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

Colorectal cancer is the second leading cause of cancer death in the United States, yet ∼25% of patients undergoing colonoscopy have suboptimal bowel preparation. Bowel preparation is cited as the leading deterrent to an elective colonoscopy.

This randomized, controlled, single-blinded noninferiority trial assessed the efficacy, safety, and patient tolerability of oral sulfate tablets (OST) compared with polyethylene glycol (PEG) based bowel preparation formulations, with explicit consideration of patient satisfaction and adverse events. Between March and August 2024, adult outpatients at Albany Medical Center requiring routine colonoscopies were consented and enrolled. Endoscopists were blinded to preparation assignments and graded the cleansing of the colon based on the US FDA Bowel Prep Scoring Scale. Patients completed a preparation satisfaction questionnaire.

This study assessed 177 patients (n=94 OST/n=83 PEG). Overall cleansing scores favored OST with 67.0% "excellent" preparations versus 57.8% for PEG. Although differences were not statistically significant in segmental analyses, trends favored OST. Generally, bowel preparation cleansing scores for the proximal, mid, and distal colon were numerically better for OST. Polyp identification was higher for OST (60.6%) versus PEG (54.2%). Tolerability favored OST, with 18.1% of patients in the OST group reporting adverse events (AE) versus 65.1% of patients in the PEG group. The most common AE for both groups was nausea. OST was "tolerable" to "very easy" to consume in 88.3% of patients compared with 78.6% for patients in the PEG group. OST was again requested by 92.6% of patients, compared with 60.7% of patients in the PEG group.

This real-world study demonstrates the noninferior efficacy and safety of OST compared with conventional PEG-based formulations while highlighting improved patient tolerability, palatability, and potential preference bias due to free-of-charge provision.