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The Cochrane Database of Systematic... Nov 2017Approximately 600 million children of preschool and school age are anaemic worldwide. It is estimated that at least half of the cases are due to iron deficiency.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Approximately 600 million children of preschool and school age are anaemic worldwide. It is estimated that at least half of the cases are due to iron deficiency. Point-of-use fortification of foods with micronutrient powders (MNP) has been proposed as a feasible intervention to prevent and treat anaemia. It refers to the addition of iron alone or in combination with other vitamins and minerals in powder form, to energy-containing foods (excluding beverages) at home or in any other place where meals are to be consumed. MNPs can be added to foods either during or after cooking or immediately before consumption without the explicit purpose of improving the flavour or colour.
OBJECTIVES
To assess the effects of point-of-use fortification of foods with iron-containing MNP alone, or in combination with other vitamins and minerals on nutrition, health and development among children at preschool (24 to 59 months) and school (five to 12 years) age, compared with no intervention, a placebo or iron-containing supplements.
SEARCH METHODS
In December 2016, we searched the following databases: CENTRAL, MEDLINE, Embase, BIOSIS, Science Citation Index, Social Science Citation Index, CINAHL, LILACS, IBECS, Popline and SciELO. We also searched two trials registers in April 2017, and contacted relevant organisations to identify ongoing and unpublished trials.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and quasi-RCTs trials with either individual or cluster randomisation. Participants were children aged between 24 months and 12 years at the time of intervention. For trials with children outside this age range, we included studies where we were able to disaggregate the data for children aged 24 months to 12 years, or when more than half of the participants were within the requisite age range. We included trials with apparently healthy children; however, we included studies carried out in settings where anaemia and iron deficiency are prevalent, and thus participants may have had these conditions at baseline.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the eligibility of trials against the inclusion criteria, extracted data from included trials, assessed the risk of bias of the included trials and graded the quality of the evidence.
MAIN RESULTS
We included 13 studies involving 5810 participants from Latin America, Africa and Asia. We excluded 38 studies and identified six ongoing/unpublished trials. All trials compared the provision of MNP for point-of-use fortification with no intervention or placebo. No trials compared the effects of MNP versus iron-containing supplements (as drops, tablets or syrup).The sample sizes in the included trials ranged from 90 to 2193 participants. Six trials included participants younger than 59 months of age only, four included only children aged 60 months or older, and three trials included children both younger and older than 59 months of age.MNPs contained from two to 18 vitamins and minerals. The iron doses varied from 2.5 mg to 30 mg of elemental iron. Four trials reported giving 10 mg of elemental iron as sodium iron ethylenediaminetetraacetic acid (NaFeEDTA), chelated ferrous sulphate or microencapsulated ferrous fumarate. Three trials gave 12.5 mg of elemental iron as microencapsulated ferrous fumarate. Three trials gave 2.5 mg or 2.86 mg of elemental iron as NaFeEDTA. One trial gave 30 mg and one trial provided 14 mg of elemental iron as microencapsulated ferrous fumarate, while one trial gave 28 mg of iron as ferrous glycine phosphate.In comparison with receiving no intervention or a placebo, children receiving iron-containing MNP for point-of-use fortification of foods had lower risk of anaemia prevalence ratio (PR) 0.66, 95% confidence interval (CI) 0.49 to 0.88, 10 trials, 2448 children; moderate-quality evidence) and iron deficiency (PR 0.35, 95% CI 0.27 to 0.47, 5 trials, 1364 children; moderate-quality evidence) and had higher haemoglobin (mean difference (MD) 3.37 g/L, 95% CI 0.94 to 5.80, 11 trials, 2746 children; low-quality evidence).Only one trial with 115 children reported on all-cause mortality (zero cases; low-quality evidence). There was no effect on diarrhoea (risk ratio (RR) 0.97, 95% CI 0.53 to 1.78, 2 trials, 366 children; low-quality evidence).
