A Comparative Trial: The Safety and Clinical Efficacy of PEG 3350 and Liquid Paraffin in Management of Chronic Functional Constipation in Children

doi:10.4236/ijcm.2012.35072

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International Journal of Clinical Medicine, 2012, 3, 383-386

http://dx.doi.org/10.4236/ijcm.2012.35072 Published Online September 2012 (http://www.SciRP.org/journal/ijcm)

A Comparative Trial: The Safety and Clinical Efficacy of

PEG 3350 and Liquid Paraffin in Management of Chronic

Functional Constipation in Children

Abbaslou Parvin1*, Abbaslou Farzaneh2, Hosseini Nasab Ali3

1Department of Pediatric Gastroenterology, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran; 2Depatment

of Pediatrics, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran; 3Department of Pediatric Infectious Dis-

ease, Afzalipour Clinical Research Unit, Kerman University of Medical Sciences, Kerman, Iran.

Email: *[email protected]

Received May 26th, 2012; revised June 28th, 2012; accepted July 14th, 2012

ABSTRACT

Background: Constipation is one of the most common problems in the pediatric age group. In the vast majority,

chronic constipation is idiopathic or functional. In addition to education and behavioral changes, disimpaction and

maintenance treatment with medications are the main pillars of successful outcome. The medications are variably effec-

tive and have potential side effects. Objectives: The current clinical trial was designed to evaluate clinical efficacy of

polyethylene glycol (PEG) 3350 and liquid paraffin in chronic functional constipation. Besides, subjects were followed

carefully for the side effects. Material and Methods: This study was involved 110 children suffering from chronic

functional constipation. They were placed into two different groups, randomly. Each group was treated with PEG 3350

or liquid paraffin. The clinical efficacy and side effects were monitored. Results: After disimpaction with bisacodyl

suppositories or combined with Mineral oil enemas in hard fecal impaction, maintenance therapy with PEG 3350 or

liquid paraffin was started. The treatment duration and efficacies were not different between the two groups. Further-

more, serious adverse drug reaction was not observed. The family history of constipation and presence of incontinence

were two worse prognostic factors. Conclusion: No difference was observed between PEG 3350 and liquid paraffin in

chronic functional constipation in children in terms of their efficacies. They are safe and effective medications in this

age group.

Keywords: Children; Constipation; Liquid Paraffin; Polyethylene Glycol

1. Introduction

Constipation is a common disorder among children; as

many as 25% of visits to pediatric gastroenterologists are

for the treatment of this condition. Chronic constipation

in children often doesn’t have any organic cause and

called functional. From 2006, ROME III Diagnostic Cri-

teria have been defined to unify the functional constipa-

tion definitions [1-3].

Functional constipation may present with difficult and

infrequent defecation or incontinence. Urinary problems,

psychological disorders such as low self-esteem and de-

pression, chronic abdominal pain and decreased appetite

are other common presentations [1,2].

NASPGHAN recommended four important steps for

treatment of functional constipation: education, disim-

paction, prevention of rectal reimpaction and regular

follow up. Various disimpaction protocols using oral or

rectal routs have been published [4-6]. After disimpac-

tion, variety of laxatives for restoring a regular defeca-

tion pattern and preventing relapses has been used [1,2].

Polyethylene glycols (PEG) are osmotic and nonab-

sorbable compounds which are not metabolized by colonic

bacteria. PEG 3350 without electrolytes is available as a

powder and widely used to treat childhood constipation

because of its effectiveness, safety and palatability [1].

Liquid paraffin is the most used lubricant laxative and

composed of saturated hydrocarbons obtained from petro-

leum. Lipoid pneumonia is the most serious complication

and a reason to avoid administration to patients with

tendency for pulmonary aspiration [1,2].

This study was aimed to compare the clinical efficacy

and side effects of these two commonly used laxatives in

childhood functional constipation.

2. Material and Mothods

The current trial was performed from April 2010 until

*Corresponding author.

A Comparative Trial: The Safety and Clinical Efficacy of PEG 3350 and Liquid Paraffin in

Management of Chronic Functional Constipation in Children

384

March 2011 in Afzalipour Hospital on 156 constipated

children who obtained ROME III Criteria. After educa-

tion, a booklet including all necessary information as

well as a symptom and medication diary for every month

of treatment were provided to each parent. Disimpaction

was managed with pediatric suppositories of bisacodyl (5

mg) two times a day or the rectal bisacodyl in combina-

tion with liquid paraffin enemas at a dose of 10 mL/Kg

body weight/dose (maximum 150 mL) two times a day in

hard fecal impaction.

