Randomised Or Quasi-randomised Controlled Trials Research Articles

Probiotics for people with cystic fibrosis.

Probiotics for people with cystic fibrosis.

Formula versus donor breast milk for feeding preterm or low birth weight infants.

When sufficient maternal breast milk is not available, alternative forms of enteral nutrition for preterm or low birth weight (LBW) infants are donor breast milk or artificial formula. Donor breast milk may retain some of the non-nutritive benefits of maternal breast milk for preterm or LBW infants. However, feeding with artificial formula may ensure more consistent delivery of greater amounts of nutrients. Uncertainty exists about the balance of risks and benefits of feeding formula versus donor breast milk for preterm or LBW infants. To determine the effect of feeding with formula compared with donor breast milk on growth and development in preterm or low birth weight (LBW) infants. We used the Cochrane Neonatal search strategy, including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 5), Ovid MEDLINE, Embase, and the Cumulative Index to Nursing and Allied Health Literature (3 May 2019), as well as conference proceedings, previous reviews, and clinical trials. Randomised or quasi-randomised controlled trials (RCTs) comparing feeding with formula versus donor breast milk in preterm or LBW infants. 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 (RRs) and risk differences (RDs) for dichotomous data, and mean differences (MDs) for continuous data, with respective 95% confidence intervals (CIs). We used a fixed-effect model in meta-analyses and explored potential causes of heterogeneity in subgroup analyses. We assessed the certainty of evidence for the main comparison at the outcome level using GRADE methods. Twelve trials with a total of 1879 infants fulfilled the inclusion criteria. Four trials compared standard term formula versus donor breast milk and eight compared nutrient-enriched preterm formula versus donor breast milk. Only the five most recent trials used nutrient-fortified donor breast milk. The trials contain various weaknesses in methodological quality, specifically concerns about allocation concealment in four trials and lack of blinding in most of the trials. Most of the included trials were funded by companies that made the study formula.Formula-fed infants had higher in-hospital rates of weight gain (mean difference (MD) 2.51, 95% confidence interval (CI) 1.93 to 3.08 g/kg/day), linear growth (MD 1.21, 95% CI 0.77 to 1.65 mm/week) and head growth (MD 0.85, 95% CI 0.47 to 1.23 mm/week). These meta-analyses contained high levels of heterogeneity. We did not find evidence of an effect on long-term growth or neurodevelopment. Formula feeding increased the risk of necrotising enterocolitis (typical risk ratio (RR) 1.87, 95% CI 1.23 to 2.85; risk difference (RD) 0.03, 95% CI 0.01 to 0.05; number needed to treat for an additional harmful outcome (NNTH) 33, 95% CI 20 to 100; 9 studies, 1675 infants).The GRADE certainty of evidence was moderate for rates of weight gain, linear growth, and head growth (downgraded for high levels of heterogeneity) and was moderate for neurodevelopmental disability, all-cause mortality, and necrotising enterocolitis (downgraded for imprecision). In preterm and LBW infants, moderate-certainty evidence indicates that feeding with formula compared with donor breast milk, either as a supplement to maternal expressed breast milk or as a sole diet, results in higher rates of weight gain, linear growth, and head growth and a higher risk of developing necrotising enterocolitis. The trial data do not show an effect on all-cause mortality, or on long-term growth or neurodevelopment.

Iodine fortification of foods and condiments, other than salt, for preventing iodine deficiency disorders.

Iodine fortification of foods and condiments, other than salt, for preventing iodine deficiency disorders.

Formula versus donor breast milk for feeding preterm or low birth weight infants.

