To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized group sequential comparative trial.
Identifieur interne : 000721 ( PubMed/Corpus ); précédent : 000720; suivant : 000722To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized group sequential comparative trial.
Auteurs : Hongli Wu ; Zhiwei Jing ; Xudong Tang ; Xinyue Wang ; Shengsheng Zhang ; Yanan Yu ; Zhong Wang ; Hongxin Cao ; Luqi Huang ; Youhua Yu ; Yongyan WangSource :
- BMC gastroenterology [ 1471-230X ] ; 2011.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Drugs, Chinese Herbal.
- drug therapy : Dyspepsia, Splenic Diseases.
- pathology : Dyspepsia, Splenic Diseases.
- Adult, Citrus, Citrus sinensis, Double-Blind Method, Female, Humans, Male, Middle Aged, Phytotherapy, Qi, Syndrome, Tablets, Treatment Outcome.
Abstract
In Traditional Chinese Medicine (TCM) theory, functional dyspepsia (FD) can be divided into different syndromes according to different clinical symptoms and signs, and the most common one is spleen-deficiency and qi-stagnation syndrome that can be treated by Chinese traditional patent medicine--two kinds of Zhizhu pills, between which the primary difference in ingredients is that one contains immature orange fruit of Citrus aurantium L.(IFCA) and the other contains that of Citrus sinensis Osbeck (IFCS). The trial's objective was to compare the efficacy of two kinds of Zhizhu pills on symptom changes in patients with FD of spleen-deficiency and qi-stagnation syndrome.
DOI: 10.1186/1471-230X-11-81
PubMed: 21762493
Links to Exploration step
pubmed:21762493Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized group sequential comparative trial.</title><author><name sortKey="Wu, Hongli" sort="Wu, Hongli" uniqKey="Wu H" first="Hongli" last="Wu">Hongli Wu</name><affiliation><nlm:affiliation>Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China.</nlm:affiliation></affiliation></author><author><name sortKey="Jing, Zhiwei" sort="Jing, Zhiwei" uniqKey="Jing Z" first="Zhiwei" last="Jing">Zhiwei Jing</name></author><author><name sortKey="Tang, Xudong" sort="Tang, Xudong" uniqKey="Tang X" first="Xudong" last="Tang">Xudong Tang</name></author><author><name sortKey="Wang, Xinyue" sort="Wang, Xinyue" uniqKey="Wang X" first="Xinyue" last="Wang">Xinyue Wang</name></author><author><name sortKey="Zhang, Shengsheng" sort="Zhang, Shengsheng" uniqKey="Zhang S" first="Shengsheng" last="Zhang">Shengsheng Zhang</name></author><author><name sortKey="Yu, Yanan" sort="Yu, Yanan" uniqKey="Yu Y" first="Yanan" last="Yu">Yanan Yu</name></author><author><name sortKey="Wang, Zhong" sort="Wang, Zhong" uniqKey="Wang Z" first="Zhong" last="Wang">Zhong Wang</name></author><author><name sortKey="Cao, Hongxin" sort="Cao, Hongxin" uniqKey="Cao H" first="Hongxin" last="Cao">Hongxin Cao</name></author><author><name sortKey="Huang, Luqi" sort="Huang, Luqi" uniqKey="Huang L" first="Luqi" last="Huang">Luqi Huang</name></author><author><name sortKey="Yu, Youhua" sort="Yu, Youhua" uniqKey="Yu Y" first="Youhua" last="Yu">Youhua Yu</name></author><author><name sortKey="Wang, Yongyan" sort="Wang, Yongyan" uniqKey="Wang Y" first="Yongyan" last="Wang">Yongyan Wang</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2011">2011</date><idno type="RBID">pubmed:21762493</idno><idno type="pmid">21762493</idno><idno type="doi">10.1186/1471-230X-11-81</idno><idno type="wicri:Area/PubMed/Corpus">000721</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized group sequential comparative trial.</title><author><name sortKey="Wu, Hongli" sort="Wu, Hongli" uniqKey="Wu H" first="Hongli" last="Wu">Hongli Wu</name><affiliation><nlm:affiliation>Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China.</nlm:affiliation></affiliation></author><author><name sortKey="Jing, Zhiwei" sort="Jing, Zhiwei" uniqKey="Jing Z" first="Zhiwei" last="Jing">Zhiwei Jing</name></author><author><name sortKey="Tang, Xudong" sort="Tang, Xudong" uniqKey="Tang X" first="Xudong" last="Tang">Xudong Tang</name></author><author><name sortKey="Wang, Xinyue" sort="Wang, Xinyue" uniqKey="Wang X" first="Xinyue" last="Wang">Xinyue Wang</name></author><author><name sortKey="Zhang, Shengsheng" sort="Zhang, Shengsheng" uniqKey="Zhang S" first="Shengsheng" last="Zhang">Shengsheng Zhang</name></author><author><name sortKey="Yu, Yanan" sort="Yu, Yanan" uniqKey="Yu Y" first="Yanan" last="Yu">Yanan Yu</name></author><author><name sortKey="Wang, Zhong" sort="Wang, Zhong" uniqKey="Wang Z" first="Zhong" last="Wang">Zhong