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This single-arm, prospective, multi-center, open-label, non-interventional, observational study was carried out to examine the safety and efficacy of fixed-dose combination of high-dose vitamins for peripheral neuropathy in the Indonesian population.
For the management of peripheral neuropathy of diverse etiologies, fixed-dose combination of vitamin B1 (100 mg), B6 (100 mg) and B12 (5000 mcg) is efficacious, well-tolerated, improves symptoms, and boosts quality of life.
This single-arm, prospective, multi-center, open-label, non-interventional, observational study was carried out to examine the safety and efficacy of fixed-dose combination of high-dose vitamins for peripheral neuropathy in the Indonesian population.
This 12-week study comprised 411 participants who had mild to moderate peripheral neuropathy due to a variety of etiologies. A participant was deemed to have "completed" the study if all the study requirements were met up until visit 3 (1 month of therapy). Clinical outcomes at 12 weeks as well as procedural findings were described.
Within fourteen days of treatment, those who received a combination of vitamins B1, B6, and B12 illustrated remarkable improvements in their overall Total Symptom Score (TSS). Individual TSS components were successfully decreased from baseline to Visit 5 by the treatment.
At the conclusion of 12 weeks, all Visual Analogue Scale (VAS) parameters revealed a profound percentage decrease, while Quality of Life scores raised from the start of treatment to the end. Of 411 participants recruited in the study, 14 participants (3.4%) experienced at least one adverse event during the study period.
Treatment with a fixed-dose combination of vitamin B1, B6 and B12 is linked with remarkable improvements in TSS, VAS, and quality of life.
Asian Journal of Medical Sciences
Management of peripheral neuropathy symptoms with a fixed dose combination of high-dose vitamin B1 , B6 and B12: A 12-week prospective non-interventional study in Indonesia
Manfaluthy Hakim et al.
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