BACKGROUND: Dyspepsia is a common primary care problem, but optimal management remains unclear. In the past decade, attempts have been made to distinguish subtypes of ulcer-like (nighttime epigastric pain), reflux-like (heartburn, regurgitation), and dysmotility-like (bloating, distention, flatulence, nausea) dyspepsia, but there is overlap among the categories. Also, 50% to 60% of dyspeptic patients fit no single pattern. The authors of this study attempted to define characteristics of patients with dyspepsia who responded to omeprazole.
POPULATION STUDIED: A total of 471 Danish primary care patients aged 18 to 65 years with ulcer-or gastroesophageal reflux (GERD)-like dyspepsia were enrolled. The protocol excluded patients with dysmotility and untypeable dyspepsia, patients with dysmotility and other types of dyspepsia, and those with a history of peptic ulcer disease, reflux esophagitis, alarm symptoms (weight loss, dysphagia, bloody or black stools, anemia, jaundice), or current nonsteroidal anti-inflammatory drug use. The average age was 42 years, with the patients evenly split by sex and smoking status. Approximately half (45%) had experienced symptoms for less than 1 month. On average the patients were slightly overweight, with an average body mass index of 24.6. Thirty-nine percent had used H2-blockers or antacids in the past month, and none had undergone endoscopy or laboratory investigations. Thus, though the clinical characteristics seem similar to patients presenting to family physicians in the United States, generalizations to all patients with dyspepsia should be cautious.
STUDY DESIGN AND VALIDITY: This study is a re-analysis of data from a randomized controlled trial of omeprazole for dyspepsia to determine a clinical prediction rule regarding which patients with dyspepsia will respond to therapy with omeprazole. Patients received omeprazole 20 mg or placebo daily for 2 weeks and were randomly divided into samples used to develop the decision rule (N=236) and to test the rule (n= 235). Logistic regression was used to identify the relationship between specific symptoms and complete response of symptoms to omeprazole. The authors then developed a rule for predicting which dyspeptic patients respond to omeprazole and validated it in the test sample.
OUTCOMES MEASURED: The major outcome was a list of symptoms associated with therapeutic response; these symptoms were used to develop a clinical decision rule to predict response to omeprazole. Patient satisfaction, adverse effects, and cost were not addressed.
RESULTS: High body mass index, nighttime pain, and recent antacid or H2-blocker use predicted a good response to omeprazole, while nausea predicted a poor response. The prediction rule incorporating these variables identified patients likely to respond to omeprazole (number needed to treat=2.6). Validity testing confirmed these findings.
This study provides good evidence that for patients with ulcer- or reflux-like dyspepsia, those with high body mass index, nighttime pain, absence of nausea, and recent antacid or H2-blocker use are more likely to respond to omeprazole 20 mg daily. Clinicians should keep in mind that the patients described in this study represent uninvestigated patients with ulcer- or GERD-like dyspepsia with new onset pain and that they may not be representative of all patients in primary care with dyspepsia. Despite this limitation, this study represents an important step forward in identifying characteristics of primary care patients with dyspepsia that predict response to therapy.