Comparison between PEG 3350 and PEG 4000 for treatment of functional constipation in children aged 4 to 18 years

Background: Two molecular weight variants of PEG, viz. PEG 3350 and PEG 4000 are available commercially for treatment of functional constipation in children, however, relative efficacy of these two formulations has not yet been established. Hence, we compared the efficacy of PEG 3350 and PEG 4000 for treatment of functional constipation in children aged 4 to 18 years. Methods: A total of 90 children were enrolled in the study. The patients were randomized either to receive PEG 3350 (Group A) or PEG 4000 (Group B). Stool frequency and other associated outcomes were noted at baseline and at 4-, 12- and 24-weeks follow-up. Results: At baseline there was no significant difference between the two groups for patient and disease characteristics. Mean stool frequency was 2.98±0.50 and 2.96±0.47 respectively in Groups A and B at baseline; 5.04±0.56 and 5.18±0.75 at 4 weeks, 6.53±0.81 and 7.00±0.00 at 12 weeks and 7.00±0.00 and 7.00±0.00 respectively at 8 weeks in the corresponding groups. Statistically, there was no significant difference between the two groups at any time interval. For other outcomes too, there was no significant difference between the two groups at any follow-up interval except for stool consistency which attained significantly higher score in Group B as compared to Group A at week 4 follow-up (p=0.006). Incidence of diarrhea was also comparable between the two groups. Conclusions: Both PEG3350 and PEG4000 were equally safe and effective measures for treatment of functional constipation in children aged 4-18 years.