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Methylcobalamin methycobal in chronic diabetic neuropathy a double blind clinical and electrophysiological study



Methylcobalamin methycobal in chronic diabetic neuropathy a double blind clinical and electrophysiological study



Clinical Trials Journal 23(2): 130-140



The value of administering vitamin B complex to diabetics with chronic neuropathy is dubious. We therefore investigated the active metabolite of vitamin B12 (methylcobalamin (CH3-B12); Methylcobal) given orally in large doses of 1500 .mu.g daily for three months in a double-blind study. The 42 patients selected had long-standing diabetes (mean duration 12 years) with symptoms of neuropathy. They were divided into two groups of 21 patients. Each group in turn was given either CH3-B12 or placebo. All patients were on a home glucose monitoring scheme and their blood sugar was fairly well controlled. A clinical evaluation, neuropsychological study and HbA1 estimation were done before and after treatment with the drug or placebo. Clinical evaluation included scoring on a 4-point scale for numbness, pain, cramps, weakness and impotence. The signs assessed were the deep tendon reflexes, sensory loss to pin-prick, two point discrimination and the bulbocavernosus reflex. The electrophysiological investigations carried out were the maximum motor conduction velocity (MMCV) and distal motor latency of the median, lateral popliteal and posterior tibial nerves; the H reflex; maximum sensory conduction velocity and amplitude of the media median and sural nerves; visual evoked responses; and the scalp somatosensory response (SSER) of the median nerve. Statistical analyses included the Student's paired t-test and the Wilcoxon's signed rank test. Three patients receiving placebo dropped out and the other placebo patients showed no significant change in any parameter. The 21 patients receiving CH3-B12 showed significant improvement (P < 0.01) for 2-point discrimination, pain and cramps. In addition there was improvement in the MMCV (P < 0.05) and SSER (P < 0.05) of the median nerve. No adverse effects were observed. We conclude that CH3-B12 provides satisfactory symptomatic relief and its action is due partly to improvement in motor and sensory function, possibly by promoting myelin and axonal phospholipid synthesis.

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Accession: 005892018

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