Evidence map›Paper›PMID 41935358›Full record

Trial reportCurrent diabetes reviews2026

Evaluation of Alpha-Lipoic Acid and B Vitamins on Quality of Life and Metabolic Parameters among Diabetic Patients with Symptomatic Distal Symmetric Polyneuropathy: A Randomized Controlled Trial.

Nani Draman, Che Nur Ain Che Abdullah, Noraini Mohamad, Zainab Mat Yudin, Wan Muhamad Amir W Ahmad, Ritzzaleena Rosli Mohd Rosli, Chee Yong Chuan

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Current diabetes reviews, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Nani DramanDepartment of Family Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia.ORCID 0000-0003-4143-6065
Che Nur Ain Che AbdullahDepartment of Family Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia.ORCID 0009-0004-4629-9121
Noraini MohamadMedical and Basic Dental Sciences Unit, School of Dental Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia.ORCID 0000-0002-1179-3005
Zainab Mat YudinMedical and Basic Dental Sciences Unit, School of Dental Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia.ORCID 0000-0003-4283-3548
Wan Muhamad Amir W AhmadBiostatistics Unit, School of Dental Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia.ORCID 0000-0003-2366-3918
Ritzzaleena Rosli Mohd RosliDepartment of Family Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia.
Chee Yong ChuanNeurology Unit, Department of Internal Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia.ORCID 0000-0003-2189-5571

Funding

BREGO Life Sciences Sdn. Bhd., Malaysia R504-LRGAL007-0000000133-B152
6 · The paper itself

Abstract

introductionDistal symmetric polyneuropathy (DSPN) is a debilitating diabetic complication that impairs Quality of Life (QoL). This study evaluated the effects of Alpha Lipoic Acid (ALA) plus B vitamins on QoL and metabolic parameters in diabetic patients with symptomatic DSPN.

methodsIn this randomized, double-blind, placebo-controlled trial, 80 patients were allocated to receive either oral ALA plus B vitamins, i.e., Bionerv® (n =40) (intervention group) or placebo (n = 40) for 12 weeks. QoL, Body Mass Index (BMI), and Blood Pressure (BP) were assessed at baseline, 6 weeks, and 12 weeks. QoL was measured using the Revised Diabetes Quality of Life Questionnaire (Rv-DQoL), where higher scores indicate poorer QoL. Metabolic parameters (glycated haemoglobin (HbA1c), fasting blood sugar (FBS), fasting lipid profile (FLP) were assessed at baseline and 12 weeks.

resultsIn the intervention group, the mean Rv-DQoL score decreased significantly in withingroup analysis from 29.50 ± 5.25 at baseline to 24.37 ± 3.43 at week 12 [F(2,156)=55.16; p-value <0.001]. However, between-group differences were not significant (p-value =0.151). Blood pressure also declined significantly within the intervention group (p-value <0.05), but no significant differences were observed between the placebo and intervention groups (p-value >0.05). Metabolic parameters (HbA1c, FBS, FLP, BMI) showed no significant changes between intervention and control groups (p-value >0.05). DISCUSSION: Twelve-week treatment with ALA plus B vitamins resulted in improvements in QoL and BP among DSPN patients. However, these changes did not reach statistical significance compared with placebo, and no alterations in metabolic parameters were observed. The short duration and small sample size may have limited the detectability of effects.

conclusionTwelve weeks of treatment with ALA and B vitamins resulted in an improvement in QoL and BP among DSPN patients. However, these changes did not reach statistical significance compared with placebo, and no alterations in metabolic parameters were observed.

Indexed as

Diabetic NeuropathiesQuality of LifeThioctic AcidVitamin B ComplexAdultAgedBlood GlucoseBlood PressureDouble-Blind MethodFemaleGlycated HemoglobinHumansMaleMiddle AgedTreatment OutcomeBlood GlucoseGlycated HemoglobinThioctic AcidVitamin B ComplexAlpha lipoic acidblood pressuredistal symmetric polyneuropathymetabolic profilequality of lifevitamin B

Identifiers

PMID41935358
PMCPMC13725150

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.