Randomised clinical trial: the effects of pregabalin vs placebo on functional dyspepsia.

Abstract

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.

• Authors: Isariyaphong Kotikula, Nithi Thinrungroj, Kanokwan Pinyopornpanish, Phuripong Kijdamrongthum, Apinya Leerapun, Taned Chitapanarux, Satawat Thongsawat, Ong-Ard Praisontarangkul
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 54 Issue 8 Pg. 1026-1032 (10 2021) ISSN: 1365-2036 [Electronic] England
• PMID: 34460973 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2021 John Wiley & Sons Ltd.

Chemical References

• Proton Pump Inhibitors
• Pregabalin

Topics

• Double-Blind Method
• Dyspepsia (drug therapy)
• Humans
• Pain
• Pregabalin (adverse effects)
• Proton Pump Inhibitors
• Quality of Life
• Treatment Outcome