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The Cochrane Database of Systematic... Sep 2011Preterm birth is a significant perinatal problem contributing to perinatal morbidity and mortality. Heavy vaginal ureaplasma colonisation is suspected of playing a role... (Review)
Review
BACKGROUND
Preterm birth is a significant perinatal problem contributing to perinatal morbidity and mortality. Heavy vaginal ureaplasma colonisation is suspected of playing a role in preterm birth and preterm rupture of the membranes. Antibiotics are used to treat infections and have been used to treat pregnant women with preterm prelabour rupture of the membranes, resulting in some short-term improvements. However, the benefit of using antibiotics in early pregnancy to treat heavy vaginal colonisation is unclear.
OBJECTIVES
To assess whether antibiotic treatment of pregnant women with heavy vaginal ureaplasma colonisation reduces the incidence of preterm birth and other adverse pregnancy outcomes.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2011).
SELECTION CRITERIA
Randomised controlled trials comparing any antibiotic regimen with placebo or no treatment in pregnant women with ureaplasma detected in the vagina.
DATA COLLECTION AND ANALYSIS
Three review authors independently assessed eligibility and trial quality and extracted data.
MAIN RESULTS
We included one trial, involving 1071 women. Of these, 644 women between 22 weeks and 32 weeks' gestation were randomly assigned to one of three groups of antibiotic treatment (n = 174 erythromycin estolate, n = 224 erythromycin stearate, and n = 246 clindamycin hydrochloride) or a placebo (n = 427). Preterm birth data was not reported in this trial. Incidence of low birthweight less than 2500 grams was only evaluated for erythromycin (combined, n = 398) compared to placebo (n = 427) and there was no statistically significant difference between the two groups (risk ratio (RR) 0.70, 95% confidence interval (CI) 0.46 to 1.07). There were no statistically significant differences in side effects sufficient to stop treatment between either group (RR 1.25, 95% CI 0.85 to 1.85).
AUTHORS' CONCLUSIONS
There is insufficient evidence to assess whether pregnant women who have vaginal colonisation with ureaplasma should be treated with antibiotics to prevent preterm birth.Preterm birth is a significant perinatal problem. Upper genital tract infections, including ureaplasmas, are suspected of playing a role in preterm birth and preterm rupture of the membranes. Antibiotics are used to treat women with preterm prelabour rupture of the membranes; this may result in prolongation of pregnancy and lowers the risks of maternal and neonatal infection. However, antibiotics may be beneficial earlier in pregnancy to eradicate potentially causative agents.
Topics: Anti-Bacterial Agents; Clindamycin; Erythromycin; Erythromycin Estolate; Female; Humans; Pregnancy; Pregnancy Complications, Infectious; Randomized Controlled Trials as Topic; Ureaplasma Infections; Vaginal Diseases
PubMed: 21901685
DOI: 10.1002/14651858.CD003767.pub3 -
The Cochrane Database of Systematic... Jun 2017Pressure ulcers, also known as bed sores, pressure sores or decubitus ulcers develop as a result of a localised injury to the skin or underlying tissue, or both. The... (Review)
Review
BACKGROUND
Pressure ulcers, also known as bed sores, pressure sores or decubitus ulcers develop as a result of a localised injury to the skin or underlying tissue, or both. The ulcers usually arise over a bony prominence, and are recognised as a common medical problem affecting people confined to a bed or wheelchair for long periods of time. Anabolic steroids are used as off-label drugs (drugs which are used without regulatory approval) and have been used as adjuvants to usual treatment with dressings, debridement, nutritional supplements, systemic antibiotics and antiseptics, which are considered to be supportive in healing of pressure ulcers. Anabolic steroids are considered because of their ability to stimulate protein synthesis and build muscle mass. Comprehensive evidence is required to facilitate decision making, regarding the benefits and harms of using anabolic steroids.
OBJECTIVES
To assess the effects of anabolic steroids for treating pressure ulcers.
SEARCH METHODS
In March 2017 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
Published or unpublished randomised controlled trials (RCTs) comparing the effects of anabolic steroids with alternative treatments or different types of anabolic steroids in the treatment of pressure ulcers.
DATA COLLECTION AND ANALYSIS
Two review authors independently carried out study selection, data extraction and risk of bias assessment.
