File Download

There are no files associated with this item.

  Links for fulltext
     (May Require Subscription)
Supplementary

Article: Low-dose imipramine for refractory functional dyspepsia: a randomised, double-blind, placebo-controlled trial

TitleLow-dose imipramine for refractory functional dyspepsia: a randomised, double-blind, placebo-controlled trial
Authors
Keywordsadult
aged
anxiety
bloating
blurred vision
Issue Date2018
PublisherElsevier: Lancet. The Journal's web site is located at http://www.sciencedirect.com/science/journal/24681253
Citation
The Lancet Gastroenterology & Hepatology, 2018, v. 3 n. 12, p. 837-844 How to Cite?
AbstractBackground: Guidelines recommend the use of neuromodulators in patients with functional dyspepsia not responding to proton pump inhibitors (PPIs) and prokinetics; however, there is a lack of data from randomised controlled trials supporting their use. We aimed to assess the safety and efficacy of imipramine, a tricyclic antidepressant (TCA), in treatment-refractory functional dyspepsia. Methods: In this single-centre, double-blind, randomised controlled trial, we enrolled consecutive patients with Rome II functional dyspepsia aged 18–80 years. Eligible patients were Helicobacter pylori-negative, had a normal upper gastrointestinal endoscopy and abdominal ultrasound, and remained symptomatic after open-label treatment with 8 weeks of esomeprazole and 4 weeks of domperidone. Patients completed questionnaires assessing dyspepsia symptoms, mood, and insomnia, and were then randomly assigned (1:1) via a computer-generated list of random numbers to receive imipramine (at a dose of 25 mg once nightly for the first 2 weeks, and then 50 mg thereafter) or placebo for 12 weeks. The primary endpoint was overall satisfactory relief of global dyspepsia symptoms at 12 weeks, via patient-reported assessment in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00164775, and is completed. Findings: Between Sept 11, 2005, and Aug 20, 2010, 107 patients with treatment-refractory functional dyspepsia were randomly assigned to receive imipramine (n=55) or placebo (n=52). Relief of global dyspepsia symptoms at 12 weeks occurred in 35 (63·6%, 95% CI 50·4–75·1) of 55 patients on imipramine compared with 19 (36·5%, 95% CI 24·8–50·1) of 52 on placebo (p=0·0051). Ten (18%) patients on imipramine discontinued the study due to adverse events (three dry mouth, two constipation, two drowsiness, and one each insomnia, palpitations, and blurred vision), compared with four (8%) on placebo (one dry mouth and constipation, and one each palpitations, worsening of gastro-oesophageal reflux, and limb paraesthesia). There were no serious adverse events. Interpretation: Low-dose imipramine should be considered as a possible therapy for patients with functional dyspepsia refractory to both PPIs and prokinetics, although patients should be cautioned about the adverse event profile. Funding: None. © 2018 Elsevier Ltd
DescriptionLink to Free access
Persistent Identifierhttp://hdl.handle.net/10722/290608
ISSN
2018 Impact Factor: 12.856
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorCheong, PK-
dc.contributor.authorFord, AC-
dc.contributor.authorCheung, CKY-
dc.contributor.authorChing, JYL-
dc.contributor.authorChan, Y-
dc.contributor.authorSung, JJY-
dc.contributor.authorChan, FKL-
dc.contributor.authorWu, JCY-
dc.date.accessioned2020-11-02T05:44:38Z-
dc.date.available2020-11-02T05:44:38Z-
dc.date.issued2018-
dc.identifier.citationThe Lancet Gastroenterology & Hepatology, 2018, v. 3 n. 12, p. 837-844-
dc.identifier.issn2468-1253-
dc.identifier.urihttp://hdl.handle.net/10722/290608-
dc.descriptionLink to Free access-
dc.description.abstractBackground: Guidelines recommend the use of neuromodulators in patients with functional dyspepsia not responding to proton pump inhibitors (PPIs) and prokinetics; however, there is a lack of data from randomised controlled trials supporting their use. We aimed to assess the safety and efficacy of imipramine, a tricyclic antidepressant (TCA), in treatment-refractory functional dyspepsia. Methods: In this single-centre, double-blind, randomised controlled trial, we enrolled consecutive patients with Rome II functional dyspepsia aged 18–80 years. Eligible patients were Helicobacter pylori-negative, had a normal upper gastrointestinal endoscopy and abdominal ultrasound, and remained symptomatic after open-label treatment with 8 weeks of esomeprazole and 4 weeks of domperidone. Patients completed questionnaires assessing dyspepsia symptoms, mood, and insomnia, and were then randomly assigned (1:1) via a computer-generated list of random numbers to receive imipramine (at a dose of 25 mg once nightly for the first 2 weeks, and then 50 mg thereafter) or placebo for 12 weeks. The primary endpoint was overall satisfactory relief of global dyspepsia symptoms at 12 weeks, via patient-reported assessment in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00164775, and is completed. Findings: Between Sept 11, 2005, and Aug 20, 2010, 107 patients with treatment-refractory functional dyspepsia were randomly assigned to receive imipramine (n=55) or placebo (n=52). Relief of global dyspepsia symptoms at 12 weeks occurred in 35 (63·6%, 95% CI 50·4–75·1) of 55 patients on imipramine compared with 19 (36·5%, 95% CI 24·8–50·1) of 52 on placebo (p=0·0051). Ten (18%) patients on imipramine discontinued the study due to adverse events (three dry mouth, two constipation, two drowsiness, and one each insomnia, palpitations, and blurred vision), compared with four (8%) on placebo (one dry mouth and constipation, and one each palpitations, worsening of gastro-oesophageal reflux, and limb paraesthesia). There were no serious adverse events. Interpretation: Low-dose imipramine should be considered as a possible therapy for patients with functional dyspepsia refractory to both PPIs and prokinetics, although patients should be cautioned about the adverse event profile. Funding: None. © 2018 Elsevier Ltd-
dc.languageeng-
dc.publisherElsevier: Lancet. The Journal's web site is located at http://www.sciencedirect.com/science/journal/24681253-
dc.relation.ispartofThe Lancet Gastroenterology & Hepatology-
dc.subjectadult-
dc.subjectaged-
dc.subjectanxiety-
dc.subjectbloating-
dc.subjectblurred vision-
dc.titleLow-dose imipramine for refractory functional dyspepsia: a randomised, double-blind, placebo-controlled trial-
dc.typeArticle-
dc.identifier.emailCheung, CKY: ckyc@hku.hk-
dc.description.naturelink_to_subscribed_fulltext-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/S2468-1253(18)30303-0-
dc.identifier.pmid30361080-
dc.identifier.scopuseid_2-s2.0-85055123449-
dc.identifier.hkuros318307-
dc.identifier.volume3-
dc.identifier.issue12-
dc.identifier.spage837-
dc.identifier.epage844-
dc.identifier.isiWOS:000450148900018-
dc.publisher.placeUnited States-
dc.identifier.issnl2468-1156-

Export via OAI-PMH Interface in XML Formats


OR


Export to Other Non-XML Formats