Volume 116, Issue 3 , Pages 517-524, September 2005
Efficacy and tolerability of antiasthma 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, antiasthma 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 FEV1 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 β2-bronchodilators, and serum IgE levels were reduced significantly, and to a similar degree in both groups (P < .001). TH2 cytokine levels were significantly reduced in both treated groups (P < .001) and were lower in the prednisone-treated group (P < .05). Serum IFN-γ 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.
Conclusion
Antiasthma 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 TH1 and TH2 balance.
Key words: Asthma, clinical trial, Chinese herbal medicine, prednisone, cortisol, TH1/TH2 balance
Abbreviations used: ASHMI, Antiasthma herbal medicine intervention, PEF, Peak expiratory flow, TCM, Traditional Chinese medicine
Supported by National Institutes of Health grant # AT001495-01A1.Disclosure of potential conflict of interest: M.-C. Wen has filed a US patent application (reference #60554775). H. Sampson has received grants/research support from the National Institutes of Health and has filed a US patent application (reference #60554775). M. Kaltan is on the speakers' bureau for AstraZeneca. X.-M. Li has received grants/research support from the National Institutes of Health and has filed a US patent application (reference #60554775).
PII: S0091-6749(05)01358-8
doi:10.1016/j.jaci.2005.05.029
© 2005 American Academy of Allergy, Asthma and Immunology. Published by Elsevier Inc. All rights reserved.
Volume 116, Issue 3 , Pages 517-524, September 2005
