National Journal of Physiology, Pharmacy and Pharmacology

RESEARCH ARTICLE
Comparative efficacy of polyethylene glycol 3350 and psyllium in
treatment of pediatric functional constipation: A randomized and
controlled trial

Utsav Shinghal1, Purshottam Kumar Kaundal1, Shruti Sharma2

1
Department of Pharmacology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India, 2Pediatric Gastroenterology, Hepatology
and Nutrition Unit, Atal Institute of Medical Super Specialities, Shimla, Himachal Pradesh, India
Correspondence to: Purshottam Kumar Kaundal, E-mail: [email protected]

Received: May 11, 2023; Accepted: June 05, 2023

ABSTRACT

Background: Functional constipation (FC) is a common childhood problem worldwide. At preseent, polyethylene
glycol (PEG) is considered as standard therapy in pediatric FC patients. Aims and Objectives: The aim of the study
was to compare the efficacy of PEG 3350 versus psyllium in treatment of pediatric FC. Materials and Methods: All
children (aged >1 year) diagnosed with FC according to Rome IV criteria and presenting to the outpatient department of
Pediatric Gastroenterology, Hepatology, and Nutrition Unit of a tertiary health center in North Indian Himalayan state
were randomized into two open label, prospective, parallel groups, namely, Group A (receiving PEG 3350) and Group B
(receiving psyllium), over a period of 16 months. The comparative efficacy was evaluated by comparing the percent of
patients with successful outcomes in two groups at 4, 8, and 12 weeks of therapy and the rate of recurrence of impaction
in two groups was also assessed and compared over same period. Results: Eighty-one patients were randomized into two
groups. A significantly higher number of patients in Group A was successfully treated after 4 weeks (Group A 68.3% vs.
Group B 42.5%; P = 0.026), 8 weeks (Group A 80.0% vs. Group B 57.9%; P = 0.049), and 12 weeks (Group A 92.3% vs.
Group B 67.6%; P = 0.009) of treatment compared with Group B. Impaction recurred in two patients in Group B while
no recurrence was observed in any of the Group A patients but the difference observed was not statistically significant
(P = 0.494). No significant adverse events were reported in either groups. Conclusion: PEG 3350 was found to be
significantly more effective than psyllium in improving the symptoms of constipation in pediatric patients.

KEY WORDS: Functional Constipation; Polyethylene Glycol; Psyllium; Rome IV Criteria

INTRODUCTION prevalence of around 9.5%.[2] In India, the prevalence ranges

from 0.5% to 30.8%.[3,4] The pediatric constipation may
Functional constipation (FC) is a frequently encountered be caused by several underlying disorders (for example,
childhood problem comprising nearly 25% of the Pediatric Hirschsprung’s disease, gluten enteropathy, hypothyroidism,
Gastroenterology outpatient department (OPD),[1] and pooled etc.) but no underlying cause can be identified in >90%
children presenting with constipation, such children are said
Access this article online to have FC.[5]
Website: www.njppp.com Quick Response code
The FC patient, according to Rome IV criteria, must have 2
or more of the following symptoms occurring at least 1/week
DOI: 10.5455/njppp.2023.13.05290202305062023 for a minimum of 1 month: ≤2 defecations in the toilet per
week in a child of at least 4 years of age, ≥1 episode of fecal
incontinence per week, history of retentive posturing, history

National Journal of Physiology, Pharmacy and Pharmacology Online 2023. © 2023 Purshottam Kumar Kaundal, et al. This is an Open Access article distributed under the terms of the
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Shinghal et al. PEG 3350 versus psyllium in pediatric FC

