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Vertebroplasty and kyphoplasty for cervical spine metastases: a systematic review and meta-analysis.International Journal of Spine Surgery 2016Vertebroplasty (VP) and kyphoplasty (KP) are two minimally invasive techniques used to relieve pain and restore stability in metastatic spinal disease. However, most of...
BACKGROUND
Vertebroplasty (VP) and kyphoplasty (KP) are two minimally invasive techniques used to relieve pain and restore stability in metastatic spinal disease. However, most of these procedures are performed in the thoracolumbar spine, and there is limited data on outcomes after VP/KP for cervical metastases. The purpose of this article is to evaluate the safety and efficacy of VP and KP for treating pain in patients with cervical spine metastases.
METHODS
A systematic review of the literature was conducted using the PubMed and Medline databases. Only studies that reported five or more patients treated with VP/KP in the cervical spine were included. Levels of evidence and grades of recommendation were established based on the Oxford Centre for Evidence-Based Medicine guidelines. Data was pooled to perform a meta-analysis for pain relief and complication rates.
RESULTS
Six studies (all level 4 studies) met the inclusion criteria, representing 120 patients undergoing VP/KP at 135 vertebrae; the most common addressed level was C2 in 83 cases. The average volume of injected cement was 2.5 ± 0.5 milliliters at each vertebra. There were 22 asymptomatic cement leaks (16%; 95% CI, 9.8% - 22.2%) most commonly occurring in the paraspinal soft tissue. There were 5 complications (4%; 95% CI, 0.5% - 7.5%): 3 cases of mild odynophagia, 1 case of occipital neuralgia secondary to leak, and 1 case of stroke secondary to cement embolism. Pain relief was achieved in 89% of cases (range: 80 - 100%). The calculated average pain score decreased significantly from 7.6 ± 0.9 before surgery to 1.9 ± 0.8 at last evaluation (p=0.006).
CONCLUSION
Although the calculated complication rate after VP/KP in the cervical spine is low (4%) and the reported pain relief rate is approximately 89%, there is lack of high-quality evidence supporting this. Future randomized controlled trials are needed.
PubMed: 26913227
DOI: 10.14444/3007 -
PloS One 2015Neck dissection is the most definitive and effective treatment for head and neck cancer. This systematic review aims to compare the efficacy and surgical outcomes of... (Comparative Study)
Comparative Study Meta-Analysis
OBJECTIVE
Neck dissection is the most definitive and effective treatment for head and neck cancer. This systematic review aims to compare the efficacy and surgical outcomes of neck dissection between the harmonic scalpel and conventional surgical techniques and conduct a quantitative meta-analysis of the randomized trials.
METHODS
Randomized controlled trials (RCTs) were identified from the major electronic databases (MEDLINE, EMBASE and Cochrane Library) using the keywords ''harmonic scalpel'' and ''neck dissection,'' and a quantitative meta-analysis was conducted. The operative time and intraoperative bleeding were the primary outcome measures, and other parameters assessed included the drainage fluid volume and length of hospital stay.
RESULTS
Seven trials that met the inclusion criteria included 406 neck dissection cases (201 in the harmonic scalpel group). Compared with conventional surgical techniques, the HS group had an operative time that was significantly reduced by 29.3 minutes [mean difference: -29.29; 95% CI = (-44.26, -14.32); P=0.0001], a reduction in intraoperative bleeding by 141.1 milliliters [mean difference: -141.13; 95% CI = (-314.99, 32.73); P=0.11], and a reduction in drainage fluid volume by 64.9 milliliters [mean difference: -64.86; 95% CI = (-110.40, -19.32); P=0.005] , but it is not significant after removal of studies driving heterogeneity. There was no significant difference in the length of the hospital stay [mean difference: -0.21; 95% CI = (-0.48, 0.07); P=0.14].
CONCLUSION
This systematic review showed that using the harmonic scalpel for neck dissection significantly reduces the operative time and drainage fluid volume and that it is not associated with an increased length of hospital stay or perioperative complications. Therefore, the harmonic scalpel method is safe and effective for neck dissection. However, the statistical heterogeneity was high. Further studies are required to substantiate our findings.
