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The Cochrane Database of Systematic... Aug 2016Constipation within childhood is an extremely common problem. Despite the widespread use of osmotic and stimulant laxatives by health professionals to manage... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Constipation within childhood is an extremely common problem. Despite the widespread use of osmotic and stimulant laxatives by health professionals to manage constipation in children, there has been a long standing paucity of high quality evidence to support this practice.
OBJECTIVES
We set out to evaluate the efficacy and safety of osmotic and stimulant laxatives used to treat functional childhood constipation.
SEARCH METHODS
We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and the Cochrane IBD Group Specialized Trials Register from inception to 10 March 2016. There were no language restrictions. We also searched the references of all included studies, personal contacts and drug companies to identify studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) which compared osmotic or stimulant laxatives to placebo or another intervention, with participants aged 0 to 18 years old were considered for inclusion. The primary outcome was frequency of defecation. Secondary endpoints included faecal incontinence, disimpaction, need for additional therapies and adverse events.
DATA COLLECTION AND ANALYSIS
Relevant papers were identified and two authors independently assessed the eligibility of trials, extracted data and assessed methodological quality using the Cochrane risk of bias tool. The primary outcome was frequency of defecation. Secondary endpoints included faecal incontinence, disimpaction, need for additional therapies and adverse events. For continuous outcomes we calculated the mean difference (MD) and 95% confidence interval (CI) using a fixed-effect model. For dichotomous outcomes we calculated the risk ratio (RR) and 95% CI using a fixed-effect model. The Chi(2) and I(2) statistics were used to assess statistical heterogeneity. A random-effects model was used in situations of unexplained heterogeneity. We assessed the overall quality of the evidence supporting the primary and secondary outcomes using the GRADE criteria.
MAIN RESULTS
Twenty-five RCTs (2310 participants) were included in the review. Fourteen studies were judged to be at high risk of bias due to lack of blinding, incomplete outcome data and selective reporting. Meta-analysis of two studies (101 patients) comparing polyethylene glycol (PEG) with placebo showed a significantly increased number of stools per week with PEG (MD 2.61 stools per week, 95% CI 1.15 to 4.08). Common adverse events in the placebo-controlled studies included flatulence, abdominal pain, nausea, diarrhoea and headache. Participants receiving high dose PEG (0.7 g/kg) had significantly more stools per week than low dose PEG (0.3 g/kg) participants (1 study, 90 participants, MD 1.30, 95% 0.76 to 1.84). Meta-analysis of 6 studies with 465 participants comparing PEG with lactulose showed a significantly greater number of stools per week with PEG (MD 0.70 , 95% CI 0.10 to 1.31), although follow-up was short. Patients who received PEG were significantly less likely to require additional laxative therapies. Eighteen per cent (27/154) of PEG patients required additional therapies compared to 31% (47/150) of lactulose patients (RR 0.55, 95% CI 0.36 to 0.83). No serious adverse events were reported with either agent. Common adverse events in these studies included diarrhoea, abdominal pain, nausea, vomiting and pruritis ani. Meta-analysis of 3 studies with 211 participants comparing PEG with milk of magnesia showed that the stools per week were significantly greater with PEG (MD 0.69, 95% CI 0.48 to 0.89). However, the magnitude of this difference was quite small and may not be clinically significant. One child was noted to be allergic to PEG, but there were no other serious adverse events reported. One study found a significant difference in stools per week favouring milk of magnesia over lactulose (MD -1.51, 95% CI -2.63 to -0.39, 50 patients), Meta-analysis of 2 studies with 287 patients comparing liquid paraffin (mineral oil) with lactulose revealed a relatively large statistically significant difference in the number of stools per week favouring liquid paraffin (MD 4.94 , 95% CI 4.28 to 5.61). No serious adverse events were reported. Adverse events included abdominal pain, distention and watery stools. No statistically significant differences in the number of stools per week were found between PEG and enemas (1 study, 90 patients, MD 1.00, 95% CI -1.58 to 3.58), dietary fibre mix and lactulose (1 study, 125 patients, P = 0.481), senna and lactulose (1 study, 21 patients, P > 0.05), lactitol and lactulose (1 study, 51 patients, MD -0.80, 95% CI -2.63 to 1.03), hydrolyzed guar gum and lactulose (1 study, 61 patients, MD 1.00, 95% CI -1.80 to 3.80), PEG and flixweed (1 study, 109 patients, MD 0.00, 95% CI -0.33 to 0.33), PEG and dietary fibre (1 study, 83 patients, MD 0.20, 95% CI -0.64 to 1.04), and PEG and liquid paraffin (2 studies, 261 patients, MD 0.35, 95% CI -0.24 to 0.95).
