Table 1

Frequency of demographic, serological, and medical characteristics in enrolled subjects who completed the study (n = 248)a

No serious adverse effects of treatment were reported. Minor side effects were common (40.6% overall), but only dysgeusia was more prevalent among treatment compared with placebo subjects (78% vs. 30%; P ≤ 0.001). Compliance with treatment was very high (93% overall).

Placebo (n = 126)Treatment (n = 122)Pb
Age (mean ± SD), years52.0 ± 9.7651.0 ± 9.220.40
Female gender, n (%)79 (62.7)78 (63.9)0.84
CagA antibody, n (%)
 Positive123 (97.6)116 (95.1)0.33
 Borderline3 (2.4)6 (4.9)
Diabetic
 Yes10 (7.9)6 (4.9)0.72
 Unknown1 (0.8)1 (0.8)
Smoking history
 None75 (59.5)67 (54.9)0.80
 Former32 (25.4)37 (30.3)
 Occasional14 (11.1)12 (9.8)
 Regular5 (4.0)6 (4.9)
History of vitamin use,c n (%)
 None28 (22.2)25 (20.5)0.88
 Former27 (21.4)24 (19.7)
 Occasional67 (53.2)67 (54.9)
 Regular4 (3.2)6 (4.9)
History of alcohol use, n (%)
 None17 (13.5)19 (15.6)0.59
 Former22 (17.5)21 (17.2)
 Occasional83 (65.9)74 (60.7)
 Regular4 (3.2)8 (6.6)
Known family history of gastric cancer, n (%)12 (9.5)7 (5.7)0.43
  • a Sixty-eight enrolled subjects who withdrew were not different from those who completed the study.

  • b t Test, χ2 test, or Fisher’s exact test, as appropriate.

  • c Dietary components other than vitamin use and alcohol consumption were not assessed.