Evidence map›Paper›PMID 32627277›Full record

SynthesisJournal of the peripheral nervous system : JPNS2020

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

Richard A Lewis, David R Cornblath, Hans-Peter Hartung, Gens Sobue, John-Philip Lawo, Orell Mielke, Billie L Durn, Vera Bril, Ingemar S J Merkies, Paul Bassett and 3 more

Open access · hybridAbstract readSystematic Review
In one paragraph

Synthesis in Journal of the peripheral nervous system : JPNS, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
1.3field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Observational
  8. Article
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  14. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 6 countries.

Richard A LewisDepartment of Neurology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
David R CornblathDepartment of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Hans-Peter HartungDepartment of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Heinrich Heine University, Düsseldorf, Germany.
Gens SobueDepartment of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
John-Philip LawoCSL Behring, Marburg, King of Prussia, Pennsylvania, USA.
Orell MielkeCSL Behring, Marburg, King of Prussia, Pennsylvania, USA.
Billie L DurnCSL Behring, Marburg, King of Prussia, Pennsylvania, USA.
Vera BrilEllen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0002-5805-4883
Ingemar S J MerkiesDepartment of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.
Paul BassettMeridian HealthComms Ltd, Manchester, UK.
Alexa CleasbyMeridian HealthComms Ltd, Manchester, UK.ORCID 0000-0002-7075-708X
Ivo N van SchaikDepartment of Neurology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.
PATH study group
CSL (United States) · USHackensack Meridian Health · USCedars-Sinai Medical Center · USHeinrich Heine University Düsseldorf · DEJohns Hopkins University · USMaastricht University · NLNagoya University · JPSpaarne Ziekenhuis · NLUniversity Health Network · CA

Funding

CSL Behring
6 · The paper itself

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.

Indexed as

Immunologic FactorsOutcome Assessment, Health CarePlacebo EffectRandomized Controlled Trials as TopicResearch DesignHumansPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingImmunologic FactorsCIDPimmunoglobulinnon-relapseplaceborelapse

Identifiers

PMID32627277
PMCPMC7497019
OpenAlexW3039245833

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.