Treatment of functional constipation in infants and young children: PEG 4000 or Milk of Magnesia?
Constipation in otherwise healthy children is a matter of great anxiety to both young patients and their parents. Though a common pediatric problem, constipation can continue long term with stool retention leading to faecal incontinence in some patients.In many cases, constipation may also persist to adulthood. (1)
The most common form of constipation is functional constipation. It is accompanied by painful bowel movements with resultant voluntary withholding of faeces by a child who wants to avoid unpleasant defecation [2].To avoid the passage of another painful bowel movement, the child will contract the anal sphincter or gluteal muscles by stiffening his or her body, hiding in a corner, rocking back and forth, or fidgeting with each urge to defecate [1]. The presence of withholding behaviors supports the diagnosis of functional constipation
When it comes to the management of constipation, maintenance therapy consists of dietary interventions, behavioral modification, and laxatives[2].Multiple kinds of laxatives such as mineral oil or osmotic agents, including magnesium hydroxide or Milk of Magnesia (MOM), lactulose, sorbitol and polyethylene glycol (PEG) with electrolytes.
Polyethylene glycol (PEG) without electrolytes is a relatively new type of osmotic laxative that used successfully in adults and children. It appears to be superior to other osmotic agents in palatability and acceptance by children [3,4,5]. Preliminary clinical data suggest that the administration of PEG to infants is effective without adverse effects noted [6].
Many studies have investigated the efficacy of polyethylene glycol (PEG) in the management of childhood constipation [7,8]. The studies show that PEG increased stool frequency and reduced faecal incontinence episodes, and some studies reported adverse effects.
Many studies have been undertaken to compare the various forms of osmotic laxatives. In a study, Loening-Baucke et al. (3) compared PEG and MOM in constipated children aged more than four years and showed similar effectiveness of PEG and MOM in the long-term treatment of children with constipation and fecal incontinence as they used different inclusion criteria and criteria for successful outcomes in the two studies, comparative effectiveness of PEG could not be assessed.
Taking a cue from this study and to perform comparative analysis in younger patients, in 2009, a study was undertaken by P. Ratanamongkol, et al. (9) from the Department of Pediatrics, Bhumibol Adulyadej Hospital, and Bangkok, to compare polyethylene glycol without electrolytes (PEG4000) with milk of magnesia (MOM) by evaluating the effectiveness, adverse effects, and patient compliance in children below 4 years.
The findings of the study were published in the Asian Biomedicine.
Methodology
All infants and children aged one to four years, who attended at the pediatric outpatient clinic of Bhumibol Adulyadej Hospital for treatment of functional constipation between March 2008 and January 2009, were eligible for this study.
Inclusion criteria were the patients who met the diagnostic Rome III criteria for functional constipation [10], including one month of at least two of the following characteristics: 1) two or fewer defecations per week, at least one episode per week of incontinence after the acquisition of toileting skills, 2) history of excessive stool retention, 3) history of painful or hard bowel movements, 4) the presence of a large faecal mass in the rectum, and 5) history of large- diameter stools that may obstruct the toilet.
Infants and children with renal insufficiency were excluded because they may have the risk of magnesium overdose from the milk of magnesia. Due Consent was taken from the parents of the patients.
Children were randomly given one of the two treatments- PEG or MOM with randomization being computer-generated
Children received initially either PEG 0.5g/kg/day (PEG400 without electrolytes, 10g/ sachet) or MOM 0.5mL/kg/day (milk of magnesia suspension, 400mg/5mL) once daily. A sachet of PEG (10 g) was mixed in 5 ounces (oz) of a beverage (such as juice, or water), making a solution of 5g/75mL. MOM could be mixed into juice or milkshakes, or chocolate and other flavourings.
Parents were provided with written instructions regarding how to adjust the dosage of medication and children were treated with the minimal effective dosage of PEG or MOM, allowing for a daily stool and preventing painful defecation and fecal incontinence. Written instructions informed the aim of treatments being one or two stools of soft consistency (Bristol type: 4-6) each day.
Patients were followed at the end of the 2nd week after initiation of treatment at the pediatric outpatient clinic for evaluation of symptoms.
