
A Comparative Trial: The Safety and Clinical Efficacy of PEG 3350 and Liquid Paraffin in
Management of Chronic Functional Constipation in Children
385
have any differences in children less or more than 2 years
old and between each different sexes (P Value > 0.05).
Considering the side effects, diarrhea in 9.8%, abdomi-
nal pain in 9.8%, vomiting in 2% and dark color stool in
2% of patients in PEG group were recorded. Oil seepage
in 25.4%, diarrhea in 10.7% and abdominal pain in 5.4%
of liquid paraffin-treated cases occurred.
In PEG group, only 30 cases signed the written consent
forms for doing some biochemical blood tests including
blood sugar, Na, K, Ca, P, BUN, Cr, SGOT and SGPT at
the end of the medical treatment. All of the blood works
were reported normal except mildly elevation of SGPT in
2 cases.
4. Discussion
Laxatives are the most important part in constipation
management. Although some authors mentioned that there
is no sufficient data for supporting better laxatives effi-
cacy than placebo, the growing body of literature rec-
ommends these medications [1,2,7].
Liquid paraffin with high compliance rate has a few
limitations especially in a patient with pulmonary aspira-
tion risk [1,2,8]. Recently, Polyethylene glycols have
received a great deal of attention due to effectiveness,
palatability and safety and they were also recommended
for subjects who have failed or are intolerant to other
medications [7,9]. Different doses, durations, and success
rates were used depending on study protocols [9-15].
Although PEG has been suggested with a dose of 0.2 -
1.5 gr/Kg/day, the starting dose of 1 gr/Kg/day with ad-
justment every 3 days was recommended by Rahhal et al.
[1,5,11-15]. The success rate was reported 55 to more
than 90% [10-14]. Long-term therapy with a mean dura-
tion of 8.4 (3 - 30) months was reported to be effective in
chronic childhood constipation [15]. In this study, 73%
of PEG group was completely recovered and 27% were
successfully treated with a dose of 0.64 gr/Kg/day for
about 6 months. Indeed, 27% of subjects needed long-
term medication for normal bowel pattern but the recov-
ery rate in almost two third of cases is completely con-
vincing to suggest PEG considering the safety and few
side effects observed in this trial. Moreover, the medica-
tion was tolerated well in subjects with the age of less
than two years and this is in agreement with the results
reported in few previous trials [10,11]. The biochemical
blood tests were in the normal ranges even though few
studies have stated some imbalances in these measure-
ments and another didn’t accept these values’ changes
[16,17]. In paraffin group, the success rates and treatment
length were similar to the PEG group. In addition, opti-
mal paraffin dosage was 0.86 mL/Kg/day without any
serious side effects and the most common side effect was
oil seepage that could be annoying in some patients.
Current data bases were searched for comparative tri-
als focusing on laxatives in children chronic constipation.
In two studies, liquid paraffin efficacy was higher than
Sena and lactulose [8,18]. Other studies were reported
better PEG efficacy than lactulose and similar efficacy
with Magnesium hydroxide [10,19]. Karami et al. per-
formed a comparative trial on PEG and liquid paraffin in
chronic childhood functional constipation and stated their
efficacies were remarkable that it was compatible with
this study, but they administered higher dosages of
medications and didn’t evaluate the short-term outcome
after drug discontinuation [14].
Positive family history of chronic constipation was a
worse prognostic factor in this study; it may be due to
common genetic background and environmental factors
in a family. Furthermore, the presence of incontinence
was another poor prognostic factor in this study as it has
been mentioned by some authors [1,11].
5. Conclusion
Polyethylene glycol 3350 and liquid paraffin are safe and
highly effective medications in pediatric functional con-
stipation even during infancy. The positive family history
of chronic constipation and incontinence were poor
prognostic factors for complete recovery. One third of
chronic constipated patients need to continue the medi-
cations for probably years. Future studies should focus
on long-term outcome.
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