Topics: Blood Loss, Surgical; Drainage; Hemostasis, Surgical; Humans; Length of Stay; Neck Dissection; Operative Time; Publication Bias; Randomized Controlled Trials as Topic; Surgical Instruments
PubMed: 26161897
DOI: 10.1371/journal.pone.0132476 -
International Braz J Urol : Official... 2012We aim to evaluate our experience and results with laparoscopic radical cystectomy and conduct a systematic review of studies reporting on 50 or more procedures. (Review)
Review
OBJECTIVE
We aim to evaluate our experience and results with laparoscopic radical cystectomy and conduct a systematic review of studies reporting on 50 or more procedures.
MATERIALS AND METHODS
Between February 2006 and March 2011, a prospective study in a single institute on patients with bladder cancer who underwent laparoscopic radical cystectomy was conducted. A search of the Cochrane Library, PubMed, Medline, and Scopus databases was conducted for studies reporting on 50 or more laparoscopic radical cystectomy procedures to compare with our results.
RESULTS
Sixty men and five women underwent laparoscopic radical cystectomy during the 5-year study period. Thirty-nine patients were submitted to ileal conduits, 24 to neobladders, and two patients to ureterocutaneostomies. The mean operative time was 294 ± 27 minutes, the mean blood loss was 249.69 ± 95.59 millilitres, the mean length of hospital stay was 9.42 ± 2 days, the mean morphine requirement was 3.69 ± 0.8 days. The overall complication rate was 44.6% (29/65). However, the majority of the patients with complications (90% (26/29)) had minor complications treated conservatively with no further surgical intervention needed. The literature search found seven studies, which reported on their institutions' laparoscopic radical cystectomy results of 50 or more patients. Generally, our results were similar to other reported studies of the same calibre.
CONCLUSION
Laparoscopic radical cystectomy is a safe and efficient modality of treatment of bladder cancer. However, it comes with a steep learning curve, once overcome, can provide an alternative to open radical cystectomy.
Topics: Aged; Blood Loss, Surgical; Cystectomy; Female; Humans; Laparoscopy; Lymph Node Excision; Male; Middle Aged; Operative Time; Prospective Studies; Treatment Outcome; Urinary Bladder Neoplasms
PubMed: 22765852
DOI: 10.1590/s1677-55382012000300006 -
The Cochrane Database of Systematic... May 2012The current recommended antiretroviral treatment is a highly active antiretroviral therapy (HAART). Although HAART has been associated with improved clinical response to... (Review)
Review
BACKGROUND
The current recommended antiretroviral treatment is a highly active antiretroviral therapy (HAART). Although HAART has been associated with improved clinical response to treatment, issues of adherence and viral resistance are major challenges limiting its success. There is a need for an effective and safe first-line regimen, to cope with the ever-increasing incidence of non-adherence and primary resistance. A more recent first-line treatment regimen consists of Tenofovir (TDF, 300 mg) + Emtricitabine (FTC, 200 mg) + Efavirenz (EFV, 600 mg).
OBJECTIVES
To evaluate the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials, EMBASE, GATEWAY, LILACS, PubMed, AEGIS, and the WHO prospective clinical trials registry in November 2011.
SELECTION CRITERIA
Randomized controlled trials evaluating the effects of TDF + FTC + EFV compared with other HAART regimens.
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed trial eligibility and risk of bias, and extracted data from the included study.
MAIN RESULTS
Only one study involving 517 antiretroviral-naive HIV infected adults was included in this review. Participants were randomly assigned to receive either a regimen of TDF (300 mg), FTC (200mg), and EFV (600mg ) once daily; or a regimen of fixed-dose zidovudine (AZT) (300 mg) and lamivudine (3TC) (150 mg) twice daily plus EFV (600mg) once daily. Significantly more patients in the TDF-FTC group reached and maintained HIV RNA levels of less than 50 copies per milliliter compared to the AZT- 3TC group (RR 1.13; 95% CI 1.02 to 1.25). Also, more participants in the TDF-FTC group had greater increase from baseline CD4 cell counts compared to the AZT-3TC group (190 vs. 158 cells per mm(3)). More patients in the AZT-3TC group than in the TDF-FTC group had adverse events resulting in discontinuation of the study drugs (9% vs. 4%, respectively; P = 0.02). There was no statistically significant difference in all cause mortality (RR 0.50; 95% CI 0.05 to 5.46).