Wang</name></author><author><name sortKey="Cao, Hongxin" sort="Cao, Hongxin" uniqKey="Cao H" first="Hongxin" last="Cao">Hongxin Cao</name></author><author><name sortKey="Huang, Luqi" sort="Huang, Luqi" uniqKey="Huang L" first="Luqi" last="Huang">Luqi Huang</name></author><author><name sortKey="Yu, Youhua" sort="Yu, Youhua" uniqKey="Yu Y" first="Youhua" last="Yu">Youhua Yu</name></author><author><name sortKey="Wang, Yongyan" sort="Wang, Yongyan" uniqKey="Wang Y" first="Yongyan" last="Wang">Yongyan Wang</name></author></analytic><series><title level="j">BMC gastroenterology</title><idno type="eISSN">1471-230X</idno><imprint><date when="2011" type="published">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Citrus</term><term>Citrus sinensis</term><term>Double-Blind Method</term><term>Drugs, Chinese Herbal (therapeutic use)</term><term>Dyspepsia (drug therapy)</term><term>Dyspepsia (pathology)</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Phytotherapy</term><term>Qi</term><term>Splenic Diseases (drug therapy)</term><term>Splenic Diseases (pathology)</term><term>Syndrome</term><term>Tablets</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Drugs, Chinese Herbal</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Dyspepsia</term><term>Splenic Diseases</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Dyspepsia</term><term>Splenic Diseases</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Citrus</term><term>Citrus sinensis</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Phytotherapy</term><term>Qi</term><term>Syndrome</term><term>Tablets</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In Traditional Chinese Medicine (TCM) theory, functional dyspepsia (FD) can be divided into different syndromes according to different clinical symptoms and signs, and the most common one is spleen-deficiency and qi-stagnation syndrome that can be treated by Chinese traditional patent medicine--two kinds of Zhizhu pills, between which the primary difference in ingredients is that one contains immature orange fruit of Citrus aurantium L.(IFCA) and the other contains that of Citrus sinensis Osbeck (IFCS). The trial's objective was to compare the efficacy of two kinds of Zhizhu pills on symptom changes in patients with FD of spleen-deficiency and qi-stagnation syndrome.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">21762493</PMID><DateCreated><Year>2011</Year><Month>8</Month><Day>24</Day></DateCreated><DateCompleted><Year>2011</Year><Month>12</Month><Day>09</Day></DateCompleted><DateRevised><Year>2015</Year><Month>2</Month><Day>4</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1471-230X</ISSN><JournalIssue CitedMedium="Internet"><Volume>11</Volume><PubDate><Year>2011</Year><Month>Jul</Month><Day>15</Day></PubDate></JournalIssue><Title>BMC gastroenterology</Title><ISOAbbreviation>BMC Gastroenterol</ISOAbbreviation></Journal><ArticleTitle>To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized group sequential comparative trial.</ArticleTitle><Pagination><MedlinePgn>81</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/1471-230X-11-81</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In Traditional Chinese Medicine (TCM) theory, functional dyspepsia (FD) can be divided into different syndromes according to different clinical symptoms and signs, and the most common one is spleen-deficiency and qi-stagnation syndrome that can be treated by Chinese traditional patent medicine--two kinds of Zhizhu pills, between which the primary difference in ingredients is that one contains immature orange fruit of Citrus aurantium L.(IFCA) and the other contains that of Citrus sinensis Osbeck (IFCS). The trial's objective was to compare the efficacy of two kinds of Zhizhu pills on symptom changes in patients with FD of spleen-deficiency and qi-stagnation syndrome.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">A randomized, group sequential, double-blinded, multicenter trial was conducted in patients with FD of spleen-deficiency and qi-stagnation syndrome at 3 hospitals in Beijing between June 2003 and May 2005. Participants were randomly allocated into two groups (IFCA group and IFCS group) in a 1:1 ratio, and respectively took one of the two kinds of Zhizhu pills orally, 6 g each time, 3 times a day, for 4 weeks. Statistical analysis was performed with use of a group sequential method, the triangular test (TT).