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Medicine May 2024Benign thyroid nodules (BTNs) represent a prevalent clinical challenge globally, with various ultrasound-guided ablation techniques developed for their management.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Benign thyroid nodules (BTNs) represent a prevalent clinical challenge globally, with various ultrasound-guided ablation techniques developed for their management. Despite the availability of these methods, a comprehensive evaluation to identify the most effective technique remains absent. This study endeavors to bridge this knowledge gap through a network meta-analysis (NMA), aiming to enhance the understanding of the comparative effectiveness of different ultrasound-guided ablation methods in treating BTNs.
METHODS
We comprehensively searched PubMed, Embase, Cochrane, Web of Science, Ovid, SCOPUS, and ProQuest for studies involving 16 ablation methods, control groups, and head-to-head trials. NMA was utilized to evaluate methods based on the percentage change in nodule volume, symptom score, and cosmetic score. This study is registered in INPLASY (registration number 202260061).
RESULTS
Among 35 eligible studies involving 5655 patients, NMA indicated that RFA2 (radiofrequency ablation, 2 sessions) exhibited the best outcomes at 6 months for percentage change in BTN volume (SUCRA value 74.6), closely followed by RFA (SUCRA value 73.7). At 12 months, RFA was identified as the most effective (SUCRA value 81.3). Subgroup analysis showed RFA2 as the most effective for solid nodule volume reduction at 6 months (SUCRA value 75.6), and polidocanol ablation for cystic nodules (SUCRA value 66.5).
CONCLUSION
Various ablation methods are effective in treating BTNs, with RFA showing notable advantages. RFA with 2 sessions is particularly optimal for solid BTNs, while polidocanol ablation stands out for cystic nodules.
Topics: Humans; Thyroid Nodule; Network Meta-Analysis; Ultrasonography, Interventional; Radiofrequency Ablation; Treatment Outcome; Ablation Techniques
PubMed: 38701262
DOI: 10.1097/MD.0000000000038014 -
Journal of Vascular Surgery. Venous and... Apr 2024We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs endovenous thermal ablation with radiofrequency or laser energy for treatment... (Review)
Review
Comparative effectiveness of non-compounded polidocanol 1% endovenous microfoam (Varithena) ablation versus endovenous thermal ablation utilizing a systematic review and network meta-analysis.
OBJECTIVE
We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs endovenous thermal ablation with radiofrequency or laser energy for treatment of venous insufficiency caused by lower extremity truncal vein incompetence via network meta-analysis of published comparative evidence.
METHODS
We conducted a systematic literature review following best practices, including a prospective protocol. We screened studies published in English from 2000 to 2023 for randomized and nonrandomized studies reporting direct or indirect comparisons between polidocanol 1% endovenous microfoam and endovenous thermal ablation. Thirteen studies met our eligibility criteria for the network meta-analysis. The co-primary effectiveness outcomes were the closure rate ≥3 months after procedure and the average change in the Venous Clinical Severity Score. For the subgroup of venous ulcer patients, the ulcer healing rate was the primary effectiveness outcome. The secondary outcomes included safety and patient-reported outcomes. Network meta-analyses were conducted on outcomes having sufficient data. Categorical outcomes were summarized using odds ratios (ORs) with 95% confidence intervals (CIs). Sensitivity tests and estimates of network inconsistency were used to investigate the robustness of our meta-analysis.
RESULTS
We found that polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure (OR, 0.65; 95% CI, 0.36-1.18; P = .16). Although not the primary aim of the study, the network meta-analysis also provided evidence to confirm our supposition that polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds for vein closure (OR, 2.91; 95% CI, 1.58-5.37; P < .01). A sensitivity analysis using the longest available time point for closure in each study, with a minimum of 12 months of follow-up (median, 48 months; range, 12-72 months), showed results similar to those of the main analysis. No association was found between the risk of deep vein thrombosis and the treatment received. The available data were insufficient for a network meta-analysis of Venous Clinical Severity Score improvement and ulcer healing rates.
CONCLUSIONS
Polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure and deep vein thrombosis risk for chronic venous insufficiency treatment, based on a network meta-analysis of published evidence. Polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds of vein closure. A sensitivity analysis found venous closure findings were robust at follow-up intervals of 12 months or greater and for up to 6 years. New evidence meeting the inclusion criteria for this review will be incorporated at regular intervals into a living network meta-analysis.
