Independent Medical Studies
Published Studies Proving
AArelief’s Formula
J Allergy Clin Immunol. 2009 Feb;123(2):297-306; quiz 307-8. Efficacy and mechanisms of action of traditional Chinese medicines for treating asthma and allergy. Li XM, Brown L. Department of Pediatrics, Mount Sinai School of Medicine, New York, NY, USA. BACKGROUND: Although corticosteroids and beta(2)-agonists are effective in managing asthma s ymptoms, a curative therapy for asthma is lacking. Traditional Chinese medicine (TCM), used in Asia for centuries, is beginning to play a role in Western health care as a complementary and alternative medicine modality. There is increasing scientific evidence supporting the use of TCM for asthma treatment. OBJECTIVE: This review article discusses promising TCM interventions for asthma and explores their possible mechanisms of action. METHODS: We first reviewed 5 clinical studies of antiasthma TCM herbal remedies published between 2005 and 2007. We then summarized possible mechanisms underlying their effects on the basis of data in the original articles, published abstracts, and available databases. Possible mechanisms include anti-inflammation, inhibition of airway smooth muscle contraction, and immunomodulation. Research on TCM herbal therapy for food allergy is rare, and we therefore focused on the effect and mechanism of action of food allergy herbal formula-2 on a murine model of peanut allergy and preliminary clinical study results. CONCLUSION: Evidence from clinical studies supports beneficial effects of TCM herbal therapy on asthma. A number of mechanis ms may be responsible for efficacy of these agents. Strong preclinical study data suggest the potential efficacy of food allergy herbal formula-2 for food allergy.
PMCID: PMC2748395 PMID: 19203653 [PubMed - indexed for MEDLINE]
No Serious Side Effects J Altern Complement Med. 2009 Jul;15(7):735-43. 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. Kelly-Pieper K, Patil SP, Busse P, Yang N, Sampson H, Li XM, Wisnivesky JP, Kattan M. Division of Pediatric Pulmonary Medicine, Columbia University, New York, NY, USA. BACKGROUND: Complementary and alternative medicines are increasingly used for the treatment of asthma in Western countries. A novel three-herb antiasthma herbal medicine intervention (ASHMI; Sino-Lion Pharmaceutical Company; Shan Dong China) was demonstrated to be effective and safe in a murine model of asthma and in a preliminary clinical study in China. OBJECTIVE: The objective of this study was to evaluate the safety and tolerability of ASHMI in adult subjects with allergic asthma. DESIGN: Randomized, double-blind, placebo-controlled, dose escalation, phase I trial aimed at developing a botanical drug under the United States Food and Drug Administration Investigational New Drug title. INTERVENTIONS: Subjects received one of three doses of ASHMI or placebo: 600 mg (2 capsules); 1200 mg (4 capsules); or 1800 mg (6 capsules) twice daily for 1 week. Four (4) ASHMI and 2 placebo subjects were treated at each dose level. Subjects continued to use their conventional asthma medications for the duration of the study. OUTCOME MEASURES: Vital signs, physical examination, laboratory data, and electrocardiogram data were monitored throughout the study to assess occurrence of adverse events (AEs).Immunomodulatory studies were performed to evaluate the effect of ASHMI on cytokine, chemokine, and growth factor levels. RESULTS: Twenty (20) nonsmoking, allergic subjects with asthma were included in the study. Eight (8) subjects (4 ASHMI and 4 placebo) reported mild gastrointestinal symptoms. No grade 3 AEs were observed during the study period. Vital signs, electrocardiogram findings, and laboratory results obtained at pre- and post-treatment visits remained within normal range. No abnormal immunologic alterations were detected. CONCLUSION: In this phase I study, ASHMI appeared to be safe and well tolerated by subjects with asthma. These findings allowed initiation of a larger phase II study to assess the efficacy of ASHMI.
