COMPARISON OF AN EPHEDRINE CAFFEINE COMBINATION AND DEXFENFLURAMINE IN THE TREATMENT OF OBESITY - A DOUBLE-BLIND MULTICENTER TRIAL IN GENERAL-PRACTICE

In previous separate studies, dexfenfluramine (DF) and ephedrine/caffe ine (EC) have been shown to promote weight loss in obese patients as c ompared with placebo. In order to compare the efficacy and safety of t hese two anorectic drugs, 103 patients with 20-80% overweight were inc luded in a 15-week double-blind study in general practice. Patients we re randomized to either 15mg DF twice daily (n = 53), or 20 mg/200 mg ephedrine/caffeine three times a day (n = 50), supplementary to a 5 MJ /day diet. Forty-three patients from the DF group and 38 from the EC g roup completed the study. After 15 weeks of treatment, the DF group (n = 43) had lost 6.9 +/- 4.3 kg and the EC group (n = 38) had lost 8.3 +/- 5.2 kg (means +/- s.d., P = 0.12). In the subgroup of patients wit h BMI greater than or equal to 30 kg/m(2) (n = 59), the mean weight lo ss was 7.0 +/- 4.2 kg in the DF group (n = 29) and 9.0 +/- 5.3 kg in t he EC group (n = 30), P < 0.05. Both systolic and diastolic blood pres sures were reduced similarly during both treatments. Twenty-three pati ents in the DF group (43%) and 27 in the EC group (54%) complained of side-effects. Central nervous system side-effects, especially agitatio n, were more pronounced in the EC group (P < 0.05), whereas gastro-int estinal symptoms were more frequent in the DF group (P < 0.05). The si de-effects declined markedly during the first month of treatment in bo th groups. In conclusion, DF and EC are comparable regarding efficacy and safety in the treatment of obesity in general practice. In patient s with BMI greater than or equal to 30 kg/m(2), the EC treatment resul ted in a slightly greater weight loss than DF treatment.