AUTHORS' CONCLUSIONS
Point-of-use fortification of foods with MNPs containing iron reduces anaemia and iron deficiency in preschool- and school-age children. However, information on mortality, morbidity, developmental outcomes and adverse effects is still scarce.
Topics: Anemia, Iron-Deficiency; Child; Child, Preschool; Dietary Supplements; Edetic Acid; Ferric Compounds; Ferrous Compounds; Food, Fortified; Humans; Iron; Micronutrients; Point-of-Care Systems; Powders; Trace Elements; Vitamins
PubMed: 29168569
DOI: 10.1002/14651858.CD009666.pub2 -
European Urology Focus Sep 2018Gallium prostate-specific membrane antigen (PSMA) ligand Ga-HBED-CC-PSMA (Ga-PSMA) is a promising radiotracer for positron emission tomography (PET)/computed tomography... (Meta-Analysis)
Meta-Analysis
CONTEXT
Gallium prostate-specific membrane antigen (PSMA) ligand Ga-HBED-CC-PSMA (Ga-PSMA) is a promising radiotracer for positron emission tomography (PET)/computed tomography (CT) of prostate cancer.
OBJECTIVE
To conduct a meta-analysis to evaluate detection rate, diagnostic test accuracy, and adverse effects of Ga-PSMA PET/CT or PET/magnetic resonance imaging (MRI) for staging of prostate cancer and for restaging of rising prostate-specific antigen (PSA) after initial treatment.
EVIDENCE ACQUISITION
Following the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines, our systematic review searched for articles in PubMed and EMBASE databases from 2012 to July 2016. The reference standard was pathology after biopsy or surgery. The analyses used a random effect model and a hierarchical summary receiver operating characteristic model.
EVIDENCE SYNTHESIS
Fifteen Ga-PSMA PET/CT studies with 1256 patients met the inclusion criteria. Seven studies of staging PET/CT or PET/MRI detected a regional site of cancer for 203 of 273 patients (74%). Nine studies of restaging PET/CT detected sites of recurrence in 799 of 983 patients (81%) with a 50% detection rate (74 of 147 patients) for restaging PSA of 0.2-0.49 ng/ml and a 53% detection rate (56 of 195 patients) for restaging PSA of 0.50-0.99 ng/ml. Staging Ga-PSMA PET/CT in the studies had higher detection rates of sites in the prostate bed than restaging Ga-PSMA PET/CT (mean 57% vs 14%, p=0.031, t test). Both staging and restaging Ga-PSMA PET/CT found that a subgroup of the patients had metastatic sites in pelvic lymph nodes or distant organs. Eight studies of staging PET/CT undertook histologic correlations. We performed prostate-segment-based analysis specifically regarding the primary cancer lesion for four of these studies, and patient-based analysis specifically regarding pelvic lymph node metastases for four other studies. The pooled sensitivities for staging in the two groups of studies were 70% and 61%, and the pooled specificities were 84% and 97%. None of the studies reported complications from the PET/CT imaging.
CONCLUSIONS
Ga-PSMA PET/CT has clinical relevance to detect sites of recurrence for patients with PSA recurrence after radical prostatectomy (RP) with PSA levels less than 1.0 ng/ml.
PATIENT SUMMARY
Choline positron emission tomography (PET)/computed tomography (CT) can detect sites of recurrent prostate cancer in an earlier phase of prostate-specific antigen (PSA) recurrence than bone scans and CT scans, but choline PET/CT is rarely positive for patients with restaging PSA levels under 1 ng/ml. A new radiotracer called Ga-PSMA for PET/CT was able to detect sites of recurring cancer in up to 50% of patients who had an early rise in PSA exceeding 0.5 ng/ml after initial radical prostatectomy. The published studies did not report adverse effects of Ga-PSMA PET/CT imaging.
