Literature DB >> 31150716

Exploring changes in placebo treatment arms in hidradenitis suppurativa randomized clinical trials: A systematic review.

Asma Amir Ali1, Elizabeth K Seng2, Afsaneh Alavi3, Michelle A Lowes4.   

Abstract

BACKGROUND: Hidradenitis suppurativa (HS) is characterized by recurrent, painful nodules in flexural areas.
OBJECTIVE: The objective of this study was to explore the placebo response in HS randomized clinical trials and to compare it briefly with the placebo response in psoriasis and atopic dermatitis.
METHODS: A Cochrane Review on interventions in HS was used as a starting point, and a systematic review was then undertaken by using the PubMed database, yielding 7 HS randomized clinical trials for inclusion in this study.
RESULTS: This review demonstrates that there is a robust placebo response in HS that is most marked in physical signs but also marked in pain responses. LIMITATIONS: Multiple outcome measures utilized in these studies and reporting bias limited this review.
CONCLUSION: This large placebo response has implications for clinical trial design. This knowledge can also help deliver improved clinical care by forming the basis of nonpharmacologic treatments and help optimize current medication use to maximize the placebo effect.
Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Hawthorne effect; atopic dermatitis; clinical outcomes; clinical trial design; hidradenitis suppurativa; pain; placebo response; psoriasis

Mesh:

Substances:

Year:  2019        PMID: 31150716      PMCID: PMC6996561          DOI: 10.1016/j.jaad.2019.05.065

Source DB:  PubMed          Journal:  J Am Acad Dermatol        ISSN: 0190-9622            Impact factor:   11.527


  27 in total

1.  Suggestions for uniform outcome variables when reporting treatment effects in hidradenitis suppurativa.

Authors:  K Sartorius; J Lapins; L Emtestam; G B E Jemec
Journal:  Br J Dermatol       Date:  2003-07       Impact factor: 9.302

Review 2.  Prevalence, Risk Factors, and Comorbidities of Hidradenitis Suppurativa.

Authors:  Iben Marie Miller; Rachel J McAndrew; Iltefat Hamzavi
Journal:  Dermatol Clin       Date:  2016-01       Impact factor: 3.478

3.  Anti-IL-5 recombinant humanized monoclonal antibody (mepolizumab) for the treatment of atopic dermatitis.

Authors:  J M Oldhoff; U Darsow; T Werfel; K Katzer; A Wulf; J Laifaoui; D J Hijnen; S Plötz; E F Knol; A Kapp; C A F M Bruijnzeel-Koomen; J Ring; M S de Bruin-Weller
Journal:  Allergy       Date:  2005-05       Impact factor: 13.146

4.  Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data.

Authors:  M K A Basra; M S Salek; L Camilleri; R Sturkey; A Y Finlay
Journal:  Dermatology       Date:  2015-01-20       Impact factor: 5.366

5.  Adalimumab alleviates skin pain in patients with moderate-to-severe hidradenitis suppurativa: Secondary efficacy results from the PIONEER I and PIONEER II randomized controlled trials.

Authors:  Alexandra B Kimball; Murali Sundaram; Alan L Shields; Stacie Hudgens; Martin Okun; Catherine Foley; Arijit Ganguli
Journal:  J Am Acad Dermatol       Date:  2018-05-19       Impact factor: 11.527

6.  Color Doppler ultrasound assessment of morphology and types of fistulous tracts in hidradenitis suppurativa (HS).

Authors:  Ximena Wortsman; Ariel Castro; Andres Figueroa
Journal:  J Am Acad Dermatol       Date:  2016-08-03       Impact factor: 11.527

7.  Influence of context effects on health outcomes: a systematic review.

Authors:  Z Di Blasi; E Harkness; E Ernst; A Georgiou; J Kleijnen
Journal:  Lancet       Date:  2001-03-10       Impact factor: 79.321

8.  Quality-of-life impairment in patients with hidradenitis suppurativa: a Canadian study.

Authors:  Afsaneh Alavi; Niloofar Anooshirvani; Whan B Kim; Pat Coutts; R Gary Sibbald
Journal:  Am J Clin Dermatol       Date:  2015-02       Impact factor: 7.403

Review 9.  Hidradenitis suppurativa: a common and burdensome, yet under-recognised, inflammatory skin disease.

Authors:  Deirdre Nathalie Dufour; Lennart Emtestam; Gregor B Jemec
Journal:  Postgrad Med J       Date:  2014-02-24       Impact factor: 2.401

Review 10.  Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects.

Authors:  Jim McCambridge; John Witton; Diana R Elbourne
Journal:  J Clin Epidemiol       Date:  2013-11-22       Impact factor: 6.437

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  4 in total

1.  Quantifying the natural variation in lesion counts over time in untreated hidradenitis suppurativa: Implications for outcome measures and trial design.

Authors:  John W Frew; Caroline S Jiang; Neha Singh; Kristina Navrazhina; Roger Vaughan; James G Krueger
Journal:  JAAD Int       Date:  2020-11-07

2.  Clinical response rates, placebo response rates, and significantly associated covariates are dependent on choice of outcome measure in hidradenitis suppurativa: A post hoc analysis of PIONEER 1 and 2 individual patient data.

Authors:  John W Frew; Caroline S Jiang; Neha Singh; David Grand; Kristina Navrazhina; Roger Vaughan; James G Krueger
Journal:  J Am Acad Dermatol       Date:  2019-12-24       Impact factor: 11.527

3.  The effect of subcutaneous brodalumab on clinical disease activity in hidradenitis suppurativa: An open-label cohort study.

Authors:  John W Frew; Kristina Navrazhina; David Grand; Mary Sullivan-Whalen; Patricia Gilleaudeau; Sandra Garcet; Jonathan Ungar; James G Krueger
Journal:  J Am Acad Dermatol       Date:  2020-05-13       Impact factor: 11.527

4.  A Scoping Review of Non-invasive Imaging Modalities in Dermatological Disease: Potential Novel Biomarkers in Hidradenitis Suppurativa.

Authors:  David Grand; Kristina Navrazhina; John W Frew
Journal:  Front Med (Lausanne)       Date:  2019-11-06
  4 in total

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