Nonpharmacologic Treatments for Childhood Constipation: Systematic Review
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REVIEW ARTICLES
Nonpharmacologic Treatments for Childhood
Constipation: Systematic Review
AUTHORS: Merit M. Tabbers, MD, PhD,a Nicole Boluyt, MD,
PhD,b Marjolein Y. Berger, MD, PhD,c and Marc A.
Benninga, MD, PhDa
abstract
OBJECTIVE: To summarize the evidence and assess the reported qual-
Departments of aPediatric Gastroenterology and Nutrition and
bPediatrics, Emma’s Children’s Hospital/Academic Medical
ity of studies concerning nonpharmacologic treatments for childhood
Centre, Amsterdam, Netherlands; and cDepartment of General constipation, including fiber, fluid, physical movement, prebiotics, pro-
Practice, University Hospital Groningen, Groningen, Netherlands biotics, behavioral therapy, multidisciplinary treatment, and forms of
KEY WORDS alternative medicine.
childhood constipation, systematic review, nonpharmacologic
treatments, complementary treatment, alternative treatment METHODS: We systematically searched 3 major electronic databases
ABBREVIATION
and reference lists of existing reviews. We included systematic reviews
RCT—randomized controlled trial and randomized controlled trials (RCTs) that reported on nonpharma-
Drs Tabbers and Berger contributed equally to this work. cologic treatments. Two reviewers rated the methodologic quality
www.pediatrics.org/cgi/doi/10.1542/peds.2011-0179 independently.
doi:10.1542/peds.2011-0179 RESULTS: We included 9 studies with 640 children. Considerable het-
Accepted for publication Jun 13, 2011 erogeneity across studies precluded meta-analysis. We found no RCTs
Address correspondence to Merit M. Tabbers, MD, PhD, for physical movement, multidisciplinary treatment, or alternative
Department of Pediatric Gastroenterology and Nutrition, Emma medicine. Some evidence shows that fiber may be more effective than
Children’s Hospital/Academic Medical Centre, H7-250, PO Box placebo in improving both the frequency and consistency of stools and
22700, 1100 DD Amsterdam, Netherlands. E-mail: m.m.tabbers@
amc.nl
in reducing abdominal pain. Compared with normal fluid intake, we
found no evidence that water intake increases or that hyperosmolar
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
fluid treatment is more effective in increasing stool frequency or de-
Copyright © 2011 by the American Academy of Pediatrics
creasing difficulty in passing stools. We found no evidence to recom-
FINANCIAL DISCLOSURE: The authors have indicated they have
no financial relationships relevant to this article to disclose. mend the use of prebiotics or probiotics. Behavioral therapy with lax-
atives is not more effective than laxatives alone.
CONCLUSIONS: There is some evidence that fiber supplements are
more effective than placebo. No evidence for any effect was found for
fluid supplements, prebiotics, probiotics, or behavioral intervention.
There is a lack of well-designed RCTs of high quality concerning non-
pharmacologic treatments for children with functional constipation.
Pediatrics 2011;128:753–761
PEDIATRICS Volume 128, Number 4, October 2011 753
Downloaded from pediatrics.aappublications.org by guest on September 28, 2015Chronic constipation is a common tions such as osteopathic and chiro- tion was applied. The full search strat-
problem in childhood; the estimated practic manipulations, and spiritual egy is available from the authors.
prevalence is 3% in the Western therapies such as yoga).6
world.1 It is a debilitating condition To date, no systematic reviews of the Study Selection, Data Extraction,
characterized by infrequent painful effectiveness of nonpharmacologic and Methodologic Quality
defecation, fecal incontinence, and ab- treatments (fiber, fluid, physical move- Two reviewers (Drs Tabbers and Bo-
dominal pain. It causes distress to the ment, prebiotics and probiotics, be- luyt) independently screened the ab-
child and family and can result in se- havioral therapy, multidisciplinary stracts of all identified published arti-
vere emotional disturbances and fam- treatment, and forms of alternative cles for eligibility. Inclusion criteria
ily discord. medicine) for childhood constipation were as follows. (1) The study was a
The cause of constipation is multifac- have been published. Furthermore, the systematic review or randomized con-
torial and is not well understood. Cri- published guidelines for the treatment trolled trial (RCT) and contained ⱖ10
teria for a definition of functional con- of functional constipation are based subjects per arm. (2) The study popu-
stipation vary widely and are based on reviews of the literature that did not lation consisted of children 0 to 18
mostly on a variety of symptoms, in- apply a systematic literature search, years of age with functional constipa-
cluding decreased frequency of bowel did not incorporate quality assess- tion. (3) A definition of constipation
movements, fecal incontinence, and a ment of studies, or used a language was provided. (4) The study evaluated
change in stool consistency.2 restriction.5,7–9 Therefore, it was our the effect of a nonpharmacologic
Constipation is difficult to treat for the aim to investigate systematically and treatment, compared with placebo, no
majority of patients and indeed is a to summarize the quantity and quality treatment, another alternative treat-
long-lasting problem. Approximately of all current evidence on the effects of ment, or medication, for constipation.
