L-carnitine supplementation in dialysis patients: does the evidence justify its use?

Beginning January 1, 2003, the Centers for Medicare and Medicaid Services (CMS) initiated a national coverage determination for the use of levo-carnitine (L-carnitine) in end-stage renal disease (ESRD) patients as a supplement for individuals defined as having a carnitine deficiency, accompanied by either erythropoietin (EPO)-resistant anemia and/or symptomatic intradialytic hypotension. The CMS criteria established for use of this supplement is minimal because EPO-resistant anemia and symptomatic intradialytic hypotension are never defined with any degree of scientific rigor. Even with the minimal criteria, CMS rejected 97% of the claims submitted over the first 6 months of the national coverage. Most importantly, scientific studies to justify use of the supplement do not exist. Based on limited scientific investigations, there appears to be no justification for the government paying for this supplement. A randomized, prospective, controlled study is needed to determine if there is any benefit from L-carnitine supplementation. Pending appropriate scientific proof, I do not believe that we should continue to waste our limited ESRD resources on a treatment of unproven benefit.