AUTHORS' CONCLUSIONS
The pooled analyses suggest that PEG preparations may be superior to placebo, lactulose and milk of magnesia for childhood constipation. GRADE analyses indicated that the overall quality of the evidence for the primary outcome (number of stools per week) was low or very low due to sparse data, inconsistency (heterogeneity), and high risk of bias in the studies in the pooled analyses. Thus, the results of the pooled analyses should be interpreted with caution because of quality and methodological concerns, as well as clinical heterogeneity, and short follow-up. There is also evidence suggesting the efficacy of liquid paraffin (mineral oil). There is no evidence to demonstrate the superiority of lactulose when compared to the other agents studied, although there is a lack of placebo controlled studies. Further research is needed to investigate the long term use of PEG for childhood constipation, as well as the role of liquid paraffin. The optimal dose of PEG also warrants further investigation.
Topics: Adolescent; Child; Child, Preschool; Constipation; Defecation; Dietary Fiber; Enema; Female; Humans; Infant; Infant, Newborn; Lactulose; Laxatives; Magnesium Hydroxide; Male; Mineral Oil; Osmosis; Polyethylene Glycols; Randomized Controlled Trials as Topic; Senna Extract; Sennosides; Treatment Outcome
PubMed: 27531591
DOI: 10.1002/14651858.CD009118.pub3 -
Alimentary Pharmacology & Therapeutics Aug 2018Fibrotic stricture is a common complication of Crohn's disease (CD) affecting approximately half of all patients. No specific anti-fibrotic therapies are available;...
BACKGROUND
Fibrotic stricture is a common complication of Crohn's disease (CD) affecting approximately half of all patients. No specific anti-fibrotic therapies are available; however, several therapies are currently under evaluation. Drug development for the indication of stricturing CD is hampered by a lack of standardised definitions, diagnostic modalities, clinical trial eligibility criteria, endpoints and treatment targets in stricturing CD.
AIM
To standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Chron's disease.
METHODS
An interdisciplinary expert panel consisting of 15 gastroenterologists and radiologists was assembled. Using modified RAND/University of California Los Angeles appropriateness methodology, 109 candidate items derived from systematic review and expert opinion focusing on small intestinal strictures were anonymously rated as inappropriate, uncertain or appropriate. Survey results were discussed as a group before a second and third round of voting.
RESULTS
Fibrotic strictures are defined by the combination of luminal narrowing, wall thickening and pre-stenotic dilation. Definitions of anastomotic (at site of prior intestinal resection with anastomosis) and naïve small bowel strictures were similar; however, there was uncertainty regarding wall thickness in anastomotic strictures. Magnetic resonance imaging is considered the optimal technique to define fibrotic strictures and assess response to therapy. Symptomatic strictures are defined by abdominal distension, cramping, dietary restrictions, nausea, vomiting, abdominal pain and post-prandial abdominal pain. Need for intervention (endoscopic balloon dilation or surgery) within 24-48 weeks is considered the appropriate endpoint in pharmacological trials.
CONCLUSIONS
Consensus criteria for diagnosis and response to therapy in stricturing Crohn's disease should inform both clinical practice and trial design.
Topics: Catheterization; Clinical Trials as Topic; Colon; Consensus; Constriction, Pathologic; Crohn Disease; Dilatation; Endoscopy; Expert Testimony; Fibrosis; Humans; Intestinal Obstruction; Intestine, Small; Practice Guidelines as Topic; Reference Standards
PubMed: 29920726
DOI: 10.1111/apt.14853 -
Frontiers in Cellular and Infection... 2022Parkinson's disease (PD)-related constipation may affects both disease occurrence and disease progression. Probiotics, as a potential therapeutic intervention, have... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Parkinson's disease (PD)-related constipation may affects both disease occurrence and disease progression. Probiotics, as a potential therapeutic intervention, have attracted the attention of researchers, but the evidence of their efficacy and safety has not been systematically reviewed.
AIM
A systematic review and meta-analysis of randomized controlled trials of probiotics in the treatment of PD constipation was conducted to determine the efficacy and safety of probiotics in the treatment of PD constipation.