MAIN RESULTS
The review contains only one trial with a total of 212 participants, all with spinal cord injury and open pressure ulcers classed as stage III and IV. The participants were mainly male (98.2%, 106/108) with a mean age of 58.4 (standard deviation 10.4) years in the oxandrolone group and were all male (100%, 104/104) with a mean age of 57.3 (standard deviation 11.6) years in the placebo group. This trial compared oxandrolone (20 mg/day, administered orally) with a dose of placebo (an inactive substance consisting of 98% starch and 2% magnesium stearate) and reported data on complete healing of ulcers and adverse events. There was very low-certainty evidence on the relative effect of oxandrolone on complete ulcer healing at the end of a 24-week treatment period (risk ratio RR) 0.81, 95% confidence interval (CI) 0.52 to 1.26) (downgraded twice for imprecision due to an extremely wide 95% CI, which spanned both benefit and harm, and once for indirectness, as the participants were mostly male spinal cord injury patients). Thus, we are uncertain whether oxandrolone improves or reduces the complete healing of pressure ulcers, as we assessed the certainty of the evidence as very low.There was low-certainty evidence on the risk of non-serious adverse events reported in participants treated with oxandrolone compared with placebo (RR 3.85, 95% CI 1.12 to 13.26) (downgraded once for imprecision and once for indirectness, as the participants were mostly male spinal cord injury patients). Thus, the treatment with oxandrolone may increase the risk of non-serious adverse events reported in participants.There was very low-certainty evidence on the risk of serious adverse events reported in participants treated with oxandrolone compared with placebo (RR 0.54, 95% CI 0.25 to 1.17) (downgraded twice for imprecision due to an extremely wide 95% CI, which spanned both benefit and harm, and once for indirectness, as the participants were mostly male spinal cord injury patients). Of the five serious adverse events reported in the oxandrolone-treated group, none were classed by the trial teams as being related to treatment. We are uncertain whether oxandrolone increases or decreases the risk of serious adverse events as we assessed the certainty of the evidence as very low.Secondary outcomes such as pain, length of hospital stay, change in wound size or wound surface area, incidence of different type of infection, cost of treatment and quality of life were not reported in the included trial.Overall the evidence in this study was of very low quality (downgraded for imprecision and indirectness). This trial stopped early when the futility analysis (interim analysis) in the opinion of the study authors showed that oxandrolone had no benefit over placebo for improving ulcer healing.
AUTHORS' CONCLUSIONS
There is no high quality evidence to support the use of anabolic steroids in treating pressure ulcers.Further well-designed, multicenter trials, at low risk of bias, are necessary to assess the effect of anabolic steroids on treating pressure ulcers, but careful consideration of the current trial and its early termination are required when planning future research.
Topics: Female; Humans; Male; Middle Aged; Off-Label Use; Oxandrolone; Pressure Ulcer; Starch; Stearic Acids; Testosterone Congeners; Wound Healing
PubMed: 28631809
DOI: 10.1002/14651858.CD011375.pub2 -
The Cochrane Database of Systematic... Apr 2014Magnesium is an essential mineral required for regulation of body temperature, nucleic acid and protein synthesis and in maintaining nerve and muscle cell electrical... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Magnesium is an essential mineral required for regulation of body temperature, nucleic acid and protein synthesis and in maintaining nerve and muscle cell electrical potentials. Many women, especially those from disadvantaged backgrounds, have low intakes of magnesium. Magnesium supplementation during pregnancy may be able to reduce fetal growth restriction and pre-eclampsia, and increase birthweight.
OBJECTIVES
To assess the effects of magnesium supplementation during pregnancy on maternal, neonatal/infant and paediatric outcomes.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2013).
SELECTION CRITERIA
Randomised and quasi-randomised trials assessing the effects of dietary magnesium supplementation during pregnancy were included. The primary outcomes were perinatal mortality (including stillbirth and neonatal death prior to hospital discharge), small-for-gestational age, maternal mortality and pre-eclampsia.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies.