PMID: 19586409 [PubMed - indexed for MEDLINE]
Proven Effectiveness J Allergy Clin Immunol. 2004 Feb;113(2):268-76. Immunomodulatory effect of the antiasthma Chinese herbal formula MSSM-002 on TH2 cells. Srivastava K, Teper AA, Zhang TF, Li S, Walsh MJ, Huang CK, Kattan M, Schofield BH, Sampson HA, Li XM. Department of Pediatrics, Mount Sinai School of Medicine, New York, NY, USA. BACKGROUND: T(H)2 cytokines play a central role in the pathogenesis of allergic asthma. We previously showed that the "antiasthma" Chinese herbal formula MSSM-002 exhibited therapeutic effects on established allergic airway responses in a murine model of allergic asthma. However, the mechanisms underlying these effects are largely unknown. OBJECTIVE: The objective of this study was to determine whether and how MSSM-002 modulates an established T(H)2 response and whether the actions of MSSM-002 on T(H)2 cell differs from corticosteroids. METHODS: T(H)2 polarized splenocytes (T(H)2-SPCs) from mice with antigen-induced airway hyperresponsiveness and T(H)2 cloned cells, D10 G4.1 (D10), were cultured in the presence or absence of antigen with or without MSSM-002 and dexamethasone, and the proliferative responses and cytokine profiles were determined. Apoptosis and T(H)2 transcription factor GATA-3 expression and binding to IL-4 gene promoter and V(A) enhancer in MSSM-002-treated D10 cells were also determined. RESULTS: MSSM-002 significantly decreased antigen-induced proliferation and IL-4 and IL-5 production but increased IFN-gamma production by T(H)2-SPCs, whereas dexamethasone suppressed IFN-gamma as well as IL-4 and IL-5. Anti-IL-12 antibody, although abrogating MSSM-002 induction of IFN-gamma, had no significant effect on MSSM-002 suppression of IL-4 and IL-5 secretion. MSSM-002 also suppressed T(H)2 cytokine secretion by D10 cells, and in contrast to dexamethasone, MSSM-002 did not induce apoptosis of D10 cells. MSSM-002 markedly suppressed GATA-3 mRNA and protein expression and the binding to IL-4 gene promoter and V(A) enhancer in D10 cells. CONCLUSION: MSSM-002, in contrast to the overall suppression of T cells by dexamethasone, exhibits immunomodulatory actions on T(H)2 cells caused, at least partially, by downregulation of GATA-3.
PMID: 14767441 [PubMed - indexed for MEDLINE]
AArelief is safe for Children Curr Opin Allergy Clin Immunol. 2009 Apr;9(2):161-7. Complementary and alternative medicine in pediatric allergic disorders. Li XM. Department of Pediatrics, Mount Sinai School of Medicine, New York, New York, USA. xiu-min.li@mssm.edu PURPOSE OF REVIEW: Allergic disorders represent a serious public health problem in children. The chronic nature of these diseases and the fear of known side effects of synthetic drugs influence many families to seek complementary and alternative medicine. This review focuses on traditional Chinese medicine (TCM) herbal products and acupuncture for treating pediatric allergies. RECENT FINDINGS: Given the general safety profile and reputed efficacy, TCM are well received by the general population. However, compared with the long human history and popularity of the use of TCM, research into its efficacy and safety is still in its infancy. In the last 2-3 years, there have been more controlled studies of TCM for allergic asthma and allergic rhinitis. Several publications including ours indicate that some TCM herbal formulas are well tolerated and produce some level of efficacy. Some herbal formulas also showed beneficial immunomodualtory effects. Several preclinical studies demonstrated that the food allergy herbal formula-2 was effective in protecting against peanut anaphylaxis in animal models. Two TCM products have entered clinical trials in the United States for treating asthma and food allergy, respectively. Both of these trials include children. SUMMARY: Recent studies indicate that TCM therapy including herbal medicines and acupuncture for allergic disorders in children is well tolerated. There a re also promising clinical and objective improvements. More controlled clinical studies are encouraged.
