Acetyl-l-Carnitine Improves Pain, Nerve Regeneration, and Vibratory Perception in Patients With Chronic Diabetic Neuropathy
An analysis of two randomized placebo-controlled trials
- Anders A.F. Sima, MD, PHD1,
- Menotti Calvani, MD2,
- Munish Mehra, PHD3,
- Antonino Amato, MD4 and
- for the Acetyl-l-Carnitine Study Group*
- 1Departments of Pathology and Neurology, Wayne State University, Detroit, MI
- 2Sigma-Tau spA, Pomezia, Rome, Italy
- 3Medifacts International, Rockville, MD
- 4Sigma-Tau Research, Gaithersburg, MD
- 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
Abstract
OBJECTIVE—We 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 METHODS—Intention-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.
RESULTS—Data 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.
CONCLUSIONS—These 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.
- 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
Footnotes
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A.A.F.S. is a consultant to Sigma-Tau Research.
- *
↵* A complete list of the participating investigators in the Acetyl-l-Carnitine Study Group is available in the appendix.
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A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
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- Accepted October 7, 2004.
- Received May 19, 2004.
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