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European Journal of Vascular and... Jan 2022This meta-analysis was conducted to investigate whether compression stockings were necessary after endovenous thermal ablation of varicose veins. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This meta-analysis was conducted to investigate whether compression stockings were necessary after endovenous thermal ablation of varicose veins.
DATA SOURCES
Electronic databases, including MEDLINE, EMBASE, and the Cochrane Library database, were searched from inception to 10 March 2021 to identify all the related trials.
METHODS
Random or fixed effects models were used to generate pooled mean difference (MD) or standardised mean difference (SMD) for continuous data, risk ratios (RRs) for dichotomous data, and related 95% confidence intervals (95% CIs). The quality of evidence was graded with a specific tool (GRADEpro GDT) from the GRADE working group.
RESULTS
A total of seven randomised controlled trials (RCTs) comprising 1 146 patients were included in this meta-analysis. Wearing compression stockings was correlated with lower post-operative pain scores from a 0 to 100 mm visual analogue scale (MD -8.00; 95% CI -12.01 - -3.99; p < .001). No difference was observed between wearing compression stockings or not in quality of life (SMD 0.45; 95% CI 0.14 - 1.04), major complications (RR 0.64; 95% CI 0.26 -1.59), target vein occlusion rates (RR 0.99; 95% CI 0.96 - 1.02), or time to return to work (MD -0.43; 95% CI 1.06 - 0.19).
CONCLUSION
After endovenous thermal ablation of varicose veins, wearing compression stockings was not associated with a better outcome except for mild pain relief. Post-operative compression stockings may be unnecessary after endovenous thermal ablation.
Topics: Catheter Ablation; Humans; Pain, Postoperative; Postoperative Complications; Quality of Life; Return to Work; Stockings, Compression; Time Factors; Unnecessary Procedures; Varicose Veins
PubMed: 34776296
DOI: 10.1016/j.ejvs.2021.09.034 -
Journal of Lasers in Medical Sciences 2021Currently, lasers are used to treat many diseases and their complications. However, the use of lasers in pregnant patients is still controversial. In this review, the... (Review)
Review
Currently, lasers are used to treat many diseases and their complications. However, the use of lasers in pregnant patients is still controversial. In this review, the application of lasers in the fields of urology, surgery, obstetrics, dermatology, and musculoskeletal disorders is evaluated. The following keywords were used to search through PubMed, Google Scholar, and Scopus: pregnancy, laser, urolithiasis, endovenous laser ablation (EVLA) or treatment, leg edema, varicose vein, venous insufficiencies, hair removal, pigmentation, telangiectasia, vascular lesions, Q switch laser, diode laser, holmium, holmium-YAG laser, erbium laser and Pulsed dye laser, low-level laser therapy, high-intensity laser therapy, pain, musculoskeletal disorders, twin to twin transfusion syndrome (TTTS), amnioreduction, and safety. Totally, 147 articles were found, and their abstracts were evaluated; out of 53 articles extracted, 14 articles were about dermatology, 24 articles were about urology, 12 articles were about obstetrics and gynecology, 10 articles were about musculoskeletal disorders and three articles were related to surgery. Laser therapy can be used as a safe treatment for urolithiasis, skin diseases, TTTS and varicose veins of the lower extremities. However, the use of laser therapy for musculoskeletal disorders during pregnancy is not recommended due to lack of evidence, and also we cannot recommend endovenous ablation.
PubMed: 34733773
DOI: 10.34172/jlms.2021.50 -
The Cochrane Database of Systematic... Sep 2021Chronic deep venous insufficiency is caused by incompetent vein valves, blockage of large-calibre leg veins, or both; and causes a range of symptoms including recurrent... (Review)
Review
BACKGROUND
Chronic deep venous insufficiency is caused by incompetent vein valves, blockage of large-calibre leg veins, or both; and causes a range of symptoms including recurrent ulcers, pain and swelling. Most surgeons accept that well-fitted graduated compression stockings (GCS) and local care of wounds serve as adequate treatment for most people, but sometimes symptoms are not controlled and ulcers recur frequently, or they do not heal despite compliance with conservative measures. In these situations, in the presence of severe venous dysfunction, surgery has been advocated by some vascular surgeons. This is an update of the review first published in 2000.
OBJECTIVES
To assess the effects of surgical management of deep venous insufficiency on ulcer healing and recurrence, complications of surgery, clinical outcomes, quality of life (QoL) and pain.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, and the WHO ICTRP and ClinicalTrials.gov trials registries to 23 June 2020.
SELECTION CRITERIA
We considered randomised controlled trials (RCTs) of surgical treatment versus another surgical procedure, usual care or no treatment, for people with deep venous insufficiency.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias with the Cochrane risk of bias tool. We evaluated the certainty of the evidence using GRADE. We were unable to pool data due to differences in outcomes reported and how these were measured. Outcomes of interest were ulcer healing and recurrence, complications of surgery, clinical changes, QoL and pain.
