Safety and efficacy of high-dose vitamin B6 for treating
antipsychotic-induced hyperprolactinemia in male patients with
treatment-resistant schizophrenia
Abstract
Background and Purpose: This study aimed to investigate the safety and
efficacy of high-dose vitamin B6 (vB6) for antipsychotic-induced
hyperprolactinemia (AIHP) treatment in male patients with
treatment-resistant schizophrenia (TRS). Experimental Approach: In this
randomized double-blinded controlled study, patients were randomized
(1:1) into a control group given aripiprazole (ARI; 10 mg/day) or an
intervention group given vB6 (300 mg/12 h for 16 weeks). Prolactin
level, psychotic symptoms [Positive and Negative Syndrome Scale
(PANSS)], cognitive function [MATRICS Consensus Cognitive Battery
(MCCB)], liver function, kidney function, growth hormone level,
micronutrient levels, blood lipids, and adverse secondary effects
(ASEs)[Treatment Emergent Symptom Scale (TESS) and Barnes-Akathisia
scale] were monitored. Key Results: After a 16-week treatment period,
the vB6 group showed a 68.1% reduction in serum prolactin levels (from
95.52 ± 6.30 μg/L to 30.43 ± 18.65 μg/L) while the ARI group showed only
a 37.4% reduction (from 89.07 ± 3.59 μg/L to 55.78 ± 7.39 μg/L). During
weeks 1–4, both treatments reduced prolactin similarly. Subsequently,
the ARI effect plateaued, while the vB6 effect remained robust. AIHP
reduction efficacy of vB6 was associated with baseline prolactin and
triglyceride levels, total vB6 dosage, and education level. Conclusion
and Implications: Compared with the ARI group, TRS patients given vB6
showed better attenuation of AIHP, lower ASE scores, and improvements in
clinical symptoms and cognitive impairments. These results support
further consideration of vB6 as a putative treatment for AIHP.