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.

Safety and efficacy of treatment with an ephedrine/caffeine mixture. The first double-blind placebo-controlled pilot study in adolescents

Abstract

OBJECTIVE: The present study was performed to investigate the efficacy and safety of a caffeine/ephedrine (CE) mixture in obese adolescents.

SUBJECTS: Thirty-two (m/f=16/16) obese children were included into the study. They were treated by diet (calculated daily energy requirement minus 500 kcal) and either CE or placebo (PL) for 20 weeks in a randomized double-blind placebo-controlled trial. Those weighing less than 80 kg took one tablet three times (100 mg/10 mg), whereas those weighing more than 80 kg took two tablets three times per day. There were three dropouts (girls) from the PL group. The age, weight body mass index (BMI) values (mean (range)) of the PL and CE groups were 16.0 (14.3–17.6) and 16.0 (14.2–17.7) y, 103.0 (77.2–126.4) and 104.8 (69.8–150.2) kg, 35.2 (28.3–42.3) and 36.5 (31.3–51.8) kg/m2, respectively.

RESULTS: The decrease in relative body weight, BMI and body fat (measured by bioelectric impedance) was significantly (P<0.05) greater in the CE group (mean±s.d.; 14.4±10.5%, 2.9±1.9 kg/m2, 6.6±6.0 kg) than in the PL group (2.2±5.8%, 0.5±1.6 kg/m2, 0.5±2.7 kg). Relative body weight decreased by more than 5% in 81% of the CE group, out only in 31% of the PL group. Adverse events were negligible and did not differ between the CE and PL groups. Withdrawal symptoms were mild, transient and their frequency and severity were not different between the placebo and active groups.

CONCLUSION: According to the present pilot study, CE can be a safe and effective compound for the treatment of obesity in adolescents.

Your institute does not have access to this article

Relevant articles

Open Access articles citing this article.

Access options

Buy article

Get time limited or full article access on ReadCube.

$32.00

All prices are NET prices.

Figure 1
Figure 2
Figure 3

References

  1. Csábi G, Török K, Jeges S, Molnár D . Presence of metabolic cardiovascular syndrome in obese children Eur J Pediatr 2000 159: 91–94.

    Article  Google Scholar 

  2. Troiano RP, Flegal KM . Overweight children and adolescents: description, epidemiology, and demographics Pediatrics 1998 101 (Suppl): 497–504.

    CAS  PubMed  Google Scholar 

  3. Astrup A, Toubro 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.

    CAS  Article  Google Scholar 

  4. 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 

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

    PubMed  Google Scholar 

  6. Eiben O, Panto E . Body measurements in the Hungarian youth at the 1980's, based on the Hungarian National Growth Study Anthrop Közll 1987–1988 31: 49–68.

    Google Scholar 

  7. Wabitsch M, Braun U, Heinze E, Muche R, Mayor H, Teller W, Fusch C . Body composition in 5–18-y-old obese children and adolescents before and after weight reduction as assessed by deuterium dilution and bioelectrical impedance analysis Am J Clin Nutr 1996 64: 1–6.

    CAS  Article  Google Scholar 

  8. Lusk G . The Elements of Science of Nutrition, 4th edn WB Saunders: Philadelphia, PA 1928.

    Google Scholar 

  9. Jones NL . Clinical Exercise Testing, 3rd edn WB Saunders: Philadelphia, PA 1988.

    Google Scholar 

  10. 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 

  11. Pasqualy R, Cesary MP, Melchionda N, Stefanini C, Raitano A, Labo G . Does ephedrine promote weight loss in low-energy-adapted obese women? Int J Obes 1987 11: 163–168.

    Google Scholar 

  12. Astrup A, Buemann B, Christensen NJ, Toubro S, Thorbek G, Victor OJ, Quaade F . The effect of ephedrine/caffeine mixture on energy expenditure and body composition in obese women Metabolism 1992 41: 686–688.

    CAS  Article  Google Scholar 

  13. Astrup A, Bülow J, Madsen J, Christensen NJ . Contribution of brown adipose tissue and skeletal muscle to thermo-genesis induced by ephedrine in man Am J Physiol 1985 248: E507–E515.

    CAS  PubMed  Google Scholar 

  14. Stich V, Hainer V, Kunesova M . Effect of ephedrine/caffeine mixture on metabolic response to excercise in obese subjects Int J Obes Relat Metab Disord 1993 17 (Suppl 2): S31.

    Google Scholar 

Download references

Acknowledgements

The project was supported by NYCOMED DAK Pharmaceutical Company, Roskilde, Denmark, and in part by the Hungarian National Research Fund (OTKA T-026663 to DM) and by the Hungarian Ministry of Welfare (081/1996 to DM).

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to D Molnár.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Molnár, D., Török, K., Erhardt, E. et al. Safety and efficacy of treatment with an ephedrine/caffeine mixture. The first double-blind placebo-controlled pilot study in adolescents. Int J Obes 24, 1573–1578 (2000). https://doi.org/10.1038/sj.ijo.0801433

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/sj.ijo.0801433

Keywords

  • obesity
  • ephedrine
  • caffeine

Further reading

Search

Quick links