of painful/hard bowel movements, presence of a large fecal the Rome IV criteria of FC were included in the study
mass in the rectum, and history of large stools that obstruct except those presenting with red flag signs of constipation
the toilet.[6] which include constipation starting before 1 month of age,
passage of meconium after 48 h, failure to thrive, gluten
The most common underlying event that predisposes to FC enteropathy, family history of Hirschsprung disease, thyroid
is the avoidance of defecation due to social reasons like disorders, ribbon stools, bloody stools, severe distension of
travelling or while in school. This leads to build-up of feces in abdomen, fever, bilious vomiting, perianal fistula, absent
colon and more and more resorption of water from the feces anal/cremasteric reflex, abnormal position of anus, anal
by the colonic mucosa, as a result the retained fecal material scars, tuft of hair on spine, and sacral dimple.[13] The study
becomes harder and cause pain on evacuation. This pain on was conducted on 81 pediatric FC patients.
evacuation further promotes the withholding of stools and
the rectum becomes progressively distended leading to fecal
incontinence and reduced GI motility causing anorexia and Run-in Phase
abdominal distension.[6] The baseline data were collected from the eligible patients
after obtaining informed consent from parents/legally
The management of pediatric FC includes patient and parents acceptable representative and assent from children (>7 years
counseling, toilet training, dietary modifications, drug of age). After the baseline evaluation, the patients were
therapy, and follow-up.[7] The drug therapy consists of two subjected to disimpaction therapy with osmotic laxative
phases, an initial disimpaction phase followed by a prolonged (PEG 3350) or combined osmotic and stimulant laxative
maintenance phase. Disimpaction means dislodging the (sodium picosulfate) or enema.
hard, impacted feces from the rectum while prolonged
maintenance therapy is aimed at passage of daily soft
painless stools and prevention of recurrence of impaction. Treatment Phase
At present, polyethylene glycol (PEG) 3350 is often used for After successful disimpaction was done, the patients were
maintenance therapy with psyllium showing contradictory randomized into two groups (Group A and Group B)
efficacy. based on random numbers (generated by a computer-based
technique) placed in an opaque sealed envelope. These
PEG acts as an osmotic laxative. It forms hydrogen bonds sequentially numbered envelopes were given by a blinded
with water molecules, in a ratio of 100 water molecules author, with no access to study subjects. The study subjects
per 1 PEG molecule leading to increase in colonic water in Group A received PEG 3350 therapy (0.8–1 g/kg body
content. After oral intake, stool consistency improves within weight/day) and Group B received psyllium therapy (6 g/day
24–48 h.[8] While psyllium acts as a bulk laxative. It is a for children aged 1 to <12 years and 12 g/day for children
hydrophilic mucilloid that is readily fermentable by colonic aged 12–18 years) for 12 weeks.
bacteria leading to an increased bacterial mass in colon.[9] In
addition, psyllium also stimulates the muscarinic and 5-HT4 The patients were advised to take their respective treatment
receptors in gut which enhances its laxative action.[10] for a 12-week period and the medication dose was gradually
tapered over this 12-week period depending on the
Foroughi et al. reported that psyllium was significantly symptomatic improvement of the patient. Furthermore, the
less effective than PEG in treating pediatric FC.[11] While a patients were given dietary advises, that is, to increase the
mixture of acacia fiber, psyllium fiber and fructose showed fiber intake in diet and take plenty of fluids. The parents were
similar efficacy to PEG in treatment of pediatric FC in a counseled to toilet-train the children.
study by Quitadamo et al.[12] Hence, considering the limited
evidence available on the comparative efficacy of two agents,
the present study was undertaken to compare the efficacy and Follow-up
safety of two agents. All the patients were followed up weekly for first 4 weeks
and fortnightly for another 8 weeks, that is, at 1, 2, 3, 4, 6,
MATERIALS AND METHODS 8, 10, and 12 weeks either in OPD visits or telephonically.
The defecation frequency per week; encopresis frequency
The study was an open label, prospective, parallel group, per week; number of stools associated with pain, straining
randomized, controlled, and clinical trial conducted in and bleeding per week; presence of retentive posturing; and
the outpatient department of Pediatric Gastroenterology, stool consistency were recorded in the proforma during each
Hepatology, and Nutrition Unit of a tertiary health center in follow-up. Furthermore, any adverse events experienced by
Himalayan region (Shimla, Himachal Pradesh) in India over the patient during the study period were recorded systemically
a period of 1 year and 4 months (July 9, 2021 to November 8, including the date/time of onset and resolution, frequency,
2022). All patients in the age group of 1–18 years fulfilling severity, and alteration in drug dose/temporary cessation of

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Shinghal et al. PEG 3350 versus psyllium in pediatric FC

