Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial

International Journal of Obesity volume 26, pages 593–604 (2002)Cite this article

Abstract

Objective: To examine long-term safety and efficacy for weight loss of an herbal Ma Huang and Kola nut supplement (90/192 mg/day ephedrine alkaloids/caffeine).

Design: Six-month randomized, double-blind placebo controlled trial.

Subjects: A total of 167 subjects (body mass index (BMI) 31.8±4.1 kg/m2) randomized to placebo (n=84) or herbal treatment (n=83) at two outpatient weight control research units.

Measurements: Primary outcome measurements were changes in blood pressure, heart function and body weight. Secondary variables included body composition and metabolic changes.

Results: By last observation carried forward analysis, herbal vs placebo treatment decreased body weight (−5.3±5.0 vs −2.6±3.2 kg, P<0.001), body fat (−4.3±3.3 vs −2.7±2.8 kg, P=0.020) and LDL-cholesterol (−8±20 vs 0±17 mg/dl, P=0.013), and increased HDL-cholesterol (+2.7±5.7 vs −0.3±6.7 mg/dl, P=0.004). Herbal treatment produced small changes in blood pressure variables (+3 to −5 mmHg, P≤0.05), and increased heart rate (4±9 vs −3±9 bpm, P<0.001), but cardiac arrhythmias were not increased (P>0.05). By self-report, dry mouth (P<0.01), heartburn (P<0.05), and insomnia (P<0.01) were increased and diarrhea decreased (P<0.05). Irritability, nausea, chest pain and palpitations did not differ, nor did numbers of subjects who withdrew.

Conclusions: In this 6-month placebo-controlled trial, herbal ephedra/caffeine (90/192 mg/day) promoted body weight and body fat reduction and improved blood lipids without significant adverse events.

This is a preview of subscription content, access via your institution

Relevant articles

Open Access articles citing this article.

Access options

Rent or buy this article

Prices vary by article type

from$1.95

to$39.95

Learn more

Prices may be subject to local taxes which are calculated during checkout

Figure 1
Figure 2
Figure 3

References

  1. NBC Nightly News In Depth Report, 10 April 2001.

  2. Haller CA, Benowitz NL . Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids New Engl J Med 2000 343: 1833–1838.

    Article  CAS  Google Scholar 

  3. Food and Drug Administration. Fed Reg 1997 62: 30678–30724.

  4. Neergaard L . Since recent deaths, the FDA is studying dangers of ephedra Associated Press 17 April 2000.

  5. Spake A . Natural hazards US News World Rep 12 February 2001 42–49.

  6. Malchow-Moller A, Larsen S, Hey H, Stokholm KH, Juhl E, Quaade F . Ephedrine as an anorectic: the story of the ‘Elsinore pill’ Int J Obes 1981 5: 183–187.

    CAS  PubMed  Google Scholar 

  7. Toubro S, Astrup AV, Breum L, Quaade F . Safety and efficacy of long-term treatment with ephedrine, caffeine and an ephedrine/caffeine mixture Int J Obes Relat Metab Disord 1993 17 (Suppl 1): S69–S72.

    PubMed  Google Scholar 

  8. Astrup A, Breum L, Toubro S, Hein P, Quaade F . The effect and safety of an ephedrine/caffeine compound compared to ephedrine, caffeine and placebo in obese subjects on an energy restricted diet. A double blind trial Int J Obes Relat Metab Disord 1992 16: 269–277.

    CAS  PubMed  Google Scholar 

  9. Daly PA, Krieger DR, Dulloo AG, Young JB, Landsberg L . Ephedrine, caffeine and aspirin: safety and efficacy for treatment of human obesity Int J Obes Relat Metab Disord 1993 17 (Suppl 1): S73–S78.

