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

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.

British Society of Gastroenterology guidelines on the management of functional dyspepsia

“…Our literature search identified 1381 citations, of which 11 were incorporated into this guideline, [186][187][188][189][190][191][192][193][194][195][196] and used to update meta-analyses. Agreement between reviewers for study eligibility was excellent (kappa statistic=0.90).…”

Letter: a randomised clinical trial comparing the effects of pregabalin with those of placebo on functional dyspepsia. Authors’ reply

“…We appreciate the interest of Dr Chen and colleagues in our research 1 . In their letter, they highlight important issues regarding our recent work, with which we agree.…”

“…The authors' declarations of personal and financial interests are unchanged from those in the original article 1 .…”

Neuromodulators for Functional Dyspepsia-A Gut-Brain Interaction Disorder: Uptodate Clinical Practice

“…Failure of PPIs to control symptoms after 8 weeks of therapy is an indication for other drugs such as neuromodulators (antidepressants, antipsychotics, and other central nervous system-targeted medications). For EPS, only tricyclic antidepressants such as amitriptyline, but not escitalopram, are effective drugs [21][22][23] and for EDS prokinetics with demonstrable benefits such as cisapride, metochloropramide, and anti-anxiety drugs such as buspirone, for nausea antiemetics [17,18]. Of the psychotropic drugs, only antipsychotics and tricyclic antidepressants may be effective treatments for FD [24].…”

“…Another recent study showed that pregabalin, a central neuromodulator, a gabapentinoid, improves visceral hypersensitivity and quality of life in patients with FD [20]. However, further studies should be performed, including FD subtypes, patients with overlapping symptoms, and a range of doses to identify the optimal one [21]. In summary, prokinetics and antidepressants, such as amitryptiline, are recommended in patients with PPI-refractory FD.…”