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International Journal of Surgery... May 2019The need for patients to wear compression stockings after varicose vein surgery and the duration of compressions tocking therapy has been debated. This study isa... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The need for patients to wear compression stockings after varicose vein surgery and the duration of compressions tocking therapy has been debated. This study isa meta-analysis of randomized controlled trials (RCTs) to determine the optimal duration of compression stocking therapy after endovenous thermal ablation (ETA) of the great saphenous vein.
METHODS
The PubMed, Embase, and Cochrane Library databases were searched before January 2019. Individual effect sizes were standardized, and a meta-analysis was conducted to calculate the pooled effect size by using a random effects model. The primary outcome was the severity of pain in the postoperative period. Secondary outcomes were quality of life (QoL), leg volume, bruising scores, consumptionof analgesic agents, recovery time off work, satisfaction, and the incidence rates of postoperative complications including paresthesia and phlebitis.
RESULTS
Five RCTsinvolving775 patients were reviewed. The long-duration (1-2 weeks) group significantly reduced postoperative pain at 1 week (mean difference [MD] 1.19; 95% confidence interval [CI]: 0.58-1.80) and recovery time off work (MD: 1.01 day, 95% CI: 0.06-1.96)when compared with the short-duration (24-48 h) group. However, the mean pain scores at 2 (0.1; 95% CI: 0-0.2) and 6 weeks postoperatively (-0.3; 95% CI: -1.09-0.49) did not differ significantly between the two groups. Moreover, the incidence rates of complication, paresthesia, and phlebitis did not differ significantly between the short-duration and long-duration groups.
CONCLUSION
The use of compression therapy for a long time (1-2 weeks) is better than short-term (24-48 h) use in terms of postoperative pain at 1 week and recovery off work. Hence, we recommend the prescription of 1-week compression stocking therapy after ETA in routine clinical practice. However, the available evidence is of variable quality, further well-structured RCTs with improved standardization of compression treatment, types of stockings, and target populations are warranted.
Topics: Catheter Ablation; Humans; Postoperative Complications; Saphenous Vein; Stockings, Compression; Time Factors; Treatment Outcome; Varicose Veins; Vascular Surgical Procedures
PubMed: 30959134
DOI: 10.1016/j.ijsu.2019.03.024 -
Medicine Feb 2019Immunoglobulin G4-related disease (IgG4-RD) is a recently recognized, immune-mediated chronic fibrotic inflammation that can involve almost all organs, causing...
BACKGROUND
Immunoglobulin G4-related disease (IgG4-RD) is a recently recognized, immune-mediated chronic fibrotic inflammation that can involve almost all organs, causing tumefaction and dysfunction. Its presence in pulmonary circulation is underestimated and has not yet been investigated.
OBJECTIVES
We describe a representative IgG4-RD patient with pulmonary artery stenosis and pulmonary embolism, leading to reversible pulmonary hypertension. Literature review of IgG4-RD with pulmonary circulation involvement was conducted.
DATA SOURCES
References for this review were identified through searches via PubMed, EBSCO, and Web of Science for published articles before November 2016.
RESULTS
There were 15 published cases of IgG4-RD with pulmonary vascular involvement, 3 with pulmonary arteritis, 2 with pulmonary artery aneurysm, 3 with pulmonary artery stenosis, 1 with obliterative phlebitis, and 1 with pulmonary embolism. Possible immunity and inflammation mechanisms were summarized.
CONCLUSIONS
IgG4-RD with pulmonary vascular involvement is rare. Echocardiogram and contrast-enhanced chest CT are helpful to screen the disease. Clinical manifestations were found from asymptomatic to dyspnea or even syncope. And nearly all cases had more than 1 organ affected, with significantly increased serum IgG4 levels. PET/CT aided in identifying affected organs and determining candidate biopsy sites. More awareness is urged to evaluate the pulmonary vascular manifestations of this disease.