When sufficient maternal breast milk is not available, alternative forms of enteral nutrition for preterm or low birth weight (LBW) infants are donor breast milk or artificial formula. Donor breast milk may retain some of the non-nutritive benefits of maternal breast milk for preterm or LBW infants. However, feeding with artificial formula may ensure more consistent delivery of greater amounts of nutrients. Uncertainty exists about the balance of risks and benefits of feeding formula versus donor breast milk for preterm or LBW infants. To determine the effect of feeding with formula compared with donor breast milk on growth and development in preterm or low birth weight (LBW) infants. We used the Cochrane Neonatal search strategy, including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 6), Ovid MEDLINE, Embase, and the Cumulative Index to Nursing and Allied Health Literature (until 8 June 2017), as well as conference proceedings and previous reviews. Randomised or quasi-randomised controlled trials (RCTs) comparing feeding with formula versus donor breast milk in preterm or LBW infants. 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 (RRs) and risk differences (RDs) for dichotomous data, and mean differences (MDs) for continuous data, with respective 95% confidence intervals (CIs). We used a fixed-effect model in meta-analyses and explored potential causes of heterogeneity in subgroup analyses. We assessed the quality of evidence for the main comparison at the outcome level using "Grading of Recommendations Assessment, Development and Evaluation" (GRADE) methods. Eleven trials, in which 1809 infants participated in total, fulfilled the inclusion criteria. Four trials compared standard term formula versus donor breast milk and seven compared nutrient-enriched preterm formula versus donor breast milk. Only the four most recent trials used nutrient-fortified donor breast milk. The trials contain various weaknesses in methodological quality, specifically concerns about allocation concealment in four trials and lack of blinding in most of the trials.Formula-fed infants had higher in-hospital rates of weight gain (mean difference (MD) 2.51, 95% confidence interval (CI) 1.93 to 3.08 g/kg/day), linear growth (MD 1.21, 95% CI 0.77 to 1.65 mm/week) and head growth (MD 0.85, 95% CI 0.47 to 1.23 mm/week). We did not find evidence of an effect on long-term growth or neurodevelopment. Formula feeding increased the risk of necrotising enterocolitis (typical risk ratio (RR) 1.87, 95% CI 1.23 to 2.85; risk difference (RD) 0.03, 95% CI 0.01 to 0.06).The GRADE quality of evidence was moderate for rates of weight gain, linear growth, and head growth (downgraded for high levels of heterogeneity) and was moderate for neurodevelopmental disability, all-cause mortality, and necrotising enterocolitis (downgraded for imprecision). In preterm and LBW infants, feeding with formula compared with donor breast milk, either as a supplement to maternal expressed breast milk or as a sole diet, results in higher rates of weight gain, linear growth, and head growth and a higher risk of developing necrotising enterocolitis. The trial data do not show an effect on all-cause mortality, or on long-term growth or neurodevelopment.

Interventions for the treatment of Frey's syndrome.

Frey's syndrome is a rare disorder, the symptoms of which include sweating, flushing and warming over the preauricular and temporal areas following a gustatory stimulus. It often occurs in patients who have undergone parotidectomy, submandibular gland surgery, radical neck dissection, infection and traumatic injury in the parotid region, and is caused by the aberrant regrowth of facial autonomic nerve fibres. Currently there are several options used to treat patients with Frey's syndrome; for example, the topical application of anticholinergics and antiperspirants, and the intradermal injection of botulinum toxin. It is uncertain which treatment is most effective and safe. To assess the efficacy and safety of different interventions for the treatment of Frey's syndrome. We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; ICTRP and additional sources for published and unpublished trials. The date of the search was 28 April 2014. We included randomised or quasi-randomised controlled trials (RCTs) in participants diagnosed with Frey's syndrome using a clinical standard such as Minor's starch-iodine test. We planned to include trials in which participants received any intervention versus no treatment (observation) or an alternative intervention, with or without a second active treatment. Our primary outcome measures were success rate (as assessed clinically by Minor's starch-iodine test, the iodine-sublimated paper histogram method, blotting paper technique or another method) and adverse events. Our secondary outcome measure was success rate as assessed by patients (disappearance or improvement of symptoms). We used the standard methodological procedures expected by The Cochrane Collaboration. We identified no RCTs or quasi-RCTs that fulfilled the inclusion criteria. Our searches retrieved eight potentially relevant studies, but after assessment of the full-text reports we excluded all of them due to the absence of randomisation or because the patients did not have Frey's syndrome. We excluded one randomised controlled trial that compared two different doses of botulinum toxin in patients with Frey's syndrome because the comparator was not an alternative treatment. We are unable to establish the efficacy and safety of the different methods used for the treatment of Frey's syndrome.RCTs are urgently needed to assess the effectiveness of interventions for the treatment of Frey's syndrome. Future RCTs should include patients with Frey's syndrome of different ranges of severity and report these patients separately. Studies should investigate all possibly effective treatments (such as anticholinergics, antiperspirants and botulinum toxin) compared to control groups using different treatments or placebo. Subjective assessment of Frey's syndrome should be considered as one of the outcome measures.

Iodine fortification of foods and condiments, other than salt, for preventing iodine deficiency disorders

Iodine fortification of foods and condiments, other than salt, for preventing iodine deficiency disorders

Shouldice technique versus other open techniques for inguinal hernia repair.

