uniassignmentshelp.comuniassignmentshelp.com/wp-content/uploads/2017/10/e… · web viewworld...

1

Running head: USE OF PROBIOTICS IN CHILDREN

An Evidence-Based Exploration of the Use of Probiotics in Children With Chronic

Constipation

Student’s Name

Institution

Abstract

2

Background: Chronic constipation among children is a worldwide problem that has negative

economic and quality of life effects. Standard treatment with laxatives can cause uncomfortable

side effects and have mixed results, prompting interest in alternative treatments. Probiotics have

long been used to treat many human conditions, and recently have been purported in the media

to treat gastrointestinal issues. This evidence-based project explored the effectiveness of

probiotics in treating constipation in children. PICO question: In children with constipation (P),

is the use of probiotics (I) as effective as a laxative (C) in relieving constipation symptoms (O)?

Methods: Using Pubmed, CINAHL, Ovid, and the Cochrane Library databases to search the

literature, one systematic review, three randomized controlled trials and two cohort studies met

the inclusion criteria and were selected as best evidence.

Results: Although the overall results were supportive of the use of probiotics to treat children

with chronic constipation, inconclusive findings across studies were found.

Conclusion: Probiotics may represent an opportunity to treat a common condition more

comfortably and conveniently. In order for a clear recommendation to be made, further research

is needed. Randomized controlled trials with larger sample sizes that do not include adjunctive

interventions and involve longer follow up represent the best opportunities for future research.

3

The National Institute of Health and Clinical Excellence (NICE 2010) defined

constipation as the passage of hard stools that cause discomfort. Symptoms include abdominal

pain, nausea and vomiting, loss of appetite, and malaise. Childhood constipation has worldwide

prevalence rate of between 0.7% and 29.6% (Mugie, Benninga, & Lorenzo, 2011). Caparell,

Pitetti, and Cross (2013) found constipation to be the most frequent diagnosis in children

presenting to the ER with abdominal pain and children with constipation have been found to

require more healthcare services, resulting in nearly three times the cost compared to children

without constipation (Liem, Harman, Benninga, Kelleher, Mousa, & Lorenzo, 2009). Besides

the financial costs, quality of life is negatively affected when childhood constipation continues

into adulthood despite treatment (Bongers, Maurice-Stan, & Grootenhuis, 2008).

The treatments for constipation recommended by NICE (2010) were initial dis-impaction

using oral cathartics, followed by daily maintenance using oral laxatives, specifically

polyethylene glycol (PEG) or lactulose. Besides the cost of these medications, deterrents to

compliance include negative side effects like abdominal cramping, diarrhea, flatulence, nausea

and bad taste (Tabbers, Chmielewska, Roseboom, Boudet, Perrin, Szajewska, & Benninga,

2009). These factors have led to interest in alternative treatments.

Probiotics are microorganisms that are believed to have a benefit to a host. Their use has

a long history, and though their popularity has increased in popular culture of late, especially

related to gastrointestinal effects, questions remain about their effectiveness (Hempel et al.,

2011). The purpose of this investigation was to address the PICO question, “In children with

constipation (P),is the use of probiotics (I) as effective as a laxative (C) in relieving constipation

symptoms (O)”?

EBP Investigation Process

4

Selection Criteria and Search Process

There are many dietary supplements available that claim to promote bowel motility and

relieve constipation, and probiotics are purported to treat many conditions within the bowel and

elsewhere in the body. Therefore, to stay true to the PICO question and to control bias, it was

necessary to limit the search to probiotics used in children with chronic constipation. Studies

were limited to English-language only, but because of the relatively recent popularity of

probiotics, no other limits were initially established because it was necessary to ascertain the

scope of evidence available.

A search of five databases (Pubmed/MEDLINE, CINAHL, Ovid, and the Cochrane

library) was conducted using the MeSH terms “ constipation,” AND “child,” AND “probiotics.”

This search yielded a total of twenty-one articles. Limiters such types of research design, year,

Human, age were used to narrow the search. According to the Hierarchy of Evidence Table

featured in Melnyk and Fineout-Overholt (2012, p. 11), randomized control trials (RCTs)

represent Level 2, and are second only to systematic reviews. Therefore, the limitation of

clinical trial was applied, which reduced the yield to seven articles. Ancestral searching was used

through scanning the reference lists of the three articles with the list of articles in which each

study was referenced.

Selection of Best Evidence

Upon review, three articles addressed the effect of probiotics in other conditions, such as

irritable bowel syndrome or bacterial infections of the bowel, and were eliminated. One article

reported a study in which probiotics were tested as an adjunct to lactulose, and was eliminated to

control bias and extraneous factors, as lactulose acting alone is a powerful laxative and because

5

of the relative age of the study (2004). This resulted in one systematic review, three randomized

control trials, and two cohort studies. Appendix A and B details each of these studies.

