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PloS One 2015To evaluate the efficacy and safety of progesterone administrated in patients with acute traumatic brain injury (TBI). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To evaluate the efficacy and safety of progesterone administrated in patients with acute traumatic brain injury (TBI).
METHODS
PubMed/MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL), Clinicaltrials.gov, ISRCTN registry and WHO International Clinical Trials Registry Platform (ICTRP) were searched for randomized controlled trials (RCTs) comparing progesterone and placebo administrated in acute TBI patients. The primary outcome was mortality and the secondary outcomes were unfavorable outcomes and adverse events. A meta-analysis was conducted to evaluate the efficacy and safety of progesterone administrated in patients with acute TBI.
RESULTS
A total of 6 studies met inclusion criteria, involving 2,476 patients. The risk of bias was considered to be low in 4 studies but high in the other 2 studies. The results of meta-analysis indicated progesterone did not reduce the mortality (RR = 0.83, 95% CI = 0.57-1.20) or unfavorable outcomes (RR = 0.89, 95% CI = 0.78-1.02) of acute TBI patients in comparison with placebo. Sensitivity analysis yielded consistent results. Progesterone was basically safe and well tolerated in TBI patients with the exception of increased risk of phlebitis or thrombophlebitis (RR = 3.03, 95% CI = 1.96-4.66).
CONCLUSIONS
Despite some modest bias, present evidence demonstrated that progesterone was well tolerated but did not reduce the mortality or unfavorable outcomes of adult patients with acute TBI.
Topics: Brain Injuries; Female; Humans; Male; Progesterone; Randomized Controlled Trials as Topic; Survival Analysis; Treatment Outcome
PubMed: 26473361
DOI: 10.1371/journal.pone.0140624 -
The Cochrane Database of Systematic... Aug 2015Venous access is an essential part of caring for the sick neonate. However, problems such as contamination of fluids with bacteria, endotoxins and particulates have been... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Venous access is an essential part of caring for the sick neonate. However, problems such as contamination of fluids with bacteria, endotoxins and particulates have been associated with intravenous infusion therapy. Intravenous in-line filters claim to be an effective strategy for the removal of bacteria, endotoxins and particulates associated with intravenous therapy in adults and are increasingly being recommended for use in neonates.
OBJECTIVES
To determine the effect of intravenous in-line filters on morbidity and mortality in neonates.
SEARCH METHODS
We used the standard search strategy of the Cochrane Neonatal Review Group. We searched the electronic databases MEDLINE (from 1966 to May, 2015), EMBASE (from 1980 to May, 2015), CINAHL (from 1982 to May 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 5). We did not impose any language restrictions. Further searching included cross references, abstracts, conferences, symposia proceedings, expert informants and journal handsearching.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) or quasi-RCTs that compared the use of intravenous in-line filters with placebo or nothing in neonates.
DATA COLLECTION AND ANALYSIS
We followed the procedures of the Cochrane Neonatal Review Group throughout. We checked titles and abstracts identified from the search. We obtained the full text of all studies of possible relevance. We independently assessed the trials for their methodological quality and subsequent inclusion in the review. We contacted authors for further information as needed. Statistical analysis followed the procedures of the Cochrane Neonatal Review Group.
MAIN RESULTS
There were four eligible studies that recruited a total of 704 neonates. This review of low to very low quality evidence found that the use of in-line filters compared with unfiltered fluids for intravenous infusion had no statistically significant difference in effectiveness on overall mortality (typical RR 0.87, 95% CI 0.52 to 1.47; typical RD -0.01, 95% CI -0.06 to 0.04; two studies, 530 infants), proven and suspect septicaemia (typical RR 0.86, 95% CI 0.59 to 1.27; typical RD -0.02, 95% CI -0.09 to 0.04; two studies, 530 infants), or other secondary outcomes (including local phlebitis and thrombus, necrotising enterocolitis, duration of cannula patency, length of stay in hospital, number of catheters inserted and financial costs).
AUTHORS' CONCLUSIONS
There is insufficient evidence to recommend the use of intravenous in-line filters to prevent morbidity and mortality in neonates.
