Publications by authors named "Ronald Lg Flumignan"

6 Publications

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Ultrasound guidance for arterial (other than femoral) catheterisation in adults.

Cochrane Database Syst Rev 2021 Oct 12;10:CD013585. Epub 2021 Oct 12.

Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Arterial vascular access is a frequently performed procedure, with a high possibility for adverse events (e.g. pneumothorax, haemothorax, haematoma, amputation, death), and additional techniques such as ultrasound may be useful for improving outcomes. However, ultrasound guidance for arterial access in adults is still under debate.

Objectives: To assess the effects of ultrasound guidance for arterial (other than femoral) catheterisation in adults.

Search Methods: We searched CENTRAL, MEDLINE, Embase, LILACS, and CINAHL on 21 May 2021. We also searched IBECS, WHO ICTRP, and ClinicalTrials.gov on 16 June 2021, and we checked the reference lists of retrieved articles.

Selection Criteria: Randomised controlled trials (RCTs), including cross-over trials and cluster-RCTs, comparing ultrasound guidance, alone or associated with other forms of guidance, versus other interventions or palpation and landmarks for arterial (other than femoral) guidance in adults.

Data Collection And Analysis: Two review authors independently performed study selection, extracted data, assessed risk of bias, and assessed the certainty of evidence using GRADE.

Main Results: We included 48 studies (7997 participants) that tested palpation and landmarks, Doppler auditory ultrasound assistance (DUA), direct ultrasound guidance with B-mode, or any other modified ultrasound technique for arterial (axillary, dorsalis pedis, and radial) catheterisation in adults. Radial artery Real-time B-mode ultrasound versus palpation and landmarks Real-time B-mode ultrasound guidance may improve first attempt success rate (risk ratio (RR) 1.44, 95% confidence interval (CI) 1.29 to 1.61; 4708 participants, 27 studies; low-certainty evidence) and overall success rate (RR 1.11, 95% CI 1.06 to 1.16; 4955 participants, 28 studies; low-certainty evidence), and may decrease time needed for a successful procedure (mean difference (MD) -0.33 minutes, 95% CI -0.54 to -0.13; 4902 participants, 26 studies; low-certainty evidence) up to one hour compared to palpation and landmarks. Real-time B-mode ultrasound guidance probably decreases major haematomas (RR 0.35, 95% CI 0.23 to 0.56; 2504 participants, 16 studies; moderate-certainty evidence). It is uncertain whether real-time B-mode ultrasound guidance has any effect on pseudoaneurysm, pain, and quality of life (QoL) compared to palpation and landmarks (very low-certainty evidence). Real-time B-mode ultrasound versus DUA One study (493 participants) showed that real-time B-mode ultrasound guidance probably improves first attempt success rate (RR 1.35, 95% CI 1.11 to 1.64; moderate-certainty evidence) and time needed for a successful procedure (MD -1.57 minutes, 95% CI -1.78 to -1.36; moderate-certainty evidence) up to 72 hours compared to DUA. Real-time B-mode ultrasound guidance may improve overall