This trial was conducted to assess the potential of Vitamin B6 in alleviating the side effects induced by the quadruple anti-Helicobacter pylori (H. pylori) therapeutic regimen, which includes Minocycline and Metronidazole.

In this randomized controlled trial, a total of 280 individuals diagnosed with H. pylori infection were randomized to either the standard treatment group or the group receiving Vitamin B6 supplements for a duration of two weeks. The major outcome measured was the overall occurrence of adverse reactions within two weeks of commencing treatment. The study adhered to the CONSORT Medicinal Interventions guidelines.

Vitamin B6 displayed no impact on the effectiveness of the standard therapeutic regimen. Notably, in the group receiving Vitamin B6 supplements, the occurrence of adverse reactions amounted to 56.92%, substantially reduced than the 74.62% observed in the standard treatment group. Furthermore, the severity of these reactions markedly decreased.

The percentage of moderate to severe central nervous system symptoms dropped from 58.7% to 14.63%. On the other hand, moderate to severe gastrointestinal reactions dropped from 33.33% to 0%. The hypothesis suggests that the mechanism through which Vitamin B6 reduces adverse reactions may be linked to its role in gamma-aminobutyric acid (GABA) production within the brain.

Vitamin B6 was promising in reducing adverse reactions when combined with Minocycline and Metronidazole in the quadruple anti-H. pylori regimen.