Topics: Catheterization, Peripheral; Drug Contamination; Filtration; Humans; Infant; Infant Mortality; Infant, Newborn; Infant, Premature; Infusions, Intravenous; Randomized Controlled Trials as Topic
PubMed: 26244380
DOI: 10.1002/14651858.CD005248.pub3 -
The Cochrane Database of Systematic... Jun 2015A peripheral venous catheter (PVC) is typically used for short-term delivery of intravascular fluids and medications. It is an essential element of modern medicine and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
A peripheral venous catheter (PVC) is typically used for short-term delivery of intravascular fluids and medications. It is an essential element of modern medicine and the most frequent invasive procedure performed in hospitals. However, PVCs often fail before intravenous treatment is completed: this can occur because the device is not adequately attached to the skin, allowing the PVC to fall out, leading to complications such as phlebitis (irritation or inflammation to the vein wall), infiltration (fluid leaking into surrounding tissues) or occlusion (blockage). An inadequately secured PVC also increases the risk of catheter-related bloodstream infection (CRBSI), as the pistoning action (moving back and forth in the vein) of the catheter can allow migration of organisms along the catheter and into the bloodstream. Despite the many dressings and securement devices available, the impact of different securement techniques for increasing PVC dwell time is still unclear; there is a need to provide guidance for clinicians by reviewing current studies systematically.
OBJECTIVES
To assess the effects of PVC dressings and securement devices on the incidence of PVC failure.
SEARCH METHODS
We searched the following electronic databases to identify reports of relevant randomised controlled trials (RCTs): the Cochrane Wounds Group Register (searched 08 April 2015): The Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 3), Ovid MEDLINE (1946 to March 7 2015); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, March 7 2015); Ovid EMBASE (1974 to March 7 2015); and EBSCO CINAHL (1982 to March 8 2015).
SELECTION CRITERIA
RCTs or cluster RCTs comparing different dressings or securement devices for the stabilisation of PVCs. Cross-over trials were ineligible for inclusion, unless data for the first treatment period could be obtained.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies, assessed trial quality and extracted data. We contacted study authors for missing information. We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included six RCTs (1539 participants) in this review. Trial sizes ranged from 50 to 703 participants. These six trials made four comparisons, namely: transparent dressings versus gauze; bordered transparent dressings versus a securement device; bordered transparent dressings versus tape; and transparent dressing versus sticking plaster. There is very low quality evidence of fewer catheter dislodgements or accidental removals with transparent dressings compared with gauze (two studies, 278 participants, RR 0.40; 95% CI 0.17 to 0.92, P = 0.03%). The relative effects of transparent dressings and gauze on phlebitis (RR 0.89; 95% CI 0.47 to 1.68) and infiltration (RR 0.80; 95% CI 0.48 to 1.33) are unclear. The relative effects on PVC failure of a bordered transparent dressing and a securement device have been assessed in only one small study and these were unclear. There was very low quality evidence from the same single study of less frequent dislodgement or accidental catheter removal with bordered transparent dressings than securement devices (RR 0.14, 95% CI 0.03 to 0.63) but more phlebitis with bordered dressings (RR 8.11, 95% CI 1.03 to 64.02) (very low quality evidence). A small single study compared bordered transparent dressings with tape and found very low quality evidence of more PVC failure with the bordered dressing (RR 1.84, 95% CI 1.08 to 3.11) but the relative effects on dislodgement were not clear (very low quality evidence). The relative effects of transparent dressings and a sticking plaster have only been compared in one small study and are unclear. More high quality RCTs are required to determine the relative effects of alternative PVC dressings and securement devices.
AUTHORS' CONCLUSIONS
It is not clear if any one dressing or securement device is better than any other in securing peripheral venous catheters. There is a need for further, independent high quality trials to evaluate the many traditional as well as the newer, high use products. Given the large cost differences between some different dressings and securement devices, future trials should include a robust cost-effectiveness analysis.
