Bowel Prep

Pediatr Gastroenterol Hepatol Nutr.
2022 May;25(3):228-239
https://doi.org/10.5223/pghn.2022.25.3.228
pISSN 2234-8646·eISSN 2234-8840
Original Article Sodium Picosulphate with Magnesium

Citrate versus Polyethylene Glycol for
Bowel Preparation in Children:
A Systematic Review
Piotr Dziechciarz , Marek Ruszczyński , and Andrea Horvath
Department of Pediatrics, The Medical University of Warsaw, Warsaw, Poland
Received: Dec 13, 2021

Accepted: Mar 7, 2022
ABSTRACT
Published online: May 9, 2022
Purpose: To compare the effectiveness, tolerability, acceptability, and safety of sodium
Correspondence to picosulphate with magnesium citrate (PS/Mg) and polyethylene glycol (PEG) in children (≤18
Piotr Dziechciarz
years) preparing for colonoscopy.
Department of Pediatrics, Medical University
of Warsaw, ul. Zwirki i Wigury 63a, 02-091
Methods: Three electronic databases (MEDLINE, EMBASE, Cochrane Central Register of
Warsaw, Poland. Controlled Trials) were searched till July 2020. Only randomized controlled trials (RCTs) were
Email: pdziechciarz@wum.edu.pl included. At least two authors independently selected studies and performed risk of bias
assessment and data extraction.
Copyright © 2022 by The Korean Society of
Results: Four RCTs (n=390), with overall good quality were included. A meta-analysis of two
Pediatric Gastroenterology, Hepatology and
Nutrition trials (n=224) found no statistically significant difference between the groups with respect
This is an open-access article distributed to the proportion of patients who had excellent and good scores (≥6 points) according to
under the terms of the Creative Commons the Boston Bowel Preparation Scale (relative risk: 0.99; 95% confidence interval [CI]: 0.90
Attribution Non-Commercial License (https:// to 1.08). Excellent and good scores were observed in both groups in approximately 90%
creativecommons.org/licenses/by-nc/4.0/)
of children. A meta-analysis of two other trials (n=150) showed no significant difference
which permits unrestricted non-commercial
use, distribution, and reproduction in any
between the groups with respect to the mean total score for the Ottawa Bowel Preparation
medium, provided the original work is properly Scale (mean difference: 0.20; 95% CI: −0.74 to 1.14). Both regimens provided a comparable
cited. safety profile; however, PS/Mg was significantly superior to high volume PEG in terms of
tolerability (abdominal pain, nausea, vomiting, bloating/flatulence/fullness) and acceptability
ORCID iDs
Piotr Dziechciarz
(ease of formulation consumption, taste acceptance, need for nasogastric tube, compliance
https://orcid.org/0000-0003-4227-3130 with full dose).
Marek Ruszczyński Conclusion: PS/Mg provides a quality and safety profile similar to PEG for bowel cleansing;
https://orcid.org/0000-0003-0352-6609 however, it has better acceptance and tolerance in children preparing for colonoscopy.
Andrea Horvath
https://orcid.org/0000-0001-9940-0001 Keywords: Endoscopy; Therapy acceptance; Drug tolerance; Safety; Bowel preparation solution
Funding
The article was funded by The Medical
University of Warsaw. INTRODUCTION
Conflict of Interest
The authors have no financial conflicts of In children, colonoscopy is performed to assess a variety of gastrointestinal conditions
interest. such as chronic diarrhea, lower gastrointestinal bleeding, unexplained anemia, or polyposis
syndrome [1]. The success of colonoscopy relies mainly on appropriate bowel preparation;
inadequate colon cleansing increases the risk of adverse events, the overall procedure time,
and the need for repeated colonoscopy while it decreases cecal intubation rate [2]. From
https://pghn.org 228
Sodium Picosulphate versus Polyethylene Glycol for Bowel Preparation in Children:
A Systematic Review
the children’s perspective, bowel preparation is the most difficult part of the procedure [3].
They are forced to drink a relatively large amount of poorly acceptable fluid in a short period
of time. Because of the lack of compliance for this, the cleansing regimen is sometimes
administered through a nasogastric tube that increases the child discomfort. Numerous
studies have evaluated the efficacy, acceptability, and safety of different bowel preparation
protocols in children. These studies showed that 10% to 30% of colonoscopies are associated
with suboptimal bowel preparation and substantial patient discomfort [4-6]. The current
(2017) ESGE (European Society of Gastrointestinal Endoscopy)/ESPGHAN (European
Society of Pediatric Gastroenterology, Hepatology and Nutrition) guidelines on pediatric
gastrointestinal endoscopy recommends either polyethylene glycol (PEG) or picosulphate
with magnesium citrate (PS/Mg) for bowel preparation [7]. The lack of available evidence
at the time of guideline release prevented the recommendation of the best regimen for
bowel preparation of the two. Therefore, we performed a systematic review to compare the
effectiveness, safety, tolerability, and acceptability of PS/Mg with PEG for bowel preparation
in children prior to colonoscopy.
MATERIALS AND METHODS

