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Randomized, controlled crossover study of IVIg for demyelinating polyneuropathy and diabetes
Ari Breiner1, Carolina Barnett Tapia2, Leif Erik Lovblom2
1From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. abreiner@toh.ca.
Objective:
To determine whether IV immunoglobulin (IVIg) is more effective than placebo at reducing disability in patients with diabetes and demyelinating polyneuropathy features.
Methods:
This is a double-blinded, single-center, randomized, controlled crossover trial of IVIg treatment vs placebo. The primary outcome measure was the mean change in Overall Neuropathy Limitation Scale (ONLS) scores during the IVIg phasecompared with the placebo phase. Secondary outcomes include changes in the Rasch-built Overall Disability Scale, Medical Research Council sum scores, grip strength, electrophysiologic measurements, quality of life, and adverse effects.
Results:
Twenty-five subjects were recruited between March 2015 and April 2017. The mean change in ONLS scores was -0.2 points during the IVIg phase and 0.0 points during the placebo phase (p = 0.23). Secondary outcomes did not show significant differences between IVIg and placebo.
Conclusions:
IVIg did not reduce disability, improve strength, or quality of life in patients with demyelinating polyneuropathy features and diabetes after 3 months of treatment in comparison with placebo. Therefore, careful consideration of the primary diagnosis is required before immunomodulatory therapy.
Classification Of Evidence:
This study provides Class I evidence that for patients with diabetes and demyelinating polyneuropathy features, IVIg did not significantly reduce disability.
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