AUTHORS' CONCLUSIONS
Only one trial has shown beneficial effects and safety of TDF+ FTC + EFV as first-line treatment for patients with HIV. The effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV cannot be assessed on the basis of only one trial. Further studies evaluating the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV are needed.
Topics: Adenine; Deoxycytidine; Drug Combinations; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; Humans; Organophosphonates; Oxazines; Reverse Transcriptase Inhibitors
PubMed: 22592718
DOI: 10.1002/14651858.CD007276.pub3 -
The Cochrane Database of Systematic... Nov 2011Prostate cancer is a common cause of death in developed countries, yet the benefits of screening for prostate cancer still remain controversial. A prostate-specific... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Prostate cancer is a common cause of death in developed countries, yet the benefits of screening for prostate cancer still remain controversial. A prostate-specific antigen (PSA) test result greater than 4 ng/mL (nanograms/millilitre) has commonly been used as the cut-off level for seeking further tests to diagnose the presence (or absence) of prostate cancer. An increase in PSA levels may not necessarily be associated with an increased risk of prostate cancer, as PSA levels may also be increased in men with benign prostatic hyperplasia and prostatitis. Despite the uncertainty of the net benefit of early detection and treatment, safe and effective methods to prevent prostate cancer are of value. Consumers, seeking greater involvement in their healthcare, are increasingly turning to lifestyle modification and complementary and alternative medicines (CAMs) to maintain their health and prevent disease. Lycopene is a member of the carotenoid family, which is found abundantly in tomatoes, tomato-based products, strawberries, and watermelon. It has been hypothesised that lycopene is a strong antioxidant, which may lower the risk of cancer (including prostate cancer) in people who have diets rich in lycopene.
OBJECTIVES
To determine whether lycopene reduces the incidence of prostate cancer and prostate cancer-specific mortality. Secondary objectives include changes in PSA levels, prostate symptoms and the nature of adverse events associated with lycopene use.
SEARCH METHODS
Electronic searches were conducted across MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) databases. No language or other limitations were imposed.
SELECTION CRITERIA
Randomised controlled trials (RCTs) that investigated the use of lycopene for the prevention of prostate cancer were eligible for inclusion in this review.
DATA COLLECTION AND ANALYSIS
A search of electronic databases, performed in August 2011, identified 64 citations. All articles were selected for full-text review. From these citations, three studies were identified as meeting the inclusion criteria. Handsearching did not provide any additional studies.
MAIN RESULTS
Three RCTs, with a total of 154 participants were included in this review. None of the studies reported data on prostate cancer mortality. All of the included studies differed with respect to design, participants included and allocation of lycopene. This clinical heterogeneity limits the value on the pooled estimated of the meta-analyses. The methodological quality of two of the three included studies was assessed as posing a 'high' risk of bias. Meta-analysis indicated no statistical difference in PSA levels between men randomised to receive lycopene and the comparison group (MD (mean difference) -0.34, 95% CI (confidence interval) -2.01, 1.32). Only one study reported incidence of prostate cancer (10% in the lycopene group versus 30% in control group). The level of lycopene was also not statistically different in men randomised to receive lycopene and the comparison group (MD 0.39 µg/mL (micrograms/millilitre), 95% CI -0.19, 0.98). No other meta-analyses were possible since other outcomes assessed only had one study contributing data.
AUTHORS' CONCLUSIONS
Given that only three RCTs were included in this systematic review, and the high risk of bias in two of the three studies, there is insufficient evidence to either support, or refute, the use of lycopene for the prevention of prostate cancer. Similarly, there is no robust evidence from RCTs to identify the impact of lycopene consumption upon the incidence of prostate cancer, prostate symptoms, PSA levels or adverse events.
