Is FAHF-2, a Chinese herbal medicine formula, effective in reducing food allergy?
Date of publication of the randomized controlled trial: October 2015
Design
Randomized controlled trial (RCT).
Participants
68 patients (median age: 16 years, male %: 61.7%) with allergies to peanut, tree nut, sesame, fish and/or shellfish confirmed by double-blind placebo controlled food challenge (DBPCFC).
Intervention
10 FAHF-2 tablets (0.5g/tablet) 3 times a day for 6 months. The formula consists of 9 Chinese herbal medicines: Ganoderma Lucidum, Fructus Pruni Mume, Pericarpium Zanthoxyli Bungeani, Rhizoma Coptidis, Cortex Phellodendri, Rhizoma Zingiberis Officinalis, Ramulus Cinnamomi Cassiae, Radix Ginseng and Corpus Radix Angelicae Sinensis.
Comparator
Comparison: FAHF-2 tablet versus placebo.
Major Outcomes
Outcome 1: Percentage of subjects having improved tolerance to allergens, measured by the consumed allergen dose at DBPCFC;
Outcome 2: Percentage of subjects requiring epinephrine to treat allergic reaction.
Settings
This trial was performed in an outpatient setting.
Comparison    FAHF-2 tablet versus placebo
Main Results
Compared to placebo, patients who were randomized to FAHF-2 tablet group had significantly worse result allergen tolerance (p=0.001). Compared to placebo, FAHF-2 did not have significant effect in reducing the need of using epinephrine for treating allergic reaction (p=0.55).
Comparison: FAHF-2 tablets versus placebo among patients with food allergy
Outcomes No. of studies (Total number of participants) Percentage/ No. of participants Heterogeneity test ( I2) p value Overall quality of evidence*
Intervention Comparator
1 1 (68) 17.4/ 46 45.5/ 22 Not applicable as there is only 1 study. 0.001 High
2 1 (68) 13/ 37 4/ 21 Not applicable as there is only 1 study. 0.55 Moderate
Keys: NA
Comparison    FAHF-2 tablet versus placebo
Main Results
Compared to placebo, patients who were randomized to FAHF-2 tablet group had significantly worse result allergen tolerance (p=0.001). Compared to placebo, FAHF-2 did not have significant effect in reducing the need of using epinephrine for treating allergic reaction (p=0.55).
Comparison: FAHF-2 tablets versus placebo among patients with food allergy
Outcomes 1 2
No. of studies (Total number of participants) 1 (68) 1 (68)
Percentage/ No. of participants Intervention 17.4/ 46 13/ 37
Comparator 45.5/ 22 4/ 21
p value 0.001 0.55
Overall quality of evidence* High Moderate
Keys: NA
Conclusion
Benefits
Compared to placebo, FAHF-2 is not significantly more effective in improving tolerance to allergen and reducing the need for epinephrine for treating allergic reaction. For Outcome 1, the overall quality of evidence is high. Further research is unlikely to have an important impact on our confidence in this estimate of effect. For Outcome 2, the overall quality of evidence is moderate. Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
Harms
387 cases of adverse event were reported with no serious adverse event. There is no significant difference in the number of adverse events between FAHF-2 and placebo group.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/26044855
The synopsis is based on the following article:
Wang J, Jones SM, Pongracic JA, Song Y, Yang N, Sicherer SH, et al. Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy. Journal of Allergy and Clinical Immunology. 2015 Oct;136(4):962-970.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.