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Factors predicting clinical and endoscopic remission with placebo therapy in East Asian patients with ulcerative colitis: a systematic review and meta-analysis

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Abstract

Background

The placebo effect in randomized controlled trials (RCTs) for East Asian patients with ulcerative colitis (UC) has been poorly characterized. This systematic review and meta-analysis aimed to determine the placebo rates of clinical and endoscopic remission in East Asian patients with UC and to identify factors that influenced placebo outcomes.

Methods

A comprehensive search was performed to identify all eligible RCTs. The placebo rates of clinical and endoscopic remission were pooled by random effects. Univariate meta-regression was performed to evaluate the influence of different factors on these placebo rates.

Results

Fourteen induction and seven maintenance RCTs were included, comprising 1781 East Asian patients with UC. The pooled placebo rates of clinical and endoscopic remission for induction trials were 13% (95% confidence interval [CI] 10–16%) and 26% (95% CI 21–32%), respectively. Corresponding values for maintenance trials were 15% (95% CI 10–23%) and 24% (95% CI 19–29%). Heterogeneity existed among the studies. On univariate meta-regression, the route of drug administration, outcome definition, disease severity, disease duration, distal disease and concomitant corticosteroids influenced the outcomes of placebo arms.

Conclusions

The placebo rates of clinical and endoscopic remission in RCTs for East Asian patients with UC range from 13 to 26%, and are influenced by specific study characteristics. These results can inform the design and interpretation of future clinical trials in this region.

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Funding

This work was supported by the 13th Five-Year Plan for National Key R&D Program of China (2018YFC1705402).

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Authors and Affiliations

  1. Department of Gastroenterology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China

    Jian Zeng & Xiao-Jun Yang

  2. Department of Gastroenterology, University of Chinese Academy of Sciences Chongqing Renji Hospital (Fifth People’s Hospital of Chongqing), Chongqing, China

    Zhong Wang

Authors
  1. Jian Zeng
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  2. Zhong Wang
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Contributions

Xiao-Jun Yang and Jian Zeng contributed to the study conception and design. Jian Zeng and Zhong Wang performed literature search, data collection, quality assessment and statistical analyses. Jian Zeng drafted the initial manuscript. All authors reviewed and approved the final version of the manuscript.

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Correspondence to Zhong Wang or Xiao-Jun Yang.

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Zeng, J., Wang, Z. & Yang, XJ. Factors predicting clinical and endoscopic remission with placebo therapy in East Asian patients with ulcerative colitis: a systematic review and meta-analysis. Eur J Clin Pharmacol 78, 1069–1077 (2022). https://doi.org/10.1007/s00228-022-03312-3

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  • DOI: https://doi.org/10.1007/s00228-022-03312-3

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