PMID: 19295428 [PubMed - indexed for MEDLINE]
J Allergy Clin Immunol. 2009 Feb;123(2):297-306; quiz 307-8. Efficacy and mechanisms of action of traditional Chinese medicines for treating asthma and allergy. Li XM, Brown L. Department of Pediatrics, Mount Sinai School of Medicine, New York, NY, USA. BACKGROUND: Although corticosteroids and beta(2)-agonists are effective in managing asthma s ymptoms, a curative therapy for asthma is lacking. Traditional Chinese medicine (TCM), used in Asia for centuries, is beginning to play a role in Western health care as a complementary and alternative medicine modality. There is increasing scientific evidence supporting the use of TCM for asthma treatment. OBJECTIVE: This review article discusses promising TCM interventions for asthma and explores their possible mechanisms of action. METHODS: We first reviewed 5 clinical studies of antiasthma TCM herbal remedies published between 2005 and 2007. We then summarized possible mechanisms underlying their effects on the basis of data in the original articles, published abstracts, and available databases. Possible mechanisms include anti-inflammation, inhibition of airway smooth muscle contraction, and immunomodulation. Research on TCM herbal therapy for food allergy is rare, and we therefore focused on the effect and mechanism of action of food allergy herbal formula-2 on a murine model of peanut allergy and preliminary clinical study results. CONCLUSION: Evidence from clinical studies supports beneficial effects of TCM herbal therapy on asthma. A number of mechanis ms may be responsible for efficacy of these agents. Strong preclinical study data suggest the potential efficacy of food allergy herbal formula-2 for food allergy.
PMCID: PMC2748395 PMID: 19203653 [PubMed - indexed for MEDLINE]
No Serious Side Effects J Altern Complement Med. 2009 Jul;15(7):735-43. 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. Kelly-Pieper K, Patil SP, Busse P, Yang N, Sampson H, Li XM, Wisnivesky JP, Kattan M. Division of Pediatric Pulmonary Medicine, Columbia University, New York, NY, USA. BACKGROUND: Complementary and alternative medicines are increasingly used for the treatment of asthma in Western countries. A novel three-herb antiasthma herbal medicine intervention (ASHMI; Sino-Lion Pharmaceutical Company; Shan Dong China) was demonstrated to be effective and safe in a murine model of asthma and in a preliminary clinical study in China. OBJECTIVE: The objective of this study was to evaluate the safety and tolerability of ASHMI in adult subjects with allergic asthma. DESIGN: Randomized, double-blind, placebo-controlled, dose escalation, phase I trial aimed at developing a botanical drug under the United States Food and Drug Administration Investigational New Drug title. INTERVENTIONS: Subjects received one of three doses of ASHMI or placebo: 600 mg (2 capsules); 1200 mg (4 capsules); or 1800 mg (6 capsules) twice daily for 1 week. Four (4) ASHMI and 2 placebo subjects were treated at each dose level. Subjects continued to use their conventional asthma medications for the duration of the study. OUTCOME MEASURES: Vital signs, physical examination, laboratory data, and electrocardiogram data were monitored throughout the study to assess occurrence of adverse events (AEs).Immunomodulatory studies were performed to evaluate the effect of ASHMI on cytokine, chemokine, and growth factor levels. RESULTS: Twenty (20) nonsmoking, allergic subjects with asthma were included in the study. Eight (8) subjects (4 ASHMI and 4 placebo) reported mild gastrointestinal symptoms. No grade 3 AEs were observed during the study period. Vital signs, electrocardiogram findings, and laboratory results obtained at pre- and post-treatment visits remained within normal range. No abnormal immunologic alterations were detected. CONCLUSION: In this phase I study, ASHMI appeared to be safe and well tolerated by subjects with asthma. These findings allowed initiation of a larger phase II study to assess the efficacy of ASHMI.