success rate (RR 1.13, 95% CI 0.99 to 1.29; low-certainty evidence) up to 72 hours compared to DUA. Pseudoaneurysm, major haematomas, pain, and QoL were not reported. Real-time B-mode ultrasound versus modified real-time B-mode ultrasound Real-time B-mode ultrasound guidance may decrease first attempt success rate (RR 0.68, 95% CI 0.55 to 0.84; 153 participants, 2 studies; low-certainty evidence), may decrease overall success rate (RR 0.93, 95% CI 0.86 to 1.01; 153 participants, 2 studies; low-certainty evidence), and may lead to no difference in time needed for a successful procedure (MD 0.04 minutes, 95% CI -0.01 to 0.09; 153 participants, 2 studies; low-certainty evidence) up to one hour compared to modified real-time B-mode ultrasound guidance. It is uncertain whether real-time B-mode ultrasound guidance has any effect on major haematomas compared to modified real-time B-mode ultrasound (very low-certainty evidence). Pseudoaneurysm, pain, and QoL were not reported. In-plane versus out-of-plane B-mode ultrasound In-plane real-time B-mode ultrasound guidance may lead to no difference in overall success rate (RR 1.00, 95% CI 0.96 to 1.05; 1051 participants, 8 studies; low-certainty evidence) and in time needed for a successful procedure (MD -0.06 minutes, 95% CI -0.16 to 0.05; 1134 participants, 9 studies; low-certainty evidence) compared to out-of-plane B-mode ultrasound up to one hour. It is uncertain whether in-plane real-time B-mode ultrasound guidance has any effect on first attempt success rate or major haematomas compared to out-of-plane B-mode ultrasound (very low-certainty evidence). Pseudoaneurysm, pain, and QoL were not reported. DUA versus palpation and landmarks DUA may lead to no difference in first attempt success rate (RR 1.01, 95% CI 0.90 to 1.14; 666 participants, 2 studies; low-certainty evidence) or overall success rate (RR 0.99, 95% CI 0.92 to 1.07; 666 participants, 2 studies; low-certainty evidence) and probably increases time needed for a successful procedure (MD 0.45 minutes, 95% CI 0.20 to 0.70; 500 participants, 1 study; moderate-certainty evidence) up to 72 hours compared to palpation and landmarks. Pseudoaneurysm, major haematomas, pain, and QoL were not reported. Oblique-axis versus long-axis in-plane B-mode ultrasound Oblique-axis in-plane B-mode ultrasound guidance may increase overall success rate (RR 1.27, 95% CI 1.05 to 1.53; 215 participants, 2 studies; low-certainty evidence) up to 72 hours compared to long-axis in-plane B-mode ultrasound. It is uncertain whether oblique-axis in-plane B-mode ultrasound guidance has any effect on first attempt success rate, time needed for a successful procedure, and major haematomas compared to long-axis in-plane B-mode ultrasound. Pseudoaneurysm, pain, and QoL were not reported. We are uncertain about effects in the following comparisons due to very low-certainty evidence and unreported outcomes: real-time B-mode ultrasound versus palpation and landmarks (axillary and dorsalis pedis arteries), real-time B-mode ultrasound versus near-infrared laser (radial artery), and dynamic versus static out-of-plane B-mode ultrasound (radial artery).

