Clinical Question: Is a one-day treatment of Helicobacter pylori as effective as a seven-day regimen in patients with dyspepsia?
Setting: Outpatient (any)
Study Design: Randomized controlled trial (nonblinded)
Synopsis: The researchers recruited 160 adult patients with dyspepsia who scored 3 or higher (of a possible 20) on the Glasgow Dyspepsia Severity Score (GDSS) and had a positive urea breath test, signifying the presence of H. pylori. Patients were randomized to receive a four-drug cocktail for one day or treatment with three drugs for seven days. Allocation may not have been concealed from the enrolling researcher (patients randomized to receive the seven-day treatment were an average of seven years older than the other patients and less likely to smoke).
The one-day regimen consisted of two 262-mg tablets of bismuth subsalicylate, 500 mg of metronidazole, and 2 g of amoxicillin (suspension). The “cocktail” was taken four times during the course of the day, along with a one-time dose of 60 mg of lansoprazole. The control group took 500 mg of clarithromycin, 1 g of amoxicillin, and 30 mg of lansoprazole twice daily for seven days.
Five weeks after treatment started, the urea breath test was readministered to the 150 patients who returned. Eradication rates were similar in the two groups: 95 percent in the one-day group, and 90 percent in the seven-day group. Treatment success rates also were similar between the two groups: the GDSS dropped an average of 7.5 points in both groups (from a baseline of 7 to 11). Side effects were tallied at the five-week follow-up rather than during or immediately after treatment and may not be accurate.
Bottom Line: A four-drug, single-day treatment was as effective as seven days of treatment with three drugs in eradicating H. pylori and symptoms in patients with H. pylori-positive dyspepsia. (Level of Evidence: 1b)