Critical Appraisal of Collective Evidence

It was apparent during the database search that the volume of evidence concerning

probiotic use for constipation was small, and that concerning children was smaller. Despite that,

the search continued diligently and judiciously. The evidence deemed best included one level

one systematic review, three level two randomized controlled studies, and two Level four pilot

studies (See Appendix C).

The studies found for this EBP project used as inclusion criteria the six Rome foundation

criteria for functional constipation. The primary symptom is less than three BMs per week, and

the other five are “straining, lumpy or hard stools, sensation of incomplete evacuation, sensation

of anorectal obstruction, and manual maneuvers to facilitate passage, in at least 25% of

defecations.’ (Rome foundation, 2006, retrieved from romecriteria.org).” The other PICO

components were also the same, except for some variance about comparison (placebo control

versus baseline data). Bowel movement (BM) frequency was a common outcome measure in all

studies selected. All three RCTs reviewed used a computer generated list to randomize their

samples, which ranged in size from 20 to 148 subjects, who were recruited from outpatient and

hospital settings.

Critical Appraisal

The systematic review (Chmielewska & Szajewska, 2011) examined randomized control

trials studying the effect of probiotic treatment on both children and adults with constipation, and

corroborated the observation that evidence is limited. A total of five randomized controlled trials

were critiqued, and only two of those studied the pediatric population. At that time, the finding

http://romecriteria.org/

6

was inconclusive that there was not enough evidence to support using or not using probiotics as a

treatment for childhood constipation.

Two cohort studies suggested that probiotic use was effective as a treatment for

constipation, as subjects in both studies demonstrated significant increases in bowel movement

(BM) frequency by the end of their respective four-week trials. Interestingly, these studies,

though performed by different researchers, were performed nearly the same way (replicate

study). Besides the small sample size in both, applicability of findings are diminished by the

additional intervention of toilet training to each trial. Additionally, in each of these studies,

bowel prep in the form of rectal enemas was administered for three days consecutively prior to

administration of the probiotics. Both of these factors could have increased BM frequency, and

cannot be ruled out as the cause of the results (Bekkali, Bongers, Van den Berg, Liem &

Benninga, 2007; Tabbers, Miliano, Roseboon, Benninga, 2011).

The randomized control trials were all placebo controlled and blinded, enhancing validity

of the results. All used a power analysis of 80% to determine the needed sample size, and all

were adequate according to that analysis. All studies used a significance level of p < .05, and

used statistics to assess the significance of change in BM frequency. Tabbers, Chmielewska,

Roseboon, Crastes, Perrin, Reitsma, Norbruis, Szajewski, and Benninga (2011) were the only

researchers to not find a significant difference in BM frequency between the intervention and

placebo group, but as found in their pilot study, toilet training and bowel prep were part of their

trial.

The remaining randomized control trials found a significant change in BM frequency

between the intervention and control (placebo) groups. One study compared the use of probiotics

not only to a placebo but to the laxative magnesium oxide. This study also allowed for a rescue

7

laxative or enema, but accounted well for their use. BM frequency was significantly increased

and enema use was significantly lower in the group that received the probiotics and the group

that received the laxative, but no significant differences between the intervention groups were

found (Bu, Chang, Ni, Chen & Cheng 2007). Guerra, Lima, Souza, Mazochi, Penna, Silva, Nioli

and Guimares, (2011) controlled confounding variables most effectively and used a compelling

crossover design to increase the validity of their promising results, however, they recognized the

need for more randomized controlled trials to corroborate the findings.

Collective Results

Summary

One RCT (Guerra et al., 2011) found a significant increase in BMs after probiotic

administration. One systematic review, two cohort studies, and the remaining two randomized

controlled trials suggest that the administration of probiotics to children with chronic

constipation may effectively treat their symptoms (Bekkali et al., 2007; Bu et al., 2007;

Chmielewska & Szajewska, 2011; Tabbers et al., 2011; Tabbers et al., 2011). In contrast, none

of the selected studies discounted the use of probiotics for treatment of constipation in children

for safety or efficacy reasons.

Synthesis Conclusions

Although an exhaustive search was performed, the volume of quality evidence was

limited. The evidence discovered yielded mixed results, and there were confounding variables,

making a recommendation impossible at this time. Future clinical trials that study the effect of

probiotics alone, without additional intervention, would provide more compelling and valid

evidence to support or to discourage their use.

