Randomised clinical trial: Polyethylene glycol 3350 with sports drink vs. polyethylene glycol with electrolyte solution as purgatives for colonoscopy--the incidence of hyponatraemia.

Abstract

Polyethylene glycol 3350 plus sports drink (PEG-SD) is a hypo-osmotic purgative commonly used for colonoscopy, though little safety data are available. To evaluate the effect of PEG-SD on serum sodium (Na) and other electrolytes compared with PEG-electrolyte solution (PEG-ELS). We performed a single center, prospective, randomised, investigator-blind comparison of PEG-ELS to PEG-SD in out-patients undergoing colonoscopy. Laboratories were obtained at baseline and immediately before and after colonoscopy. The primary endpoint was development of hyponatraemia (Na <135 mmol/L) the day of colonoscopy. Changes in electrolyte levels were computed as the difference between the lowest value on the day of colonoscopy and baseline. Purgative tolerance and efficacy were assessed. A total of 389 patients were randomised; 364 took purgative and had baseline and day of colonoscopy labs (180 PEG-SD, 184 PEG-ELS). The groups were well matched except for a higher fraction of women and Blacks in PEG-ELS. Seven patients (3.9%) in PEG-SD and four patients (2.2%) in PEG-ELS developed hyponatraemia (OR = 1.82, 95% CI: 0.45-8.62, P = 0.376). Changes in electrolytes from baseline were small but significantly worse with PEG-SD for sodium, potassium and chloride (P = 0.001, 0.012, 0.001, respectively). Preparation completion, adverse events, and overall colon cleansing were similar between the groups, but PEG-ELS had more excellent preparations (52% vs. 30%; P = 0.001). Greater, but very modest, electrolyte changes occur with PEG-SD. Hyponatraemia is infrequent with both purgatives. A significant increase in hyponatraemia was not identified for PEG-SD vs. PEG-ELS, but the sample size may have been inadequate to identify a small, but clinically important difference. ClinicalTrials.gov identifier NCT01299779.