Comparison of the efficacy and safety of tramadol/acetaminophen combination therapy and gabapentin in the treatment of painful diabetic neuropathy

S. H. Ko, H. S. Kwon, J. M. Yu, Sei-Hyun Baik, I. B. Park, J. H. Lee, K. S. Ko, J. H. Noh, D. S. Kim, C. H. Kim, J. O. Mok, T. S. Park, H. S. Son, B. Y. Cha

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Abstract

Aims This study compared the efficacy and safety of tramadol/acetaminophen (T/A) and gabapentin in the management of painful diabetic neuropathy. Methods An open, randomized, comparative study was conducted. Subjects with painful symmetric neuropathy in the lower limbs and mean pain-intensity score ≥ 4 on a numeric rating scale were eligible. Subjects were randomized to receive either tramadol (37.5 mg)/acetaminophen (325 mg) or gabapentin (300 mg) for 6 weeks. After 2 weeks of the titration period (1200 mg/day for gabapentin and three tablets/day for T/A), the doses were maintained if the pain was relieved. The primary efficacy outcome was a reduction in pain intensity. Secondary measures evaluated a pain relief scale, a Brief Pain Inventory, a 36-item Short Form Health Survey, average pain intensity and sleep disturbance. Results One hundred and sixty-three subjects (T/A 79; gabapentin 84) were included. At the final visit, the mean doses were 1575 mg/day for gabapentin and 4.22 tablets/day for T/A. Both groups were similar in terms of baseline pain intensity (mean intensity: T/A 6.7 ± 1.6; gabapentin 6.3 ± 1.6, P = 0.168). At the final visit, the mean reductions in pain intensity were similar in both groups (T/A -3.1 ± 2.0; gabapentin -2.7 ± 2.1, P = 0.744). Both groups had similar improvements in every Short Form Health Survey category and Brief Pain Inventory subcategory, and in the mean pain relief scores. Conclusion This study suggests that the T/A combination treatment is as effective as gabapentin in the treatment of painful diabetic neuropathy in patients with Type 2 diabetes.

Original languageEnglish
Pages (from-to)1033-1040
Number of pages8
JournalDiabetic Medicine
Volume27
Issue number9
DOIs
Publication statusPublished - 2010 Sep 1

Keywords

  • diabetic complication
  • painful diabetic neuropathy
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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    Ko, S. H., Kwon, H. S., Yu, J. M., Baik, S-H., Park, I. B., Lee, J. H., Ko, K. S., Noh, J. H., Kim, D. S., Kim, C. H., Mok, J. O., Park, T. S., Son, H. S., & Cha, B. Y. (2010). Comparison of the efficacy and safety of tramadol/acetaminophen combination therapy and gabapentin in the treatment of painful diabetic neuropathy. Diabetic Medicine, 27(9), 1033-1040. https://doi.org/10.1111/j.1464-5491.2010.03054.x