Randomised Clinical Trial

Randomised Clinical Trial: The Effects of Pregabalin vs Placebo on Functional Dyspepsia

Isariyaphong Kotikula; Nithi Thinrungroj; Kanokwan Pinyopornpanish; Phuripong Kijdamrongthum; Apinya Leerapun; Taned Chitapanarux; Satawat Thongsawat; Ong-Ard Praisontarangkul


Aliment Pharmacol Ther. 2021;54(8):1026-1032. 

In This Article

Abstract and Introduction


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.


Functional dyspepsia (FD) is a common disease worldwide, with the prevalence varying between 10% and 16%.[1,2] This disease can be categorised into epigastric pain syndrome (EPS) characterised by epigastric pain or burning, and post-prandial distress syndrome (PDS) characterised by early satiety or post-prandial fullness without other unexplained organic causes. Although FD does not increase morbidity and mortality, it significantly affects the patient's quality of life, work performance and utilisation of medical resources.[3,4]

The efficacy of the proton pump inhibitor (PPI) treatment is between 30%-50% in FD patients, compared to a 10%-20% response rate in a placebo treatment group.[5–8] Therefore, alternative treatments for patients who fail to respond to PPI are needed and are currently under-investigated. These treatments include prokinetics,[9,10] neuromodulators[11,12] or anxiolytics.[13,14]

Pregabalin is a second-generation gabapentinoid drug acting on α2–δ calcium channel subunit ligands. Compared to gabapentin, pregabalin has a better pharmacokinetic profile, relatively higher potency and fewer side effects.[15] This drug has an established role in the treatment of neuropathic pain and generalised anxiety disorder. Delta ligand agents have been recommended for use in functional GI disorders with limited supporting evidence.[16,17] To the best of our knowledge, there have been no randomised controlled trials evaluating the efficacy of pregabalin in FD patients. Therefore, we conducted a randomised, double-blind, placebo-controlled trial aimed to evaluate the efficacy and safety profile of pregabalin in FD patients who had an incomplete response to PPI therapy.