Authors' Conclusions: Real-time B-mode ultrasound guidance may improve first attempt success rate, overall success rate, and time needed for a successful procedure for radial artery catheterisation compared to palpation, or DUA. In addition, real-time B-mode ultrasound guidance probably decreases major haematomas compared to palpation. However, we are uncertain about the evidence on major haematomas and pain for other comparisons due to very low-certainty evidence and unreported outcomes. We are also uncertain about the effects on pseudoaneurysm and QoL for axillary and dorsalis pedis arteries catheterisation. Given that first attempt success rate and pseudoaneurysm are the most relevant outcomes for people who underwent arterial catheterisation, future studies must measure both. Future trials must be large enough to detect effects, use validated scales, and report longer-term follow-up.
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http://dx.doi.org/10.1002/14651858.CD013585.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8507521PMC
October 2021

Treatment for telangiectasias and reticular veins.

Cochrane Database Syst Rev 2021 Oct 12;10:CD012723. Epub 2021 Oct 12.

Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.

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.
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http://dx.doi.org/10.1002/14651858.CD012723.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8507602PMC
October 2021

Prophylactic anticoagulants for people hospitalised with COVID-19.

Cochrane Database Syst Rev 2020 10 2;10:CD013739. Epub 2020 Oct 2.

Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Coronavirus disease 2019 (COVID-19) is a serious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The primary manifestation is respiratory insufficiency that can also be related to diffuse pulmonary microthrombosis in people with COVID-19. This disease also causes thromboembolic events, such as pulmonary embolism, deep venous thrombosis, arterial thrombosis, catheter thrombosis, and disseminated intravascular coagulopathy. Recent studies have indicated a worse prognosis for people with COVID-19 who developed thromboembolism. Anticoagulants are medications used in the prevention and treatment of venous or arterial thromboembolic events. Several drugs are used in the prophylaxis and treatment of thromboembolic events, such as heparinoids (heparins or pentasaccharides), vitamin K antagonists and direct anticoagulants. Besides their anticoagulant properties, heparinoids have an additional anti-inflammatory potential, that may affect the clinical evolution of people with COVID-19. Some practical guidelines address the use of anticoagulants for thromboprophylaxis in people with COVID-19, however, the benefit of anticoagulants for people with COVID-19 is still under debate.

Objectives: To assess the effects of prophylactic anticoagulants versus active comparator, placebo or no intervention, on mortality and the need for respiratory support in people hospitalised with COVID-19.

Search Methods: We searched CENTRAL, MEDLINE, Embase, LILACS and IBECS databases, the Cochrane COVID-19 Study Register and medRxiv preprint database from their inception to 20 June 2020. We also checked reference lists of any relevant systematic reviews identified and contacted specialists in the field for additional references to trials.

Selection Criteria: Randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and cohort studies that compared prophylactic anticoagulants (heparin, vitamin K antagonists, direct anticoagulants, and pentasaccharides) versus active comparator, placebo or no intervention for the management of people hospitalised with COVID-19. We excluded studies without a comparator group. Primary outcomes were all-cause mortality and need for additional respiratory support. Secondary outcomes were mortality related to COVID-19, deep vein thrombosis (DVT), pulmonary embolism, major bleeding, adverse events, length of hospital stay and quality of life.

Data Collection And Analysis: We used standard Cochrane methodological procedures. We used ROBINS-I to assess risk of bias for non-randomised studies (NRS) and GRADE to assess the certainty of evidence. We reported results narratively.

Main Results: We identified no RCTs or quasi-RCTs that met the inclusion criteria. We included seven retrospective NRS (5929 participants), three of which were available as preprints. Studies were conducted in China, Italy, Spain and the USA. All of the studies included people hospitalised with COVID-19, in either intensive care units, hospital wards or emergency departments. The mean age of participants (reported in 6 studies) ranged from 59 to 72 years. Only three included studies reported the follow-up period, which varied from 8 to 35 days. The studies did not report on most of our outcomes of interest: need for additional respiratory support, mortality related to COVID-19, DVT, pulmonary embolism, adverse events, and quality of life. Anticoagulants (all types) versus no treatment (6 retrospective NRS, 5685 participants) One study reported a reduction in all-cause mortality (adjusted odds ratio (OR) 0.42, 95% confidence interval (CI) 0.26 to 0.66; 2075 participants). One study reported a reduction in mortality only in a subgroup of 395 people who required mechanical ventilation (hazard ratio (HR) 0.86, 95% CI 0.82 to 0.89). Three studies reported no differences in mortality (adjusted OR 1.64, 95% CI 0.92 to 2.92; 449 participants; unadjusted OR 1.66, 95% CI 0.76 to 3.64; 154 participants and adjusted risk ratio (RR) 1.15, 95% CI 0.29 to 2.57; 192 participants). One study reported zero events in both intervention groups (42 participants). The overall risk of bias for all-cause mortality was critical and the certainty of the evidence was very low. One NRS reported bleeding events in 3% of the intervention group and 1.9% of the control group (OR 1.62, 95% CI 0.96 to 2.71; 2773 participants; low-certainty evidence). Therapeutic-dose anticoagulants versus prophylactic-dose anticoagulants (1 retrospective NRS, 244 participants) The study reported a reduction in all-cause mortality (adjusted HR 0.21, 95% CI 0.10 to 0.46) and a lower absolute rate of death in the therapeutic group (34.2% versus 53%). The overall risk of bias for all-cause mortality was serious and the certainty of the evidence was low. The study also reported bleeding events in 31.7% of the intervention group and 20.5% of the control group (OR 1.8, 95% CI 0.96 to 3.37; low-certainty evidence). Ongoing studies We found 22 ongoing studies in hospital settings (20 RCTs, 14,730 participants; 2 NRS, 997 participants) in 10 different countries (Australia (1), Brazil (1), Canada (2), China (3), France (2), Germany (1), Italy (4), Switzerland (1), UK (1) and USA (6)). Twelve ongoing studies plan to report mortality and six plan to report additional respiratory support. Thirteen studies are expected to be completed in December 2020 (6959 participants), eight in July 2021 (8512 participants), and one in December 2021 (256 participants). Four of the studies plan to include 1000 participants or more.

