Study
Efficacy and Safety of Pregabalin and Alpha-Lipoic Acid Combination in Patients With Painful Diabetic Peripheral Neuropathy: A Randomized, Open-Label, Non-Inferiority, Phase IV Clinical Trial and Subgroup Analysis (OPTIMUM Study).
In 151 people with painful diabetic neuropathy, adding alpha-lipoic acid did not beat pregabalin alone for pain at 12 weeks.
Summary Does adding alpha-lipoic acid improve diabetic nerve pain beyond pregabalin? Show / hide ↓
Researchers studied 151 adults with type 2 diabetes and painful diabetic peripheral neuropathy, meaning nerve pain caused by diabetes. For 12 weeks, people were randomly assigned to alpha-lipoic acid, pregabalin, or both medicines. Pain fell by about 20 points out of 100 with pregabalin alone and 23 points with the combination, a difference too small to show a clear benefit from adding alpha-lipoic acid. Side effects were broadly similar, although one smaller subgroup appeared to benefit more from the combination.
What this means for you: This study does not show that adding alpha-lipoic acid improves pain relief overall. Do not buy it specifically for this purpose based on this trial, and remember that the study was fairly small and openly conducted.
moderate evidenceThis 12-week, phase IV multicentre trial enrolled 151 people with type 2 diabetes and painful diabetic peripheral neuropathy. Participants were allocated 1:1:1 to alpha-lipoic acid (ALA) 480 mg/day, pregabalin 150 mg/day, or their combination. The primary endpoint was change from baseline in visual analogue scale pain score. Pregabalin alone reduced pain by 19.73 ± 18.94 mm at week 12, versus 23.28 ± 18.15 mm with the combination. The least-squares mean difference was 3.46 mm (95% CI -4.94 to 11.87), meeting the trial's non-inferiority criterion for pregabalin alone. Safety did not differ significantly among the groups. A cluster with relatively shorter neuropathy duration had a 14.79 mm difference between pregabalin alone and combination treatment (95% CI 4.59 to 24.99; p=0.0055), but this was a subgroup analysis. The reported comparison does not show that adding ALA improved pain overall. This is a treatment study in people with diabetic neuropathic pain, not a study of healthy ageing or longevity.
Pregabalin monotherapy was non-inferior to the combination therapy in alleviating diabetic peripheral neuropathy pain.
The trial was open-label and lasted only 12 weeks. Its endpoint was a pain score in a type 2 diabetes population; the potentially favourable result came from a cluster analysis that requires confirmation.
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