Topics: Aged; Antigens, Surface; Choline; Edetic Acid; Gallium; Glutamate Carboxypeptidase II; Humans; Lymphatic Metastasis; Male; Middle Aged; Neoplasm Recurrence, Local; Neoplasm Staging; Outcome Assessment, Health Care; Positron Emission Tomography Computed Tomography; Prostate-Specific Antigen; Prostatectomy; Prostatic Neoplasms
PubMed: 28753806
DOI: 10.1016/j.euf.2016.11.002 -
General Dentistry 2017This study aimed to evaluate the scientific evidence regarding the effectiveness of silver diamine fluoride (SDF) in preventing and arresting caries in the primary... (Review)
Review
This study aimed to evaluate the scientific evidence regarding the effectiveness of silver diamine fluoride (SDF) in preventing and arresting caries in the primary dentition and permanent first molars. A systematic review (SR) was performed by 2 independent reviewers using 3 electronic databases (PubMed, ScienceDirect, and Scopus). The database search employed the following key words: "topical fluorides" AND "children" AND "clinical trials"; "topical fluorides" OR "silver diamine fluoride" AND "randomized controlled trial"; "silver diamine fluoride" AND "children" OR "primary dentition" AND "tooth decay"; "silver diamine fluoride" OR "sodium fluoride varnish" AND "early childhood caries"; and "silver diamine fluoride" AND "children". Inclusion criteria were articles published in English, from 2005 to January 2016, on clinical studies using SDF as a treatment intervention to evaluate caries arrest in children with primary dentition and/or permanent first molars. Database searches provided 821 eligible publications, of which 33 met the inclusion criteria. After the abstracts were prescreened, 25 articles were dismissed based on exclusion criteria. The remaining 8 full-text articles were assessed for eligibility. Of these, 7 publications were included in the SR. These included 1 study assessing the effectiveness of SDF at different concentrations; 3 studies comparing SDF with other interventions; 2 investigations comparing SDF at different application frequencies and with other interventions; and 1 study comparing semiannual SDF applications versus a control group. The literature indicates that SDF is a preventive treatment for dental caries in community settings. At concentrations of 30% and 38%, SDF shows potential as an alternative treatment for caries arrest in the primary dentition and permanent first molars. To establish guidelines, more studies are needed to fully assess the effectiveness of SDF and to determine the appropriate application frequency.
Topics: Cariostatic Agents; Child; Dental Caries; Fluorides, Topical; Humans; Molar; Quaternary Ammonium Compounds; Silver Compounds; Tooth, Deciduous
PubMed: 28475081
DOI: No ID Found -
Clinical Infectious Diseases : An... Jun 2017Evidence-based recommendations for treating persons having presumed latent tuberculosis (LTBI) after contact to infectious multidrug-resistant (MDR) tuberculosis (TB)... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND.
Evidence-based recommendations for treating persons having presumed latent tuberculosis (LTBI) after contact to infectious multidrug-resistant (MDR) tuberculosis (TB) are lacking because published data consist of small observational studies. Tuberculosis incidence in persons treated for latent MDR -TB infection is unknown.
METHODS.
We conducted a systematic review of studies published 1 January 1994-31 December 2014 to analyze TB incidence, treatment completion and discontinuation, and cost-effectiveness. We considered contacts with LTBI effectively treated if they were on ≥1 medication to which their MDR-TB strain was likely susceptible. We selected studies that compared treatment vs nontreatment outcomes and performed a meta-analysis to estimate the relative risk of TB incidence and its 95% confidence interval.
RESULTS.
We abstracted data from 21 articles that met inclusion criteria. Six articles presented outcomes for contacts who were treated compared with those not treated for MDR-LTBI; 10 presented outcomes only for treated contacts, and 5 presented outcomes only for untreated contacts. The estimated MDR-TB incidence reduction was 90% (9%-99%) using data from 5 comparison studies. We also found high treatment discontinuation rates due to adverse effects in persons taking pyrazinamide-containing regimens. Cost-effectiveness was greatest using a fluoroquinolone/ethambutol combination regimen.
