Although participating PCPs knew they were involved in a study concerning their behavior in treating dyspepsia, they did not know the study’s goal: to determine the rate at which they had prescribed eradication therapy to dyspeptic patients. Physicians were given personal computers as an incentive to participate in the study.
All computers were linked to a central server, located in the epidemiology laboratory of Tor Vergata University of Rome, to which all data were transferred weekly. Each patient was identified by a code number assigned by the attending physician.
The physicians who agreed to participate in the study were stratified according to the following geographic criteria. Approximately one half were in the north of Italy and the other half were in the south. Within each of these areas, approximately one half of participating PCPs worked in cities with 100,000 inhabitants or fewer and the other half in towns with more than 100,000 inhabitants. Forty PCPs were randomly excluded from the study to avoid overrepresentation of certain areas of the country, particularly large cities. Therefore, the data in our study refer to a total of 80 PCPs. The age range of participating physicians was 32 years to 63 years; 61 were men; and all had been practicing PCPs for at least 5 years (range: 5 years to 36 years). Eight PCPs were specialists: 6 in internal medicine, 1 in gynecology, and 1 in rheumatology.
A definitive diagnosis of peptic ulcer was based on findings obtained by the reference standard examination (upper gastrointestinal endoscopy for the definitive diagnosis of PUD) or by a combination of findings (a definitive diagnosis of NUD required normal findings at upper gastrointestinal endoscopy and abdominal sonography). In the other cases, the diagnosis was considered presumptive.
Therapy
We considered the combination therapies most frequently evaluated in clinical trials: bismuth-based triple therapy (bismuth plus metronidazole and tetracycline; bismuth plus clarithromycin and tetracycline; bismuth plus clarithromycin and amoxicillin; bismuth plus metronidazole and amoxicillin11,12); proton pump inhibitor (PPI)–based triple therapy (PPI plus 2 of the following: amoxicillin, clarithromycin, or metronidazole13); PPI-based dual therapy (PPI plus amoxicillin or clarithromycin or metronidazole14); and others (none of the former).
Statistical analysis
The chi-squared test was used to compare the frequency of discrete variables. A P value of less than .05 was required for statistical significance. Statistical Package for the Social Sciences software was used for the evaluation of significance.
Results
PUD was diagnosed in 2162 patients (1412 men, average age = 45 ± 15.8 years). NUD was diagnosed in 4704 patients (1328 men, average age = 42 ± 13.2 years). Among the 2162 patients with PUD, eradication therapy was prescribed for 481. However, since 115 of the 2162 patients had received such therapy before entering the study, the total number of patients who received antibiotic therapy was 596 (27.6%). Other treatments (mostly H2-receptor antagonists or PPIs) were prescribed to the remaining 1566 patients with PUD.
Eradication therapy was given to 94 (2%) of 4704 patients diagnosed with NUD (17 patients had received treatment before 1998). Table 1 shows that eradication therapy was prescribed more frequently for patients with PUD than for those with NUD (27.6% vs 2%; P = .0001).
Among patients with PUD, eradication therapy was prescribed more frequently for those with a definitive diagnosis than for those with a presumptive diagnosis (37.7% vs 20.3%, respectively; P < .0001), but the reverse was observed in NUD patients (0.9% vs 2.2%; P = .025) (Table 2). The latter difference is of uncertain clinical significance.
Of 904 patients with a definitive diagnosis of PUD, 223 had a newly diagnosed peptic ulcer; 97 (43.5%) of these were treated with eradication therapy. We observed no change in the percentage of patients with PUD receiving eradication therapy during the study period: 220 of 1005 (22%) during the first year and 261 out of 1157 (22.6%) during the second year.
Of the 80 PCPs, 72 prescribed some kind of eradication therapy. Seven of the 8 physicians who had never prescribed eradication therapy were living in small towns in the south of Italy. Other characteristics of the nonprescribers, such as age and sex, were similar to those of the remaining physicians.
Of 690 patients who received eradication therapy, the type of combination was known for 558. The combination regimen used for the 132 patients treated before the study began was not available. Of 558 patients, 301 (54%) were given PPI-based dual therapy and 225 (40.3%) received PPI-based triple therapy. Other treatments were prescribed to 32 (5.7%) patients (Table 3).
Among patients in whom dual therapy was prescribed, PPI plus clarithromycin was used in 242 patients (43.4% of the total population of treated patients; 80.4% of the subgroup receiving dual therapy). The combination of PPI, clarithromycin, and metronidazole was the most widely used treatment in patients who received triple therapy: it was prescribed to 192 patients (34.4% of all treated patients; 85.3% of the subgroup given PPI-based triple therapy).