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
Coffey CS, Steiner D, Baker BA, Allison DB
International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity · 40 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2004-08-31 · Int J Obes Relat Metab Disord · vol. 28 · número 11 · págs. 1411–1419
- Editorial
- Springer Nature
- Citado
- 67 citas · más que el 86% de estudios similares · 2.2× el promedio de su campo
- Referencias
- 31 trabajos
- Acceso
- De pago
- Áreas de investigación
- Pharmacology and Obesity Treatment · Complementary and Alternative Medicine Studies · Regulation of Appetite and Obesity
- Palabras clave
- ephedrine, caffeine, herbal weight loss supplements, weight loss, obesity, overweight, body mass index, waist circumference, fat mass, blood pressure, adverse events
- MeSH
- humans, salix, cola, ephedra sinica, plants, medicinal, obesity, weight loss, ephedrine, benzyl alcohols, caffeine, glucosides, anti-obesity agents, drug combinations, body mass index, phytotherapy, logistic models, statistics, nonparametric, double-blind method, time factors, adult, middle aged, female, male
4 autores
- Christopher S. Coffey🇺🇸University of Alabama at Birmingham
- D Steiner
- B A Baker🇺🇸University of Alabama at Birmingham
- David Blair Allison🇺🇸 · autor de correspondenciaUniversity of Alabama at Birmingham
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
To evaluate the efficacy and side effects of an herbal formulation to promote weight loss, as compared to placebo.
Design
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.
Subjects
102 overweight/obese (30<BMI</=39.9 kg/m(2)) volunteers between the ages of 18 and 65 y.
Main outcome measures
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.
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