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SUMMARY OF CLINICAL DATA, ANIMAL DATA, REVIEWS, AND REPORTS SUPPORTING EPHEDRA SAFETY



Overview

  • 55 clinical studies and 4 animal studies support the safety of ephedra
  • More than 1000 participants consumed ephedrine or ephedra
  • No serious or medically significant adverse events (AE) attributed to ephedra or ephedrine were reported

Weight Loss Clinical Studies

  • 26 clinical studies on weight loss or obesity
  • 2/26 were also looked at cardiac symptoms (hypertension and cardiovascular effects)
  • Abstracts published between 1982 - 2002 (20 year period)
  • 16/26 were random, double-blind, and placebo controlled, including 3 crossover studies
  • Length of studies range from 2 doses to 52 weeks
  • Approximately 1751 total patients enrolled
  • Approximately 907 received study drug, 312 received placebo, and 244 dropped out
  • Ephedrine given alone or in combination with caffeine and/or aspirin
  • Ephedrine dose ranges from 72 mg/day to 90 mg/day
  • Caffeine dose ranges from 192 mg/day to 400 mg/day
  • Aspirin dose ranges from 300 mg/day to 330 mg/day
  • One significant adverse event (SAE) of death reported due to gastric bleeding, believed to be alcohol-related and not attributed to study drug by the investigators
  • Common AE reported: insomnia, anxiety and nervousness, palpitation and tremor, vomiting, dry mouth, constipation

Bronchodilator Clinical Studies

  • 23 clinical studies on use of ephedrine as a bronchodilator
  • Published between 1969 - 1982
  • 20/23 were random, double-blind, and placebo controlled, including 14 crossover studies
  • Length of studies range from 7 hours to 52 weeks
  • Approximately 493 patients enrolled ‚ approximately 422 received ephedrine
  • Ephedrine given in combination with caffeine, Terbutaline, Theophylline, Aminophylline, Fenoterol, and Phenobarbitol
  • No reports of SAE

Exercise Clinical Studies

  • 5 clinical studies on the effects of ephedrine and caffeine and exercise
  • Published between 1977 and 1999
  • 3/5 were random, double-blind, crossover studies
  • Approximately 60 patients enrolled and received ephedrine
  • Ephedrine given in combination with caffeine
  • Ephedrine dose ranges from 20 mg/day to 60 mg/day
  • Caffeine dose ranges from 200 mg/day to 600 mg/day
  • No reports of SAE

Misc. Clinical Studies

  • 1 clinical study on cold tolerance with ephedrine 1 mg/kg vs. 2.5 mg/kg caffeine
  • Published in 1989
  • 9 subjects enrolled and treated with ephedrine
  • No reports of SAE

Animal Studies

  • 4 animal studies: 2 in rats, 1 in rats and mice, and 1 in dogs
  • Published between 1986 and 1992

Reviews and Reports Supporting Ephedra Safety

  • Astrup, et al., Pharmacology of Thermogenic Drugs, 55 (1 Supp.) American Journal of Clinical Nutrition 1992; 55 (Supp. 1): 246S.
  • Bucci, L.R., Selected Herbals and Human Exercise Performance, 72 (2 Supp.) American Journal of Clinical Nutrition 624S (Aug. 2000).
  • Dulloo, A.G., Ephedrine, Xanthines And Prostaglandin-Inhibitors: Actions And Interactions In The Stimulation Of Thermogenesis, International Journal Obesity 17 (Suppl 1) 536-540 (1993).
  • Falliers, C.J., Controlled Assessment Of Beta2 Adrenergic Therapy For Childhood Asthma. Chest, 73 (6 Supp.): 1008-10 (1978).
  • Pasquali, R., Casimirri, F., Clinical Aspects Of Ephedrine In The Treatment Of Obesity, International Journal Of Obesity, Vol. 17, Supp. 1: S65-8 (Feb. 1993).
  • Greenway, F. L., The Safety and Efficacy of Pharmaceutical and Herbal Caffeine and Ephedrine Use as a Weight Loss Agent, 2 Obesity Reviews 199 (2001).
  • Cantox Health Sciences International Report, Safety Assessment and Determination of Tolerable Upper Limits for Ephedra, Council for Responsible Nutrition (Dec. 19, 2000). Available at http://www.crnusa.org/cantoxoverview.html.
  • The Expert Panel Ephedra Education Council, The Expert Panel Report (Sept. 29, 2000). Available at http://www.ephedrafacts.com/studies.html.


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