MAIN RESULTS
We included four RCTs (273 participants) comparing valvuloplasty plus surgery of the superficial venous system with surgery of the superficial venous system for primary valvular incompetence. Follow-up was two to 10 years. All included studies investigated primary valve incompetence. No studies investigated other surgical procedures for the treatment of people with deep venous insufficiency or surgery for secondary valvular incompetence or venous obstruction. The certainty of the evidence was downgraded for risk of bias concerns and imprecision due to small numbers of included trials, participants and events. None of the studies reported ulcer healing or ulcer recurrence. One study included 27 participants with active venous ulceration at the time of surgery; the other three studies did not include people with ulcers. There were no major complications of surgery, no incidence of deep vein thrombosis and no deaths reported (very low-certainty evidence). All four studies reported clinical changes but the data could not be pooled due to different outcome measures and reporting of the data. Two studies assessed clinical changes using subjective and objective measurements, as specified in the clinical, aetiological, anatomical and pathophysiological (CEAP) classification score (low-certainty evidence). One study reported mean CEAP severity scores and one study reported change in clinical class using CEAP. At baseline, the mean CEAP severity score was 18.1 (standard deviation (SD) 4.4) for limbs undergoing external valvuloplasty with surgery to the superficial venous system and 17.8 (SD 3.4) for limbs undergoing surgery to the superficial venous system only. At three years post-surgery, the mean CEAP severity score was 5.2 (SD 1.6) for limbs that had undergone external valvuloplasty with surgery to the superficial venous system and 9.2 (SD 2.6) for limbs that had undergone surgery to the superficial venous system only (low-certainty evidence). In another study, participants with progressive clinical dynamics over the five years preceding surgery had higher rates of improvement in clinical condition in the treatment group (valvuloplasty plus ligation) compared with the control group (ligation only) (80% versus 51%) after seven years of follow-up. Participants with stable preoperative clinical dynamics demonstrated similar rates of improvement in both groups (95% with valvuloplasty plus ligation versus 90% with ligation only) (low-certainty evidence). One study reported disease-specific QoL using cumulative scores from a 10-item visual analogue scale (VAS) and reported that in the limited anterior plication (LAP) plus superficial venous surgery group the score decreased from 49 to 11 at 10 years, compared to a decrease from 48 to 36 in participants treated with superficial venous surgery only (very low-certainty evidence). Two studies reported pain. Within the QoL VAS scale, one item was 'pain/discomfort' and scores decreased from 4 to 1 at 10 years for participants in the LAP plus superficial venous surgery group and increased from 2 to 3 at 10 years in participants treated with superficial venous surgery only. A second study reported that 'leg heaviness and pain' was resolved completely in 36/40 limbs treated with femoral vein external valvuloplasty plus high ligation and stripping of the great saphenous vein (GSV) and percutaneous continuous circumsuture and 22/40 limbs treated with high ligation and stripping of GSV and percutaneous continuous circumsuture alone, at three years' follow-up (very low-certainty evidence).
AUTHORS' CONCLUSIONS
We only identified evidence from four RCTs for valvuloplasty plus surgery of the superficial venous system for primary valvular incompetence. We found no studies investigating other surgical procedures for the treatment of people with deep venous insufficiency, or that included participants with secondary valvular incompetence or venous obstruction. None of the studies reported ulcer healing or recurrence, and few studies reported complications of surgery, clinical outcomes, QoL and pain (very low- to low-certainty evidence). Conclusions on the effectiveness of valvuloplasty for deep venous insufficiency cannot be made.
Topics: Edema; Humans; Saphenous Vein; Stockings, Compression; Varicose Ulcer; Venous Insufficiency
PubMed: 34591328
DOI: 10.1002/14651858.CD001097.pub4 -
The Cochrane Database of Systematic... Sep 2021Many surgical approaches are available to treat varicose veins secondary to chronic venous insufficiency. One of the least invasive techniques is the ambulatory... (Review)
Review
BACKGROUND
Many surgical approaches are available to treat varicose veins secondary to chronic venous insufficiency. One of the least invasive techniques is the ambulatory conservative hemodynamic correction of venous insufficiency method (in French 'cure conservatrice et hémodynamique de l'insuffisance veineuse en ambulatoire' (CHIVA)), an approach based on venous hemodynamics with deliberate preservation of the superficial venous system. This is the second update of the review first published in 2013.
