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Clinical trial: a c...
Clinical trial: a controlled trial of baclofen add-on therapy in PPI-refractory gastro-oesophageal reflux symptoms
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Pauwels, A. (author)
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Raymenants, K. (author)
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Geeraerts, A. (author)
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Boecxstaens, V. (author)
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Masuy, I. (author)
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Broers, C. (author)
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Vanuytsel, T. (author)
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- Tack, Jan, 1962 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition
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(creator_code:org_t)
- 2022-06-03
- 2022
- English.
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In: Alimentary Pharmacology and Therapeutics. - : Wiley. - 0269-2813 .- 1365-2036. ; 56:2, s. 231-239
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Abstract
Subject headings
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- Background Proton pump inhibitors (PPI) have no effect on non-acid reflux events which can continue to provoke gastro-oesophageal reflux disease (GERD) symptoms. Baclofen, a gamma-aminobutyric acid agonist, can decrease non-acid reflux but its symptomatic benefit in refractory GERD symptoms is understudied. Aims To assess the efficacy of baclofen 10 mg t.i.d. vs placebo as add-on therapy in PPI-refractory GERD symptoms, in a randomised, double-blind, placebo-controlled study. Methods Patients with persisting typical GERD symptoms on b.i.d. PPI therapy were randomised to 4 weeks of baclofen 10 mg or placebo t.i.d. Before and after treatment, patients underwent 24 h impedance-pH monitoring on-PPI. Throughout the study, patients filled out ReQuest diaries. Data were analysed using mixed models. Results About 60 patients were included (age 47.5 years [range 19-73], 41f/19 m), 31 patients were randomised to baclofen. One patient withdrew consent and five in the baclofen group stopped treatment due to side effects. There was a trend towards a better response for general wellbeing in the baclofen-treated group compared to placebo (p = 0.06). When subdividing patients according to symptom association probability (SAP), only the SAP+ (n = 25) group improved significantly with baclofen (p(corr) = 0.02), and worsened with placebo (p(corr) = 0.008). The total number of reflux events decreased over time (p = 0.01), mainly due to the baclofen condition (p(corr) = 0.1). The number of reflux events with a high proximal extent dropped significantly after baclofen (p(corr) = 0.009), but not placebo. Conclusion Baclofen decreases several reflux parameters in PPI refractory GERD symptoms, but pH-impedance monitoring is necessary before treatment as only SAP+ patients experience clinical benefit after 4 weeks.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)
Keyword
- esophageal sphincter relaxations
- gaba(b) agonist baclofen
- arbaclofen
- placarbil
- double-blind
- acid reflux
- gerd
- hypersensitivity
- request(tm)
- perception
- mechanisms
- Gastroenterology & Hepatology
- Pharmacology & Pharmacy
Publication and Content Type
- ref (subject category)
- art (subject category)
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