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


The treatment of FD remains unsatisfactory for many patients. Dietary advice is routinely provided although there are few data available to support clinicians' recommendations. Eradication of H. pylori improves dyspeptic symptoms in only 7% of patients treated (NNT = 14), while H2RAs are somewhat better, with a calculated NNT of 7. Prokinetic agents are theoretically appealing for FD patients with delayed gastric emptying. However, the results from studies of tegaserod, itopride and mosapride are unimpressive, and since the withdrawal of cisapride, only metoclopramide is currently available in the US; potentially serious side effects limit metoclopramide's use. Other promotility agents (e.g. domperidone) are available outside the U.S. Complementary agents are commonly used by patients for a number of reasons, including ease of use, the perceived safety compared to prescription pharmacological agents, and the perceived appeal of using a 'natural' substance as opposed to a prescription medication. STW-5 has demonstrated benefit in patients with FD, although the mechanism of action is unknown. Hypnotherapy is likely to improve global symptoms in FD patients, although well-trained hypnotherapists are difficult to find and most insurance companies will not pay for this form of therapy.

In the light of these limitations it is not surprising that no agent is approved for the treatment of FD. On the basis of the data contained in this review, a treatment algorithm for FD is proposed (see Figure 1). In areas with H. pylori prevalence >10% patients with a normal endoscopy (without gastric biopsies having been performed) should be tested for H. pylori using either a breath test or stool antigen test, and if positive, treated. Empiric treatment for H. pylori based only on symptoms is not recommended. After H. pylori treatment (assuming that H. pylori has been eradicated), the majority of FD patients will have persistent symptoms, and empiric therapy for 6–8 weeks with a once-daily PPI is reasonable. If symptoms persist then a low-dose TCA may be initiated (e.g. amitriptyline at 10 mg each day with slow escalation to 50 or 75 mg/day; alternatively desipramine at 10–50 mg q day). If symptoms persist, then a trial of a prokinetic agent is reasonable, especially if the patient has concomitant symptoms of nausea and/or postprandial fullness. Alternatively, other anti-nociceptive agents can be used, recognising the lack of evidence from prospective trials to guide clinical care. Finally, if the patient wishes to pursue alternative therapies, then STW-5 can be initiated or a referral to a hypnotherapist may be offered.

Figure 1.

Proposed treatment algorithm for FD. In this algorithm the patient with dyspepsia undergoes an upper endoscopy which, by definition, has to be grossly normal. If biopsies for Helicobacter pylori (HP) were performed and were negative (upper left corner) then the patient should be treated with a daily proton pump inhibitor (PPI). If symptoms (Sx) do not improve after 4–8 weeks, a therapeutic trial with a TCA should be initiated (the percentage of patients with FD symptom resolution is shown in parentheses). If upper endoscopy is grossly normal but gastric biopsies were not obtained for H. pylori, then the algorithm should begin with an assessment of H. pylori prevalence (upper right side). If present, H. pylori should be treated and the occasional patient with H. pylori will experience FD symptom resolution. If the patient is H. pylori-negative, then PPI therapy should be initiated (upper middle of diagram). The percentage of H. pylori-negative FD patients previously treated with a PPI and then a TCA, who will improve with an anti-nociceptive agent or CAM, is unknown. Therapeutic Gain (T.G.) refers to the reported symptom improvement rate above the placebo response (i.e. not including the placebo response). The overall Response Rate (R.R.) refers to the overall response rate which includes the placebo response. For example, on the right hand side of the diagram, the therapeutic gain (T.G.) of treating an FD patient who is H.P (+) has been reported as 6–14%. Alternatively, this portion of the figure could have been labelled using the overall response rate (R.R.) for FD symptom improvement in a patient treated for HP, which is approximately 31–39%, as this includes the placebo response rate which is approximately 25%.


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