Topics: Adhesives; Bandages; Calcium Sulfate; Catheter Obstruction; Catheter-Related Infections; Catheterization, Peripheral; Catheters; Extravasation of Diagnostic and Therapeutic Materials; Humans; Oligopeptides; Phlebitis; Randomized Controlled Trials as Topic; Surgical Tape
PubMed: 26068958
DOI: 10.1002/14651858.CD011070.pub2 -
The Cochrane Database of Systematic... Feb 2015Dehydration is an important cause of death in patients with Ebola virus disease (EVD). Parenteral fluids are often required in patients with fluid requirements in excess... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Dehydration is an important cause of death in patients with Ebola virus disease (EVD). Parenteral fluids are often required in patients with fluid requirements in excess of their oral intake. The peripheral intravenous route is the most commonly used method of parenteral access, but inserting and maintaining an intravenous line can be challenging in the context of EVD. Therefore it is important to consider the advantages and disadvantages of different routes for achieving parenteral access (e.g. intravenous, intraosseous, subcutaneous and intraperitoneal).
OBJECTIVES
To compare the reliability, ease of use and speed of insertion of different parenteral access methods.
SEARCH METHODS
We ran the search on 17 November 2014. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily, Ovid MEDLINE(R) and Ovid OLDMEDLINE(R), Embase Classic + Embase (OvidSP), CINAHL (EBSCOhost), clinicaltrials.gov and screened reference lists.
SELECTION CRITERIA
Randomised controlled trials comparing different parenteral routes for the infusion of fluids or medication.
DATA COLLECTION AND ANALYSIS
Two review authors examined the titles and abstracts of records obtained by searching the electronic databases to determine eligibility. Two review authors extracted data from the included trials and assessed the risk of bias. Outcome measures of interest were success of insertion; time required for insertion; number of insertion attempts; number of dislodgements; time period with functional access; local site reactions; clinicians' perception of ease of administration; needlestick injury to healthcare workers; patients' discomfort; and mortality. For trials involving the administration of fluids we also collected data on the volume of fluid infused, changes in serum electrolytes and markers of renal function. We rated the quality of the evidence as 'high', 'moderate', 'low' or 'very low' according to the GRADE approach for the following outcomes: success of insertion, time required for insertion, number of dislodgements, volume of fluid infused and needlestick injuries.
MAIN RESULTS
We included 17 trials involving 885 participants. Parenteral access was used to infuse fluids in 11 trials and medications in six trials. None of the trials involved patients with EVD. Intravenous and intraosseous access was compared in four trials; intravenous and subcutaneous access in 11; peripheral intravenous and intraperitoneal access in one; saphenous vein cutdown and intraosseous access in one; and intraperitoneal with subcutaneous access in one. All of the trials assessing the intravenous method involved peripheral intravenous access.We judged few trials to be at low risk of bias for any of the assessed domains.Compared to the intraosseous group, patients in the intravenous group were more likely to experience an insertion failure (risk ratio (RR) 3.89, 95% confidence interval (CI) 2.39 to 6.33; n = 242; GRADE rating: low). We did not pool data for time to insertion but estimates from the trials suggest that inserting intravenous access takes longer (GRADE rating: moderate). Clinicians judged the intravenous route to be easier to insert (RR 0.15, 95% CI 0.04 to 0.61; n = 182). A larger volume of fluids was infused via the intravenous route (GRADE rating: moderate). There was no evidence of a difference between the two routes for any other outcomes, including adverse events.Compared to the subcutaneous group, patients in the intravenous group were more likely to experience an insertion failure (RR 14.79, 95% CI 2.87 to 76.08; n = 238; GRADE rating: moderate) and dislodgement of the device (RR 3.78, 95% CI 1.16 to 12.34; n = 67; GRADE rating: low). Clinicians also judged the intravenous route as being more difficult to insert and patients were more likely to be agitated in the intravenous group. Patients in the intravenous group were more likely to develop a local infection and phlebitis, but were less likely to develop erythema, oedema or swelling than those in the subcutaneous group. A larger volume of fluids was infused into patients via the intravenous route. There was no evidence of a difference between the two routes for any other outcome.There were insufficient data to reliably determine if the risk of insertion failure differed between the saphenous vein cutdown (SVC) and intraosseous method (RR 4.00, 95% CI 0.51 to 31.13; GRADE rating: low). Insertion using SVC took longer than the intraosseous method (MD 219.60 seconds, 95% CI 135.44 to 303.76; GRADE rating: moderate). There were no data and therefore there was no evidence of a difference between the two routes for any other outcome.There were insufficient data to reliably determine the relative effects of intraperitoneal or central intravenous access relative to any other parenteral access method.