Topics: Humans; Male; Middle Aged; Echocardiography; Hypertension, Pulmonary; Immunoglobulin G4-Related Disease; Pulmonary Embolism; Radiography, Thoracic; Stenosis, Pulmonary Artery
PubMed: 30732204
DOI: 10.1097/MD.0000000000014437 -
The Cochrane Database of Systematic... Jan 2019US Centers for Disease Control guidelines recommend replacement of peripheral intravenous catheters (PIVC) no more frequently than every 72 to 96 hours. Routine... (Meta-Analysis)
Meta-Analysis
BACKGROUND
US Centers for Disease Control guidelines recommend replacement of peripheral intravenous catheters (PIVC) no more frequently than every 72 to 96 hours. Routine replacement is thought to reduce the risk of phlebitis and bloodstream infection. Catheter insertion is an unpleasant experience for patients and replacement may be unnecessary if the catheter remains functional and there are no signs of inflammation or infection. Costs associated with routine replacement may be considerable. This is the third update of a review first published in 2010.
OBJECTIVES
To assess the effects of removing peripheral intravenous catheters when clinically indicated compared with removing and re-siting the catheter routinely.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 18 April 2018. We also undertook reference checking, and contacted researchers and manufacturers to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials that compared routine removal of PIVC with removal only when clinically indicated, in hospitalised or community-dwelling patients receiving continuous or intermittent infusions.
DATA COLLECTION AND ANALYSIS
Three review authors independently reviewed trials for inclusion, extracted data, and assessed risk of bias using Cochrane methods. We used GRADE to assess the overall evidence certainty.
MAIN RESULTS
This update contains two new trials, taking the total to nine included studies with 7412 participants. Eight trials were conducted in acute hospitals and one in a community setting. We rated the overall certainty of evidence as moderate for most outcomes, due to serious risk of bias for unblinded outcome assessment or imprecision, or both. Because outcome assessment was unblinded in all of the trials, none met our criteria for high methodological quality.Primary outcomesSeven trials (7323 participants), assessed catheter-related bloodstream infection (CRBSI). There is no clear difference in the incidence of CRBSI between the clinically indicated (1/3590) and routine change (2/3733) groups (risk ratio (RR) 0.61, 95% confidence interval (CI) 0.08 to 4.68), low-certainty evidence (downgraded twice for serious imprecision).All trials reported incidence of thrombophlebitis and we combined the results from seven of these in the analysis (7323 participants). We excluded two studies in the meta-analysis because they contributed to high heterogeneity. There is no clear difference in the incidence of thrombophlebitis whether catheters were changed according to clinical indication or routinely (RR 1.07, 95% CI 0.93 to 1.25; clinically indicated 317/3590; 3-day change 307/3733, moderate-certainty evidence, downgraded once for serious risk of bias). The result was unaffected by whether the infusion was continuous or intermittent. Six trials provided thrombophlebitis rates by number of device days (32,709 device days). There is no clear difference between groups (RR 0.90, 95% CI 0.76 to 1.08; clinically indicated 248/17,251; 3-day change 236/15,458; moderate-certainty evidence, downgraded once for serious risk of bias).One trial (3283 participants), assessed all-cause blood stream infection (BSI). We found no clear difference in the all-cause BSI rate between the two groups (RR 0.47, 95% CI 0.15 to 1.53; clinically indicated: 4/1593 (0.02%); routine change 9/1690 (0.05%); moderate-certainty evidence, downgraded one level for serious imprecision).Three trials (4244 participants), investigated costs; clinically indicated removal probably reduces device-related costs by approximately AUD 7.00 compared with routine removal (MD -6.96, 95% CI -9.05 to -4.86; moderate-certainty evidence, downgraded once for serious risk of bias).Secondary outcomesSix trials assessed infiltration (7123 participants). Routine replacement probably reduces infiltration of fluid into surrounding tissues compared with a clinically indicated change (RR 1.16 (95% CI 1.06 to 1.26; routine replacement 747/3638 (20.5%); clinically indicated 834/3485 (23.9%); moderate-certainty evidence, downgraded once for serious risk of bias).Meta-analysis of seven trials (7323 participants), found that rates of catheter failure due to blockage were probably lower in the routine-replacement group compared to the clinically indicated group (RR 1.14, 95% CI 1.01 to 1.29; routine-replacement 519/3733 (13.9%); clinically indicated 560/3590 (15.6%); moderate-certainty evidence, downgraded once for serious risk of bias).Four studies (4606 participants), reported local infection rates. It is uncertain if there are differences between groups (RR 4.96, 95% CI 0.24 to 102.98; clinically indicated 2/2260 (0.09%); routine replacement 0/2346 (0.0%); very low-certainty evidence, downgraded one level for serious risk of bias and two levels for very serious imprecision).One trial (3283 participants), found no clear difference in the incidence of mortality when clinically indicated removal was compared with routine removal (RR 1.06, 95% CI 0.27 to 4.23; low-certainty evidence, downgraded two levels for very serious imprecision).One small trial (198 participants) reported no clear difference in device-related pain between clinically indicated and routine removal groups (MD -0.60, 95% CI -1.44 to 0.24; low-certainty evidence, downgraded one level for serious risk of bias and one level for serious imprecision).The pre-planned outcomes 'number of catheter re-sites per patient', and 'satisfaction' were not reported by any studies included in this review.