50% of all children who were moni- fiber, fluid, physical movement, prebi- (5) Nonpharmacologic treatments in-
tored for 6 to 12 months were found to otics, probiotics, behavioral therapy, cluded fiber, fluid, physical movement,
recover and successfully discontinued multidisciplinary treatment, and alter- prebiotics, probiotics, behavioral ther-
laxative therapy.3 A study in a tertiary native medicine (including acupunc- apy, multidisciplinary treatment, and
hospital showed that, despite intensive ture, homeopathy, mind-body therapy, alternative medicine. (6) Outcome
medical and behavioral therapy, 30% musculoskeletal manipulations such measures were either establishment
of patients who developed constipa- as osteopathic and chiropractic ma- of normal bowel habits (increase in
tion before the age of 5 years contin- nipulations, and spiritual therapies defecation frequency and/or decrease
ued to have severe complaints of such as yoga) in the treatment of child- in fecal incontinence frequency) or
constipation, infrequent painful defe- hood constipation. treatment success as defined by the
cation, and fecal incontinence beyond authors of the study, adverse effects,
puberty.4 METHODS and costs. All potentially relevant stud-
The first step in treatment consists of ies were retrieved as full articles. Arti-
Data Sources
education, dietary advice, and behav- cles concerning children with organic
ioral modifications.2 If these are not ef- The Embase, Medline, and PsycINFO da- causes of constipation and children
fective, then laxatives are prescribed. tabases were searched by a clinical li- with exclusively functional, nonreten-
Although there is a lack of placebo- brarian from inception to January tive, fecal incontinence were excluded.
controlled trials showing the effective- 2010. The key words used to describe Data were extracted by 2 reviewers
ness of laxatives, their use in clinical the study population were “constipa- (Drs Tabbers and Boluyt), who used
practice is widely accepted.5 The tion,” “obstipation,” “fecal inconti- structured data extraction forms. Two
chronic nature of the disease, in com- nence,” “coprostasis,” “encopresis,” reviewers independently rated the
bination with a lack of clear effects of and “soiling.” These words were com- methodologic quality of the included
laxatives and parents’ general fear of bined with key words referring to the studies by using a standardized list de-
adverse effects with daily medication different types of interventions that veloped for RCTs, that is, the Delphi list
use, is probably why 36.4% of children were investigated in the present re- (Table 1). Disagreements in any of the
with functional constipation use some view. Additional strategies for identify- aforementioned steps were resolved
form of alternative treatment (eg, ing studies included searching the ref- through consensus, when possible, or
acupuncture, homeopathy, mind-body erence lists of review articles and a third person (Prof Dr Benninga)
therapy, musculoskeletal manipula- included studies. No language restric- made the final decision.
754 TABBERS et al
Downloaded from pediatrics.aappublications.org by guest on September 28, 2015REVIEW ARTICLES
TABLE 1 Delphi List culty in defecation for ⬎2 weeks. If lax-
Item No. Question ative therapy was instituted, then all
Study population children continued to receive the same
D1 Was a method of randomization performed?
amount of laxatives during the study.
D2 Was the allocation of treatment concealed?