PubMed: 38679141
DOI: 10.1016/j.jvsv.2024.101896 -
Techniques in Coloproctology Jan 2024This systematic review and meta-analysis aimed to evaluate the safety and efficacy of sclerotherapy methods for hemorrhoidal disease (HD) over the past 40 years. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This systematic review and meta-analysis aimed to evaluate the safety and efficacy of sclerotherapy methods for hemorrhoidal disease (HD) over the past 40 years.
METHODS
The review followed the 2020 Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A comprehensive literature search was conducted, including studies reporting the use of sclerotherapy in patients with HD. Study eligibility criteria were defined, and data were extracted independently by the authors. Random-effects meta-analyses were performed to assess outcomes of interest.
RESULTS
Out of 1965 records identified, 44 studies met the inclusion criteria, involving 9729 patients. The majority of studies were conducted in Japan, followed by the UK, Italy, and Portugal. The median age of participants was 52 years, and the majority were male. The Goligher grade distribution indicated varying degrees of HD severity. Sclerotherapy was predominantly administered through anoscopy, with polidocanol being the most commonly used agent. The procedure was generally performed without pre-injection analgesia. The meta-analysis of 14 randomized controlled trials (RCTs) revealed that sclerotherapy was not inferior to control interventions in terms of success rate (risk ratio [RR] 1.00, 95% CI 0.71-1.41) and recurrence rate (RR 1.11, 95% CI 0.69-1.77), while resulting in fewer complications (RR 0.46, 95% CI 0.23-0.92).
CONCLUSIONS
This systematic review highlights the safety and efficacy of sclerotherapy for HD, which yields similar success rates and fewer complications compared to other conservative or surgical approaches. Further research is warranted to optimize sclerotherapy techniques and evaluate long-term outcomes.
REGISTRATION
PROSPERO 2023 CRD42023396910.
Topics: Male; Humans; Female; Middle Aged; Sclerotherapy; Hemorrhoids; Italy; Odds Ratio; Polidocanol
PubMed: 38261136
DOI: 10.1007/s10151-023-02908-w -
Journal of Clinical Medicine Nov 2023Percutaneous treatment for primary aneurysmal bone cysts (ABCs) has been widely accepted. The study aimed to evaluate the efficacy of various sclerotherapy agents on... (Review)
Review
BACKGROUND
Percutaneous treatment for primary aneurysmal bone cysts (ABCs) has been widely accepted. The study aimed to evaluate the efficacy of various sclerotherapy agents on patients with primary ABCs.
METHODS
A meta-analysis of relevant studies. A systematic search was conducted on five databases, resulting in the inclusion of 25 studies with different percutaneous agents.
RESULTS
A total of 729 patients with primary ABCs were included. Patients were administered with Ethibloc, doxycycline, embolization, alcohol, polidocanol, and calcitonin with methylprednisolone, respectively. Overall, 542 (74.3%) patients with ABCs had complete healing, 120 (16.4%) had partial healing, 44 (6%) had no-ossification or failure, and 26 (3.5%) had a recurrence. However, there was a total of 45 (6.1%) patients who had surgical curettage after sclerotherapy. Among the sclerotherapy agents, doxycycline showed highly effective results with minimal complications and recurrence, but it required multiple injections per patient. Ethibloc and embolization also proved to be highly effective with fewer injections required but had a higher rate of complications. Absolute alcohol, polidocanol, and calcitonin with methylprednisolone had similar efficacity and favorable success with fewer complications and fewer injections.
CONCLUSION
Percutaneous treatment showed promising results in treating primary ABCs. However, more robust research is needed to establish the best approach for sclerotherapy in clinical practice and to address the limitations of the current literature.
PubMed: 38068264
DOI: 10.3390/jcm12237213 -
BMC Pregnancy and Childbirth Mar 2023The aim of this systematic review and meta-analysis was to introduce the relatively novel method of ultrasound-guided local lauromacrogol injection (USG-LLI) followed by... (Meta-Analysis)
Meta-Analysis
Comparison of clinical safety and efficacy of ultrasound-guided local lauromacrogol injection versus uterine artery embolization in the treatment of caesarean scar pregnancy: a systematic review and meta-analysis.
