Randomized, double-blind, placebo-controlled trial of herbal therapy for children with asthma.
OBJECTIVE
The purpose of this trial was to evaluate whether the herbal formula of CUF2 used as complementary therapy improves the clinical symptoms and biochemical markers in children with asthma using inhaled corticosteroids.


METHODS
In a double-blind, placebo-controlled prospective trial, 85 children with asthma aged 7-15 years were randomly assigned to receive either a daily oral herbal formula of 0.619-g CUF2 capsule of dried aqueous extract with an equal weight of five herbs (Astragalus mongholius Bunge, Cordyceps sinensis Sacc., Radix stemonae, Bulbus fritillariae cirrhosae, and Radix scutellariae) or placebo for 6 months.


RESULTS
The primary endpoint was the change in steroids dosage; the secondary outcomes included the disease severity score, lung function test, and biochemical markers in blood. Eighty-five (85) children (42 on active treatment and 43 on placebo) completed the 6-month clinical trial. Children randomized to the herbal formula of CUF2 and the placebo showed a similar improvement in clinical symptoms and biomedical markers. The comparison between the CUF2 group and the placebo group showed no significant difference on the dosage of steroids (-2.3 versus -3.1 mg, p = 0.915), disease severity score (-2.3 versus -3.1, p = 0.215), and lung function test of forced expiratory volume in 1 second/forced vital capacity percent (0.1 versus 0.6%, p = 0.809) and peak expiratory flow rate (-7.3 versus -0.6 l/minutes, p = 0.118). No significant difference was found between the two study groups in the biochemical outcomes measured. The intervention effect of CUF2 was smaller than the placebo effect.


CONCLUSIONS
This study provides no evidence to support the use of the herbal formula of CUF2 in children with asthma. Parents are thus advised to discuss with health professionals before choosing an herbal formula in preference to conventional treatment modes.
Wong
Eliza L Y
EL
1 Department of Community & Family Medicine, School of Public Health, The Chinese University of Hong Kong , Prince of Wales Hospital, Hong Kong SAR, China.
Sung
Rita Yn Tz
RY
Leung
Ting Fan
TF
Wong
Yeuk Oi
YO
Li
Albert M C
AM
Cheung
Kam Lau
KL
Wong
Chun Kwok
CK
Fok
Tai Fai
TF
Leung
Ping Chung
PC
D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D015415:Biomarkers / Q000097:blood; D002648:Child; D032661:Cordyceps; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008168:Lung / Q000187:drug effects; D019684:Magnoliopsida; D008297:Male; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D008517:Phytotherapy; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013256:Steroids / Q000008:administration & dosage / Q000627:therapeutic use*; D014797:Vital Capacity / Q000187:drug effects
D018927:Anti-Asthmatic Agents; D015415:Biomarkers; D010936:Plant Extracts; D013256:Steroids