CONCLUSIONS.
Few studies met inclusion criteria, therefore results should be cautiously interpreted. We found a reduced risk of TB incidence with treatment for MDR-LTBI, suggesting effectiveness in prevention of progression to MDR-TB, and confirmed cost-effectiveness. However, we found that pyrazinamide-containing MDR-LTBI regimens often resulted in treatment discontinuation due to adverse effects.
Topics: Antitubercular Agents; Cost-Benefit Analysis; Disease Progression; Drug Resistance, Multiple, Bacterial; Ethambutol; Fluoroquinolones; Humans; Latent Tuberculosis; Pyrazinamide; Treatment Outcome; Tuberculosis, Multidrug-Resistant
PubMed: 28329197
DOI: 10.1093/cid/cix208 -
The Cochrane Database of Systematic... Dec 2016Chronic lung disease (CLD) occurs frequently in preterm infants. Bronchodilators have the potential effect of dilating small airways with muscle hypertrophy. Increased... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Chronic lung disease (CLD) occurs frequently in preterm infants. Bronchodilators have the potential effect of dilating small airways with muscle hypertrophy. Increased compliance and tidal volume and decreased pulmonary resistance have been documented with the use of bronchodilators in infants with CLD. Therefore, bronchodilators might have a role in the prevention and treatment of CLD.
OBJECTIVES
To determine the effect of bronchodilators given as prophylaxis or as treatment for CLD on mortality and other complications of preterm birth in infants at risk for or identified as having CLD.
SEARCH METHODS
On 2016 March 7, we used the standard strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2), MEDLINE (from 1966), Embase (from 1980) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; from 1982). We searched clinical trials databases, conference proceedings and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We applied no language restrictions.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials involving preterm infants were eligible for inclusion. Initiation of bronchodilator therapy for prevention of CLD had to occur within two weeks of birth. Treatment of patients with CLD had to be initiated before discharge from the neonatal unit. The intervention had to include administration of a bronchodilator by nebulisation, by metered dose inhaler (with or without a spacer device) or by intravenous or oral administration versus placebo or no intervention. Eligible studies had to include at least one of the following predefined clinical outcomes: mortality, CLD, number of days on oxygen, number of days on ventilator, patent ductus arteriosus (PDA), pulmonary interstitial emphysema (PIE), pneumothorax, intraventricular haemorrhage (IVH) of any grade, necrotising enterocolitis (NEC), sepsis and adverse effects of bronchodilators.
DATA COLLECTION AND ANALYSIS
We used the standard method described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Two review authors extracted and assessed all data provided by each study. We reported risk ratio (RR), risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB) with 95% confidence interval (CI) for dichotomous outcomes and mean difference (MD) for continuous data. We assessed the quality of the evidence by using the GRADE approach.
MAIN RESULTS
For this update, we identified one new randomised controlled trial investigating effects of bronchodilators in preterm infants. This study, which enrolled 73 infants but reported on 52 infants, examined prevention of CLD with the use of aminophylline. According to GRADE, the quality of the evidence was very low. One previously included study enrolled 173 infants to look at prevention of CLD with the use of salbutamol. According to GRADE, the quality of the evidence was moderate. We found no eligible trial that studied the use of bronchodilator therapy for treatment of individuals with CLD. Prophylaxis with salbutamol led to no statistically significant differences in mortality (RR 1.08, 95% CI 0.50 to 2.31; RD 0.01, 95% CI -0.09 to 0.11) nor in CLD (RR 1.03, 95% CI 0.78 to 1.37; RD 0.02, 95% CI -0.13 to 0.17). Results showed no statistically significant differences in other complications associated with CLD nor in preterm birth. Investigators in this study did not comment on side effects due to salbutamol. Prophylaxis with aminophylline led to a significant reduction in CLD at 28 days of life (RR 0.18, 95% CI 0.04 to 0.74; RD -0.35, 95% CI -0.56 to -0.13; NNTB 3, 95% CI 2 to 8) and no significant difference in mortality (RR 3.0, 95% CI 0.33 to 26.99; RD 0.08, 95% CI -0.07 to 0.22), along with a significantly shorter dependency on supplementary oxygen in the aminophylline group compared with the no treatment group (MD -17.75 days, 95% CI -27.56 to -7.94). Tests for heterogeneity were not applicable for any of the analyses, as each meta-analysis included only one study.
