms to a cumulative dose of 4444 mg of protein after discontinuing treatment for 3 months.

resultsThirty-three subjects were randomized. A total of 63.6% were desensitized to 4444 mg of protein for each allergen at 26 months, and 24.2% met the primary outcome of remission at 29 months, with no difference between the treatment groups. There was good adherence (>85%) with study medications, with no difference between the treatment groups. There was no difference in reported overall adverse events between the treatment groups.

conclusionOmalizumab-facilitated multifood OIT was safe and effective, and remission was achieved in about a quarter of subjects. However, outcomes were not improved by the addition of E-B-FAHF-2.

Indexed as

OmalizumabPeanut Hypersensitivity1-ButanolAdministration, OralAllergensButanolsDesensitization, ImmunologicDouble-Blind MethodHumansPlant Extracts1-ButanolAllergensButanolsFood Allergy Herbal Formula-2OmalizumabPlant ExtractsChinese herbal therapyDesensitizationE-B-FAHF-2Food allergyPeanut allergyRemission

Identifiers

PMID37087097
PMCPMC10330343
OpenAlexW4366498107

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.