Oral Alpha-Lipoic Acid, Vitamin B Complex, and Vitamin E Combination (Bionerv E+) for Treating Symptomatic Distal Sensory Polyneuropathy: Interim Analysis of a Randomized, Placebo-Controlled Trial
https://doi.org/10.15605/jafes.041.S1
- Author:
Fathimath Shazoo
1
;
Ilham Ismail
2
;
Rathika Rajah
3
;
Wan Asyraf Wan Zaidi
4
;
Rabani Remli
4
;
Mahrunissa Mahadi
2
;
Norlaila Mustafa
1
;
Roszita Ibrahim
5
;
Norasyikin A. Wahab
1
Author Information
1. Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia; Endocrine Unit, Department of Medicine, Hospital Canselor Tuanku Muhriz
2. Endocrine Unit, Department of Medicine, Hospital Canselor Tuanku Muhriz
3. Neurology Unit, Department of Medicine, Hospital Canselor Tuanku Muhriz
4. Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia; Neurology Unit, Department of Medicine, Hospital Canselor Tuanku Muhriz
5. Department of Community Health, Faculty of Medicine
- Publication Type:Journal Article
- MeSH:
Thioctic Acid;
Vitamin B Complex;
Polyneuropathies;
Vitamin E
- From:
Journal of the ASEAN Federation of Endocrine Societies
2026;41(S1):35-36
- CountryPhilippines
- Language:English
-
Abstract:
Introduction:Diabetic sensorimotor polyneuropathy (DSPN) is a
common complication of long-standing diabetes mellitus
marked by neuropathic pain and sensory deficits. Evidence
supporting combination antioxidant and vitamin-based
therapy remains limited, particularly in patients with
chronic disease. This study aims to determine symptom
improvement after 12 weeks of oral alpha-lipoic acid,
vitamin B complex, and vitamin E (Bionerv E+) in chronic
diabetic patients with symptomatic DSPN.
Methodology:This single-centre, randomized, double-blind, placebocontrolled trial at HCTM enrolled 31 patients with symptomatic DSPN, assigned to Bionerv E+ (n = 16) or placebo
(n = 15) for 12 weeks. Symptoms were assessed at baseline
and post intervention using the Neuropathy Impairment
Score–Lower Limb (NIS LL), Short Form McGill Pain
Questionnaire (SF MPQ), Toronto Clinical Scoring System
(TCSS), and nerve conduction studies (NCS).
Results:A total of 31 participants were recruited; 18 completed
the study (11 intervention, 7 placebo). The cohort was
predominantly elderly (median age 68 ± 12 years), male
(51.6%), with long-standing diabetes (mean duration of
18.6 ± 8.2 years), and a mean hemoglobin A1c of 7.3 ± 0.6%.
A statistically significant reduction in TCSS score was
observed in the intervention arm (5.5 ± 3.8 vs 3.3 ± 3.4; p
= 0.002), indicating improvement in neuropathic symptom
severity in this chronic population. The SF MPQ scores
showed a downward trend in both arms, but were not
statistically significant. Among intervention participants
who completed sural NCS, three patients demonstrated
normalization, and five showed partial amplitude gains,
indicating directional improvement in nerve function. Four
patients with normal baseline studies exhibited further
amplitude gains. Otherwise, limited improvements were
observed in those with abnormal conduction velocity
parameters. Bionerv E+ was well tolerated, with only mild
and self-limiting adverse events reported.
Conclusion:Short-term supplementation with Bionerv E+ showed
improvement in neuropathic symptoms among longstanding diabetic patients. However, longer-term studies
with larger cohorts are necessary to determine its effects
on patients with DSPN.
- Full text:2026072817101424373EP_A031.pdf