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Can vitamin B6 alleviate the adverse reactions of quadruple anti-Helicobacter pylori regimen? : randomized controlled trial.

  • 2023-09-11
  • BMC infectious diseases 23(1)
    • Meng-Yan Cui
    • Meng-Jie Zhang
    • Qiao-Li Jiang
    • Zhong-Mei Pei
    • Zhen-Yu Cui
    • Mei Kang
    • Lun-Gen Lu
    • Ying-Ying Lu

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 280
Population
280 patients with H. pylori infection
Methods
randomized controlled trial; patients randomly placed into one of two treatment groups—the conventional treatment group and the vitamin B6 supplement treatment group—for 2 weeks
Duration
2 weeks
Funding
Unclear
  • Large Human Trial

Background

Vitamin B6 is an essential water-soluble vitamin for humans. It is often used to prevent a variety of neuropathies, relieve vomiting, and relieve symptoms such as hand and foot neuritis.

Aim

To evaluate whether vitamin B6 can alleviate the adverse reactions caused by the quadruple anti-Helicobacter pylori treatment regimen containing minocycline and metronidazole.

Methods

In this randomized controlled trial, 280 patients with H. pylori infection were randomly placed into one of two treatment groups-the conventional treatment group and the vitamin B6 supplement treatment group-for 2 weeks. The primary endpoint was the total incidence of adverse reactions up to 2 weeks after treatment initiation. The study was designed according to CONSORT Medicinal Interventions. And it was registered with Chinese Clinical Trial Registry under the number ChiCTR2100053833.

Results

In terms of efficacy, vitamin B6 does not affect the efficacy of conventional regimen. In the vitamin B6 supplement treatment group, the incidence of adverse reactions was 56.92%, which was significantly lower than the 74.62% observed in the conventional treatment group. In addition, the severity of adverse reactions was also significantly reduced. The proportion of moderate to severe central nervous system symptoms decreased from 58.7 to 14.63%. And, the proportion of moderate to severe gastrointestinal reactions decreased from 33.33 to 0%. We speculate that the mechanism of vitamin B6 of reducing adverse reaction may be related to the production of GABA in the brain.

Conclusions

Vitamin B6 can alleviate adverse reactions of the quadruple anti-H. pylori regimen containing minocycline and metronidazole.

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