scholarly journals Efficacy and Safety of Pulsed Radiofrequency as a Method of Dorsal Root Ganglia Stimulation in Patients with Neuropathic Pain: A Systematic Review

Pain Medicine ◽  
2020 ◽  
Vol 21 (12) ◽  
pp. 3320-3343 ◽  
Author(s):  
Ivana Vuka ◽  
Tihana Marciuš ◽  
Svjetlana Došenović ◽  
Lejla Ferhatović Hamzić ◽  
Katarina Vučić ◽  
...  

Abstract Objective Pulsed radiofrequency (PRF) is a nonablative pain treatment that uses radiofrequency current in short high-voltage bursts, resulting in interruption of nociceptive afferent pathways. We conducted a systematic review with the aim to create a synthesis of evidence about the efficacy and safety of PRF applied to the dorsal root ganglion (DRG) for the treatment of neuropathic pain. Methods We searched MEDLINE, CINAHL, Embase, and PsycINFO through January 8, 2019, as well as ClinicalTrials.gov and the clinical trial register of the World Health Organization. All study designs were eligible. We assessed risk of bias using the Cochrane tool for randomized controlled trials and the Risk Of Bias In Non-Randomized Studies of Interventions (ROBINS-I). We assessed level of evidence using the Oxford tool and quality of evidence with GRADE. Results We included 28 studies with participants suffering from lumbosacral, cervical, or thoracic radicular pain, post-herpetic neuralgia, neuropathicbone pain in cancer patients, or carpal tunnel syndrome. Only five studies were randomized controlled trials (RCTs), while others were of nonrandomized designs, predominantly before and after comparisons. A total of 991 participants were included, with a median number (range) of 31 (1–101) participants. Only 204 participants were included in the RCTs, with a median number (range) of 38 (23–62) participants. The overall quality of evidence was low, as the majority of the included studies were rated as evidence level 4 or 5. The quality of evidence was very low. Conclusions Evidence about the efficacy and safety of PRF of the DRG for the treatment of neuropathic pain is based mainly on results from very small studies with low evidence quality. Current research results about the benefits of PRF of the DRG for the treatment of neuropathic pain should be considered preliminary and confirmed in high-quality RCTs with sufficient numbers of participants.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jiayuan Hu ◽  
Ruijin Qiu ◽  
Chengyu Li ◽  
Min Li ◽  
Qianqian Dai ◽  
...  

Abstract Background Traditional Chinese medicine (TCM) has gained widespread application in treating chronic heart failure (CHF) secondary to coronary heart disease (CHD). However, the sound clinical evidence is still lacking. Corresponding clinical trials vary considerably in the outcome measures assessing the efficacy of TCM, some that showed the improvement of clinical symptoms are not universally acknowledged. Rational outcome measures are the key to evaluate efficacy and safety of each treatment and significant elements of a convincing clinical trial. We aimed to summarize and analyze outcome measures in randomized controlled trials (RCTs) of TCM in treating CHF caused by CHD, subsequently identify the present problems and try to put forward solutions. Methods We systematically searched databases including Embase, PubMed, Cochrane Library, CBM, CNKI, VIP and Wanfang from inception to October 8, 2018, to identify eligible RCTs using TCM interventions for treating CHF patients caused by CHD. Cochrane Database of Systematic Reviews (CDSR) was searched to include Cochrane systematic reviews (CSRs) of CHF. Two authors independently assessed the risk of bias of the included RCTs according to the Cochrane Handbook. Outcome measures of each trial were extracted and analyzed those compared with the CSRs. We also evaluated the reporting quality of the outcome measures. Results A total of 31 RCTs were included and the methodology quality of the studies was generally low. Outcome measures in these RCTs were mortality, rehospitalization, efficacy of cardiac function, left ventricular ejection fraction (LVEF), 6 min’ walk distance (6MWD) and Brain natriuretic peptide (BNP), of which mortality and rehospitalization are clinical end points while the others are surrogate outcomes. The reporting rate of mortality and rehospitalization was 12.90% (4/31), the other included studies reported surrogate outcomes. As safety measure, 54.84% of the studies reported adverse drug reactions. Two trials were evaluated as high in reporting quality of outcomes and that of the other 29 studies was poor due to lack of necessary information for reporting. Conclusions The present RCTs of TCM in treating CHF secondary to CHD did not concentrate on the clinical end points of heart failure, which were generally small in size and short in duration. Moreover, these trials lacked adequate safety evaluation, had low quality in reporting outcomes and certain risk of bias in methodology. For objective assessment of the efficacy and safety of TCM in treating CHF secondary to CHD, future research should be rigorous designed, set end points as primary outcome measures and pay more attention to safety evaluation throughout the trial.