Intervention Decision

8

EBP Model Application

The Stetler model for EBP implementation has five phases: 1) preparation, 2) validation,

3) comparative evaluation/decision making, 4) translation/application, and 5) evaluation (Ciliska,

Dicenso, Melnyk, Fineout-Overholt, Stetler, Cullen, Larrabee, Schultz, Rycroft-Malone,

Newhouse & Dang, 2011, pp. 248-249). This project represents phases one and two. A search

of the evidence concerning the effectiveness of probiotics in treating children with constipation

was performed, and the yielded evidence was critiqued. In accordance with the Stetler model,

because there is insufficient credible evidence to support or discourage use at this time, the

process has stopped. The increasing interest in this topic and call for more evidence points to

future promise, and future exploration. At that time the remaining phases of the process can be

completed. Once there is adequate credible evidence, phase 3 will involve making a decision if

probiotics should be used in practice to treat childhood constipation, and in phase 4, a

practitioner will be able to decide to informally implement usage with his or her patients, or to

develop a formal pilot study or EBP package for dissemination. Phase five will be an evaluation

of the results on his or her patients or subjects or to evaluate routine practice after the

dissemination of findings.

Implementation Implications

The use of probiotics to treat childhood constipation, if found to be effective, could be

implemented in the primary care setting as a more affordable and comfortable solution to the

problem. To recommend a commercially available yogurt to parents would take minimal clinical

resources and the increasing movement toward more ‘natural’ remedies to health problems could

appeal to some parents, but because it is a relatively new concept, confidence in their use would

take time. This is true of colleagues and administrators as well, but a comprehensive search and

9

review of evidence, as performed here, would help to dissuade any misgivings about initial

implementation.

Implementation Plan

An advanced practice nurse wishing to implement the use of probiotics as a treatment for

childhood constipation could, according to the Stetler model for EBP implementation either use a

formal or informal approach (Ciliska et al., 2011). If future evidence indicates probiotics are an

effective treatment, a practitioner would have to assess many factors for feasibility before

implementing a plan. Barriers to implementation include attitudes of administration, fellow

practitioners and parents about the efficacy and appropriateness of use, as well as the

availability of the product, depending on whether a commercially available yogurt or

prescription capsule is used.

The simplest way to implement this intervention as mentioned in phase 4 of Stetler’s

model would be to start recommending the use of probiotics in practice for one’s pediatric

patients with chronic constipation (Ciliska et al., 2011). Discussion with the parents regarding

their values and eating preferences, as well as their willingness to try a new approach would need

to be evaluated. Recording patients’ reported symptoms and BM frequency before

administration would be the marker against which to evaluate effectiveness. Within four weeks,

parents would be expected to report an increase of BMs to greater than three a week, and a

decrease in other symptoms, like abdominal pain. Long-term follow up at eight weeks, three, six

and twelve months would be expected and discussed. The practitioner would need to make

clear that regular follow up appointments would be expected, or follow up phone calls would

need to be made. Obviously, if the probiotics were ineffective, a back-up rescue plan of

laxatives would need to be available to patients.

10

If finances from administration are available, and it would be feasible to obtain

manpower assistance and institutional review board (IRB) approval, a pilot study, like the ones

critiqued in this project, could be developed and implemented according to the Stetler model

(Ciliska et al., 2011). Strict attention to inclusion and exclusion criteria as well as to protocol

would be key, and data would have to be recorded at more frequent intervals. BM frequency at

baseline and at weekly intervals after implementing the use of probiotics in either yogurt or

capsule form would be appropriate data to collect and analyze. Barriers to this approach would

vary depending on the location of the study. In rural areas, participants would likely be more

sparse, and qualified research assistants and statisticians are rare. The sample would be

undoubtedly homogenous in terms of ethnicity eating habits and socioeconomic status, making

generalizability an issue. An advantage to a rural pilot study would be the relative ease of

follow-up and increased compliance of subjects due to the physical and emotional closeness of

most patients and families to their providers in these areas.

Polit and Beck (2012) indicate that qualitative research exploring the experience of a

condition is often a necessary part of a pilot study and enhances preparation for further trials or

implementation. Therefore, in order to increase the chance of success, a qualitative study of

children with constipation and their parents to learn about their eating habits, toileting habits and

day-to-day life could assist a practitioner and the team to develop and evaluate the specific

probiotic administration protocol. Documentation of issues encountered and solutions

discovered is an essential part of a pilot study (Polit & Beck, 2012), and would be useful for

future implementation or research.

11

Conclusion

Probiotics represent an alternative method to treat a problem that has a great economic

impact and affects the quality of life of millions (Liem et al., 2009; Bongers et al., 2009; Mugie

et al., 2011). The effect of probiotic use on childhood constipation is just beginning to be

evaluated, with some promising results. Future research in the form of randomized controlled

trials examining the use probiotics alone to treat childhood constipation could lead to a

revolution in how the condition is treated and prevented.

12

References

Bekkali, N., Bongers, M.E., Van den Berg, M.M., Liem, O., & Benninga, M. A. (2007). The

role of a probiotics mixture in the treatment of childhood constipation: Results from a pi

lot study. Nutrition Journal, 6, 17. doi: 10/1186.1475-2891-6-17.

