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Article: Randomised clinical trial: rifaximin versus placebo for the treatment of functional dyspepsia

TitleRandomised clinical trial: rifaximin versus placebo for the treatment of functional dyspepsia
Authors
Issue Date2017
PublisherWiley-Blackwell. The Journal's web site is located at http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1365-2036
Citation
Alimentary Pharmacology and Therapeutics, 2017, v. 45 n. 6, p. 767-776 How to Cite?
AbstractBACKGROUND: Gut dysbiosis may contribute to pain and bloating in patients with functional gastrointestinal disease. AIMS: To determine if treatment with rifaximin would improve the symptoms of functional dyspepsia in Chinese patients in a double-blinded, randomised, placebo-controlled trial. METHODS: Consecutive subjects with a diagnosis of functional dyspepsia as per the Rome III criteria were randomised to receive rifaximin 400 mg or placebo, all taken three times daily for 2 weeks. The investigators and study subjects were blinded to the treatment allocation. Subjects were followed up for 8 weeks. The primary end point was adequate relief of global dyspeptic symptoms (GDS). Secondary endpoints were relief of individual dyspeptic symptoms. RESULTS: Eighty-six subjects were recruited. At week 8, there were significantly more subjects in the rifaximin than in the placebo group who experienced adequate relief of GDS (78% vs. 52%, P = 0.02). A trend favouring rifaximin group was also noted in the preceding 4 weeks. Rifaximin was also superior to placebo in providing adequate relief of belching and post-prandial fullness/bloating (PPF) in subjects at week 4. Subgroup analysis revealed that female subjects had more significant response to rifaximin treatment (adequate relief of GDS at week 4: 76% vs. 42%, P = 0.006; week 8: 79% vs. 47%, P = 0.008), as well as improvements in their belching and PPF at week 4. The incidences of adverse effects were similar in both groups. CONCLUSIONS: Treatment with 2 weeks of rifaximin led to adequate relief of global dyspeptic symptoms, belching and post-prandial fullness/bloating in subjects with functional dyspepsia. The difference was more marked in females. (clinicaltrials.org NCT01643083).
Persistent Identifierhttp://hdl.handle.net/10722/242798
ISSN
2019 Impact Factor: 7.515
2015 SCImago Journal Rankings: 2.833
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorTan, VPY-
dc.contributor.authorLiu, KSH-
dc.contributor.authorLam, FYF-
dc.contributor.authorHung, IFN-
dc.contributor.authorYuen, MF-
dc.contributor.authorLeung, WK-
dc.date.accessioned2017-08-25T02:45:27Z-
dc.date.available2017-08-25T02:45:27Z-
dc.date.issued2017-
dc.identifier.citationAlimentary Pharmacology and Therapeutics, 2017, v. 45 n. 6, p. 767-776-
dc.identifier.issn0269-2813-
dc.identifier.urihttp://hdl.handle.net/10722/242798-
dc.description.abstractBACKGROUND: Gut dysbiosis may contribute to pain and bloating in patients with functional gastrointestinal disease. AIMS: To determine if treatment with rifaximin would improve the symptoms of functional dyspepsia in Chinese patients in a double-blinded, randomised, placebo-controlled trial. METHODS: Consecutive subjects with a diagnosis of functional dyspepsia as per the Rome III criteria were randomised to receive rifaximin 400 mg or placebo, all taken three times daily for 2 weeks. The investigators and study subjects were blinded to the treatment allocation. Subjects were followed up for 8 weeks. The primary end point was adequate relief of global dyspeptic symptoms (GDS). Secondary endpoints were relief of individual dyspeptic symptoms. RESULTS: Eighty-six subjects were recruited. At week 8, there were significantly more subjects in the rifaximin than in the placebo group who experienced adequate relief of GDS (78% vs. 52%, P = 0.02). A trend favouring rifaximin group was also noted in the preceding 4 weeks. Rifaximin was also superior to placebo in providing adequate relief of belching and post-prandial fullness/bloating (PPF) in subjects at week 4. Subgroup analysis revealed that female subjects had more significant response to rifaximin treatment (adequate relief of GDS at week 4: 76% vs. 42%, P = 0.006; week 8: 79% vs. 47%, P = 0.008), as well as improvements in their belching and PPF at week 4. The incidences of adverse effects were similar in both groups. CONCLUSIONS: Treatment with 2 weeks of rifaximin led to adequate relief of global dyspeptic symptoms, belching and post-prandial fullness/bloating in subjects with functional dyspepsia. The difference was more marked in females. (clinicaltrials.org NCT01643083).-
dc.languageeng-
dc.publisherWiley-Blackwell. The Journal's web site is located at http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1365-2036-
dc.relation.ispartofAlimentary Pharmacology and Therapeutics-
dc.titleRandomised clinical trial: rifaximin versus placebo for the treatment of functional dyspepsia-
dc.typeArticle-
dc.identifier.emailTan, VPY: vpytan@hku.hk-
dc.identifier.emailLiu, KSH: drkliu@hku.hk-
dc.identifier.emailLam, FYF: fyflam@hku.hk-
dc.identifier.emailHung, IFN: ivanhung@hkucc.hku.hk-
dc.identifier.emailYuen, MF: mfyuen@hku.hk-
dc.identifier.emailLeung, WK: hku75407@hku.hk-
dc.identifier.authorityTan, VPY=rp01458-
dc.identifier.authorityLam, FYF=rp02564-
dc.identifier.authorityHung, IFN=rp00508-
dc.identifier.authorityYuen, MF=rp00479-
dc.identifier.authorityLeung, WK=rp01479-
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1111/apt.13945-
dc.identifier.pmid28112426-
dc.identifier.scopuseid_2-s2.0-85010465168-
dc.identifier.hkuros273718-
dc.identifier.volume45-
dc.identifier.issue6-
dc.identifier.spage767-
dc.identifier.epage776-
dc.identifier.isiWOS:000394694600001-
dc.publisher.placeUnited Kingdom-
dc.identifier.f1000727233700-
dc.identifier.issnl0269-2813-

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