METHODS
Four databases (The Cochrane Central Register of Controlled Trials, Embase, PubMed, and Web of Science) were searched from their establishment to June 1, 2022. We included randomized controlled trials of probiotics for the treatment of constipation in patients with PD, with probiotics in the experimental group and a placebo, another treatment, or no treatment in the control group. The primary outcome was the number of bowel movements per week. Secondary outcomes included nonmotor symptoms (NMS), gut transit time (GTT), abdominal pain, abdominal distention, constipation, and quality of life scores. Stata15.1 was used to generate a summary of the data and perform a descriptive analysis if necessary. The GRADE tool was used to assess the quality of the evidence and the Cochrane guidelines to assess the risk of bias for each study.
RESULTS
Finally, four qualified RCTs were included, comprising 287 participants. Compared with the control group, probiotics could effectively increase the frequency of defecation per week in PD patients (WMD = 1.02. 95%CI: 0.56-1.48, and < 0.00001), but the heterogeneity was high, and the quality of the evidence was low. There was no significant difference in average stool consistency between patients with PD treated with probiotics and those given a placebo in (WMD = -0.08. 95%CI: -1.42-1.26, and = 0.908). In addition, the results suggested that probiotics have no obvious effect on additional indicators of gastrointestinal dysfunction, such as GTT, abdominal pain, and abdominal distension, and there is insufficient evidence on their ability to improve NMS and Parkinson's disease Questionnaire 39 summary indices (PDQ39-SI). Safety issues should be carefully explained.
CONCLUSION
There is insufficient evidence supporting the use of probiotics to treat constipation in patients with PD. Taking all the results together, probiotics have potential value in the treatment of PD-related constipation.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42022331325.
Topics: Humans; Parkinson Disease; Quality of Life; Treatment Outcome; Randomized Controlled Trials as Topic; Constipation; Probiotics; Abdominal Pain
PubMed: 36439217
DOI: 10.3389/fcimb.2022.1038928 -
Nursing Open May 2023This study aimed to evaluate the effect of abdominal massage (AM) on feeding intolerance (FI) in patients receiving enteral nutrition (EN). (Meta-Analysis)
Meta-Analysis Review
AIM
This study aimed to evaluate the effect of abdominal massage (AM) on feeding intolerance (FI) in patients receiving enteral nutrition (EN).
DESIGN
A systematic review and meta-analysis.
METHODS
We searched seven electronic databases to September 2021. STATA and RevMan were used to analyse the data.
RESULTS
Eleven studies were included. The results revealed that AM could significantly reduce gastric residual volume and abdominal circumference difference, and reduce the incidence of gastric retention, vomiting, abdominal distention (all p < 0.001), diarrhoea (p = 0.02) and constipation (p = 0.002) in the experimental group. One study reported the incidence of aspiration in the control group was higher, but this was not statistically significant (p = 0.07). The meta-regression analysis showed there was a statistically significant correlation between intervention personnel and gastric residual volume (p = 0.035).
CONCLUSION
AM could reduce the amount and incidence of gastric retention and the changes in abdominal circumference, and significantly reduce the incidence of gastrointestinal symptoms, without increasing the incidence of aspiration for EN patients. No Patient or Public Contribution.
Topics: Humans; Infant, Newborn; Enteral Nutrition; Gastrointestinal Diseases; Vomiting; Constipation; Massage
PubMed: 36517968
DOI: 10.1002/nop2.1537 -
Journal of Pregnancy 2014The aim of this review was to identify clinically significant ultrasound predictors of adverse neonatal outcome in fetal gastroschisis. (Review)
Review
OBJECTIVES
The aim of this review was to identify clinically significant ultrasound predictors of adverse neonatal outcome in fetal gastroschisis.
METHODS
A quasi-systematic review was conducted in PubMed and Ovid using the key terms "gastroschisis," "predictors," "outcome," and "ultrasound."
RESULTS
A total of 18 papers were included. The most common sonographic predictors were intra-abdominal bowel dilatation (IABD), intrauterine growth restriction (IUGR), and bowel dilatation not otherwise specified (NOS). Three ultrasound markers were consistently found to be statistically insignificant with respect to predicting adverse outcome including abdominal circumference, stomach herniation and dilatation, and extra-abdominal bowel dilatation (EABD).
CONCLUSIONS
Gastroschisis is associated with several comorbidities, yet there is much discrepancy in the literature regarding which specific ultrasound markers best predict adverse neonatal outcomes. Future research should include prospective trials with larger sample sizes and use well-defined and consistent definitions of the adverse outcomes investigated with consideration given to IABD.