AUTHORS' CONCLUSIONS
Data are insufficient for reliable assessment of the use of salbutamol for prevention of CLD. One trial of poor quality reported a reduction in the incidence of CLD and shorter duration of supplementary oxygen with prophylactic aminophylline, but these results must be interpreted with caution. Additional clinical trials are necessary to assess the role of bronchodilator agents in prophylaxis or treatment of CLD. Researchers studying the effects of bronchodilators in preterm infants should include relevant clinical outcomes in addition to pulmonary mechanical outcomes. We identified no trials that studied the use of bronchodilator therapy for treatment of CLD.
Topics: Albuterol; Aminophylline; Beclomethasone; Bronchodilator Agents; Chronic Disease; Drug Therapy, Combination; Humans; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Lung Diseases; Randomized Controlled Trials as Topic
PubMed: 27960245
DOI: 10.1002/14651858.CD003214.pub3 -
The Cochrane Database of Systematic... Nov 2016Tuberculosis (TB) of the gastrointestinal tract and any other organ within the abdominal cavity is abdominal TB, and most guidelines recommend the same six-month regimen... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Tuberculosis (TB) of the gastrointestinal tract and any other organ within the abdominal cavity is abdominal TB, and most guidelines recommend the same six-month regimen used for pulmonary TB for people with this diagnosis. However, some physicians are concerned whether a six-month treatment regimen is long enough to prevent relapse of the disease, particularly in people with gastrointestinal TB, which may sometimes cause antituberculous drugs to be poorly absorbed. On the other hand, longer regimens are associated with poor adherence, which could increase relapse, contribute to drug resistance developing, and increase costs to patients and health providers.
OBJECTIVES
To compare six-month versus longer drug regimens to treat people that have abdominal TB.
SEARCH METHODS
We searched the following electronic databases up to 2 September 2016: the Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase (accessed via OvidSP), LILACS, INDMED, and the South Asian Database of Controlled Clinical Trials. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for ongoing trials. We also checked article reference lists.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) that compared six-month regimens versus longer regimens that consisted of isoniazid, rifampicin, pyrazinamide, and ethambutol to treat adults and children that had abdominal TB. The primary outcomes were relapse, with a minimum of six-month follow-up after completion of antituberculous treatment (ATT), and clinical cure at the end of ATT.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, extracted data, and assessed the risk of bias in the included trials. For analysis of dichotomous outcomes, we used risk ratios (RR) with 95% confidence intervals (CIs). Where appropriate, we pooled data from the included trials in meta-analyses. We assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
We included three RCTs, with 328 participants, that compared six-month regimens with nine-month regimens to treat adults with intestinal and peritoneal TB. All trials were conducted in Asia, and excluded people with HIV, those with co-morbidities and those who had received ATT in the previous five years. Antituberculous regimens were based on isoniazid, rifampicin, pyrazinamide, and ethambutol, and these drugs were administered daily or thrice weekly under a directly observed therapy programme. The median duration of follow-up after completion of treatment was between 12 and 39 months.Relapse was uncommon, with two cases among 140 participants treated for six months, and no events among 129 participants treated for nine months. The small number of participants means we do not know whether or not there is a difference in risk of relapse between the two regimens (very low quality evidence). At the end of therapy, there was probably no difference in the proportion of participants that achieved clinical cure between six-month and nine-month regimens (RR 1.02, 95% CI 0.97 to 1.08; 294 participants, 3 trials, moderate quality evidence). For death, there were 2/150 (1.3%) in the six-month group and 4/144 (2.8%) in the nine-month group. All deaths occurred in the first four months of treatment, so was not linked to the duration of treatment in the included trials. Similarly, the number of participants that defaulted from treatment was small in both groups, and there may be no difference between them (RR 0.50, 95% CI 0.10 to 2.59; 294 participants, 3 trials, low quality evidence). Only one trial reported on adherence to treatment, with only one participant allocated to the nine-month regimen presenting poor adherence to treatment. We do not know whether six-month regimens are associated with fewer people experiencing adverse events that lead to treatment interruption (RR 0.53, 95% CI 0.18 to 1.55; 318 participants, 3 trials, very low quality evidence).
