Vitamin B12 Supplementation in Diabetic Neuropathy: A 1-Year, Randomized, Double-Blind, Placebo-Controlled Trial

What Was Tested

Researchers studied Cyanocobalamin (Vitamin B12) in this randomized controlled trial publication.

The researchers also used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE, respectively) and questionnaires to evaluate quality of life (QoL) and level of pain (pain score).

Who Took Part

The abstract describes 90 patients taking part.

PubMed indexes the participants as middle-aged adults, both men and women.

In this prospective, double-blind, placebo-controlled trial, 90 patients with type 2 diabetes on metformin for at least four years and both peripheral and autonomic DN were randomized to an active treatment group (n = 44) receiving B12 and a control group (n = 46) receiving a placebo.

Subjects underwent measurements of sural nerve conduction velocity (SNCV), sural nerve action potential (amplitude) (SNAP), and vibration perception threshold (VPT), and they performed cardiovascular autonomic reflex tests (CARTs: mean circular resultant (MCR), Valsalva test, postural index, and orthostatic hypotension).

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Neither the patients nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Cyanocobalamin (Vitamin B12) could be set against what happens without it.

Sudomotor function was assessed with the SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF, respectively).

What Was Measured

The subject headings attached to it are Cholesterol, Creatinine, Diabetes Mellitus, Type 2, Diabetic Neuropathies, Dietary Supplements, Folic Acid and Glycated Hemoglobin.

The authors tagged it with the keywords SUDOSCAN, autonomic neuropathy, diabetic foot, diabetic neuropathy, metformin and painful neuropathy.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Cyanocobalamin (Vitamin B12) in 90 patients.

The abstract goes on to report its results in about 4 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2021 (Nutrients), a journal based in Switzerland.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.