2019 ◽  
Vol 2019 ◽  
pp. 1-21
Author(s):  
Meng-Qi Yang ◽  
Yong-Mei Song ◽  
Huan-Yu Gao ◽  
Yi-Tao Xue

Objective. Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods. RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration’s tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results. Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee’s heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion. The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Ivana Vuka ◽  
Svjetlana Došenović ◽  
Tihana Marciuš ◽  
Lejla Ferhatović Hamzić ◽  
Katarina Vučić ◽  
...  

2020 ◽  
Author(s):  
Guoying Gao ◽  
Siu-wai Leung ◽  
Yongliang Jia

Abstract Background: The efficacy of traditional Chinese medicine injections (TCMIs) for angina pectoris has never been well investigated for lacking quality assessment of evidence. This study aimed to conduct a comprehensive and rigorous network meta-analysis and assess the quality of evidence according to the Grading of Recommendations and Assessment, Development, and Evaluation (GRADE) approach to compare the efficacy of all TCMIs in treating angina pectoris.Methods: Following the protocol (reference: CRD42018117720), randomized controlled trials (RCTs) which compared one TCMI with another TCMI or conventional treatments on anginal outcome measures (i.e. symptomatic improvement, electrocardiography improvement, symptomatic recovery, and electrocardiography recovery) were included. The risk of bias among included RCTs was assessed with the revised Cochrane’s risk of bias tool 2. Frequentist statistical analyses including subgroup analysis, sensitivity analysis, meta-regression and publication bias analysis were performed. The certainty of evidence was assessed with the GRADE approach.Results: Totally, 475 RCTs including all 24 TCMIs were identified, while the quality of all but two included RCTs was poor. According to the network meta-analysis, Honghua (Safflower) injection were preferable both in improving symptoms and electrocardiography. However, significant inconsistency showed the intransitivity among indirect comparisons, results in network meta-analysis seemed thus not trustworthy. The quality of evidence was assessed as low or very low.Conclusions: The low-quality evidence reduced the confidence in the efficacious results. Current evidence hardly supports the beneficial effects of TCMIs in treating angina pectoris.


2019 ◽  
Author(s):  
Serena Brusamento ◽  
Bhone Myint Kyaw ◽  
Penny Whiting ◽  
Li Li ◽  
Lorainne Tudor Car

BACKGROUND Reducing childhood morbidity and mortality is challenging, particularly in countries with a shortage of qualified health care workers. Lack of trainers makes it difficult to provide the necessary continuing education in pediatrics for postregistration health professionals. Digital education, teaching and learning by means of digital technologies, has the potential to deliver medical education to a large audience while limiting the number of trainers needed. OBJECTIVE The goal of the research was to evaluate whether digital education can replace traditional learning to improve postregistration health professionals’ knowledge, skills, attitudes, and satisfaction and foster behavior change in the field of pediatrics. METHODS We completed a systematic review of the literature by following the Cochrane methodology. We searched 7 major electronic databases for articles published from January 1990 to August 2017. No language restrictions were applied. We independently selected studies, extracted data, and assessed risk of bias, and pairs of authors compared information. We contacted authors of studies for additional information if necessary. All pooled analyses were based on random effects models. We included individually or cluster randomized controlled trials that compared digital education with traditional learning, no intervention, or other forms of digital education. We assessed the quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria. RESULTS Twenty studies (1382 participants) were included. Participants included pediatricians, physicians, nurses, and midwives. Digital education technologies were assessed including high-fidelity mannequins (6 studies), computer-based education (12 studies), mobile learning (1 study), and virtual reality (1 study). Most studies reported that digital education was either as effective as or more effective than the control intervention for outcomes including skill, knowledge, attitude, and satisfaction. High-fidelity mannequins were associated with higher postintervention skill scores compared with low-fidelity mannequins (standardized mean difference 0.62; 95% CI 0.17-1.06; moderate effect size, low-quality evidence). One study reported physician change in practicing behavior and found similar effects between offline plus online digital education and no intervention. The only study that assessed impact on patient outcome found no difference between intervention and control groups. None of the included studies reported adverse or untoward effects or economic outcomes of the digital education interventions. The risk of bias was mainly unclear or high. The quality of evidence was low due to study inconsistencies, limitations, or imprecision across the studies. CONCLUSIONS Digital education for postregistration health professions education in pediatrics is at least as effective as traditional learning and more effective than no learning. High-fidelity mannequins were found to be more effective at improving skills than traditional learning with low-fidelity mannequins. Computer-based offline/online digital education was better than no intervention for knowledge and skill outcomes and as good as traditional face-to-face learning. This review highlights evidence gaps calling for more methodologically rigorous randomized controlled trials on the topic.


