Real-World Evidence: A Randomized, Controlled, Single-Blinded Trial Comparing Oral Sulfate Tablets Versus PEG...

Area of Science:

• Gastroenterology
• Oncology
• Clinical Trials

Background:

• Colorectal cancer is a leading cause of cancer death in the U.S.
• Suboptimal bowel preparation affects approximately 25% of colonoscopies.
• Poor bowel preparation is a significant deterrent to undergoing colonoscopy.

Purpose of the Study:

• To compare the efficacy, safety, and patient tolerability of oral sulfate tablets (OST) versus polyethylene glycol (PEG) for bowel preparation.
• To assess patient satisfaction and adverse events associated with different bowel preparation methods.
• To evaluate polyp detection rates in relation to bowel preparation quality.

Main Methods:

• A randomized, controlled, single-blinded noninferiority trial involving 177 adult outpatients.
• Endoscopists, blinded to preparation, assessed colon cleansing using the US FDA Bowel Prep Scoring Scale.
• Patients completed questionnaires on preparation satisfaction and adverse events.

Main Results:

• Overall cleansing scores favored OST (67.0% excellent) over PEG (57.8%).
• Polyp identification was higher with OST (60.6%) compared to PEG (54.2%).
• Adverse events were significantly lower with OST (18.1%) versus PEG (65.1%), with nausea being most common in both.

Conclusions:

• Oral sulfate tablets (OST) demonstrate noninferior efficacy and safety compared to PEG formulations.
• OST significantly improves patient tolerability, palatability, and satisfaction.
• OST may be a preferred bowel preparation method for patients undergoing colonoscopy.