Inguinal hernia repair is the most frequent operation in general surgery. There are several techniques: the Shouldice technique is sometimes considered the best method but different techniques are used as the "gold standard" for open hernia repair. Outcome measures, such as recurrence rates, complications and length of post operative stay, vary considerably among the various techniques. To evaluate the efficacy and safety of the Shouldice technique compared to other non-laparoscopic techniques for hernia repair. We searched MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (CENTRAL), April 2008 and updated the searches September 2011, for relevant randomised controlled trials. Any randomised or quasi-randomised controlled trials (RCT) on the treatment of primary inguinal hernia in adults were considered for inclusion. All abstracts identified by the search strategies were assessed by two independent researchers to exclude studies that did not meet the inclusion criteria. The full publications of all possibly relevant abstracts were obtained and formally assessed. Missing or updated informations was sought by contacting the authors. Sixteen trials contributed to this review. A total of 2566 hernias were analysed in the Shouldice group with 1121 mesh and 1608 non-mesh techniques. The recurrence rate with Shouldice techniques was higher than mesh techniques (OR 3.80, 95% CI 1.99 to 7.26) but lower than non-mesh techniques (OR 0.62, 95% CI 0.45 to 0.85). There were no significant differences in chronic pain, complications and post-operative stay. Female were nearly 3% of included patients. Shouldice herniorrhaphy is the best non-mesh technique in terms of recurrence, though it is more time consuming and needs a slightly longer post-operative hospital stay. The use of mesh is associated with a lower rate of recurrence. The quality of included studies, assessed with jaded scale, were low. Patients have similar characteristic in the treatment and control group but seems more healthy than in general population, this features may affect the dimension of effect in particularly recurrence rate could be higher in general population. Lost to follow-up were similar in the treatment and control group but the reasons were often not reported. The length of follow-up vary broadly among the studies from 1 year to 13.7 year.

Effectiveness of support services for children and young people with challenging behaviours related to or secondary to disability, who are in out-of-home care: A systematic review

Abstract Context In Australia, government policies support therapeutic interventions for children and young people (CYP) with challenging behaviours related to or secondary to disability, who are in out-of-home care. The aims of interventions are to enhance the skills of both CYP and foster caregivers/parents in order to enhance placement stability, community participation and the overall well-being of the CYP. These interventions are costly and time consuming for CYP, their foster caregivers/parents and the professionals/agencies involved, and evaluation of their effectiveness is warranted. Objectives To review the effectiveness of current practices and interventions for CYP in out-of-home care who have challenging behaviours related to disabilities. Data sources Databases searched included: PsycINFO (1840–September 2010), ERIC (1966–September 2010), MEDLINE (1950–September 2010), CINAHL (1982–September 2010), Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, 2010), Social Services Abstracts (1979–September 2010), PAIS international (1972–September 2010), PsycARTICLES (1894–September 2010), Sociological abstracts (1952–September 2010). Study selection Randomised or quasi-randomised controlled trials (RCT), non-randomised controlled trials, and cohort studies of interventions or programs for CYP with complex psychological and/or behavioural issues, and/or a disability in foster care were included. Data extraction Details of study characteristics, population demographics and intervention content were tabulated. Qualitative analysis was performed by two independent raters using the Physiotherapy Evidence Database (PEDro) scale for RCTs and an adapted version of The Downs and Black Checklist for Measuring Study Quality (DB Scale) for non-randomised control trials. Data synthesis Four studies met inclusion criteria (two RCTs and two non-randomised control trials). The two RCTS were of moderate methodological quality, each scoring five points (out of a maximum of 10) on the PEDro Scale. The two non-randomised control trials were of similar methodological quality, scoring 14–17 points (out of a maximum of 28) on the adapted Downs and Black Checklist. Content The included studies evaluated a variety of interventions which differed considerably with respect to services offered, approach/philosophy, service delivery models and intensity/duration. Two of the four studies were of behaviourally based parent training interventions. Whilst the other two studies also involved parent training, the primary focus of intervention was the implementation of individualised case management plans by key stakeholders in the CYP's life. The frequency of intervention and length of follow-up in the included studies varied greatly. Three of the reviewed studies reported positive outcomes for children and young people, as well as their caregivers/parents, whilst the fourth found no significant change. Conclusions Studies generally demonstrated gains from the interventions provided, however the nature and extent of these benefits differed greatly across the various outcomes measured. Further, studies often did not take into account other factors which may have contributed towards the observed outcomes. In light of the complexity of providing services to CYP with behavioural issues and/or disability who are in out-of-home care, the costs associated with these services, and the risks if these are not effective, this review highlights the need the need for further research of the efficacy of support services for this group.