D3 Were the groups similar at baseline regarding the most important prognostic Patients filled out a daily bowel diary.
indicators (age, gender, disease duration, and disease severity)? Physician-rated treatment success
D4 Were both inclusion and exclusion criteria specified? was defined as ⬎3 bowel movements
Blinding
D5 Was the outcome assessor blinded? per week and ⱕ1 episode of encopre-
D6 Was the care provider blinded? sis every 3 weeks, with no abdominal
D7 Was the patient blinded? pain. Remarkably, the initial daily fiber
Analysis
D8 Were point estimates and measures of variability presented for the primary outcome intake was low for 71% of all children.
measures? Before crossover, the RCT found that the
D9 Did the analysis include an intention-to-treat analysis? proportion of children with ⬍3 bowel
D10 Is the withdrawal/drop-out rate ⬍20% and equally distributed?
movements per week and abdominal
pain was significantly smaller in the fi-
ber group, compared with the placebo
Data Analyses of all included studies could not be per- group. The proportion of children who
Methodologic quality scores were cal- formed. Consequently, we discuss all were rated by their physicians as being
culated as a percentage of the maxi- studies separately, including their treated successfully and by their par-
mal quality score on the Delphi list. most important methodologic short- ents as experiencing improvement was
High quality was defined as a score of comings. Only 5 studies (56%) had significantly larger after treatment with
ⱖ60% (ie, ⱖ6 points) and low quality scores of ⱖ6 points, which indicated fiber, compared with placebo.
as a score of ⬍60%.10 Table 1 presents good methodologic quality. The second RCT, of high quality, com-
the Delphi list. pared fiber (a cocoa husk supplement)
Fiber
and placebo among otherwise-healthy
RESULTS Studies Included children.13 The study fulfilled most of
Study Selection and Methodologic One systematic review was found in the criteria for validity, such as ade-
Quality Assessment which fiber was one of the options quate randomization and blinding and
We included 9 studies with survey data evaluated.5 The authors included 2 a low dropout rate (⬍20%) distributed
(collected in 1986 –2008) for 640 chil- RCTs comparing the effects of fiber equally over the 2 groups. Children
dren. The sample sizes of the studies versus placebo.11,13 An additional filled out a daily diary. The difference in
ranged from 3111 to 134.12 Table 2 pres- search yielded 1 relevant RCT compar- mean basal dietary fiber intake was
ents the characteristics of the studies ing fiber versus lactulose.14 All 3 RCTs not statistically significant. Moreover,
included. No RCTs on the effects of are discussed briefly. the mean basal dietary fiber intake
physical movement, multidisciplinary was close to the value recommended
treatment, or alternative medicine Fiber Versus Placebo for children (age plus 5 g) in both
(acupuncture, homeopathy, mind-body A small crossover RCT of low quality groups (12.3 g/day with fiber and 13.4
therapy, musculoskeletal manipula- compared fiber (glucomannan) versus g/day with placebo; P not reported).13
tions such as osteopathic and chiro- placebo among children with func- No significant difference between the
practic manipulations, or spiritual tional constipation.11 The study used groups in the change in total colon
therapies such as yoga) for children an adequate randomization proce- transit time or in the mean defecation
with constipation were found. All stud- dure, but no information on blinding of frequency per week was found. Signif-
ies were hospital-based; 3 were con- the outcome assessor was provided icantly more children (or parents) re-
ducted in a general pediatric depart- and an intention-to-treat analysis was ported a subjective improvement in
ment14,18,19 and 6 were conducted in a not performed. Other major shortcom- stool consistency but not a subjective
pediatric gastroenterology depart- ings that might have caused bias were improvement in pain during defeca-
ment.11–13,15–17 The studies were highly the unclear definition of constipation tion with fiber, compared with pla-
diverse with regard to the partici- and the unexplained high rate of loss cebo. A subanalysis of data for 12 chil-
