Efficacy and tolerability of anti-asthma herbal medicine intervention in adult patients with moderate-severe allergic asthma.
BACKGROUND
Chinese herbal medicine has a long history of human use. A novel herbal formula, anti-asthma herbal medicine intervention (ASHMI), has been shown to be an effective therapy in a murine model of allergic asthma.


OBJECTIVE
This study was undertaken to compare the efficacy, safety, and immunomodulatory effects of ASHMI treatment in patients with moderate-severe, persistent asthma with prednisone therapy.


METHODS
In a double-blind trial, 91 subjects underwent randomization. Forty-five subjects received oral ASHMI capsules and prednisone placebo tablets (ASHMI group) and 46 subjects received oral prednisone tablets and ASHMI placebo capsules (prednisone group) for 4 weeks. Spirometry measurements; symptom scores; side effects; and serum cortisol, cytokine, and IgE levels were evaluated before and after treatment.


RESULTS
Posttreatment lung function was significantly improved in both groups as shown by increased FEV(1) and peak expiratory flow findings (P<.001). The improvement was slightly but significantly greater in the prednisone group (P<.05). Clinical symptom scores, use of beta(2)-bronchodilators, and serum IgE levels were reduced significantly, and to a similar degree in both groups (P<.001). T(H)2 cytokine levels were significantly reduced in both treated groups (P<.001) and were lower in the prednisone-treated group (P<.05). Serum IFN-gamma and cortisol levels were significantly decreased in the prednisone group (P<.001) but significantly increased in the ASHMI group (P<.001). No severe side effects were observed in either group.


CONCLUSIONS
Anti-asthma herbal medicine intervention appears to be a safe and effective alternative medicine for treating asthma. In contrast with prednisone, ASHMI had no adverse effect on adrenal function and had a beneficial effect on T(H)1 and T(H)2 balance.
Wen
Ming-Chun
MC
Weifang Asthma Hospital, Shandong, China. wen637@hotmail.com
Wei
Chun-Hua
CH
Hu
Zhao-Qiu
ZQ
Srivastava
Kamal
K
Ko
Jimmy
J
Xi
Su-Ting
ST
Mu
Dong-Zhen
DZ
Du
Ji-Bin
JB
Li
Guo-Hua
GH
Wallenstein
Sylvan
S
Sampson
Hugh
H
Kattan
Meyer
M
Li
Xiu-Min
XM
D000328:Adult; D018927:Anti-Asthmatic Agents / Q000009:adverse effects*; D001249:Asthma / Q000188:drug therapy*; D016207:Cytokines / Q000097:blood / Q000187:drug effects; D004365:Drugs, Chinese Herbal / Q000009:adverse effects*; D004804:Eosinophils / Q000187:drug effects; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007073:Immunoglobulin E / Q000097:blood / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000627:therapeutic use; D012129:Respiratory Function Tests
D018927:Anti-Asthmatic Agents; D016207:Cytokines; D004365:Drugs, Chinese Herbal; D007073:Immunoglobulin E; D011239:Prednisolone; D006854:Hydrocortisone