CLINICAL RESEARCH POSTER PRESENTATION ABSTRACTS
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FRIDAY, 5:45-6:30 PM
Wong YO, Sung R*, Wong E, Leung TF, Li A, Cheung KL,
Lam SY, So KT, Fok TF, Fung KP, Leung PC.
Efficacy of the Chinese herbal formula CUF2 in the treatment
of childhood asthma: animal study and a randomized, double blind, placebo-controlled
clinical trial.
The Chinese University of Hong Kong yntzsung@cuhk.edu.hk
*Presenting author
PURPOSE: to evaluate the efficacy of an innovative
Chinese herbal formula in the treatment of asthma.
METHODS: CUF2 (Bulbus fritillariae cirrhosae,
Cordyceps sinensis, Radix astragali, Scutellaria baicalensis
and Radix stemonae) in low, medium or high dose was given as pretreatment
to 3 groups of Sprague-Dawley rats which were sensitized with ovalbumin
and challenged 3 weeks later with nebulized ovalbumin. The same herbal
mixture was used in a randomized clinical trial in 85 children aged
7-15 yrs with moderate to severe asthma as an adjuvant therapy for 6
months. The primary outcome measure was the steroid dosage reduction.
Other outcome measures included changes in disease severity score, lung
function, serum concentrations of total IgE and ECP (eosinophil cationic
protein), exhaled nitric oxide (NO) level, and frequency of asthma attacks
and quality of life. All patients were maintained on inhaled corticosteroid
at their usual dose and dosing interval, and continued to receive short-acting,
inhaled b2- agonists as needed.
RESULTS: a) Animal study: Pretreatment with
CUF2 for 28 days could suppress total cell number and eosinophilia in
bronchalveolar lavage fluid, decrease pulmonary infiltration of eosinophils
and lymphocytes, and reduce goblet cell hyperplasia. There were decreased
production of inflammatory cytokines and chemokines (IL-4, IL-6, TNF-_,
MIP-2 and MCP-1) and increased production of IL-10 and IFN-_ in the
bronchoalveolar lavage fluid. There was a dose-response relationship
with more prominent effects seen with higher doses of CUF2. b) Clinical
trial: CUF2 was well tolerated in asthmatic children. The dosage of
inhaled corticosteroid was successfully reduced in 70% of the patients
in both groups. Both groups had similar decrease in disease severity
scores and improved quality of life. A trend of greater improvement
in allergy and inflammatory markers (decrease in eosinophil count and
TNF-alpha, increase in IL-18) in TCM group was noted, but no statistical
significance was attained.
DISCUSSION: Although remarkable beneficial effects
of CUF2 were observed in animal study. The results were not as good
in the clinical trial. Possible explanations include: (1) Concurrent
use of inhaled steroid in the clinical trial masked the effects of CUF2.
(2) The dosage of CUF2 used in the clinical trial was inadequate.
CONCLUSION: Our results provided strong evidence
of the beneficial effects of CUF2 in the treatment of asthma in a rat
asthma model, but further clinical trial with improved design is needed
to further elucidate its potential use in asthmatic children.
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