AUTHORS' CONCLUSIONS
We found no evidence to suggest that six-month treatment regimens are inadequate for treating people that have intestinal and peritoneal TB, but numbers are small. We did not find any incremental benefits of nine-month regimens regarding relapse at the end of follow-up, or clinical cure at the end of therapy, but our confidence in the relapse estimate is very low because of size of the trials. Further research is required to make confident conclusions regarding the safety of six-month treatment for people with abdominal TB. Larger studies that include HIV-positive people, with long follow-up for detecting relapse with reliability, would help improve our knowledge around this therapeutic question.
Topics: Abdomen; Antitubercular Agents; Drug Administration Schedule; Ethambutol; Humans; Isoniazid; Pyrazinamide; Randomized Controlled Trials as Topic; Recurrence; Rifampin; Time Factors; Tuberculosis, Gastrointestinal
PubMed: 27801499
DOI: 10.1002/14651858.CD012163.pub2 -
PloS One 2016Adequate asthma treatment of childhood exacerbations with IV aminophylline depends on appropriate dosage. Recommendations to aim for a target therapeutic range may be... (Review)
Review
BACKGROUND
Adequate asthma treatment of childhood exacerbations with IV aminophylline depends on appropriate dosage. Recommendations to aim for a target therapeutic range may be inappropriate as serum concentrations correlate poorly with clinical improvement. This review aims to evaluate the evidence for the optimum dosage strategy of intravenous aminophylline in children suffering an exacerbation of asthma.
METHODS
A systematic review comparing dosage regimens of intravenous aminophylline in children suffering an exacerbation of asthma. Primary outcomes were time until resolution of symptoms, mortality and need for mechanical ventilation. Secondary outcomes were date until discharge criteria are met, actual discharge and adverse effects.
DATA SOURCES
CENTRAL, CINAHL, MEDLINE and Web of Science. Search performed in March 2016.
ELIGIBILITY CRITERIA
Studies using intravenous aminophylline in children with an acute exacerbation of asthma which reported the dosage and clinical outcomes.
FINDINGS
14 RCTs were included. There is a poor relationship between the dosage administered to children and symptom resolution, length of stay or need for mechanical ventilation. This study is limited due to its use of indirect evidence.
CONCLUSION
The currently recommended dosage regimens may not represent the optimum safety and efficacy of intravenous aminophylline. There is a need to develop the evidence base correlating dosage with patient centered clinical outcomes, to improve prescribing practices.
Topics: Administration, Intravenous; Aminophylline; Asthma; Bronchodilator Agents; Child; Dose-Response Relationship, Drug; Humans; Treatment Outcome
PubMed: 27483163
DOI: 10.1371/journal.pone.0159965 -
The Cochrane Database of Systematic... Jul 2016There have been a number of studies with conflicting results which have examined the effect of anti-tuberculous therapy in Crohn's disease. A meta-analysis was performed... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
There have been a number of studies with conflicting results which have examined the effect of anti-tuberculous therapy in Crohn's disease. A meta-analysis was performed to evaluate the use of anti-tuberculous therapy for the maintenance of remission in Crohn's disease.