OBJECTIVES
To compare the efficacy and safety of the CHIVA method with alternative therapeutic techniques to treat varicose veins.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, AMED, and the World Health Organisation International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries to 19 October 2020. We also searched PUBMED to 19 October 2020 and checked the references of relevant articles to identify additional studies.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) that compared CHIVA to other therapeutic techniques to treat varicose veins.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed and selected studies, extracted data, and performed quantitative analysis from the selected papers. A third author solved any disagreements. We assessed the risk of bias in included trials with the Cochrane risk of bias tool. We calculated the risk ratio (RR), mean difference (MD), number of people needed to treat for an additional beneficial outcome (NNTB), and the number of people needed to treat for an additional harmful outcome (NNTH), with 95% confidence intervals (CI). We evaluated the certainty of the evidence using GRADE. The main outcomes of interest were the recurrence of varicose veins and side effects.
MAIN RESULTS
For this update, we identified two new additional studies. In total, we included six RCTs with 1160 participants (62% women) and collected from them eight comparisons. Three RCTs compared CHIVA with vein stripping. One RCT compared CHIVA with compression dressings in people with venous ulcers. The new studies included three comparisons, one compared CHIVA with vein stripping and radiofrequency ablation (RFA), and one compared CHIVA with vein stripping and endovenous laser therapy. We judged the certainty of the evidence for our outcomes as low to very low due to inconsistency, imprecision caused by the low number of events and risk of bias. The overall risk of bias across studies was high because neither participants nor personnel were blinded to the interventions. Two studies attempted to blind outcome assessors, but the characteristics of the surgery limited concealment. Five studies reported the outcome clinical recurrence of varicose veins with a follow-up of 18 months to 10 years. CHIVA may make little or no difference to the recurrence of varicose veins in the lower limb compared to stripping (RR 0.74, 95% CI 0.46 to 1.20; 5 studies, 966 participants; low-certainty evidence). We are uncertain whether CHIVA reduced recurrence compared to compression dressing (RR 0.23, 95% CI 0.06 to 0.96; 1 study, 47 participants; very low-certainty evidence). CHIVA may make little or no difference to clinical recurrence compared to RFA (RR 2.02, 95% CI 0.74 to 5.53; 1 study, 146 participants; low-certainty evidence) and endovenous laser (RR 0.20, 95% CI 0.01 to 4.06; 1 study, 100 participants; low-certainty evidence). We found no clear difference between CHIVA and stripping for the side effects of limb infection (RR 0.83, 95% CI 0.33 to 2.10; 3 studies, 746 participants; low-certainty evidence), and superficial vein thrombosis (RR 1.05, 95% CI 0.51 to 2.17; 4 studies, 846 participants; low-certainty evidence). CHIVA may reduce slightly nerve injury (RR 0.14, 95% CI 0.02 to 0.98; NNTH 9, 95% CI 5 to 100; 4 studies, 846 participants; low-certainty evidence) and hematoma compared to stripping (RR 0.59, 95% CI 0.37 to 0.97; NNTH 11, 95% CI 5 to 100; 2 studies, 245 participants; low-certainty evidence). For bruising, one study found no differences between groups while another study found reduced rates of bruising in the CHIVA group compared to the stripping group. Compared to RFA, CHIVA may make little or no difference to rates of limb infection, superficial vein thrombosis, nerve injury or hematoma, but may cause more bruising (RR 1.15, 95% CI 1.04 to 1.28; NNTH 8, CI 95% 5 to 25; 1 study, 144 participants; low-certainty evidence). Compared to endovenous laser, CHIVA may make little or no difference to rates of limb infection, superficial vein thrombosis, nerve injury or hematoma. The study comparing CHIVA versus compression did not report side effects.
AUTHORS' CONCLUSIONS
There may be little or no difference in the recurrence of varicose veins when comparing CHIVA to stripping (low-certainty evidence), but CHIVA may slightly reduce nerve injury and hematoma in the lower limb (low-certainty evidence). Very limited evidence means we are uncertain of any differences in recurrence when comparing CHIVA with compression (very low-certainty evidence). CHIVA may make little or no difference to recurrence compared to RFA (low-certainty evidence), but may result in more bruising (low-certainty evidence). CHIVA may make little or no difference to recurrence and side effects compared to endovenous laser therapy (low-certainty evidence). However, we based these conclusions on a small number of trials with a high risk of bias as the effects of surgery could not be concealed, and the results were imprecise due to the low number of events. New RCTs are needed to confirm these results and to compare CHIVA with approaches other than open surgery.