BACKGROUND
The aim of this systematic review and meta-analysis was to introduce the relatively novel method of ultrasound-guided local lauromacrogol injection (USG-LLI) followed by dilatation and curettage for caesarean scar pregnancy (CSP) and to investigate the clinical safety and efficacy between uterine artery embolization (UAE) and USG-LLI in the treatment of CSP.
METHODS
The relevant literature and articles about USG-LLI, UAE and CSP published in eight electronic databases were searched to extract the primary outcomes for the selected articles. Review Manager Software(RevMan) V.5.2 was used for quantitative data synthesis and data analysis. Forest plots, sensitivity analysis and bias analysis were also performed on the included articles.
RESULTS
Of 10 studies included in our search, 623 patients were in the USG-LLI group and 627 patients were in the UAE groups. There were no significant differences between the two groups in terms of success rate, blood loss and time to human chorionic gonadotropin (hCG) normalization. However, USG-LLI group patients than UAE group patients had a shorter duration of hospital stay (mean difference [MD] = -1.97; 95% confidence intervals [CI] -2.63 to -1.31; P < 0.05; I = 95%), shorter restored menses (MD = -4.84; 95%CI -5.78 to -3.90; P < 0.05; I = 95%), and lower complication rates [odds ratio(OR) = 0.21; 95%CI:0.15 to 0.30; P < 0.05]; and cheaper on expenses of hospitalization (MD = -8028.29; 95%CI -10,311.18 to -5745.40; P < 0.05; I = 100%).
CONCLUSIONS
The results demonstrate that USG-LLI is comparable in curative effect and success rates with UAE in the therapy of CSP, but patients in the USG-LLI group seem to have fewer complications rates, shorter duration of hospital stays and lower costs.
Topics: Female; Pregnancy; Humans; Polidocanol; Cicatrix; Uterine Artery Embolization; Ultrasonography, Interventional; Cesarean Section
PubMed: 36882695
DOI: 10.1186/s12884-023-05455-2 -
Journal of the European Academy of... Feb 2023Skin hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants is a common local side effect. Sclerotherapists should be familiar with factors that... (Review)
Review
Skin hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants is a common local side effect. Sclerotherapists should be familiar with factors that trigger hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants. A systematic literature review of works reporting hyperpigmentation after sclerotherapy for telangiectasias, reticular veins, side branches and truncal varices with polidocanol-containing sclerosants was performed. Reported incidence rates, follow-up periods and potentially triggering factors were assessed and analysed. The search yielded 1687 results; of these, 27 reports met the inclusion criteria. The incidence of hyperpigmentation seemed to increase with higher concentrations of polidocanol and was more evident after sclerotherapy for epifascial veins than for intrafascial truncal veins when the polidocanol concentration was more than 0.25%. Regarding sclerotherapy for telangiectasias and reticular veins, the incidence of hyperpigmentation ranged between 2% and 25% for polidocanol 0.25% (liquid and foam), between 12.5% and 67.9% for polidocanol 0.5% (liquid and foam) and between 13% and 73% for polidocanol 1% (liquid and foam). Regarding truncal veins, the incidence ranged from 7% to 45.8% for polidocanol 1% (liquid and foam), from 16% to 17% for polidocanol 2% (foam) and from 7.4% to 32.5% for polidocanol 3% (liquid and foam). Regarding the treatment of side branches, the incidence of hyperpigmentation ranged from 5.6% to 53% for both foam and liquid sclerotherapy. Regarding the duration of hyperpigmentation, there are few data describing reticular veins and telangiectasias. Hyperpigmentation persisting for more than 6 months has been reported to have an incidence of up to 7.5%. Hyperpigmentation persisting for more than 1 year after foam polidocanol 1%-3% treatment for truncal veins has an incidence ranging from 8.1% to 17.5%. Other factors such as higher volumes and compression therapy after treatment seem to have a minor influence. Data regarding hyperpigmentation after polidocanol-related sclerotherapy are poor and should be improved by higher-quality research.