therapy/withdrawal of therapy needed to treat the adverse Statistical Analysis

event and outcome (resolved/ongoing/death/unknown).
SPSS version 20.0 was used for data analysis. The
quantitative variables were reported as mean ± SD and
Efficacy and Safety qualitative variables as percentage. The Kolmogorov–
The comparative efficacy of PEG 3350 and psyllium was Smirnov test was used to evaluate the normality of the data.
evaluated by comparing the percent of patients with successful Fisher’s exact test was applied for comparison of categorical
outcomes in these two groups at 4, 8, and 12 weeks of therapy. variables in two unrelated samples. The difference between
Successful outcome of treatment was defined as the passage continuous variables in two unrelated samples was analyzed
of daily, not hard nor loose-watery, stools with absence of using Mann–Whitney U-test if not normally distributed and
pain, straining, bleeding, posturing, or incontinence. Student’s t test if normally distributed. P = 0.05 or less was
accepted as statistically significant.
The mean defecation frequency; mean encopresis frequency;
frequency of stools associated with pain, straining, and
bleeding; percent of patients with posturing; and mean stool RESULTS
consistency scores were computed for two groups after 4,
8, and 12 weeks of therapy. The comparative improvement After successful disimpaction, 81 patients were randomized
in symptoms with two agents was evaluated after 4, 8, and to receive either PEG 3350 (Group A) or psyllium therapy
12 weeks of therapy. (Group B) for 12 weeks [Figure 1]. No significant differences
were found with respect to baseline sociodemographic
We, also, compared the rate of recurrence of impaction in two data, anthropometric parameters, and presenting symptoms
groups after 12 weeks of therapy. The safety profiles of PEG between the two groups [Table 1]. During 12 weeks of
and psyllium were also assessed. maintenance therapy, two patients in Group A and one in

Figure 1: Flow chart of study design

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Shinghal et al. PEG 3350 versus psyllium in pediatric FC

Table 1: Comparison of baseline characteristics of patients in Group A and Group B

Variables Group A (n=41) (%) Group B (n=40) (%) P-value
Age, in years (Mean ± Std deviation) 6.15±4.04 5.83±3.92 0.693
Gender
Females (%) 53.66 (n=22) 52.5 (n=21) 1.000
Males (%) 46.34 (n=19) 47.5 (n=19)
Community
Urban (%) 21.95 (n=32) 25.00 (n=10) 0.798
Rural (%) 78.05 (n=9) 75.00 (n=30)
Socioeconomic class
Upper 4.88 (n=2) 0 (n=0) 0.864
Upper middle 48.78 (n=20) 50.0 (n=20)
Lower middle 36.59 (n=15) 40.0 (n=16)
Upper lower 7.32 (n=3) 7.5 (n=3)
Lower 2.44 (n=1) 2.5 (n=1)
Weight, in kg (Mean ± SD deviation) 18.05±9.48 19.76±12.29 0.590
Height, in cm (Mean ± SD deviation) 109.17±26.08 108.94±24.34 0.976
BMI, in kg/m (Mean ± SD deviation)
2
14.53±2.54 15.44±3.33 0.142
No. of stools associated with pain per week (Mean ± SD) 2.95±3.23 2.66±2.58 0.979
No. of stools associated with straining per week (Mean ± SD) 3.27±3.08 2.63±2.47 0.305
No. of stools associated with bleeding per week (Mean ± SD) 0.44±0.84 0.43±0.94 0.647
History of retentive posturing 70.7 (n=29) 70.0 (n=28) 1.000
Presence of palpable fecaloma 87.8 (n=36) 87.5 (n=35) 1.000
History of large diameter stools that can obstruct the toilet 17.07 (n=7) 15.0 (n=6) 1.000
Stool consistency score (Mean ± SD) 1.76±0.86 1.88±0.99 0.694

Group B were lost to follow-up [Figure 1]. Recurrence of was not statistically significant. Furthermore, no patient in
impaction was observed in two patients in Group B, subjected Group A presented with retentive posturing after 8 weeks
to poor compliance of patients to psyllium therapy due to its of therapy compared to 10.53% (n = 4) in Group B with
non-palatable taste. difference not amounting to statistical significance (P = 0.052)
[Table 3].
Comparative Efficacy at 4 Weeks
Comparative Efficacy at 12 Weeks
After 4 weeks of treatment, the Group A patients had a
significantly higher defecation frequency (P = 0.007); a After 12 weeks of maintenance therapy, the statistically
significantly lesser number of stools associated with pain significant improvements in defecation frequency (P = 0.004);
(P < 0.001) and straining (P = 0.004); and a significantly better stools associated with pain (P = 0.003) and straining
stool consistency scores (P < 0.001) compared to those in (P = 0.018); and stool consistency (P = 0.003) were observed
Group B. Although Group A patients did perform better than in Group A patients over Group B patients. No encopresis
those in Group B in encopresis episodes (P = 0.329), bleeding events, bleeding episodes, and posturing was observed in
episodes (P = 0.494), and retentive posturing (P = 0.14) but Group A patients. While in Group B, no bleeding episodes
the differences were not statistically significant [Table 2]. were observed in any patient, posturing was observed in a
single patient and encopresis events were still present in four
patients although still not statistically significant [Table 4].
Comparative Efficacy at 8 Weeks
The significantly better performance of Group A patients
Successful Outcomes
over Group B patients in improvement of defecation
frequency (P = 0.041); stools associated with pain (P < 0.001) Successful outcome of treatment was defined as the passage
and straining (P = 0.003); and stool consistency (P < 0.001) of daily, not hard nor loose-watery, stools with absence
observed at 4 weeks was maintained at 8 weeks as well. of pain, straining, bleeding, posturing, or incontinence.
No bleeding episodes were observed in either Groups after A significantly higher number of patients in the Group A
8 weeks of therapy. The Group A patients had a lesser were successfully treated after 4 weeks (Group A 68.3% vs.
encopresis frequency (P = 0.306) compared to Group B but Group B 42.5%; P = 0.026), 8 weeks (Group A 80.0% vs.