AUTHORS' CONCLUSIONS
There are several different ways of achieving parenteral access in patients who are unable meet their fluid requirements with oral intake alone. The quality of the evidence, as assessed using the GRADE criteria, is somewhat limited because of the lack of adequately powered trials at low risk of bias. However, we believe that there is sufficient evidence to draw the following conclusions: if peripheral intravenous access can be achieved easily, this allows infusion of larger volumes of fluid than other routes; but if this is not possible, the intraosseous and subcutaneous routes are viable alternatives. The subcutaneous route may be suitable for patients who are not severely dehydrated but in whom ongoing fluid losses cannot be met by oral intake.A film to accompany this review can be viewed here (http://youtu.be/ArVPzkf93ng).
Topics: Dehydration; Disease Management; Hemorrhagic Fever, Ebola; Humans; Hypodermoclysis; Infusions, Intraosseous; Infusions, Intravenous; Infusions, Parenteral; Saphenous Vein
PubMed: 25914907
DOI: 10.1002/14651858.CD011386.pub2 -
The Cochrane Database of Systematic... Jun 2014Up to 80% of hospitalised patients receive intravenous therapy at some point during their admission. About 20% to 70% of patients receiving intravenous therapy develop... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Up to 80% of hospitalised patients receive intravenous therapy at some point during their admission. About 20% to 70% of patients receiving intravenous therapy develop phlebitis. Infusion phlebitis has become one of the most common complications in patients with intravenous therapy. However, the effects of routine treatments such as external application of 75% alcohol or 50% to 75% magnesium sulphate (MgSO4) are unsatisfactory. Therefore, there is an urgent need to develop new methods to prevent and alleviate infusion phlebitis.
OBJECTIVES
To systematically assess the effects of external application of Aloe vera for the prevention and treatment of infusion phlebitis associated with the presence of an intravenous access device.
SEARCH METHODS
The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched February 2014) and CENTRAL (2014, Issue 1). In addition the TSC searched MEDLINE to week 5 January 2014, EMBASE to Week 6 2014 and AMED to February 2014. The authors searched the following Chinese databases until 28 February 2014: Chinese BioMedical Database; Traditional Chinese Medical Database System; China National Knowledge Infrastructure; Chinese VIP information; Chinese Medical Current Contents; Chinese Academic Conference Papers Database and Chinese Dissertation Database; and China Medical Academic Conference. Bibliographies of retrieved and relevant publications were searched. There were no restrictions on the basis of date or language of publication.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and quasi-randomised controlled trials (qRCTs) were included if they involved participants receiving topical Aloe vera or Aloe vera-derived products at the site of punctured skin, with or without routine treatment at the same site.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted the data on the study characteristics, description of methodology and outcomes of the eligible trials, and assessed study quality. Data were analysed using RevMan 5.1. For dichotomous outcomes, the effects were estimated by using risk ratio (RR) with its 95% confidence interval (CI). For continuous outcomes, mean differences (MD) with 95% CIs were used to estimate their effects.