Topics: Humans; Polidocanol; Sclerotherapy; Sclerosing Solutions; Varicose Veins; Polyethylene Glycols; Telangiectasis; Hyperpigmentation; Treatment Outcome
PubMed: 36196455
DOI: 10.1111/jdv.18639 -
Frontiers in Pediatrics 2022The aim of this study was to investigate the efficacy of polidocanol against venous malformations (VMs).
OBJECTIVE
The aim of this study was to investigate the efficacy of polidocanol against venous malformations (VMs).
METHODS
Studies reporting the treatment of VMs using polidocanol (published until February 15, 2020) were reviewed in the Embase and PubMed databases. After excluding the same literature, part of the studies were excluded by reading the title, abstract, full text. Eleven studies (with 287 participants) that fulfilled the inclusion criteria were included. Systematic meta-analysis was performed using Reviews Manager 5.2, and a fixed-effects model was used to calculate the pooled effective rate of polidocanol against VMs and the 95% confidence intervals (CI).
RESULTS
Lesion reduction of more than 50% was considered effective. A total of 287 patients were treated, and treatment in 271 was considered effective. The efficacy of polidocanol was 0.89 (95% CI = 0.83-0.93). Heterogeneity among the studies was small ( = 0%, = 0.47). T The funnel plot was roughly symmetric.
CONCLUSION
Our study suggested that polidocanol is effective in the treatment of VMs. VMs at different sites can be treated without serious complications. Therefore, we have reason to believe that polidocanol is a safe and an effective drug for VMs.
PubMed: 35967557
DOI: 10.3389/fped.2022.925318 -
Orthopaedics & Traumatology, Surgery &... Jun 2022The optimal treatment of aneurysmal bone cysts (ABC) remains controversial. Surgery has long been considered as the treatment that yields the best outcomes. Some authors... (Review)
Review
INTRODUCTION
The optimal treatment of aneurysmal bone cysts (ABC) remains controversial. Surgery has long been considered as the treatment that yields the best outcomes. Some authors now prefer using less invasive options as the primary treatment. The primary objective of this systematic literature review was to determine if treatments that are less invasive than surgery are also effective in curing the ABC. The secondary objective was to determine the respective role of each treatment in the therapeutic arsenal.
HYPOTHESIS
Less invasive treatments can replace surgery as the base treatment for ABC.
PATIENTS AND METHODS
A PubMed® search was carried out for this review. The inclusion criteria were ABC treatment without cyst removal, case series, clinical case reports, reviews, publication in French or English. Excluded were articles that described the results of surgical treatment only, cranial or maxillofacial cysts, secondary ABC, duplicates, no abstract available. Based on the first six items of the "MINOR criteria", we selected 42 studies. For each selected study, we analyzed the number of cases, clinical response to treatment, radiological healing, recurrence or failure rate, complications and side effects of the treatment.
RESULTS
This review found that less invasive treatments generate results that are at least as good as surgery, often with fewer complications. Thus, in certain cases, these treatments can be recommended as first-line therapy. This category includes selective arterial embolization, sclerotherapy (alcohol, polidocanol) and injection of demineralized bone matrix.
DISCUSSION
Selective arterial embolization yields good results. While this is a difficult, operator-dependent technique that is not suitable for all ABCs (no identifiable feeding vessel), we recommend it as the primary treatment for spinal ABCs. For ABCs in other locations, sclerotherapy can be used as the primary treatment. However, this treatment becomes inconvenient if the number of injections is too high. Radiation therapy is not a first-line treatment because of its side effects. Bisphosphonates and denosumab can be used when the other treatments are contraindicated.
Topics: Bone Cysts, Aneurysmal; Embolization, Therapeutic; Humans; Radiography; Sclerotherapy; Treatment Outcome
PubMed: 35331923
DOI: 10.1016/j.otsr.2022.103272 -
The Cochrane Database of Systematic... Dec 2021Varicose veins are enlarged and tortuous veins, affecting up to one-third of the world's population. They can be a cause of chronic venous insufficiency, which is... (Review)
Review
BACKGROUND
Varicose veins are enlarged and tortuous veins, affecting up to one-third of the world's population. They can be a cause of chronic venous insufficiency, which is characterised by oedema, pigmentation, eczema, lipodermatosclerosis, atrophie blanche, and healed or active venous ulcers. Injection sclerotherapy (liquid or foam) is widely used for treatment of varicose veins aiming to transform the varicose veins into a fibrous cord. However, there is limited evidence regarding its effectiveness and safety, especially in patients with more severe disease. This is the second update of the review first published in 2002.
