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.
Identifieur interne : 001E22 ( Main/Exploration ); précédent : 001E21; suivant : 001E23A 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.
Auteurs : C S Coffey [États-Unis] ; D. Steiner ; B A Baker ; D B AllisonSource :
- International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity ; 2004.
Descripteurs français
- KwdFr :
- Adulte (MeSH), Adulte d'âge moyen (MeSH), Agents antiobésité (usage thérapeutique), Alcools benzyliques (administration et posologie), Association médicamenteuse (MeSH), Caféine (administration et posologie), Cola (MeSH), Ephedra sinica (MeSH), Facteurs temps (MeSH), Femelle (MeSH), Glucosides (MeSH), Humains (MeSH), Indice de masse corporelle (MeSH), Modèles logistiques (MeSH), Mâle (MeSH), Méthode en double aveugle (MeSH), Obésité (thérapie), Perte de poids (MeSH), Phytothérapie (méthodes), Plantes médicinales (MeSH), Salix (MeSH), Statistique non paramétrique (MeSH), Éphédrine (administration et posologie).
- MESH :
- administration et posologie : Alcools benzyliques, Caféine, Éphédrine.
- méthodes : Phytothérapie.
- thérapie : Obésité.
- usage thérapeutique : Agents antiobésité.
- Adulte, Adulte d'âge moyen, Association médicamenteuse, Cola, Ephedra sinica, Facteurs temps, Femelle, Glucosides, Humains, Indice de masse corporelle, Modèles logistiques, Mâle, Méthode en double aveugle, Perte de poids, Plantes médicinales, Salix, Statistique non paramétrique.
English descriptors
- KwdEn :
- Adult (MeSH), Anti-Obesity Agents (therapeutic use), Benzyl Alcohols (administration & dosage), Body Mass Index (MeSH), Caffeine (administration & dosage), Cola (MeSH), Double-Blind Method (MeSH), Drug Combinations (MeSH), Ephedra sinica (MeSH), Ephedrine (administration & dosage), Female (MeSH), Glucosides (MeSH), Humans (MeSH), Logistic Models (MeSH), Male (MeSH), Middle Aged (MeSH), Obesity (therapy), Phytotherapy (methods), Plants, Medicinal (MeSH), Salix (MeSH), Statistics, Nonparametric (MeSH), Time Factors (MeSH), Weight Loss (MeSH).
- MESH :
- chemical , administration & dosage : Benzyl Alcohols, Caffeine, Ephedrine.
- chemical , therapeutic use : Anti-Obesity Agents.
- methods : Phytotherapy.
- therapy : Obesity.
- Adult, Body Mass Index, Cola, Double-Blind Method, Drug Combinations, Ephedra sinica, Female, Glucosides, Humans, Logistic Models, Male, Middle Aged, Plants, Medicinal, Salix, Statistics, Nonparametric, Time Factors, Weight Loss.
Abstract
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
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.
DOI: 10.1038/sj.ijo.0802784
PubMed: 15356670
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en">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.</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term>
<term>Anti-Obesity Agents (therapeutic use)</term>
<term>Benzyl Alcohols (administration & dosage)</term>
<term>Body Mass Index (MeSH)</term>
<term>Caffeine (administration & dosage)</term>
<term>Cola (MeSH)</term>
<term>Double-Blind Method (MeSH)</term>
<term>Drug Combinations (MeSH)</term>
<term>Ephedra sinica (MeSH)</term>
<term>Ephedrine (administration & dosage)</term>
<term>Female (MeSH)</term>
<term>Glucosides (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Logistic Models (MeSH)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Obesity (therapy)</term>
<term>Phytotherapy (methods)</term>
<term>Plants, Medicinal (MeSH)</term>
<term>Salix (MeSH)</term>
<term>Statistics, Nonparametric (MeSH)</term>
<term>Time Factors (MeSH)</term>
<term>Weight Loss (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte (MeSH)</term>
<term>Adulte d'âge moyen (MeSH)</term>
<term>Agents antiobésité (usage thérapeutique)</term>
<term>Alcools benzyliques (administration et posologie)</term>
<term>Association médicamenteuse (MeSH)</term>
<term>Caféine (administration et posologie)</term>
<term>Cola (MeSH)</term>
<term>Ephedra sinica (MeSH)</term>
<term>Facteurs temps (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Glucosides (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Indice de masse corporelle (MeSH)</term>
<term>Modèles logistiques (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Méthode en double aveugle (MeSH)</term>
<term>Obésité (thérapie)</term>
<term>Perte de poids (MeSH)</term>
<term>Phytothérapie (méthodes)</term>
<term>Plantes médicinales (MeSH)</term>
<term>Salix (MeSH)</term>
<term>Statistique non paramétrique (MeSH)</term>
<term>Éphédrine (administration et posologie)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Benzyl Alcohols</term>
<term>Caffeine</term>
<term>Ephedrine</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Obesity Agents</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Alcools benzyliques</term>
<term>Caféine</term>
<term>Éphédrine</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Phytotherapy</term>
</keywords>
<keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Phytothérapie</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Obesity</term>
</keywords>
<keywords scheme="MESH" qualifier="thérapie" xml:lang="fr"><term>Obésité</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Agents antiobésité</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Body Mass Index</term>
<term>Cola</term>
<term>Double-Blind Method</term>
<term>Drug Combinations</term>
<term>Ephedra sinica</term>
<term>Female</term>
<term>Glucosides</term>
<term>Humans</term>
<term>Logistic Models</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Plants, Medicinal</term>
<term>Salix</term>
<term>Statistics, Nonparametric</term>
<term>Time Factors</term>
<term>Weight Loss</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Association médicamenteuse</term>
<term>Cola</term>
<term>Ephedra sinica</term>
<term>Facteurs temps</term>
<term>Femelle</term>
<term>Glucosides</term>
<term>Humains</term>
<term>Indice de masse corporelle</term>
<term>Modèles logistiques</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Perte de poids</term>
<term>Plantes médicinales</term>
<term>Salix</term>
<term>Statistique non paramétrique</term>
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<front><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b>
</p>
<p>To evaluate the efficacy and side effects of an herbal formulation to promote weight loss, as compared to placebo.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>DESIGN</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>SUBJECTS</b>
</p>
<p>102 overweight/obese (30</p>
</div>
<div type="abstract" xml:lang="en"><p><b>MAIN OUTCOME MEASURES</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b>
</p>
<p>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.</p>
</div>
</front>
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<Title>International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity</Title>
<ISOAbbreviation>Int J Obes Relat Metab Disord</ISOAbbreviation>
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<ArticleTitle>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.</ArticleTitle>
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<Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To evaluate the efficacy and side effects of an herbal formulation to promote weight loss, as compared to placebo.</AbstractText>
<AbstractText Label="DESIGN" NlmCategory="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.</AbstractText>
<AbstractText Label="SUBJECTS" NlmCategory="METHODS">102 overweight/obese (30</AbstractText>
<AbstractText Label="MAIN OUTCOME MEASURES" NlmCategory="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.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="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.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="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.</AbstractText>
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