We followed the Cochrane Collaboration guidelines and the PRISMA (Preferred Reporting
Items for Systematic Reviews and Meta-Analyses) statement for this review [8]. No ethical
approval was needed to perform this systematic review.
Criteria for considering studies for this review

1. Type of studies
Randomized controlled trials (RCTs) were considered for inclusion.
2. Type of participants
All children under the age of 18 who underwent bowel preparation before colonoscopy.
3. Type of interventions
We included trials that compared the administration of PS/Mg with PEG which were given as
monotherapy in all delivery formulations and vehicles, at any dose.
4. Type of outcomes
Our primary outcome measure was efficacy of total colon cleansing before colonoscopy as
assessed by investigators. If a study used more than one method of quality evaluation of
bowel preparation, we extracted all available methods for comparison.
Secondary outcome measures included tolerability, acceptability, and safety of bowel

preparation. Acceptability was defined as the child’s or caregiver’s assessment of ease
of intake, taste acceptance, need for nasogastric tube, and willingness to repeat the
formulation. Tolerability outcomes were evaluated as the child’s/caregiver assessment of
gastrointestinal or extraintestinal symptoms during bowel preparation such as nausea,
vomiting, abdominal pain, abdominal bloating, dizziness, apathy, or headache. Safety
included adverse events such as electrolyte disturbances, hypotension, or serious adverse
events. We decided to combine secondary outcome measures which were differently defined
but may essentially be summed under the same outcome. All outcome measures had to be
assessed during or after bowel cleansing but before colonoscopy.
https://pghn.org https://doi.org/10.5223/pghn.2022.25.3.228 229

A Systematic Review
Search methods for identification of studies

We searched the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane
Library), MEDLINE via PubMed, and EMBASE databases from January 1980 to July 2020. The
principal search text included word terms and MeSH headings as well as terms describing
populations of interest. We did not apply any language restrictions to our search strategy
(supplementary materials). Additionally, we screened the reference lists from all identified
studies and systematic reviews of interest. We also searched The ClinicalTrials.gov and
ClinicalTrialsRegister.eu websites to identify potentially relevant unpublished RCTs. We did not
consider letters to the editor, abstracts, and proceedings from scientific meetings for inclusion.
Data collection and analysis

Two independent reviewers (MR, PD) used standardized approach and EndNote® software
(Endnote™, Clarivate, Philadelphia, PA, USA) to search the literature, perform data
extraction, and make quality assessment. Any disagreements were resolved by discussion.
Assessment of risk of bias in included studies

Assessing the risk of bias in the identified studies that met the inclusion criteria was
performed by all the reviewers independently using the Cochrane Collaboration’s tool
(Cochrane Collaboration, London, UK) [9]. If the evaluation was not feasible due to missing
information, we rated the respective item as unclear risk of bias.
Assessment of heterogeneity and reporting biases

Heterogeneity was quantified by X2 and I2, which are interpreted as the percentage of the
total variation between studies that is attributable to heterogeneity rather than to chance. No
observed heterogeneity is indicated by a value of 0%, whereas larger values show increasing
heterogeneity. We planned to assess publication bias using the funnel plot proposed by Egger
et al. [10]. However, given the small number of studies (<10) included in the analyses, this
was not performed.
Data synthesis (statistical methods)

We analyzed the data with the use of Review Manager (RevMan [Computer program] Version
5.3 Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). The
dichotomous outcomes, individual study results, and pooled statistics were reported as
risk ratio (RR) between the experimental and control groups with 95% confidence intervals
(95% CI). The mean difference between the treatment and control groups with 95% CI was
reported for all continuous outcomes. If the 95% CI was provided in the original study, we
calculated standard deviation according to the method described in Cochrane Handbook [9].
The random-effects model was applied in all analyses.
RESULTS
Fig. 1 shows the flow diagram documenting the identification process of eligible trials. There
was no disagreement between authors on inclusion and exclusion of studies. Finally, four
RCTs that randomized 380 participants (190 in the PS/Mg and 190 in PEG group) with age
from 2 to 18 years were identified [11-14]. The sample size of trials ranged from 71 to 144
participants. Three studies used the same age adjusted doses of PS/Mg. One RCT used unified
dose of PS/Mg for children >10 years [13]. Four trials provided PEG in the dose which was
rated by authors as high volume and one trial used low volume PEG for bowel cleansing [12].