    PubMed  Google Scholar 

  10. Breum L, Pedersen JK, Ahlstrom F, Frimodt-Moller J . Comparison of an ephedrine/caffeine combination and dexfenfluramine in the treatment of obesity. A double-blind multi-centre trial in general practice Int J Obes Relat Metab Disord 1994 18: 99–103.

    CAS  PubMed  Google Scholar 

  11. Boozer C, Nasser J, Heymsfield S, Wang V, Chen G, Solomon J . An herbal supplement containing Ma Huang-Guarana for weight loss: a randomized, double-blind trial Int J Obes Relat Metab Disord 2001 25: 316–324.

    Article  CAS  Google Scholar 

  12. Kaats G, Adelman J, Blum K . Effects of a multiple herbal formulation on body composition, blood chemistry, vital signs, and self-reported energy levels & appetite control Int J Obes Relat Metab Disord 1994 18: S145.

    Google Scholar 

  13. Lohman T . Advances in body composition assessment Human Kinetics: Champaigne, IL 1992.

    Google Scholar 

  14. Siri W . Body composition from fluid spaces and density: analysis of methods In Techniques for measuring body composition NAS: Washington, DC 1961 pp 223–248.

    Google Scholar 

  15. Agresti A . Categorical Data Analysis Wiley: New York 1990.

    Google Scholar 

  16. Dulloo AG, Miller DS . Reversal of obesity in the genetically obese fa/fa Zucker rat with an ephedrine/methylxanthines thermogenic mixture J Nutr 1987 117: 383–389.

    Article  CAS  Google Scholar 

  17. Dulloo AG, Miller DS . The thermogenic properties of ephedrine/methylxanthine mixtures: animal studies Am J Clin Nutr 1986 43: 388–394.

    Article  CAS  Google Scholar 

  18. Toubro S, Astrup A, Breum L, Quaade F . The acute and chronic effects of ephedrine/caffeine mixtures on energy expenditure and glucose metabolism in humans Int J Obes Relat Metab Disord 1993 17 (Suppl 3): S73–S77.

    PubMed  Google Scholar 

  19. Dulloo AG, Miller DS . Aspirin as a promoter of ephedrine-induced thermogenesis: potential use in the treatment of obesity Am J Clin Nutr 1987 45: 564–569.

    Article  CAS  Google Scholar 

  20. Astrup A, Toubro S, Cannon S, Hein P, Madsen J . Thermogenic synergism between ephedrine and caffeine in healthy volunteers: a double-blind, placebo-controlled study Metabolism 1991 40: 323–329.

    Article  CAS  Google Scholar 

  21. Astrup A, Buemann B, Christensen NJ et al. The effect of ephedrine/caffeine mixture on energy expenditure and body composition in obese women Metabolism 1992 41: 686–688.

    Article  CAS  Google Scholar 

  22. Buemann B, Marckmann P, Christensen NJ, Astrup A . The effect of ephedrine plus caffeine on plasma lipids and lipoproteins during a 4.2 MJ/day diet Int J Obes Relat Metab Disord 1994 18: 329–332.

    CAS  PubMed  Google Scholar 

  23. Astrup A, Toubro S . Thermogenic, metabolic, and cardiovascular responses to ephedrine and caffeine in man Int J Obes Relat Metab Disord 1993 17 (Suppl 1): S41–S43.

    CAS  PubMed  Google Scholar 

  24. Bray GA, Blackburn GL, Ferguson JM, Greenway FL, Jain AK, Mendel CM, Mendels J, Ryan DH, Schwartz SL, Scheinbauml ML, Seaton TB . Sibutramine produces dose-related weight loss Obes Res 1999 7: 189–198.

    Article  CAS  Google Scholar 

  25. White LM, Gardner SF, Gurley BJ, Marx MA, Wang PL, Estes M . Pharmacokinetics and cardiovascular effects of ma-huang (Ephedra sinica) in normotensive adults J Clin Pharmac 1997 37: 116–122.

