A randomized, placebo-controlled study of oxcarbazepine in painful diabetic neuropathy.
OBJECTIVE
To evaluate the efficacy and safety of oxcarbazepine (1200 mg/day) in patients with painful diabetic neuropathy in a multicentre, double-blind, placebo-controlled, 16-week study.


METHODS
A total of 141 patients were randomized to oxcarbazepine (1200 mg/day) (n = 71) or placebo (n = 70). The primary efficacy variable was the change in mean visual analogue scale (VAS) score from baseline to the last week the patient participated in the study.


RESULTS
The reduction in mean VAS score from baseline to the last study week was similar between the oxcarbazepine and placebo groups. The majority of adverse events (most of which first occurred during titration) were mild to moderate in severity and resolved over the course of the study.


CONCLUSIONS
In this study, no statistically significant difference in therapeutic effect was observed between oxcarbazepine (1200 mg/day) and placebo. However, further studies are necessary to assess the effective dose range of oxcarbazepine in the treatment of painful diabetic neuropathy.
Grosskopf
J
J
Diabetologische Schwerpunktpraxis, Wallerfing, Germany. dr.grosskopf@t-online.de
Mazzola
J
J
Wan
Y
Y
Hopwood
M
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002220:Carbamazepine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003929:Diabetic Neuropathies / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy* / Q000209:etiology; D000078330:Oxcarbazepine; D010147:Pain Measurement; D016896:Treatment Outcome
D000927:Anticonvulsants; D002220:Carbamazepine; D000078330:Oxcarbazepine