pants, interventions, and outcome to follow-up monitoring of 32%. Consti- dren with a total basal intestinal
measures; therefore, a meta-analysis pation was defined as a delay or diffi- transit time of ⬎50th percentile
PEDIATRICS Volume 128, Number 4, October 2011 755
Downloaded from pediatrics.aappublications.org by guest on September 28, 2015TABLE 2 Study Characteristics of Included Pediatric Studies on Constipation
756
Study Participants Intervention vs Control Study Duration Outcome Measure Results Loss to Follow-up
Monitoring, n/N
(%)
Fiber
Loening-Baucke 31 children, 4.5–11.7 y of age, with Glucomannan (fiber), 100 mg/kg 4 wk Defecation frequency of Intervention: 19%; control: 52% (P ⬍ 15/46 (32)
TABBERS et al
et al11 (LQ) constipation for ⱖ6 mo, per d up to 5 g/d, vs placebo ⬍3 times per wk .05)
recruited from tertiary (maltodextrins) Abdominal pain Intervention: 10%; control: 42% (P ⬍
pediatric gastroenterology “Improved” (physician .05)
clinic in United States rating) Intervention: 45%; control: 13% (P ⬍
“Improved” (parent rating) .05)
Intervention: 68%; control: 13% (P ⬍
.05)
Castillejo et al13 56 children, 3–10 y of age, with Cocoa husk supplement (fiber), 4 wk Change in colonic transit Intervention: 61.4 h to 43.6 h; control: Intervention: 4/28
(HQ) chronic idiopathic constipation 10.4 g/d (3–6 y) or 20.8 g/d time 71.5 h to 61.5 h (no significance) (14); control:
according to Rome II criteria, (7–10 y), vs placebo Mean defecation frequency Intervention: 6.2 times per wk; control: 4/28 (14)
recruited from tertiary No. of patients with 5.1 times per wk (P ⫽ .78)
pediatric gastroenterology subjective improvement Intervention: 14; control: 6 (P ⬍ .039)
clinic in Spain in stool consistency Intervention: 16; control: 11 (P ⫽ .109)
No. of patients with
subjective improvement
in pain
Kokke et al14 97 children, 1–13 y of age, with Fiber (10 g in 125-mL yogurt 8 wk ⱖ1 fecal incontinence Intervention: 4%; control: 3% (P ⫽ .084) Intervention: 1/65
(LQ) ⱖ2 of 4 criteria for drink) vs lactulose (10 g in episode per wk Week 3: intervention: 1.58; control: 1.43 (1.5), 22/65
constipation (⬍3 bowel 125-mL yogurt drink) Mean abdominal pain (P ⫽ .33); week 8: intervention: 1.49; (33.8) stopped;
movements per wk, ⱖ2 fecal scores control: 1.39 (P ⫽ .50) control: 2/70
incontinence episodes per wk, Mean flatulence scores Week 3: intervention: 1.9; control: 2.0 (2.9), 11/7
periodic passage of stool at Necessity of step-up (P ⫽ .70); week 8: intervention: 2.0; (15.7) stopped
least once every 7–30 d, or medication control: 1.9 (P ⫽ .94)
palpable abdominal or rectal Taste scores P ⫽ .99; absolute numbers not reported
mass), recruited from general P ⫽ .657; absolute numbers not
pediatric practice clinic in reported
Netherlands
Fluid
Young et al15 108 children, 2–12 y of age, with 50% water intake increase, 3 wk Stool frequency 50% water intake increase: 3.70 times ?
(LQ) scores of ⱖ8 on constipation hyperosmolar (⬎600 mOsm/ Difficulty in passing stools per wk; hyperosmolar fluid: 3.44
assessment scale, recruited L) supplemental fluid (0 ⫽ no problem, 1 ⫽ times per wk; normal fluid intake:
from pediatric treatment, or normal fluid some problem, 2 ⫽ 3.40 times per wk (significance not
gastroenterology department intake severe problem) assessed)
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in United States Stool consistency score 50% water intake increase: 0.87;
hyperosmolar fluid: 0.62; normal fluid
intake: 1.06 (significance not
assessed)
50% water intake increase: 6.30;
hyperosmolar fluid: 5.79; normal fluid
intake: not reported (significance not
assessed)TABLE 2 Continued
Study Participants Intervention vs Control Study Duration Outcome Measure Results Loss to Follow-up
Monitoring, n/N
(%)
Prebiotics and
probiotics
Bongers et al16 38 children, 3–20 wk of age, New formula with high 3 wk Mean defecation frequency Intervention: 5.6 times per wk; control: 3 wk: 3/38 (7.9); 6
(HQ) receiving ⱖ2 bottles of milk- concentration of sn-2 palmitic Improvement of hard stools Intervention: 90%; control: 4.9 times per wk (P ⫽ .36) wk: 14/38 (37)
based formula per d with ⱖ1 of acid, mixture of prebiotic to soft stools 50% (P ⫽ .14)