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Shinghal et al. PEG 3350 versus psyllium in pediatric FC

Table 2: Comparative evaluation of two groups after 4 weeks of treatment

Variables Group A (n=41) Group B (n=40) P-value
Defecation frequency per week (Mean ± SD) 9.90±4.30 7.93±2.73 0.007
Encopresis frequency per week (Mean ± SD) 0.20±0.87 0.97±5.07 0.329
No. of stools associated with pain per week (Mean ± SD) 0.39±0.95 1.55±1.79 <0.001
No. of stools associated with straining per week (Mean ± SD) 0.78±1.82 2.21±2.65 0.004
No. of stools associated with bleeding per week (Mean ± SD) 0 0.08±0.47 0.494
Retentive posturing observed in % of patients 9.76 (n=4) 22.5 (n=9) 0.140
Stool consistency score (Mean ± SD) 4.83±1.02 4.05±0.64 <0.001

Table 3: Comparative evaluation of two groups after 8 weeks of treatment

Variables Group A (n=40) Group B (n=38) P-value
Defecation frequency per week (Mean ± SD) 8.89±3.18 7.74±2.74 0.041
Encopresis frequency per week (Mean ± SD) 0.08±0.35 0.38±1.68 0.306
No. of stools associated with pain per week (Mean ± SD) 0.08±0.35 0.87±1.38 <0.001
No. of stools associated with straining per week (Mean ± SD) 0.32±0.89 1.42±2.05 0.003
No. of stools associated with bleeding per week (Mean ± SD) 0 0 1.000
Retentive posturing observed in % of patients 0 10.53 (n=4) 0.052
Stool consistency score (Mean ± SD) 4.65±0.77 4.03±0.75 <0.001

Table 4: Comparative evaluation of two groups after 12 weeks of treatment

Variables Group A (n=39) Group B (n=37) P-value
Defecation frequency per week (Mean ± SD) 8.06±1.91 7.08±2.02 0.004
Encopresis frequency per week (Mean ± SD) 0 0.28±1.19 0.051
No. of stools associated with pain per week (Mean ± SD) 0.03±0.16 0.49±0.99 0.003
No. of stools associated with straining per week (Mean ± SD) 0.18±0.68 0.81±1.41 0.018
No. of stools associated with bleeding per week (Mean ± SD) 0 0 1.000
Retentive posturing observed in % of patients 0 2.7 (n=1) 0.487
Stool consistency score (Mean ± SD) 4.44±0.55 4.05±0.47 0.003

Group B 57.9%; P = 0.049), and 12 weeks (Group A 92.3% Table 5: Comparison of percentage of patients achieving
vs. Group B 67.6%; P = 0.009) of treatment compared with successful outcome between two groups at 4, 8 and 12
the Group B [Table 5]. weeks of treatment
Variables Group A (%) Group B (%) P-value
Recurrence of Impaction during Maintenance Therapy At 4 weeks 68.3 42.5 0.026

During 12 weeks of maintenance therapy, impaction recurred At 8 weeks 80.0 57.9 0.049

in two patients in Group B while no recurrence was noted At 12 weeks 92.3 67.6 0.009

in any of the Group A patients but this difference was not

statistically significant (P = 0.494) [Table 6]. Table 6: Comparison of percentage of patients having
recurrence of impaction between two groups
Adverse Events Variables Group A Group B P-value
(n=39) (%) (n=39) (%)
During the 12-week study period, no significant clinical Recurrence 0 (n=0) 5.13 (n=2) 0.494
adverse effects were reported in either groups. Two patients of impaction
in Group A and one patient in Group B complained of
intermittent episodes of abdominal pain of mild severity DISCUSSION
which gradually resolved without any dose alteration. One
patient in Group A had 3–4 episodes of vomiting over 3 days The present study was conducted to compare the efficacy of
which also resolved spontaneously. PEG 3350 and psyllium in treatment of pediatric FC patients.

