Tags

Type your tag names separated by a space and hit enter

A comparative double-blind randomized study on the effectiveness of Duloxetine and Gabapentin on painful diabetic peripheral polyneuropathy.
Drug Des Devel Ther. 2019; 13:1985-1992.DD

Abstract

Background:

The most common cause of polyneuropathy is diabetes mellitus. Neuropathic pain is seen in 26% of diabetic population. Therapeutic techniques for this disease can become challenging. Method: This study was a prospective comparative double-blind randomized study which was conducted during an eight-week period. Totally, 104 painful diabetic peripheral polyneuropathy (PDPP) patients who had a minimum Visual Analog Scale (VAS) of 40 millimeters, received no pain-controlling medication, and had no other severe disease at its final stage were randomly assigned to two groups (n=52) through the four block method. One group received Duloxetine and the other received Gabapentin. The effectiveness was measured through primary effectiveness (VAS scale) and secondary effectiveness (Sleep Interference Score, and Clinical Global Impression of Change (CGIC)). Medication compliance was assessed by enumerating the number of patients who refused treatment because of side effects. The Fisher's exact T-test and ANOVA were used for data analysis. This study was approved by the Ethics Committee of Jundishapur, University of Medical sciences Ahvaz, Iran, under reference number: IR.AJUMS.REC.1395.78. In addition, this study was registered and approved in the Iranian Registry of Clinical Trials (IRCT ID: IRCT20161023030455N2) (http://irct.ir/).

Results:

VAS, Sleep Interference Score, and CGIC were significantly improved (P<0.05) through time in both groups, [For GBP: VASBaseline=64±20.03, VASweek1=55.32±18.76, VASweek4=44.68±15.82, VASweek8=39.43±14.32; For DLX: VASBase-line=62±21.18, VASweek1=58.76±20.37, VASweek4=45.84±16.21, VASweek8=36.78±15.62] while a significant difference between the two groups was not observed (P<0.05). However, such significant improvements were not observed in the Duloxetine group at the end of the first week (P=674). Improvement in Sleep Interference Score and CGIC were similar to the results for the VAS scale. Side effects in the Duloxetine group (n=2) compared to the Gabapentin group (n=9) were significantly less (P<0.001). As a result, medication acceptance in the Duloxetine group (n=47) was significantly better than the Gabapentin (n=41) group (P<0.001).

Conclusion:

Both Duloxetine and Gabapentin are effective for the treatment of PDPP. On the one hand, Gabapentin shows the effect earlier while has more side effects. Conversely, Duloxetine has better medication compliance. Trial registration: The method of this study was approved by the Ethics Committee of Jundishapur University of Medical Sciences, Ahvaz, Iran, under reference number: IR.AJUMS.REC.1395.78. In addition, this study was registered and approved in the Iranian Registry of Clinical Trials (IRCT ID: IRCT20161023030455N2) (http://irct.ir/).

Authors+Show Affiliations

Musculoskeletal Rehabilitation Research Center, Jundishapur University of Medical Sciences, Ahvaz, Iran.Department of Neurology, Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.Department of Pediatrics, Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