AUTHORS' CONCLUSIONS
There is moderate-certainty evidence of no clear difference in rates of CRBSI, thrombophlebitis, all-cause BSI, mortality and pain between clinically indicated or routine replacement of PIVC. We are uncertain if local infection is reduced or increased when catheters are changed when clinically indicated. There is moderate-certainty evidence that infiltration and catheter blockage is probably lower when PIVC are changed routinely; and moderate-certainty evidence that clinically indicated removal probably reduces device-related costs. The addition of two new trials for this update found no further evidence to support changing catheters every 72 to 96 hours. Healthcare organisations may consider changing to a policy whereby catheters are changed only if there is a clinical indication to do so, for example, if there were signs of infection, blockage or infiltration. This would provide significant cost savings, spare patients the unnecessary pain of routine re-sites in the absence of clinical indications and would reduce time spent by busy clinicians on this intervention. To minimise PIVC-related complications, staff should inspect the insertion site at each shift change and remove the catheter if signs of inflammation, infiltration, occlusion, infection or blockage are present, or if the catheter is no longer needed for therapy.
Topics: Catheter-Related Infections; Catheterization, Peripheral; Catheters, Indwelling; Device Removal; Guideline Adherence; Humans; Incidence; Phlebitis; Randomized Controlled Trials as Topic; Thrombophlebitis; Time Factors
PubMed: 30671926
DOI: 10.1002/14651858.CD007798.pub5 -
BMJ Open Jul 2018To summarise available data on the risk factors, complications and the factors associated with complications of lower limb cellulitis in Africa.
OBJECTIVE
To summarise available data on the risk factors, complications and the factors associated with complications of lower limb cellulitis in Africa.
METHODS
We did electronic searches on PubMed, EMBASE, Scopus and African Journals Online from 1 January 1986 to 30 October 2017, extracted and summarised data on the risk factors, complications and the factors associated with the complications of lower limb cellulitis from eligible literature.
RESULTS
A total of seven studies were retained for final review after the search and screening processes. Local risk factors of cellulitis reported were: disruption of the skin barrier, neglected wounds, toe-web intertrigo, leg ulcers, use of depigmentation drugs and leg oedema. Obesity was the only reported general risk factor of cellulitis. Five studies reported on the complications of cellulitis which included: abscess formation, necrotising fasciitis, bullae, haemorrhagic lesions, necrosis, phlebitis and amputations. Nicotine addiction, chronic use of non-steroidal anti-inflammatory drugs, delay in the initiation of antibiotic treatment and elevated erythrocyte sedimentation rate were risk factors of complications of lower limb cellulitis identified from three studies.
CONCLUSION
This review highlights the important role of local risk factors in the pathogenesis of lower limb cellulitis in Africa. The association between voluntary skin depigmentation and lower limb cellulitis should alert public health authorities and the general population to the health risks associated with this practice. The identification and improved management of the risk factors of lower limb cellulitis and its complications could go a long way in decreasing the morbidity and health costs incurred by lower limb cellulitis in Africa.
