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High Effective of 14-Day High-Dose PPI- Bismuth-Containing Quadruple Therapy with Probiotics Supplement for Helicobacter Pylori Eradication: A Double Blinded-Randomized Placebo-Controlled Study

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This double-blind randomized trial in 100 Thai adults compared 7-day and 14-day bismuth-containing quadruple therapy for Helicobacter pylori, each with a Lactobacillus reuteri probiotic or placebo. Each patient took 1,048 mg of bismuth subsalicylate twice daily alongside three other drugs. The 14-day regimen with probiotic cured 96 percent of patients, and adding the probiotic lowered nausea and vomiting, abdominal discomfort and bitter taste in the 14-day arms.

Key numbers

  • Bismuth dose: bismuth subsalicylate 1,048 mg orally twice daily after meals, with metronidazole, tetracycline and dexlansoprazole, for 7 or 14 days (p. 2860).
  • Eradication with probiotic: 68% (7-day) versus 96% (14-day), p = 0.027 (p. 2860, Figure 1).
  • 14-day arms, probiotic versus placebo: nausea and vomiting 6% versus 26% (p = 0.002), abdominal discomfort 4% versus 18% (p = 0.017), bitter taste 4% versus 26% (p = 0.001) (Table 4, p. 2862).
  • Black stool is listed among common adverse events of these regimens, but Table 4 gives no rate for it (p. 2861).
  • Antibiotic resistance among 68 tested strains: clarithromycin 15.6%, metronidazole 34.1% (p. 2860).

Methods (brief)

Patients with non-ulcer dyspepsia and confirmed H. pylori were randomized by computer-generated list to four arms (7 or 14 days, probiotic or placebo), 25 per arm. Eradication was judged by 13C-urea breath test at least 4 weeks after treatment. Adverse events were collected by questionnaire and interview. CYP2C19 genotype and antibiotic susceptibility were also determined.

Evidence fitness

The trial documents a medicinal bismuth dose given to adults and the adverse-event profile of a four-drug regimen containing bismuth. It does not support conclusions about bismuth toxicity on its own, because every arm received bismuth with antibiotics and a proton pump inhibitor, and no bismuth-free comparison or bismuth blood levels were included. It provides no information on dietary bismuth.

Limitations

Small arms of 25 patients; adverse events self-reported; bismuth was not measured in blood or urine. Adverse effects cannot be separated between bismuth and the other drugs. The discussion’s list of bismuth side effects (nausea, vomiting, numbness, metallic taste, black stool) draws on earlier work.

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