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Dr Swati Bhave 04 July 2018
Data on comparisons of efficacy of various formulations of polyethylene glycol (PEG) is limited.
A recent study published in the Journal of Pediatric Gastroenterology and Nutrition assessed long-term efficacy and safety of polyethylene glycol 3350 with electrolytes (PEG3350 + E) compared to PEG4000 without electrolytes (PEG4000) in constipated children.
This was a double-blinded trial, which included 97 children, 0.5-16 years of age, with constipation – defined as a defecation frequency of less than 3 times per week. Participants were randomized to receive either PEG3350 + E or PEG4000. Primary outcomes were change in total sum score (TSS) at week-52 compared to the baseline, and dose range determination. Treatment success was defined as a defecation frequency of ≥3 per week with <1 episode of fecal incontinence.
Overall, 82 children completed the study. The results revealed that the mean reduction in TSS was -3.81 and -3.74, for PEG3350 + E and PEG4000, respectively. Daily sachet use was: 0-2 years of age - 0.4 to 2.3 and 0.9 to 2.1; 2-4 years of age - 0.1 to 3.5, and 1.2 to 3.2; 4-8 years of age - 1.1 to 2.8 and 0.7 to 3.8; 8-16 years of age - 0.6 to 3.7 and 1.0 to 3.7, in PEG3350 + E and PEG4000, respectively. Meanwhile, treatment success after 52 weeks was achieved in 50% and 45% of the children, respectively. On the other hand, the rates of adverse events were similar between groups, and no drug-related serious adverse events occurred.
The findings indicated comparable efficacy and safety outcomes with both the formulations of PEG.
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