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

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 > or = 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.

• Authors: S-H Ko, H-S Kwon, J-M Yu, S-H 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
• Journal: Diabetic medicine : a journal of the British Diabetic Association (Diabet Med) Vol. 27 Issue 9 Pg. 1033-40 (Sep 2010) ISSN: 1464-5491 [Electronic] England
• PMID: 20722677 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Amines
• Analgesics, Opioid
• Cyclohexanecarboxylic Acids
• Acetaminophen
• Tramadol
• gamma-Aminobutyric Acid
• Gabapentin

Topics

• Acetaminophen (administration & dosage)
• Adult
• Aged
• Amines (administration & dosage)
• Analgesics, Opioid (administration & dosage)
• Cyclohexanecarboxylic Acids (administration & dosage)
• Diabetes Mellitus, Type 2 (complications, drug therapy, physiopathology)
• Diabetic Neuropathies (drug therapy, physiopathology)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Gabapentin
• Humans
• Male
• Middle Aged
• Pain (drug therapy)
• Tramadol (administration & dosage)
• Treatment Outcome
• gamma-Aminobutyric Acid (administration & dosage)