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Manual Physical Therapy in the Treatment of Functional Constipation in Children: A Pilot Randomized Controlled Trial.
Blanco Díaz, M, Bousoño García, C, Segura Ramírez, DK, Rodríguez Rodriguez, ÁM
Journal of alternative and complementary medicine (New York, N.Y.). 2020;(7):620-627
Abstract
Objectives: Make a preliminary assessment of the efficacy of manual physical therapy (MPT) compared to conventional pharmacologic treatment (CPT) in chronic pediatric functional constipation (CPC). Design: A pilot randomized and controlled trial was conducted. Settings/Location: Subjects were recruited in a tertiary university hospital in the north of Spain. Subjects: Forty-seven children (2-14 years) were included. Participants were assessed by Pediatric Gastroenterologist. They were recruited in a tertiary university hospital. Subjects were randomly allocated. MPT was performed in a private clinic. Interventions: Control group (CG) received CPT and intervention group (IG) received MPT, consisting in nine sessions of MPT with a 45-min initial session and 30 min for the rest of sessions distributed weekly during the first and second months and biweekly in the third month. Outcome Measures: At times 0-1-3 months and 5 years, results obtained were checked and compared, according to the defecatory pattern ("Symptom Severity Score" SSS), quality of life (Pediatric Quality of Life Inventory Scale), Bristol Stool Form Scale (BSFS), and the defecation frequency (DF). Results: Results from SSS, BSFS, and DF revealed no statistically significant differences between groups in median values at any follow-up. However, there were significant changes over time. The full sample median for SSS was reduced from baseline 24 (interquartile range 20-27) to 11 (6-13) at month 1, 7 (3-13) at month 3, (8 CG; 5 IG), and 5 (1-12) at year 5. The BSFS scale increased from 2 (1-3) at baseline to 4 (3-4) at month 1 and year 5. DF increases progressively from 1 per week to 5 in the fifth year. Higher rates of quality of life were observed at month 3 in IG for the total, physical, and emotional functioning scores and at fifth year for total, emotional, social, and school functioning scores. Conclusions: This study gives preliminary evidence of no difference between MPT and CPT for improvement in measures of CPC, although there was some advantage for MPT in quality of life. Study results justify the conduct of a full-scale efficacy trial of MPT, as well as a noninferiority trial comparing MPT and CPT.
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Lactobacillus reuteri DSM 17938 and Magnesium Oxide in Children with Functional Chronic Constipation: A Double-Blind and Randomized Clinical Trial.
Kubota, M, Ito, K, Tomimoto, K, Kanazaki, M, Tsukiyama, K, Kubota, A, Kuroki, H, Fujita, M, Vandenplas, Y
Nutrients. 2020;(1)
Abstract
OBJECTIVE Chronic functional constipation is a frequent condition. The aim of the study was to evaluate the efficacy of the probiotic Lactobacillus (L.) reuteri DSM 17938 and magnesium oxide (MgO) for relieving chronic functional constipation in children. STUDY DESIGN A prospective, double-blind, placebo-controlled, randomized, and parallel-group trial was conducted in five pediatric outpatient clinics in Japan. Sixty patients who were more than six months old and under six years of age with a diagnosis of functional constipation according to Rome IV criteria were randomly divided into three groups: group A (n = 20) received L. reuteri DSM 17938 and lactose hydrate as a placebo of MgO; group B (n = 19) received L. reuteri DSM 17938 and MgO; and group C (n = 21) received a placebo of L. reuteri DSM 17938 and MgO. RESULTS All three groups exhibited significant improvement in defecation frequency in the fourth week compared with the baseline condition (group A: p < 0.05; group B: p < 0.05; group C: p < 0.05). The MgO group and combination group showed a significant decrease in stool consistency, but the L. reuteri DSM 17938 group did not (group A: p = 0.079; group B: p < 0.05; group C: p < 0.05). MgO significantly suppressed the presence of the genus Dialister. Defecation frequency negatively correlated with the frequency of Clostridiales-belonging bacteria among the gut microbiome. CONCLUSIONS L. rueteri DSM 17938 and MgO were both effective in the management of functional constipation in young children. MgO caused an imbalance in the gastrointestinal microbiome, which was not the case in the probiotic group.
