To evaluate the efficacy of tegaserod as an adjunct to a polyethylene glycol electrolyte solution (PEG-E), given as a whole dose or split dose, in colonoscopy preparation.
Randomized, placebo-controlled, double-blind trial.
A single university-based hospital.
Patients who were undergoing elective colonoscopy.
A 4-arm randomization scheme that compared tegaserod with a placebo, each with whole-dose or split-dose PEG-E preparation.
Efficacy of colon cleansing was the primary outcome. Secondary outcomes included adherence, tolerability, adverse effects, and patient perceptions of their preparation quality.
A total of 382 patients completed the trial. Patients who received the split-dose preparation had significantly better colon cleansing than those who received the whole-dose preparation (88.9 % vs 42.6 % , P < .001). The addition of tegaserod did not significantly improve the overall colonoscopy preparation quality compared with a placebo. However, there were fewer poor preparations in the whole-dose PEG-E group (12.4 % vs 1.1 % , P = .002, Bonferroni correction removes significance) and more excellent preparations in the split-dose group (53.3 % vs 38.3 % , P = .035, Bonferroni correction removes significance) in favor of tegaserod. Interobserver and intraobserver variability analysis showed substantial agreement among endoscopists. Adherence was significantly lower in the whole-dose group versus the split-dose PEG-E group (68.8 % vs 91 % , P < .001), independent of the use of tegaserod. Adverse effects were not different between study groups.
A 4-arm randomization and the single-center nature of the study.
Tegaserod has a marginal effect on the quality of colonoscopy preparation when used as an adjuvant to PEG-E. The split-dose PEG-E was superior to the whole-dose PEG-E and resulted in better colon cleansing, adherence, and tolerance.