AB Prep: colon cleansing made easier
With the colonoscopy being the main procedure that evaluates and prevents colon cancer; efforts to make the experience tolerable and pleasant has always been a priority and a challenge.
In the United States out of all the people meeting the criteria for screening colonoscopy only 35% of the people actually undergo the procedure. Therefore, thousands of people still develop colon cancer and die unnecessarily.
The AB Prep is made out of three FDA approved generic medications. The mechanism of cleansing is a combination of osmotic and stimulant laxatives ).
A total of 16 tablets taken over two main steps.
Clinincal trial was conducted to evaluate the safety and efficacy of the prep.
1-Patients’ electrolytes including Glucose, Sodium, Potassium, Chloride, Bun, Creatinine, Co2, Calcium, Alkaline Phosphotase, ALT, AST, Magnesium, and Phosphorus, EKG with QTc were compared before and after Prep consumption.
2-In addition subjective data was collected from the patients to grade compliance, satisfaction, abdominal bloating, abdominal pain, nausea, and vomiting, also would they recommend the prep to their family members and friends.
3-To objectively grade the colon cleansing, the colon cleansing was divided into either achieved or not achieved. A picture of the colon was obtained at the end of the procedure to document the colonic mucosa appearance in the cecum, transverse, left colon, and the rectum; the amount of irrigation used to achieve the final cleansing and the duration of the procedures were documented, and graphed, presenting an objective reproducible grading of the cleansing.
A total of 200 patients were evaluated in phase II: 54% women and 46% men, with the mean age of 61, and included patients with hypertension, diabetes, renal, cardiac, pulmonary, liver and or seizure disorder. SPSS program was used to evaluate the data.
Results: The prep was noted to be 99.5% effective, 89% had excellent to good cleansing (the mean average plus a standard deviation) and 10.5% had fair cleansing. There was an excellent tolerability, with 100% compliance, 100% satisfaction, 1.5% had abdominal pain, 1.5% abdominal bloating, 2% had nausea, and none had any vomiting.
The electrolytes, QTc interval and EKG remained within normal limits throughout the study with:
-No statistically significant changes noted in:
1-Creatinine 2-Sodium 3-Chloride 4-CO2 5-Calcium 6-Alk Phos. 7-Magnesium 8-Phosphorus
-Statistically significant changes after taking the Prep were noted in:
1-Glucose 8% decrease 2-Bun 23.6% decrease 3- Potassium 3.87% decrease 4-AST 12.6% increase 5-ALT 8.5% increase 6-QTC 2.4% increase, (on the average).
The most important finding throughout phase I and Phase II, that despite the statistical significant changes noted; all the variables studied remained within normal limits. That safety profile was also observed in patients with cardiac, hypertension, renal, diabetes, and seizure disorder.
Patients with severe constipation (One bowel movement per week or more, or one bowel movement every three days or more with the help of laxatives) were treated with two days prep, and the same safety profile was observed.
Conclusion: Although The AB Prep is an effective colon cleansing as the rest of the available preparation; it does however, offer an excellent unmatched safety profile with minimal side effects even when it is taken over two days, with no contraindication even in patients with renal disease. Furthermore, it could be used as a safe and an effective treatment for patients with severe chronic constipation.
Session: Podium Presentation
Program Number: S044