Bongers, M.E., Benninga, M.A., Maurice-Stam, H., & Grootenhuis, M.A. (2009). Health-related

quality of life in young adults with symptoms of constipation continuing from childhood

to adulthood. Health and Quality Outcomes, 7, 20. doi: 10.1186/1477-7525-7-

20.

Bu, L., Chang, M., Yi, N., Chen, H.,& Cheng, C. ( 2007). Lactobacillus casei rhamnosous Lcr35

in children with constipation. Pediatrics International, 49, 485-490. doi: 10.1111/j.

1442-200x.2007.02397

Ciliska, D. Dicenso, A., Melnyk, B.M., Fineout-Overholt, E., Stetler, C.B., Cullen, L., Larrabee,

J.H., Schultz, A.A., Rycroft-Malone, J., Newhouse, R.P., & Dang, D. (2011).

Models to guide implementation of evidence-based practice. In B. Melnyk & E.

Fineout-Overholt (Eds.), Evidence-based practice in nursing& healthcare: A guide

to best practice. (2nd ed., pp. 241-275). Philadelohia, PA: Wolters Kluwer Lipppincott

Williams & Wilkins.

Chmielewska, A. & Szajewska, H. (2010). Systematic review of randomized controlled trials:

Probiotics for functional constipation. World Journal of Gastroenterology, 16

(1), 69-75. doi 10.3748/wjg.v16.il.69

Guerra, P., Lima, L. N., Souza, T. C., Mazochi, V, Penna, f.J., Silva, A.M., Nicoli, J.R., &

Guimaraes, E.V. (2011). Pediatric functional constipation with bifidobacterium

containing yogurt: A crossover, double-blind, controlled trial. World

13

Journal of Gastroenterology, 17(34/), 3916-3921. doi:

10.3748/wjg.v17.i34.3916.

Hempel, S., Newberry, S., Ruelaz, A., Wang, Z., Miles, J., Suttorp, M.J., Johnsen, B., Shanman,

R., Slusser, W., Fu, N., Smith, A., Roh, B., Polak, J. Motala, A.,Perry, T.,&

Shekelle, P.

G. (2011). Safety of probiotics to reduce risk and prevent or treat disease. Agency for

Healthcare Research and Quality, publication No. 11-E007. available at

http://ahrq.gov/clinic/probiotictp.htm.

Liem, O., Harman, J., Benninga, M.A., Kelleher, K. Mousa, H. & Di Lorenzo, C. (2009)

Health utilization nd cost impact of childhood constipation in the United States.

Journal of Pediatrics, 154, 258-262. doi: 10.1016/j.peds208.07060.

Mcbride, D. (2013). Childhood constipation in the emergency department. Journal of Pediatric

Nursing, 28, 502-503. doi: 10.1016/j.pedn.2013.06.002

Mugie, S.M., Benninga, M.A., Di Lorenzo, C, (2011) Epidemiology of constipation in children

and adults: A systematic review. Best Practice and Research Clinical Gastoenterology,

25, 3-18. doi: 10.1016/j,bpg.2010.12.010.

National Institute of Health and Clinical Excellence (2010). Constipation in children and young

people: Diagnosis and management of idiopathic childhood constipation in primary and

secondary care. [Care guideline]. Retrieved from

http://publicatins.nice.org.uk/constipation-in-children-and-young-people.

Polit, D.F., & Beck, C.T Nursing research: Generating and assessing evidence for nursing

practice. (9th Ed.) Philadelphia, PA: Wolters Kluwer Lippincott Williams &

Wilkins.

http://ahrq.gov/clinic/probiotictp.htm

14

Rome foundation (2006). Rome III diagnostic criteria for functional constipation. [diagnostic

criteria]. retrieved from romecriteria.org.

Salkind, N.J (2011). Ststistics for people who (think they) hate statistics. ( 4th Ed. ). Los

Angeles, CA: Sage

Tabbers, M.M., Chmielewska, A., & Benninga, M. A (2009). Effect of the consumption of a

fermented dairy product containing bifidobacterium lactis DN-173 010 on

constipation in childhood: A multicentre randomized control trial ( NTRTC1571). BMC

Pediatrics, 9 , 22. doi: 10.1186/1471-2431-9-22.

Tabbers, M.M., de Milliano, I., Roseboom, M.G., Benninga, M. A. (2011). Is bifidobacterium

breve effective in the treatment of childhood constipation? results from a pilot

study. Nutrition Journal, 49, 485-490. doi: 10.1186/1475-2891-10-19.

Tabbers, M.M.m Chmielewska, A., Roseboom, M.G., Crostes, N., Perrin, C. Reitsma, J.B.,

Norbruis, O., Szajewska, H., & Benninga, M.A. (2011). Fermented milk

containing bifidobacterium lactis DN-173 010 in childhood constipation: A

randomized, double- blind, controlled trial. Pediatrics, 127, e1392-e1399. doi:

10.1542/peds.2010-2590.

http://romecriteria.org/

15

Appendix A: Review of Literature MatrixDirections: Complete matrix for each of the studies/publications you have selected as “best evidence” for your PICOT question.

