Forty-eight patients were from the Gastroenterology Department, First Affiliated Hospital of Zhejiang University and Red Cross Hospital of Hangzhou (26 men, 22 women, age range from 21 to 73 years, average 47 years). All patients did not receive antibiotics, bismuth, steroid and non-steroid drugs before their enrollment in the study. Hyperplastic gastric polyps (3-10 mm in diameter) were diagnosed on the basis of the examination results at least three histological samples. Patients were considered to have multiple gastric polyps (at least 5) when they were easily cut. Our criteria for hyperplastic gastric polyps included hyperplasia of the foveolar epithelium on histologic examination and infiltration of inflammatory cells into the stroma in biopsy specimens [7,8]. Hyperplastic gastric polyps were diagnosed by two blinded pathologists. Patients with adenomatous gastric polyps, Peutz-Jegher syndrome and juvenile polyps were excluded. The diagnosis of H pylori infection was based the positive results of staining with Giemsa and ¹⁴C-urea breath test. The patients were randomly assigned to two groups and sequentially numbered. In the treatment group (n = 24), patients received proton-pump inhibitor (omeprazole 20mg/d or lansoprazole 30 mg/d), clarithromycin (1g/d), bismuth citrate (440 mg/d) and tinidazole (1g/d), 2 weeks a course. In the control group (n = 24), patients had endoscopic examination and received protective agent of gastric mucosa (tepretone 150 mg/d). Two patients of the treatment group did not take the drugs for one course. In the control group, 2 patients lost follow-up and 1 patient took both proton-pump inhibitor and amoxicillin. These 5 patients exited from our study. If polyps progressed and were accompanied with malignant transformation, the study was stopped and the polyps were removed endoscopically. After completion of our study, endoscopic removal of polyps or eradication of H pylori was proposed for those who failed in H pylori eradication.

Patients in the treatment group underwent endoscopy every 3 months after the treatment. On each occasion, biopsy specimens were taken from the same areas (three from the antrum and three from the body) for histologic examination. If patients without eradication of H pylori were not adapted to endoscopic examination very well, controls underwent endoscopy every 3 months after enrollment. Biopsy specimens for histologic examination were stained with Giemsa and evaluated for the presence of H pylori. Histologic diagnosis of the biopsied mucosa of the antrum and body was made by two blinded pathologists. The severity of activity, inflammation, atrophy, and metaplasia was graded on a scale from 1 to 4 and expressed as the histologic index according to the updated Sydney System: 1: normal, 2: mild, 3: moderate, and 4: marked [9]. Eradication of H pylori was confirmed by the negative results of these two tests 1-3 months after the treatment and endoscopic examination. The size and number of polyps were measured at each endoscopic examination using biopsy forceps (GIF XQ240 or GIF140, Olympus) placed near the polyp (open size: 6 mm in diameter; closed size: 2 mm in diameter). The endoscopic data on the disappearance and regression of polyps were reviewed independently by two blinded endoscopists.

All data were analyzed by unpaired t test (for age), Wilcoxon rank-sum test and Fisher’s exact test. P < 0.05 was considered statistically significant. All data were coordinated by SPSS RDS and statistical analyses were done by SPSS software.

Twenty-two patients in the treatment group and 21 patients in the control group completed the entire study. The two groups were similar with respect to the number, age, sex, coexisting disease, as well as the number, size and distribution of polyps, histologic findings (Table 1). The two groups were comparable.

In the treatment group, H pylori was eradicated without serious side effects in 19 of 22 patients (86.3% [95% CI, 63%-99%]), and polyps disappeared in 15 of 22 patients (68.2% [95% CI, 54%-91%]) 1-12 months after treatment (Figure 1). Hyperplastic gastric polyps in the other 4 patients with successful H pylori eradication regressed to a certain extent, decreasing in size or number. However, in the remaining 3 patients without H pylori eradication, no polyps showed regression and no diminution of inflammation in the gastric mucosa 12 months after the treatment. In the control group, all patients showed no change of H pylori infection (0% [95% CI, 0%-21%]), no hyperplastic gastric polyp regression or disappearance (0% [95% CI, 0%-21%]) and no significant diminution of inflammation (Table 2). Polyps were enlarged or increased in number in 5 of the 21 patients. The rates of eradication of H pylori and disappearance of polyps in the treatment group were significantly higher than those in the control group (P < 0.01).

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Figure 1 Effect of drug treatment on hyperplastic gastric polyps infected with H pyori. A and B: Multiple gastric polyps of the antrum and body; C: Decreased size of gastric polyps 7 mo after treatment; D and E: Disappearance of gastric polyps 11 mo after treatment.