A Systematic Review
Identification
Records identified through Additional records identified
database searching through other sources
(n=501) (n=0)
Records after duplicates removed

(n=348)
Screening Records screened Records excluded

(n=345) (n=328)
Full-text articles assessed Full-text articles excluded,

for eligibility with reasons (n=14)
(n=18)
Eligibility
- Not RCT
- Other cleansing agent
- Not colonoscopy
Studies included in - Adult patients
qualitative synthesis
(n=4)
Included
Studies included in quantitative

synthesis (meta-analysis)
(n=4)
Fig. 1. Flow diagram.

RCT: randomized controlled trial.
The trials were carried out in Canada, Italy, Poland, and Sweden. The detailed characteristics
of the included RCTs are presented in Table 1.
Risk of bias within studies

Overall, the methodological quality of the 4 RCTs was similar and good (Fig. 2). Sequence
generation and allocation concealment was unclear in one trial. Blinding of participants and
personnel was impossible because of the nature of the intervention. However, it is unlikely
that this affected the primary outcome since it was scored by an endoscopist, for whom
blinding of the outcome assessment was ensured in all trials.
Quality of colon cleansing

The meta-analysis of two trials (n=224) found no difference (relative risk [RR]: 0.99; 95% CI:
0.90 to 1.08) between PS/Mg and high-volume PEGs in the proportion of patients who had
excellent and good scores (≥6) according to Boston Bowel Preparation Scale (BPPS) (Fig. 3).
In both groups, successful colon cleansing (BPPS≥6) was observed in approximately 90% of
patients (PS/Mg: 89%, PEG: 90%) [12,14].
The meta-analysis of the other two trials (n=150) showed no statistically significant difference
between groups on mean total score in the Ottawa Bowel Preparation Scale (MD: 0.20; 95%
CI: −0.74 to 1.14) (Fig. 4) [11,13].
The other bowel preparation quality outcomes were assessed in single studies. Except for
enema requirement (RR: 0.36; 95% CI: 0.14 to 0.91) favoring the PS/Mg group, none of them
found any significant difference between the analyzed group (Table 2). One trial comparing

