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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.
Diabetic medicine, September 2010, Volume: 27, Issue: 9Journal Article
Diabet. Med. 27, 1033–1040 (2010) 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.
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