What's New
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.
Back to top
|
