Asthma diagnosis and treatment
Efficacy and tolerability of antiasthma herbal medicine intervention in adult patients with moderate-severe allergic asthma

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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.

Section snippets

Patients

A randomized, double-blind, placebo-controlled study was performed at Weifang Asthma Hospital from September 2003 to September 2004. Weifang Asthma Hospital is a chronic asthma treatment facility receiving patients nationwide. The 4-week study was conducted in the inpatient unit. The recruiting process involved 3 screening steps: clinical history, clinical testing, and laboratory testing. Patients prescreened and recruited from the outpatient facility were admitted to the hospital for purposes

Patient characteristics

One patient in the ASHMI group acquired an infection in the fourth week of treatment and dropped out of the study. Forty-five patients in the ASHMI group and 46 patients in the prednisone group completed the study. There were no significant differences between the 2 groups in age, sex, asthma duration, or body weight before treatment. The baseline FEV1, PEF measurements, symptom scores, and use of β2-agonist in the 2 groups were not different (Table I).

Effect of ASHMI treatment on pulmonary function, symptom scores, and β2-agonist use

By week 4 (the last week of treatment),

Discussion

In this study, we found that ASHMI significantly reduced symptom scores, increased lung function as determined by increased FEV1 and PEF, reduced use of β2-agonist, and reduced peripheral blood eosinophil numbers and serum IgE levels. Although the improvement in FEV1 levels and PEF in the ASHMI-treated group was slightly but significantly less than in the prednisone-treated group, reduction in use of β2-agonist, eosinophil counts, and serum IgE levels was comparable with the prednisone-treated

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    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).

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