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The Cochrane Database of Systematic... Jul 2014Since hypercoagulability might result in recurrent miscarriage, anticoagulant agents could potentially increase the chance of live birth in subsequent pregnancies in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Since hypercoagulability might result in recurrent miscarriage, anticoagulant agents could potentially increase the chance of live birth in subsequent pregnancies in women with unexplained recurrent miscarriage, with or without inherited thrombophilia.
OBJECTIVES
To evaluate the efficacy and safety of anticoagulant agents, such as aspirin and heparin, in women with a history of at least two unexplained miscarriages with or without inherited thrombophilia.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 October 2013) and scanned bibliographies of all located articles for any unidentified articles.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials that assessed the effect of anticoagulant treatment on live birth in women with a history of at least two unexplained miscarriages with or without inherited thrombophilia were eligible. Interventions included aspirin, unfractionated heparin (UFH), and low molecular weight heparin (LMWH) for the prevention of miscarriage. One treatment could be compared with another or with no-treatment (or placebo).
DATA COLLECTION AND ANALYSIS
Two review authors (PJ and SK) assessed the studies for inclusion in the review and extracted the data. If necessary they contacted study authors for more information. We double checked the data.
MAIN RESULTS
Nine studies, including data of 1228 women, were included in the review evaluating the effect of either LMWH (enoxaparin or nadroparin in varying doses) or aspirin or a combination of both, on the chance of live birth in women with recurrent miscarriage, with or without inherited thrombophilia. Studies were heterogeneous with regard to study design and treatment regimen and three studies were considered to be at high risk of bias. Two of these three studies at high risk of bias showed a benefit of one treatment over the other, but in sensitivity analyses (in which studies at high risk of bias were excluded) anticoagulants did not have a beneficial effect on live birth, regardless of which anticoagulant was evaluated (risk ratio (RR) for live birth in women who received aspirin compared to placebo 0.94, (95% confidence interval (CI) 0.80 to 1.11, n = 256), in women who received LMWH compared to aspirin RR 1.08 (95% CI 0.93 to 1.26, n = 239), and in women who received LMWH and aspirin compared to no-treatment RR 1.01 (95% CI 0.87 to 1.16) n = 322).Obstetric complications such as preterm delivery, pre-eclampsia, intrauterine growth restriction and congenital malformations were not significantly affected by any treatment regimen. In included studies, aspirin did not increase the risk of bleeding, but treatment with LWMH and aspirin increased the risk of bleeding significantly in one study. Local skin reactions (pain, itching, swelling) to injection of LMWH were reported in almost 40% of patients in the same study.
AUTHORS' CONCLUSIONS
There is a limited number of studies on the efficacy and safety of aspirin and heparin in women with a history of at least two unexplained miscarriages with or without inherited thrombophilia. Of the nine reviewed studies quality varied, different treatments were studied and of the studies at low risk of bias only one was placebo-controlled. No beneficial effect of anticoagulants in studies at low risk of bias was found. Therefore, this review does not support the use of anticoagulants in women with unexplained recurrent miscarriage. The effect of anticoagulants in women with unexplained recurrent miscarriage and inherited thrombophilia needs to be assessed in further randomised controlled trials; at present there is no evidence of a beneficial effect.
Topics: Abortion, Habitual; Anticoagulants; Antiphospholipid Syndrome; Aspirin; Enoxaparin; Female; Heparin, Low-Molecular-Weight; Humans; Live Birth; Nadroparin; Pregnancy; Pregnancy Complications, Hematologic; Randomized Controlled Trials as Topic; Thrombophilia
PubMed: 24995856
DOI: 10.1002/14651858.CD004734.pub4 -
The Cochrane Database of Systematic... Apr 2013The 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 second update of a review first published in 2007.
OBJECTIVES
To assess the efficacy and safety of topical, medical, and surgical treatments in patients presenting with ST of the legs.
SEARCH METHODS
For this update, the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched November 2012) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 11). 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 participants with a clinical diagnosis of ST of the legs or an 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.