2023 | Vol 13 | Issue 07 National Journal of Physiology, Pharmacy and Pharmacology  1524
Shinghal et al. PEG 3350 versus psyllium in pediatric FC

Over a period of 12 weeks, PEG treated patients were J Pediatr 2018;198:121-30.e6.

observed to have a significantly better defecation frequency 3. Bhatia V, Deswal S, Seth S, Kapoor A, Sibal A, Gopalan S.
and stool consistency compared to psyllium treated patients. Prevalence of functional gastrointestinal disorders among
Furthermore, stools associated with pain and staining were adolescents in Delhi based on Rome III criteria: A school-
significantly lesser in PEG treated patients. Although PEG based survey. Indian J Gastroenterol 2016;35:294-8.
4. Kondapalli CS, Gullapalli S. Constipation in children:
did perform better than psyllium in reducing encopresis,
Incidence, causes in relation to diet pattern and psychosocial
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not amount to statistical significance. A significantly higher 5. Tambucci R, Quitadamo P, Thapar N, Zengeri L, Caldaro T,
number of patients in the PEG group were successfully Staiano A, et al. Diagnostic tests in pediatric constipation.
treated after 4, 8 and 12 weeks of therapy compared to the J Pediatr Gastroenterol Nutr 2018;66:e89-98.
psyllium group. Furthermore, PEG 3350 appears to be more 6. Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van
effective in preventing reimpaction but this difference was Tilburg M. Childhood functional gastrointestinal disorders:
not statistically significant. No significant adverse effects Child/adolescent. Gastroenterology 2016;150:1456-68.
were reported in either groups. 7. Yachha SK, Srivastava A, Mohan N, Bharadia L,
Sarma MS. Management of childhood functional constipation:
The findings of our study are in coherence with that of Consensus practice guidelines of Indian society of pediatric
Foroughi et al. who also observed superior efficacy of PEG gastroenterology, hepatology and nutrition and pediatric
gastroenterology chapter of Indian academy of pediatrics.
over psyllium in treating pediatric FC in study done over
Indian Pediatr 2018;55:885-92.
a period of 3 weeks and differs from that of Quitadamo 8. Koppen IJ, Broekaert IJ, Wilschanski M, Papadopoulou A,
et al.[11,12] The differences may be attributable to the fact that Ribes-Koninckx C, Thapar N, et al. Role of polyethylene
Quitadamo et al. used a mixture of acacia fiber, psyllium glycol in the treatment of functional constipation in children.
fiber, and fructose rather than psyllium alone. J Pediatr Gastroenterol Nutr 2017;65:361-3.
9. Brunton LL, Dandan RH, Knollmann BC. Goodman and
Major limitation of our study is that it was an open label Gilman’s: The Pharmacological Basis of Therapeutics. 13th ed.
study and an amount of recall bias (as data were collected on New York: McGraw Hill; 2018.
weekly and fortnightly basis) may be present. 10. Mehmood MH, Aziz N, Ghayur MN, Gilani AH.
Pharmacological basis for the medicinal use of psyllium
husk (Ispaghula) in constipation and diarrhea. Dig Dis Sci
CONCLUSION 2011;56:1460-71.
11. Foroughi M, Ardakani AT, Taghizadeh M, Sharif MR.
From our study, it was concluded that PEG 3350 was Comparing the effect of polyethylene glycol, psyllium seed
significantly more effective than psyllium in treating pediatric husk powder, and probiotics on constipation in children. Iran J
FC. Both PEG 3350 and psyllium were well tolerated with no Pediatr 2022;32:e126565.
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Campanozzi A, et al. A randomized, prospective, comparison
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ACKNOWLEDGMENT vs polyethylene glycol 3350 with electrolytes for the treatment
of chronic functional constipation in childhood. J Pediatr
We wish to acknowledge the valuable assistance of entire 2012;161:710-5.e1.
department of pharmacology, nursing staff of pediatrics ward, 13. Tabbers MM, DiLorenzo C, Berger MY, Faure C,
and all the patients who participated in the present study with Langendam MW, Staiano A, et al. Evaluation and treatment
full patience in contributing to the successful conduct of the of functional constipation in infants and children: Evidence-
study. based recommendations from ESPGHAN and NASPGHAN.
J Pediatr Gastroenterol Nutr 2014;58:258-74.

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