Table 1. Characteristics of the included studies
Picosulphate/mag nesium
Polyethelene glycol: product
Age of citrate: product and
https://pghn.org
and manufacturer name, dose,
Study patients manufacturer name, dose, Efficacy outcomes Tolerability outcomes Acceptability outcomes Safety outcomes
preparation regimen, number
(y) preparation regimen, number
A Systematic Review
of patients
of patients
Turner et 4–18 Picosalax (Ferring PEG 3350 with electrolytes Ottawa Bowel Preparation Occurrence of Ease of taking colon Any adverse event
al., 2009 Pharmascience Inc., Montreal, (Pharmascience Inc., Score (total); physician gastrointestinal or cleansing preparation, including laboratory
[11] Canada): <6 y: 2x1/4 sachet*; Montreal, Canada) 100 mL/ impression of bowel extraintestinal symptoms taste acceptance, parameters except
6–12 y: 2x1/2 sachet; >12 y: 2x1 year of age/h (max 1 L/h up preparation, enema during colonoscopy compliance with full dose those assessed as
sachet; diluted in 150 mL of to 4 h) starting 6 h before requirement, time required preparation (e.g., nausea, of preparation, satisfaction tolerability outcomes
water at 6 PM the day before colonoscopy, n=40 to reach cecum, proportion vomiting, fullness), need for with colon cleansing
colonoscopy and at 8 AM the of completed colonoscopy, nasogastric tube regimen
day of colonoscopy, n=43 proportion of patients
with failed preparation for
colonoscopy
Di Nardo 2–18 Picoprep, Ferring Italia, <6 y: High dose: PEG 4000 with BBPS for: right colon, Occurrence of Ease of taking colon Any adverse event
et al., 2x1/4 sachet*; 6–12 y: 2x1/2 electrolytes with simeticon medium colon, left colon, gastrointestinal or cleansing preparation; or exacerbation
2014 [12] sachet; >12 y: 2x1 sachet each (PEG-ELS, Selg Esse proportion of patients extraintestinal symptoms willingness to repeat of preexisting
diluted in 150 mL of water, Promefarm, Italy) starting 4 PM >6 pts for total BBPS; during colonoscopy the same intervention; symptoms including
at 4 PM and 5 hours later the day before colonoscopy physician impression of preparation (e.g., nausea, compliance with >75% dose abnormalities in
in the evening before the max. 4 L for 4–6 hours, n=72 bowel preparation cecal vomiting, abdominal pain, of preparation laboratory parameters
colonoscopy, n=72 Low dose: PEG 3350 with intubation rate; time to anal discomfort) need for except those assessed
ascorbic acid (Moviprep reach cecum nasogastric tube as tolerability
Norgine Ltd, Harefield, UK) outcomes
starting at 4 PM the day before
colonoscopy 50 mL/kg (max.
2 L) with additional 25 mL/kg
clear fluid (max. 1l), n=72
https://doi.org/10.5223/pghn.2022.25.3.228
Vejzovic et 10–18 Manufacturer name not PEG 3350 with electrolytes Ottawa Bowel Preparation Occurrence of Ease of taking colon Not provided
al., 2016 provided 2x1 sachet, first (BioPhausia, Stockholm, Score (right colon, medium gastrointestinal or cleansing preparation, taste
[13] sachet mixed with water at Sweden): 25–35 mL/kg body colon, left colon, total), extraintestinal symptoms acceptance
8:00 AM the day before the weight per hour until clear proportion of completed during colonoscopy
colonoscopy. The second intestinal fluid was obtained, colonoscopy, time to reach preparation (e.g., nausea,
sachet was taken 6 to 8 hours either orally or by nasogastric cecum vomiting, abdominal pain,
later, n=36 tube, n=35 anal discomfort, sleeping
problems)
Szaflarska- 1–18 Citrafleet (Takeda PEG 4000 with electrolytes Proportion of patients with Occurrence of Ease of taking colon Not provided
Popławska Pharmaceutical Company (Fortrans Ipsen Pharma) 100 >6 pts for total BBPS, need gastrointestinal or cleansing preparation; taste
et al., Limited, Tokyo, Japan) 2x1† mL/kg (max. 4 L)+simethicone for repeated colonoscopy extraintestinal symptoms acceptance, willingness
2019 [14] sachet diluted in 150 mL of (80 mg/1 L solution), n=43 during colonoscopy to repeat the same
water, n=39 preparation (e.g., nausea, intervention, compliance
vomiting, abdominal pain, with >75% dose of
anal discomfort, sleep preparation
disturbances, sleeping
problems)
PEG: polyethylene glycol, BBPS: Boston Bowel Preparation Scale.
*Each sachet contains: sodium picosulfate 10 mg, magnesium oxide 3.5 mg, citric acid 12 g. †Each sachet contains: sodium picosulfate 10 mg, magnesium oxide 3.5 mg, citric acid 10.97 g.
232
A Systematic Review
Blinding of participants and personnel (performance bias)

Blinding of outcome assessment (detection bias)
Random sequence generation (selection bias)
Incomplete outcome data (attrition bias)

Allocation concealment (selection bias)
Selective reporting (reporting bias)

Other bias
Di Nardo et al., 2014 [12]
Szaflarska-Pop awska et al., 2019 [14]
Turner et al., 2009 [11]
Vejzovic et al., 2016 [13]
Fig. 2. Risk of bias summary.
Picopil Control Odds ratio Odds ratio

Study or subgroup Events Total Events Total Weight M-H, fixed, 95% CI M-H, fixed, 95% CI
Di Nardo et al., 2014 [12] 65 72 66 72 58.1% 0.84 [0.27, 2.65]
Szaflarska-Pop awska et al., 2019 [14] 34 39 38 43 41.9% 0.89 [0.24, 3.36]
Total (95% CI) 111 115 100.0% 0.87 [0.36, 2.05]

Total events 99 104
2 2
Heterogeneity: Chi =0.00, df=1 (p=0.95); I =0% 0.01 0.1 1 10 100
Test for overall effect: Z=0.33 (p=0.74) Favours [experimental] Favours [control]
Fig. 3. Sodium picosulphate/magnesium vs. high volume polyethylene glycol. Meta-analysis of efficacy outcome
measures: Boston Bowel Preparation Scale.
CI: confidence interval.
Picopil Control Mean difference Mean difference