2019 ◽  
Vol 53 (1) ◽  
Author(s):  
Rowena Natividad S. Flores-Genuino ◽  
Belen L. Dofitas ◽  
Leonila F. Dans ◽  
Ma. Lourdes E. Amarillo

Background. Oral azole drugs are a second-line option for the treatment of pityriasis versicolor but evidence on their efficacy and safety is unclear. Objectives. To determine the efficacy and safety of oral azoles in the treatment of patients with pityriasis versicolor. Methods: We searched MEDLINE, CENTRAL, EMBASE, LILACS, and HERDIN, from inception to the period between January to February 2014. We did not restrict the search by language or publication status.We included randomized controlled trials (RCTs) that compared the efficacy of oral azoles with placebo or no treatment, with topical agents, other oral azoles or dosing regimens in the treatment of pityriasis versicolor, and that measured any of the pre-specified outcomes (mycologic cure, clinical cure, recurrence, duration to cure, timeto-cure, and quality of life). For adverse effects, we also included non-randomized studies (NRS). We used Cochrane methods to select studies, extract data, assess risk of bias, pool studies, and calculate for treatment effects. Results. We included 38 RCTs (n=2894) and 56 NRS (n=3452). Overall, there were few pooled studies and evidence was low to moderate quality. Oral azoles were more effective than placebo (mycologic cure, RR 11.34, 95% CI 4.90, 26.28; 3 RCTs, n=131; I2=0%; low quality of evidence) and as effective as topical agents (mycologic cure, RR 1.02, 95% CI 0.86, 1.21; 4 RCTs, n=232; I2=60%; moderate quality of evidence).There were few adverse effects and were mostly minor and transient. Conclusions. Oral azoles may be more effective than placebo, and are probably as effective as topical agents in the treatment of PV. Triazoles are probably as effective as ketoconazole. Adverse effects were few, mostly minor, and transient.


2020 ◽  
Vol 54 ◽  
Author(s):  
Lia M. Palileo-Villanueva ◽  
Elenore Judy B. Uy

KEY FINDINGS There is insufficient evidence to support the routine use of HCQ or CQ for the treatment of COVID-19. Results from interim analyses of 2 large RCTs, the Recovery and the Solidarity trials, reportedly showed no clinical benefit from HCQ for hospitalized patients with COVID-19. There are 3 randomized controlled trials that investigated the efficacy and safety of HCQ compared to standard therapy. Overall quality of evidence was very low. Meta-analyses from the “COVID-19 Living Data” project suggests that the use of HCQ may increase the incidence of adverse events at day 14 to day 28 (RR 2.49, 95% confidence interval: 1.04 to 5.98, moderate quality of evidence); the most common adverse event across the two trials is diarrhea (n=8). In a statement dated June 5, 2020, the investigators of the Recovery trial announced their decision to halt further enrollment to the HCQ arm of the trial because an interim analysis showed no clinical benefit from the use of HCQ in hospitalized patients with COVID. On June 15, 2020, the US FDA revoked the emergency use authorization for HCQ and CQ as treatment for COVID-19. On June 18, 2020, the WHO announced that recruitment to the HCQ arm of the Solidarity trial has been halted.


Nutrients ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3352 ◽  
Author(s):  
Fatme AlAnouti ◽  
Myriam Abboud ◽  
Dimitrios Papandreou ◽  
Nadine Mahboub ◽  
Suzan Haidar ◽  
...  

Background: Metabolic syndrome (MetS) increases the risk of cardiovascular disease, with atherogenic dyslipidemia being a major contributing factor. Methods: A systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement to assess whether vitamin D supplementation (VDS) alleviates dyslipidemia in adults with MetS. Scientific databases (PUBMED, MEDLINE, CINAHL, EMBASE, Cochrane Library, ClinicalTrials.gov, International Clinical Trials Registry Platform) and the gray literature were searched for randomized controlled trials of VDS, reporting on blood lipids. A narrative review, meta-analyses, sensitivity analyses, and appraisal of the risk of bias and overall quality of evidence produced were conducted. Results: Seven studies were included, and four were meta-analyzed. The risk of bias was generally low, and the final quality of evidence was low or very low. VDS, whether in high or low dose, significantly increased endline vitamin D blood levels; did not affect total, low-density, high-density cholesterol levels, and novel lipid-related biomarkers; yet, significantly increased triglycerides (TG) levels compared with placebo (MD: 30.67 (95%CI: 4.89–56.45) mg/dL; p = 0.02 for low-dose VDS; and MD: 27.33 (95%CI: 2.06–52.59) mg/dL; p = 0.03 for high-dose VDS). Pertaining heterogeneity was high (I2 = 86%; and I2 = 51%, respectively), and some included studies had significantly higher baseline TG in the intervention arm. The sensitivity analyses revealed robust results. Conclusion: VDS seems not to affect blood lipids in adults with MetS.


