Is Cerebrolysin effective in reducing symptoms of Diabetic Peripheral Neuropathy?

Abstract

Aim This is an investigator initiated observational comparative medical program, to test the efficacy of Cerebrolysin® intake for 1 month versus 2 months, in patients clinically diagnosed with type 2 diabetes mellitus (T2DM) and suffering from peripheral neuropathy. Methods Patients aged ≥ 18 years old, clinically diagnosed with mild or moderate painful diabetic polyneuropathy, received Cerebrolysin® for 1 or 2 months according to investigators’ decision. Demographic data, detailed medical history, and laboratory results were collected at baseline. All enrolled patients were evaluated for Toronto Clinical Scoring System (TCSS), Visual Analogue Scale (VAS) and Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS) at baseline and end of the program (1 month/2 month). Results VAS, TCSS, and LANSS were significantly improved for all 136 enrolled patients at the end of their treatment with Cerebrolysin® for 1 or 2 months, regarding gender, duration since diagnosis of T2DM (more than or less than 10 years) and HbA1c ≤ 9% or ˃ 9%, with a very highly statistically significant difference (p-value ˂ 0.001). They were slightly improved more in patients received Cerebrolysin® for 1 month more than for 2 months. There was no statistically significant difference for gender, duration of diagnosis with diabetes mellitus less or more than 10 years, and HbA1c ≤ 9% & ˃ 9% regarding the change of VAS, TCSS, and LANSS as dependent variables, using Linear stepwise regression. While there was noticed improvement in VAS, TCSS, and LANSS with use of Cerebrolysin® for 1 month more than 2 months, Regression Coefficient (B (95% of Confidence interval)) B=0.794 (0.29-1.29), B=1.472 (0.87-2.074), B=2.143 (0.45-3.83) and p-value = 0.002, p-value ˂ 0.001, p-value = 0.13 respectively. There was no adverse event (AE) or serious adverse event (SAE) reported during the program. Conclusion: Cerebrolysin® is considered effective in the management of peripheral neuropathy in patients with T2DM Abbreviations: Adverse Event (AE), Advanced Glycation End products (AGE), Contract Research Organization (CRO), Diabetic Peripheral Neuropathy (DPN), Diacylglycerol (DAG), estimated Glomerular Filtration (eGFR), Fasting Blood Sugar (FBS), Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS), Peripheral Vascular Disease (PVD), Pin- Prick Threshold (PPT), Protein Kinase C (PKC), Statistical Analysis Plan (SAP), Serious Adverse Event (SAE), Standard Deviation (SD), Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM), Toronto Clinical Scoring System (TCSS), Traumatic Brain Injury (TBI), Visual Analogue Scale (VAS).