MAIN RESULTS
A total of 43 trials (35 RCTs and eight qRCTs) with 7465 participants were identified. Twenty-two trials with 5546 participants were involved in prevention of Aloe vera for phlebitis, and a further 21 trials with 1919 participants were involved in the treatment of phlebitis. The included studies compared external application of Aloe vera alone or plus non-Aloe vera interventions with no treatment or the same non-Aloe vera interventions. The duration of the intervention lasted from one day to 15 days. Most of the included studies were of low methodological quality with concerns for selection bias, attrition bias, reporting bias and publication bias.The effects of external application of fresh Aloe vera on preventing total incidence of phlebitis varied across the studies and we did not combine the data. Aloe vera reduced the occurrence of third degree phlebitis (RR 0.06, 95% CI 0.03 to 0.11, P < 0.00001) and second degree phlebitis (RR 0.18, 95% CI 0.10 to 0.31, P < 0.00001) compared with no treatment. Compared with external application of 75% alcohol, or 33% MgSO4 alone, Aloe vera reduced the total incidence of phlebitis (RR 0.02, 95% CI 0.00 to 0.28, P = 0.004 and RR 0.43, 95% CI 0.24 to 0.78, P = 0.005 respectively) but there was no clear evidence of an effect when compared with 50% or 75% MgSO4 (total incidence of phlebitis RR 0.41, 95% CI 0.16 to 1.07, P = 0.07 and RR 1.10 95% CI 0.54 to 2.25, P = 0.79 respectively; third degree phlebitis (RR 0.28, 95% CI 0.07 to 1.02, P = 0.051 and RR 1.19, 95% CI 0.08 to 18.73, P = 0.9 respectively; second degree phlebitis RR 0.68, 95% CI 0.21 to 2.23, P = 0.53 compared to 75% MgSO4) except for a reduction in second degree phlebitis when Aloe vera was compared with 50% MgSO4 (RR 0.26, 95% CI 0.14 to 0.50, P < 0.0001).For the treatment of phlebitis, Aloe vera was more effective than 33% or 50% MgSO4 in terms of both any improvement (RR 1.16, 95% CI 1.09 to 1.24, P < 0.0001 and RR 1.22, 95% CI 1.16 to 1.28, P < 0.0001 respectively) and marked improvement of phlebitis (RR 1.97, 95% CI 1.44 to 2.70, P < 0.001 and RR 1.56, 95% CI 1.29 to 1.87, P = 0.0002 respectively). Compared with 50% MgSO4, Aloe vera also improved recovery rates from phlebitis (RR 1.42, 95% CI 1.24 to 1.61, P < 0.0001). Compared with routine treatments such as external application of hirudoid, sulphonic acid mucopolysaccharide and dexamethasone used alone, addition of Aloe vera improved recovery from phlebitis (RR 1.75, 95% CI 1.24 to 2.46, P = 0.001) and had a positive effect on overall improvement (marked improvement RR 1.26, 95% CI 1.09 to 1.47, P = 0.0003; any improvement RR 1.23, 95% CI 1.13 to 1.35, P < 0.0001). Aloe vera, either alone or in combination with routine treatment, was more effective than routine treatment alone for improving the symptoms of phlebitis including shortening the time of elimination of red swelling symptoms, time of pain relief at the location of the infusion vein and time of resolution of phlebitis. Other secondary outcomes including health-related quality of life and adverse effects were not reported in the included studies.
AUTHORS' CONCLUSIONS
There is no strong evidence for preventing or treating infusion phlebitis with external application of Aloe vera. The current available evidence is limited by the poor methodological quality and risk of selective outcome reporting of the included studies, and by variation in the size of effect across the studies. The positive effects observed with external application of Aloe vera in preventing or treating infusion phlebitis compared with no intervention or external application of 33% or 50% MgSO4 should therefore be viewed with caution.
Topics: Administration, Topical; Aloe; Central Venous Catheters; Humans; Infusions, Intravenous; Phlebitis; Phytotherapy; Randomized Controlled Trials as Topic
PubMed: 24895299
DOI: 10.1002/14651858.CD009162.pub2 -
Journal of Evaluation in Clinical... Apr 2014Phlebitis is a common and painful complication of peripheral intravenous cannulation. The aim of this review was to identify the measures used in infusion phlebitis... (Review)
Review
RATIONALE, AIMS AND OBJECTIVES
Phlebitis is a common and painful complication of peripheral intravenous cannulation. The aim of this review was to identify the measures used in infusion phlebitis assessment and evaluate evidence regarding their reliability, validity, responsiveness and feasibility.