Topics: Anticarcinogenic Agents; Carotenoids; Humans; Lycopene; Male; Prostate-Specific Antigen; Prostatic Neoplasms; Randomized Controlled Trials as Topic
PubMed: 22071840
DOI: 10.1002/14651858.CD008007.pub2 -
The Cochrane Database of Systematic... Apr 2011Upper tract transitional cell carcinomas (TCC) are uncommon and aggressive tumours. There are a number of surgical approaches to manage this condition including open... (Review)
Review
BACKGROUND
Upper tract transitional cell carcinomas (TCC) are uncommon and aggressive tumours. There are a number of surgical approaches to manage this condition including open radical nephroureterectomy and laparoscopic procedures.
OBJECTIVES
To determine the best surgical management option for upper tract transitional cell carcinoma.
SEARCH STRATEGY
A sensitive search strategy was developed to identify relevant studies for inclusion in this review. The following databases were searched for randomised trials evaluating surgical approaches to the management of upper tract TCC: Medline EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, British Nursing Index, AMED, LILACS, Web of Science®, Scopus, Biosis, TRIP, Biomed Central, Dissertation Abstracts, and ISI Proceedings.
SELECTION CRITERIA
The following criteria that were considered for this review.Types of studies - All randomised or quasi-randomised controlled trials comparing the various surgical methods and approaches for the management of localised upper tract transitional cell carcinoma. Types of participants - All adult patients with localised transitional cell carcinoma. Localised disease was defined as limited to the kidney or ureter with no gross regional lymph nodal enlargement on imaging. Types of interventions - Any surgical method or approach for managing localised upper tract transitional cell carcinoma. Types of outcome measures - Overall and cancer-specific survival were primary outcomes. Surgery-related morbidity. Quality of life and health economics outcomes were secondary outcomes.
DATA COLLECTION AND ANALYSIS
Two review authors examined the search results independently to identify trials for inclusion.
MAIN RESULTS
We identified one randomised controlled trial that met our inclusion criteria. The trial showed that the laparoscopic approach had superior peri-operative outcomes compared to open approach. Laparoscopic was superior and statistically significant for blood loss (104 mL (millilitres) versus 430 mL, P < 0.001) and mean time to discharge (2.3 days versus 3.7, P < 0.001). Oncological outcomes (bladder tumour-free survival, metastasis-free survival, cancer-specific survival curves), at a median follow up of 44 months and in organ-confined disease, were comparable for both groups.
AUTHORS' CONCLUSIONS
There is no high quality evidence available from adequately controlled trials to determine the best surgical management of upper tract transitional cell carcinoma. However, one small randomised trial and observational data suggests that laparoscopic approach is associated with less blood loss and early recovery from surgery with similar cancer outcomes when compared to open approach.
Topics: Adult; Carcinoma, Transitional Cell; Humans; Kidney Neoplasms; Laparoscopy; Nephrectomy; Randomized Controlled Trials as Topic; Ureter; Ureteral Neoplasms
PubMed: 21491399
DOI: 10.1002/14651858.CD007349.pub2 -
Iranian Journal of Kidney Diseases Jul 2010The efficacy and safety of pegylated and standard interferon (IFN) have been scrutinized in meta-analyses; however, factors associated with hepatitis C viral response in... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The efficacy and safety of pegylated and standard interferon (IFN) have been scrutinized in meta-analyses; however, factors associated with hepatitis C viral response in patients on hemodialysis are not well investigated.
MATERIALS AND METHODS
We evaluated factors that could be associated with sustained virological response (SVR) to pegylated or standard IFN monotherapy in patients on hemodialysis with chronic hepatitis C virus (HCV) infection, by performing a systematic review of the literature with a meta-analysis of clinical trials. We used both Mantel-Haenszel and DerSimonian and Laird random effects models, with heterogeneity and sensitivity analyses.
