© 2005 by the American Diabetes Association, Inc.
Acetyl-L-Carnitine Improves Pain, Nerve Regeneration, and Vibratory Perception in Patients With Chronic Diabetic NeuropathyAn analysis of two randomized placebo-controlled trials
1 Departments of Pathology and Neurology, Wayne State University, Detroit, MI Address correspondence and reprint requests to Dr. A.A.F. Sima, Department of Pathology, Wayne State University School of Medicine, 540 E. Canfield Ave., Detroit, MI 48201. E-mail: asima{at}med.wayne.edu OBJECTIVEWe evaluated frozen databases from two 52-week randomized placebo-controlled clinical diabetic neuropathy trials testing two doses of acetyl-L-carnitine (ALC): 500 and 1,000 mg/day t.i.d. RESEARCH DESIGN AND METHODSIntention-to-treat patients amounted to 1,257 or 93% of enrolled patients. Efficacy end points were sural nerve morphometry, nerve conduction velocities, vibration perception thresholds, clinical symptom scores, and a visual analogue scale for most bothersome symptom, most notably pain. The two studies were evaluated separately and combined. RESULTSData showed significant improvements in sural nerve fiber numbers and regenerating nerve fiber clusters. Nerve conduction velocities and amplitudes did not improve, whereas vibration perception improved in both studies. Pain as the most bothersome symptom showed significant improvement in one study and in the combined cohort taking 1,000 mg ALC. CONCLUSIONSThese studies demonstrate that ALC treatment is efficacious in alleviating symptoms, particularly pain, and improves nerve fiber regeneration and vibration perception in patients with established diabetic neuropathy.
Abbreviations: ALC, acetyl-L-carnitine ARI, aldose reductase inhibitor DPN, diabetic polyneuropathy NCV, nerve conduction velocity UCES, U.S.-Canadian-European Study UCS, U.S.-Canadian Study
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