Topics: Africa; Cellulitis; Humans; Lower Extremity; Risk Factors
PubMed: 30037869
DOI: 10.1136/bmjopen-2017-021175 -
Revista Gaucha de Enfermagem Jun 2018To describe the scientific evidence published in literature regarding the risk factors for the development of phlebitis.
OBJECTIVE
To describe the scientific evidence published in literature regarding the risk factors for the development of phlebitis.
METHOD
Integrative literature review with the inclusion of 14 original articles found in the LILACS, Scielo and Pubmed bases from January 2004 to April 2015, analyzed by levels of evidence and frequency, associated factors, degree and treatment of phlebitis.
RESULTS
The frequency / incidence / minimum rate of phlebitis was 3% and the maximum was 59.1%. Most articles (57.14%) reported an association of phlebitis with risk factors, including the dwell time, puncture site and / or anatomical region, hospitalization period, number of accesses, reason for removal, sex, antibiotics, intermittent maintenance and emergency insertion.
CONCLUSIONS
The need for standardizing the quantification of this event and a weak connection between the risk factors associated with phlebitis were identified. Further studies need to be developed in order to grant a real understanding of this disease in the daily routines of a hospital.
Topics: Anti-Bacterial Agents; Bibliometrics; Catheterization, Peripheral; Disease Susceptibility; Epidemiologic Studies; Evidence-Based Medicine; Female; Hospitalization; Humans; Male; Observational Studies as Topic; Phlebitis; Phlebotomy; Randomized Controlled Trials as Topic; Risk Factors; Veins
PubMed: 29933415
DOI: 10.1590/1983-1447.2017.04.57489 -
The Cochrane Database of Systematic... Feb 2018The optimal treatment of superficial thrombophlebitis (ST) of the legs remains poorly defined. While improving or relieving the local painful symptoms, treatment should... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The optimal treatment of superficial thrombophlebitis (ST) of the legs remains poorly defined. While improving or relieving the local painful symptoms, treatment should aim at preventing venous thromboembolism (VTE), which might complicate the natural history of ST. This is the third update of a review first published in 2007.
OBJECTIVES
To assess the efficacy and safety of topical, medical, and surgical treatments for ST of the leg in improving local symptoms and decreasing thromboembolic complications.
SEARCH METHODS
For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (March 2017), CENTRAL (2017, Issue 2), and trials registries (March 2017). We handsearched the reference lists of relevant papers and conference proceedings.
SELECTION CRITERIA
Randomised controlled trials (RCTs) evaluating topical, medical, and surgical treatments for ST of the legs that included people with a clinical diagnosis of ST of the legs or objective diagnosis of a thrombus in a superficial vein.
DATA COLLECTION AND ANALYSIS
Two authors assessed the trials for inclusion in the review, extracted the data, and assessed the quality of the studies. Data were independently extracted from the included studies and any disagreements resolved by consensus. We assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
We identified three additional trials (613 participants), therefore this update considered 33 studies involving 7296 people with ST of the legs. Treatment included fondaparinux; rivaroxaban; low molecular weight heparin (LMWH); unfractionated heparin (UFH); non-steroidal anti-inflammatory drugs (NSAIDs); compression stockings; and topical, intramuscular, or intravenous treatment to surgical interventions such as thrombectomy or ligation. Only a minority of trials compared treatment with placebo rather than an alternative treatment and many studies were small and of poor quality. Pooling of the data was possible for few outcomes, and none were part of a placebo-controlled trial. In one large, placebo-controlled RCT of 3002 participants, subcutaneous fondaparinux was associated with a significant reduction in symptomatic VTE (risk ratio (RR) 0.15, 95% confidence interval (CI) 0.04 to 0.50; moderate-quality evidence), ST extension (RR 0.08, 95% CI 0.03 to 0.22; moderate-quality evidence), and ST recurrence (RR 0.21, 95% CI 0.08 to 0.54; moderate-quality evidence) relative to placebo. Major bleeding was infrequent in both groups with very wide CIs around risk estimate (RR 0.99, 95% CI 0.06 to 15.86; moderate-quality evidence). In one RCT on 472 high-risk participants with ST, fondaparinux was associated with a non-significant reduction of symptomatic VTE compared to rivaroxaban 10 mg (RR 0.33, 95% CI 0.03 to 3.18; low-quality evidence). There were no major bleeding events in either group (low-quality evidence). In another placebo-controlled trial, both prophylactic and therapeutic doses of LMWH (prophylactic: RR 0.44, 95% CI 0.26 to 0.74; therapeutic: RR 0.46, 95% CI 0.27 to 0.77) and NSAIDs (RR 0.46, 95% CI 0.27 to 0.78) reduced the extension (low-quality evidence) and recurrence of ST (low-quality evidence) in comparison to placebo, with no significant effects on symptomatic VTE (low-quality evidence) or major bleeding (low-quality evidence). Overall, topical treatments improved local symptoms compared with placebo, but no data were provided on the effects on VTE and ST extension. Surgical treatment combined with elastic stockings was associated with a lower VTE rate and ST progression compared with elastic stockings alone. However, the majority of studies that compared different oral treatments, topical treatments, or surgery did not report VTE, ST progression, adverse events, or treatment adverse effects.
