Reducing the Placebo Effect in IBD Clinical Trials:
Study Overview: Post hoc analysis of three placebo-controlled clinical trials (GEMINI-2, UNITI-1/2, CLASSIC-1) involving 683 patients with moderate to severe Crohn’s disease.
Key Findings:
- Predictors of Clinical Remission: Lower CRP levels (<5 mg/L), higher albumin levels (>40 g/L), and shorter disease duration (<5 years) were initially identified as predictors.
- Significant Predictor: On adjusted analysis, shorter disease duration remained the only significant predictor of clinical remission (adjusted OR, 1.67).
Conclusion: To minimize placebo responses in IBD trials, strategies like excluding participants based on disease duration and mild disease severity, as indicated by objective biomarkers, are recommended.
Low-Volume Colonoscopy Preparations in IBD:
- Study Overview: Examined the safety and efficacy of three low-volume colonoscopy preparations in 92 outpatients with IBD.
- Preparations Used:
- 1 L of polyethylene glycol ascorbate (33 patients)
- 2 L of polyethylene glycol ascorbate (28 patients)
- Oral laxative sodium picosulfate (31 patients)
Results:
- No serious adverse events were reported for any preparation.
- All preparations effectively cleansed the bowel, as shown by the Boston Bowel Preparation Scale.
- Sodium picosulfate was the most preferred by patients, both in terms of complete intake and willingness to use again.
Implications for Clinical Practice and Research
- Placebo Effects in IBD Trials: The study on placebo effects highlights the importance of selecting appropriate patients for IBD clinical trials. Focusing on objective measures like CRP and albumin levels, and considering disease duration, can help in accurately assessing the efficacy of new treatments and reducing placebo responses.
- Colonoscopy Preparations for IBD Patients: The findings on low-volume colonoscopy preparations provide valuable insights for improving patient comfort and compliance. These preparations are not only safe and effective but also more palatable for IBD patients, making the colonoscopy preparation process more tolerable.