PMID: 19586409 [PubMed - indexed for MEDLINE]
Proven Effectiveness J Allergy Clin Immunol. 2004 Feb;113(2):268-76. Immunomodulatory effect of the antiasthma Chinese herbal formula MSSM-002 on TH2 cells. Srivastava K, Teper AA, Zhang TF, Li S, Walsh MJ, Huang CK, Kattan M, Schofield BH, Sampson HA, Li XM. Department of Pediatrics, Mount Sinai School of Medicine, New York, NY, USA. BACKGROUND: T(H)2 cytokines play a central role in the pathogenesis of allergic asthma. We previously showed that the "antiasthma" Chinese herbal formula MSSM-002 exhibited therapeutic effects on established allergic airway responses in a murine model of allergic asthma. However, the mechanisms underlying these effects are largely unknown. OBJECTIVE: The objective of this study was to determine whether and how MSSM-002 modulates an established T(H)2 response and whether the actions of MSSM-002 on T(H)2 cell differs from corticosteroids. METHODS: T(H)2 polarized splenocytes (T(H)2-SPCs) from mice with antigen-induced airway hyperresponsiveness and T(H)2 cloned cells, D10 G4.1 (D10), were cultured in the presence or absence of antigen with or without MSSM-002 and dexamethasone, and the proliferative responses and cytokine profiles were determined. Apoptosis and T(H)2 transcription factor GATA-3 expression and binding to IL-4 gene promoter and V(A) enhancer in MSSM-002-treated D10 cells were also determined. RESULTS: MSSM-002 significantly decreased antigen-induced proliferation and IL-4 and IL-5 production but increased IFN-gamma production by T(H)2-SPCs, whereas dexamethasone suppressed IFN-gamma as well as IL-4 and IL-5. Anti-IL-12 antibody, although abrogating MSSM-002 induction of IFN-gamma, had no significant effect on MSSM-002 suppression of IL-4 and IL-5 secretion. MSSM-002 also suppressed T(H)2 cytokine secretion by D10 cells, and in contrast to dexamethasone, MSSM-002 did not induce apoptosis of D10 cells. MSSM-002 markedly suppressed GATA-3 mRNA and protein expression and the binding to IL-4 gene promoter and V(A) enhancer in D10 cells. CONCLUSION: MSSM-002, in contrast to the overall suppression of T cells by dexamethasone, exhibits immunomodulatory actions on T(H)2 cells caused, at least partially, by downregulation of GATA-3.
PMID: 14767441 [PubMed - indexed for MEDLINE]
AArelief is safe for Children Curr Opin Allergy Clin Immunol. 2009 Apr;9(2):161-7. Complementary and alternative medicine in pediatric allergic disorders. Li XM. Department of Pediatrics, Mount Sinai School of Medicine, New York, New York, USA. xiu-min.li@mssm.edu PURPOSE OF REVIEW: Allergic disorders represent a serious public health problem in children. The chronic nature of these diseases and the fear of known side effects of synthetic drugs influence many families to seek complementary and alternative medicine. This review focuses on traditional Chinese medicine (TCM) herbal products and acupuncture for treating pediatric allergies. RECENT FINDINGS: Given the general safety profile and reputed efficacy, TCM are well received by the general population. However, compared with the long human history and popularity of the use of TCM, research into its efficacy and safety is still in its infancy. In the last 2-3 years, there have been more controlled studies of TCM for allergic asthma and allergic rhinitis. Several publications including ours indicate that some TCM herbal formulas are well tolerated and produce some level of efficacy. Some herbal formulas also showed beneficial immunomodualtory effects. Several preclinical studies demonstrated that the food allergy herbal formula-2 was effective in protecting against peanut anaphylaxis in animal models. Two TCM products have entered clinical trials in the United States for treating asthma and food allergy, respectively. Both of these trials include children. SUMMARY: Recent studies indicate that TCM therapy including herbal medicines and acupuncture for allergic disorders in children is well tolerated. There a re also promising clinical and objective improvements. More controlled clinical studies are encouraged.
PMID: 19295428 [PubMed - indexed for MEDLINE]