MAIN RESULTS
Ten trials involving 9090 women and their babies were included; one trial had a cluster design (with randomisation by study centre). All 10 trials randomly allocated women to either an oral magnesium supplement or a control group; in eight trials a placebo was used, and in two trials no treatment was given to the control group. In the 10 included trials, the compositions of the magnesium supplements, gestational ages at commencement, and doses administered varied, including: magnesium oxide, 1000 mg daily from ≤ four months post-conception (one trial); magnesium citrate, 365 mg daily from ≤ 18 weeks until hospitalisation after 38 weeks (one trial), and 340 mg daily from nine to 27 weeks' gestation (one trial); magnesium gluconate, 2 to 3 g from 28 weeks' gestation until birth (one trial), and 4 g daily from 23 weeks' gestation (one trial); magnesium aspartate, 15 mmol daily (three trials, commencing from either six to 21 weeks' gestation until birth, ≤ 16 weeks' gestation until birth, or < 12 weeks until birth), or 365 mg daily from 13 to 24 weeks until birth (one trial); and magnesium stearate, 128 mg elemental magnesium from 10 to 35 weeks until birth (one trial).In the analysis of all trials, oral magnesium supplementation compared to no magnesium was associated with no significant difference in perinatal mortality (stillbirth and neonatal death prior to discharge) (risk ratio (RR) 1.10; 95% confidence interval (CI) 0.72 to 1.67; five trials, 5903 infants), small-for-gestational age (RR 0.76; 95% CI 0.54 to 1.07; three trials, 1291 infants), or pre-eclampsia (RR 0.87; 95% CI 0.58 to 1.32; three trials, 1042 women). None of the included trials reported on maternal mortality.Considering secondary outcomes, while no increased risk of stillbirth was observed, a possible increased risk of neonatal death prior to hospital discharge was shown for infants born to mothers who had received magnesium (RR 2.21; 95% CI 1.02 to 4.75; four trials, 5373 infants). One trial contributed over 70% of the participants to the analysis for this outcome; the trial authors suggested that the large number of severe congenital anomalies in the supplemented group (unlikely attributable to magnesium) and the deaths of two sets of twins (with birthweights < 750 g) in the supplemented group likely accounted for the increased risk of death observed, and thus this result should be interpreted with caution. Furthermore, when the deaths due to severe congenital abnormalities in this trial were excluded from the meta-analysis, no increased risk of neonatal death was seen for the magnesium supplemented group. Magnesium supplementation was associated with significantly fewer babies with an Apgar score less than seven at five minutes (RR 0.34; 95% CI 0.15 to 0.80; four trials, 1083 infants), with meconium-stained liquor (RR 0.79; 95% CI 0.63 to 0.99; one trial, 4082 infants), late fetal heart decelerations (RR 0.68; 95% CI 0.53 to 0.88; one trial, 4082 infants), and mild hypoxic-ischaemic encephalopathy (RR 0.38; 95% CI 0.15 to 0.98; one trial, 4082 infants). Women receiving magnesium were significantly less likely to require hospitalisation during pregnancy (RR 0.65, 95% CI 0.48 to 0.86; three trials, 1158 women).Of the 10 trials included in the review, only two were judged to be of high quality overall. When an analysis was restricted to these two trials none of the review's primary outcomes (perinatal mortality, small-for-gestational age, pre-eclampsia) were significantly different between the magnesium supplemented and control groups.
AUTHORS' CONCLUSIONS
There is not enough high-quality evidence to show that dietary magnesium supplementation during pregnancy is beneficial.
Topics: Administration, Oral; Congenital Abnormalities; Dietary Supplements; Female; Humans; Infant Mortality; Infant, Newborn; Magnesium; Pre-Eclampsia; Pregnancy; Pregnancy Outcome; Pregnancy, High-Risk; Randomized Controlled Trials as Topic; Stillbirth
PubMed: 24696187
DOI: 10.1002/14651858.CD000937.pub2 -
Polymers Oct 2021Layered double hydroxides (LDHs) have attracted interest as reinforcing fillers in elastomers due to their ease of synthesis and customisability. A systematic review was... (Review)
Review
Layered double hydroxides (LDHs) have attracted interest as reinforcing fillers in elastomers due to their ease of synthesis and customisability. A systematic review was performed on the effect of LDHs on the mechanical properties of elastomers using the Scopus database. Of the 61 articles relevant to the search criteria, the majority were published on polyurethane (PU) and nitrile butadiene rubber (NBR). Mg-Al LDH was used in most of the studies and Zn-Al LDH was used second most common. LDH can act as a reinforcing filler, typically increasing tensile strength even at low concentrations, so it could be used as an alternative to traditional reinforcing fillers for elastomers. LDH can also be made a functional filler by selecting the right metals and interlayer anions. It was found that Mg-Al LDH and Zn-Al LDH can both participate in crosslinking reactions and can replace MgO and ZnO, respectively. Less Zn ions are required for crosslinking when LDH is used than when ZnO is used, making LDH more environmentally friendly. Organic modification is usually required to improve compatibility with the elastomer matrix, especially in non-polar elastomers. It enables exfoliation of the LDH and intercalation of polymer chains into the LDH interlayer to occur. Organic modifiers can also be used to functionalise the LDH. Stearic acid used in crosslinking systems can be replaced by stearate anions from stearate-modified LDH.
PubMed: 34771273
DOI: 10.3390/polym13213716