Purpose To study the eff ects of palmitoylethanolamide (PEA), a fatty acid ethanolamide, on IOP, visual fi eld and pattern-ERG in glaucoma patients. Methods 36 glaucoma (POAG) patients treated topically with timolol 0.5% were randomly assigned to either orally PEA 300 mg/die 2 times daily (Group A) or placebo (Group B). ! e patients had at least 5 VF tests using the Humphrey Visual Field Analyzer (! reshold 30-2) for more than a 2-year period before PEA treatment. At baseline and after 6, 12, 18, 24 months of treatments we evaluated in both groups the change of progression rate of visual fi eld using mean deviation (MD), and pattern standard deviation (PSD). Comparison of means was performed with the paired t-test. ! e involvement of retinal ganglion cells (RGCs) were investigated using pattern electroretinograms (PERG) recorded twice a year in 36 glaucoma patients over at least 2 years. Results Signifi cative IOP reduction was observed in the Group A, PEA treated patients (16.94 ± 3.96 vs. 13.8 ± 3.24 mm Hg; P < 0.001).A statistically signifi cant diff erence in the MD was found between the two groups (PEA treated, -2.9 dB±2.93; Placebo treated, -8.55 dB±6.51 P=0.001). Furthermore, the change in PSD reached statistical signifi cance: PEA 2.63 dB ±1.47; Placebo 6.59 dB ±6.51 P=0.002. PERG amplitude decreased signifi cantly (P<0.01) in patients treated with placebo compared with PEA. PEA tablets continued to be safe and well-tolerated, with no drug-related adverse events. Conclusion ! ese fi ndings show substantial clinical benefi ts of PEA treatment in POAG patients:reduction of IOP as well as signifi cative improvement in visual fi eld and PERG
Clinical trial for the evaluation of neuroprotective eff ects of palmitoylethanolamide: Visual Field and Pattern-ERG
GAGLIANO C;
2012-01-01
Abstract
Purpose To study the eff ects of palmitoylethanolamide (PEA), a fatty acid ethanolamide, on IOP, visual fi eld and pattern-ERG in glaucoma patients. Methods 36 glaucoma (POAG) patients treated topically with timolol 0.5% were randomly assigned to either orally PEA 300 mg/die 2 times daily (Group A) or placebo (Group B). ! e patients had at least 5 VF tests using the Humphrey Visual Field Analyzer (! reshold 30-2) for more than a 2-year period before PEA treatment. At baseline and after 6, 12, 18, 24 months of treatments we evaluated in both groups the change of progression rate of visual fi eld using mean deviation (MD), and pattern standard deviation (PSD). Comparison of means was performed with the paired t-test. ! e involvement of retinal ganglion cells (RGCs) were investigated using pattern electroretinograms (PERG) recorded twice a year in 36 glaucoma patients over at least 2 years. Results Signifi cative IOP reduction was observed in the Group A, PEA treated patients (16.94 ± 3.96 vs. 13.8 ± 3.24 mm Hg; P < 0.001).A statistically signifi cant diff erence in the MD was found between the two groups (PEA treated, -2.9 dB±2.93; Placebo treated, -8.55 dB±6.51 P=0.001). Furthermore, the change in PSD reached statistical signifi cance: PEA 2.63 dB ±1.47; Placebo 6.59 dB ±6.51 P=0.002. PERG amplitude decreased signifi cantly (P<0.01) in patients treated with placebo compared with PEA. PEA tablets continued to be safe and well-tolerated, with no drug-related adverse events. Conclusion ! ese fi ndings show substantial clinical benefi ts of PEA treatment in POAG patients:reduction of IOP as well as signifi cative improvement in visual fi eld and PERGI documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