31354243

Citation

Majdinasab, Nastaran, et al. "A Comparative Double-blind Randomized Study On the Effectiveness of Duloxetine and Gabapentin On Painful Diabetic Peripheral Polyneuropathy." Drug Design, Development and Therapy, vol. 13, 2019, pp. 1985-1992.
Majdinasab N, Kaveyani H, Azizi M. A comparative double-blind randomized study on the effectiveness of Duloxetine and Gabapentin on painful diabetic peripheral polyneuropathy. Drug Des Devel Ther. 2019;13:1985-1992.
Majdinasab, N., Kaveyani, H., & Azizi, M. (2019). A comparative double-blind randomized study on the effectiveness of Duloxetine and Gabapentin on painful diabetic peripheral polyneuropathy. Drug Design, Development and Therapy, 13, 1985-1992. https://doi.org/10.2147/DDDT.S185995
Majdinasab N, Kaveyani H, Azizi M. A Comparative Double-blind Randomized Study On the Effectiveness of Duloxetine and Gabapentin On Painful Diabetic Peripheral Polyneuropathy. Drug Des Devel Ther. 2019;13:1985-1992. PubMed PMID: 31354243.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparative double-blind randomized study on the effectiveness of Duloxetine and Gabapentin on painful diabetic peripheral polyneuropathy. AU - Majdinasab,Nastaran, AU - Kaveyani,Hossein, AU - Azizi,Mojgan, Y1 - 2019/06/17/ PY - 2018/08/31/received PY - 2019/04/16/accepted PY - 2019/7/30/entrez PY - 2019/7/30/pubmed PY - 2020/2/7/medline KW - Duloxetine KW - Gabapentin KW - painful diabetic peripheral neuropathy SP - 1985 EP - 1992 JF - Drug design, development and therapy JO - Drug Des Devel Ther VL - 13 N2 - Background: The most common cause of polyneuropathy is diabetes mellitus. Neuropathic pain is seen in 26% of diabetic population. Therapeutic techniques for this disease can become challenging. Method: This study was a prospective comparative double-blind randomized study which was conducted during an eight-week period. Totally, 104 painful diabetic peripheral polyneuropathy (PDPP) patients who had a minimum Visual Analog Scale (VAS) of 40 millimeters, received no pain-controlling medication, and had no other severe disease at its final stage were randomly assigned to two groups (n=52) through the four block method. One group received Duloxetine and the other received Gabapentin. The effectiveness was measured through primary effectiveness (VAS scale) and secondary effectiveness (Sleep Interference Score, and Clinical Global Impression of Change (CGIC)). Medication compliance was assessed by enumerating the number of patients who refused treatment because of side effects. The Fisher's exact T-test and ANOVA were used for data analysis. This study was approved by the Ethics Committee of Jundishapur, University of Medical sciences Ahvaz, Iran, under reference number: IR.AJUMS.REC.1395.78. In addition, this study was registered and approved in the Iranian Registry of Clinical Trials (IRCT ID: IRCT20161023030455N2) (http://irct.ir/). Results: VAS, Sleep Interference Score, and CGIC were significantly improved (P<0.05) through time in both groups, [For GBP: VASBaseline=64±20.03, VASweek1=55.32±18.76, VASweek4=44.68±15.82, VASweek8=39.43±14.32; For DLX: VASBase-line=62±21.18, VASweek1=58.76±20.37, VASweek4=45.84±16.21, VASweek8=36.78±15.62] while a significant difference between the two groups was not observed (P<0.05). However, such significant improvements were not observed in the Duloxetine group at the end of the first week (P=674). Improvement in Sleep Interference Score and CGIC were similar to the results for the VAS scale. Side effects in the Duloxetine group (n=2) compared to the Gabapentin group (n=9) were significantly less (P<0.001). As a result, medication acceptance in the Duloxetine group (n=47) was significantly better than the Gabapentin (n=41) group (P<0.001). Conclusion: Both Duloxetine and Gabapentin are effective for the treatment of PDPP. On the one hand, Gabapentin shows the effect earlier while has more side effects. Conversely, Duloxetine has better medication compliance. Trial registration: The method of this study was approved by the Ethics Committee of Jundishapur University of Medical Sciences, Ahvaz, Iran, under reference number: IR.AJUMS.REC.1395.78. In addition, this study was registered and approved in the Iranian Registry of Clinical Trials (IRCT ID: IRCT20161023030455N2) (http://irct.ir/). SN - 1177-8881 UR - https://www.unboundmedicine.com/medline/citation/31354243/A_comparative_double_blind_randomized_study_on_the_effectiveness_of_Duloxetine_and_Gabapentin_on_painful_diabetic_peripheral_polyneuropathy_ L2 - https://dx.doi.org/10.2147/DDDT.S185995 DB - PRIME DP - Unbound Medicine ER -