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The effect of synbiotic supplementation on anthropometric indices, appetite, and constipation in people with hypothyroidism: A randomized, double-blind, placebo-controlled trial.
Talebi, S, Karimifar, M, Heidari, Z, Mohammadi, H, Asbaghi, O, Hadi, A, Marx, W, Askari, G
Phytotherapy research : PTR. 2020;(10):2712-2720
Abstract
Hypothyroidism and obesity are two highly prevalent conditions that appear to be closely related. Hypothyroidism is correlated with weight gain, loss of appetite, constipation, and a higher incidence of obesity. The present study aimed to investigate the effects of synbiotic supplementation on anthropometric indices, appetite, and constipation in subjects with hypothyroidism. Sixty subjects with hypothyroidism were assigned into two groups to receive either 500 mg/day of synbiotic (n = 30) or a placebo (n = 30) per day for 8 weeks. Anthropometric indices, appetite, and constipation were assessed at study baseline and end of the trial. At the end of trial, waist-to-hip ratio was significantly decreased in the synbiotic group (p = .030), whereas there were no significant differences between groups. We did not observe any statistically significant change in appetite or other anthropometric indices (p > .05). Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048). The results of the present trial indicated that synbiotic supplementation may have favorable results in constipation among subjects with hypothyroidism for 8 weeks. Further studies with larger sample size and longer duration are needed to confirm our findings.
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Development of a multidisciplinary colorectal and pelvic health program: Program implementation and clinical impact.
Style, CC, Hsu, DM, Verla, MA, Mittal, AG, Austin, P, Seth, A, Dietrich, JE, Adeyemi-Fowode, OA, Bercaw-Pratt, JL, Chiou, EH, et al
Journal of pediatric surgery. 2020;(11):2397-2402
Abstract
INTRODUCTION Pediatric patients with complex colorectal and genitourinary conditions often require coordinated multidisciplinary care; however, this coordinated care can be hard to structure and deliver. The purpose of this paper is to review the development and implementation of a multidisciplinary colorectal and pelvic health program, one year after the program's initiation. METHODS This is an observational retrospective 1-year study (10/1/2017 to 9/30/2018). In fiscal year (FY) 2018, a multidisciplinary colorectal and pelvic health program was initiated. The program development incorporated bimonthly team meetings, educational conferences, and initiation of three clinics: a complex colorectal and genitourinary reconstruction clinic, a bowel management clinic, and a colonic motility clinic. Conditions treated included complex anorectal and cloacal malformations, Hirschsprung disease, and idiopathic constipation. The fiscal year was selected to provide comparative administrative data after program implementation. RESULTS During the study period, 121 patients underwent comprehensive collaborative evaluation of which 58 (47%) were new to the institution compared to 12 (19%) new patients in the previous year (p < 0.001). In FY 2018, there were 130 procedures performed and 512 collaborative visits with an average of 47 visits per month. This was a 3.4-fold increase in visits compared to FY2017 (171 visits). Of the new patients, 60% (35/58), traveled a median of 181 miles, representing 33 statewide counties, and 4 states compared to a median of 93 miles in the previous fiscal year (p = 0.004). CONCLUSION The development of a colorectal and pelvic health program is feasible and requires a collaborative approach, necessitating multiple service lines within an institution. Program creation and implementation can result in rapid institutional clinical growth by filling a local and regional need through coordinated multidisciplinary care. LEVEL OF EVIDENCE IV.
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Treatment of childhood constipation: a synthesis of systematic reviews and meta-analyses.
Southwell, BR
Expert review of gastroenterology & hepatology. 2020;(3):163-174
Abstract
Introduction: Constipation occurs in many children and can become chronic. Many grow out of it but for one third, it continues into adulthood. For most patients, there is no identifiable organic disorder and it is classified as functional constipation.Areas covered: In 2016, treatment of childhood constipation was extensively reviewed by Rome IV. This review covers meta-analyses and evidence for treatment of paediatric constipation since 2016 and new emerging treatments.Expert opinion: Since 2016, meta-analyses conclude 1) fibre should be included in a normal diet, but further supplementation does not improve constipation; 2) probiotics may increase stool frequency in children, but evidence from larger RCTs is needed; 3) comparing laxatives, polyethylene glycol (PEG) is superior to placebo, lactulose and milk of magnesia, and 4) appendix stomas are effective and should be considered before surgery. Emerging areas of study include food intolerance, electrical stimulation and faecal microbiota transplant. For research, outcome measures need standardising to allow comparison between studies and allow meta-analyses. To assist this, validated GI instruments have been developed by Rome IV and PedsQl.
