title: Nutritional management of patients with diabetic peripheral neuropathy with L-methylfolate-methylcobalamin-pyridoxal-5-phosphate: results of a real-world patient experience trial.
abstract: OBJECTIVE
  Current therapies for diabetic peripheral neuropathy with pain mask the painful symptoms while the underlying pathology continues to progress. This study assessed changes in symptoms and quality of life in patients taking a novel prescription medical food, L-methylfolate-methylcobalamin-pyridoxal-5-phosphate (LMF-MC-PP, Metanx ), intended to address the underlying metabolic needs of patients with diabetic peripheral neuropathy.
  
  
  METHODS
  Between November 2010 and April 2012, patients rated their experiences before and after using LMF-MC-PP through an automated telephone system that included symptomatic items from the Neuropathy Total Symptom Score-6 (NTSS-6) questionnaire and questions related to quality of life and medication satisfaction.
  
  
  RESULTS
  A total of 544 patients participated in the study. Patients reported a mean reduction of 35% in NTSS-6 scores from after 12 weeks on LMF-MC-PP. Mean (standard deviation) score was reduced by 1.5 (1.8) at 12 weeks from a baseline of 4.3 (1.5) (p < 0.05). Patients achieved significant reductions in self-reported disruptions in work/school activities, social life, and family life, respectively. Overall pain rating decreased by 32% (p < 0.05). Patients previously treated with medications reported a 52% improvement in medication satisfaction (p < 0.05).
  
  
  CONCLUSIONS
  In a real-world clinical setting, patients with diabetic peripheral neuropathy treated with LMF-MC-PP achieved significant improvements in total symptom score (NTSS-6) and in quality of life and functioning, together with greater medication satisfaction. A limitation of this study was the use of a survey instrument to collect data on patient outcomes.
authors.affiliation: a a Endocrinology Associates of Montgomery , Montgomery , AL , USA.
authors.forename: Bruce S
authors.initials: BS
authors.lastname: Trippe
authors.affiliation: b b Department of Research and Development , Nestlé Health Science - Pamlab Inc. , Covington , LA , USA.
authors.forename: Lori W
authors.initials: LW
authors.lastname: Barrentine
authors.affiliation: b b Department of Research and Development , Nestlé Health Science - Pamlab Inc. , Covington , LA , USA.
authors.forename: Melanie V
authors.initials: MV
authors.lastname: Curole
authors.affiliation: c c InfoMedics , Reading , MA , USA.
authors.forename: Eleanor
authors.initials: E
authors.lastname: Tipa
mesh_terms: D000328:Adult; D000368:Aged; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D011732:Pyridoxal Phosphate / Q000008:administration & dosage*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013763:Tetrahydrofolates / Q000008:administration & dosage*; D014805:Vitamin B 12 / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D013763:Tetrahydrofolates; D011732:Pyridoxal Phosphate; C019476:mecobalamin; D014805:Vitamin B 12; C005984:5-methyltetrahydrofolate
keywords: Diabetic peripheral neuropathy; Endothelial dysfunction; L-methylfolate; Methylcobalamin; Pyridoxal 5′-phosphate