OBJECTIVES
To assess the effectiveness and safety of injection sclerotherapy for the treatment of varicose veins.
SEARCH METHODS
For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED, CINAHL, and LILACS databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries, on 20 July 2021.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) (including cluster-randomised trials and first phase cross-over studies) that used injection sclerotherapy for the treatment of varicose veins.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed, selected and extracted data. Disagreements were cross-checked by a third review author. We used Cochrane's Risk of bias tool to assess the risk of bias. The outcomes of interest were cosmetic appearance, complications, residual varicose veins, quality of life (QoL), persistence of symptoms, and recurrent varicose veins. We calculated risk ratios (RRs) or mean difference (MD) with 95% confidence intervals (CIs). We used the worst-case-scenario for dichotomous data imputation for intention-to-treat analyses. For continuous outcomes, we used the 'last-observation-carried-forward' for data imputation if there was balanced loss to follow-up. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included 23 new RCTs for this update, bringing the total to 28 studies involving 4278 participants. The studies differed in their design, and in which sclerotherapy method, agent or concentration was used. None of the included RCTs compared sclerotherapy to no intervention or to any pharmacological therapy. The certainty of the evidence was downgraded for risk of bias, low number of studies providing information for each outcome, low number of participants, clinical differences between the study participants, and wide CIs. Sclerotherapy versus placebo Foam sclerotherapy may improve cosmetic appearance as measured by IPR-V (independent photography review - visible varicose veins scores) compared to placebo (polidocanol 1%: mean difference (MD) -0.76, 95% CI -0.91 to -0.60; 2 studies, 223 participants; very low-certainty evidence); however, deep vein thrombosis (DVT) rates may be slightly increased in this intervention group (RR 5.10, 95% CI 1.30 to 20.01; 3 studies, 302 participants; very low-certainty evidence). Residual varicose vein rates may be decreased following polidocanol 1% compared to placebo (RR 0.19, 95% CI 0.13 to 0.29; 2 studies, 225 participants; very low-certainty evidence). Following polidocanol 1% use, there may be a possible improvement in QoL as assessed using the VEINES-QOL/Sym questionnaire (MD 12.41, 95% CI 9.56 to 15.26; 3 studies, 299 participants; very low-certainty evidence), and possible improvement in varicose vein symptoms as assessed using the Venous Clinical Severity Score (VCSS) (MD -3.25, 95% CI -3.90 to -2.60; 2 studies, 223 participants; low-certainty evidence). Recurrent varicose veins were not reported for this comparison. Foam sclerotherapy versus foam sclerotherapy with different concentrations Three individual RCTs reported no evidence of a difference in cosmetic appearance after comparing different concentrations of the intervention; data could not be pooled for two of the three studies (RR 1.11, 95% CI 0.84 to 1.47; 1 study, 80 participants; very low-certainty evidence). Similarly, there was no clear difference in rates of thromboembolic complications when comparing one foam concentration with another (RR 1.47, 95% CI 0.41 to 5.33; 3 studies, 371 participants; very low-certainty evidence). Three RCTs investigating higher concentrations of polidocanol foam indicated the rate of residual varicose veins may be slightly decreased in the polidocanol 3% foam group compared to 1% (RR 0.67, 95% CI 0.43 to 1.04; 3 studies, 371 participants; moderate-certainty evidence). No clear improvement in QoL was detected. Two RCTs reported improved VCSS scores with increasing concentrations of foam. Persistence of symptoms were not reported for this comparison. There was no clear difference in recurrent varicose vein rates (RR 0.91, 95% CI 0.62 to 1.32; 1 study, 148 participants; low-certainty evidence). Foam sclerotherapy versus liquid sclerotherapy One RCT reported on cosmetic appearance with no evidence of a difference between foam or liquid sclerotherapy (patient satisfaction scale MD 0.2, 95% CI -0.27 to 0.67; 1 study, 126 participants; very low-certainty evidence). None of the RCTs investigated thromboembolic complications, QoL or persistence of symptoms. Six studies individually showed there may be a benefit to polidocanol 3% foam over liquid sclerotherapy in reducing residual varicose vein rate; pooling data from two studies showed a RR of 0.51, with 95% CI 0.41 to 0.65; 203 participants; very low-certainty evidence. One study reported no clear difference in recurrent varicose vein rates when comparing sodium tetradecyl sulphate (STS) foam or liquid (RR 1.10, 95% CI 0.86 to 1.42; 1 study, 286 participants; very low-certainty evidence). Sclerotherapy versus sclerotherapy with different substances Four RCTs compared sclerotherapy versus sclerotherapy with any other substance. We were unable to combine the data due to heterogeneity or assess the certainty of the evidence due to insufficient data.
