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    Placebo effect in chronic inflammatory demyelinating polyneuropathy: The PATH study and a systematic review.

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    Author
    Lewis, RA; Cornblath, DR; Hartung, H-P; Sobue, G; Lawo, J-P; Mielke, O; Durn, BL; Bril, V; Merkies, ISJ; Bassett, P; ...
    Date
    2020-09
    Source Title
    Journal of the Peripheral Nervous System
    Publisher
    Wiley
    University of Melbourne Author/s
    Roberts, Leslie
    Affiliation
    Medical Education
    Metadata
    Show full item record
    Document Type
    Journal Article
    Citations
    Lewis, R. A., Cornblath, D. R., Hartung, H. -P., Sobue, G., Lawo, J. -P., Mielke, O., Durn, B. L., Bril, V., Merkies, I. S. J., Bassett, P., Cleasby, A., van Schaik, I. N. & PATH study group (2020). Placebo effect in chronic inflammatory demyelinating polyneuropathy: The PATH study and a systematic review.. J Peripher Nerv Syst, 25 (3), pp.230-237. https://doi.org/10.1111/jns.12402.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/251528
    DOI
    10.1111/jns.12402
    Open Access at PMC
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7497019
    Abstract
    The Polyneuropathy And Treatment with Hizentra (PATH) study required subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) to show dependency on immunoglobulin G (IgG) and then be restabilized on IgG before being randomized to placebo or one of two doses of subcutaneous immunoglobulin (SCIG). Nineteen of the 51 subjects (37%) randomized to placebo did not relapse over the next 24 weeks. This article explores the reasons for this effect. A post-hoc analysis of the PATH placebo group was undertaken. A literature search identified other placebo-controlled CIDP trials for review and comparison. In PATH, subjects randomized to placebo who did not relapse were significantly older, had more severe disease, and took longer to deteriorate in the IgG dependency period compared with those who relapsed. Published trials in CIDP, whose primary endpoint was stability or deterioration, had a mean non-deterioration (placebo effect) of 43%, while trials with a primary endpoint of improvement had a placebo response of only 11%. Placebo is an important variable in the design of CIDP trials. Trials designed to show clinical improvement will have a significantly lower effect of this phenomenon than those designed to show stability or deterioration.

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