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The effect of probiotics used as a single therapy on functional constipation: Study protocol for a systematic review and meta-analysis.
Wen, Y, Li, J, Tang, X
Medicine. 2020;(17):e19824
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BACKGROUND Constipation is a frequent gastrointestinal symptom. It is intimately related to many diseases. 1st-line therapy can not alleviate constipation for some patients. Alternative treatments are therefore commonly used, such as probiotics. Nevertheless, the efficacy and safety of probiotics used as a single treatment are still uncertain. A systematic review and meta-analysis will be carried out to answer the issue. METHODS The protocol accompanied Preferred Reporting Items for Systematic Reviews and Protocol Meta-Analysis. PubMed, Cochrane, Embase, and Web of Science databases were practiced for randomized controlled trials without language constraint. In addition, We have also conducted backward (manually) and forward (with Google Scholar) citation checks to identify any additional relevant papers.Two reviewers will conduct studies selection, data extraction, and risk of bias assessment independently. The primary outcome is treatment success (spontaneous bowel movements (sBMs) >3 times per week), defecation frequency. The second result will be consistency, fecal incontinence, other symptoms (e.g. flatulence, abdominal pain), and adverse event rates and types. RESULTS This study provides helpful information about whether probiotics can be used as a single therapy on functional constipation CONCLUSION The findings of the review will be disseminated through peer-review publications.
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Impact of Clinical Outcome Measures on Placebo Response Rates in Clinical Trials for Chronic Constipation: A Systematic Review and Meta-analysis.
Chen, J, Liu, X, Bai, T, Hou, X
Clinical and translational gastroenterology. 2020;(11):e00255
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OBJECTIVES Chronic constipation (CC) is a recurrent functional bowel disorder worldwide. The purpose of this study is to examine its pooled placebo response rate and compare placebo response level in randomized controlled trials (RCTs) with different endpoint assessments. METHODS PubMed, Cochrane Library, and Embase were electronically searched for therapeutic RCTs of CC with placebo control. Data extraction and assessment of risk of bias were performed independently by 2 reviewers. All the statistical calculation and analysis were performed using R 3.6.0. Our protocol has registered in PROSPERO with registration number: CRD42019121287. RESULTS There were 46 studies included with 5,992 constipated patients allocated to the placebo arm in total. The pooled placebo response rate was 28.75% (95% confidence interval: 23.83%-33.67%) with significant heterogeneity among trials ((Equation is included in full-text article.)= 93.6%). Treatment efficacy assessed using subjective improvement had a significantly higher placebo response rate than that assessed with improvement in complete (spontaneous) bowel movements or composite improvement (41.40% vs 18.31% or 20.35%, P < 0.001). According to the results of meta-regression, active treatment and endpoint assessment were most likely to lead to the huge heterogeneity among studies. DISCUSSION Patients with CC have significant response level to placebo. Based on findings in this study, we do not recommend subjective improvement as endpoint while designing therapeutic RCTs for chronic constipated patients.
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Chemical stability of fructans in apple beverages and their influence on chronic constipation.
Glibowski, P, Skrzypek, M, Ćwiklińska, M, Drozd, M, Kowalska, A
Food & function. 2020;(5):3860-3866
Abstract
The aim of this study was to analyse the concentration of reducing sugars in beverages based on apple juice with the addition of 2 and 4% of native and high polymerized inulin as well as oligofructose. Moreover, the effect of the consumption of this potentially prebiotic beverage containing highly polymerized inulin (12 g per 300 mL) on constipation was analysed. Pasteurization of the studied beverages followed by 120-day storage at ambient temperature, carried out in three independent trials, did not cause the hydrolysis of fructans into reducing sugars. Sensory analysis showed that the presence of fructans in beverages based on apple juice did not change the colour, clarity, odour, flavour, sweetness and acidity in comparison to apple juice. A placebo-controlled, randomized study involving 20 volunteers of age 20-29 with symptoms related to chronic constipation showed that the consumption of juice enriched with highly polymerized inulin significantly (p≤ 0.05) increased the frequency of bowel movements and facilitated defecation. The final conclusion is that fructans in beverages based on apple juice are chemically stable, do not affect sensory sensation and can help those with chronic constipation.
