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Meta-Analysis: Evaluating Placebo Rates Across Outcomes in Eosinophilic Oesophagitis Randomised Controlled Trials.

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Over 40% of patients with eosinophilic oesophagitis show clinical improvement with placebo, influenced by trial design. Objective measures like endoscopy and histology show minimal placebo response, aiding future clinical trial efficiency.

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Area of Science:

  • Gastroenterology
  • Clinical Trials
  • Pharmacology

Background:

  • High placebo response rates complicate drug development for eosinophilic oesophagitis.
  • Optimal trial outcome measures for eosinophilic oesophagitis are not well-defined.

Purpose of the Study:

  • To characterize clinical, endoscopic, and histologic placebo responses in eosinophilic oesophagitis randomized controlled trials (RCTs).
  • To inform the design of more efficient future clinical trials for eosinophilic oesophagitis.

Main Methods:

  • Updated a Cochrane systematic review and meta-analysis of placebo-controlled RCTs for eosinophilic oesophagitis therapies.
  • Pooled proportions of clinical, endoscopic, and histologic responders/remitters to placebo using intention-to-treat and random-effects models.
  • Explored sources of heterogeneity using meta-regression.

Main Results:

  • Included 25 RCTs. Pooled clinical response to placebo was 41.0% (substantial heterogeneity).
  • Older age and higher randomization probability to placebo decreased clinical response.
  • Histologic remission rates were low (4.3% for PEC ≤ 6, 1.3% for PEC ≤ 1).
  • Placebo showed a standardized mean difference of -0.25 in the Eosinophilic Oesophagitis Endoscopic Reference Score.

Conclusions:

  • Over 40% of patients with eosinophilic oesophagitis experience clinical placebo response, influenced by trial design factors.
  • Objective endoscopic and histologic outcomes demonstrate very low placebo response rates.
  • Findings support the use of objective measures to improve the efficiency of eosinophilic oesophagitis clinical trials.