Topics: Dilatation, Pathologic; Female; Fetal Growth Retardation; Gastroschisis; Humans; Intestines; Predictive Value of Tests; Pregnancy; Pregnancy Outcome; Ultrasonography, Prenatal
PubMed: 25587450
DOI: 10.1155/2014/239406 -
Academic Emergency Medicine : Official... Jun 2013Small bowel obstruction (SBO) is a clinical condition that is often initially diagnosed and managed in the emergency department (ED). The high rates of potential... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Small bowel obstruction (SBO) is a clinical condition that is often initially diagnosed and managed in the emergency department (ED). The high rates of potential complications that are associated with an SBO make it essential for the emergency physician (EP) to make a timely and accurate diagnosis.
OBJECTIVES
The primary objective was to perform a systematic review and meta-analysis of the history, physical examination, and imaging modalities associated with the diagnosis of SBO. The secondary objectives were to identify the prevalence of SBO in prospective ED-based studies of adult abdominal pain and to apply Pauker and Kassirer's threshold approach to clinical decision-making to the diagnosis and management of SBO.
METHODS
MEDLINE, EMBASE, major emergency medicine (EM) textbooks, and the bibliographies of selected articles were scanned for studies that assessed one or more components of the history, physical examination, or diagnostic imaging modalities used for the diagnosis of SBO. The selected articles underwent a quality assessment by two of the authors using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Data used to compile sensitivities and specificities were obtained from these studies and a meta-analysis was performed on those that examined the same historical component, physical examination technique, or diagnostic test. Separate information on the prevalence and management of SBO was used in conjunction with the meta-analysis findings of computed tomography (CT) to determine the test and treatment threshold.
RESULTS
The prevalence of SBO in the ED was determined to be approximately 2% of all patients who present with abdominal pain. Having a previous history of abdominal surgery, constipation, abnormal bowel sounds, and/or abdominal distention on examination were the best history and physical examination predictors of SBO. X-ray was determined to be the least useful imaging modality for the diagnosis of SBO, with a pooled positive likelihood ratio (+LR) of 1.64 (95% confidence interval [CI] = 1.07 to 2.52). On the other hand, CT and magnetic resonance imaging (MRI) were both quite accurate in diagnosing SBO with +LRs of 3.6 (5- to 10-mm slices, 95% CI = 2.3 to 5.4) and 6.77 (95% CI = 2.13 to 21.55), respectively. Although limited to only a select number of studies, the use of ultrasound (US) was determined to be superior to all other imaging modalities, with a +LR of 14.1 (95% CI = 3.57 to 55.66) and a negative likelihood ratio (-LR) of 0.13 (95% CI = 0.08 to 0.20) for formal scans and a +LR of 9.55 (95% CI = 2.16 to 42.21) and a -LR of 0.04 (95% CI = 0.01 to 0.13) for beside scans. Using the CT results of the meta-analysis for the 5- to 10-mm slice subgroup as well as information on intravenous (IV) contrast reactions and nasogastric (NG) intubation management, the pretest probability threshold for further testing was determined to be 1.5%, and the pretest probability threshold for beginning treatment was determined to be 20.7%.
CONCLUSIONS
The potentially useful aspects of the history and physical examination were limited to a history of abdominal surgery, constipation, and the clinical examination findings of abnormal bowel sounds and abdominal distention. CT, MRI, and US are all adequate imaging modalities to make the diagnosis of SBO. Bedside US, which can be performed by EPs, had very good diagnostic accuracy and has the potential to play a larger role in the ED diagnosis of SBO. More ED-focused research into this area will be necessary to bring about this change.
Topics: Adult; Emergency Medical Services; Four-Dimensional Computed Tomography; Humans; Intestinal Obstruction; Intestine, Small; Magnetic Resonance Angiography; Physical Examination; Prospective Studies; Ultrasonography, Doppler
PubMed: 23758299
DOI: 10.1111/acem.12150 -
Orphanet Journal of Rare Diseases Jun 2019Congenital tuberculosis is rare and carries a high mortality rate. Our objective was to summarize the current experience of the diagnosis and treatment of patients with... (Review)
Review
BACKGROUND
Congenital tuberculosis is rare and carries a high mortality rate. Our objective was to summarize the current experience of the diagnosis and treatment of patients with congenital tuberculosis.
METHODS
In total, 73 reported cases of congenital tuberculosis published in Chinese and 19 patients with congenital tuberculosis admitted to West China Second University Hospital, Sichuan University, were retrospectively reviewed.
