A randomized study to determine the efficacy of pregabalin for the treatment of moderate or severe baseline neuropathic pain at a tertiary care centre in Ganjam, Odisha

Abstract

Background: Neuropathic pain (NeP) is caused by a disease like lesion; it is the disease of the somatosensory nervous system. NeP also caused some severe health disorders such as diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), and spinal cord injury (SCI). Along with the severe health issues, NeP adversely affects the quality of life (QOL) as well as an economic burden on the infected persons and their family plus society. Aim: The aim of the study is to define the efficiency of pregabalin for the treatment of moderate or severe baseline neuropathic pain at a tertiary care centre in Ganjam, Odisha. Materials and Methods: It was a randomized study conducted between August 2019 and January 2020 at the MKCG Medical College Berhampur, Ganjam, Odisha on 700 patients. Simple randomization technique was employed to give patients either pregabalin or placebo. All the patients aged >18 years were selected for the study. The pain was assessed for all the patients using the 11-point numeric rating scale, where 0 = no pain and 10 = worst possible pain. All the patients having pain score >4 were involved in the study. Patients who were below 18 years of age were omitted from the study. Further, the patients whose pain score was below four were also omitted from the study. Results: It was observed that there were 455 patients in the Pregabalin group, and in the placebo group, there were 245 patients. The patients were also bifurcated as per the severity of their discomfort, in which 513 patients were comprised in the moderate section, whereas 187 patients were encompassed in the severe section. 63-71 years was the median age. In the moderate and severe pain group, standard mean pain scores were equivalent among the pregabalin and placebo treatment groups. There was a statistically significant difference among both the groups with respect to the change in pain score. This implies that pregabalin reduced pain more significantly as compared to the placebo group. The above table also depicted the improvement in mean sleep scores as well. There was a statistically significant difference among both the groups with respect to the sleep scores. The sleep score in the pregabalin group improved from the baseline to endpoint more significantly as compared to the placebo group. In the moderate to severe pregabalin group, 90% of the patients experienced at least one treatment-emergent as compared to 70% in the placebo group. The most common side effects of the AE were weight gain, dizziness, and peripheral edema. The highest discontinuation from the study was observed in the pregabalin group. Conclusion: It was found that the pregabalin was effective in terms of reducing pain and had greater tolerability with the patients. It was also identified that the patients in the severe pain segment shifted to mild segment with the use of pregabalin dosage.