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Chan-Young Kwon ◽  
Boram Lee ◽  
Sun-Yong Chung ◽  
Jong Woo Kim ◽  
Aesook Shin ◽  
...  

Abstract This systematic review and meta-analysis aimed to analyze the efficacy and safety of Sihogayonggolmoryeo-tang (SGYMT), a classical herbal medicine consisting of 11 herbs, for treatment of post-stroke depression (PSD). Thirteen databases were comprehensively searched from their inception dates until July 2019. Only randomized controlled trials (RCTs) using SGYMT as a monotherapy or adjunctive therapy for PSD patients were included. Where appropriate data were available, meta-analysis was performed and presented as risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs). We assessed the quality of RCTs using the Cochrane risk of bias tool and the Jadad scale. The quality of evidence for each main outcome was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Twenty-one RCTs with 1,644 participants were included. In the comparison between the SGYMT and antidepressants groups, the SGYMT group scored significantly lower on both the Hamilton Depression Scale (HAMD) (8 studies; MD −2.08, 95% CI −2.62 to −1.53, I2 = 34%) and the National Institutes of Health Stroke Scale (NIHSS) (2 studies; MD −0.84, 95% CI −1.40 to −0.29, I2 = 19%), and significantly higher on the Barthel index (3 studies; MD 4.30, 95% CI 2.04 to 6.57, I2 = 66%). Moreover, the SGYMT group was associated with significantly fewer adverse events (6 studies; RR 0.13, 95% CI 0.05 to 0.37, I2 = 0%) than the antidepressants group. In the subgroup analysis, SGYMT treatment consistently reduced HAMD scores within the first 8 weeks of treatment, but thereafter this difference between groups disappeared. Comparisons between SGYMT combined with antidepressants, and antidepressants alone, showed significantly lower scores in the combination group for both HAMD (7 studies; MD = −6.72, 95% CI = −11.42 to −2.01, I2 = 98%) and NIHSS scores (4 studies; MD −3.03, 95% CI −3.60 to −2.45, I2 = 87%). In the subgroup analysis, the reductions of HAMD scores in the SGYMT combined with antidepressants group were consistent within 4 weeks of treatment, but disappeared thereafter. The quality of RCTs was generally low and the quality of evidence evaluated by the GRADE approach was rated mostly “Very low” to “Moderate.” The main causes of low quality ratings were the high risk of bias and imprecision of results. Current evidence suggests that SGYMT, used either as a monotherapy or an adjuvant therapy to antidepressants, might have potential benefits for the treatment of PSD, including short-term reduction of depressive symptoms, improvement of neurological symptoms, and few adverse events. However, since the methodological quality of the included studies was generally low and there were no large placebo trials to ensure reliability, it remains difficult to draw definitive conclusions on this topic. Further well-designed RCTs addressing these shortcomings are needed to confirm our results.


2019 ◽  
Vol 40 (05) ◽  
pp. 584-602 ◽  
Author(s):  
Niklas Kahr Rasmussen ◽  
Tobias Thostrup Andersen ◽  
Jonathan Carlsen ◽  
Mia Louise Østergaard ◽  
Lars Konge ◽  
...  

Abstract Purpose To perform a systematic review of the effect of simulation-based training (SBT) of percutaneous abdominal and thoracic ultrasound-guided procedures and to assess the transfer of procedural competence to a clinical context. Materials and Methods This systematic review was conducted in accordance with the PRISMA statement. Pubmed, Embase, Web of Science, and the Cochrane Library were searched for studies assessing procedural competence after SBT. Two authors independently reviewed all studies and extracted data. Risk of bias was assessed using the Cochrane tool for randomized studies (RoB) and non-randomized studies (ROBINS-I). Quality of evidence was assessed using the GRADE approach. Results 42 studies were included. 6 were randomized controlled, 3 non-randomized controlled, and 33 non-randomized non-controlled. 26 studies examined US-guided abdominal procedures, 13 examined thoracic procedures, and 3 examined both. The results favored SBT compared to other educational interventions and found that training was superior to no training. Only two studies examined the transfer of procedural skills to a clinical context. All studies had a high or critical risk of bias. Thus, the quality of evidence for the effect of SBT on procedural competence was low, and evidence for its transfer to a clinical context was very low. Conclusion The evidence supporting SBT of percutaneous abdominal and thoracic US-guided procedures remains insufficient due to methodological problems and a high risk of bias. Future studies should be randomized and single-blinded, use assessment tools supported by validity evidence, compare different educational strategies, and examine the transfer of skills to a clinical setting.


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