RESULTS
Sixty-four male and 28 female patients were identified. The majority of the patients were less than 3 weeks old at the time of presentation (range, 0-67 days). With regard to the tuberculosis type, 89 patients had pulmonary tuberculosis, and 20 patients had hepatic tuberculosis. There was active tuberculosis in 71 mothers, no tuberculosis in 12 mothers, and an unknown history of tuberculosis in 9 mothers. Fever, cyanosis, jaundice, shortness of breath, cough, pulmonary moist rales, hepatomegaly, splenomegaly and abdominal distention were the main clinical symptoms at the time of presentation. The abnormal ratios of chest, abdomen and head radiographic images were 97.53, 75 and 81.25%, respectively. The positive rates of acid-fast staining of sputum smears and tuberculosis bacillus DNA were 62.50 and 66.67%, respectively. The misdiagnosis rate was 59.78%. The overall mortality due to congenital tuberculosis was 43.48%. Respiratory failure was the most common cause of death. Sixty-five patients received anti-tuberculosis therapy, and of those, only 16 (15.38%) died.
CONCLUSIONS
The clinical manifestations and radiographic findings of congenital tuberculosis are nonspecific. It is important to thoroughly evaluate the mothers of infants with suspected congenital tuberculosis. Good outcomes can be achieved in infants with the early identification of congenital tuberculosis and early administration of anti-tuberculosis treatment.
Topics: Adult; Aged; Aged, 80 and over; Female; Humans; Male; Middle Aged; Respiratory Insufficiency; Retrospective Studies; Tuberculosis; Tuberculosis, Hepatic; Tuberculosis, Pulmonary; Young Adult
PubMed: 31182120
DOI: 10.1186/s13023-019-1101-x -
Journal of Vascular Surgery Feb 2014The purpose of this study was to summarize the current evidence of the association between markers of hemostasis and both the presence and size of abdominal aortic... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The purpose of this study was to summarize the current evidence of the association between markers of hemostasis and both the presence and size of abdominal aortic aneurysms (AAAs).
METHODS
A systematic review and meta-analysis was performed according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines by use of the search terms "aneurysm AND abdominal AND aortic AND coagulation" NOT "thoracic." Outcome data including concentration of hemostatic marker, number of patients, and significance level were recorded.
RESULTS
A total of 22 nonrandomized studies were included in the analysis, with a total of 9862 patients. Fibrinogen mean difference (MD) (0.43 g/L; 95% confidence interval [CI], 0.28-0.58 g/L; P ≤ .00001), D-dimer MD (325.82 ng/mL; 95% CI, 199.74-451.89 ng/mL; P ≤ .00001), and thrombin-antithrombin III complex MD (5.58 g/L; 95% CI, 3.34-7.83 g/L; P ≤ .0001) were significantly elevated in the presence of AAAs. Tissue plasminogen activator, prothrombin fragments F1+F2, and platelet count were not shown to be significantly different between patients with and those without AAAs. Meta-regression of studies reporting plasma D-dimer concentration and aneurysm diameter suggests a strong and significant association (r(2) = 0.94; P ≤ .0001).
CONCLUSIONS
This study suggests that the presence of AAAs is associated with increased fibrin turnover, fibrinolysis, and thrombin generation, as shown by increased levels of fibrinogen, D-dimer, and thrombin-antithrombin III complex. This is clinically relevant because markers of hemostasis are independent risk factors for cardiovascular events, highlighting the necessity of addressing all modifiable cardiovascular risk factors in patients with AAAs. Furthermore, the finding that plasma D-dimer concentration appears to have a linear relationship with aneurysm diameter may be useful as a future biomarker of AAAs.
Topics: Antithrombin III; Aorta, Abdominal; Aortic Aneurysm, Abdominal; Biomarkers; Dilatation, Pathologic; Fibrin Fibrinogen Degradation Products; Fibrinogen; Hemostasis; Humans; Peptide Hydrolases; Prognosis; Risk Factors
PubMed: 24461868
DOI: 10.1016/j.jvs.2013.10.088 -
Alimentary Pharmacology & Therapeutics Nov 2015Consensus on standard methods to assess chronic abdominal pain in patients with irritable bowel syndrome (IBS) is currently lacking. (Review)
Review
BACKGROUND
Consensus on standard methods to assess chronic abdominal pain in patients with irritable bowel syndrome (IBS) is currently lacking.
AIM
To systematically review the literature with respect to instruments of measurement of chronic abdominal pain in IBS patients.