Study or subgroup Mean SD Total Mean SD Total Weight IV, fixed, 95% CI IV, fixed, 95% CI
Turner et al., 2009 [11] 3 3.67 43 4 3.126 40 41.4% 1.00 [ 2.46, 0.46]
Vejzovic et al., 2016 [13] 4.73 2.75 33 3.68 2.37 34 58.6% 1.05 [ 0.18, 2.28]
Total (95% CI) 76 74 100.0% 0.20 [ 0.74, 1.14]

2 2
Heterogeneity: Chi =4.41, df=1 (p=0.04); I =77%
Test for overall effect: Z=0.42 (p=0.68) 4 2 0 2 4
Favours [experimental] Favours [control]
Fig. 4. Sodium picosulphate/magnesium vs. high volume polyethylene glycol. Meta-analysis of efficacy outcome
measures: Ottawa Bowel Preparation Scale.
SD: standard deviation, CI: confidence interval.
PS/Mg with low volume PEG showed no statistically significant differences in any of the
quality outcome measures (Table 2) [12].
Acceptability
The meta-analyses found that PS/Mg is superior to high volume PEG in taste acceptance,
ease of drinking, decreased need for nasogastric tube, willingness to repeat formulation,
and compliance with the full dose of study formulation (Fig. 5). One study showed that 7/31
patients badly tolerated the nasogastric tube [11].

A Systematic Review
Table 2. Quality of bowel preparation in single center studies

Outcome PS/Mg (n/N) PEG (n/N) RR (95% CI)
PS/Mg vs. high volume PEG
Good or excellent preparation according to physcian 33/40 32/40 1.03 (0.84 to 2.7)
Enema requirement 5/43 13/40 0.36 (0.14 to 0.91)
Failed preparation 1/43 2/40 0.49 (0.05 to 5.19)
Colonoscopy completed 35/36 36/36 3 (0.12 to 71)
PS/Mg vs. low volume PEG
BPPS≥6 63/74 56/76 1.15 (0.98 to 1.36)
Cecal intubation rate 71/72 71/72 1 (0.96 to 1.04)
PS/Mg: picosulphate/magnesium, PEG: polyethtylene glycol, BPPS: Boston Bowel Preparation Scale, RR: relative
risk, CI: confidence interval.
Picopil Control Risk ratio (non-event) Risk ratio (non-event)

1.2.1 Ease of drink
Di Nardo et al., 2014 [12] 66 72 25 72 14.9% 0.13 [0.06, 0.28]
Turner et al., 2009 [11] 36 43 7 40 10.8% 0.20 [0.10, 0.39]
Vejzovic et al., 2016 [13] 34 36 5 35 9.6% 0.06 [0.02, 0.25]
Subtotal (95% CI) 190 190 46.2% 0.22 [0.16, 0.30]
Total events 159 44
2 2
Test for overall effect: Z=9.24 (p<0.00001)
1.2.2 Taste acceptance

Turner et al., 2009 [11] 32 43 23 40 5.6% 0.60 [0.32, 1.12]
Vejzovic et al., 2016 [13] 28 35 0 35 11.2% 0.21 [0.11, 0.40]
Subtotal (95% CI) 117 118 21.6% 0.30 [0.19, 0.45]
Total events 97 50
2 2
1.2.3 Willingnes to repeat

Di Nardo et al., 2014 [12] 68 72 25 72 14.9% 0.09 [0.03, 0.22]
Subtotal (95% CI) 111 115 23.0% 0.14 [0.08, 0.26]
Total events 101 41
2 2
1.2.4 Full compliance

Turner et al., 2009 [11] 38 43 22 40 5.9% 0.26 [0.11, 0.63]
Subtotal (95% CI) 82 83 9.2% 0.24 [0.11, 0.51]
Total events 75 54
2 2
Test for overall effect: Z=3.69 (p=0.0002)
Total (95% CI) 500 506 100.0% 0.22 [0.17, 0.27]

Total events 432 189
2 2
Test for overall effect: Z=13.17 (p<0.00001) 0.005 0.1 1 10 200
2 2
Test for subgroup differences: Chi =3.96, df=3 (p=0.27), I =24.3% Worse Control Worse Picopil
Fig. 5. Sodium picosulphate/magnesium vs. high volume polyethylene glycol. Meta-analyses of acceptability
outcome measures.
The study comparing PS/Mg with low volume PEG showed that there is a significantly higher
number of patients randomized to PS/Mg group who reported ease of taking formulation
(RR: 1.41; 95% CI: 1.23 to 1.82), willingness to repeat the bowel cleansing regimen, and
compliance with >75% of the prescribed dose (RR: 1.19; 95% CI: 1.05 to 1.35). Patients given
low volume PEG had comparable need for nasogastric tube with patients given PS/Mg (RR:
0.25; 95% CI: 0.03 to 2.19).