METHOD
We conducted a systematic literature review of the Cochrane library, Ovid MEDLINE and EBSCO CINAHL until September 2013. All English-language studies (randomized controlled trials, prospective cohort and cross-sectional) that used an infusion phlebitis scale were retrieved and analysed to determine which symptoms were included in each scale and how these were measured. We evaluated studies that reported testing the psychometric properties of phlebitis assessment scales using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
RESULTS
Infusion phlebitis was the primary outcome measure in 233 studies. Fifty-three (23%) of these provided no actual definition of phlebitis. Of the 180 studies that reported measuring phlebitis incidence and/or severity, 101 (56%) used a scale and 79 (44%) used a definition alone. We identified 71 different phlebitis assessment scales. Three scales had undergone some psychometric analyses, but no scale had been rigorously tested.
CONCLUSION
Many phlebitis scales exist, but none has been thoroughly validated for use in clinical practice. A lack of consensus on phlebitis measures has likely contributed to disparities in reported phlebitis incidence, precluding meaningful comparison of phlebitis rates.
Topics: Catheterization, Peripheral; Cross-Sectional Studies; Humans; Incidence; Phlebitis; Psychometrics; Reproducibility of Results
PubMed: 24401116
DOI: 10.1111/jep.12107 -
Current Therapeutic Research, Clinical... Oct 2008Kanglaite (KLT) is a botanically sourced, molecularly targeted agent that is prepared as a microemulsion for IV use. The active substance is extracted from the herb...
BACKGROUND
Kanglaite (KLT) is a botanically sourced, molecularly targeted agent that is prepared as a microemulsion for IV use. The active substance is extracted from the herb Semen coicis.
OBJECTIVE
The aim of this study was to evaluate the effectiveness and tolerability of KLT injection in patients with primary non-small cell lung cancer (NSCLC).
METHODS
We electronically searched the literature of the China National Knowledge Infrastructure (Chinese language, 1979-March 2008), CBMdisc (Chinese, 1978-March 2008), The Cochrane Library (English, Issue 4, 2007), MEDLINE (English, 1966-March 2008), and EMBASE (English, 1984-March 2008), and manually searched 20 Chinese-language oncology journals to identify randomized controlled trials (RCTs) of KLT injection plus chemotherapy versus chemotherapy alone, regardless of their having been published or not, blinding, duration of treatment, or duration of follow-up. The quality of the included trials was assessed using the method recommended by The Cochrane Collaboration. The studies were assigned to 1 of the following 3 categories: A = all quality criteria met, low risk of bias; B = ≥1 of the quality criteria only partially met, moderate risk of bias; or C = ≥1 of the quality criteria not met, high risk of bias. If heterogeneity existed among subgroups, then overall results were calculated based on a random-effects model; otherwise, a fixed-effects model was used.
RESULTS
Electronic database searches yielded 596 citations. A title review eliminated 377 manuscripts; 219 citations were marked for further evaluation. Finally, we identified 26 trials that met the inclusion and exclusion criteria. The 26 RCTs included in this meta-analysis included 2209 patients with NSCLC; no study was graded A, 9 were graded B, and 17 were graded C. The sample size of each trial varied from 40 to 305 patients; none of the trials had precalculated sample sizes. Pooled analyses performed using both fixed- and random-effects models revealed that compared with chemotherapy alone, KLT injection plus chemotherapy improved the response rate (relative risk [RR], 1.34; 95% CI, 1.19-1.51 and RR, 1.35; 95% CI, 1.20-1.51, respectively) and quality of life as measured by an increase ≥10 points in the Karnofsky Performance Status score (RR, 2.05; 95% CI, 1.60-2.64). KLT injection plus chemotherapy was associated with improvement in the symptoms of cough, dyspnea, chest pain, fatigue, and anorexia. KLT injection plus chemotherapy was also associated with significant reduction in the incidence of the following adverse events (AEs) based on the fixed and random effects models, respectively: grade II to IV leukopenia (RR, 0.29; 95% CI, 0.22-0.39 and RR, 0.33; 95% CI, 0.22-0.48), anemia (RR, 0.54; 95% CI, 0.42-0.70 and RR, 0.55; 95% CI, 0.40-0.76), thrombocytopenia (RR, 0.39; 95% CI, 0.21-0.71 and RR, 0.40; 95% CI, 0.21-0.78), nausea and vomiting (RR, 0.44; 95% CI, 0.34-0.57 and RR, 0.44; 95% CI, 0.35-0.57), phlebitis (RR, 3.44; 95% Cl, 1.30-9.15 and RR, 3.38; 95% CI, 1.28-8.89), and hepatic dysfunction (RR, 0.44; 95% CI, 0.15-1.35 and RR, 0.44; 95% CI, 0.24-0.81).
