Randomised clinical trial: the effects of pregabalin vs placebo on functional dyspepsia. Issue 8 (30th August 2021)

• Record Type: Journal Article
• Authors: Kotikula, Isariyaphong; Thinrungroj, Nithi; Pinyopornpanish, Kanokwan; Kijdamrongthum, Phuripong; Leerapun, Apinya; Chitapanarux, Taned; Thongsawat, Satawat; Praisontarangkul, Ong‐Ard
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 54:Issue 8(2021)
• Page Start: 1026
• Page End: 1032
• Publication Date: 2021-08-30
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.16588
• Languages: English
• ISSNs: 0269-2813

Abstract

Summary: Background: Currently, central neuromodulators are among the therapeutic options for the treatment of functional dyspepsia (FD). Pregabalin, a gabapentinoid, is a neuromodulator that could potentially improve visceral hypersensitivity in FD patients. Aim: To assess the efficacy and safety of pregabalin for the treatment of FD Methods: We performed a randomised placebo‐controlled study including FD patients who did not respond to proton pump inhibitors. Patients were randomly assigned to receive pregabalin (75 mg daily) or placebo for 8 weeks. The primary outcome was an adequate relief response rate. The secondary outcomes were improvement in quality of life, pain scores in divided categories, and safety profile. Results: Of 72 patients enrolled, 34 received pregabalin and 38 received placebo. The self‐reported adequate relief rates in the pregabalin and placebo groups were 70.6% and 42.1% at week 4 ( P = 0.02), and 70.6% and 44.7% at week 8 ( P = 0.03), respectively. The reduction in global symptoms in the pregabalin and placebo groups were 11.7 ± 10.6 and 3.7 ± 8.9 points at week 4 ( P < 0.01) and 15.1 ± 12.2 and 8.0 ± 10.2 points at week 8 ( P = 0.01), respectively. Pregabalin improved the overall quality of life ( P = 0.03). The most common adverse event with pregabalin was dizziness, occurring in 51.6% of patients. Conclusions: Pregabalin led to significant alleviation of dyspeptic symptoms, especially in patients with predominant epigastric pain . Thaiclinicaltrials.org #TCTR20200404002. Abstract : Pregabalin led to significant alleviation of dyspeptic symptoms. However, the concerning adverse effect was dizziness.