A Systematic Review
Tolerability
Six meta-analyses were performed on tolerability endpoints. PS/Mg had lower RR than high
volume PEG for nausea, vomiting, bloating/flatulence/fullness, abdominal pain, and had
comparable chance for anal discomfort and sleep disturbance (Fig. 6). Single center trials
Picopil Control Risk ratio Risk ratio

1.1.2 Vomiting
Turner et al., 2009 [11] 8 43 14 40 29.2% 0.53 [0.25, 1.13]
Vejzovic et al., 2016 [13] 16 36 31 35 63.2% 0.50 [0.34, 0.74]
Subtotal (95% CI) 118 118 100.0% 0.51 [0.36, 0.73]
Total events 26 49
2 2
1.1.3 Bloating/flatulence/fullness
Di Nardo et al., 2014 [12] 5 72 33 72 38.6% 0.15 [0.06, 0.37]
Turner et al., 2009 [11] 17 43 21 40 25.5% 0.75 [0.47, 1.21]
Vejzovic et al., 2016 [13] 20 36 26 35 30.9% 0.75 [0.53, 1.06]
Subtotal (95% CI) 190 190 100.0% 0.49 [0.37, 0.65]
Total events 42 84
2 2
1.1.4 Nausea
Di Nardo et al., 2014 [12] 10 72 38 72 56.9% 0.26 [0.14, 0.49]
Turner et al., 2009 [11] 15 43 20 40 31.0% 0.70 [0.42, 1.16]
Subtotal (95% CI) 154 155 100.0% 0.37 [0.25, 0.55]
Total events 25 66
2 2
1.1.5 Stomachache
Di Nardo et al., 2014 [12] 2 72 22 72 23.8% 0.09 [0.02, 0.37]
Turner et al., 2009 [11] 23 43 23 40 25.8% 0.93 [0.63, 1.37]
Vejzovic et al., 2016 [13] 30 36 31 35 34.0% 0.94 [0.78, 1.14]
Subtotal (95% CI) 190 190 100.0% 0.73 [0.59, 0.90]
Total events 68 92
2 2
1.1.6 Sleep disturbance

Turner et al., 2009 [11] 16 43 5 40 13.1% 2.98 [1.20, 7.37]
Vejzovic et al., 2016 [13] 13 36 19 35 48.6% 0.67 [0.39, 1.13]
Subtotal (95% CI) 118 118 100.0% 1.13 [0.81, 1.60]
Total events 45 40
2 2
1.1.7 Anal disturbance

Di Nardo et al., 2014 [12] 0 72 6 72 44.7% 0.08 [0.00, 1.34]
Turner et al., 2009 [11] 5 43 5 40 35.6% 0.93 [0.29, 2.97]
Subtotal (95% CI) 154 155 100.0% 0.65 [0.30, 1.43]
Total events 9 14
2 2
1.1.8 Need for nasogastric tube

Di Nardo et al., 2014 [12] 1 72 15 72 32.5% 0.07 [0.01, 0.49]
Szaflarska-Pop awska et al., 2019 [14] 0 39 0 43 Not estimable
Turner et al., 2009 [11] 1 43 30 40 67.5% 0.03 [0.00, 0.22]
Subtotal (95% CI) 154 155 100.0% 0.04 [0.01, 0.17]
Total events 2 45
2 2
2 2
0.1 0.2 0.5 1 2 5 10
Test for subgroup differences: Chi =38.85, df=6 (p<0.00001), I =84.6% Favours [experimental] Favours [control]
Fig. 6. Sodium picosulphate/magnesium vs. high volume polyethylene glycol. Meta-analyses of tolerability
outcome measures.