Authors' Conclusions: There is currently insufficient evidence to determine the risks and benefits of prophylactic anticoagulants for people hospitalised with COVID-19. Since there are 22 ongoing studies that plan to evaluate more than 15,000 participants in this setting, we will add more robust evidence to this review in future updates.
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http://dx.doi.org/10.1002/14651858.CD013739DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166900PMC
October 2020

Complementary and alternative therapies for post-caesarean pain.

Cochrane Database Syst Rev 2020 Sep 1;9:CD011216. Epub 2020 Sep 1.

Emergency Medicine and Evidence Based Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Pain after caesarean sections (CS) can affect the well-being of the mother and her ability with her newborn. Conventional pain-relieving strategies are often underused because of concerns about the adverse maternal and neonatal effects. Complementary alternative therapies (CAM) may offer an alternative for post-CS pain.

Objectives: To assess the effects of CAM for post-caesarean pain.

Search Methods: We searched Cochrane Pregnancy and Childbirth's Trials Register, LILACS, PEDro, CAMbase, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (6 September 2019), and checked the reference lists of retrieved articles.

Selection Criteria: Randomised controlled trials (RCTs), including quasi-RCTs and cluster-RCTs, comparing CAM, alone or associated with other forms of pain relief, versus other treatments or placebo or no treatment, for the treatment of post-CS pain.

Data Collection And Analysis: Two review authors independently performed study selection, extracted data, assessed risk of bias and assessed the certainty of evidence using GRADE.