PICOT question: In children with constipation (P), is the use of probiotics (I) as effective as a laxative (C) in relieving constipation symptoms (O)?

Author, Year, Title, Design/Type & Level

of Evidence

Study Purpose

Population investigated

Intervention/Comparison & Outcomes

(Independent/Dependent Variables)

Summary of Results

Chmielewska & Szajewska (2010)Systematic review of randomized controlled trials: Probiotics for functional constipation.Systematic review of RCTsLevel 1

To systematically evaluate evidence concerning safety and efficacy of probiotics to treat constipation

Children and adults

IV = probioticDV = decreased constipation

Insufficient evidence to make a general recommendation for or against using probiotics in either children or adults with constipation. Mixed findings among studies included.

Guerra et al. (2011)Pediatric functional constipation treatment with bifidobacterium-containg yogurt: A crossover, double-blind, controlled trialRCT, crossover design placebo controlledLevel II

To assess effect of probiotic-containing yogurt in children with constipation

Children aged 5-15 years with BM < 3/week plus one other ROME III criteria

IV = study groups (One with goat yogurt with probiotics, the other group given same goat yogurt without supplementation, and control group received probiotics halfway through study)

DV= BM frequency

Significant differences were observed between probiotic yogurt and yogurt only for defecation frequency (P = 0.012), defecation pain (P = 0.046) and abdominal pain (P = 0.015). May be useful as a treatment, but further controlled trials are needed.

Bu et al (2007)Lactobacillus casei rhamnosus Lcr35 in children with chronic constipation. RCT-placebo controlledLevel II

To assess efficacy of probiotics for treating children with chronic constipation

Children less than 10 years of age with with less than 3 BMs a week for greater than 2 months

Three groups- one given Magnesium oxide, one given probiotics, one given placebo. IV= probiotic or laxativeDV= BM frequency, enema use, abdominal pain

Both the group that was given the laxative and the group that was given probiotics had significant increase in BM frequency, but no significant increase between the two. There was less abdominal pain noted with the probiotics. Patients who received MgO or probiotics had a higher defecation frequency (P = 0.03), higher percentage of treatment success (P = 0.01), less use of glycerin enema (P = 0.04) and less hard stool (P =

16

0.01) than the placebo group.

Tabbers et al (2011)Fermented milk containing bifidibacterium lactis DN-173010 in childhood constipation: A randomized, double-blind, controlled trial RCT, placebo-controlled, blinded Level II

To examine the effects of probiotic administration in treating childhood constipation

Children aged 3-16 with constipation according to ROME III criteria

Two groups-one received probiotics, one received a placebo

IV= probiotic and toilet trainingDV= BM frequency

Both groups achieved success according to investigators criteria, with no significance between groups in frequency of BMs. Cannot make a recommendation based on this study. Need further research,RCTs, possibly with less bowel prep prior to start.

Bekkali et al (2007). The role of a probiotic mixture un the treatment of childhood constipation: a pilot study.Pilot cohort study-observationalLevel IV

To assess the efficacy of using probiotics to treat childhood constipation.

Children aged 4 to 16 with chronic constipation according to ROME III criteria

One group monitored before and after administration of a probiotic mixture. Subjects were also instructed to sit on toilet for 5 minutes after every meal (toilet training). Data was collected from diaries.IV= probiotics and toilet trainingDV= BM frequency

BM frequency was not significantly increased from baseline after probiotic administration. Mixture of probiotics could enhance colon motility, but RCTs with placebo are needed. The frequency of BMs per week increased from 2.0 (1.0–5.0) to 4.2 (0.0–16.0) in week 2 (p = 0.10) and 3.8 (2.1–7.0) in week 4 (p = 0.13).

Tabbers et al (2011. Is bufudibacterium breve effective in the treatment of childhood constipation? Results from a pilot study. Pilot cohort study.Level IV

To assess the efficacy of a specific probiotic in the treatment of childhood constipation

Children aged 3-16 with constipation according to ROME III criteria

One group was monitored before and for 4 weeks after administration of probiotic. BM frequency was increased from baseline at week 1 and week 4IV= probioticDV= BM frequency

The defecation frequency per week significantly increased from 0.9 (0-2) at baseline to 4.9 (0-21) in week 4 (p < 0.01Results suggest efficacy but cannot recommend without RCT.

Appendix BCritique Template

Systematic Review TemplateCitation (APA) Chmielewska, A. & Szajewska, H. (2011) Systematic review of

randomized control trials: Probiotics for functional constipation.

17

World Journal of Gastroenterology, 16 (1) 69-75. doi: 10.3748/wjg.v16il.69.