Following successful disimpaction, patients received

PEG 3350 or liquid paraffin randomly as a maintenance

treatment. The questionnaire regarding demographic data,

growth measures, symptoms, past medical and family

histories and physical examination findings were recorded.

The children were followed through periodic appoint-

ments while the dose adjustment was advised to yield

one or two soft stools daily and the side effects were

monitored. When behavioral and dietary changes were

established and normal bowel pattern (≤2 smears in a

month, ≥3 bowel movements in a week without abdomi-

nal pain during maintenance therapy) were achieved for a

few months, the investigator decided to discontinue the

medication gradually. In addition, one month after the

complete discontinuation, patients were visited for re-

lapses. In fact, they would be considered as a complete

recovery case if they didn’t experience any relapse with-

out medication. If so, they called successfully treated

subjects and needed to continue the medication longer.

Moreover, during the follow up, retractable cases were

worked up for organic causes and the case would be ex-

cluded from the study if an organic etiology was found.

The collected data were analyzed by SPSS V16 soft-

ware. Furthermore, all criteria were carried out with α =

0.05 level of significance.

3. Findings

In this trial, 156 children aged 9 months to 11 years were

enrolled. 24 cases were excluded due to absence of

timely manner follow up and early cessation of medica-

tions. 17 retractable cases proceeded with further studies

for organic causes and didn’t complete the trial because

of finding organic etiologies. These secondary etiologies

included: hypocalcemia in 1, hypokalemia in 1, hypo-

thyroidism in 2, cow’s milk protein allergy in 2, ultra

short Hirshprung disease in 2, and anterior ectopic anus

in 8 subjects.

The rest of patients, 110 cases with mean age 36.76 ±

26.94 months, completed the study. They were 59 girls

and 51 boys. Constipation began in mean age 19.62 (2 -

78) months. Recorded symptoms included: withholding

behavior in 93.6%, decreased appetite in 62.5%, chronic

abdominal pain in 34.5% and incontinence in 25% of

cases. Moreover, urinary problems were reported in

21.8%; the most common was urinary tract infection.

The family history of constipation was positive in 22.7%

of subjects. Children nutritional status was assessed ac-

cording to Gomez and Waterlow Criteria: 45.5% of all

patients were mildly underweighted and 6.4% of them

were mildly stunted. Anogenital index was 0.44 ± 0.09

(0.35 - 0.65) in girls and 0.51 ± 0.11 (0.40 - 0.60) in boys.

What’s more, anal fissure in 62.7% and rectal fecal im-

paction in 35.5% of children were detected in the first

examination.

All cases with fecal impaction were free of impaction

in maximum of 5 days while 7.27 ± 2.25 doses of paraf-

fin enemas and rectal bisacodyl were administered. Next,

cases were randomly divided into two groups for main-

tenance treatment; the baseline characteristics of either

group were balanced. Fifty one cases received PEG 3350

with initial mean dosage 0.6 ± 0.16 g/Kg body weight/day

which was altered to optimal mean dosage 0.64 ± 0.24

g/Kg/day. In the next group, 59 children used liquid par-

affin. The starting paraffin dosage was 0.52 ± 0.15

mL/Kg/day and further adjustment resulted in 0.86 ±

1.53 mL/Kg/day.

In PEG group, 37 cases (73%) obtained complete re-

covery, and 14 patients (27%) were treated successfully.

In liquid paraffin group, 38 cases (64%) recovered com-

pletely, 19 cases (32%) were treated successfully and 2

children (4%) didn’t respond (Table 1). There was no

difference between the two groups in terms of full recov-

ery or successfully treatment rates (P Value = 0.333).

The length of the drug therapy to obtain successful

treatment in PEG group was 6.44 ± 3.05 months and in

liquid paraffin group was 6.96 ± 2.76 months without

any statistical difference (P Value = 0.355). The treat-

ment duration to complete recovery was 5.89 ± 2.60

months in PEG group and 6.27 ± 2.53 months in paraffin

group. The difference wasn’t statistically meaningful (P

Value = 0.119).

Recovery rate in continent patients was higher than

incontinent subjects (P Value < 0.0001). Furthermore,

recovery rate was lower in children with positive family

history of chronic constipation in first-degree relatives (P

Value < 0.0001). In addition, the recovery rate didn’t

Table 1. The comparison of PEG and liquid paraffin effi-

cacy in childhood functional constipation.

Drug

Drug effect Paraffin PEG P Value

Treatment Failure 2 (4%) 0 0.333

Successful Treatment 19 (32%) 14 (27%) 0.333

Complete Recovery 38 (64%) 37 (73%) 0.333

Total 59 (100%) 51 (100%)

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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