A Systematic Review
showed that there were no significant differences in the risk of headache, anxiety, dizziness,
apathy, and sadness for both formulations (data not shown). However, one trial found that
patients given PS/Mg had increased risk for the two defecation episodes during the night
before colonoscopy (RR: 12.09; 96% CI: 1.66 to 88.28) [11].
PS/Mg compared with low volume PEG showed lower risk for nausea (RR: 0.34; 95% CI: 0.18
to 0.65), bloating (RR: 0.18; 95% CI: 0.07 to 0.44), and abdominal pain (RR: 0.17; 95% CI:
0.04 to 0.72) and comparable risk for anal discomfort (RR: 0.03; 95% CI: 0.01 to 6.05).
Safety
Two trials showed similar safety profile in both groups [11,12]. They reported no significant
difference in the number of dehydration episodes, as judged by clinical signs and need for
intravenous fluids (no data provided). Each study documented one temporary episode of
lethargy and dehydration: one in PS/Mg group and one in high volume PEG group. One
child treated with PS/Mg had a sodium level of 128 mmol/L without any clinical symptoms of
hyponatremia [11]. One study reported a higher rate of mild hypokalemia (>2.7 mmol/L) in
the high-volume PEG group (58% vs. 34%) and higher frequency of mild hypermagnesemia
(<1.1 mmol/L) in the PS/Mg group (44% vs. 0%) [11]. There were no significant differences
found for the other laboratory values [11,12].
DISCUSSION
Our systematic review of RCTs showed that PS/Mg for children is as effective as high-
volume PEG for colon cleansing before colonoscopy regardless of the method of the of
bowel preparation quality assessment. The meta-analysis of two studies which used BPPS,
currently the most validated and reliable tool for the evaluation of bowel preparation quality,
found that around 90% of children cleaned with each regimen had adequate colon cleansing
[15]. However, our meta-analyses showed that PS/Mg is superior to high volume PEG for
tolerability (abdominal pain, nausea, vomiting, bloating/flatulence/fullness) and acceptability
(ease of formulation taking, taste acceptance, need for nasogastric tube, willingness to repeat
the bowel cleansing regimen, compliance with the full dose of study formulation) outcome
measures. We have not found any important differences in terms of safety measures between
PS/Mg and PEG.
We only identified one study comparing PS/Mg with low volume PEG. This study found mixed
results for efficacy endpoints favoring either PS/Mg (BPPS>6) and showed no difference
between groups on the other quality colon cleansing outcomes (subjective score, mean BPPS
in each of the segments, mean cecal insertion time). Low volume PEG, similar to high volume
regimen, is also inferior in tolerability (nausea, bloating, abdominal pain) and acceptability
endpoints (ease of taking, willingness to repeat, >75% compliance in taking regimens)
but is comparable to PS/Mg on the need for nasogastric tube. The better acceptability and
tolerability of PS/Mg appear to be the result of better taste, and probably to a lesser extent
to lower volume of this agent. Considering the unique needs of the pediatric population,
acceptability and tolerability of bowel cleansing formulation is vital. For this reason, it seems
that PS/Mg can be an appealing alternative to PEG, which is currently the most commonly
used formulation for bowel cleansing in children and adolescents [16]. However it must be
emphasized that three out of four studies were designed to assess the efficacy but not the
tolerability or acceptability. Moreover, these outcome measures were assessed with non-