AUTHORS' CONCLUSIONS
Prophylactic dose fondaparinux given for 45 days appears to be a valid therapeutic option for ST of the legs for most people. The evidence on topical treatment or surgery is too limited and does not inform clinical practice about the effects of these treatments in terms of VTE. Further research is needed to assess the role of rivaroxaban and other direct oral factor-X or thrombin inhibitors, LMWH, and NSAIDs; the optimal doses and duration of treatment in people at various risk of recurrence; and whether a combination therapy may be more effective than single treatment. Adequately designed and conducted studies are required to clarify the role of topical and surgical treatments.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Anticoagulants; Factor Xa Inhibitors; Fondaparinux; Hemorrhage; Heparin, Low-Molecular-Weight; Humans; Polysaccharides; Randomized Controlled Trials as Topic; Rivaroxaban; Stockings, Compression; Thrombectomy; Thromboembolism; Thrombophlebitis; Venous Thromboembolism
PubMed: 29478266
DOI: 10.1002/14651858.CD004982.pub6 -
Experimental and Therapeutic Medicine Aug 2017Heparin has typically been used as a flushing or infusion solution for vascular lines in daily practice. However, several clinical trials have yielded controversial...
Heparin has typically been used as a flushing or infusion solution for vascular lines in daily practice. However, several clinical trials have yielded controversial results about the benefits of heparin in maintaining peripheral venous catheters. The present meta-analysis was conducted to evaluate the efficacy of heparin on the patency profiles and complications in peripheral intravenous catheters. PubMed, Embase and Cochrane Central Register of Controlled Trials were searched up to February 2016 for randomized controlled trials comparing heparin with placebo in maintaining peripheral intravenous catheters. Additional studies were retrieved from the reference lists of identified articles. In total 32 eligible studies were included, from which the pooled standard mean difference (SMD), relative risk (RR) and corresponding 95% confidence interval (CI) were calculated. The use of heparin as a continuous infusion significantly prolonged the duration of patency (SMD, 0.90; 95% CI, 0.48-1.32; P<0.001), reduced rates of infusion failure (RR, 0.83; 95% CI, 0.76-0.92; P<0.001) and occlusion (RR, 0.82; 95% CI, 0.69-0.98; P<0.05) in a peripheral intravenous catheter. However, there were no significant changes in the duration of patency and infusion failure when heparin was used intermittently as a flushing solution, although a significantly decreased risk of occlusion was observed in this setting (RR, 0.80; 95% CI, 0.66-0.98; P<0.05). Furthermore, the risk of phlebitis was significantly decreased by both continuous infusion (RR, 0.66; 95% CI, 0.58-0.75; P<0.01) and intermittent flushing (RR, 0.70; 95% CI, 0.56-0.86; P<0.01) of heparin in peripheral venous catheters. In conclusion, the use of heparin as continuous infusion in peripheral intravenous catheters improved the duration of patency, reduced infusion failure and phlebitis, whereas heparin as intermittent flushing showed more benefits in ameliorating phlebitis rather than in patency profiles.
