Journal of Clinical & Experimental Pharmacology

Abstract

The Improvement of Ankle Reflex, Knee Reflex, Muscle Strength, and Sensory Perception after Fixed Dose Combination of Vitamin B1, B6, and B12 in Subjects with Peripheral Neuropathy (Secondary Analysis of the NENOIN Study)

Manfaluthy Hakim, Roger D Gibb, Poonam Nitin Sule, Yan Lid and Rizaldy Taslim Pinzon*

Background: Most peripheral neuropathy (PN) treatments relieve pain but do not restore neuronal health and function. A fixed dose combination (FDC) of vitamin B1, B6 and B12 was previously reported to improve subjective symptom perception in patients with mild to moderate PN.

Methods: The Neurobion Non-interventional (NENOIN) study was a prospective, open-label, multi-center, single-arm observational study. 411 subjects with mild to moderate PN of various etiologies were prescribed once-daily dose of 100mg of vitamin B1, 100mg of B6 and 5mg of B12 (Neurobion^® Forte tablets) for 90 days and evaluated with neurological examination comprising 51 assessments at baseline, Days 14, 30, 60, and 90.

Results: Statistically significant (p<0.001) reflex improvements were observed in 67.6%, 54.3%, 92.3%, and 75.0% patients with absent baseline reflex on their left ankle, right ankle, left knee, and right knee, respectively. The percentage of subjects with normal ankle dorsiflexion strength increased significantly (p<0.001) from 86% (baseline) to 97% (Day 90). Sensory assessments in the finger and toes showed significant (p<0.001) improvement. Significantly (p<0.001) greater improvement in Total Symptom Score was observed among subjects with comparatively more abnormal baseline sensory outcomes.

Conclusion: Treatment with an FDC of vitamin B1, B6, and B12 for 90 days progressively improved ankle and knee reflex, motor strength, and sensory perception status in the toes and fingers.

Published Date: 2023-10-23; Received Date: 2023-09-22