Combined analysis to evaluate two different modes of intake of a new 2 litre PEG+E gut cleansing solution for the efficacy, acceptability and safety

Aim: To investigate if different schedules for oral intake of a new 2-litre PEG+E plus ascorbate-containing gut cleansing solution (2L PEG+E) have an effect on the bowel cleansing quality.

Methods: Four controlled clinical studies assed in 413 patients the use of the new 2L PEG+E solution using different schedules of intake. All studies assessed the efficacy, acceptability and safety of Mode 1 („split intake“) with 1L in the evening followed by 1L on the morning of the colonoscopy versus Mode 2 („single intake“) with 2L in the evening before the colonoscopy (control: established comparators). Random allocation was not applied for all included patients receiving 2L PEG+E. Therefore, all patients were stratified according to propensity score for the pooled meta-analysis variables. A p-value of 0.05 was regarded as significant.

Results: 214 patients took 2L PEG+E via mode 1 versus 199 patients using mode 2. The mean age was different with 56.7±14.7 yrs. (mode 1) versus 52.2±12.2 yrs. (mode 2). Gender distribution was similar in both groups. The majority of patients in both groups (95% and 97%, respectively) drank >75% of the scheduled amount. The success rate of effective gut cleansing was 87.4% for mode 1 versus 73.4% for mode 2. The difference with a 95% confidence interval from –21.6% to –6.5% is statistically significant. The timing of the intake also affected the taste evaluation with 81.3% of patients giving an „acceptable/satisfactory“ rating in mode 1 versus 50.8% for mode 2. 41 patients (9.9%) reported 49 drug related adverse events with no significant difference between the different intake groups. In addition, some changes in laboratory shifts (mainly affecting: chloride, potassium, hematocrit) were observed, but without clinical significance.

Conclusion: This meta-analysis demonstrated, that the split intake of the new 2L PEG+E gut lavage solution is associated with a high effective gut cleansing rate (close to 90%), but also that the single dose intake allows successful gut cleansing in more then 70% of patients. The choice for the timing of the intake of 2L PEG+E can be used flexible based on the colonoscopy procedure requirements and/or the professional and social needs of the patients.

Keywords: acceptability, colonoscopy, efficacy, gut preparation, mode of intake