PubMed: 28810636
DOI: 10.3892/etm.2017.4706 -
The Cochrane Database of Systematic... Dec 2016Traumatic brain injury (TBI) is a leading cause of death and disability, and the identification of effective, inexpensive and widely practicable treatments for brain... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Traumatic brain injury (TBI) is a leading cause of death and disability, and the identification of effective, inexpensive and widely practicable treatments for brain injury is of great public health importance worldwide. Progesterone is a naturally produced hormone that has well-defined pharmacokinetics, is widely available, inexpensive, and has steroidal, neuroactive and neurosteroidal actions in the central nervous system. It is, therefore, a potential candidate for treating TBI patients. However, uncertainty exists regarding the efficacy of this treatment. This is an update of our previous review of the same title, published in 2012.
OBJECTIVES
To assess the effects of progesterone on neurologic outcome, mortality and disability in patients with acute TBI. To assess the safety of progesterone in patients with acute TBI.
SEARCH METHODS
We updated our searches of the following databases: the Cochrane Injuries Group's Specialised Register (30 September 2016), the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 9, 2016), MEDLINE (Ovid; 1950 to 30 September 2016), Embase (Ovid; 1980 to 30 September 2016), Web of Science Core Collection: Conference Proceedings Citation Index-Science (CPCI-S; 1990 to 30 September 2016); and trials registries: Clinicaltrials.gov (30 September 2016) and the World Health Organization (WHO) International Clinical Trials Registry Platform (30 September 2016).
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of progesterone versus no progesterone (or placebo) for the treatment of people with acute TBI.
DATA COLLECTION AND ANALYSIS
Two review authors screened search results independently to identify potentially relevant studies for inclusion. Independently, two review authors selected trials that met the inclusion criteria from the results of the screened searches, with no disagreement.
MAIN RESULTS
We included five RCTs in the review, with a total of 2392 participants. We assessed one trial to be at low risk of bias; two at unclear risk of bias (in one multicentred trial the possibility of centre effects was unclear, whilst the other trial was stopped early), and two at high risk of bias, due to issues with blinding and selective reporting of outcome data.All included studies reported the effects of progesterone on mortality and disability. Low quality evidence revealed no evidence of a difference in overall mortality between the progesterone group and placebo group (RR 0.91, 95% CI 0.65 to 1.28, I² = 62%; 5 studies, 2392 participants, 2376 pooled for analysis). Using the GRADE criteria, we assessed the quality of the evidence as low, due to the substantial inconsistency across studies.There was also no evidence of a difference in disability (unfavourable outcomes as assessed by the Glasgow Outcome Score) between the progesterone group and placebo group (RR 0.98, 95% CI 0.89 to 1.06, I² = 37%; 4 studies; 2336 participants, 2260 pooled for analysis). We assessed the quality of this evidence to be moderate, due to inconsistency across studies.Data were not available for meta-analysis for the outcomes of mean intracranial pressure, blood pressure, body temperature or adverse events. However, data from three studies showed no difference in mean intracranial pressure between the groups. Data from another study showed no evidence of a difference in blood pressure or body temperature between the progesterone and placebo groups, although there was evidence that intravenous progesterone infusion increased the frequency of phlebitis (882 participants). There was no evidence of a difference in the rate of other adverse events between progesterone treatment and placebo in the other three studies that reported on adverse events.
AUTHORS' CONCLUSIONS
This updated review did not find evidence that progesterone could reduce mortality or disability in patients with TBI. However, concerns regarding inconsistency (heterogeneity among participants and the intervention used) across included studies reduce our confidence in these results.There is no evidence from the available data that progesterone therapy results in more adverse events than placebo, aside from evidence from a single study of an increase in phlebitis (in the case of intravascular progesterone).There were not enough data on the effects of progesterone therapy for our other outcomes of interest (intracranial pressure, blood pressure, body temperature) for us to be able to draw firm conclusions.Future trials would benefit from a more precise classification of TBI and attempts to optimise progesterone dosage and scheduling.