Main Results: We included 37 studies (3076 women) which investigated eight different CAM therapies for post-CS pain relief. There is substantial heterogeneity among the trials. We downgraded the certainty of evidence due to small numbers of women participating in the trials and to risk of bias related to lack of blinding and inadequate reporting of randomisation processes. None of the trials reported pain at six weeks after discharge. Primary outcomes were pain and adverse effects, reported per intervention below. Secondary outcomes included vital signs, rescue analgesic requirement at six weeks after discharge; all of which were poorly reported, not reported, or we are uncertain as to the effect Acupuncture or acupressure We are very uncertain if acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus placebo plus analgesia) has any effect on pain because the quality of evidence is very low. Acupuncture or acupressure plus analgesia (versus analgesia) may reduce pain at 12 hours (standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.64 to 0.07; 130 women; 2 studies; low-certainty evidence) and 24 hours (SMD -0.63, 95% CI -0.99 to -0.26; 2 studies; 130 women; low-certainty evidence). It is uncertain whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus analgesia) has any effect on the risk of adverse effects because the quality of evidence is very low. Aromatherapy Aromatherapy plus analgesia may reduce pain when compared with placebo plus analgesia at 12 hours (mean difference (MD) -2.63 visual analogue scale (VAS), 95% CI -3.48 to -1.77; 3 studies; 360 women; low-certainty evidence) and 24 hours (MD -3.38 VAS, 95% CI -3.85 to -2.91; 1 study; 200 women; low-certainty evidence). We are uncertain if aromatherapy plus analgesia has any effect on adverse effects (anxiety) compared with placebo plus analgesia. Electromagnetic therapy Electromagnetic therapy may reduce pain compared with placebo plus analgesia at 12 hours (MD -8.00, 95% CI -11.65 to -4.35; 1 study; 72 women; low-certainty evidence) and 24 hours (MD -13.00 VAS, 95% CI -17.13 to -8.87; 1 study; 72 women; low-certainty evidence). Massage We identified six studies (651 women), five of which were quasi-RCTs, comparing massage (foot and hand) plus analgesia versus analgesia. All the evidence relating to pain, adverse effects (anxiety), vital signs and rescue analgesic requirement was very low-certainty. Music Music plus analgesia may reduce pain when compared with placebo plus analgesia at one hour (SMD -0.84, 95% CI -1.23 to -0.46; participants = 115; studies = 2; I = 0%; low-certainty evidence), 24 hours (MD -1.79, 95% CI -2.67 to -0.91; 1 study; 38 women; low-certainty evidence), and also when compared with analgesia at one hour (MD -2.11, 95% CI -3.11 to -1.10; 1 study; 38 women; low-certainty evidence) and at 24 hours (MD -2.69, 95% CI -3.67 to -1.70; 1 study; 38 women; low-certainty evidence). It is uncertain whether music plus analgesia has any effect on adverse effects (anxiety), when compared with placebo plus analgesia because the quality of evidence is very low. Reiki We are uncertain if Reiki plus analgesia compared with analgesia alone has any effect on pain, adverse effects, vital signs or rescue analgesic requirement because the quality of evidence is very low (one study, 90 women). Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence). Transcutaneous electrical nerve stimulation TENS (versus no treatment) may reduce pain at one hour (MD -2.26, 95% CI -3.35 to -1.17; 1 study; 40 women; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce pain compared with placebo plus analgesia at one hour (SMD -1.10 VAS, 95% CI -1.37 to -0.82; 3 studies; 238 women; low-certainty evidence) and at 24 hours (MD -0.70 VAS, 95% CI -0.87 to -0.53; 108 women; 1 study; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce heart rate (MD -7.00 bpm, 95% CI -7.63 to -6.37; 108 women; 1 study; low-certainty evidence) and respiratory rate (MD -1.10 brpm, 95% CI -1.26 to -0.94; 108 women; 1 study; low-certainty evidence). We are uncertain if TENS plus analgesia (versus analgesia) has any effect on pain at six hours or 24 hours, or vital signs because the quality of evidence is very low (two studies, 92 women).

Authors' Conclusions: Some CAM therapies may help reduce post-CS pain for up to 24 hours. The evidence on adverse events is too uncertain to make any judgements on safety and we have no evidence about the longer-term effects on pain. Since pain control is the most relevant outcome for post-CS women and their clinicians, it is important that future studies of CAM for post-CS pain measure pain as a primary outcome, preferably as the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. Measuring pain as a dichotomous variable would improve the certainty of evidence and it is easy to understand for non-specialists. Future trials also need to be large enough to detect effects on clinical outcomes; measure other important outcomes as listed lin this review, and use validated scales.
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http://dx.doi.org/10.1002/14651858.CD011216.pub2DOI Listing
September 2020

Internal iliac artery revascularisation versus internal iliac artery occlusion for endovascular treatment of aorto-iliac aneurysms.

Cochrane Database Syst Rev 2020 07 21;7:CD013168. Epub 2020 Jul 21.

Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Endovascular aortic aneurysm repair (EVAR) is used to treat aorto-iliac and isolated iliac aneurysms in selected patients, and prospective studies have shown advantages compared with open surgical repair, mainly in the first years of follow-up. Although this technique produces good results, anatomic issues (such as common iliac artery ectasia or an aneurysm that involves the iliac bifurcation) can make EVAR more complex and challenging and can lead to an inadequate distal seal zone for the stent-graft. Inadequate distal fixation in the common iliac arteries can lead to a type Ib endoleak. To avoid this complication, one of the most commonly used techniques is unilateral or bilateral internal iliac artery occlusion and extension of the iliac limb stent-graft to the external iliac arteries with or without embolisation of the internal iliac artery. However, this occlusion is not without harm and is associated with ischaemic complications in the pelvic territory such as buttock claudication, sexual dysfunction, ischaemic colitis, gluteal necrosis, and spinal cord injury. New endovascular devices and alternative techniques such as iliac branch devices and the sandwich technique have been described to maintain pelvic perfusion and decrease complications, achieving revascularisation of the internal iliac arteries in patients not suitable for an adequate seal zone in the common iliac arteries. These approaches may also preserve the quality of life of treated individuals and may decrease other serious complications including spinal cord ischaemia, ischaemic colitis, and gluteal necrosis, thereby decreasing the morbidity and mortality of EVAR.

Objectives: To assess the effects of internal iliac artery revascularisation versus internal iliac artery occlusion during endovascular repair of aorto-iliac aneurysms and isolated iliac aneurysms involving the iliac bifurcation.

Search Methods: The Cochrane Vascular Information Specialists searched the Cochrane Vascular Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; Embase; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 28 August 2019. The review authors searched Latin American Caribbean Health Sciences Literature (LILACS) and the Indice Bibliográfico Español de Ciencias de la Salud (IBECS) on 28 August 2019 and contacted specialists in the field and manufacturers to identify relevant studies.

Selection Criteria: We planned to include all randomised controlled trials (RCTs) that compared internal iliac artery revascularisation with internal iliac artery occlusion for patients undergoing endovascular treatment of aorto-iliac aneurysms and isolated iliac aneurysms involving the iliac bifurcation.

Data Collection And Analysis: Two review authors independently assessed identified studies for potential inclusion in the review. We used standard methodological procedures in accordance with the Cochrane Handbook for Systematic Review of Interventions.

Main Results: We identified no RCTs that met the inclusion criteria.

Authors' Conclusions: We found no RCTs that compared internal iliac artery revascularisation versus internal iliac artery occlusion for endovascular treatment of aorto-iliac aneurysms and isolated iliac aneurysms involving the iliac bifurcation. High-quality studies that evaluate the best strategy for managing endovascular repair of aorto-iliac aneurysms with inadequate distal seal zones in the common iliac artery are needed.
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http://dx.doi.org/10.1002/14651858.CD013168.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7389186PMC
July 2020

Acetyl-L-carnitine for the treatment of diabetic peripheral neuropathy.

Cochrane Database Syst Rev 2019 06 15;6:CD011265. Epub 2019 Jun 15.

Department of Internal Medicine, Universidade Federal de São Paulo, Rua Borges Lagoa, 1065/110, São Paulo, São Paulo, Brazil, 04038-032.

Background: Diabetic peripheral neuropathy (DPN) is a common and severe complication that affects 50% of people with diabetes. Painful DPN is reported to occur in 16% to 24% of people with diabetes. A complete and comprehensive management strategy for the prevention and treatment of DPN, whether painful or not, has not yet been defined.Research into treatment for DPN has been characterised by a series of failed clinical trials, with few noteworthy advances. Strategies that support peripheral nerve regeneration and restore neurological function in people with painful or painless DPN are needed. The amino acid acetyl-L-carnitine (ALC) plays a role in the transfer of long-chain fatty acids into mitochondria for β-oxidation. ALC supplementation also induces neuroprotective and neurotrophic effects in the peripheral nervous system. Therefore, ALC supplementation targets several mechanisms relevant to potential nerve repair and regeneration, and could have clinical therapeutic potential. There is a need for a systematic review of the evidence from clinical trials.

Objectives: To assess the effects of ALC for the treatment of DPN.

Search Methods: On 2 July 2018, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. We checked references, searched citations, and contacted study authors to identify additional studies.