RESULTS
Twenty-one studies on IFN-alfa2a or IFN-alfa2b (491 patients) and 12 on pegylated-IFN-alfa2a or PEG-IFN-alfa2b (279 patients) were evaluated. The pooled SVR for standard and pegylated IFN monotherapy in random effects model was 39.1% (95% confidence interval [CI], 32.1 to 46.1) and 39.3% (95% CI, 26.5 to 52.1), respectively. Pooled dropout rates were 22.6% (95% CI, 10.4 to 34.8) and 29.7% (95% CI, 21.7 to 37.7), respectively. Female gender, HCV-RNA copies per milliliter, HCV genotype, alanine transaminase pattern, duration of infection, liver fibrosis stage, and treatment duration were not associated with SVR. Only an age less than 40 years was significantly associated with SVR in both models (odds ratio, 2.17; 95% CI, 1.03 to 4.50).
CONCLUSIONS
Additional benefit of monotherapy with pegylated IFN in patients on hemodialysis with HCV infection in terms of viral response and adverse events is still unclear. According the current literature, younger age was the only determinant of SVR.
Topics: Antiviral Agents; Hepatitis C, Chronic; Humans; Interferon alpha-2; Interferon-alpha; Polyethylene Glycols; Recombinant Proteins; Renal Dialysis
PubMed: 20622305
DOI: No ID Found -
BMC Pregnancy and Childbirth Jul 2009Post partum haemorrhage is a leading cause of maternal death worldwide. It also contributes to maternal morbidity as women may require a hysterectomy to control... (Review)
Review
BACKGROUND
Post partum haemorrhage is a leading cause of maternal death worldwide. It also contributes to maternal morbidity as women may require a hysterectomy to control bleeding, or may require a blood transfusion, which can transmit viral infections. Anti-fibrinolytic agents have been proposed as a treatment for post partum haemorrhage. We conducted a systematic review to assess the effectiveness and safety of anti-fibrinolytic agents in post partum bleeding.
METHODS
All randomised controlled trials of anti-fibrinolytic agents given for bleeding during the postpartum period were included in this review. We searched Medline, PubMed, EMBASE, Cochrane Central Register of Controlled trials, Web of Science, metaRegister of controlled trials, LILACS, Reproductive Health Library, African healthline, POPLINE, MedCarib, CINAHL, Clinicaltrials.gov and the reference lists of eligible trials. Two authors extracted data. Methodological quality was assessed by evaluating allocation concealment. The primary outcome was maternal mortality. Secondary outcomes were blood loss, blood transfusion, hysterectomy, mean haemoglobin concentration, thrombo-embolic events and other adverse effects.
RESULTS
We identified three randomised controlled trials involving 461 participants. The trials compared tranexamic acid with no treatment and reported blood loss after delivery. In all three trials, allocation concealment was either inadequate or unclear. The administration of tranexamic acid was associated with a reduction in blood loss of 92 millilitres (95%CI 76 to 109). The most frequently reported adverse effect of tranexamic acid was nausea, although the increase was easily compatible with the play of chance (RR 4.63, 95%CI 0.23 to 95.14).
CONCLUSION
Tranexamic acid may reduce blood loss in post partum haemorrhage. However, the quality of the currently available evidence is poor. Adequately powered, high quality randomised controlled trials are needed.
Topics: Antifibrinolytic Agents; Female; Humans; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 19604358
DOI: 10.1186/1471-2393-9-29 -
The Cochrane Database of Systematic... Jul 2009Expectant management of the third stage of labour involves allowing the placenta to deliver spontaneously or aiding by gravity or nipple stimulation. Active management... (Review)
Review
BACKGROUND
Expectant management of the third stage of labour involves allowing the placenta to deliver spontaneously or aiding by gravity or nipple stimulation. Active management involves administration of a prophylactic oxytocic before delivery of the placenta, and usually early cord clamping and cutting, and controlled cord traction of the umbilical cord.
OBJECTIVES
The objective of this review was to assess the effects of active versus expectant management on blood loss, post partum haemorrhage and other maternal and perinatal complications of the third stage of labour.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group trials register.
SELECTION CRITERIA
Randomised trials comparing active and expectant management of the third stage of labour in women who were expecting a vaginal delivery.
