Abstract
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.
Glossary
- 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
Footnotes
Go to Neurology.org/NN for full disclosures. Funding information is provided at the end of the article.
The Article Processing Charge was funded by the authors.
- Received February 13, 2019.
- Accepted in final form May 28, 2019.
- Copyright © 2019 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
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