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

Journal of Alternative and Complementary Medicine

Volumn 15, Issue 7, 2009, Pages 735-743

  Kelly Pieper, Kristin ^a   Patil, Sangita P ^b   Busse, Paula ^b   Yang, Nan ^b   Sampson, Hugh ^b   Li, Xiu Min ^b   Wisnivesky, Juan P ^b   Kattan, Meyer ^a  

^a Howard Hughes Medical Institute   (United States)

^b MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ALPHA2 INTERFERON; ANTIASTHMATIC AGENT; ASHMI; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CHEMOKINE; COLONY STIMULATING FACTOR 1; CREATININE; CYTOKINE; EOTAXIN; GAMMA INTERFERON INDUCIBLE PROTEIN 10; GRANULOCYTE COLONY STIMULATING FACTOR; GROWTH FACTOR; HERBACEOUS AGENT; INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; INTERLEUKIN 12; INTERLEUKIN 13; INTERLEUKIN 16; INTERLEUKIN 18; INTERLEUKIN 2; INTERLEUKIN 3; INTERLEUKIN 9; LEUKOCYTE MIGRATION INHIBITION FACTOR; MACROPHAGE MIGRATION INHIBITION FACTOR; PLACEBO; TUMOR NECROSIS FACTOR ALPHA; TUMOR NECROSIS FACTOR RELATED APOPTOSIS INDUCING LIGAND; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ABDOMINAL DISCOMFORT; ABDOMINAL DISTENSION; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALLERGIC ASTHMA; ALOPECIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BICARBONATE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CHINA; CHINESE HERB; CHLORIDE BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG CAPSULE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAM; EOSINOPHIL COUNT; FEMALE; FEVER; FOOD AND DRUG ADMINISTRATION; GANODERMA LUCIDUM; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; GLYCYRRHIZA URALENSIS; GRANULOCYTE; HEART ARRHYTHMIA; HEART MUSCLE ISCHEMIA; HEARTBURN; HEMATURIA; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERCALCEMIA; HYPERGLYCEMIA; HYPOCALCEMIA; HYPOGLYCEMIA; HYPOTENSION; IMMUNOMODULATION; INSOMNIA; LABORATORY TEST; LEUKOCYTE COUNT; MALE; MOOD CHANGE; MOTOR PERFORMANCE; MUSCLE INJURY; NAUSEA; PAIN; PATIENT MONITORING; PHASE 1 CLINICAL TRIAL; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; PROTEINURIA; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; SODIUM BLOOD LEVEL; SOPHORA FLAVESCENS; THROMBOCYTE COUNT; TRICHOMONIASIS; UPPER RESPIRATORY TRACT INFECTION; UREA BLOOD LEVEL; UREA NITROGEN BLOOD LEVEL; URINARY TRACT DISEASE; VITAL SIGN; VOMITING;

ADULT; ANTI-ASTHMATIC AGENTS; ASTHMA; CYTOKINES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUGS, CHINESE HERBAL; FEMALE; GLYCYRRHIZA URALENSIS; HUMANS; MALE; PHYTOTHERAPY; PLANT ROOTS; REISHI; SEVERITY OF ILLNESS INDEX; SOPHORA; YOUNG ADULT;

EID: 67749133979     PISSN: 10755535     EISSN: None     Source Type: Journal    
DOI: 10.1089/acm.2008.0543     Document Type: Article

References (26)