Topics: Female; Humans; Laser Therapy; Male; Varicose Ulcer; Varicose Veins; Venous Insufficiency; Venous Thrombosis
PubMed: 34590305
DOI: 10.1002/14651858.CD009648.pub4 -
The Cochrane Database of Systematic... Aug 2021Great saphenous vein (GSV) incompetence, causing varicose veins and venous insufficiency, makes up the majority of lower-limb superficial venous diseases. Treatment... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Great saphenous vein (GSV) incompetence, causing varicose veins and venous insufficiency, makes up the majority of lower-limb superficial venous diseases. Treatment options for GSV incompetence include surgery (also known as high ligation and stripping), laser and radiofrequency ablation, and ultrasound-guided foam sclerotherapy. Newer treatments include cyanoacrylate glue, mechanochemical ablation, and endovenous steam ablation. These techniques avoid the need for a general anaesthetic, and may result in fewer complications and improved quality of life (QoL). These treatments should be compared to inform decisions on treatment for varicosities in the GSV. This is an update of a Cochrane Review first published in 2011.
OBJECTIVES
To assess the effects of endovenous laser ablation (EVLA), radiofrequency ablation (RFA), endovenous steam ablation (EVSA), ultrasound-guided foam sclerotherapy (UGFS), cyanoacrylate glue, mechanochemical ablation (MOCA) and high ligation and stripping (HL/S) for the treatment of varicosities of the great saphenous vein (GSV).
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases, and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 2 November 2020. We undertook reference checking to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) treating participants for varicosities of the GSV using EVLA, RFA, EVSA, UGFS, cyanoacrylate glue, MOCA or HL/S. Key outcomes of interest are technical success, recurrence, complications and QoL.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, applied Cochrane's risk of bias tool, and extracted data. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) and assessed the certainty of evidence using GRADE.
MAIN RESULTS
We identified 11 new RCTs for this update. Therefore, we included 24 RCTs with 5135 participants. Duration of follow-up ranged from five weeks to eight years. Five comparisons included single trials. For comparisons with more than one trial, we could only pool data for 'technical success' and 'recurrence' due to heterogeneity in outcome definitions and time points reported. All trials had some risk of bias concerns. Here we report the clinically most relevant comparisons. EVLA versus RFA Technical success was comparable up to five years (OR 0.98, 95% CI 0.41 to 2.38; 5 studies, 780 participants; moderate-certainty evidence); over five years, there was no evidence of a difference (OR 0.85, 95% CI 0.30 to 2.41; 1 study, 291 participants; low-certainty evidence). One study reported recurrence, showing no clear difference at three years (OR 1.53, 95% CI 0.78 to 2.99; 291 participants; low-certainty evidence), but a benefit for RFA may be seen at five years (OR 2.77, 95% CI 1.52 to 5.06; 291 participants; low-certainty evidence). EVLA versus UGFS Technical success may be better in EVLA participants up to five years (OR 6.13, 95% CI 0.98 to 38.27; 3 studies, 588 participants; low-certainty evidence), and over five years (OR 6.47, 95% CI 2.60 to 16.10; 3 studies, 534 participants; low-certainty evidence). There was no clear difference in recurrence up to three years and at five years (OR 0.68, 95% CI 0.20 to 2.36; 2 studies, 443 participants; and OR 1.08, 95% CI 0.40 to 2.87; 2 studies, 418 participants; very low-certainty evidence, respectively). EVLA versus HL/S Technical success may be better in EVLA participants up to five years (OR 2.31, 95% CI 1.27 to 4.23; 6 studies, 1051 participants; low-certainty evidence). No clear difference in technical success was seen at five years and beyond (OR 0.93, 95% CI 0.57 to 1.50; 5 studies, 874 participants; low-certainty evidence). Recurrence was comparable within three years and at 5 years (OR 0.78, 95% CI 0.47 to 1.29; 7 studies, 1459 participants; and OR 1.09, 95% CI 0.68 to 1.76; 7 studies, 1267 participants; moderate-certainty evidence, respectively). RFA versus MOCA There was no clear difference in technical success (OR 1.76, 95% CI 0.06 to 54.15; 3 studies, 435 participants; low-certainty evidence), or recurrence (OR 1.00, 95% CI 0.21 to 4.81; 3 studies, 389 participants; low-certainty evidence). Long-term data are not available. RFA versus HL/S No clear difference in technical success was detected up to five years (OR 5.71, 95% CI 0.64 to 50.81; 2 studies, 318 participants; low-certainty evidence); over five years, there was no evidence of a difference (OR 0.88, 95% CI 0.29 to 2.69; 1 study, 289 participants; low-certainty evidence). No clear difference in recurrence was detected up to three years (OR 0.93, 95% CI 0.58 to 1.51; 4 studies, 546 participants; moderate-certainty evidence); but a possible long-term benefit for RFA was seen (OR 0.41, 95% CI 0.22 to 0.75; 1 study, 289 participants; low-certainty evidence). UGFS versus HL/S Meta-analysis showed a possible benefit for HL/S compared with UGFS in technical success up to five years (OR 0.32, 95% CI 0.11 to 0.94; 4 studies, 954 participants; low-certainty evidence), and over five years (OR 0.09, 95% CI 0.03 to 0.30; 3 studies, 525 participants; moderate-certainty evidence). No clear difference was detected in recurrence up to three years (OR 1.81, 95% CI 0.87 to 3.77; 3 studies, 822 participants; low-certainty evidence), and after five years (OR 1.24, 95% CI 0.57 to 2.71; 3 studies, 639 participants; low-certainty evidence). Complications were generally low for all interventions, but due to different definitions and time points, we were unable to draw conclusions (very-low certainty evidence). Similarly, most studies evaluated QoL but used different questionnaires at variable time points. Rates of QoL improvement were comparable between interventions at follow-up (moderate-certainty evidence).