MAIN RESULTS
We identified four additional trials (986 patients), so this update considered 30 studies involving 6507 participants with ST of the legs.Treatment ranged from fondaparinux, low molecular weight heparin (LMWH), unfractionated heparin (UFH), non-steroidal anti-inflammatory agents (NSAIDs), topical treatment, oral treatment, intramuscular treatment, and intravenous treatment to surgery. Only a minority of trials compared treatment with placebo rather than an alternative treatment, none evaluated the same treatment comparisons on the same study outcomes (which precluded meta-analysis), and many of the studies were small and of poor quality. In one large, placebo-controlled RCT of about 3000 patients, subcutaneous fondaparinux was associated with a significant reduction in symptomatic VTE (RR 0.15; 95% CI 0.04 to 0.50), ST extension (RR 0.08; 95% CI 0.03 to 0.22), and ST recurrence (RR 0.21; 95% CI 0.08 to 0.54) with comparable rates of major bleeding (RR 0.99; 95% CI 0.06 to 15.86) relative to placebo. In a further placebo-controlled trial, both prophylactic and therapeutic doses of LMWH (RR 0.40; 95% CI 0.22 to 0.72 and RR 0.42; 95% CI 0.23 to 0.75, respectively) and NSAIDs (RR 0.41; 95% CI 0.23 to 0.75) reduced the extension and recurrence of ST in comparison to placebo, with no significant effects on symptomatic VTE nor major bleeding. 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 treatment, topical treatment, or surgery did not report VTE, ST progression, adverse events, or treatment side effects.
AUTHORS' CONCLUSIONS
Prophylactic dose fondaparinux given for six weeks appears to be a valid therapeutic option for ST of the legs. The evidence on oral treatments, topical treatment, or surgery is too limited and does not inform clinical practice about the effects of these treatments in terms of VTE and ST progression. Further research is needed to assess the role of the new oral direct thrombin and activated factor-X inhibitors, LMWH, and NSAIDs; the optimal doses and duration of treatment; 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; Fondaparinux; Heparin, Low-Molecular-Weight; Humans; Polysaccharides; Randomized Controlled Trials as Topic; Thromboembolism; Thrombophlebitis; Venous Thromboembolism
PubMed: 23633322
DOI: 10.1002/14651858.CD004982.pub5 -
The Cochrane Database of Systematic... Mar 2012The 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 an update of a review first published in 2007.
OBJECTIVES
To assess the efficacy and safety of topical, medical, and surgical treatments in patients presenting with ST of the legs.
SEARCH METHODS
For this update the Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (last searched 29 November 2011) and CENTRAL (2011, Issue 4). We handsearched reference lists of relevant papers and conference proceedings.
SELECTION CRITERIA
Randomised controlled trials (RCTs) evaluating topical, medical, and surgical treatments for ST of the leg that included participants with a clinical diagnosis of ST of the legs or objective diagnosis of a thrombus in the 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.
MAIN RESULTS
Twenty-six studies involving 5521 participants with ST of the legs were included in this review. The methodological quality of most of the trials was poor. Treatment ranged from fondaparinux, low molecular weight heparin (LMWH), unfractionated heparin (UFH), non-steroidal anti-inflammatory agents (NSAIDs), topical treatment, oral treatment, intramuscular treatment, and intravenous treatment to surgery. In a placebo-controlled RCT of about 3000 patients, fondaparinux was associated with a significant reduction in symptomatic VTE (RR 0.15; 95% CI 0.04 to 0.50), extension (RR 0.08; 95% CI 0.03 to 0.22), and recurrence of ST (RR 0.21; 95% CI 0.08 to 0.54) with comparable rates of major bleeding (RR 0.99; 95% CI 0.06 to 15.86) relative to placebo. Both prophylactic and therapeutic doses of LMWH (RR 0.40; 95% CI 0.22 to 0.72 and RR 0.42; 95% CI 0.23 to 0.75, respectively) and NSAIDs (RR 0.41; 95% CI 0.23 to 0.75) reduced the extension and recurrence of ST in comparison to placebo, with no significant effects on symptomatic VTE nor major bleeding. Overall, topical treatments improved local symptoms. However, no data were provided on the effects of these treatments on VTE and ST extension. Surgical treatment combined with elastic stockings in ST was associated with a lower VTE rate and ST progression compared with elastic stockings alone.
AUTHORS' CONCLUSIONS
Prophylactic dose fondaparinux given for six weeks appears to be a valid therapeutic option for ST of the legs. Further research is needed to assess the role of new oral direct thrombin and activated factor-X inhibitors, LMWH, NSAIDs; the optimal doses and duration of treatment; 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; Fondaparinux; Heparin, Low-Molecular-Weight; Humans; Polysaccharides; Randomized Controlled Trials as Topic; Thrombophlebitis; Venous Thromboembolism
PubMed: 22419302
DOI: 10.1002/14651858.CD004982.pub4 -
Haemophilia : the Official Journal of... May 2012Thrombotic adverse events (AEs) after clotting factor concentrate administration are rare but the actual rate is unknown. A systematic review of prospective studies... (Review)
Review
Thrombotic adverse events to coagulation factor concentrates for treatment of patients with haemophilia and von Willebrand disease: a systematic review of prospective studies.