Occlusal splints for treating sleep bruxism (tooth grinding)

Sleep bruxism is an oral activity characterised by teeth grinding or clenching during sleep. Several treatments for sleep bruxism have been proposed such as pharmacological, psychological, and dental. To evaluate the effectiveness of occlusal splints for the treatment of sleep bruxism with alternative interventions, placebo or no treatment. We searched the Cochrane Oral Health Group's Trials Register (to May 2007); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 1); MEDLINE (1966 to May 2007); EMBASE (1980 to May 2007); LILACS (1982 to May 2007); Biblioteca Brasileira de Odontologia (1982 to May 2007); Dissertation, Theses and Abstracts (1981 to May 2007); and handsearched abstracts of particular importance to this review. Additional reports were identified from the reference lists of retrieved reports and from article reviews about treating sleep bruxism. There were no language restrictions. We selected randomised or quasi-randomised controlled trials (RCTs), in which splint therapy was compared concurrently to no treatment, other occlusal appliances, or any other intervention in participants with sleep bruxism. Data extraction was carried out independently and in duplicate. Validity assessment of the included trials was carried out at the same time as data extraction. Discrepancies were discussed and a third review author consulted. The author of the primary study was contacted when necessary. Thirty-two potentially relevant RCTs were identified. Twenty-four trials were excluded. Five RCTs were included. Occlusal splint was compared to: palatal splint, mandibular advancement device, transcutaneous electric nerve stimulation, and no treatment. There was just one common outcome (arousal index) which was combined in a meta-analysis. No statistically significant differences between the occlusal splint and control groups were found in the meta-analyses. There is not sufficient evidence to state that the occlusal splint is effective for treating sleep bruxism. Indication of its use is questionable with regard to sleep outcomes, but it may be that there is some benefit with regard to tooth wear. This systematic review suggests the need for further investigation in more controlled RCTs that pay attention to method of allocation, outcome assessment, large sample size, and sufficient duration of follow up. The study design must be parallel, in order to eliminate the bias provided by studies of cross-over type. A standardisation of the outcomes of the treatment of sleep bruxism should be established in the RCTs.

Review: lorazepam provides the best control for status epilepticus

Prasad K, Al-Roomi K, Krishnan P, et al. Anticonvulsant therapy for status epilepticus. Cochrane Database Syst Rev 2005;(4):CD003723. Q In patients with status epilepticus (SE), which anticonvulsant drugs are most...

Hip protectors for preventing hip fractures in the elderly.

Hip fracture in the elderly usually results from a fall on the hip. Hip protectors have been advocated as a means to reduce the risk of sustaining a hip fracture. To determine if external hip protectors reduce the incidence of hip fractures in elderly persons following a fall. We searched the Cochrane Musculoskeletal Injuries Group trials register (February 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to February Week 2 2004), EMBASE (1988 to 2004 Week 08), CINAHL (1982 to February Week 2 2004), other databases and reference lists of relevant articles. We also contacted trialists. All randomised or quasi-randomised controlled trials comparing the use of hip protectors with a control group. Two reviewers independently assessed trial quality and extracted data. We sought additional information from all trialists. An additional trial with 4169 participants was included in this update, giving a total of 14 included trials. One, which was a study of compliance (adherence) lasting 12 weeks, contributed no fracture outcome data. Five studies involving 4316 participants were cluster randomised by care unit, nursing home or nursing home ward rather than by the individual. Each of these studies reported a reduced incidence of hip fractures within those units allocated to receive the protectors. Because the majority of these trials had not been analysed to allow for clustering, pooling of their results was not undertaken. Pooling of data from five individually randomised trials conducted in nursing/residential care settings (1426 participants) showed no significant reduction in hip fracture incidence (hip protectors 37/822, controls 40/604, relative risk (RR) 0.83, 95% confidence interval (CI) 0.54 to 1.29). Three individually randomised trials of 5135 community dwelling participants, reported no reduction in hip fracture incidence with the hip protectors (RR 1.16, 95% CI 0.85 to 1.59). No important adverse effects of the hip protectors were reported but compliance, particularly in the long term, was poor. There is no evidence of effectiveness of hip protectors from studies in which randomisation was by individual patient within an institution, or for those living in their own homes. Data from cluster randomised studies indicate that, for those living in institutional care with a high background incidence of hip fracture, a programme of providing hip protectors appears to reduce the incidence of hip fractures. Acceptability by users of the protectors remains a problem, due to discomfort and practicality.