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The efficacy and safety of probiotics for patients with constipation-predominant irritable bowel syndrome: A systematic review and meta-analysis based on seventeen randomized controlled trials.
Wen, Y, Li, J, Long, Q, Yue, CC, He, B, Tang, XG
International journal of surgery (London, England). 2020;:111-119
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BACKGROUND & Objectives: Constipation-predominant irritable bowel syndrome (IBS-C) is functional bowel disorders that may involve disturbance of the gastrointestinal microbiota. We performed a systematic review and meta-analysis of the efficacy and safety of probiotics in patients with IBS-C. METHODS We searched the Cochrane Library, PubMed, EMBASE and Web of Science databases up to 1 May 2019. Randomized controlled trials (RCTs) involving adults with IBS-C that compared probiotics to placebo or no therapy were eligible for the analysis. Dichotomous symptom data were pooled to calculate the relative risk (RR) with a 95% confidence interval (CI) of remaining symptoms after therapy. Continuous data were pooled using a standardized or weighted mean difference (MD) with the 95% CI. Two reviewers assessed trial quality and extracted data independently. The analysis was performed using Review Manager version 5.2. RESULTS Seventeen RCTs involving 1469 patients were included in the analysis. Overall, probiotics significantly increased stool frequency by 1.29 bowel movements (BM)/wk (95% CI: 0.69 to 1.89 BM/wk; P < 0.0001), and improved stool consistency (SMD: 0.55; 95% CI: 0.27 to 0.82; P = 0.0001). Compared with placebo, patients using probiotics experienced a shorter gut transit time by 12.36 h (95% CI: -20.74 to -3.98 h; P = 0.004). No serious adverse events were reported. CONCLUSIONS Generally, probiotics may be safe and may improve whole gut transit time, stool frequency, and stool consistency. However, adequately powered RCTs are required to better determine the species or strains, doses, and duration of use of probiotics that are most efficacious. Further research and evidence is required before probiotics is adopted as one of treatments of IBS-C.
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A prospective, double-blind, randomized, placebo-controlled trial comparing the efficacy of polyethylene glycol versus polyethylene glycol combined with topical diltiazem for treating anal fissure in children.
Alshehri, A, Barghouthi, R, Albanyan, S, Alayed, M, Alsubaie, H, Alhayyan, R, Alzahem, A, Altokhais, T, Albassam, A, Aljazaeri, A
Journal of pediatric surgery. 2020;(10):2017-2021
Abstract
BACKGROUND Anal fissure (AF) in children is usually treated with laxatives and/or topical agents such as calcium channel blockers. We hypothesize that owing to the superior efficacy of Polyethylene glycol (PEG) in treating constipation in children, adding diltiazem (DTZ) might not improve healing of AF. METHODS Children ≤14 years with anal fissure presented to the pediatric surgery clinic between November 2014 and March 2016 were recruited. Randomization was performed to either PEG with DTZ or PEG with placebo. Study personnel, patients, and their families were blinded. Primary outcome was resolution of symptoms. Secondary outcomes were constipation and treatment complications at 12-week follow up. RESULTS 48 patients were randomized: 24 to PEG + DTZ and 24 to PEG + placebo. Both groups were similar in their baseline characteristics. At week 12, majority of patients' symptoms have improved without significant difference between groups; painful defecation at week 12: 20.8% and 8.3% (p-value 0.41), blood per rectum at week 12: 4.2% and 8.3% (p value 0.58) in the DTZ and placebo groups, respectively. Additionally, there was similar improvement in constipation in both groups. CONCLUSION PEG alone was associated with similar improvement in anal fissure symptoms in children compared to PEG and topical diltiazem combined. LEVEL OF EVIDENCE I.