Management of diabetic neuropathy by sodium valproate and glyceryl trinitrate spray: A prospective double-blind randomized placebo-controlled study

Abstract Objectives Combination of drugs with different mechanisms of action helps in achieving synergistic analgesic effect in neuropathic pain. Keeping this point in view, the effect and safety aspects of sodium valproate and GTN were assessed alone as well as in combination in this study. Design...

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Published in:Diabetes research and clinical practice 2009-03, Vol.83 (3), p.371-378
Main Authors: Agrawal, R.P, Goswami, Jitender, Jain, Shreyans, Kochar, D.K
Format: Article
Language:English
Subjects:
Alanine Transaminase - blood
Aspartate Aminotransferases - blood
Diabetes Mellitus, Type 2 - physiopathology
Diabetic Neuropathies - drug therapy
Diabetic Neuropathies - physiopathology
Diabetic neuropathy
Double-Blind Method
Endocrinology & Metabolism
Female
GABA Agents - therapeutic use
Glycated Hemoglobin A - metabolism
Glyceryl trinitrate spray
Humans
Male
Middle Aged
Nitroglycerin - therapeutic use
Pain - drug therapy
Pain - etiology
Pain Measurement
Patient Selection
Placebos
Sodium valproate
Valproic Acid - therapeutic use
Vasodilator Agents - therapeutic use
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Summary:Abstract Objectives Combination of drugs with different mechanisms of action helps in achieving synergistic analgesic effect in neuropathic pain. Keeping this point in view, the effect and safety aspects of sodium valproate and GTN were assessed alone as well as in combination in this study. Design Prospective double-blind randomized placebo-controlled study. Material and method Eighty-seven type 2 diabetics with painful neuropathy were enrolled. Four were excluded: three with HbA1 c > 11 while one withdrew consent. The remaining 83 were given either sodium valproate and GTN spray (group A) or placebo drug and GTN spray (group B) or sodium valproate and placebo spray (group C) or placebo drug and placebo spray (group D). Quantitative assessment of pain was done by McGill pain questionnaire, visual analogue score (VAS) and present pain intensity (PPI) at the beginning of the study and after 3 months along with motor and sensory nerve conduction velocities measurements. Results All the three treatment groups experienced significant improvement in pain score in their drug phase of trial ( p < 0.001/ < 0.05) along with some of the electrophysiological parameters. The assessment of the magnitude of therapeutic effect of sodium valproate, GTN and their combination gave numbers needed to treat (NNT) of 7, 5 and 4, respectively. Conclusion Sodium valproate and GTN are well tolerated and provide significant improvement in pain scores as well as in electrophysiological parameters.
ISSN:0168-8227
1872-8227
DOI:10.1016/j.diabres.2008.12.018