CONCLUSION
This meta-analysis found that KLT injection in combination with chemotherapy was associated with improved response rate, quality of life, and symptoms, and a reduced incidence of AEs compared with chemotherapy alone in patients with NSCLC. These findings should be viewed with caution because of the low quality of the included trials.
PubMed: 24692815
DOI: 10.1016/j.curtheres.2008.10.004 -
The Cochrane Database of Systematic... Apr 2007Short term side-effects of chemotherapy include fatigue, nausea, vomiting, mucositis and myelosuppression or neutropenia. These occur during the course of treatment and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Short term side-effects of chemotherapy include fatigue, nausea, vomiting, mucositis and myelosuppression or neutropenia. These occur during the course of treatment and generally resolve within months of completion of chemotherapy. A variety of Chinese medicinal herbs have been used for managing these side effects.
OBJECTIVES
To assess the effectiveness and safety of Chinese medicinal herbs in alleviating chemotherapy-induced short term side effects in breast cancer patients.
SEARCH STRATEGY
We searched The Cochrane Breast Cancer Specialised Register (15/02/2007), The Cochrane Central Register of Controlled Trials (CENTRAL); (The Cochrane Library 2006, Issue 4); MEDLINE (1966 to December 2006); EMBASE (1990 to December 2006); and Chinese Biomedical Literature (2006, Issue 4). A number of journals were hand searched.
SELECTION CRITERIA
Randomised controlled trials comparing chemotherapy with or without Chinese herbs in women with breast cancer.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted the data, which were analysed using RevMan 4.2. For dichotomous data, we estimated the relative risk. For continuous data, we calculated the weighted mean difference.
MAIN RESULTS
We identified seven randomised controlled trials involving 542 breast cancer patients undergoing or having recently undergone chemotherapy. All studies were conducted and published in China. We did not pool the results because few studies were identified and no more than two used the same intervention. All were of low quality and used CMH plus chemotherapy compared with chemotherapy alone.CMH combined with chemotherapy showed no statistically significant difference for the outcomes of phlebitis and alopecia. Only one study showed an improvement in nausea and vomiting, and in fatigue. Three indicated an improvement in white blood cells in the group receiving CMH. Two showed an increase in percentage changes in T-lymphocyte subsets CD4 and CD8. One study showed a statistically significant difference for CMH in percentage changes in T-lymphocyte subsets CD3, CD4 and CD8. Two herbal compounds may have improved quality of life. One study reported that CMH may have some effect on reducing toxicity in liver and kidney, but differences were not statistically significant.
AUTHORS' CONCLUSIONS
This review provides limited evidence about the effectiveness and safety of Chinese medicinal herbs in alleviating chemotherapy induced short term side effects. Chinese medicinal herbs, when used together with chemotherapy, may offer some benefit to breast cancer patients in terms of bone marrow improvement and quality of life, but the evidence is too limited to make any confident conclusions. Well designed clinical trials are required before any conclusions can be drawn about the effectiveness and safety of CHM in the management of breast cancer patients.
Topics: Antineoplastic Agents; Breast Neoplasms; Drugs, Chinese Herbal; Female; Humans; Phytotherapy; Randomized Controlled Trials as Topic
PubMed: 17443560
DOI: 10.1002/14651858.CD004921.pub2 -
The Cochrane Database of Systematic... Jul 2006Dehydration associated with gastroenteritis is a serious complication. Oral rehydration is an effective and inexpensive treatment, but some physicians prefer intravenous... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Dehydration associated with gastroenteritis is a serious complication. Oral rehydration is an effective and inexpensive treatment, but some physicians prefer intravenous methods.
OBJECTIVES
To compare oral with intravenous therapy for treating dehydration due to acute gastroenteritis in children.