The primary outcome measure was the improvement rate, defined as the proportion of patients who had > three bowel movements per week and two episodes of fecal incontinence per month, and painful defecation, with or without laxative therapy.
Secondary outcomes included 1) improvement in stool frequency per week; 2) the proportion of the patients who had any adverse effects; and 3) the compliance rate, defined as the proportion of patients who received more than 80% of the medication.
A comparison between the two groups was done by Chi-square or Fisher's exact test.
Results
94 patients were enrolled in the study. The 47 patients were randomly allocated into the PEG group and 47 into the MOM group. Eighty nine patients completed the study.
The key facts that emerged were as follows –
1. Baseline characteristics of age, body weight, sex, initial stool frequency, and duration of constipation were similar between groups.
2. At the four-week follow-up visit, 91% of PEG-treated patients and 65% of the MOM- treated patients exhibited improvement (p=0.003). Patients in the PEG group had a greater improvement in stool frequency after treatment than patients in the MOM group.
3. Overall, adverse effects were mild, transient, and not different among groups, but there were more diarrhoeas in MOM treated patients. No serious adverse effects were observed.
4. Compliance rates were 89% for PEG and 72% for MOM (p=0.041).
Based on the findings, the researchers made some important observations.
• The difference in the effectiveness of treatment between the two medications was observed at two weeks follow-up visit in the study. Patients in the PEG group had more improvement than the MOM group at this time. The treatment response was earlier than expected.
• Diarrhoea occurred more frequently in the MOM group than in the PEG group. These symptoms resolved by reducing the dosage.
• The PEG 4000had a good taste with orange-grapefruit flavor and could be mixed in fruit juice. On the other hand, MOM did not have good palatability, and its taste could not be hidden even when it is mixed with some foods. This difference led to higher compliance in the PEG group
"Present study is the first randomized controlled trial in which all eligible patients were enrolled using newly-defined Rome III criteria for infants and children aged from one to four years withfunctional constipation. This is also the first study that compared the two laxatives, PEG and MOM,in this young age group," noted the authors.
"PEG had more effectiveness and better patient compliance than MOM for the management of functional constipation in infants and children aged from one to four years. Paediatricians and general practitioners will have a new choice of medication for the treatment of functional constipation in infant and children," concluded the authors
The above article has been published by Medical Dialogues under the MD Brand Connect Initiative. For more details on PEG 4000, click here
References
1. SAMUEL NURKO, MD, and LORI A. ZIMMERMAN, MD, Boston Children's Hospital, Boston, Massachusetts Am Fam Physician. 2014 Jul 15;90(2):82-90.
2. Clinical Practice Guideline: Evaluation and treatment of constipation in infants and children: Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2006; 43:e1-13.
3. Loening-Baucke V. Polyethylene glycol without electrolytes for children with constipation andencopresis. J Pediatr Gastroenterol Nutr. 2002; 34: 372-7.
4. Gremse DA, Hixon J, Crutchfield A. Comparison of polyethylene glycol 3350 and lactulose for treatment of chronic constipation in children. Clin Pediatr (Phila). 2002; 41:225-9.
5. Staiano A. Use of polyethylene glycol solution in functional and organic constipation in children. Ital JGastroenterol Hepatol. 1999; 31(Suppl 3): S260-3.
6. Michail S, Gendy E, Preud'Homme D, Mezoff A. Polyethylene glycol for constipation in childrenyounger than eighteen months old. J Pediatr Gastroenterol Nutr. 2004; 39:197-9.
7. Vera L, Dinesh S. Pashankar. A randomized, prospective comparison study of polyethylene glycol 3350 without electrolytes and milk of magnesia for children with constipation and fecal Incontinence. Pediatrics. 2006; 118:528-35.
8. Staiano A. Use of polyethylene glycol solution in functional and organic constipation in
children. Ital JGastroenterol Hepatol. 1999; 31(Suppl 3): S260-3.
9. Ratanamongkol, P., Lertmaharit, S., &Jongpiputvanich, S. (2009). Polyethylene glycol 4000 without electrolytes versus milk of magnesia for the treatment of functional constipation in infants and young children: a randomized controlled trial. Asian Biomedicine, 3, 391-399.
10. Paule E, Peter J, Milla A. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterol. 2006; 130:1519-26.
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