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 : 001D69 ( Main/Corpus ); précédent : 001D68; suivant : 001D70A 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 ; 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.
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
Links to Exploration step
pubmed:15356670Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><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><author><name sortKey="Coffey, C S" sort="Coffey, C S" uniqKey="Coffey C" first="C S" last="Coffey">C S Coffey</name><affiliation><nlm:affiliation>Department of Biostatistics, University of Alabama at Birmingham, AL 35294-0022, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Steiner, D" sort="Steiner, D" uniqKey="Steiner D" first="D" last="Steiner">D. Steiner</name></author><author><name sortKey="Baker, B A" sort="Baker, B A" uniqKey="Baker B" first="B A" last="Baker">B A Baker</name></author><author><name sortKey="Allison, D B" sort="Allison, D B" uniqKey="Allison D" first="D B" last="Allison">D B Allison</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2004">2004</date><idno type="RBID">pubmed:15356670</idno><idno type="pmid">15356670</idno><idno type="doi">10.1038/sj.ijo.0802784</idno><idno type="wicri:Area/Main/Corpus">001D69</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001D69</idno></publicationStmt><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><author><name sortKey="Coffey, C S" sort="Coffey, C S" uniqKey="Coffey C" first="C S" last="Coffey">C S Coffey</name><affiliation><nlm:affiliation>Department of Biostatistics, University of Alabama at Birmingham, AL 35294-0022, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Steiner, D" sort="Steiner, D" uniqKey="Steiner D" first="D" last="Steiner">D. Steiner</name></author><author><name sortKey="Baker, B A" sort="Baker, B A" uniqKey="Baker B" first="B A" last="Baker">B A Baker</name></author><author><name sortKey="Allison, D B" sort="Allison, D B" uniqKey="Allison D" first="D B" last="Allison">D B Allison</name></author></analytic><series><title level="j">International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity</title><imprint><date when="2004" type="published">2004</date></imprint></series></biblStruct></sourceDesc></fileDesc><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="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="methods" xml:lang="en"><term>Phytotherapy</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Obesity</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></textClass></profileDesc></teiHeader><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></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">15356670</PMID><DateCompleted><Year>2004</Year><Month>12</Month><Day>28</Day></DateCompleted><DateRevised><Year>2014</Year><Month>06</Month><Day>03</Day></DateRevised><Article PubModel="Print"><Journal><JournalIssue CitedMedium="Print"><Volume>28</Volume><Issue>11</Issue><PubDate><Year>2004</Year><Month>Nov</Month></PubDate></JournalIssue><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></Journal><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><Pagination><MedlinePgn>1411-9</MedlinePgn></Pagination><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></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Coffey</LastName><ForeName>C S</ForeName><Initials>CS</Initials><AffiliationInfo><Affiliation>Department of Biostatistics, University of Alabama at Birmingham, AL 35294-0022, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Steiner</LastName><ForeName>D</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Baker</LastName><ForeName>B A</ForeName><Initials>BA</Initials></Author><Author ValidYN="Y"><LastName>Allison</LastName><ForeName>D B</ForeName><Initials>DB</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Int J Obes Relat Metab Disord</MedlineTA><NlmUniqueID>9313169</NlmUniqueID></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D019440">Anti-Obesity Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001592">Benzyl Alcohols</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D005960">Glucosides</NameOfSubstance></Chemical><Chemical><RegistryNumber>3G6A5W338E</RegistryNumber><NameOfSubstance UI="D002110">Caffeine</NameOfSubstance></Chemical><Chemical><RegistryNumber>4649620TBZ</RegistryNumber><NameOfSubstance UI="C005696">salicin</NameOfSubstance></Chemical><Chemical><RegistryNumber>GN83C131XS</RegistryNumber><NameOfSubstance UI="D004809">Ephedrine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019440" MajorTopicYN="N">Anti-Obesity Agents</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001592" MajorTopicYN="N">Benzyl Alcohols</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015992" MajorTopicYN="N">Body Mass Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002110" MajorTopicYN="N">Caffeine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D030221" MajorTopicYN="N">Cola</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004338" MajorTopicYN="N">Drug Combinations</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D029790" MajorTopicYN="N">Ephedra sinica</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004809" MajorTopicYN="N">Ephedrine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005960" MajorTopicYN="N">Glucosides</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016015" MajorTopicYN="N">Logistic Models</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009765" MajorTopicYN="N">Obesity</DescriptorName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008517" MajorTopicYN="N">Phytotherapy</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010946" MajorTopicYN="Y">Plants, Medicinal</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D032108" MajorTopicYN="N">Salix</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018709" MajorTopicYN="N">Statistics, 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