Randomized, double-blind, controlled trial of a combination of alpha-lipoic acid and pregabalin for neuropathic pain: the PAIN-CARE trial

Author:

Gilron Ian12,Robb Sylvia1,Tu Dongsheng3,Holden Ronald R.4,Jackson Alan C.5,Duggan Scott1,Milev Roumen246

Affiliation:

1. Departments of Anesthesiology & Perioperative Medicine and Biomedical & Molecular Sciences, Queen's University, Kingston, ON, Canada

2. Providence Care Hospital, Queen's University, Kingston, ON, Canada

3. Departments of Public Health Sciences and Mathematics and Statistics, and the Cancer Research Institute, Queen's University, Kingston, ON, Canada

4. Department of Psychology, Queen's University, Kingston, ON, Canada

5. Department of Internal Medicine (Section of Neurology), University of Manitoba, Health Sciences Centre, Winnipeg, MB, Canada. Jackson is now with the Department of Clinical Neurosciences (Section of Neurology), University of Calgary, Calgary, AB, Canada

6. Departments of Psychiatry and Psychology, Queen's University, Kingston, ON, Canada

Abstract

Abstract We compared a combination of the nonsedating antioxidant, alpha-lipoic acid (ALA), with the sedating anticonvulsant, pregabalin, vs each monotherapy to treat neuropathic pain due to peripheral neuropathies. In this randomized, double-blind, 3-period crossover trial, participants received oral ALA, pregabalin, and their combination—each for 6 weeks. The primary outcome was mean daily pain intensity at maximal tolerated doses (MTD); secondary outcomes included quality of life (SF-36), sleep (Medical Outcomes Study-Sleep Scale), adverse effects, drug doses, and other measures. Of 55 participants randomized (20—diabetic neuropathy, 19—small fiber neuropathy, and 16—other neuropathies), 46 completed 2 periods, and 44 completed 3. At MTD, the primary outcome of mean pain intensity (0-10) was 5.32 (standard error, SE = 0.18), 3.96 (0.25), 3.25 (0.25), and 3.16 (0.25) at baseline, ALA, pregabalin, and combination, respectively (P < 0.01 for ALA vs combination and pregabalin). Treatment differences were similar in subgroups with diabetic neuropathy and with other neuropathies. SF-36 total scores (higher number indicates better quality of life) were 66.6 (1.88), 70.1 (1.88), and 69.4 (1.87) with ALA, pregabalin, and combination (P < 0.05 for ALA vs combination and pregabalin). At MTD, there were no statistically significant treatment differences in adverse effects or drug doses. This trial demonstrates superiority of pregabalin vs ALA but provides no evidence to suggest added benefit of combining ALA with pregabalin to treat neuropathic pain.

Funder

Institute of Neurosciences, Mental Health and Addiction

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Anesthesiology and Pain Medicine,Neurology (clinical),Neurology

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