A Systematic Review
validated scales and subjective measurement tools. Lastly, the data gathering was performed
either in different ways or was not specified by the authors of primary studies, which limits
the reliability of the results of our meta-analyses.
We also acknowledge other limitations of our study. (i) The evidence is based on a
small number of trials; (ii) the bowel preparation regimens and diet restriction prior to
colonoscopy were slightly different among individual studies, thus our pooled results may
be biased; (iii) some outcomes in the present study were reported by a single RCT with a
low number of participants; (iv) even pooled results were of relatively small sample size;
and (v) there is high degree of heterogeneity for most of the meta-analyses on acceptability
and tolerability. However, it must be emphasized that the low number of participants in
these studies are mainly the result of the difficulties in enrolling pediatric patients [17].
Comparing to adult trials, there is a smaller pool of children available due to the lower burden
of diseases. Besides, some parents perceive research studies as a threat and inconvenience to
their children. Thus, they are reluctant to give consent for trial participation. Moreover, the
assessment of subjective outcome measures is difficult in younger children and some of them
have special compliance challenges, including acceptance of trial products which further
limits the recruitment rate in this group of patients.
However, our systematic review has several strengths. The review was based on the
methodology developed by the Cochrane Collaboration and reported according to the
PRISMA statement with assessment of the risk of bias. Multiple efforts were made to decrease
the risk of biases in trial inclusion (e.g., no language or date restrictions imposed and not yet
published trials were searched for). The methodological quality of the individual trials was
good. The meta-analyses on our primary outcome measures including validated scores such
as Ottawa and Boston Bowel Preparation Scales were homogenous and compatible with each
other. The results of our systematic review are d consistent and clear, which we believe are
important for clinical practice.
Recently published systematic review on various bowel preparation formulations for all
indications in children included only two trials at the time of search, comparing PS/Mg
with PEG [6]. The authors of the study combined two different efficacy scoring systems
and found that these two regimens were equally effective for bowel preparation. It must be
acknowledged that putting different bowel cleansing measurement tools in a meta-analysis
makes drawing reliable conclusions difficult. The authors of the aforementioned study
also analyzed the proportion of patients who do not need a nasogastric tube and found
that there was a significantly lower need for nasogastric tube in the PS/Mg group, which is
similar to our meta-analysis results. Our systematic review also showed that both regimens
have a comparable quality of bowel cleaning. We were able to perform meta-analyses on
the effectiveness of colon cleansing with two objective and validated measurement tools.
Moreover, our study provided a larger body of evidence due to the inclusion of more trials
and analysis of more outcome measures. In other systematic review performed in adults, it
was found that PS/Mg and PEG (either low or high volume) without additional agents was
equally effective in colon cleansing, which was similar with our findings [18]. Moreover,
this systematic review found that in almost all (7/8) available trials, PS/Mg based regimen
was generally better accepted and patients were more compliant with the bowel cleansing
protocol (pooled results of 2 studies). However, in contrast to our study, the risk for nausea,
vomiting, and abdominal pain was not different between PS/Mg and PEG in adults. This
could be the result of different methods of data collection in primary studies [18].

A Systematic Review
Aside from giving some implications useful for clinical practice, the findings of this review
also provides useful information for future research. The results of our study emphasizes the
need for adequately powered RCTs comparing PS/Mg with low volume PEG. These should
focus on tolerability and acceptability outcomes assessed with a validated questionnaire
designed also for smaller children.
In summary, both PS/Mg and PEG provide adequate colon cleansing in approximately 90%
of children. Both preparations are equally effective and safe, however most tolerability and
acceptability measures seem to favor PS/Mg for bowel preparations in pediatric patients.
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A Systematic Review
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Pediatr Gastroenterol Hepatol Nutr.

Original Article Sodium Picosulphate with Magnesium

Piotr Dziechciarz , Marek Ruszczyński , and Andrea Horvath

Department of Pediatrics, The Medical University of Warsaw, Warsaw, Poland

Received: Dec 13, 2021

MATERIALS AND METHODS

Criteria for considering studies for this review

Secondary outcome measures included tolerability, acceptability, and safety of bowel

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Search methods for identification of studies

Data collection and analysis

Assessment of risk of bias in included studies

Assessment of heterogeneity and reporting biases

Data synthesis (statistical methods)

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Records after duplicates removed

Screening Records screened Records excluded

Full-text articles assessed Full-text articles excluded,

Studies included in quantitative

Fig. 1. Flow diagram.

Risk of bias within studies

Quality of colon cleansing

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Blinding of participants and personnel (performance bias)

Incomplete outcome data (attrition bias)

Selective reporting (reporting bias)

Fig. 2. Risk of bias summary.

Picopil Control Odds ratio Odds ratio

Total (95% CI) 111 115 100.0% 0.87 [0.36, 2.05]

Picopil Control Mean difference Mean difference

Total (95% CI) 76 74 100.0% 0.20 [ 0.74, 1.14]

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Table 2. Quality of bowel preparation in single center studies

Picopil Control Risk ratio (non-event) Risk ratio (non-event)

1.2.2 Taste acceptance

1.2.3 Willingnes to repeat

1.2.4 Full compliance

Total (95% CI) 500 506 100.0% 0.22 [0.17, 0.27]

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Picopil Control Risk ratio Risk ratio

1.1.6 Sleep disturbance

1.1.7 Anal disturbance

1.1.8 Need for nasogastric tube

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14. Szaflarska-Popławska A, Tunowska D, Sobieska-Poszwa O, Krogulska A. The effectiveness, tolerability,

https://pghn.org https://doi.org/10.5223/pghn.2022.25.3.228 239

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