OBJECTIVES: To evaluate the efficacy of a combination of ephedrine and caffeine on smoking cessation rates, postcessation weight gain, and withdrawal symptoms and to examine changes in glycosylated hemoglobin (HbA1c) after smoking cessation. METHODS: This randomized double-blind placebo-controlled study with a 1-year follow-up period was carried out at the Department of Pulmonary Medicine in Denmark. Study subjects were 225 heavy smokers who wanted to quit smoking without gaining weight. Two-thirds of the subjects were randomized to receive 20 mg ephedrine plus 200 mg caffeine three times a day; one-third of the subjects received placebo treatment. The dosage was gradually decreased from week 12 to discontinuation at week 39. Group support and control were performed at entry and after 1, 3, 6, 12, 26, 39, and 52 weeks. Main outcome measures were (1) self-reported abstinence with validation by carbon monoxide in expired air and serum cotinine and (2) weight gain. RESULTS: The success rates after 1 year were 17% in the group treated with ephedrine plus caffeine and 16% in the group treated with placebo; the success rates were not significantly different at any time. The success rates for the four counseling physicians varied between 7% and 27% after 1 year (p < 0.05). The weight gain was significantly lower in the ephedrine plus caffeine-treated group during the first 12 weeks, but weight gains were similar after 1 year. No differences in the smoking withdrawal symptoms could be observed between the treatment groups. HbA1c was lower 6 weeks and 1 year after smoking cessation (p < 0.05). CONCLUSIONS: We found an effect of this combination of ephedrine and caffeine on weight gain during the first 12 weeks, but we found no effect on the success rates or craving for cigarettes.
RCT Entities:
OBJECTIVES: To evaluate the efficacy of a combination of ephedrine and caffeine on smoking cessation rates, postcessation weight gain, and withdrawal symptoms and to examine changes in glycosylated hemoglobin (HbA1c) after smoking cessation. METHODS: This randomized double-blind placebo-controlled study with a 1-year follow-up period was carried out at the Department of Pulmonary Medicine in Denmark. Study subjects were 225 heavy smokers who wanted to quit smoking without gaining weight. Two-thirds of the subjects were randomized to receive 20 mg ephedrine plus 200 mg caffeine three times a day; one-third of the subjects received placebo treatment. The dosage was gradually decreased from week 12 to discontinuation at week 39. Group support and control were performed at entry and after 1, 3, 6, 12, 26, 39, and 52 weeks. Main outcome measures were (1) self-reported abstinence with validation by carbon monoxide in expired air and serum cotinine and (2) weight gain. RESULTS: The success rates after 1 year were 17% in the group treated with ephedrine plus caffeine and 16% in the group treated with placebo; the success rates were not significantly different at any time. The success rates for the four counseling physicians varied between 7% and 27% after 1 year (p < 0.05). The weight gain was significantly lower in the ephedrine plus caffeine-treated group during the first 12 weeks, but weight gains were similar after 1 year. No differences in the smoking withdrawal symptoms could be observed between the treatment groups. HbA1c was lower 6 weeks and 1 year after smoking cessation (p < 0.05). CONCLUSIONS: We found an effect of this combination of ephedrine and caffeine on weight gain during the first 12 weeks, but we found no effect on the success rates or craving for cigarettes.