Current issues of ACP Journal Club are published in Annals of Internal Medicine


Therapeutics

Antibacterial therapy was as effective as omeprazole for Helicobacter pylori-associated gastric ulcers

ACP J Club. 1995 May-June;122:68. doi:10.7326/ACPJC-1995-122-3-068


Source Citation

Sung JJ, Chung SC, Ling TK, et al. Antibacterial treatment of gastric ulcers associated with Helicobacter pylori. N Engl J Med. 1995 Jan 19; 332:139-42.


Abstract

Objective

To evaluate the effectiveness of antibacterial therapy (without medication to suppress gastric acid) for the treatment of patients with Helicobacter pylori infection and gastric ulcers unrelated to the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Design

Randomized controlled trial with 9-week follow-up.

Setting

Prince of Wales Hospital, Hong Kong.

Patients

100 patients (mean age, 56 y; 73 men) presenting to the hospital with dys-pepsia or epigastric pain who were found to have gastric ulcer by endoscopy and H. pylori infection confirmed by smear or culture. Exclusion criteria were age < 16 years, use of NSAIDs in the previous 3 months, gastrointestinal bleeding within the previous 4 weeks, previous surgery to reduce gastric acid, or previous receipt of antibacterial therapy. 85 patients completed the trial.

Intervention

54 patients were assigned to receive bismuth subcitrate, 120 mg, tetracycline, 500 mg, and metronidazole, 400 mg, orally 4 times daily for 1 week. 46 patients were assigned to receive omeprazole, 20 mg/d, orally for 4 weeks.

Main Outcome Measures

H. pylori eradication, gastric ulcer healing, and symptoms.

Main Results

After 5 weeks, H. pylori was eradicated in 91.1% of patients who received antibacterial therapy compared with 12.5% of those who received omeprazole {95% CI for the 78.6% absolute risk improvement [ARI], 65.4% to 91.8%; P < 0.001; relative risk improvement, 629%; number needed to treat, 1; CI, 1 to 2}*. Endoscopy at 5 weeks showed complete healing of the ulcers in 84.4% of patients in the antibacterial group compared with 72.5% in the omeprazole group {95% CI for the 11.9% ARI, -5.5% to 29.4%; P = 0.18}*. At 9 weeks, the ulcers had completely healed in 95.6% of the patients who received antibacterial therapy compared with 94.9% of those who received omeprazole (P = 1.0). The mean duration of epigastric pain during the first week of treatment was longer in the antibacterial group than in the omeprazole group (3.6 vs. 1.9 days; P = 0.004). The duration of pain from week 2 to week 5 did not differ between the 2 groups.

Conclusion

In patients with Helicobacter pylori infection and gastric ulcers unrelated to the use of nonsteroidal anti-inflammatory drugs, 1 week of antibacterial therapy without acid suppression is as effective as 4 weeks of omeprazole therapy in healing gastric ulcers.

Source of funding: Research Grant Committee of Hong Kong.

For article reprint: Dr. J.J. Sung, Department of Medicine, Prince of Wales Hospital, Shatin, Hong Kong. FAX 852-637-3852.

*Numbers calculated from data in article.


Commentary

H. pylori has challenged the pivotal role of gastric acid in peptic ulcer disease. In response to unequivocal evidence that H. pylori eradication drastically reduces ulcer recurrence, an NIH Consensus Conference concluded that "ulcer patients with H. pylori infection require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation with the illness or on recurrence" (1). Sung and colleagues question the use of antisecretory agents in managing gastric ulcer disease. These same investigators used antibiotic therapy to heal duodenal ulcers without acid suppression (2).

Is acid suppression for peptic ulcer disease an outdated therapy? Some limitations of this study restrict the application of its findings to all patients with ulcers who are seen in clinical practice. The ulcers studied were small (mean size, 8 mm) and not associated with bleeding and therefore represented a subset of clinical ulcer disease. Despite the efficacy reported with 1 week of antibacterial therapy, most investigators have reported that 2 weeks of therapy are required to eliminate the infection. In clinical practice, the drop-out rate (10% in this study) caused by antibacterial side effects may be much higher, and adherence to antibiotic regimens is critical to eliminate the infection.

Healing a peptic ulcer and preventing recurrence without acid suppression is a remarkable achievement that strongly supports the role of H. pylori in ulcerogenesis. Ulcers caused by NSAIDs, the other major risk factor for ulcer disease, develop by mechanisms independent of H. pylori and require antisecretory therapy (3). Because the recurrence of H. pylori is approximately 1%/y, freedom from the ulcer diathesis (in the absence of NSAID use) is expected after the infection is eradicated. In all patients with H. pylori infection and ulcer disease, the infection should be eliminated. Antisecretory drugs are needed during antibacterial therapy to ensure ulcer healing (in the event of failure to eradicate H. pylori) and to control ulcer symptoms.

James Scheiman, MD
The University of Michigan Medical Center Ann Arbor, Michigan