SEARCH STRATEGY
We searched the Cochrane Infectious Diseases Group Specialized Register (March 2006), CENTRAL (The Cochrane Library 2006, Issue 1), MEDLINE (1966 to March 2006), EMBASE (1974 to March 2006), LILACS (1982 to March 2006), and reference lists. We also contacted researchers, pharmaceutical companies, and relevant organizations.
SELECTION CRITERIA
Randomized and quasi-randomized controlled trials comparing intravenous rehydration therapy (IVT) with oral rehydration therapy (ORT) in children up to 18 years of age with acute gastroenteritis.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted data and assessed quality using the Jadad score. We expressed dichotomous data as a risk difference (RD) and number needed to treat (NNT), and continuous data as a weighted mean difference (WMD). We used meta-regression for subgroup analyses.
MAIN RESULTS
Seventeen trials (1811 participants), of poor to moderate quality, were included. There were more treatment failures with ORT (RD 4%, 95% confidence interval (CI) 1 to 7, random-effects model; 1811 participants, 18 trials; NNT = 25). Six deaths occurred in the IVT group and two in the ORT groups (4 trials). There were no significant differences in weight gain (369 participants, 6 trials), hyponatremia (248 participants, 2 trials) or hypernatremia (1062 participants, 10 trials), duration of diarrhea (960 participants, 8 trials), or total fluid intake at six hours (985 participants, 8 trials) and 24 hours (835 participants, 7 trials). Shorter hospital stays were reported for the ORT group (WMD -1.20 days, 95% CI -2.38 to -0.02 days; 526 participants, 6 trials). Phlebitis occurred more often in the IVT group (NNT 50, 95% CI 25 to 100) and paralytic ileus more often in the ORT group (NNT 33, 95% CI 20 to 100, fixed-effect model), but there was no significant difference between ORT using the low osmolarity solutions recommended by the World Health Organization and IVT (729 participants, 6 trials).
AUTHORS' CONCLUSIONS
Although no clinically important differences between ORT and IVT, the ORT group did have a higher risk of paralytic ileus, and the IVT group was exposed to risks of intravenous therapy. For every 25 children (95% CI 14 to 100) treated with ORT one would fail and require IVT.
Topics: Administration, Oral; Child; Dehydration; Fluid Therapy; Gastroenteritis; Humans; Infusions, Intravenous; Randomized Controlled Trials as Topic; Rehydration Solutions
PubMed: 16856044
DOI: 10.1002/14651858.CD004390.pub2 -
European Journal of Vascular and... Aug 2006The aim of this study was to assess whether there is enough evidence to suggest that compression with or without early ambulation after proximal DVT reduces the risk of... (Review)
Review
INTRODUCTION
The aim of this study was to assess whether there is enough evidence to suggest that compression with or without early ambulation after proximal DVT reduces the risk of post-thrombotic syndrome (PTS).
METHODS
Systematic review based on electronic and hand searching of the relevant literature.
RESULTS
Four randomized studies were identified and despite the fact that there was lack of uniformity in reporting standards all but one showed significant risk reduction of PTS using compression. No difference in recurrent thromboembolic events (DVT or pulmonary embolism) was observed between the compression and control group. In one study the early outcome from the combination of early ambulation with compression was faster reduction of swelling with better well-being without increased risk of PE compared to the control group. Pooled analysis of all studies showed that PTS developed in 24% (61/254) in the compression group and in 46% (110/239) in the control group (chi2=25.36, p=0.0001; OR: 0.37, 95%CI: 0.25, 0.54; RR: 0.52, 95%CI: 0.40, 0.67; and RRR: 0.48, 95%CI: 0.33, 0.60) with a 48% risk reduction from the use of compression.
CONCLUSION
Despite the fact that compression with or without early ambulation appears to be safe and it is more often associated with a decreased rate of PTS, the four existing studies do not permit meaningful data comparison due to lack of uniformity in reporting standards.
Topics: Bandages; Early Ambulation; Humans; Intermittent Pneumatic Compression Devices; Postphlebitic Syndrome; Quality of Life; Randomized Controlled Trials as Topic; Secondary Prevention
PubMed: 16546415
DOI: 10.1016/j.ejvs.2005.11.036