AUTHORS' CONCLUSIONS
Our conclusions are limited due to the relatively small number of studies for each comparison and differences in outcome definitions and time points reported. Technical success was comparable between most modalities. EVLA may offer improved technical success compared to UGFS or HL/S. HL/S may have improved technical success compared to UGFS. No evidence of a difference was detected in recurrence, except for a possible long-term benefit for RFA compared to EVLA or HL/S. Studies which provide more evidence on the breadth of treatments are needed. Future trials should seek to standardise clinical terminology of outcome measures and the time points at which they are measured.
Topics: Catheter Ablation; Female; Humans; Male; Randomized Controlled Trials as Topic; Saphenous Vein; Sclerotherapy; Varicose Veins; Venous Insufficiency
PubMed: 34378180
DOI: 10.1002/14651858.CD005624.pub4 -
BJS Open Jul 2021Advances in natural language processing and other machine learning techniques have led to the development of automated agents (chatbots) that mimic human conversation....
BACKGROUND
Advances in natural language processing and other machine learning techniques have led to the development of automated agents (chatbots) that mimic human conversation. These systems have mainly been used in commercial settings, and within medicine, for symptom checking and psychotherapy. The aim of this systematic review was to determine the acceptability and implementation success of chatbots in the follow-up of patients who have undergone a physical healthcare intervention.
METHODS
A systematic review of MEDLINE, MEDLINE In-process, EMBASE, PsychINFO, CINAHL, CENTRAL and the grey literature using a PRISMA-compliant methodology up to September 2020 was conducted. Abstract screening and data extraction were performed in duplicate. Risk of bias and quality assessments were performed for each study.
RESULTS
The search identified 904 studies of which 10 met full inclusion criteria: three randomised control trials, one non-randomised clinical trial and six cohort studies. Chatbots were used for monitoring after the management of cancer, hypertension and asthma, orthopaedic intervention, ureteroscopy and intervention for varicose veins. All chatbots were deployed on mobile devices. A number of metrics were identified and ranged from a 31 per cent chatbot engagement rate to a 97 per cent response rate for system-generated questions. No study examined patient safety.
CONCLUSION
A range of chatbot builds and uses was identified. Further investigation of acceptability, efficacy and mechanistic evaluation in outpatient care pathways may lend support to implementation in routine clinical care.
Topics: Humans; Communication; Aftercare; Machine Learning; Natural Language Processing; Clinical Trials as Topic
PubMed: 34323916
DOI: 10.1093/bjsopen/zrab070 -
The Cochrane Database of Systematic... Jul 2021Leg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Most leg ulcers are the result of venous diseases. First-line treatment... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Leg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Most leg ulcers are the result of venous diseases. First-line treatment options often include the use of compression bandages or stockings.
OBJECTIVES
To assess the effects of using compression bandages or stockings, compared with no compression, on the healing of venous leg ulcers in any setting and population.
SEARCH METHODS
In June 2020 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions by language, date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials that compared any types of compression bandages or stockings with no compression in participants with venous leg ulcers in any setting.
DATA COLLECTION AND ANALYSIS
At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, and risk-of-bias assessment using the Cochrane risk-of-bias tool. We assessed the certainty of the evidence according to GRADE methodology.