OBJECTIVES
To evaluate the effects of anti-tuberculous therapy for the maintenance of remission in patients with Crohn's disease.
SEARCH METHODS
We searched MEDLINE, EMBASE, the Cochrane LIbrary, and the Cochrane IBD Group Specialized Register from inception to June 22, 2015.
SELECTION CRITERIA
Randomized controlled trials (RCTs) of anti-tuberculous therapy compared to placebo or another active therapy in patients with quiescent Crohn's disease were considered for inclusion.
DATA COLLECTION AND ANALYSIS
At least two authors independently extracted data and assessed the quality of included studies using the Cochrane risk of bias tool. We calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for dichotomous outcomes.. The primary outcome was relapse. Secondary outcomes included adverse events, withdrawals due to adverse events and serious adverse events. All data were analyzed on an intention-to-treat basis. The overall quality of the evidence supporting the primary and secondary outcomes was evaluated using the GRADE criteria.
MAIN RESULTS
Four placebo-controlled RCTs including 206 participants were included. Three trials included an 8 to 16 week induction phase with tapering corticosteroids (prednisone, prednisolone or methylprednisolone) as induction therapy. Anti-tuberculous therapy included monotherapy with clofazimine, combination therapy with clofazimine, rifampin, ethambutol, and dapsone or combination therapy with clarithromycin, rifabutin and clofazimine. All of the studies were rated as unclear risk of bias for allocation concealment, three were rated as unclear risk of bias for random sequence generation and two were rated as unclear risk of bias for blinding or participants and personnel. There was a statistically significant difference in relapse rates favoring anti-tuberculous therapy over placebo. Thirty-nine per cent (44/112) of patients in the anti-tuberculous therapy group relapsed at 9 months to 2 years compared to 67% (63/94) of placebo patients (RR 0.58, 95% CI 0.45 to 0.75, I(2) = 47%). A GRADE analysis indicates that the overall quality of the evidence supporting this outcome was very low due to unknown risk of bias and sparse data. Adverse events occurred more frequently in the anti-tuberculous therapy group (37/159) compared to the placebo group (14/163) with a pooled RR of 2.57 (95% CI 1.45 to 4.55; N=322; studies=4, I(2)=64%). A GRADE analysis indicates that the overall quality of the evidence supporting this outcome was very low due to unknown risk of bias, unexplained heterogeneity and sparse data. There was no difference in withdrawals due to adverse events. Nine per cent (14/159) of anti-tuberculous therapy patients withdrew due to adverse events compared to 7% (11/163) of placebo patients (RR 1.29, 95% CI 0.60 to 2.77, I(2) = 0%). Common adverse events included increased skin pigmentation and rashes. No serious adverse events were reported in any of the included studies.
AUTHORS' CONCLUSIONS
Anti-tuberculous therapy may provide a benefit over placebo for the prevention of relapse in participants with Crohn's disease in remission. However, this result is very uncertain due to unclear study quality and the small numbers of patients assessed. Further studies are needed to provide better quality evidence for the use of anti-tuberculous therapy for maintaining remission in people with quiescent Crohn's disease.
Topics: Antitubercular Agents; Clarithromycin; Clofazimine; Crohn Disease; Ethambutol; Glucocorticoids; Humans; Maintenance Chemotherapy; Methylprednisolone; Prednisone; Randomized Controlled Trials as Topic; Recurrence; Remission Induction; Rifabutin; Rifampin; Secondary Prevention
PubMed: 27444319
DOI: 10.1002/14651858.CD000299.pub3 -
BMC Oral Health Feb 2016As a low-cost and easily operated treatment, the use of professionally applied topical fluoride was approved for preventing dental caries and remineralising early enamel... (Review)
Review
BACKGROUND
As a low-cost and easily operated treatment, the use of professionally applied topical fluoride was approved for preventing dental caries and remineralising early enamel caries or white spot lesions. It is also used to arrest dentine caries. The aim of this study is to investigate the clinical efficacy of professional fluoride therapy in remineralising and arresting caries in children.
