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- Publisher Website: 10.1016/S2468-1253(18)30303-0
- Scopus: eid_2-s2.0-85055123449
- PMID: 30361080
- WOS: WOS:000450148900018
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Article: Low-dose imipramine for refractory functional dyspepsia: a randomised, double-blind, placebo-controlled trial
Title | Low-dose imipramine for refractory functional dyspepsia: a randomised, double-blind, placebo-controlled trial |
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Authors | |
Keywords | adult aged anxiety bloating blurred vision |
Issue Date | 2018 |
Publisher | Elsevier: 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? |
Abstract | Background: 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 |
Description | Link to Free access |
Persistent Identifier | http://hdl.handle.net/10722/290608 |
ISSN | 2023 Impact Factor: 30.9 2023 SCImago Journal Rankings: 8.957 |
ISI Accession Number ID |
DC Field | Value | Language |
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dc.contributor.author | Cheong, PK | - |
dc.contributor.author | Ford, AC | - |
dc.contributor.author | Cheung, CKY | - |
dc.contributor.author | Ching, JYL | - |
dc.contributor.author | Chan, Y | - |
dc.contributor.author | Sung, JJY | - |
dc.contributor.author | Chan, FKL | - |
dc.contributor.author | Wu, JCY | - |
dc.date.accessioned | 2020-11-02T05:44:38Z | - |
dc.date.available | 2020-11-02T05:44:38Z | - |
dc.date.issued | 2018 | - |
dc.identifier.citation | The Lancet Gastroenterology & Hepatology, 2018, v. 3 n. 12, p. 837-844 | - |
dc.identifier.issn | 2468-1253 | - |
dc.identifier.uri | http://hdl.handle.net/10722/290608 | - |
dc.description | Link to Free access | - |
dc.description.abstract | Background: 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.language | eng | - |
dc.publisher | Elsevier: Lancet. The Journal's web site is located at http://www.sciencedirect.com/science/journal/24681253 | - |
dc.relation.ispartof | The Lancet Gastroenterology & Hepatology | - |
dc.subject | adult | - |
dc.subject | aged | - |
dc.subject | anxiety | - |
dc.subject | bloating | - |
dc.subject | blurred vision | - |
dc.title | Low-dose imipramine for refractory functional dyspepsia: a randomised, double-blind, placebo-controlled trial | - |
dc.type | Article | - |
dc.identifier.email | Cheung, CKY: ckyc@hku.hk | - |
dc.description.nature | link_to_subscribed_fulltext | - |
dc.description.nature | link_to_subscribed_fulltext | - |
dc.identifier.doi | 10.1016/S2468-1253(18)30303-0 | - |
dc.identifier.pmid | 30361080 | - |
dc.identifier.scopus | eid_2-s2.0-85055123449 | - |
dc.identifier.hkuros | 318307 | - |
dc.identifier.volume | 3 | - |
dc.identifier.issue | 12 | - |
dc.identifier.spage | 837 | - |
dc.identifier.epage | 844 | - |
dc.identifier.isi | WOS:000450148900018 | - |
dc.publisher.place | United States | - |
dc.identifier.issnl | 2468-1156 | - |