1. Moorman JE, Rudd RA, Johnson CA, et al. National surveillance for asthma: United States, 1980-2004. MMWR Surveill Summ 2007;56:1-54.
2. National Asthma Education and Prevention Program. Expert panel report 3 (EPR-3): Guidelines for the diagnosis and management of asthma-summary report 2007. J Allergy Clin Immunol 2007;120(suppl):S94-S138.
3. Apter AJ, Boston RC, George M, et al. Modifiable barriers to adherence to inhaled steroids among adults with asthma: It's not just black and white. J Allergy Clin Immunol 2003;111:1219-1226.
4. George M, Freedman TG, Norfleet AL, et al. Qualitative research-enhanced understanding of patients' beliefs: Results of focus groups with low-income, urban, African American adults with asthma. J Allergy Clin Immunol 2003;111:967-973.
5. Bielory L, Russin J, Zuckerman GB. Clinical efficacy, mechanisms of action, and adverse effects of complementary and alternative medicine therapies for asthma. Allergy Asthma Proc 2004;25:283-291.
6. Slader CA, Reddel HK, Jenkins CR, et al. Complementary and alternative medicine use in asthma: Who is using what? Respirology 2006;11:373-387.
7. Li XM, Huang CK, Zhang TF, et al. The Chinese herbal medicine formula MSSM-002 suppresses allergic airway hyperreactivity and modulates TH1=TH2 responses in a murine model of allergic asthma. J Allergy Clin Immunol 2000;106:660-668.
8. Busse PJ, Wen MC, Huang CK, et al. Therapeutic effects of the Chinese herbal formula, MSSM-03d, on persistent airway hyperreactivity and airway remodeling [abstr]. J Allergy Clin Immunol 2004;113:S220.
9. Busse PJ, Zhang T, Srivastava K, et al. Prophylactic effects of the Chinese herbal formula, ASHMI, in a murine model of late onset atopic asthma [abstr]. J Allergy Clin Immunol 2007;119:S247.
10. Li XM, Zhang TF, Sampson H, et al. The potential use of Chinese herbal medicines in treating allergic asthma. Ann Allergy Asthma Immunol 2004;93(suppl 1):S35-S44.
11. Li XM. Traditional Chinese herbal remedies for asthma and food allergy. J Allergy Clin Immunol 2007;120:25-31.
12. Wen MC, Wei CH, Hu ZQ, et al. Efficacy and tolerability of anti-asthma herbal medicine intervention in adult patients with moderate-severe allergic asthma. J Allergy Clin Immunol 2005;116:517-524.
13. U.S. Food and Drug Administration (FDA), and Center for Drug Evaluation and Research. Guidance for Industry Botanical Drug Products. Rockville, MD: U.S. Department of Health and Human Services, 2004.
14. Bensky D, Gamble A. Chinese Herbal Medicine: Materia Medica. Seattle: Eastland Press, 1993.
15. The State Pharmacopoeia Commission of The People's Republic of China. Pharmacopoeia of the People's Republic of China Beijing: People's Medical Publishing House, 2005.
16. Raman P, Patino LC, Nair MG. Evaluation of metal and microbial contamination in botanical supplements. J Agric Food Chem 2004;52:7822-7827.
17. Dolan SP, Nortrup DA, Bolger PM, Capar SG. Analysis of dietary supplements for arsenic, cadmium, mercury, and lead using inductively coupled plasma mass spectrometry. J Agric Food Chem 2003;51:1307-1312.
18. Caldas ED, Machado LL. Cadmium, mercury and lead in medicinal herbs in Brazil. Food Chem Toxicol 2004;42:599- 603.
19. Franklin HR, Simonetti GP, Dubbelman AC, et al. Toxicity grading systems: A comparison between the WHO scoring system and the common toxicity criteria when used for nausea and vomiting. Ann Oncol 1994;5:113-117.
20. Aickin M. The importance of early phase research. J Altern Complement Med 2007;13:447-450.
21. Schwartz GE. Early phase research and the process of scientific discovery. J Altern Complement Med 2007;13:399.
22. Fonnebo V. Early phase methodology is needed in CAM and conventional research endeavors. J Altern Complement Med 2007;13:397-398.
23. Mahony J, Chong S, Merante F, et al. Development of a respiratory virus panel test for detection of twenty human respiratory viruses by use of multiplex PCR and a fluid microbead-based assay. J Clin Microbiol 2007;45:2965- 2970.
24. Yurkovetsky ZR, Kirkwood JM, Edington HD, et al. Multiplex analysis of serum cytokines in melanoma patients treated with interferon-alpha2b. Clin Cancer Res 2007;13:2422-2428.
25. Dehqanzada ZA, Storrer CE, Hueman MT, et al. Assessing serum cytokine profiles in breast cancer patients receiving a HER2=neu vaccine using luminex technology. Oncol Rep 2007;17:687-694.
26. Termanini SM. Potent and persistent effects of an anti-asthma herbal formula (ASHMI) on severe allergic airway responses in chronic asthma model [abstr]. J Allergy Clin Immunol 2006;117:S276.