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Metanx in type 2 diabetes with peripheral neuropathy: a randomized trial.

Abstract

PURPOSE

To determine whether a combination of L-methylfolate, methylcobalamin, and pyridoxal-5'-phosphate (LMF-MC-PLP [Metanx; Pamlab LLC, Covington, La]) improves sensory neuropathy.

RESEARCH DESIGN AND METHODS

This multicenter, randomized, double-blind, placebo-controlled trial involved 214 patients with type 2 diabetes and neuropathy (baseline vibration perception threshold [VPT]: 25-45 volts), who were randomly assigned to 24 weeks of treatment with either L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg or placebo. The primary end point was effect on VPT. Secondary end points included Neuropathy Total Symptom Score (NTSS-6) and Short Form 36 (SF-36), as well as plasma levels of folate, vitamins B(6) and B(12), methylmalonic acid (MMA), and homocysteine.

RESULTS

There was no significant effect on VPT. However, patients receiving LMF-MC-PLP consistently reported symptomatic relief, with clinically significant improvement in NTSS-6 scores at week 16 (P=.013 vs placebo) and week 24 (P=.033). Improvement in NTSS scores was related to baseline MMA and inversely related to baseline PLP and metformin use. Quality-of-life measures also improved. Homocysteine decreased by 2.7±3.0 μmol/L with LMF-MC-PLP versus an increase of 0.5±2.4 μmol/L with placebo (P=.0001). Adverse events were infrequent, with no single event occurring in ≥2% of subjects.

CONCLUSIONS

LMF-MC-PLP appears to be a safe and effective therapy for alleviation of peripheral neuropathy symptoms, at least in the short term. Additional long-term studies should be conducted, as the trial duration may have been too short to show an effect on VPT. In addition, further research on the effects in patients with cobalamin deficiency would be useful.

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  • Authors+Show Affiliations

    ,

    Tulane University Health Sciences Center, New Orleans, LA 70112, USA. vfonseca@tulane.edu

    , , , , , , , ,

    Source

    The American journal of medicine 126:2 2013 Feb pg 141-9

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Diabetes Mellitus, Type 2
    Diabetic Neuropathies
    Double-Blind Method
    Female
    Folic Acid
    Humans
    Male
    Middle Aged
    Pyridoxal Phosphate
    Treatment Outcome
    Vitamin B 12

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    23218892

    Citation

    Fonseca, Vivian A., et al. "Metanx in Type 2 Diabetes With Peripheral Neuropathy: a Randomized Trial." The American Journal of Medicine, vol. 126, no. 2, 2013, pp. 141-9.
    Fonseca VA, Lavery LA, Thethi TK, et al. Metanx in type 2 diabetes with peripheral neuropathy: a randomized trial. Am J Med. 2013;126(2):141-9.
    Fonseca, V. A., Lavery, L. A., Thethi, T. K., Daoud, Y., DeSouza, C., Ovalle, F., ... Rosenstock, J. (2013). Metanx in type 2 diabetes with peripheral neuropathy: a randomized trial. The American Journal of Medicine, 126(2), pp. 141-9. doi:10.1016/j.amjmed.2012.06.022.
    Fonseca VA, et al. Metanx in Type 2 Diabetes With Peripheral Neuropathy: a Randomized Trial. Am J Med. 2013;126(2):141-9. PubMed PMID: 23218892.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Metanx in type 2 diabetes with peripheral neuropathy: a randomized trial. AU - Fonseca,Vivian A, AU - Lavery,Lawrence A, AU - Thethi,Tina K, AU - Daoud,Yahya, AU - DeSouza,Cyrus, AU - Ovalle,Fernando, AU - Denham,Douglas S, AU - Bottiglieri,Teodoro, AU - Sheehan,Peter, AU - Rosenstock,Julio, Y1 - 2012/12/05/ PY - 2012/01/05/received PY - 2012/05/08/revised PY - 2012/06/05/accepted PY - 2012/12/11/entrez PY - 2012/12/12/pubmed PY - 2013/3/13/medline SP - 141 EP - 9 JF - The American journal of medicine JO - Am. J. Med. VL - 126 IS - 2 N2 - PURPOSE: To determine whether a combination of L-methylfolate, methylcobalamin, and pyridoxal-5'-phosphate (LMF-MC-PLP [Metanx; Pamlab LLC, Covington, La]) improves sensory neuropathy. RESEARCH DESIGN AND METHODS: This multicenter, randomized, double-blind, placebo-controlled trial involved 214 patients with type 2 diabetes and neuropathy (baseline vibration perception threshold [VPT]: 25-45 volts), who were randomly assigned to 24 weeks of treatment with either L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg or placebo. The primary end point was effect on VPT. Secondary end points included Neuropathy Total Symptom Score (NTSS-6) and Short Form 36 (SF-36), as well as plasma levels of folate, vitamins B(6) and B(12), methylmalonic acid (MMA), and homocysteine. RESULTS: There was no significant effect on VPT. However, patients receiving LMF-MC-PLP consistently reported symptomatic relief, with clinically significant improvement in NTSS-6 scores at week 16 (P=.013 vs placebo) and week 24 (P=.033). Improvement in NTSS scores was related to baseline MMA and inversely related to baseline PLP and metformin use. Quality-of-life measures also improved. Homocysteine decreased by 2.7±3.0 μmol/L with LMF-MC-PLP versus an increase of 0.5±2.4 μmol/L with placebo (P=.0001). Adverse events were infrequent, with no single event occurring in ≥2% of subjects. CONCLUSIONS: LMF-MC-PLP appears to be a safe and effective therapy for alleviation of peripheral neuropathy symptoms, at least in the short term. Additional long-term studies should be conducted, as the trial duration may have been too short to show an effect on VPT. In addition, further research on the effects in patients with cobalamin deficiency would be useful. SN - 1555-7162 UR - https://www.unboundmedicine.com/medline/citation/23218892/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9343(12)00586-4 DB - PRIME DP - Unbound Medicine ER -