TY - JOUR
T1 - Cerebral Biochemical Effect of Pregabalin in Patients with Painful Diabetic Neuropathy
T2 - A Randomized Controlled Trial
AU - De Jaeger, Mats
AU - Goudman, Lisa
AU - Van Schuerbeek, Peter
AU - De Mey, Johan
AU - Keymeulen, Bart
AU - Brouns, Raf
AU - Moens, Maarten
PY - 2018/8
Y1 - 2018/8
N2 - INTRODUCTION: With the development of new neuroimaging tools it has become possible to assess neurochemical alterations in patients experiencing chronic pain and to determine how these factors change during pharmacological treatment. The goal of this study was to examine the exact neurochemical mechanism underlying pregabalin treatment, utilizing magnetic resonance spectroscopy (1H-MRS), in a population of patients with painful diabetic polyneuropathy (PDN), with the overall aim to ultimately objectify the clinical effect of pregabalin.METHODS: A double blind, randomized, placebo-controlled study was conducted. A total of 27 patients with PDN were enrolled in the study, of whom 13 received placebo treatment (control group) and 14 received pregabalin (intervention group). Pregabalin treatment consisted of stepwise dose escalation over the study period from 75 mg daily ultimately to 600 mg daily. 1H-MRS was performed at 3T on four regions of interest in the brain: the rostral anterior cingulate cortex (rACC), left and right thalamus and prefrontal cortex. The absolute concentrations of N-acetyl aspartate, glutamate, glutamine, gamma-amino-butyric-acid (GABA), glucose (Glc) and myo-inositol (mINS) were determined using LCModel.RESULTS: The concentration of most neurometabolites in the placebo and pregabalin group did not significantly differ over time, with only a small significant difference in Glc level in the left thalamus (p = 0.049). Comparison of the effects of the different doses revealed significant differences for mINS in the rACC (baseline 2.42 ± 1.21 vs. 450 mg 1.58 ± 0.94; p = 0.022) and dorsolateral prefrontal cortex (75 mg 2.38 ± 0.89 vs. 450 mg 1.59 ± 0.85; p = 0.042) and also for GABA in the rACC (75 mg 0.53 ± 0.51 vs. 225 mg 0.28 ± 0.19; p = 0.014).CONCLUSION: No differences were found in metabolite concentrations between the placebo (control) and intervention groups, but some differences, although small, were found between the different doses.TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov (NCT01180608).FUNDING: Lyrica Independent Investigator Research Award (LIIRA) 2010 (Pfizer) funded the study.
AB - INTRODUCTION: With the development of new neuroimaging tools it has become possible to assess neurochemical alterations in patients experiencing chronic pain and to determine how these factors change during pharmacological treatment. The goal of this study was to examine the exact neurochemical mechanism underlying pregabalin treatment, utilizing magnetic resonance spectroscopy (1H-MRS), in a population of patients with painful diabetic polyneuropathy (PDN), with the overall aim to ultimately objectify the clinical effect of pregabalin.METHODS: A double blind, randomized, placebo-controlled study was conducted. A total of 27 patients with PDN were enrolled in the study, of whom 13 received placebo treatment (control group) and 14 received pregabalin (intervention group). Pregabalin treatment consisted of stepwise dose escalation over the study period from 75 mg daily ultimately to 600 mg daily. 1H-MRS was performed at 3T on four regions of interest in the brain: the rostral anterior cingulate cortex (rACC), left and right thalamus and prefrontal cortex. The absolute concentrations of N-acetyl aspartate, glutamate, glutamine, gamma-amino-butyric-acid (GABA), glucose (Glc) and myo-inositol (mINS) were determined using LCModel.RESULTS: The concentration of most neurometabolites in the placebo and pregabalin group did not significantly differ over time, with only a small significant difference in Glc level in the left thalamus (p = 0.049). Comparison of the effects of the different doses revealed significant differences for mINS in the rACC (baseline 2.42 ± 1.21 vs. 450 mg 1.58 ± 0.94; p = 0.022) and dorsolateral prefrontal cortex (75 mg 2.38 ± 0.89 vs. 450 mg 1.59 ± 0.85; p = 0.042) and also for GABA in the rACC (75 mg 0.53 ± 0.51 vs. 225 mg 0.28 ± 0.19; p = 0.014).CONCLUSION: No differences were found in metabolite concentrations between the placebo (control) and intervention groups, but some differences, although small, were found between the different doses.TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov (NCT01180608).FUNDING: Lyrica Independent Investigator Research Award (LIIRA) 2010 (Pfizer) funded the study.
KW - cerebral
KW - biochemical
KW - pregabalin
KW - painful
KW - diabetic
KW - neuropathy
KW - Painful diabetic polyneuropathy
KW - Proton magnetic resonance spectroscopy
KW - Pregabalin
KW - Neuropathic pain
UR - http://www.scopus.com/inward/record.url?scp=85050760502&partnerID=8YFLogxK
U2 - 10.1007/s13300-018-0460-y
DO - 10.1007/s13300-018-0460-y
M3 - Article
C2 - 29951977
VL - 9
SP - 1591
EP - 1604
JO - Diabetes Technology & Therapeutics
JF - Diabetes Technology & Therapeutics
SN - 1520-9156
IS - 4
ER -