MAIN RESULTS
We included 14 studies (1391 participants) in the review. Most studies were small (median study sample size: 51 participants). Participants were recruited from acute-care settings, outpatient settings and community settings, and a large proportion (65.9%; 917/1391) of participants had a confirmed history or clinical evidence of chronic venous disease, a confirmed cause of chronic venous insufficiency, or an ankle pressure/brachial pressure ratio of greater than 0.8 or 0.9. The average age of participants ranged from 58.0 to 76.5 years (median: 70.1 years). The average duration of their leg ulcers ranged from 9.0 weeks to 31.6 months (median: 22.0 months), and a large proportion of participants (64.8%; 901/1391) had ulcers with an area between 5 and 20 cm. Studies had a median follow-up of 12 weeks. Compression bandages or stockings applied included short-stretch bandage, four-layer compression bandage, and Unna's boot (a type of inelastic gauze bandage impregnated with zinc oxide), and comparator groups used included 'usual care', pharmacological treatment, a variety of dressings, and a variety of treatments where some participants received compression (but it was not the norm). Of the 14 included studies, 10 (71.4%) presented findings which we consider to be at high overall risk of bias. Primary outcomes There is moderate-certainty evidence (downgraded once for risk of bias) (1) that there is probably a shorter time to complete healing of venous leg ulcers in people wearing compression bandages or stockings compared with those not wearing compression (pooled hazard ratio for time-to-complete healing 2.17, 95% confidence interval (CI) 1.52 to 3.10; I = 59%; 5 studies, 733 participants); and (2) that people treated using compression bandages or stockings are more likely to experience complete ulcer healing within 12 months compared with people with no compression (10 studies, 1215 participants): risk ratio for complete healing 1.77, 95% CI 1.41 to 2.21; I = 65% (8 studies with analysable data, 1120 participants); synthesis without meta-analysis suggests more completely-healed ulcers in compression bandages or stockings than in no compression (2 studies without analysable data, 95 participants). It is uncertain whether there is any difference in rates of adverse events between using compression bandages or stockings and no compression (very low-certainty evidence; 3 studies, 585 participants). Secondary outcomes Moderate-certainty evidence suggests that people using compression bandages or stockings probably have a lower mean pain score than those not using compression (four studies with 859 participants and another study with 69 ulcers): pooled mean difference -1.39, 95% CI -1.79 to -0.98; I = 65% (two studies with 426 participants and another study with 69 ulcers having analysable data); synthesis without meta-analysis suggests a reduction in leg ulcer pain in compression bandages or stockings, compared with no compression (two studies without analysable data, 433 participants). Compression bandages or stockings versus no compression may improve disease-specific quality of life, but not all aspects of general health status during the follow-up of 12 weeks to 12 months (four studies with 859 participants; low-certainty evidence). It is uncertain if the use of compression bandages or stockings is more cost-effective than not using them (three studies with 486 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS
If using compression bandages or stockings, people with venous leg ulcers probably experience complete wound healing more quickly, and more people have wounds completely healed. The use of compression bandages or stockings probably reduces pain and may improve disease-specific quality of life. There is uncertainty about adverse effects, and cost effectiveness. Future research should focus on comparing alternative bandages and stockings with the primary endpoint of time to complete wound healing alongside adverse events including pain score, and health-related quality of life, and should incorporate cost-effectiveness analysis where possible. Future studies should adhere to international standards of trial conduct and reporting.
Topics: Aged; Bandages, Hydrocolloid; Bias; Compression Bandages; Dermatologic Agents; Humans; Middle Aged; Pain Management; Quality of Life; Randomized Controlled Trials as Topic; Stockings, Compression; Time Factors; Varicose Ulcer; Wound Healing; Zinc Oxide
PubMed: 34308565
DOI: 10.1002/14651858.CD013397.pub2 -
The Cochrane Database of Systematic... Jul 2021Compression hosiery or stockings are often the first line of treatment for varicose veins in people without either healed or active venous ulceration. Evidence is...
BACKGROUND
Compression hosiery or stockings are often the first line of treatment for varicose veins in people without either healed or active venous ulceration. Evidence is required to determine whether the use of compression stockings can effectively manage and treat varicose veins in the early stages. This is the second update of a review first published in 2011.
OBJECTIVES
To assess the effectiveness of compression stockings for the only and initial treatment of varicose veins in people without healed or active venous ulceration.
SEARCH METHODS
For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 May 2020. We also checked references of studies identified from the literature searches.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) involving people diagnosed with primary trunk varicose veins without healed or active venous ulceration (Clinical, Etiology, Anatomy, Pathophysiology (CEAP) classification C2 to C4). Included trials assessed compression stockings versus no treatment or placebo stockings, or compression stockings plus drug intervention versus drug intervention alone. We also included trials comparing different lengths and pressures of stockings. We excluded trials involving other types of treatment for varicose veins (either as a comparator to stockings or as an initial non-randomised treatment), including sclerotherapy and surgery.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methodology. Two review authors independently assessed trials for inclusion, extracted data, assessed risk of bias and assessed the certainty of the evidence using GRADE. Outcomes of interest were change in symptoms; physiological measures; complications; compliance; comfort, tolerance and acceptability of wearing stockings; and quality of life.
