Metanx in type 2 diabetes with peripheral neuropathy: A randomized trial

Vivian A. Fonseca, Lawrence A. Lavery, Tina K. Thethi, Yahya Daoud, Cyrus V Desouza, Fernando Ovalle, Douglas S. Denham, Teodoro Bottiglieri, Peter Sheehan, Julio Rosenstock

Research output: Contribution to journalArticle

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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 B12, 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.

Original languageEnglish (US)
Pages (from-to)141-149
Number of pages9
JournalAmerican Journal of Medicine
Volume126
Issue number2
DOIs
StatePublished - Feb 1 2013

Fingerprint

Peripheral Nervous System Diseases
Vibration
Type 2 Diabetes Mellitus
Placebos
Methylmalonic Acid
Pyridoxal Phosphate
Homocysteine
Vitamin B 6
Metformin
Vitamin B 12
Folic Acid
Research Design
Quality of Life
Calcium
metanx
Therapeutics
Research
mecobalamin

Keywords

  • Diabetic peripheral neuropathy
  • Symptomatic treatment
  • Vitamin B complex

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Fonseca, V. A., Lavery, L. A., Thethi, T. K., Daoud, Y., Desouza, C. V., Ovalle, F., ... Rosenstock, J. (2013). Metanx in type 2 diabetes with peripheral neuropathy: A randomized trial. American Journal of Medicine, 126(2), 141-149. https://doi.org/10.1016/j.amjmed.2012.06.022

Metanx in type 2 diabetes with peripheral neuropathy : A randomized trial. / Fonseca, Vivian A.; Lavery, Lawrence A.; Thethi, Tina K.; Daoud, Yahya; Desouza, Cyrus V; Ovalle, Fernando; Denham, Douglas S.; Bottiglieri, Teodoro; Sheehan, Peter; Rosenstock, Julio.

In: American Journal of Medicine, Vol. 126, No. 2, 01.02.2013, p. 141-149.

Research output: Contribution to journalArticle

Fonseca, VA, Lavery, LA, Thethi, TK, Daoud, Y, Desouza, CV, Ovalle, F, Denham, DS, Bottiglieri, T, Sheehan, P & Rosenstock, J 2013, 'Metanx in type 2 diabetes with peripheral neuropathy: A randomized trial', American Journal of Medicine, vol. 126, no. 2, pp. 141-149. https://doi.org/10.1016/j.amjmed.2012.06.022
Fonseca, Vivian A. ; Lavery, Lawrence A. ; Thethi, Tina K. ; Daoud, Yahya ; Desouza, Cyrus V ; Ovalle, Fernando ; Denham, Douglas S. ; Bottiglieri, Teodoro ; Sheehan, Peter ; Rosenstock, Julio. / Metanx in type 2 diabetes with peripheral neuropathy : A randomized trial. In: American Journal of Medicine. 2013 ; Vol. 126, No. 2. pp. 141-149.
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AU - Desouza, Cyrus V

AU - Ovalle, Fernando

AU - Denham, Douglas S.

AU - Bottiglieri, Teodoro

AU - Sheehan, Peter

AU - Rosenstock, Julio

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