METHODS
Systematic literature search was performed in PubMed/Medline databases for studies using pain measurement instruments in patients with IBS.
RESULTS
One hundred and ten publications were reviewed. A multitude of different instruments is currently used to assess chronic abdominal pain in IBS patients. The single-item methods, e.g. the validated 10-point numeric rating scale (NRS), and questionnaires assessing gastrointestinal symptoms severity, focus mostly on the assessment of only the intensity of abdominal pain. Of these questionnaires, the validated IBS-Symptom Severity Scale includes the broadest measurement of pain-related aspects. General pain questionnaires and electronic momentary symptom assessment tools have been used to study abdominal pain in IBS patients, but have not yet been validated for this purpose. The evidence for the use of provocation tests, e.g. the rectal barostat with balloon distention, for measurement of abdominal pain in IBS is weak, due to the poor correlation between visceral pain thresholds assessed by provocation tests and abdominal pain as assessed by retrospective questionnaires.
CONCLUSIONS
The multitude of different instruments to measure chronic abdominal pain in IBS makes it difficult to compare endpoints of published studies. There is need for validated instruments to assess chronic abdominal pain in IBS patients, that overcome the limitations of the currently available methods.
Topics: Abdominal Pain; Adult; Aged; Aged, 80 and over; Databases, Factual; Humans; Irritable Bowel Syndrome; Middle Aged; Pain Measurement; Surveys and Questionnaires; Visceral Pain
PubMed: 26290286
DOI: 10.1111/apt.13378 -
The Cochrane Database of Systematic... Oct 2017When human milk is not available for feeding preterm infants, protein hydrolysate rather than standard cow's milk formulas (with intact proteins) are often used because... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
When human milk is not available for feeding preterm infants, protein hydrolysate rather than standard cow's milk formulas (with intact proteins) are often used because they are perceived as being tolerated better and less likely to lead to complications. However, protein hydrolysate formulas are more expensive than standard formulas, and concern exists that their use in practice is not supported by high-quality evidence.
OBJECTIVES
To assess the effect of feeding preterm infants with hydrolysed formula (versus standard cow's milk formulas) on the risk of feed intolerance, necrotising enterocolitis, and other morbidity and mortality in preterm infants.
SEARCH METHODS
We used the standard Cochrane Neonatal search strategy including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4), Ovid MEDLINE, Ovid Embase, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (to April 2017), as well as conference proceedings and previous reviews.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials that compared feeding preterm infants with protein hydrolysate versus standard (non-hydrolysed) cow's milk formula.
DATA COLLECTION AND ANALYSIS
Two review authors assessed trial eligibility and risk of bias and extracted data independently. We analysed treatment effects as described in the individual trials and reported risk ratios and risk differences for dichotomous data, and mean differences for continuous data, with respective 95% confidence intervals (CI). We used a fixed-effect model in meta-analyses and explored potential causes of heterogeneity in sensitivity analyses. We assessed quality of evidence at the outcome level using the GRADE approach.
MAIN RESULTS
We identified 11 trials for inclusion in the review. All trials were small (total participants 665) and had various methodological limitations including uncertainty about methods to ensure allocation concealment and blinding. Most participants were clinically stable preterm infants of gestational age less than about 34 weeks or birth weight less than about 1750 g. Fewer participants were extremely preterm, extremely low birth weight, or growth-restricted. Most trials found no effects on feed intolerance assessed variously as mean prefeed gastric residual volume, incidence of abdominal distention or other concerning gastrointestinal signs, or time taken to achieve full enteral feeds (meta-analysis was limited because studies used different measures). Meta-analysis found no effect on the risk of necrotising enterocolitis (typical risk ratio 1.10, 95% CI 0.36 to 3.34; risk difference 0.00, 95% CI -0.03 to 0.04; 5 trials, 385 infants) (low quality evidence; downgraded for imprecision and design weaknesses).
AUTHORS' CONCLUSIONS
The identified trials provide only low quality evidence about the effects of feeding preterm infants with protein hydrolysate versus standard formula. The existing data did not support conclusions that feeding with protein hydrolysate affects the risk of feed intolerance or necrotising enterocolitis. Further large, pragmatic trials are needed to provide more reliable and precise estimates of effectiveness and cost-effectiveness.
Topics: Animals; Enterocolitis, Necrotizing; Food Intolerance; Humans; Infant Formula; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Milk; Protein Hydrolysates; Randomized Controlled Trials as Topic
PubMed: 28968486
DOI: 10.1002/14651858.CD012412.pub2