following symptoms: 3 bowel oligosaccharides, and
movements per wk, painful partially hydrolyzed whey
defecation (crying), or protein (Nutrilon Omneo) vs
abdominal or rectal palpable standard formula (Nutrilon 1)
mass, recruited from tertiary
PEDIATRICS Volume 128, Number 4, October 2011
pediatric gastroenterology
department in Netherlands
Banaszkiewicz 84 children, 2–16 y of age. with Lactobacillus GG, 109 colony- 12 wk Treatment success (⬎3 12 wk: intervention: 72%; control: 68% Intervention: 5/43
et al17 (HQ) ⬍3 bowel movements per wk forming units twice per d, ⫹ Mean defecation frequency bowel movements per (P ⫽ .9); 24 wk: intervention: 64%; (11.6); control:
for ⱖ12 wk, recruited from 70% lactulose, 1 mL/kg per d, at 12 wk wk without fecal soiling) control: 65% (P ⫽ 1.0) 3/41 (7.3)
pediatric gastroenterology vs placebo ⫹ 70% lactulose, Mean frequency of fecal Intervention: 6.1 times per
department in Poland 1 mL/kg per d soiling at 12 wk wk; control: 6.8 times
Mean frequency of per wk (P ⫽ .5)
straining at 12 wk Intervention: 0.8 episodes
per wk; control: 0.3
episodes per wk (P ⫽
.9)
Intervention: 1.3 times per
wk; control: 1.6 times
per wk (P ⫽ .6)
Bu et al18 (HQ) 45 children, 0–10 y of age, with Lactobacillus casei rhamnosus 4 wk Mean defecation frequency Intervention: 0.6 times per d; control 1: 4/45 (8.8)
⬍3 bowel movements per wk (N ⫽ 18), 8 ⫻108 colony- Mean frequency of Intervention: 1.9 times per 0.5 times per d (P ⫽ .77)
for ⬎2 mo and 1 of the forming units per d; abdominal pain d; control 1: 4.8 times
following: anal fissures with magnesium oxide (control 1), Treatment success (defined per d (P ⫽ .04)
bleeding, fecal soiling, or 50 mg/kg per d (N ⫽ 18); or as ⱖ3 bowel movements Intervention: 78%; control
passage of large hard stools, placebo (control 2) (N ⫽ 9) per wk without fecal 1: 72% (P ⫽ .71)
recruited from general soiling by fourth wk) Intervention: 2.1 episodes
pediatric practice in Taiwan Mean frequency of fecal per wk; control 1: 2.7
soiling episodes per wk
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Proportion of hard stools (significance not
Frequency of use of assessed)
lactulose Intervention: 22.4%; control
1: 23.5% (P ⫽ .89)
Intervention: 4.4 times per
wk; control 1: 5.0 times
per wk (significance not
assessed)
REVIEW ARTICLES
757showed that the change in total intes-
Loss to Follow-up
Monitoring, n/N
tinal transit time was significantly
20/134 (14.9)
(%)
17/47 (36)
greater with fiber, compared with pla-
cebo (⫺38.1 hours [95% confidence in-
terval: ⫺67.9 to ⫺8.4 hours]; P ⬍
22 wk: 5.4 vs 7.2 times per wk; 6 mo: 5.3
.015).
Cure: n ⫽ 22; improvement: n ⫽ 8; no
vs 6.6 times per wk (P ⫽ .021)
Fiber Versus Lactulose
A low-quality RCT compared fiber with
Results
lactulose for 8 weeks, followed by 4
response: n ⫽ 16
weeks of weaning, among otherwise-
healthy children with constipation.14
The study used an adequate random-
ization procedure, but no information
on blinding of the outcome assessor
22 wk: 51.5% vs 62.3% (P ⫽
Mean defecation frequency
was provided, no intention-to-treat
per wk; 6 mo: 8.6 vs 6.4
Cure, improvement, or no
episodes per wk (P ⫽
22 wk: 5 vs 2.1 episodes
.249); 6 mo: 42.3% vs
analysis was performed, and the drop-
Outcome Measure
response (see text)
57.3% (P ⫽ .095)
out rate was high and not equally dis-
tributed. Polyethylene glycol (macro-
gol 3350) was added if no clinical
.135)
improvement was observed after 3
weeks. The RCT found no significant dif-
ference between the groups in the
per 2 wk, irrespective of
movements per wk and
numbers of children with ⱖ1 fecal in-
Mean fecal incontinence
Success rate (ⱖ3 bowel
frequency of ⱕ1 time
Study Duration
fecal incontinence
continence episode per week or in the
mean scores (scale: 0 ⫽ not at all, 1 ⫽
laxative use)
frequency
sometimes, 2 ⫽ often, 3 ⫽ continuous)
for people with abdominal pain or flat-
12 mo
6 mo
ulence at weeks 3 and 8 of follow-up
monitoring. The RCT also found no sig-
nificant difference between the groups
Intervention vs Control
Psychotherapy vs behavior
modification techniques
conventional treatment
in the necessity for step-up medication
Behavioral therapy vs
or in taste scores, but absolute num-
bers were not reported. All included
RCTs reported no adverse effects of
fiber.
