A randomized double-blind placebo-controlled clinical trial of a product containing ephedrine, caffeine, and other ingredients from herbal sources for treatment of overweight and obesity in the absence of lifestyle treatment.
OBJECTIVE
To evaluate the efficacy and side effects of an herbal formulation to promote weight loss, as compared to placebo.


METHODS
12-week multicenter double-blind, placebo-controlled, randomized parallel groups design. Study conducted at three clinical sites in New York State. Subjects were randomized to receive either the 'active' product or a 'placebo' supplement for 12 weeks. Minimal steps were taken to influence lifestyle changes with regard to diet or exercise.


METHODS
102 overweight/obese (30<BMI</=39.9 kg/m(2)) volunteers between the ages of 18 and 65 y.


METHODS
Weight, percent body fat, fat mass, waist circumference, BMI, blood pressure, and pulse measured at 2 days, 1 week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks postrandomization.


RESULTS
Subjects receiving the 'active' treatment experienced, on average, an additional 1.5 kg of weight loss compared with subjects receiving the placebo. In addition, subjects receiving the 'active' treatment experienced greater reductions in BMI and waist circumference over the 12-week period. No differences were observed with respect to percent body fat, fat mass, diastolic or systolic blood pressure, pulse, the occurrence of any adverse event, or the occurrence of any presumed treatment-related adverse event. Testing of the study product by two independent laboratories indicated that it had only approximately half of the intended amount of ephedrine alkaloids and caffeine.


CONCLUSIONS
Over the 12-week trial, subjects on the active treatment experienced significantly greater weight loss than subjects on placebo, without an increase in blood pressure, pulse, or the rate of adverse events. These benefits were achieved in the absence of any lifestyle treatment to change dietary or exercise behavior and with lower doses of ephedrine alkaloids and caffeine than those commonly utilized.
Coffey
C S
CS
Department of Biostatistics, University of Alabama at Birmingham, AL 35294-0022, USA.
Steiner
D
D
Baker
B A
BA
Allison
D B
DB
D000328:Adult; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D001592:Benzyl Alcohols / Q000008:administration & dosage; D015992:Body Mass Index; D002110:Caffeine / Q000008:administration & dosage; D030221:Cola; D004311:Double-Blind Method; D004338:Drug Combinations; D029790:Ephedra sinica; D004809:Ephedrine / Q000008:administration & dosage; D005260:Female; D005960:Glucosides; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000628:therapy*; D008517:Phytotherapy / Q000379:methods*; D010946:Plants, Medicinal; D032108:Salix; D018709:Statistics, Nonparametric; D013997:Time Factors; D015431:Weight Loss
D019440:Anti-Obesity Agents; D001592:Benzyl Alcohols; D004338:Drug Combinations; D005960:Glucosides; D002110:Caffeine; C005696:salicin; D004809:Ephedrine