DATA COLLECTION AND ANALYSIS
Trial quality was assessed and data were extracted independently by the reviewers.
MAIN RESULTS
Five studies were included. Four of the trials were of good quality. Compared to expectant management, active management (in the setting of a maternity hospital) was associated with the following reduced risks: maternal blood loss (weighted mean difference -79.33 millilitres, 95% confidence interval -94.29 to -64.37); post partum haemorrhage of more than 500 millilitres (relative risk 0.38, 95% confidence interval 0.32 to 0.46); prolonged third stage of labour (weighted mean difference -9.77 minutes, 95% confidence interval -10.00 to -9.53). Active management was associated with an increased risk of maternal nausea (relative risk 1.83, 95% confidence interval 1.51 to 2.23), vomiting and raised blood pressure (probably due to the use of ergometrine). No advantages or disadvantages were apparent for the baby.
AUTHORS' CONCLUSIONS
Routine 'active management' is superior to 'expectant management' in terms of blood loss, post partum haemorrhage and other serious complications of the third stage of labour. Active management is, however, associated with an increased risk of unpleasant side effects (eg nausea and vomiting), and hypertension, where ergometrine is used. Active management should be the routine management of choice for women expecting to deliver a baby by vaginal delivery in a maternity hospital. The implications are less clear for other settings including domiciliary practice (in developing and industrialised countries).
Topics: Delivery, Obstetric; Female; Humans; Labor Stage, Third; Postpartum Hemorrhage; Pregnancy
PubMed: 19588315
DOI: 10.1002/14651858.CD000007.pub2 -
The Canadian Journal of Hospital... Mar 2009Concomitant enteral administration of ciprofloxacin with products containing magnesium, aluminum, and calcium (e.g., as enteral feeds) decreases the oral bioavailability...
BACKGROUND
Concomitant enteral administration of ciprofloxacin with products containing magnesium, aluminum, and calcium (e.g., as enteral feeds) decreases the oral bioavailability of this antibiotic. The manufacturer currently recommends holding enteral feeds for a total of 8 h after ciprofloxacin is given, but this is not feasible for patients who are receiving continuous enteral feeding. A previous study demonstrated that a higher dose of oral ciprofloxacin (750 mg BID) may compensate for the reduced bioavailability associated with this drug-food interaction, allowing adequate concentrations for effective bactericidal activity.
OBJECTIVE
To evaluate whether ciprofloxacin 750 mg administered enterally is a clinically feasible alternative to ciprofloxacin 400 mg administered intravenously for adults receiving enteral feeds.
METHODS
A literature search was conducted in EMBASE (January 1980 to April 2008) and MEDLINE (January 1949 to April 2008), with no language restrictions, using the key words "ciprofloxacin", "fluoroquinolone", "tube feed", and "enteral". For trials that remained after screening of the abstract, the full text was reviewed and the reference lists were hand-searched to identify additional trials. The following outcomes were prespecified: death, serious adverse events, clinical cure, microbiological cure, re-infection, total adverse events, ratio of area under the curve (AUC, in microgram-hours per millilitre) to minimum inhibitory concentration (MIC, in micrograms per millilitre), ratio of maximum serum concentration (C(max), in micrograms per millilitre) to MIC, and C(max).
RESULTS
The search identified 121 potentially eligible studies, which were screened on the basis of information provided in the abstract. From this initial screening, it was clear that 113 studies did not meet the inclusion criteria. The remaining 8 studies were subjected to a full-text review, which revealed that only 1 study met the inclusion criteria. In that study, ciprofloxacin 750 mg given enterally yielded an AUC similar to that achieved with 400 mg given parentally, but the C(max) was lower. No clinical outcomes were reported.
CONCLUSIONS
There is insufficient evidence from this systematic review to determine whether patients receiving enteral feeds concomitantly with enteral ciprofloxacin 750 mg BID will achieve clinical outcomes similar to those receiving parenteral ciprofloxacin 400 mg BID.
PubMed: 22478878
DOI: 10.4212/cjhp.v62i2.441