Comparative Study of Safety and Efficacy of Gabapentin Versus Amitriptyline in Patients With Painful Diabetic Peripheral Neuropathy, A Randomized open Label Parallel Group Study
Pavithira Sekar1, K. Punnagai2 and Darling Chellathai David2

1Department of Pharmacology, Sri Muthukumaran Medical College Hospital and RI, Chikkarayapuram, Chennai-600069.

2Department of Pharmacology, Sri Ramachandra Medical College and Research Institute, Porur, Chennai-600116.

Corresponding Author E-mail: drpavithras06@gmail.com

Abstract: The study was aimed to compare the safety and efficacy of Gabapentin vs amitriptyline in patients with painful diabetic peripheral neuropathy. Study was conducted in Chennai during the period from October 2014 to May 2015 were a total of 100 patients were randomized to two treatment groups in 1:1 ratio. Gabapentin 600 mg per day and increased upto a maximum of 1800 mg per day, at bed time.  Amitriptyline 25 mg per day and increased upto a maximum of 75 mg per day, at bed time. There were four scheduled visits during the study. All study participants were given a diary and necessary scales (Visual analog scale and sleep interference scale). Categorical variables are analysed using Chi square test and Paired Students‘t’ test. With similar baseline for both groups, Gabapentin produced significant improvement versus amitriptyline for mean pain scores (P<0.05); mean sleep interference scores (P<0.05). Additional statistically significant (P<0.05) differences favouring gabapentin treatment were observed in measures of quality of life (Global Impression of Change in both Patient and Clinician perspective). Gabapentin group showed more number of adverse events like increased appetite, somnolence and liver function test increase, while amitriptyline group had increased micturition and dizziness. The study revealed that gabapentin is safer and efficacious compared to amitriptyline in patients with painful diabetic peripheral neuropathy

Keywords: Painful Diabetic peripheral Neuropathy; Gabapentin; Amitriptyline; visual analog scale; sleep interference

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