AUTHORS' CONCLUSIONS
There is a very low to low-certainty evidence that, compared to placebo, sclerotherapy is an effective and safe treatment for varicose veins concerning cosmetic appearance, residual varicose veins, QoL, and persistence of symptoms. Rates of DVT may be slightly increased and there were no data concerning recurrent varicose veins. There was limited or no evidence for one concentration of foam compared to another; foam compared to liquid sclerotherapy; foam compared to any other substance; or one technique compared to another. There is a need for high-quality trials using standardised sclerosant doses, with clearly defined core outcome sets, and measurement time points to increase the certainty of the evidence.
Topics: Humans; Sclerotherapy; Varicose Ulcer; Varicose Veins; Veins; Venous Insufficiency
PubMed: 34883526
DOI: 10.1002/14651858.CD001732.pub3 -
The Cochrane Database of Systematic... Oct 2021Telangiectasias (spider veins) and reticular veins on the lower limbs are very common, increase with age, and have been found in 41% of women. The cause is unknown and... (Review)
Review
BACKGROUND
Telangiectasias (spider veins) and reticular veins on the lower limbs are very common, increase with age, and have been found in 41% of women. The cause is unknown and the patients may be asymptomatic or can report pain, burning or itching. Treatments include sclerotherapy, laser, intense pulsed light, microphlebectomy and thermoablation, but none is established as preferable.
OBJECTIVES
To assess the effects of sclerotherapy, laser therapy, intensive pulsed light, thermocoagulation, and microphlebectomy treatments for telangiectasias and reticular veins.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 16 March 2021. We undertook additional searches in LILACS and IBECS databases, reference checking, and contacted specialists in the field, manufacturers and study authors to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-RCTs that compared treatment methods such as sclerotherapy, laser therapy, intensive pulsed light, thermocoagulation, and microphlebectomy for telangiectasias and reticular veins in the lower limb. We included studies that compared individual treatment methods against placebo, or that compared different sclerosing agents, foam or laser treatment, or that used a combination of treatment methods.
DATA COLLECTION AND ANALYSIS
Three review authors independently performed study selection, extracted data, assessed risks of bias and assessed the certainty of evidence using GRADE. The outcomes of interest were resolution or improvement (or both) of telangiectasias, adverse events (including hyperpigmentation, matting), pain, recurrence, time to resolution, and quality of life.
