Nutritional management of patients with diabetic peripheral neuropathy with L-methylfolate-methylcobalamin-pyridoxal-5-phosphate: results of a real-world patient experience trial.

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. RESEARCH DESIGN AND 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.

Assessing Effects of l-Methylfolate in Depression Management: Results of a Real-World Patient Experience Trial.

OBJECTIVE: l-Methylfolate has been shown in retrospective and prospective studies to enhance antidepressant response. The aim of this study was to prospectively assess change in depression severity and medication satisfaction in patients prescribed l-methylfolate within a naturalistic setting. METHOD: Between November 2010 and April 2012, patients who reported being treated for major depressive disorder rated their experiences before and after 3 months on the prescription medical food l-methylfolate (Deplin) 7.5 mg or 15 mg, through an automated telephone system. Survey questions included the 9-item Patient Health Questionnaire (PHQ-9), as well as quality of life and medication satisfaction questions. The primary outcome was change in depression severity from baseline to endpoint. RESULTS: Of 554 patients, 502 reported that l-methylfolate was added to their existing antidepressant and 52 were treated with l-methylfolate alone, without an antidepressant. Enrolled participants reported a mean reduction of 8.5 points (58.2% decrease) in their PHQ-9 score (mean baseline PHQ-9 score = 14.6, mean follow-up PHQ-9 score = 6.1; P = .000); 376 (67.9%) responded to treatment (50% reduction in baseline PHQ-9 score) and 253 (45.7%) achieved remission (follow-up PHQ-9 score < 5) after an average of 95 days of therapy. In addition, patients achieved significant reductions in self-reported impairment in their work/home/social life (P = .000). Medication satisfaction with l-methylfolate (mean satisfaction score = 7.0) was significantly higher than with prior medication (mean satisfaction score = 5.2; P = .000). CONCLUSIONS: RESULTS show that in a naturalistic setting, patients managed with l-methylfolate achieved statistically significant improvements in self-reported depression symptoms and functioning and greater satisfaction with their medication treatment.