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  ASHMI™ Appears to Be Safe and Well-tolerated in Adults with Allergic Asthma

Date 08-31-2009
HC# 080191-383
Keywords:
Asthma
Safety and Tolerability
Antiasthma Herbal Medicine Intervention (ASHMI™)

Kelly-Pieper K, Patil SP, Busse P, et al. Safety and tolerability of an antiasthma herbal formula (ASHMI™) in adult subjects with asthma: a randomized, double-blinded, placebo-controlled, dose-escalation phase I study. J Altern Complement Med. 2009;15(7):735-743.

Asthma affects an average of 20 million persons in the United States annually and is a major public health problem throughout the world. The standard therapy for persistent asthma is inhaled corticosteroids (ICS); however, some patients treated long-term with ICS remain symptomatic. Furthermore, many patients who use ICS experience unwanted side effects. For these reasons and others, many asthma patients are increasingly seeking complementary and alternative medicine (CAM) to treat their condition. A recent study showed that as many as 30% of adults and 60% of children use some form of CAM to treat their asthma. A novel nonsteroidal Chinese herbal formula, known as antiasthma herbal medicine intervention (ASHMI™; Sino-Lion Pharmaceutical Co.; Shan Dong, China) was recently developed to treat asthma. ASHMI was derived from a traditional Chinese medicine 14-herb formula (MSSM-002) and contains three of the constituent herbs of that formula, namely, reishi (Ling-Zhi; Ganoderma lucidum), shrubby sophora (Ku-Shen; Sophora flavescens), and Chinese licorice (Gan-Cao; Glycyrrhiza uralensis). MSSM-002 has been found to suppress allergic airway hyperactivity and to modulate TH1/TH2 responses in a murine model of allergic asthma.1 Also, a recent study in an animal model of asthma showed that ASHMI decreases airway hyperreactivity and eosinophilic inflammation, and a recent study in humans showed that ASHMI improves lung function. On the basis of these observations, the authors initiated a phase I study to assess the safety and tolerability of ASHMI in subjects with allergic asthma as a US Food and Drug Administration Investigational New Drug botanical drug product.

Twenty nonsmoking, physician-diagnosed, asthmatic adults aged 18-55 years were enrolled in this randomized, double-blind, placebo-controlled, dose-escalation, phase I trial. Subjects with uncontrollable asthma, defined as acute asthmatic exacerbations that require systemic steroids, were excluded. The subjects received 1 of 3 doses of ASHMI (n = 12) or placebo (n = 8): 600 mg (2 capsules), 1200 mg (4 capsules), or 1800 mg (6 capsules) twice per day with meals for 1 week. Four subjects were treated with ASHMI, and 2 were treated with placebo at each dose level. (Although the protocol specified the enrollment of 18 subjects, an error in randomization resulted in the need to enroll an additional 2 subjects.) The dose of ASHMI was escalated to the next higher dose only after the safety data for the 6 subjects were reviewed. The subjects continued to use their conventional asthma medication during the study, but were advised to not use any other herbal preparations. Peripheral blood samples were collected at baseline and at the end of the treatment period to evaluate the effect of ASHMI on serum cytokines, chemokine growth factors, and adhesion molecules and receptors. A physical examination was conducted, and vital signs, electrocardiogram data, and laboratory data were collected and reviewed to monitor the patients for adverse events.

The production of serum cytokines, chemokines, growth factors, and adhesion molecules and receptors remained normal after the 1-week treatment period with ASHMI. The pro-inflammatory cytokines tumor necrosis factor-a, interleukin-1, and interleukin-6 did not increase after treatment with ASHMI, which suggests that ASHMI had no harmful effect on the immunologic response, in the short term. The vital signs, electrocardiogram data, laboratory data, and results of the physical examination at baseline and after treatment were within the normal range. No serious adverse events occurred in the ASHMI-treated patients; however, 3 subjects in the placebo group had a grade 3 adverse event. Compliance was determined to be 98% in the ASHMI group and was 96% in the placebo group.

The authors conclude that "ASHMI was safe and well tolerated in allergic asthmatic patients." They suggest that additional research is needed to determine the therapeutic potential of ASHMI. A phase II trial of ASHMI in adults is currently being initiated.

—Brenda Milot, ELS

Reference

1 Li  XM, Huang CK, Zhang TF, et al. The Chinese herbal medicine formula MSSM-002 suppresses allergic airway hyperactivity and modulates TH1/TH2 responses in a murine model of allergic asthma. J Allergy Clin Immunol. 2000;106:660-668.