Sodium valproate in the management of painful neuropathy in type 2 diabetes - a randomized placebo controlled study.
OBJECTIVE
To study the effectiveness and safety aspects of sodium valproate in the management of painful neuropathy in patients of type 2 diabetes mellitus.


METHODS
A randomized double-blind placebo controlled trial of sodium valproate was done in type 2 diabetic patients to assess its efficacy and safety in the management of painful neuropathy. We screened 60 patients but eight patients could not complete the study; hence, the present study was done on 52 patients. Each patient was assessed by clinical examination, pain score by short form of the McGill pain questionnaire (SF-MPQ) and electrophysiological examination, which included motor and sensory nerve conduction velocity, amplitude and H-reflex initially and at the end of 1 month of treatment.


RESULTS
Significant improvement was noticed in the pain score of patients receiving sodium valproate in comparison to patients receiving placebo at the end of 1 month (P < 0.05). The changes in electrophysiological data were not significant. The drug was well tolerated by all patients except one who developed a raised aspartate transaminase (AST)/alanine transaminase (ALT) level after 15 days of treatment.


CONCLUSIONS
Sodium valproate is a well-tolerated drug and provides significant subjective improvement in painful diabetic neuropathy. These data provide a basis for future trials of longer duration in a larger group of patients.
Kochar
D K
DK
Department of Medicine, SP Medical College, Bikaner, Rajasthan, India. drdkkochar@indiatimes.com
Jain
N
N
Agarwal
R P
RP
Srivastava
T
T
Agarwal
P
P
Gupta
S
S
D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000503:physiopathology; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D004311:Double-Blind Method; D004594:Electrophysiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009046:Motor Neurons / Q000187:drug effects / Q000502:physiology; D009475:Neurons, Afferent / Q000187:drug effects / Q000502:physiology; D010146:Pain / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D010147:Pain Measurement; D013997:Time Factors; D014635:Valproic Acid / Q000009:adverse effects / Q000627:therapeutic use*
D000927:Anticonvulsants; D014635:Valproic Acid