MAIN RESULTS
We included 13 studies with 1021 participants with varicose veins without healed or active venous ulceration. One study included pregnant women while other studies included participants who had sought medical intervention for their varicose veins by being on surgical waiting lists, or attending vascular surgery or dermatology clinics or outpatient departments. The stockings used in the studies exerted different levels of pressure, ranging from 10 mmHg to 50 mmHg. Five studies assessed compression stockings versus no compression stockings or placebo stockings. Three of these studies used knee-length stockings, one used full-length stockings and one used full tights. Eight studies compared different types or pressures of knee-length stockings. The risk of bias of many included trials was unclear, mainly because of inadequate reporting. We were unable to pool studies as they did not report the same outcomes or used different ways to assess them. Many studies were small and there were differences in the populations studied. The certainty of the evidence was therefore low to very low. Compression stockings compared with no treatment or placebo stockings All four studies that reported change in symptoms found a subjective improvement by the end of the study. However, change in symptoms was not always analysed by comparing the randomised arms of the studies and was therefore subject to bias. Two studies assessed physiological measures using either ankle circumference or duplex sonography to measure oedema. Ankle circumference showed no clear difference between baseline and follow-up while oedema was reduced in the stocking group compared with the placebo stocking group. Three studies reported complications or side effects with itching and irritation the main side effects reported. None of the trials reported severe side effects. Reports of compliance varied between studies. One study reported a high dropout rate with low levels of compliance due to discomfort, application and appearance; two studies reported generally good levels of compliance in the stocking group compared to placebo/no treatment. Two studies reported comfort, tolerance and acceptability with outcomes affected by the study population. Compression tights were increasingly rejected by pregnant women as their pregnancy progressed, while in one study of non-pregnant women, the stockings group showed no more hindrance of normal activities and daytime discomfort when compared with placebo stockings. One study reported quality of life showing no clear differences between the stocking and placebo stocking groups. Compression stockings compared with different compression stockings All five studies that reported change in symptoms found a subjective improvement in symptoms by the end of the study. Change in symptoms was not always analysed comparing the randomised arms of the trials and was therefore subject to bias. Five studies reported a variety of physiological measures such as foot volumetry, volume reduction and change in diameter. Generally, there were no clear differences between study arms. Four studies reported complications or side effects, including sweating, itching, skin dryness, and constriction and tightness. None of the trials reported severe side effects. Two studies reported compliance showing no difference in compliance rates between stockings groups, although one study reported high initial levels of dropout due to discomfort, appearance, non-effectiveness and irritation. Four studies reported comfort, tolerance and acceptability. Two studies reported similar levels of tolerance and discomfort between groups. Discomfort was the main reason for indicating a preference for one type of stocking over another. None of the studies assessed quality of life. No conclusions regarding the optimum length or pressure of compression stockings could be made as there were no conclusive results from the included studies.
AUTHORS' CONCLUSIONS
There is insufficient high-certainty evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in people without healed or active venous ulceration, or whether any type of stocking is superior to any other type. Future research should consist of large RCTs of participants with trunk varices either wearing or not wearing compression stockings to assess the efficacy of this intervention. If compression stockings are found to be beneficial, further studies assessing which length and pressure is the most efficacious could then take place.
Topics: Adult; Bias; Edema; Female; Humans; Male; Pregnancy; Quality of Life; Randomized Controlled Trials as Topic; Stockings, Compression; Treatment Outcome; Varicose Ulcer; Varicose Veins
PubMed: 34271595
DOI: 10.1002/14651858.CD008819.pub4 -
Ontario Health Technology Assessment... 2021Varicose veins are part of the spectrum of chronic venous disease and are a sign of underlying chronic venous insufficiency. Treatments to address varicose veins include... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Varicose veins are part of the spectrum of chronic venous disease and are a sign of underlying chronic venous insufficiency. Treatments to address varicose veins include surgical vein removal under general anesthesia, or endovenous laser (EVLA) or radiofrequency ablation (RFA) under tumescent anesthesia. Two newer nonthermal endovenous procedures can close veins without any tumescent anesthesia, using either mechanochemical ablation (MOCA, a combination of mechanical and chemical techniques) or cyanoacrylate adhesive closure (CAC). We conducted a health technology assessment of these nonthermal endovenous procedures for people with symptomatic varicose veins, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding MOCA and CAC, and patient preferences and values.
METHODS
We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk of Bias or RoBANS tool, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. Meta-analysis was conducted using Review Manager 5.2, where appropriate.We performed a systematic economic literature search and conducted a cost-utility analysis with a 5-year time horizon from the perspective of Ontario Ministry of Health. In our primary economic evaluation, we assessed the cost-effectiveness of nonthermal endovenous procedures (CAC and MOCA) compared with surgical vein stripping and thermal endovenous therapies (EVLA and RFA). We also analyzed the budget impact of publicly funding nonthermal and thermal endovenous therapies for adults with symptomatic varicose veins in Ontario over the next 5 years. Costs are expressed in 2020 Canadian dollars.To contextualize the potential value of nonthermal endovenous treatments, we spoke with 13 people with varicose veins who had sought various treatment options. We conducted phone interviews and qualitatively analyzed their responses regarding their care journey and the impact of different treatment options; the only nonthermal treatment that participants had experience with was CAC.
