RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECTS OF DULOXETINE ALONE AND IN COMBINATION WITH ALPHA-LIPOIC ACID ON SYMPTOMATIC IMPROVEMENT OF DIABETIC NEUROPATHY

Objectives: To treat peripheral neuropathy in diabetic patients with minimum dose of duloxetine in combination with alpha lipoic acid avoiding the side effects associated with high dose of duloxetine Methods: The study was conducted in the department of Medicine Lahore General Hospital, Lahore from November 2022 to April 2023. Sample size was calculated by using epi-info statistical package. Convenient sampling technique was used to enroll 240 patients, with distribution of 120 patients in each group. The patients included in the study with diabetes of more than 10 years of duration and HbA1C level < 8% having symptoms of numbness, paresthesia, tingling or burning sensation, pain and sensitivity to touch. The qualitative data was expressed as means and frequency distribution while the quantitative data was used to compare the means and standard deviations by using students T test. Results: In group A, duloxetine alone was used in a dose of 30mg / day and the desired response compared between those who showed improvement in their symptoms and those who did not show any improvement. The calculated value of t came out to be t = 0.9161 and the p value = 0.3864 at 95% confidence level was not found statistically significant. In group B patients duloxetine 30mg / day along with lipoic acid 1200mg / day was used and the response between those who responded to treatment versus those who did not respond to treatment was compared and the calculated value of t = 2.6526 and the p value = 0.0291 at 95% confidence level was found statistically significant. Conclusion: Duloxetine 30mg/day plus lipoic acid 1200mg/day can be used with significant improvement in numbness, paresthesia, tingling and burning sensation, hypersensitivity to touch and pain associated with peripheral neuropathy in diabetic patients. Combination therapy helps to avoid unpleasant side effects associated with high dose of duloxetine when used alone