    Article  CAS  Google Scholar 

  26. Ramsey JJ, Colman RJ, Swick AG, Kemnitz JW . Energy expenditure, body composition, and glucose metabolism in lean and obese rhesus monkeys treated with ephedrine and caffeine Am J Clin Nutr 1998 68: 42–51.

    Article  CAS  Google Scholar 

  27. Karch S . Ma Huang and the ephedra alkaloids In: Cupp M (ed.) Toxicology and clinical pharmacology of herbal products Humana Press: Totowa, NJ 2000 pp 11–30.

    Chapter  Google Scholar 

  28. Fleming GA . The FDA, regulation, and the risk of stroke New Engl J Med 2000 343: 1886–1887.

    Article  CAS  Google Scholar 

  29. Hutchins GM . Dietary supplements containing ephedra alkaloids New Engl J Med 2001 344: 1095–1096.

    Article  CAS  Google Scholar 

Download references

Acknowledgements

The authors gratefully acknowledge the help of the following individuals: Wayne Snodgrass, MD, PhD, for contributing to protocol design; Stanley Heshka, PhD, for the randomization procedure; Sheila Dawling, PhD, for supervising urine toxicologic screening, Steven B Heymsfield, MD, for EKG evaluations and for supervision of physical evaluations. Research support was provided by: Science Toxicology and Technology Consulting, San Francisco, CA, USA and National Institutes of Health grant P30DK 26687.

Author information

Author notes

  1. T Meredith

    Present address: World Health Organization, Geneva, Switzerland

Authors and Affiliations

  1. New York Obesity Research Center, St Luke's-Roosevelt Hospital and Columbia University, New York, USA

    CN Boozer, JL Solomon & JA Nasser

  2. Beth Israel-Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA

    PA Daly & D Blanchard

  3. Beth Israel Medical Center, New York, USA

    P Homel

  4. Cigna Health Care, Los Angeles, California, USA

    R Strauss

  5. Vanderbilt University Medical Center, Nashville, Tennessee, USA

    T Meredith

Authors
  1. CN Boozer
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. PA Daly
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. P Homel
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. JL Solomon
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. D Blanchard
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. JA Nasser
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. R Strauss
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. T Meredith
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to CN Boozer.

Appendices

Appendix I: medical exclusions from the study

Active heart disease, a positive history of palpitations, hypertension (office measurement ≥140 systolic BP or diastolic BP ≥90 or ABPM mean 24 h systolic BP ≥139 mmHg or diastolic BP ≥87 mmHg), epilepsy, history of mental illness, hyperthyroidism, chronic use of any drug (by self-report or by presence in urine toxicology screen) except oral contraceptives, hormone replacement therapy or synthetic thyroid hormone, active bulimia, known prostatic hypertrophy, pregnancy (reported or detected by HCG testing), glaucoma, active cancer or cancer in remission for ≤5 y, renal dysfunction, liver dysfunction (ALT, alkaline phosphatase>2×upper limit of normal), acute or chronic active hepatitis, AIDS, any acute illness within the past 4 weeks, any other chronic illness that might be adversely impacted by concurrent use of the herbal compound, concurrent participation in another research protocol involving diet or any drug use, concurrent participation in a diet program involving severe calorie restriction (800 or fewer calories per day), caffeine intake of 500 mg per day or greater, use of appetite suppressant drugs or ephedra-containing herbal supplements within the last 6 months and weight change of 5 kg or more within the past 3 months.

Appendix II: urine toxicology screen

Amphetamine metabolites, salicylates, phenothiazines, amphetamine class, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates, methadone, phencyclidine, tricyclics, methanol, ethanol, acetone, iso-propanol, ethchlorvynol.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Boozer, C., Daly, P., Homel, P. et al. Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial. Int J Obes 26, 593–604 (2002). https://doi.org/10.1038/sj.ijo.0802023

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/sj.ijo.0802023

Keywords

This article is cited by

Search

Advanced search

Quick links