Neuropathic pain is intense in nature and difficult to manage. Thus, the primary goal is maximum relief from
pain. The aim of this study was to assess the efficacy and safety of a fixed-dose combination of sustained-release
pregabalin and
methylcobalamin in reducing
neuropathic pain in Indian patients, in the real-life situation.
METHODS: This was a multicenter, prospective, open-labeled, single-arm, observational, 14-day study. Patients received fixed dose combination of 75 or 150 mg sustained-release
pregabalin combined with 1500 mcg immediate release
methylcobalamin, depending on the clinical requirement. Data was collected for
pain reduction and other positive and negative symptoms associated with neuropathy, including
hyperesthesia,
paresthesia,
numbness/tingling, burning sensation,
muscle weakness, sleep disturbances, and impairment of movement.
Pain intensity was measured on a ten-point visual analog scale (VAS) (0 represented "no
pain," and 10 represented "worst
pain ever"). The safety of the
drug was also evaluated throughout the study duration. Data was analyzed using appropriate statistical methods.
RESULTS: The overall reduction in mean VAS score over 14 days was 72.3%. The reduction in mean VAS score was significant as early as the first week. Both positive and negative symptoms of
peripheral neuropathy were significantly improved in >50% patients within the 2 weeks. Giddiness (4.7%), followed by sedation (3.6%),
dizziness (2.9%), drowsiness (2.3%), and
nausea (2.3%) were the most commonly observed adverse effects. The overall efficacy and tolerability was rated as good to excellent by >95% of the investigators and patients.
CONCLUSION: Fixed dose combination of sustained-release
pregabalin and
methylcobalamin significantly reduced
neuropathic pain, with significant improvement in both the positive and negative symptoms associated with neuropathy, in Indian patients and was well tolerated.