Review of Patient Reported Outcomes of Pregabalin Treatment for NeP- A Short Summary

Introduction Neuropathic pain (NeP) is a disorder of the nervous system resulting from pathologies of multiple aetiologies. It affects 2-8% of the world population and can have serious outcomes on a patient’s functionality and wellbeing1. Clinical studies have established the effectiveness of Pregabalin as a first line treatment for NeP2 as per recent reviews and meta-analyses which have largely focused on pain outcomes in the treatment of NeP with Pregabalin3,4. However, little synthesis has been performed on patient-reported outcome (PRO) measures in the treatment of NeP, which present an important aspect of understanding the clinical importance of Pregabalin treatment. This review aims to fill this gap by conducting a systematic narrative synthesis to explore the various PROs reported by patients in the treatment of NeP outside of measures of pain. 

Objectives This narrative review aims to synthesize the PROs reported in clinical studies assessing the treatment of NeP with Pregabalin. Further, this review synthesises treatment effects of Pregabalin on PROs narratively.

Methods  MEDLINE, Embase, CINHAL Cochrane Database of Systematic Reviews, and CENTRAL were searched for randomized control trials (RCTs) within phase II or III clinical testing. To focus the review on PROs, pain-related outcomes were not considered in the narrative synthesis of this review.. This study employed Cochrane Collaboration Methods to conduct rapid reviews, which include an appropriate search strategy, screening using a predefined criterion, and data extraction and synthesis utilizing a pre-developed tool. In order to increase the transparency of the results, this review followed the Preferred Reporting Items for Systematic review and Meta-Analyses (PRISMA)5.

Results After screening of 298 records from the database search, 17 RCTs were included for analysis in this review. The review found multiple  PROs  measured in patients with NeP treated with Pregabalin. These included sleep interference, mood, anxiety, and depression, and health related quality of life (HRQOL) measures. Included studies report mixed results when assessing the treatment effects of Pregabalin on PROs.

Conclusions The results indicate the multidimensional nature of the effect of NeP on patients sleep, psychological health, and quality of life, with particularly strong treatment effect of Pregabalin on reducing sleep disturbance in NeP patients.  The review highlighted the difficulty in measuring PROs in NeP patients and how a more holistic understanding of patient experiences may yield a better clinical understanding of Pregabalin treatment. Future reviews and studies should aim to better measure PROs through understanding the histories of patients suffering from NeP by considering longer and multidimensional study designs. This can lead to creating treatment plans that are multimodal and effective in improving NeP patient’s quality of life.