OBJECTIVETo assess the clinical efficacy of the therapeutic schema for treatment of diabetic peripheral neuropathy (DPN) with ligustrazine and citicoline injection in combination.

METHODSAdopting double-centered randomized controlled trial, 300 patients were randomly assigned to 3 groups, who were treated respectively by ligustrazine plus citicoline (group A), ligustrazine alone (group B) and citicoline alone (group C). Clinical efficacy, symptomatic integral (SI), electromyogram ( EMG), blood sugar and blood lipids were assessed 4 weeks after treatment, and the clinical efficacy and SI were assessed at the end of 3-month follow-up.

RESULTSAfter 4-week treatment, improvements of blood sugar and blood lipids were seen in all the three groups, showing insignificant difference among them (P > 0.05). But the clinical efficacy, improvement of SI and EMG in group A were superior to those in group B and C (P < 0.05), while the difference between group B and C was insignificant. No severe adverse reaction was found. Results at the end of 3-month follow-up showed that the clinical efficacy in group A was still better than in the other two groups, so did the SI (6.39 +/- 2.04 vs 8.36 +/- 1.17 and 8.05 +/- 1.34, P < 0.05).

CONCLUSIONThe therapeutic schema of using ligustrazine and citicoline in combination is effective and safe for improving DPN, and worthy of clinical spreading.