Simethicone in the treatment of infant colic: a randomized, placebo-controlled, multicenter trial.
Identifieur interne : 002311 ( Main/Curation ); précédent : 002310; suivant : 002312Simethicone in the treatment of infant colic: a randomized, placebo-controlled, multicenter trial.
Auteurs : T J Metcalf [États-Unis] ; T G Irons ; L D Sher ; P C YoungSource :
- Pediatrics [ 0031-4005 ] ; 1994.
Descripteurs français
- KwdFr :
- MESH :
- traitement médicamenteux : Colique.
- usage thérapeutique : Siméticone.
- Humains, Méthode en double aveugle, Nourrisson, Nouveau-né, Résultat thérapeutique.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Simethicone.
- drug therapy : Colic.
- Double-Blind Method, Humans, Infant, Infant, Newborn, Treatment Outcome.
Abstract
OBJECTIVE
To determine the efficacy of simethicone in the treatment of infant colic.
DESIGN
Randomized, double blind, placebo-controlled.
SETTING
Three general pediatric practices in distinct geographic regions.
PATIENTS
Eighty-three infants between 2 and 8 weeks of age with infant colic.
INTERVENTIONS
Treatment with simethicone and placebo in double blind crossover fashion.
RESULTS
A total of 166 treatment periods, ranging from 3 to 10 days, were evaluated in the 83 infants. Compared to baseline, improvement in symptoms was reported for 54% of the treatment periods, worsening was reported for 22%, and, for 24%, there was no change. The likelihood of the treatment period being rated as showing improvement, worsening, or no change was the same whether the infant was receiving placebo or simethicone. Twenty-eight percent of he infants responded only to simethicone, 37% only to placebo, and 20% responded to both. No statistically significant differences were noted among these three groups of responders. No difference could be shown even when infants with "gas-related symptoms" (by parental report) were separated out as a group.
CONCLUSION
Although both produced perceived improvements in symptoms, simethicone is no more effective than placebo in the treatment of infantile colic.
PubMed: 8008533
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Compared to baseline, improvement in symptoms was reported for 54% of the treatment periods, worsening was reported for 22%, and, for 24%, there was no change. The likelihood of the treatment period being rated as showing improvement, worsening, or no change was the same whether the infant was receiving placebo or simethicone. Twenty-eight percent of he infants responded only to simethicone, 37% only to placebo, and 20% responded to both. No statistically significant differences were noted among these three groups of responders. No difference could be shown even when infants with "gas-related symptoms" (by parental report) were separated out as a group.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>Although both produced perceived improvements in symptoms, simethicone is no more effective than placebo in the treatment of infantile colic.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">8008533</PMID><DateCompleted><Year>1994</Year><Month>07</Month><Day>19</Day></DateCompleted><DateRevised><Year>2010</Year><Month>03</Month><Day>24</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0031-4005</ISSN><JournalIssue CitedMedium="Print"><Volume>94</Volume><Issue>1</Issue><PubDate><Year>1994</Year><Month>Jul</Month></PubDate></JournalIssue><Title>Pediatrics</Title><ISOAbbreviation>Pediatrics</ISOAbbreviation></Journal><ArticleTitle>Simethicone in the treatment of infant colic: a randomized, placebo-controlled, multicenter trial.</ArticleTitle><Pagination><MedlinePgn>29-34</MedlinePgn></Pagination><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To determine the efficacy of simethicone in the treatment of infant colic.</AbstractText><AbstractText Label="DESIGN" NlmCategory="METHODS">Randomized, double blind, placebo-controlled.</AbstractText><AbstractText Label="SETTING" NlmCategory="METHODS">Three general pediatric practices in distinct geographic regions.</AbstractText><AbstractText Label="PATIENTS" NlmCategory="METHODS">Eighty-three infants between 2 and 8 weeks of age with infant colic.</AbstractText><AbstractText Label="INTERVENTIONS" NlmCategory="METHODS">Treatment with simethicone and placebo in double blind crossover fashion.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 166 treatment periods, ranging from 3 to 10 days, were evaluated in the 83 infants. Compared to baseline, improvement in symptoms was reported for 54% of the treatment periods, worsening was reported for 22%, and, for 24%, there was no change. The likelihood of the treatment period being rated as showing improvement, worsening, or no change was the same whether the infant was receiving placebo or simethicone. Twenty-eight percent of he infants responded only to simethicone, 37% only to placebo, and 20% responded to both. No statistically significant differences were noted among these three groups of responders. No difference could be shown even when infants with "gas-related symptoms" (by parental report) were separated out as a group.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Although both produced perceived improvements in symptoms, simethicone is no more effective than placebo in the treatment of infantile colic.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Metcalf</LastName><ForeName>T J</ForeName><Initials>TJ</Initials><AffiliationInfo><Affiliation>Willow Creek Pediatrics, Salt Lake City, UT.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Irons</LastName><ForeName>T G</ForeName><Initials>TG</Initials></Author><Author ValidYN="Y"><LastName>Sher</LastName><ForeName>L D</ForeName><Initials>LD</Initials></Author><Author ValidYN="Y"><LastName>Young</LastName><ForeName>P C</ForeName><Initials>PC</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Pediatrics</MedlineTA><NlmUniqueID>0376422</NlmUniqueID><ISSNLinking>0031-4005</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>8050-81-5</RegistryNumber><NameOfSubstance UI="D012841">Simethicone</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D003085" MajorTopicYN="N">Colic</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007231" MajorTopicYN="N">Infant, Newborn</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012841" MajorTopicYN="N">Simethicone</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>1994</Year><Month>7</Month><Day>1</Day></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>1994</Year><Month>7</Month><Day>1</Day><Hour>0</Hour><Minute>1</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>1994</Year><Month>7</Month><Day>1</Day><Hour>0</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">8008533</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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