Title Systematic review of randomized control trials: Probiotics for functional constipation

Database Source (& ID number) doi: 10.3748/wjg.v16il.69

Type of Evidence Systematic review

Hierarchical Evidence Rating Level I

Your Summary of the Study/Publication (use paraphrasing, not quotes)

What was the stated research question/objective of the study?

To systematically evaluate evidence concerning safety and efficacy of probiotics to treat constipation in children and adults

What search strategies were used to locate applicable studies for possible inclusion?

Cochrane collaboration guidelines: searched Medline, Embase and Cinahl using keywords “constipation” AND “probiotic” Narrowed to RCTs in English or language known to researchers, from inception to May 2009. Intervention had to be a well defined regimen of probiotics, Outcome measure was treatment success as defined by the individual researchers.

What were the stated inclusion/exclusion criteria?

RCTs in English or language known to researchers, from inception to May 2009. Intervention had to be a well defined regimen of probiotics, and control groups had to be no intervention or a placebo. Outcome measure was treatment success as defined by the individual researchers. Studies were further assessed for good methodology.

What was the total sample size (e.g., how many studies were included, number of subjects)?

For pediatrics, 2 RCTs, N= 111Adult studies, 3 trials, N= 266

What were the results of the study? Evidence published to date is not sufficient to support a recommendation to use or to not use probiotics to treat childhood constipation.

What conclusions/implications for practice were drawn by the authors?

As above, insufficient evidence to make implication

Your Critical Appraisal of the Study’s Appropriateness for Application to Clinical Practice

Is the sample size adequate? Support your response.

No. Only two RCTs were analyzed. Indeed, evidence on this topic, especially concerning children is spare.

Are the research methods used appropriate for the study’s research question/objective? Support your response.

Yes. A meta-analysis was not possible because the studies found lacked similarity and quality. Data extraction for dichotomous outcomes compared total number of participants to the total number of participants who experienced the outcome. For continuous variable outcomes, standard deviations and means were calculated.

Was the completed search systematic, comprehensive, and without bias? Support your response.

Yes, although the evidence search yielded few RCTs. As the authors stated publication bias can not be ruled out for individual studies.

Were selection criteria clearly described? Are they appropriate? Was bias demonstrated in the study’s inclusion/exclusion criteria? Support your responses.

Yes. very thorough inclusion criteria and assessment for quality was described. The most common reasons for study exclusion were provided and appropriate, demonstrating rigor in the process

Single Quantitative Study (e.g., Randomized Controlled Trial, Nonrandomized Controlled

18

Trial, Case-Control Study, Cohort Study) TemplateCitation (APA) Guerra, et al. (2011).

Title Pediatric functional constipation treatment with bifidobacterium: A crossover, double-blind, controlled trial.

Database Source (& ID number) doi: 10.3748/wjg.v17134.3916

Type of Evidence Randomized Controlled Trial

Hierarchical Evidence Rating Level II



The purpose of this study was to assess the efficacy of probiotic-containing yogurt on treating children with chronic constipation.

What research methodology was used (e.g., RCT, Case-Control, Cohort)?

Randomized controlled trial, double blinded, placebo-controlled, with crossover at mid point

Describe the sample (including size)? Referred to a public school in Brazil. Children aged 5-15 years meeting ROME III criteria N=60-1 to attrition. 2 groups: intervention group received probiotic-containing yogurt N= 30, control group received same yogurt without probiotics N= 30 the two groups crossed half-way through study.

How was the sample selected (e.g., randomization, inclusion/exclusion criteria)?

Inclusion: 2 out of 6 ROME III criteria for 2 or more monthsExclusion: Use of oral laxatives less than 4 weeks prior to study, underlying metabolic or spinal disease, history of GI surgerySample was randomized by a computer generated list.

What methods were used for data analysis? Pearson exact test and Wilcoxin test was used to compare defecation frequency, stool consistency, and abdominal pain between groups at each week before and after crossover. The Wilcoxin test is a nonparametric comparison test that appropriately assess magnitude and direction(Polit & Beck, 2012; Salkind, 2011)

What were the results of the study? At what Level of Significance?

p< .05. Defecation frequency increased significantly after probiotic administration. When crossover data were analyzed there was a significant improvement in BM frequency(p= .012) , abdominal pain (.015) and pain with BM (.046)


There was a significant increase in BM frequency after probiotic administration, and no adverse effects, suggesting probiotic containing yogurt may be a useful alternative to treating this condition; more RCTs needed


Was the research design appropriate for the research question (e.g., RCT for cause-effect questions, Case Control for harm or causation questions, Cohort for questions regarding prognosis)? Support your response.

RCT to examine if probiotics decrease symptoms of constipation was appropriate.

Was the sample size adequate? Was bias controlled with sample selection methods? Support your responses.

Power analysis of 80% indicated that a sample size o f 22 per group was needed; actual sample size was 30 per group, minus one to attrition.