Topics: Brain Injuries; Disability Evaluation; Glasgow Coma Scale; Humans; Injury Severity Score; Intracranial Pressure; Neuroprotective Agents; Progesterone; Randomized Controlled Trials as Topic; Risk
PubMed: 28005271
DOI: 10.1002/14651858.CD008409.pub4 -
The Cochrane Database of Systematic... Aug 2016Genital herpes is incurable, and is caused by the herpes simplex virus (HSV). First-episode genital herpes is the first clinical presentation of herpes that a person... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Genital herpes is incurable, and is caused by the herpes simplex virus (HSV). First-episode genital herpes is the first clinical presentation of herpes that a person experiences. Current treatment is based around viral suppression in order to decrease the length and severity of the episode.
OBJECTIVES
To determine the effectiveness and safety of the different existing treatments for first-episode genital herpes on the duration of symptoms and time to recurrence.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (from inception to April 2016), MEDLINE (from inception to April 2016), the Specialised Register of the Cochrane Sexually Transmitted Infections Review Group (from inception to April 2016), EMBASE (from inception to April 2016), PsycINFO (from inception to April 2016), CINAHL (from inception to April 2016), LILACS (from inception to April 2016), AMED (from inception to April 2016), and the Alternative Medicines Specialised Register (from inception to April 2016). We handsearched a number of relevant journals, searched reference lists of all included studies, databases of ongoing trials, and other Internet databases.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) on participants with first-episode genital herpes. We excluded vaccination trials, and trials in which the primary objective assessed a complication of HSV infection.
DATA COLLECTION AND ANALYSIS
All studies written in English were independently assessed by at least two review authors for inclusion, risk of bias for each trial, and to extract data. Studies requiring translation were assessed for inclusion, trial quality, and data extraction by external translators.
MAIN RESULTS
We included 26 trials with 2084 participants analysed. Most of the studies were conducted in the United Kingdom (UK) and United States (US), and involved men and women experiencing their first episode of genital herpes, with the exception of three studies which included only women. We rated the majority of these studies as having an unclear risk of bias; largely due to lack of information supplied in the publications, and due to the age of the trials. This review found low quality evidence from two studies of oral acyclovir, when compared to placebo, reduced the duration of symptoms in individuals undergoing their first episode of genital herpes (mean difference (MD) -3.22, 95% confidence interval (CI) -5.91 to -0.54; I(2) = 52%). In two studies (112 participants), intravenous acyclovir decreased the median number of days that patients with first-episode herpes suffered symptoms. Oral valaciclovir (converted to acyclovir) also showed a similar length of symptom duration when compared to acyclovir in two studies.There is currently no evidence that topical acyclovir reduces symptoms (MD -0.61 days, 95% CI -2.16 to 0.95; 3 RCTs, 195 participants, I(2) statistic = 56%). There is also no current evidence that the topical treatments of cicloxolone cream, carbenoxolone sodium cream, adenosine arabinoside, idoxuridine in dimethyl sulfoxide, when compared to placebo reduced the duration of symptoms in people undergoing their first episode of herpes.Two studies reported no evidence of a reduction in the number of median days to recurrence following treatment with oral acyclovir versus placebo. Adverse events were generally poorly reported by all of the included studies and we were unable to quantitatively analyse this outcome. For those taking acyclovir, there were no serious adverse events; the most common adverse events reported for oral acyclovir were coryza, dizziness, tiredness, diarrhoea and renal colic. For intravenous acyclovir these were phlebitis, nausea and abnormal liver function tests and for topical acyclovir there was pain with the topical application.Those undergoing interferon treatment had significantly more adverse events compared to those taking placebo.
AUTHORS' CONCLUSIONS
There is low quality evidence from this review that oral acyclovir reduced the duration of symptoms for genital herpes. However, there is low quality evidence which did not show that topical antivirals reduced symptom duration for patients undergoing their first episode of genital herpes. This review was limited by the inclusion of skewed data, resulting in few trials that we were able to meta-analyse.