Fluid
incontinence ⱖ2 times per wk,
constipation (ⱖ2 of 4 criteria:
stool at least once every 7–30
general pediatric department
gastroenterology department
One low-quality RCT that compared 3
incontinence, with or without
passage of large amounts of
constipation, recruited from
rectal fecal mass) recruited
d, or palpable abdominal or
defecation frequency of ⬍3
134 children with functional
groups, that is, 50% water intake in-
from tertiary pediatric
crease, hyperosmolar (⬎600 mOsm/L)
Participants
times per wk, fecal
47 children with fecal
in United Kingdom
supplemental fluid treatment, and nor-
in Netherlands
mal fluid intake, met our inclusion cri-
HQ indicates high quality; LQ, low quality.
teria.15 No information was provided
about randomization, blinding, or the
rate of loss to follow-up monitoring.
TABLE 2 Continued
Furthermore, no statistical assess-
Taitz et al19 (LQ)
van Dijk et al12
ment was conducted, and data were
therapy
Study
reported incompletely. Similar stool
Behavioral
(HQ)
frequencies were found at 3 weeks for
the 3 groups, and no differences with
758 TABBERS et al
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respect to difficulty in passing stools weeks.17 There were no significant dif- tional fecal incontinence and therefore
were found (significance not as- ferences in rates of treatment success are not discussed) that compared be-
sessed). Stool consistencies were re- (defined as ⱖ3 bowel movements per havioral and/or cognitive interven-
ported only for the water increase week with no episodes of fecal inconti- tions, with or without other treat-
group and the hyperosmolar fluid nence) at 12 and 24 weeks between the ments, for the management of fecal
group and were similar at 3 weeks L rhamnosus GG group and the pla- incontinence attributable to organic or
(significance was not assessed). cebo group. No significant differences functional constipation in children.20
between the probiotic group and the An additional search found 42 studies,
Prebiotics placebo group with respect to the of which 1 RCT met our inclusion
One systematic review was found that numbers of episodes of fecal soiling criteria.12
included 1 small, high-quality RCT com- per week at 12 weeks, frequencies of The systematic review included 1 low-
paring a standard formula (Nutrilon 1 straining at 12 weeks, and proportions quality RCT that compared behavioral
[Nutricia Nederland BV, Zoetermeer, of children using laxatives at 24 weeks interventions (education) and a sys-
Netherlands]) with a formula with a were found. tem of rewards from a pediatrician
high concentration of sn-2 palmitic
The second high-quality RCT compared with monthly psychotherapy with a
acid, a mixture of prebiotic oligosac-
magnesium oxide with the probiotic child psychiatrist.19 The method of ran-
charides, and partially hydrolyzed
Lactobacillus casei rhamnosus or pla- domization was not stated clearly.
whey protein (Nutrilon Omneo [Nutri-
cebo.18 The placebo group included Blinding in this case was not possible
cia Nederland BV]).5,16 That study ful-
only 9 patients and therefore is not dis- for the care provider or the patient.