Were the study results significant (level of significance)? Are the results valid and reliable? Is there a possibility of bias or of confounding variables? Support your responses.

Bias reduced by:Both physicians and children were blinded to which treatment was administered. Both yogurts looked, smelled, and tasted the same. Participants instructed to avoid fermented dairy products. Unlike other studies, no bowel prep was done before the study began and no rescue laxative was provided, which could have increased BMs. Study results showed a significant increase in BMs in the probiotic group. (p=0.12).

Is the study and its findings directly This study matches EBP in terms of population( children with chronic constipation),

19

applicable to your EBP question (match all selection criteria)? Support your response.

intervention (probiotic administration), and outcome (BM frequency), but there is no comparison except to a placebo. Need larger scale RCTs to enhance evidence.

Single Quantitative Study (e.g., Randomized Controlled Trial, Nonrandomized Controlled Trial, Case-Control Study, Cohort Study) TemplateCitation (APA) Bu et al (2007).

Title Lactobacillus caseirhamnosus Lcr35 in children with chronic constipation

Database Source (& ID number) doi: 10.1111/j.1442.2008.2077.02397.x

Type of Evidence RCT, placebo controlled




Evaluate efficacy of probiotics in treating children with chronic constipation.


Randomized Control Trial, placebo controlled

Describe the sample (including size)? Referred to a university hospital in Taiwan less than 10 years old with BM frequency of <3 per week for >2 months


Inclusion: BM<3/ week for > 2 months, plus 1 other constipation symptom. Exclusion: History of spinal , metabolic, or mental disorders, or those on any medication besides laxatives that affect GI function Randomization by computer generated randomized list.

What methods were used for data analysis? ANOVA and Chi- square test to asses s BM frequency, stool consistency, and use of rescue enema between the 3 groups (probiotics, laxative, and placebo) Boneferroni procedure used if overall comparison was significant. Thorough and appropriate parametric measurements.


p< .05, The group who had either probiotic or MgO had increase of BM frequency (p= .03)less use of rescue enema (p=.03) than placebo group, but no significant difference between the laxative and probiotic group


Cannot make a recommendation, suggest longer follow up of subjects. Only adverse effect was one case of mild diarrhea in MgO group.



Compared the effect of probiotic use compared to laxatives and no treatment on BM frequency and constipation symptoms. A randomized control study was appropriate


Power analysis and preliminary trial to assess effect size and indicated 45 to be the smallest sample size possible. N= 45. Ratio was skewed toward intervention group 2:2:1 or 18: 18: 9. All investigators, participants and data analysts were blinded. All treatments were placed in same capsule. Could not exclude previous use of probiotics due to their popularity in Taiwan.

20


The findings were significant that some treatment of constipation is more effective than no treatment, but there was no significant difference between the group that took Magnesium Oxide and the group that took probiotics. Because probiotic-containing beverages and foods are popular in Taiwan, dietary influence could be a bias, but other sources of bias were well controlled by blinding and exclusion criteria.

Is the study and its findings directly applicable to your EBP question (match all selection criteria)? Support your response.

This study supports EBP in terms of P population (children with chronic constipation), intervention(probiotic administration), comparison Magnesium oxide or placebo group and outcome (BM frequency). The findings are clinically significant in that there is no difference between probiotic and laxative. Further studies to explore the effect of probiotics needed.

Single Quantitative Study (e.g., Randomized Controlled Trial, Nonrandomized Controlled Trial, Case-Control Study, Cohort Study) TemplateCitation (APA) Tabbers et al (2011)

Title Fermented milk containing bifidobacterium lactis DN-173 010 in childhood constipation: A randomized, double-blind, controlled trial.

Database Source (& ID number) doi: 10/1542/peds.2010-2590

Type of Evidence RCT




Examine efficacy of a probiotic product in treating children with chronic constipation


RCT One group given probiotics, one given placebo. Instructed to sit on toilet for 5 minutes after every meal.

Describe the sample (including size)? Children aged 3 to 16 years with constipation according to ROME III criteria. N=74 per group or 148


Enrolled when in 3 academic hospitals in either the Netherlands or Poland. Inclusion: BM frequency of <3 per week plus one other ROME III criteria. Exlusion: treatment for constipation 2 weeks or less prior to study, Underlying metabolic, spinal, or mental disorders Randomized consecutively using a computer generated list at 1:1 ratio.

What methods were used for data analysis? Linear mixed model was used to assess the relationship between time, product and the interaction between time and product. On the basis of this model 95% CI were calculated to assess the difference between the groups. Findings confirmed by independent biostatistician, but linear regression is an unconventional method when compared to other studies.


p<.05. Difference in BM frequency between the groups was not significant (p= 0.5)


Cannot make a recommendation. Further RCTs needed.