Topics: Acyclovir; Administration, Oral; Antiviral Agents; Female; Herpes Genitalis; Humans; Injections, Intravenous; Male; Randomized Controlled Trials as Topic; Recurrence; Valacyclovir; Valine
PubMed: 27575957
DOI: 10.1002/14651858.CD010684.pub2 -
The Cochrane Database of Systematic... Nov 2015Although superficial thrombophlebitis of the upper extremity represents a frequent complication of intravenous catheters inserted into the peripheral veins of the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Although superficial thrombophlebitis of the upper extremity represents a frequent complication of intravenous catheters inserted into the peripheral veins of the forearm or hand, no consensus exists on the optimal management of this condition in clinical practice.
OBJECTIVES
To summarise the evidence from randomised clinical trials (RCTs) concerning the efficacy and safety of (topical, oral or parenteral) medical therapy of superficial thrombophlebitis of the upper extremity.
SEARCH METHODS
The Cochrane Vascular Group Trials Search Co-ordinator searched the Specialised Register (last searched April 2015) and the Cochrane Register of Studies (2015, Issue 3). Clinical trials registries were searched up to April 2015.
SELECTION CRITERIA
RCTs comparing any (topical, oral or parenteral) medical treatment to no intervention or placebo, or comparing two different medical interventions (e.g. a different variant scheme or regimen of the same intervention or a different pharmacological type of treatment).
DATA COLLECTION AND ANALYSIS
We extracted data on methodological quality, patient characteristics, interventions and outcomes, including improvement of signs and symptoms as the primary effectiveness outcome, and number of participants experiencing side effects of the study treatments as the primary safety outcome.
MAIN RESULTS
We identified 13 studies (917 participants). The evaluated treatment modalities consisted of a topical treatment (11 studies), an oral treatment (2 studies) and a parenteral treatment (2 studies). Seven studies used a placebo or no intervention control group, whereas all others also or solely compared active treatment groups. No study evaluated the effects of ice or the application of cold or hot bandages. Overall, the risk of bias in individual trials was moderate to high, although poor reporting hampered a full appreciation of the risk in most studies. The overall quality of the evidence for each of the outcomes varied from low to moderate mainly due to risk of bias and imprecision, with only single trials contributing to most comparisons. Data on primary outcomes improvement of signs and symptoms and side effects attributed to the study treatment could not be statistically pooled because of the between-study differences in comparisons, outcomes and type of instruments to measure outcomes.An array of topical treatments, such as heparinoid or diclofenac gels, improved pain compared to placebo or no intervention. Compared to placebo, oral non-steroidal anti-inflammatory drugs reduced signs and symptoms intensity. Safety issues were reported sparsely and were not available for some interventions, such as notoginseny creams, parenteral low-molecular-weight heparin or defibrotide. Although several trials reported on adverse events with topical heparinoid creams, Essaven gel or phlebolan versus control, the trials were underpowered to adequately measure any differences between treatment modalities. Where reported, adverse events with topical treatments consisted mainly of local allergic reactions. Only one study of 15 participants assessed thrombus extension and symptomatic venous thromboembolism with either oral non-steroidal anti-inflammatory drugs or low-molecular-weight heparin, and it reported no cases of either. No study reported on the development of suppurative phlebitis, catheter-related bloodstream infections or quality of life.
AUTHORS' CONCLUSIONS
The evidence about the treatment of acute infusion superficial thrombophlebitis is limited and of low quality. Data appear too preliminary to assess the effectiveness and safety of topical treatments, systemic anticoagulation or oral non-steroidal anti-inflammatory drugs.
Topics: Anti-Inflammatory Agents; Anticoagulants; Catheterization, Peripheral; Dalteparin; Diclofenac; Drug Combinations; Drugs, Chinese Herbal; Escin; Gels; Heparin; Heparinoids; Humans; Ibuprofen; Nitroglycerin; Pentosan Sulfuric Polyester; Phospholipids; Polydeoxyribonucleotides; Randomized Controlled Trials as Topic; Thrombophlebitis; Upper Extremity
PubMed: 26588711
DOI: 10.1002/14651858.CD011015.pub2