COMPARISON OF THE EFFICACY OF DULOXETINE VERSUS DULOXETINE PLUS ORAL VITAMIN D IN TREATING PERIPHERAL DIABETIC NEUROPATHY

Authors

  • HMS JEHANGIR Department of Emergency Medicine. King Edward Medical University, Lahore, Pakistan
  • S KHAN THQ Hospital Dogar, Pakistan
  • A HUSSAIN Department of Cardiology. Punjab Institute of Cardiology, Lahore, Pakistan
  • HS KHOKHAR King Edward Medical University, Lahore, Pakistan
  • H IQBAL King Edward Medical University, Lahore, Pakistan
  • S ASIF Department of Rheumatology. Fatima Memorial Hospital, Lahore, Pakistan
  • HM MAHBOOB Department of Cardiology. Punjab Institute of Cardiology, Lahore, Pakistan

DOI:

https://doi.org/10.54112/bcsrj.v2022i1.109

Keywords:

Diabetic neuropathies, Duloxetine, Vitamin D, Pain management, Randomized controlled trial.

Abstract

Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus that affects the quality of life. Duloxetine and vitamin D have been used for its management, but there is limited literature comparing the efficacy of these drugs. In this study, we aimed to compare Duloxetine alone versus Duloxetine in combination with vitamin D for treating PDPN. An open-labeled randomized controlled trial was conducted at King Edward Medical University, Mayo Hospital, Lahore, for a duration of 6 months, starting from July 1, 2021, to December 31, 2021. The study included 78 patients aged 20 to 60 years suffering from PDPN as per inclusion and exclusion criteria. Participants were randomly assigned to two groups, with 39 participants in each group. Group A was given Duloxetine 60mg OD, and Group B was given Duloxetine 60mg OD plus oral Vitamin D3 2000IU daily for 8 weeks. Patients were assessed before the start of treatment and followed up after 8 weeks in the outpatient department to measure the mean reduction in pain score using the Visual Analogue Scale. All the collected data was analyzed using SPSS 26.0. The mean age of the participants was 44.46 ± 6.51 years. Of the 78 participants, 51 were female, and 27 were male. 89.8% of patients tolerated the drugs well with no side effects. Only 6.4% of patients complained of tiredness, and 3.8% experienced constipation. The mean VAS before treatment and at the end of the 8th week was 7.41 ± 0.98 and 3.48 ± 1.01, respectively. There was a marked reduction in pain after using both regimens, which was statistically significant (p-value < 0.001). The mean VAS before and after the treatment in Group A was 7.46 ± 0.99 and 4.17 ± 0.72, respectively. In Group B, the mean VAS before and after the treatment was 7.35 ± 0.978 and 2.79 ± 0.832, respectively. This reduction was statistically significant compared to the two groups (p-value < 0.001). The combination of Duloxetine and vitamin D proved superior to the Duloxetine group and is a recommended regimen according to our results. Further studies with more extensive data from multiple centers are required to establish the guidelines.

Downloads

Download data is not yet available.

References

Alam, U., Petropoulos, I. N., Ponirakis, G., Ferdousi, M., Asghar, O., Jeziorska, M., Marshall, A., Boulton, A. J., Efron, N., and Malik, R. A. (2021). Vitamin D deficiency is associated with painful diabetic neuropathy. Diabetes/metabolism research and reviews 37, e3361.

Basit, A., Basit, K. A., Fawwad, A., Shaheen, F., Fatima, N., Petropoulos, I. N., Alam, U., and Malik, R. A. (2016). Vitamin D for the treatment of painful diabetic neuropathy. BMJ Open Diabetes Research and Care 4, e000148.

Boulton, A. J. (2014). Diabetic neuropathy and foot complications. Handbook of clinical neurology 126, 97-107.

Bril, V., England, J., Franklin, G. M., Backonja, M., Cohen, J., Del Toro, D., Feldman, E., Iverson, D. J., Perkins, B., and Russell, J. W. (2011). Evidence-based guideline: treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Pm&r 3, 345-352. e21.

Carlson, A. N., and Kenny, A. M. (2007). Is vitamin D insufficiency associated with peripheral neuropathy? The Endocrinologist 17, 319-325.

Goldstein, D. J., Lu, Y., Detke, M. J., Lee, T. C., and Iyengar, S. (2005). Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain 116, 109-118.

Gomez Gomez, D. (2021). Análisis de costo-efectividad de la cirugía bariátrica comparada con manejo médico en pacientes obesos con diabetes mellitus en Colombia, 2020.

Qu, G.-B., Wang, L.-L., Tang, X., Wu, W., and Sun, Y.-H. (2017). The association between vitamin D level and diabetic peripheral neuropathy in patients with type 2 diabetes mellitus: An update systematic review and meta-analysis. Journal of clinical & translational endocrinology 9, 25-31.

Shehab, D., Al-Jarallah, K., Abdella, N., Mojiminiyi, O. A., and Al Mohamedy, H. (2015). Prospective evaluation of the effect of short-term oral vitamin D supplementation on peripheral neuropathy in type 2 diabetes mellitus. Medical Principles and Practice 24, 250-256.

Shehab, D., Al‐Jarallah, K., Mojiminiyi, O., Al Mohamedy, H., and Abdella, N. (2012). Does Vitamin D deficiency play a role in peripheral neuropathy in Type 2 diabetes? Diabetic medicine 29, 43-49.

Smith, T. R. (2006). Duloxetine in diabetic neuropathy. Expert Opinion on Pharmacotherapy 7, 215-223.

Sultan, A., Gaskell, H., Derry, S., and Moore, R. A. (2008). Duloxetine for painful diabetic neuropathy and fibromyalgia pain: systematic review of randomised trials. BMC neurology 8, 1-9.

Wang, Y., Guan, Y., Wang, D., and Li, J. (2015). The relationship of 25 (OH) D deficiency with diabetic peripheral neuropathy. Prog Anat Sci 21, 352-354.

Wernicke, J., Pritchett, Y., D’souza, D., Waninger, A., Tran, P., Iyengar, S., and Raskin, J. (2006). A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology 67, 1411-1420.

Yammine, K., Wehbe, R., and Assi, C. (2020). A systematic review on the efficacy of vitamin D supplementation on diabetic peripheral neuropathy. Clinical nutrition 39, 2970-2974.

Downloads

Published

2022-07-05

How to Cite

JEHANGIR , H., KHAN , S., HUSSAIN, A., KHOKHAR , H., IQBAL, H., ASIF, S., & MAHBOOB , H. (2022). COMPARISON OF THE EFFICACY OF DULOXETINE VERSUS DULOXETINE PLUS ORAL VITAMIN D IN TREATING PERIPHERAL DIABETIC NEUROPATHY. Biological and Clinical Sciences Research Journal, 2022(1), 109. https://doi.org/10.54112/bcsrj.v2022i1.109

Issue

Section

Original Research Articles

Most read articles by the same author(s)

1 2 3 > >>