Review Article: Current Treatment Options and Management of Functional Dyspepsia

B. E. Lacy; N. J. Talley; G. R. Locke III; E. P. Bouras; J. K. DiBaise; H. B. El-Serag; B. P. Abraham; C. W. Howden; P. Moayyedi; C. Prather


Aliment Pharmacol Ther. 2012;36(1):3-15. 

In This Article

Abstract and Introduction


Background Functional dyspepsia (FD), a common functional gastrointestinal disorder, is defined by the Rome III criteria as symptoms of epigastric pain or discomfort (prevalence in FD of 89–90%), postprandial fullness (75–88%), and early satiety (50–82%) within the last 3 months with symptom onset at least 6 months earlier. Patients cannot have any evidence of structural disease to explain symptoms and predominant symptoms of gastroesophageal reflux are exclusionary. Symptoms of FD are non-specific and the pathophysiology is diverse, which explains in part why a universally effective treatment for FD remains elusive.
Aim To present current management options for the treatment of FD (therapeutic gain/response rate noted when available).
Results The utility of Helicobacter pylori eradication for the treatment of FD is modest (6–14% therapeutic gain), while the therapeutic efficacy of proton pump inhibitors (PPI) (7–10% therapeutic gain), histamine-type-2-receptor antagonists (8–35% therapeutic gain), prokinetic agents (18–45%), tricyclic antidepressants (TCA) (response rates of 64–70%), serotonin reuptake inhibitors (no better than placebo) is limited and hampered by inadequate data. This review discusses dietary interventions and analyses studies involving complementary and alternative medications, and psychological therapies.
Conclusions A reasonable treatment approach based on current evidence is to initiate therapy with a daily PPI in H. pylori-negative FD patients. If symptoms persist, a therapeutic trial with a tricyclic antidepressant may be initiated. If symptoms continue, the clinician can possibly initiate therapy with an anti-nociceptive agent, a prokinetic agent, or some form of complementary and alternative medications, although evidence from prospective studies to support this approach is limited.


Healthcare providers of all specialties routinely evaluate patients for symptoms of dyspepsia. The prevalence of dyspepsia in the general population has been estimated to be 20–40% and the majority of these patients are believed to have FD.[1] A systematic review found that the prevalence of FD (after normal upper endoscopy) is 12–15%,[2] while the incidence of dyspepsia (most of whom have FD) has been calculated at <1% over 3 months to up to 2.8% per year.[3,4] The natural history of FD has not been well characterised, although the limited available data suggest that approximately 50% of patients remain symptomatic over a 5-year follow-up period.[2]

Functional dyspepsia, defined by Rome III criteria, is the presence of symptoms thought to originate in the gastroduodenal region in the absence of any organic, systemic, or metabolic disease likely to explain the symptoms.[5] In their recent guidelines, the Rome committee introduced two new subcategories for FD - postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS; see Table 1). Recent studies have shown that these two subcategories accurately reflect clinical patients.[6,7] Epigastric pain or discomfort is the hallmark symptom in patients with FD. The word discomfort is important to emphasise, as many patients will not complain of pain, but rather state that they have burning, pressure or fullness in the epigastric area, or cannot finish a normal-sized meal (early satiety). Other common symptoms that occur in FD patients include post prandial nausea, belching and abdominal bloating. Frustratingly, symptoms of FD do not consistently predict underlying pathophysiology and do not reliably guide therapy.[8–10]

Functional dyspepsia markedly reduces patients' quality of life and imparts a significant economic burden to the healthcare system.[11] This reduction in quality of life is similar to that experienced by patients with mild heart failure and menopause.[12] Interestingly, a lower quality of life is in itself an independent risk factor for developing dyspepsia (odds ratio = 2.63; 99% CI 1.86–3.71; 4). The economic impact of FD should not be underestimated. Analysing data from the Leeds UK HELP (Helicobacter pylori eradication in general practice) study, the costs of evaluating and treating dyspepsia were estimated to be 1 billion pounds per year.[12] A recent retrospective analysis of health insurance claims of over 275 000 US employees determined that FD patients incurred costs that were $5138 greater than employees without FD.[13]

The treatment of FD can be confusing to healthcare providers because no medication is currently approved in the US, Canada or the European Union for the treatment of FD. However, recent clinical trials have provided new information on the management of FD.[14] The purpose of this narrative review is to evaluate treatment options available for FD patients and provide recommendations using the most recent data from the literature.


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