MAIN RESULTS
We included 3632 participants from 35 RCTs. Studies compared a variety of sclerosing agents, laser treatment and compression. No studies investigated intensive pulsed light, thermocoagulation or microphlebectomy. None of the included studies assessed recurrence or time to resolution. Overall the risk of bias of the included studies was moderate. We downgraded the certainty of evidence to moderate or low because of clinical heterogeneity and imprecision due to the wide confidence intervals (CIs) and few participants for each comparison. Any sclerosing agent versus placebo There was moderate-certainty evidence that sclerosing agents showed more resolution or improvement of telangiectasias compared to placebo (standard mean difference (SMD) 3.08, 95% CI 2.68 to 3.48; 4 studies, 613 participants/procedures), and more frequent adverse events: hyperpigmentation (risk ratio (RR) 11.88, 95% CI 4.54 to 31.09; 3 studies, 528 participants/procedures); matting (RR 4.06, 95% CI 1.28 to 12.84; 3 studies, 528 participants/procedures). There may be more pain experienced in the sclerosing-agents group compared to placebo (SMD 0.70, 95% CI 0.06 to 1.34; 1 study, 40 participants; low-certainty evidence). Polidocanol versus any sclerosing agent There was no clear difference in resolution or improvement (or both) of telangiectasias (SMD 0.01, 95% CI -0.13 to 0.14; 7 studies, 852 participants/procedures), hyperpigmentation (RR 0.94, 95% CI 0.62 to 1.43; 6 studies, 819 participants/procedures), or matting (RR 0.82, 95% CI 0.52 to 1.27; 7 studies, 859 participants/procedures), but there were fewer cases of pain (SMD -0.26, 95% CI -0.44 to -0.08; 5 studies, 480 participants/procedures) in the polidocanol group. All moderate-certainty evidence. Sodium tetradecyl sulphate (STS) versus any sclerosing agent There was no clear difference in resolution or improvement (or both) of telangiectasias (SMD -0.07, 95% CI -0.25 to 0.11; 4 studies, 473 participants/procedures). There was more hyperpigmentation (RR 1.71, 95% CI 1.10 to 2.64; 4 studies, 478 participants/procedures), matting (RR 2.10, 95% CI 1.14 to 3.85; 2 studies, 323 participants/procedures) and probably more pain (RR 1.49, 95% CI 0.99 to 2.25; 4 studies, 409 participants/procedures). All moderate-certainty evidence. Foam versus any sclerosing agent There was no clear difference in resolution or improvement (or both) of telangiectasias (SMD 0.04, 95% CI -0.26 to 0.34; 2 studies, 187 participants/procedures); hyperpigmentation (RR 2.12, 95% CI 0.44 to 10.23; 2 studies, 187 participants/procedures) or pain (SMD -0.10, 95% CI -0.44 to 0.24; 1 study, 147 participants/procedures). There may be more matting using foam (RR 6.12, 95% CI 1.04 to 35.98; 2 studies, 187 participants/procedures). All low-certainty evidence. Laser versus any sclerosing agent There was no clear difference in resolution or improvement (or both) of telangiectasias (SMD -0.09, 95% CI -0.25 to 0.07; 5 studies, 593 participants/procedures), or matting (RR 1.00, 95% CI 0.46 to 2.19; 2 studies, 162 participants/procedures), and maybe less hyperpigmentation (RR 0.57, 95% CI 0.40 to 0.80; 4 studies, 262 participants/procedures) in the laser group. All moderate-certainty evidence. High heterogeneity of the studies reporting on pain prevented pooling, and results were inconsistent (low-certainty evidence). Laser plus sclerotherapy (polidocanol) versus sclerotherapy (polidocanol) Low-certainty evidence suggests there may be more resolution or improvement (or both) of telangiectasias in the combined group (SMD 5.68, 95% CI 5.14 to 6.23; 2 studies, 710 participants), and no clear difference in hyperpigmentation (RR 0.83, 95% CI 0.35 to 1.99; 2 studies, 656 participants) or matting (RR 0.83, 95% CI 0.21 to 3.28; 2 studies, 656 participants). There may be more pain in the combined group (RR 2.44, 95% CI 1.69 to 3.55; 1 study, 596 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS
Small numbers of studies and participants in each comparison limited our confidence in the evidence. Sclerosing agents were more effective than placebo for resolution or improvement of telangiectasias but also caused more adverse events (moderate-certainty evidence), and may result in more pain (low-certainty evidence). There was no evidence of a benefit in resolution or improvement for any sclerosant compared to another or to laser. There may be more resolution or improvement of telangiectasias in the combined laser and polidocanol group compared to polidocanol alone (low-certainty evidence). There may be differences between treatments in adverse events and pain. Compared to other sclerosing agents polidocanol probably causes less pain; STS resulted in more hyperpigmentation, matting and probably pain; foam may cause more matting (low-certainty evidence); laser treatment may result in less hyperpigmentation (moderate-certainty evidence). Further well-designed studies are required to provide evidence for other available treatments and important outcomes (such as recurrence, time to resolution and delayed adverse events); and to improve our confidence in the identified comparisons.
Topics: Female; Humans; Pruritus; Sclerotherapy; Telangiectasis; Veins
PubMed: 34637138
DOI: 10.1002/14651858.CD012723.pub2