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Meta-Analysis of the Placebo Response in Ulcerative Colitis

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Abstract

Purpose The placebo response rate in randomized controlled trials (RCTs) in ulcerative colitis (UC) varies from 0 to 76%. The aims of this study were to quantify the pooled placebo response rate and identify the factors affecting it. Methods We performed a meta-analysis of 110 RCTs carried out between 1955 and 2005 and published in English. Regression analysis was used to identify factors significantly modifying placebo response. Results The pooled placebo remission rate was 23% (95%CI: 18.4–28%) and the pooled placebo improvement rate was 32.1% (95%CI: 28.1–36.3%). Multivariate analysis showed that the country where the study was performed (P = 0.025 for placebo remission and P = 0.0083 for placebo response rates) significantly influenced the placebo remission and response rates. Conclusion Placebo remission and response rates in RCTs of UC are highly variable and are significantly influenced by the country in which the RCT is performed.

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Author information

Authors and Affiliations

  1. Department of Medicine, Beth Israel Deaconess Medical Center, 300 Deaconess Building, 1 Deaconess Road, Boston, MA, 02215, USA

    Sagar Garud

  2. Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA

    Alphonso Brown, Adam Cheifetz & Ciaran P. Kelly

  3. Cardiovascular Epidemiology Research Unit, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA

    Emily B. Levitan

Authors
  1. Sagar Garud
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  2. Alphonso Brown
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  3. Adam Cheifetz
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  5. Ciaran P. Kelly
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Correspondence to Sagar Garud.

Appendices

Appendix 1

Characteristics of studies reporting maintenance of remission as an endpoint 

Table 5
Full size table

Appendix 2

Forrest plot (random effects) showing maintenance of remission rates in placebo groups in 62 studies. On the Y-axis are the first authors with the publication year. The X-axis shows the placebo group maintenance of remission rate. The placebo group maintenance of remission rates for individual studies are on the right side.

figure a

Appendix 3

Characteristics of studies reporting remission as an endpoint

   
Full size table

Appendix 4

Characteristics of studies reporting improvement as an endpoint

   
Full size table

Appendix 5

Forrest plot (random effects) showing clinical improvement rates in placebo groups in 62 studies. On the Y-axis are the first authors with the publication year. The X-axis shows the placebo improvement rate. The placebo group improvement rates for individual studies are on the right side.

figure b

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Garud, S., Brown, A., Cheifetz, A. et al. Meta-Analysis of the Placebo Response in Ulcerative Colitis. Dig Dis Sci 53, 875–891 (2008). https://doi.org/10.1007/s10620-007-9954-6

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