Thrombotic adverse events (AEs) after clotting factor concentrate administration are rare but the actual rate is unknown. A systematic review of prospective studies (1990-2011) reporting safety data of factor concentrates in patients with haemophilia A (HA), haemophilia B (HB) and von Willebrand disease (VWD) was conducted to identify the incidence and type of thrombotic AEs. In 71 studies (45 in HA, 15 HB, 11 VWD) enrolling 5528 patients treated with 27 different concentrates (20 plasma-derived, 7 recombinant), 20 thrombotic AEs (2 HA, 11 HB, 7 VWD) were reported, including two major venous thromboembolic episodes (both in VWD patients on prolonged replacement for surgery). The remaining thrombotic AEs were superficial thrombophlebitis, mostly occurring at infusion sites in surgical patients and/or during concentrate continuous infusion. The overall prevalence was 3.6 per 10(3) patients (3.6 per 10(4) for severe AEs) and 1.13 per 10(5) infusions, with higher figures in VWD than in haemophilia. Thrombotic AEs accounted for 1.9% of non-inhibitor-related AEs. Thrombosis-related complications occurred in 10.8% of patients with central venous access devices (CVADs) reported in six studies, the risk increasing with time of CVAD use. Data from prospective studies over the last 20 years suggest that the risk of thrombotic AEs from factor concentrate administration is small and mainly represented by superficial thrombophlebitis. These findings support the high degree of safety of products currently used for replacement treatment.
Topics: Blood Coagulation Factors; Hemophilia A; Hemophilia B; Humans; Incidence; Prospective Studies; Thrombosis; von Willebrand Diseases
PubMed: 22335611
DOI: 10.1111/j.1365-2516.2012.02758.x -
Dermatologic Surgery : Official... Aug 2009In the last decade, minimally invasive techniques have been introduced in the treatment of lower extremity varicosities. Of these therapies, endovenous laser ablation is... (Review)
Review
BACKGROUND
In the last decade, minimally invasive techniques have been introduced in the treatment of lower extremity varicosities. Of these therapies, endovenous laser ablation is the most widely accepted and used treatment option for insufficient great and short saphenous veins.
OBJECTIVE
To present a review of reported common and rare and minor and major complications associated with endovenous laser ablation.
METHODS
A systematic review of studies and case reports on endovenous laser ablation-induced complications. The complications were classified as minor or major according to the Society of Interventional Radiology Standards of Practice Committee guidelines on reporting complications. A case-series of complications after endovenous laser ablation is presented.
RESULTS
Ecchymoses and pain are frequently reported side effects of endovenous laser ablation. Nerve injury, skin burns, deep vein thrombosis and pulmonary embolism seldom occur. An exceptional complication is a material or device that by accident remains inside the body after the procedure. Ecchymosis, pain, induration, skin burns, dysesthesia, superficial thrombophlebitis, and hematoma were classified as minor complications. Deep vein thrombosis and nerve injury were classified as major complications.
CONCLUSION
Endovenous laser ablation may be considered a safe treatment of lower extremity varicosities. The incidence of common side effects may decrease with better laser parameters.
Topics: Ecchymosis; Humans; Laser Therapy; Male; Middle Aged; Pain; Postoperative Complications; Saphenous Vein; Varicose Veins
PubMed: 19469796
DOI: 10.1111/j.1524-4725.2009.01215.x -
The Cochrane Database of Systematic... Apr 2007The 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.
OBJECTIVES
To assess the efficacy and safety of topical, medical, and surgical treatments in patients presenting with ST of the legs.
SEARCH STRATEGY
The Cochrane Peripheral Vascular Diseases Group searched their specialized register (last searched 16 February 2007), and the Cochrane Central Register of Controlled Trials (CENTRAL) (last searched Issue 1, 2007. We searched MEDLINE (1966 to January 2006), EMBASE (1980 to January 2006), and handsearched reference lists of relevant papers and conference proceedings.
SELECTION CRITERIA
Randomized trials evaluating topical, medical, and surgical treatments for ST of the leg including participants with a clinical diagnosis of ST of the legs or objective diagnosis of a thrombus in the 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 extracted independently from the included studies and any disagreements resolved by consensus.
MAIN RESULTS
Twenty-four studies involving 2469 participants with ST of the legs were included in this review. The methodological quality of most of the trials was poor. Treatment ranged from low molecular weight heparin (LMWH), to non-steroidal anti-inflammatory agents (NSAIDs), topical treatment, surgery, oral, intramuscular, and intravenous treatments. Both LMWH and NSAIDs significantly reduced the incidence of ST extension or recurrences by about 70% compared with placebo and both seemed to have a similar efficacy and safety. Overall, topical treatments improved local symptoms. However, no data were provided on the effects of these treatments on VTE and ST extension. Surgical treatment combined with elastic stockings in ST was associated with a lower VTE rate and ST progression, compared with elastic stockings alone.