RESULTS
We included 19 primary studies reported in 25 publications comparing either MOCA or CAC with at least one other invasive treatment for symptomatic varicose veins. No studies compared MOCA with CAC. Based on evidence of low to moderate quality, MOCA resulted in slightly poorer technical outcomes (vein closure and recanalization) than thermal endovenous ablation procedures. However, clinical outcomes, quality of life improvement, and patient satisfaction were similar compared with RFA (GRADE: Very low to Moderate) and EVLA (GRADE: High). Cyanoacrylate adhesive closure resulted in little to no difference in technical outcomes, clinical outcomes, and quality of life improvement compared with RFA and EVLA (GRADE: Moderate). Patient satisfaction may also be similar (GRADE: Low). Recovery time was slightly reduced with nonthermal endovenous procedures compared with thermal ablation (GRADE: Moderate). The effect of CAC compared with surgical vein stripping is very uncertain (GRADE: Very low). Major complications of any procedure were rare, with minor complications occurring as expected and resolving.We included two European studies in the economic evidence review that were partially applicable to the Ontario context. Both studies found that thermal ablation procedures (RFA, EVLA, or steam vein sclerosis) were the most cost-effective treatments, compared with surgical vein stripping and nonthermal therapies. Our cost-utility analysis showed that surgical vein stripping is the least effective and most costly treatment among five treatments for varicose veins. Differences in quality-adjusted life-years (QALYs) between endovenous treatments (CAC, MOCA, RFA, and EVLA) were small. When the willingness-to-pay (WTP) value was $50,000 per QALY gained, the probabilities of being cost-effective were 55.6%, 18.8%, 15.6%, 10.0%, and 0%, for EVLA, CAC, MOCA, RFA, and surgical vein stripping, respectively. When the WTP was $100,000 per QALY gained, the probabilities of being cost-effective were 40.2%, 30.0%, 17.7%, 12.1%, and 0%, for EVLA, CAC, RFA, MOCA, and surgical vein stripping, respectively. Publicly funding endovenous procedures (both nonthermal and thermal) would increase the total volume of treatments, resulting in a total 5-year budget impact of around $17 million.People with varicose veins with whom we spoke reported positively on their experiences with the CAC procedure and its outcomes. They also described geographic and financial barriers to accessing the range of available treatment options.
CONCLUSIONS
Cyanoacrylate adhesive closure and MOCA produced similar patient-important outcomes, and slightly shorter recovery compared with thermal ablation. Cyanoacrylate adhesive closure yielded similar anatomical outcomes as thermal endovenous ablation, but the technical outcomes of MOCA were slightly poorer.Compared with surgical vein stripping, all endovenous treatments were more effective and less expensive. If we were to look at the most cost-effective strategy (at WTP less than $100,000 per QALY), EVLA is most likely to be cost-effective. Assuming an 80% increase in the number of eligible people over the next 5 years, we estimate that publicly funding nonthermal and thermal endovenous treatments for varicose veins in Ontario would range from $2.59 million in year 1 to $4.35 million in year 5, and that the total 5-year budget impact would be around $17 million.For people with varicose veins, the CAC procedure was seen as a positive treatment method that reduced their symptoms and improved their quality of life.
Topics: Adult; Humans; Laser Therapy; Ontario; Quality of Life; Technology Assessment, Biomedical; Treatment Outcome; Varicose Veins; Venous Insufficiency
PubMed: 34211617
DOI: No ID Found -
Jornal Vascular Brasileiro Jun 2021The main signs and symptoms of chronic venous insufficiency are pain, edema, varicose veins, and tissue changes; conditions that compromise functionality and quality of... (Review)
Review
The main signs and symptoms of chronic venous insufficiency are pain, edema, varicose veins, and tissue changes; conditions that compromise functionality and quality of life. Management of the disease aims to mitigate these losses and involves a wide range of interventions, one of which is therapeutic exercise. This article presents the existing evidence on the effectiveness of therapeutic exercises for quality of life, pain, and functionality in chronic venous insufficiency. Searches were run on the databases CENTRAL, CINAHL, LILACS, MEDLINE, PEDro, SciELO, Science Direct, Scopus, and Web of Science. Four of the 2,961 results met the eligibility criteria. Only one of these studies showed benefits of exercise for improving quality of life and reducing pain. The others had low methodological quality. The existing evidence is therefore insufficient to indicate or contraindicate therapeutic exercises for improvement of quality of life, pain, and functionality in patients with chronic venous insufficiency.
PubMed: 34211542
DOI: 10.1590/1677-5449.200248