Safety and efficacy of long-term treatment with ephedrine, caffeine and an ephedrine/caffeine mixture.

In a randomized, placebo-controlled, double blind study, 180 obese patients were treated by diet (4.2 MJ/day) and either an ephedrine/caffeine combination (20mg/200mg), ephedrine (20mg), caffeine (200mg) or placebo 3 times a day for 24 weeks. 141 patients completed this part of the study. All medication was stopped between week 24-26 in order to catch any withdrawal symptoms. From week 26 to 50, 99 patients completed treatment with the ephedrine/caffeine compound in an open trial design, resulting in a statistically significant (p = 0.02) weight loss of 1.1kg. In another randomized, double-blind, placebo-controlled 8 week study on obese subjects we found the mentioned compound showed lean body mass conserving properties. We conclude that the ephedrine/caffeine combination is effective in improving and maintaining weight loss, further it has lean body mass saving properties. The side effects are minor and transient and no withdrawal symptoms have been found.