AUTHORS' CONCLUSIONS
Low molecular weight heparin and NSAIDs appear as the current best therapeutic options for ST of the legs. While the available data are too limited to make clear recommendations, an intermediate dose of LMWH for at least a month might be advised. Further research is needed to assess the role of NSAIDs and LMWH, the optimal doses and duration of treatment, 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; Heparin, Low-Molecular-Weight; Humans; Randomized Controlled Trials as Topic; Thromboembolism; Thrombophlebitis
PubMed: 17443561
DOI: 10.1002/14651858.CD004982.pub3 -
The Cochrane Database of Systematic... Jan 2007The 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.
OBJECTIVES
To assess the efficacy and safety of topical, medical, and surgical treatments in patients presenting with ST of the legs.
SEARCH STRATEGY
The Cochrane Peripheral Vascular Diseases Group searched their specialized register (last searched October 2006), and the Cochrane Central Register of Controlled Trials (CENTRAL) (last searched Issue 4, 2006. We searched MEDLINE (1966 to January 2006), EMBASE (1980 to January 2006), and handsearched reference lists of relevant papers and conference proceedings.
SELECTION CRITERIA
Randomized trials evaluating topical, medical, and surgical treatments for ST of the leg including participants with a clinical diagnosis of ST of the legs or objective diagnosis of a thrombus in the 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 extracted independently from the included studies and any disagreements resolved by consensus.
MAIN RESULTS
Twenty-four studies involving 2469 participants with ST of the legs were included in this review. The methodological quality of most of the trials was poor. Treatment ranged from low molecular weight heparin (LMWH), to non-steroidal anti-inflammatory agents (NSAIDs), topical treatment, surgery, oral, intramuscular, and intravenous treatments. Both LMWH and NSAIDs significantly reduced the incidence of ST extension or recurrences by about 70% compared with placebo and both seemed to have a similar efficacy and safety. Overall, topical treatments improved local symptoms. However, no data were provided on the effects of these treatments on VTE and ST extension. Surgical treatment combined with elastic stockings in ST was associated with a lower VTE rate and ST progression, compared with elastic stockings alone.
AUTHORS' CONCLUSIONS
Low molecular weight heparin and NSAIDs appear as the current best therapeutic options for ST of the legs. While the available data are too limited to make clear recommendations, an intermediate dose of LMWH for at least a month might be advised. Further research is needed to assess the role of NSAIDs and LMWH, the optimal doses and duration of treatment, 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: Anticoagulants; Humans; Randomized Controlled Trials as Topic; Thromboembolism; Thrombophlebitis
PubMed: 17253533
DOI: 10.1002/14651858.CD004982.pub2 -
Haematologica May 2005The aim of this systematic review was to summarize the evidence from randomized controlled trials (RCT) concerning the efficacy and safety of medical or surgical... (Review)
Review
BACKGROUND AND OBJECTIVES
The aim of this systematic review was to summarize the evidence from randomized controlled trials (RCT) concerning the efficacy and safety of medical or surgical treatments of superficial vein thrombosis (SVT) for the prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE).
DESIGN AND METHODS
A systematic search was performed in MEDLINE, EMBASE and the Cochrane (CENTRAL) database to identify all randomized trials that evaluated the effect of surgical or medical treatment in the prevention of venous thromboembolism (VTE) in patients with SVT of the legs.
RESULTS
Five studies were included. Pooling of the data was not possible due to the heterogeneity among the studies. Moreover, three studies had major methodological drawbacks limiting the clinical applicability of the results. One of the remaining (pilot) studies showed a non-significant trend in favor of high- compared to low-dose unfractionated heparin for the prevention of VTE. The last remaining study showed a non-significant trend in favor of short-term treatment with low-molecular-weight heparin (LMWH) or a non-steroidal anti-inflammatory drug (NSAID) as compared to placebo shortly after treatment with respect to VTE, but the apparent benefit disappeared after three months of follow-up. Active treatment of SVT reduced the incidences of SVT extension or recurrence.
INTERPRETATION AND CONCLUSIONS
Treatment with a therapeutic or prophylactic dose of LMWH or a NSAID reduces the incidence of SVT extension or recurrence, but not VTE. More RCT are needed before any evidence-based recommendations on the treatment of SVT for the prevention of VTE can be given. With the present lack of solid evidence we would suggest treating patients with at least intermediate doses of LMWH.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Anticoagulants; Double-Blind Method; Follow-Up Studies; Heparin, Low-Molecular-Weight; Humans; Incidence; Ligation; Pilot Projects; Pulmonary Embolism; Randomized Controlled Trials as Topic; Recurrence; Research Design; Stockings, Compression; Thrombophlebitis; Treatment Outcome; Ultrasonography; Vascular Surgical Procedures; Venous Thrombosis
PubMed: 15921382
DOI: No ID Found