Was the research design appropriate for the research question (e.g., RCT for cause-

Yes an RCT is appropriate to assess the efficacy of probiotics in treating constipation compared to no treatment

21

effect questions, Case Control for harm or causation questions, Cohort for questions regarding prognosis)? Support your response.


No significant difference in frequency of BM or any other symptom. Bias would be the addition of toilet training to the intervention, and the use of rescue laxatives. Both could have caused the effect. Bias was controlled somewhat by making all interventions into same formula that looked, tasted and smelled the same. There was no clinical significance to this study.


This study supported EBP in terms of population( Children with constipation , intervention (Probiotic administration), and outcome (frequency of BM , comparison was to placebo.


Power analysis of 80% required a sample of 146. 160 subjects were randomized.Subjects were recruited in two nations at university hospitals and randomized consecutively using a computer program. There were very clear inclusion and exclusion criteria.

Single Quantitative Study (e.g., Randomized Controlled Trial, Nonrandomized Controlled Trial, Case-Control Study, Cohort Study) TemplateCitation (APA) Bekkali et al. (2007)

Title The role of a probiotics mixture in the treatment of childhood constipation: A pilot study.

Database Source (& ID number) doi: 10.1186/1475-2891-6-17

Type of Evidence Pilot study

Hierarchical Evidence Rating Level IV



To determine efficacy of probiotics in treating childhood constipation


Cohort pilot study

Describe the sample (including size)? Children aged 4 to 16 years with 2 out of 6 ROME III criteria (BM < 3 /week plus one other symptom) N= 20


Referred to out patient clinic in the Netherlands Inclusion as above. Exclusion: laxative use < weeks prior to study, metabolic, spinal or mental disease or GI . No randomization; one group compared before and after treatment

What methods were used for data analysis? Change in BM frequency assessed using paired wilcoxin test (non-parametric) 95% CIs calculated.

What were the results of the study? At what p< 0.5 BM frequency increased significantly at every week. By week 4, had increased from 2 95%CI (1-5)CI to 3 CI (0-10), p=.0.13. By week 4 abdominal

22

Level of Significance? pain had decreased from 45 % to 20% p=0.006—A significant finding


Probiotics could enhance colon motility ands be a useful treatment, but large scale RCT needed



Cohort study assumes probiotics will increase BM frequency, monitor effect on subjects. Randomized control trial is needed to confirm findings.


Sample size small. Bias was controlled by excluding underlying disorders, but because there was no control group, evidence is limited.


BM frequency increased at a significant level p=0.13 Because no rescue laxatives were used, validity is increased, but toilet training was also instructed ( sit for 5 minutes on toilet after every meal, which causes bias. Additionally all participants were given bowel prep prior to study which could have affected results. The small sample size also decreases validity


The study matched the EBP question in terms of: P) children with constipation, I) probiotic administration C) baseline, O) BM frequency.

Single Quantitative Study (e.g., Randomized Controlled Trial, Nonrandomized Controlled Trial, Case-Control Study, Cohort Study) TemplateCitation (APA) Tabbers et al (2011)

Title Is bifidobacterium breveveffective in the treatment of childhood constipation? Results from a pilot study.

Database Source (& ID number) doi: 10.1186/1475-2891-10-19

Type of Evidence Cohort study

Hierarchical Evidence Rating Level IV



Is probiotic effective in treating childhood constipation? BM frequency was primary outcome


Pilot study

Describe the sample (including size)? Children aged 3 to 16 years referred to an outpatient clinic with BM < 3/week and one other ROME III criteria. N=20

How was the sample selected (e.g., randomization, inclusion/exclusion

Inclusion: As above BM < 3/ week plus one other symptom.Exclusion: Treatment for constipation < 2 weeks prior to study. Underlying spinal,

23

criteria)? mental or GI disease

What methods were used for data analysis? Before and after BM frequency at each week compared using nonparametric Wilcoxin test


p<.05 BM frequebcy increased significantly every week. By week 4, frequency had hincreased from 0.9/ week CI ( 0-2) to 4.9/week CI (0-21). p<0.01


Suggested that probiotics may be an effective treatment, but RCT is needed.



A randomized control trial is needed to examine the true effect of probiotic administration on childhood constipation, but using this design to examine if probiotics cause increased BMs in a single group is a good beginning.


No. Sample size was very small, N=20. Bias was reduced b exclusion criteria, but a larger study is needed


Results are significant, but biased by the provision of a rescue laxative. The small sample size and lack of control group diminishes validity and limits its use. Additionally the authors published a paper describing the preparation for this study published in Pediatrics. In both articles the supplier of the product is mentioned, and it is stated that the suppliers (Yakult and Danone) funded the study.


This study matched PICO components: P) children with constipation, I) use of probiotics, C) baseline O) BM frequency

uniassignmentshelp.comuniassignmentshelp.com/wp-content/uploads/2017/10/e… · web viewworld...

Documents