</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 163 patients were randomized, and 3 patients were excluded from analysis because of early dropouts, leaving 160 patients (IFCA group: n = 82; IFCS group: n = 78) for statistical analysis. Three interim analyses were done after 62, 116, and 160 patients had completed their 4-week treatment, respectively. At the third interim analysis, the sample path crossed the upper boundary and the trial was stopped, the cure-markedly effective rates were 45% for IFCS group and 67% for IFCA group, respectively, the one-sided p-value was 0.0036, the median unbiased estimate of the odds ratio (OR) for the benefit of IFCA relative to IFCS was 2.91 with 95%CI: 1.40 to 6.06.No adverse events were observed in the two groups.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Zhizhu pills containing IFCA was superior to Zhizhu pills containing IFCS in the treatment of FD of spleen-deficiency and qi-stagnation syndrome. The application of group sequential analysis in clinical trials of TCM may offer some financial and ethical benefits.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-00000485.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Wu</LastName><ForeName>Hongli</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jing</LastName><ForeName>Zhiwei</ForeName><Initials>Z</Initials></Author><Author ValidYN="Y"><LastName>Tang</LastName><ForeName>Xudong</ForeName><Initials>X</Initials></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Xinyue</ForeName><Initials>X</Initials></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Shengsheng</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Yu</LastName><ForeName>Yanan</ForeName><Initials>Y</Initials></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Zhong</ForeName><Initials>Z</Initials></Author><Author ValidYN="Y"><LastName>Cao</LastName><ForeName>Hongxin</ForeName><Initials>H</Initials></Author><Author ValidYN="Y"><LastName>Huang</LastName><ForeName>Luqi</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Yu</LastName><ForeName>Youhua</ForeName><Initials>Y</Initials></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Yongyan</ForeName><Initials>Y</Initials></Author></AuthorList><Language>ENG</Language><PublicationTypeList><PublicationType UI="D003160">Comparative Study</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><ArticleDate DateType="Electronic"><Year>2011</Year><Month>Jul</Month><Day>15</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>BMC Gastroenterol</MedlineTA><NlmUniqueID>100968547</NlmUniqueID><ISSNLinking>1471-230X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004365">Drugs, Chinese Herbal</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013607">Tablets</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Biometrics. 1983 Mar;39(1):227-36</RefSource><PMID Version="1">6871351</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Therapie. 1991 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Version="1">18463436</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Stat Methods Med Res. 2011 Dec;20(6):635-56</RefSource><PMID Version="1">20876163</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Aliment Pharmacol Ther. 2004 Mar 15;19(6):643-54</RefSource><PMID Version="1">15023166</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Aliment Pharmacol Ther. 1998 Nov;12(11):1055-65</RefSource><PMID Version="1">9845395</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002957" MajorTopicYN="Y">Citrus</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D032084" MajorTopicYN="Y">Citrus sinensis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004365" MajorTopicYN="N">Drugs, Chinese Herbal</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004415" MajorTopicYN="N">Dyspepsia</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008517" MajorTopicYN="Y">Phytotherapy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019413" MajorTopicYN="N">Qi</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013158" MajorTopicYN="N">Splenic Diseases</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013577" MajorTopicYN="N">Syndrome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013607" MajorTopicYN="N">Tablets</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC3160401</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2009</Year><Month>12</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2011</Year><Month>7</Month><Day>15</Day></PubMedPubDate><PubMedPubDate 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