Safety and Efficacy of High-Dose Vitamin B6 as an Adjunctive Treatment for Antipsychotic-Induced Hyperprolactinemia in Male Patients With Treatment-Resistant Schizophrenia.
Level 2 - randomized trial
Randomized double-blind controlled trial
PubMed 34512411 · doi:10.3389/fpsyt.2021.681418
What was done
A 16-week randomized, double-blind controlled trial evaluated the efficacy and safety of high-dose vitamin B6 compared to aripiprazole for antipsychotic-induced hyperprolactinemia in 200 male patients with treatment-resistant schizophrenia. Participants were randomized (1:1) to receive either oral vitamin B6 (300 mg every 12 hours; n = 100) or aripiprazole (10 mg/day; n = 100). Evaluated outcomes included serum prolactin levels, psychiatric symptoms (PANSS), cognitive performance (MCCB), metabolic and organ function markers, and adverse secondary effects (TESS and Barnes-Akathisia scale).
What was found
Over 16 weeks, the vitamin B6 group achieved a 68.1% reduction in serum prolactin levels (decreasing from 95.52 ± 6.30 μg/L to 30.43 ± 18.65 μg/L), whereas the aripiprazole group achieved a 37.4% reduction (decreasing from 89.07 ± 3.59 μg/L to 55.78 ± 7.39 μg/L). Both arms had similar reductions during weeks 1–4, after which aripiprazole plateaued while vitamin B6 continued to lower prolactin. The vitamin B6 group also demonstrated greater improvements in psychotic symptoms and cognitive impairment. No serious adverse secondary effects occurred, and adverse secondary effects were more frequent in the aripiprazole group.
Why it matters
High-dose vitamin B6 may provide an effective adjunctive alternative to aripiprazole for managing antipsychotic-induced hyperprolactinemia, potentially improving symptom control and cognition with fewer adverse secondary effects.
Limits
The study included only male patients with treatment-resistant schizophrenia, limiting generalizability to females or other patient groups. The abstract omits numerical scores, effect sizes, and p-values for PANSS, MCCB, and specific adverse event rates, and observation was limited to 16 weeks.
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