Hip protectors for preventing hip fractures in the elderly

BACKGROUND: Hip fracture in the elderly is usually the result of a simple fall. Hip protectors have been advocated as a means to reduce the risk of sustaining a fracture in a fall on the hip. OBJECTIVES: To determine if external hip protectors reduce the incidence of hip fractures in elderly persons following a fall. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register (April 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2003), MEDLINE (1966 to April 2003), EMBASE (1988 to 2003 week 14), CINAHL (1982 to April 2003) and reference lists of relevant articles. Trialists were contacted, and ongoing trials identified in The National Research Register (http://www.update-software.com/national/ accessed 20/01/03) and Current Controlled Trials (http://controlled-trials.com/ accessed 20/01/03). SELECTION CRITERIA: All randomised or quasi-randomised controlled trials (RCTs) comparing the use of hip protectors with a control group. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, using a 10-item scale, and extracted data. Additional information was sought from all trialists. Wherever appropriate and possible, the data are presented graphically. MAIN RESULTS: In this third update, 13 randomised controlled trials were included. One, which was a study of compliance lasting 12 weeks, contributed no fracture outcome data. Five studies involving 4316 participants were cluster randomised by care unit, nursing home or nursing home ward rather than by the individual. Individually, each of these studies reported a reduced incidence of hip fractures within those units allocated to receive the protectors. Because of the use of cluster randomisation pooling of results of these studies was not undertaken. Pooling of data from five individually randomised trials conducted in nursing/residential care settings (1426 participants) showed no significant reduction in hip fracture incidence (hip protectors 37/822, controls 40/604, RR 0.83, 95% CI 0.54 to 1.29). Two individually randomised trials of 966 community dwelling participants, reported no reduction in hip fracture incidence with the hip protectors (RR 1.11, 95% CI 0.65 to 1.90). No important adverse effects of the hip protectors were reported but compliance, particularly in the long term, was poor. REVIEWER'S CONCLUSIONS: There is no evidence of effectiveness of hip protectors from studies in which randomisation was by individual patient within an institution, or for those living in their own homes. Data from cluster randomised studies indicates that, for those living in institutional care with a high background incidence of hip fracture, a programme of providing hip protectors appears to reduce the incidence of hip fractures. Acceptability by users of the protectors remains a problem, due to discomfort and practicality. Cost effectiveness remains unclear.

Occlusal adjustment for treating and preventing temporomandibular joint disorders.

There has been a long history of using occlusal adjustment in the management of temporomandibular disorders (TMD). It is not clear if occlusal adjustment is effective in treating TMD. To assess the effectiveness of occlusal adjustment for treating TMD in adults and preventing TMD. We searched the Cochrane Oral Health Group's Trials Register (April 2002); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2002); MEDLINE (1966 to 8th April 2002); EMBASE (1980 to 8th April 2002) and handsearched journals of particular importance to this review. Additional reports were identified from the reference lists of retrieved reports and from review articles of treating TMD. There were no language restrictions. Unpublished reports or abstracts were considered from the SIGLE database. All randomised or quasi-randomised controlled trials (RCTs) comparing occlusal adjustment to placebo, reassurance or no treatment in adults with TMD. The outcomes were global measures of symptoms, pain, headache and limitation of movement. Data were independently extracted, in duplicate, by two reviewers, Holy Koh (HK) and Peter G Robinson (PR). Authors were contacted for details of randomisation and withdrawals and a quality assessment was carried out. The Cochrane Oral Health Group's statistical guidelines were followed and relative risk values calculated using random effects models where significant heterogeneity was detected (P<0.1). Over 660 trials were identified by the initial search. Six of these trials, which reported results from a total of 392 patients, were suitable for inclusion in the review. From the data provided in the published reports, symptom-based outcomes were extracted from trials on treatment. Data on incidence of symptoms were extracted from trials on prevention. Neither showed any difference between occlusal adjustment and control group. There is an absence of evidence, from RCTs, that occlusal adjustment treats or prevents TMD. Occlusal adjustment cannot be recommended for the management or prevention of TMD. Future trials should use standardised diagnostic criteria and outcome measures when evaluating TMD.