PT  - JOURNAL ARTICLE
AU  - Ari Breiner
AU  - Carolina Barnett Tapia
AU  - Leif Erik Lovblom
AU  - Bruce A. Perkins
AU  - Hans D. Katzberg
AU  - Vera Bril
TI  - Randomized, controlled crossover study of IVIg for demyelinating polyneuropathy and diabetes
AID  - 10.1212/NXI.0000000000000586
DP  - 2019 Sep 01
TA  - Neurology - Neuroimmunology Neuroinflammation
PG  - e586
VI  - 6
IP  - 5
4099  - http://nn.neurology.org/content/6/5/e586.short
4100  - http://nn.neurology.org/content/6/5/e586.full
SO  - Neurol Neuroimmunol Neuroinflamm2019 Sep 01; 6
AB  - 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.AE=adverse event; ANCOVA=analysis of covariance; CIDP=chronic inflammatory demyelinating polyneuropathy; DM=diabetes mellitus; DSP=diabetic sensorimotor polyneuropathy; EFNS=European Federation of Neurological Societies; IQR=interquartile range; IVIg=IV immunoglobulin; LLN=lower limit of normal; MRC=Medical Research Council; NCS=nerve conduction study; ONLS=Overall Neuropathy Limitation Scale; R-ODS=Rasch-based Overall Disability Scale; SF=Short Form 36-item; ULN=upper limit of normal