Comparison of Gabapentin Monotherapy vs. Combination Therapy of Methyl Cobalamin and Gabapentin in Treating Diabetic Neuropathic Pain

Diabetic neuropathy is a painful and disabling condition that has huge incurring costs in terms of disturbed quality of life and financial burden while treating its complications. Its incidence is increasing as a consequence of poor treatment compliance and so faulty glycaemic control [6]. According to one estimate every third diabetic patient suffers from diabetic neuropathy [7].Its prevalence is different in various countries owing to heterogeneity of population and other factors such as heathcare systems, economical dynamics and social awareness [7].A UK study reported prevalence of painful diabetic neuropathy around 21% [6]. However, it is different in different countries depending upon the strictness of glycemic control [7,8]. Diabetic neuropathy (a painful condition) manifests as hike in symptoms at night. It has wide spectrum of symptoms such as sensation of needles, pins and burning sensations, sometimes electric or stabbing sensations. These may be intermittent or continuous. Stimuli of intensity as little as a touch of dressing (clothing) induce agonizing pain. This pain at night lead to disturbed sleep, resultantly affecting day time activities. This has negative impact on the office or work place efficiency and their social life. In extreme scenarios, there can be also being loss of appetite leading to diabetic neuropathic cachexia [8]. Management of diabetic neuropathic pain includes tight glycemic control and alleviation of symptomatic pain. Over course of time, utilization of antidepressants (amitriptyline or duloxetine), other drugs such as gabapentin and pregabalinhave been in use. Opiods have also been tried in this condition. And others topical agents such as capsaicin are also under trial
Group 1 was given Gabapentin alone while Group 2 was administered combination therapy of methylcobalamin and gabapentin. Patients were taught about the importance of compliance to both pain medication and the sugar control. At start of inclusion into study each patient underwent assessment for computing baseline pain score utilizing tool of visual analogue pain score. Patients were called to Outdoor clinic on monthly basis till next three months after starting the pain control regimen. At each visit they were assessed for pain score using visual analogue pain score. Diabetes Mellitus was labeled as fasting blood sugar levels exceeding cut off value of 126 mg/dl or if the postprandial blood sugar (at 2 hours) was exceeding 200 mg/dl as computed on two different timings while patients were on treatment for diabetes. Different variables were recorded in the proforma for each patient at the time of follow up interviews regarding their overall pain control, included gender, BMI, age, HbA1C status at induction of start of treatment, pain at baseline and then at follow up visit after commencing the pain treatment. After proforma filling the data was transferred into SPSS (SPSS version 16).For describing continuous variables Mean and standard deviation values were utilized (such as Age, pain score).For depicting categorical variables frequency/percentages were computed (such as gender). To compare efficacy among these groups chi square test was applied. The p-value of less than 0.05 was labelled as a statistically significant value. Paired sample t test was applied to see efficacy of treatment in group 1 and group 2. p value of less than 0.05 was taken as significant. While student test was used to see difference between the two groups.