Proton-pump inhibitors for the treatment of functional dyspepsia

Abstract

In the Rome III classification, functional dyspepsia (FD) has been further subcategorized into two different syndromes, namely, epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS). Acid-related pathophysiology seems to be mainly responsible for EPS, and antisecretory agents such as proton-pump inhibitors (PPIs) seem to be effective mainly against EPS. However, recent information as to the relationship between initial duodenal acid sensitization in the early postprandial phase and delayed gastric emptying in the later postprandial phase would suggest the amelioration of PDS by antisecretory agents. In the present review, we summarized the recent literature on the direct and indirect effect of PPIs in FD (including not only Rome III, but also Rome II criteria). The effects of PPIs against FD are heterogeneous, depending on the protocol of the clinical studies, and the inclusion criteria of each randomized controlled trial (primary care or tertiary care population). As the placebo effects cannot be ignored in this disease, a placebo-controlled study would be necessary, at least for the evaluation of the effect of each agent on symptom relief in patients with FD. Further studies directly comparing PPIs with suitable placebos in terms of their effects in reducing the symptoms of endoscopically confirmed, Rome III-based FD are awaited.

Effect of lansoprazole on the epigastric symptoms of functional dyspepsia (ELF study): A multicentre, prospective, randomized, double‐blind, placebo‐controlled clinical trial

“…23 According to our previous systematic review, although significant improvements were shown in all observational studies for the efficacy of PPIs on FD symptoms, improvements in placebo-controlled studies were limited. 12 The placebo effect in the present cohorts was smaller than previously reported, 23 possibly due to the enrolment of FD patients only with moderate to severe symptoms recruited mainly from the tertiary care institute. In addition, our results showed that, in the placebo group, the scores for epigastric pain or burning scores were hardly improved, while the score for postprandial fullness or early satiety was remarkably improved.…”

“…7 Although several randomized placebo-controlled studies on the efficacy of PPIs for FD have been performed, [8][9][10][11] the results of these studies are controversial. 12 In addition, in a previous largescale study involving cohorts with uninvestigated dyspepsia, the possible inclusion of cohorts with peptic ulcer disease or reflux oesophagitis may have caused overestimation of the efficacy of anti-secretory agents such as PPIs. 13 Furthermore, double-blind, randomized, placebo-controlled trials to investigate the efficacy of PPIs for FD, but not for uninvestigated dyspepsia, using the Rome III criteria have been scarcely performed.…”

Medical and non‐medical predictors of initiating long‐term use of proton pump inhibitors: a nationwide cohort study of first‐time users during a 10‐year period

“…PPIs are highly effective in the treatment of gastro‐oesophageal reflux disease (GERD), but the most common cause of dyspepsia in primary care patients is functional dyspepsia, where the effect of PPIs is modest. Meta analyses have demonstrated a therapeutic gain of 7–10% and a number needed to treat of 14.6 for PPI treatment in patients with functional dyspepsia . Hence, frequently PPIs may be prescribed and continued for questionable reasons…”

Chinese herbal medicine for functional dyspepsia: systematic review of systematic reviews

“…For example, acotiamide has a number needed to treat (NNT) of 16 17 for symptom elimination, while the NNT figures of omeprazole and lansoprazole are 9. 18 The side effects of pharmacotherapy also trigger concerns among medical practitioners. Current evidence has shown its association with extra-pyramidal reactions, cardiac arrhythmia and neurological disorders, such as Parkinsonism.…”