filled most of the criteria for validity,
cussed. The study fulfilled almost all However, no information on whether
such as adequate randomization and
important criteria for validity. Similar the outcome assessor was blinded
blinding, and inclusion and exclusion
differences in defecation frequencies was provided. The analysis did not in-
criteria were both clearly specified;
were found for the probiotic group and clude an intention-to-treat analysis,
however, the study was designed orig-
the magnesium oxide group. The clini- and the dropout rate was ⬎20%. All
inally as a crossover trial but, because
cal relevance of these differences in children were seen every 6 weeks for
of the high rate of loss to follow-up
defecation frequencies is unclear. The periods from 3 months to 1 year. At
monitoring (37% after 6 weeks), the re-
RCT also found that probiotics signifi- every visit with the child psychiatrist,
sults of the first treatment period only
cantly reduced abdominal pain, com- the mother and the child were seen
were analyzed. No significant differ-
pared with osmotic laxatives. It found separately for 15 to 30 minutes. The
ence between the 2 groups in the mean
no significant difference in rates of authors did not provide any clear de-
defecation frequency per week after 3
treatment success (defined as ⱖ3 tails about this psychotherapy. A total
weeks was found. A difference in im-
provement of hard stools to soft stools spontaneous defecations per week of 22 children experienced cures (ⱖ5
in favor of the prebiotic group was with no episodes of fecal incontinence bowel movements per week with no
found; however, this difference was by the fourth week) between probiot- episodes of fecal incontinence per
not statistically significant. ics and osmotic laxatives, compared week and no use of laxatives), 8 chil-
with placebo. The RCT also found simi- dren experienced improvement (ⱖ3
Probiotics lar rates of fecal incontinence (statis- bowel movements per week with ⱕ1
One systematic review was found that tical significance between groups was episode of fecal incontinence per
included 2 RCTs evaluating the effects not assessed). It found no significant week), and 16 did not experience im-
of probiotics.5,17,18 The first high-quality difference in the proportions of hard provement (⬍3 bowel movements per
trial was conducted to determine stools between probiotics and osmotic week or ⬎1 episode of fecal inconti-
whether Lactobacillus rhamnosus GG laxatives. Both trials did not report any nence per week). However, it was not
was an effective adjunct to lactulose adverse events for the groups receiv- clear from the study how many chil-
for treating constipation in children. ing probiotics. dren in each group experienced cures,
The study fulfilled all criteria for valid- improvement, or no improvement.
ity. Children with constipation received Behavioral Therapy One subsequent high-quality RCT com-
1 mL/kg per day of 70% lactulose plus We found 1 systematic review (search pared behavioral therapy by a child
109 colony-forming units of L rhamno- date from inception to 2006, including psychologist (learning process to re-
sus GG or 1 mL/kg per day of 70% lac- 18 RCTs and 1186 children; 17 of the 18 duce phobic reactions related to defe-
tulose plus placebo twice daily for 12 RCTs investigated children with func- cation, which consisted of 5 sequential
PEDIATRICS Volume 128, Number 4, October 2011 759
Downloaded from pediatrics.aappublications.org by guest on September 28, 2015steps, ie, know, dare, can, will, and do) The results of the few, mainly under- well known that patients given placebo
and conventional treatment by a pedi- powered, studies included in this re- have expectations of future responses,
atric gastroenterologist (education, view should be interpreted cautiously, which influences outcomes. In fact, the
diary, and toilet training with a reward given the lack of uniform definitions reported responses to placebo in RCTs
system) over 22 weeks (12 visits).12 The used for constipation and the meth- might point toward the natural course
study fulfilled all important criteria for odologic limitations of the published of disease, fluctuations in symptoms,
validity. Both groups used similar lax- studies. Each included trial used a dif- regression to the mean, or effects of
ative therapy. Although statistically ferent study design with respect to the other simultaneous treatments. There-
significant increases in defecation fre- duration of the study, the number of fore, studies with such children that
quency and statistically significant re- visits, the method of blinding, the out- include groups that receive no treat-
ductions in fecal incontinence epi- come measures, and follow-up moni- ment, to control for natural history
sodes were found in both groups, no toring. Future studies with children and regression to the mean and to
significant differences between the with constipation should be conducted make the studies more likely to deter-
groups in defecation frequencies at 22 not only in tertiary care settings but mine a real placebo effect, are
weeks and 6 months or in episodes of also in primary and secondary care necessary.