Selection Criteria: We included randomised controlled trials (RCTs) and quasi-RCTs of ALC compared with placebo, other therapy, or no intervention in the treatment of DPN. Participants could be of any sex and age, and have type 1 or type 2 diabetes mellitus, of any severity, with painful or painless DPN. We accepted any definition of minimum criteria for DPN, in accordance with the Toronto Consensus. We imposed no language restriction.Pain was the primary outcome, measured as the proportion of participants with at least 30% (moderate) or 50% (substantial) decrease in pain over baseline, or as the score on a visual analogue scale (VAS) or Likert scale for pain.

Data Collection And Analysis: We followed standard Cochrane methods.

Main Results: We included four studies with 907 participants, which were reported in three publications. Three trials studied ALC versus placebo (675 participants); in one trial the dose of ALC was 2000 mg/day, and in the other two trials, it was 1500 mg/day or 3000 mg/day. The fourth trial studied ALC 1500 mg/day versus methylcobalamin 1.5 mg/day (232 participants). The risk of bias was high in both trials of different ALC doses and low in the other two trials.No included trial measured the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. ALC reduced pain more than placebo, measured on a 0- to 100-mm VAS (MD -9.16, 95% CI -16.76 to -1.57; three studies; 540 participants; P = 0.02; I² = 56%; random-effects; very low-certainty evidence; a higher score indicating more pain). At doses of 1500 mg/day or less, the VAS score after ALC treatment was little different from placebo (MD -0.05, 95% CI -10.00 to 9.89; two studies; 159 participants; P = 0.99; I² = 0%), but at doses greater than 1500 mg/day, ALC reduced pain more than placebo (MD -14.93, 95% CI -19.16 to -10.70; three studies; 381 participants; P < 0.00001; I² = 0%). This subgroup analysis should be viewed with caution as the evidence was even less certain than the overall analysis, which was already of very low certainty.Two placebo-controlled studies reported that vibration perception improved after 12 months. We graded this evidence as very low certainty, due to inconsistency and a high risk of bias, as the trial authors did not provide any numerical data. The placebo-controlled studies did not measure functional impairment and disability scores. No study used validated symptom scales. One study performed sensory testing, but the evidence was very uncertain.The fourth included study compared ALC with methylcobalamin, but did not report effects on pain. There was a reduction from baseline to 24 weeks in functional impairment and disability, based on the change in mean Neuropathy Disability Score (NDS; scale from zero to 10), but there was no important difference between the ALC group (mean score 1.66 ± 1.90) and the methylcobalamin group (mean score 1.35 ± 1.65) groups (P = 0.23; low-certainty evidence).One placebo-controlled study reported that six of 147 participants in the ALC > 1500 mg/day group (4.1%) and two of 147 participants in the placebo group (1.4%) discontinued treatment because of adverse events (headache, facial paraesthesia, and gastrointestinal disorders) (P = 0.17). The other two placebo-controlled studies reported no dropouts due to adverse events, and more pain, paraesthesia, and hyperaesthesias in the placebo group than the 3000 mg/day ALC group, but provided no numerical data. The overall certainty of adverse event evidence for the comparison of ALC versus placebo was low.The study comparing ALC with methylcobalamin reported that 34/117 participants (29.1%) experienced adverse events in the ALC group versus 33/115 (28.7%) in the methylcobalamin group (P = 0.95). Nine participants discontinued treatment due to adverse events (ALC: 4 participants, methylcobalamin: 5 participants), which were most commonly gastrointestinal symptoms. The certainty of the adverse event evidence for ALC versus methylcobalamin was low.Two studies were funded by the manufacturer of ALC and the other two studies had at least one co-author who was a consultant for an ALC manufacturer.

Authors' Conclusions: We are very uncertain whether ALC causes a reduction in pain after 6 to 12 months' treatment in people with DPN, when compared with placebo, as the evidence is sparse and of low certainty. Data on functional and sensory impairment and symptoms are lacking, or of very low certainty. The evidence on adverse events is too uncertain to make any judgements on safety.
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http://dx.doi.org/10.1002/14651858.CD011265.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6953387PMC
June 2019
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