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Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy.
Curr Med Res Opin. 2007 Jan; 23(1):147-61.CM

Abstract

OBJECTIVE

To examine the efficacy and safety of tramadol/acetaminophen (APAP) for the management of painful diabetic peripheral neuropathy (DPN).

METHODS

Adults with painful DPN involving the lower extremities received 37.5 mg tramadol/325 mg APAP or placebo, up to 1-2 tablets four times daily, for 66 days. Subjects rated average daily pain and sleep interference from 0 ('none') to 10 ('pain as bad as you can imagine' or 'complete interference') every night. Baseline values were recorded for 7 days before starting study medication. The primary endpoint was change in mean of average daily pain scores from baseline to final week. Secondary efficacy outcomes included pain intensity, sleep interference, quality of life, mood, and global impression of change. Potential study limitations included permission to use serotonin reuptake inhibitors concomitantly (except venlafaxine or duloxetine) and the lack of a tramadol-alone or APAP-alone control group.

RESULTS

A total of 160 subjects received tramadol/APAP and 153 received placebo. Tramadol/APAP reduced average daily pain significantly compared to placebo from baseline to the final week (-2.71 vs. -1.83, p = 0.001). Tramadol/APAP was associated with significantly greater improvement than placebo (p < or = 0.05) for all measures of pain intensity, sleep interference, and global impression, as well as several measures of quality of life and mood. The only adverse event reported by > 10% of subjects in either the tramadol/APAP or placebo group was nausea (11.9% and 3.3%, respectively). Adverse events resulted in early study discontinuation for 8.1% and 6.5% of subjects in the tramadol/APAP and placebo groups, respectively.

CONCLUSION

Tramadol/APAP was more effective than placebo and was well tolerated in the management of painful DPN.

Authors+Show Affiliations

Center for Autonomic and Peripheral Nerve Disorders, Beth Israel-Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA. rfreeman@bidmc.harvard.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17257476

Citation

Freeman, Roy, et al. "Randomized Study of Tramadol/acetaminophen Versus Placebo in Painful Diabetic Peripheral Neuropathy." Current Medical Research and Opinion, vol. 23, no. 1, 2007, pp. 147-61.
Freeman R, Raskin P, Hewitt DJ, et al. Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy. Curr Med Res Opin. 2007;23(1):147-61.
Freeman, R., Raskin, P., Hewitt, D. J., Vorsanger, G. J., Jordan, D. M., Xiang, J., & Rosenthal, N. R. (2007). Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy. Current Medical Research and Opinion, 23(1), 147-61.
Freeman R, et al. Randomized Study of Tramadol/acetaminophen Versus Placebo in Painful Diabetic Peripheral Neuropathy. Curr Med Res Opin. 2007;23(1):147-61. PubMed PMID: 17257476.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy. AU - Freeman,Roy, AU - Raskin,Philip, AU - Hewitt,David J, AU - Vorsanger,Gary J, AU - Jordan,Donna M, AU - Xiang,Jim, AU - Rosenthal,Norman R, AU - ,, PY - 2007/1/30/pubmed PY - 2007/4/4/medline PY - 2007/1/30/entrez SP - 147 EP - 61 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 23 IS - 1 N2 - OBJECTIVE: To examine the efficacy and safety of tramadol/acetaminophen (APAP) for the management of painful diabetic peripheral neuropathy (DPN). METHODS: Adults with painful DPN involving the lower extremities received 37.5 mg tramadol/325 mg APAP or placebo, up to 1-2 tablets four times daily, for 66 days. Subjects rated average daily pain and sleep interference from 0 ('none') to 10 ('pain as bad as you can imagine' or 'complete interference') every night. Baseline values were recorded for 7 days before starting study medication. The primary endpoint was change in mean of average daily pain scores from baseline to final week. Secondary efficacy outcomes included pain intensity, sleep interference, quality of life, mood, and global impression of change. Potential study limitations included permission to use serotonin reuptake inhibitors concomitantly (except venlafaxine or duloxetine) and the lack of a tramadol-alone or APAP-alone control group. RESULTS: A total of 160 subjects received tramadol/APAP and 153 received placebo. Tramadol/APAP reduced average daily pain significantly compared to placebo from baseline to the final week (-2.71 vs. -1.83, p = 0.001). Tramadol/APAP was associated with significantly greater improvement than placebo (p < or = 0.05) for all measures of pain intensity, sleep interference, and global impression, as well as several measures of quality of life and mood. The only adverse event reported by > 10% of subjects in either the tramadol/APAP or placebo group was nausea (11.9% and 3.3%, respectively). Adverse events resulted in early study discontinuation for 8.1% and 6.5% of subjects in the tramadol/APAP and placebo groups, respectively. CONCLUSION: Tramadol/APAP was more effective than placebo and was well tolerated in the management of painful DPN. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/17257476/Randomized_study_of_tramadol/acetaminophen_versus_placebo_in_painful_diabetic_peripheral_neuropathy_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079906X162674 DB - PRIME DP - Unbound Medicine ER -