fecal incontinence were seen. Further- settings, with standardized protocols Despite the high levels of use of non-
more, no significant differences be- as suggested by experts in both adult pharmacologic treatments, we did not
tween the groups with respect to suc- and pediatric functional gastrointesti- find any comparative trial evaluating
cess rates were found. After 6 months, nal disease. With improvements in the their efficacy in childhood constipa-
the proportion of children with behav- quality of research methods, the qual- tion.6 Widespread use of therapies
ioral problems was significant smaller ity of care should improve through ear- such as homeopathy, massage ther-
in the behavioral therapy group, com- lier and better recognition of constipa- apy, and acupuncture with no evidence
pared with the conventional treatment tion and improved diagnostic and of efficacy emphasizes the vulnerable
group (11.7% vs 29.2%; P ⫽ .039). therapeutic strategies. Therefore, in- disposition of patients, who at times
volved researchers should use homo- seek out such treatments because of
DISCUSSION geneous patient populations and out- inadequate effects achieved with con-
This systematic review clearly shows a come measures, including standard ventional treatments and the miscon-
lack of adequately powered, high- definitions as described in the Rome III ception that complementary medicine
quality studies evaluating the thera- criteria.21,22 Because functional consti- (forms of alternative medicine) lacks
peutic role of nonpharmacologic treat- pation is a long-lasting problem in adverse effects and may not interfere
ments. Although the first step of many cases, long-term follow-up mon- with prescribed medications.6 In addi-
treatment consists of dietary advice itoring is necessary for better under- tion, use of these interventions is
(adequate fiber and fluid intake) and standing of the clinical course of the costly. A study involving adults with
behavioral interventions, no evidence disease.4 Growing up with a chronic functional gastrointestinal diseases in
from trials suggesting any effect for disorder may impede the child’s devel- the United States showed that one-
fluid supplements or behavioral ther- opment and may affect psychological third of the patients used some com-
apy was found. Only marginal evidence and psychosocial functioning. There- plementary or alternative medicine
showing that fiber supplements are fore, quality-of-life assessments, using (most used were ginger, massage
more effective than placebo in the care baseline generic and before/after therapy, and yoga); the median yearly
of children with constipation exists. disease-specific quality-of-life instru- cost was $200.25
Also, no evidence was found for prebi- ments, are important secondary out- The main unanswered question is why
otics or probiotics. Moreover, no RCTs come measures.20 well-designed trials concerning fre-
involving physical movement, multidis- High success rates for placebo (60%) quently used complementary treat-
ciplinary treatment, or alternative often are reported for pediatric and ments are lacking for one of the most
medicine (including acupuncture, adult patients with functional gastro- prevalent, frustrating, long-lasting, pe-
homeopathy, mind-body therapy, mus- intestinal disorders.23,24 Despite the diatric gastrointestinal disorders.1,4,6
culoskeletal manipulations such as os- high response rates for placebo, there There are some explanations. Lack of
teopathic and chiropractic manipula- is a paucity of placebo-controlled stud- funding may play an important role. Al-
tions, and spiritual therapies such as ies with large patient samples for pe- though governments and private foun-
yoga) were found. diatric patients with constipation. It is dations are increasingly investigating
760 TABBERS et al
Downloaded from pediatrics.aappublications.org by guest on September 28, 2015REVIEW ARTICLES
nonpharmacologic treatments, the To minimize this risk, we performed a pharmacologic treatments for chil-
available budgets are still very small, sensitive literature search without lan- dren with functional constipation.
in comparison with the budgets for guage restrictions. Therefore, we recommend additional,
conventional treatment research.6 well-designed RCTs of high quality to
Furthermore, blinding patients to their CONCLUSIONS investigate the efficacy, safety, and
treatment arm could be difficult in We found only some evidence that fiber cost-effectiveness of the different
some nonpharmacologic studies, such supplements were more effective than treatment forms investigated in this
as studies assessing the efficacy of placebo in the care of children with review, using homogeneous patient
massage-based therapies. As in every constipation. This study clearly shows populations and outcome measures,
systematic review, there is a risk that that there is a lack of well-designed including standard definitions as de-
not all relevant studies were included. RCTs of high quality concerning non- scribed in the Rome III criteria.
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Merit M. Tabbers, Nicole Boluyt, Marjolein Y. Berger and Marc A. Benninga
Pediatrics 2011;128;753; originally published online September 26, 2011;
DOI: 10.1542/peds.2011-0179
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PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly
publication, it has been published continuously since 1948. PEDIATRICS is owned, published,
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Downloaded from pediatrics.aappublications.org by guest on September 28, 2015Nonpharmacologic Treatments for Childhood Constipation: Systematic Review
Merit M. Tabbers, Nicole Boluyt, Marjolein Y. Berger and Marc A. Benninga
Pediatrics 2011;128;753; originally published online September 26, 2011;
DOI: 10.1542/peds.2011-0179
The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/128/4/753.full.html
PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly
publication, it has been published continuously since 1948. PEDIATRICS is owned,
published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point
Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2011 by the American Academy
of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
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