Although there is no causal treatment that can prevent or reverse diabetic neuropathy, we have available many drugs that alleviate the unpleasant symptoms. The goal of our study was to compare the short- and long-term effect of Cerebrolysin and placebo in the treatment of painful diabetic neuropathy. Patients and Methods: Eighteen patients with diabetes of type I and II were randomised into 2 groups for a prospective, longitudinal, placebo-controlled cross-over study.Group A (10 patients) started with 10 days of Cerebrolysin (C) infusions (20 ml of drug in 500 ml of saline for 10 days), after 3 months, they came back for placebo (P) infusions (500 ml of saline for 10 days). Group B (8 patients) had the opposite schedule. We investigated the following parameters: For pain evaluation, the VAS (visual analog scale, 1-10) at the beginning and end of both infusion series, and at 1 and 3 months after end of therapy. For objective assessment of clinical impairment, the NDS (neurological disability score) and EMG at the beginning of both infusion series and 3 months later, biothesiometer and monofilaments at the beginning and the end of both infusion series. Diabetes control was evaluated with glycosylated haemoglobin. Malondialdehyde (MDA) and glutathion (GSH), indicators of oxidative stress, were evaluated at the beginning, and after 5 and 10 infusions. Statistical analysis: median ± SD (standard deviation), T-test, Mann-Whitney U test and analysis of variance. Results: Both medications, C and P, significantly reduced the severity of pain by the VAS (p <0.05, C before/after 5.50 ± 1.35/4.0 ± 1.24, P before/after 5.25 ± 2.0/3.28 ± 1.50). The degree of pain reduction was comparable. Comparable was also the effect on VAS at 1 or 3 months after medication (C: 3.97 ± 1.74/4.50 ± 1.84; P: 3.31 ± 1.42/3.92 ± 1.72). In the case of C medication, a significant decrease in MDA occurred after treatment (before, 2.89 ± 0.29, after 2.50 ± 0.57, p = 0.03). There was no significant inter-group difference (A vs. B) in the value of glycosylated haemoglobin. The other parameters likewise showed no significant differences between Cerebrolysin and placebo. Conclusion: The study did not detect any significant difference in short- or long-term treatment with Cerebrolysin when compared to placebo in the management of neuropathic pain. Both medications, Cerebrolysin and placebo, positively influenced the severity of pain in diabetic neuropathy, the effect of both decreased with time. Cerebrolysin had a positive effect onMDA decrease after 10 days of infusions. The treatment with C was well tolerated, no adverse effects were noted.

        Key words: diabetes mellitus, peripheral neuropathy, pain, treatment