METHOD
A systematic search of publications from 1948 to 2014 was conducted using four databases: PubMed, Cochrane Library, ISI Web of Science and Embase. The key words used were (fluoride) AND (remineralisation OR remineralization OR arresting) AND (children caries OR early childhood caries). The title and abstract of initially identified publications were screened. Clinical trials about home-use fluorides, laboratory studies, case reports, reviews, non-English articles and irrelevant studies were excluded. The full texts of the remaining papers were retrieved. Manual screening was conducted on the bibliographies of the remaining papers to identify relevant articles.
RESULTS
A total of 2177 papers were found, and 17 randomised clinical trials were included in this review. Ten studies investigated the remineralising effect on early enamel caries using silicon tetrafluoride, fluoride gel, silver diamine fluoride or sodium fluoride. Seven studies reported an arresting effect on dentine caries using silver diamine fluoride or nano-silver fluoride. Meta-analysis was performed on four papers using 5 % sodium fluoride varnish to remineralise early enamel caries, and the overall percentage of remineralised enamel caries was 63.6 % (95 % CI: 36.0 % - 91.2 %; p < 0.001). Meta-analysis was also performed on five papers using 38 % silver diamine fluoride to arrest dentine caries and the overall proportion of arrested dentine caries was 65.9 % (95 % CI: 41.2 % - 90.7 %; p < 0.001).
CONCLUSION
Professionally applied 5 % sodium fluoride varnish can remineralise early enamel caries and 38 % silver diamine fluoride is effective in arresting dentine caries.
Topics: Cariostatic Agents; Child; Dental Care; Dental Caries; Fluorides, Topical; Humans; Quaternary Ammonium Compounds; Randomized Controlled Trials as Topic; Silver Compounds; Sodium Fluoride; Tooth Remineralization
PubMed: 26831727
DOI: 10.1186/s12903-016-0171-6 -
Biomedical and Environmental Sciences :... Nov 2015To assess the effect of sodium iron ethylenediaminetetraacetate (NaFeEDTA)-fortified soy sauce on anemia prevalence in the Chinese population. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To assess the effect of sodium iron ethylenediaminetetraacetate (NaFeEDTA)-fortified soy sauce on anemia prevalence in the Chinese population.
METHODS
A systematic review was performed to identify potential studies by searching the electronic databases of PubMed, Cochrane Library, WHO Library, HighWire, CNKI, and other sources. The selection criteria included randomized controlled trials that compared the efficacy of NaFeEDTA-fortified soy sauce with that of non-fortified soy sauce. Anemia rates and hemoglobin levels were the outcomes of interest. Inclusion decisions, quality assessment, and data extraction were performed by two reviewers independently. A total of 16 studies met the inclusion criteria for anemia rate analysis, of which 12 studies met the inclusion criteria for hemoglobin analysis. All included studies assessed the effect of NaFeEDTA-fortified soy sauce on anemia rates and hemoglobin concentrations.
RESULTS
After the intervention, the hemoglobin concentration increased and anemia rates decreased significantly as compared with the non-fortified soy sauce groups. For anemia rates, data from 16 studies could be pooled, and the pooled estimate odds ratio was 0.25 (95% CI 0.19-0.35). For hemoglobin concentrations, data from 12 studies could be pooled, and the pooled weighted mean difference was 8.81 g/L (95% CI 5.96-11.67).
CONCLUSION
NaFeEDTA-fortified soy sauce has a positive effect on anemia control and prevention in the at-risk population.
Topics: Age Factors; Anemia, Iron-Deficiency; China; Edetic Acid; Ferric Compounds; Food, Fortified; Hematocrit; Humans; Prevalence; Randomized Controlled Trials as Topic; Soy Foods
PubMed: 26695357
DOI: 10.3967/bes2015.110