scholarly journals Effectiveness and safety of low-level laser therapy in diabetic peripheral neuropathy: a protocol for a systematic review and meta-analysis

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Lin Lin ◽  
Jingjing Li ◽  
Jingshan Lin ◽  
Shiheng Tang ◽  
Yuxia Li

Abstract Background Diabetic peripheral neuropathy (DPN) is one of the most common chronic complications of diabetes mellitus. The main symptoms of DPN include numbness or pain in both extremities and paresthesia (such as formication or burning sensations), which greatly affect patients’ quality of life. Pharmacological treatments for DPN are associated with both uncertain therapeutic effects and adverse effects, as well as with high costs. Some clinical studies have reported that low-level laser therapy (LLLT) relieves clinical symptoms and improves nerve function in patients with DPN. We intend to conduct a systematic review and meta-analysis to further evaluate the effectiveness and safety of LLLT for DPN. Methods The following electronic databases will be searched to retrieve literature from their inception until December 2020: MEDLINE (PubMed), Embase, Cochrane Central Register of Controlled Trials, Web of Science (the Science and Social Science Citation Index), CNKI, VIP, WanFang, and SinoMed. Simultaneously, clinical registration tests and gray literature will also be retrieved. Randomized controlled trials (RCTs) comparing LLLT with either sham LLLT, no (specific) treatment, or active conventional medical treatments will be included. The primary outcomes will be nerve conduction velocity as well as clinical scores that assess neurological function and related symptoms. The risk of bias of each study and quality of evidence will be assessed using the updated Cochrane Risk of Bias 2.0 tool and GRADE approach, respectively. A meta-analysis will then be conducted using Review Manager software version 5.3. Discussion This study will integrate RCTs and analyze data to provide a detailed summary of the evidence relating to the effects and safety of LLLT in patients with DPN. LLLT will be compared with sham LLLT, no (specific) treatment, or active conventional medical treatments, especially in terms of neurological function, quality of life, and adverse events. In conclusion, this systematic review will generate evidence regarding the use of LLLT to treat DPN, in terms of both its efficacy and safety. Systematic review registration This protocol was registered with the International Prospective Register of Systematic Reviews on April 2020 (registration number: CRD42020170625).

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031142 ◽  
Author(s):  
Martin Bjørn Stausholm ◽  
Ingvill Fjell Naterstad ◽  
Jon Joensen ◽  
Rodrigo Álvaro Brandão Lopes-Martins ◽  
Humaira Sæbø ◽  
...  

ObjectivesLow-level laser therapy (LLLT) is not recommended in major knee osteoarthritis (KOA) treatment guidelines. We investigated whether a LLLT dose–response relationship exists in KOA.DesignSystematic review and meta-analysis.Data sourcesEligible articles were identified through PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Physiotherapy Evidence Database and Cochrane Central Register of Controlled Trials on 18 February 2019, reference lists, a book, citations and experts in the field.Eligibility criteria for selecting studiesWe solely included randomised placebo-controlled trials involving participants with KOA according to the American College of Rheumatology and/or Kellgren/Lawrence criteria, in which LLLT was applied to participants’ knee(s). There were no language restrictions.Data extraction and synthesisThe included trials were synthesised with random effects meta-analyses and subgrouped by dose using the World Association for Laser Therapy treatment recommendations. Cochrane’s risk-of-bias tool was used.Results22 trials (n=1063) were meta-analysed. Risk of bias was insignificant. Overall, pain was significantly reduced by LLLT compared with placebo at the end of therapy (14.23 mm Visual Analogue Scale (VAS; 95% CI 7.31 to 21.14)) and during follow-ups 1–12 weeks later (15.92 mm VAS (95% CI 6.47 to 25.37)). The subgroup analysis revealed that pain was significantly reduced by the recommended LLLT doses compared with placebo at the end of therapy (18.71 mm (95% CI 9.42 to 27.99)) and during follow-ups 2–12 weeks after the end of therapy (23.23 mm VAS (95% CI 10.60 to 35.86)). The pain reduction from the recommended LLLT doses peaked during follow-ups 2–4 weeks after the end of therapy (31.87 mm VAS significantly beyond placebo (95% CI 18.18 to 45.56)). Disability was also statistically significantly reduced by LLLT. No adverse events were reported.ConclusionLLLT reduces pain and disability in KOA at 4–8 J with 785–860 nm wavelength and at 1–3 J with 904 nm wavelength per treatment spot.PROSPERO registration numberCRD42016035587.


BMJ ◽  
2021 ◽  
pp. m4743
Author(s):  
Joshua Z Goldenberg ◽  
Andrew Day ◽  
Grant D Brinkworth ◽  
Junko Sato ◽  
Satoru Yamada ◽  
...  

Abstract Objective To determine the efficacy and safety of low carbohydrate diets (LCDs) and very low carbohydrate diets (VLCDs) for people with type 2 diabetes. Design Systematic review and meta-analysis. Data sources Searches of CENTRAL, Medline, Embase, CINAHL, CAB, and grey literature sources from inception to 25 August 2020. Study selection Randomized clinical trials evaluating LCDs (<130 g/day or <26% of a 2000 kcal/day diet) and VLCDs (<10% calories from carbohydrates) for at least 12 weeks in adults with type 2 diabetes were eligible. Data extraction Primary outcomes were remission of diabetes (HbA 1c <6.5% or fasting glucose <7.0 mmol/L, with or without the use of diabetes medication), weight loss, HbA 1c , fasting glucose, and adverse events. Secondary outcomes included health related quality of life and biochemical laboratory data. All articles and outcomes were independently screened, extracted, and assessed for risk of bias and GRADE certainty of evidence at six and 12 month follow-up. Risk estimates and 95% confidence intervals were calculated using random effects meta-analysis. Outcomes were assessed according to a priori determined minimal important differences to determine clinical importance, and heterogeneity was investigated on the basis of risk of bias and seven a priori subgroups. Any subgroup effects with a statistically significant test of interaction were subjected to a five point credibility checklist. Results Searches identified 14 759 citations yielding 23 trials (1357 participants), and 40.6% of outcomes were judged to be at low risk of bias. At six months, compared with control diets, LCDs achieved higher rates of diabetes remission (defined as HbA 1c <6.5%) (76/133 (57%) v 41/131 (31%); risk difference 0.32, 95% confidence interval 0.17 to 0.47; 8 studies, n=264, I 2 =58%). Conversely, smaller, non-significant effect sizes occurred when a remission definition of HbA 1c <6.5% without medication was used. Subgroup assessments determined as meeting credibility criteria indicated that remission with LCDs markedly decreased in studies that included patients using insulin. At 12 months, data on remission were sparse, ranging from a small effect to a trivial increased risk of diabetes. Large clinically important improvements were seen in weight loss, triglycerides, and insulin sensitivity at six months, which diminished at 12 months. On the basis of subgroup assessments deemed credible, VLCDs were less effective than less restrictive LCDs for weight loss at six months. However, this effect was explained by diet adherence. That is, among highly adherent patients on VLCDs, a clinically important reduction in weight was seen compared with studies with less adherent patients on VLCDs. Participants experienced no significant difference in quality of life at six months but did experience clinically important, but not statistically significant, worsening of quality of life and low density lipoprotein cholesterol at 12 months. Otherwise, no significant or clinically important between group differences were found in terms of adverse events or blood lipids at six and 12 months. Conclusions On the basis of moderate to low certainty evidence, patients adhering to an LCD for six months may experience remission of diabetes without adverse consequences. Limitations include continued debate around what constitutes remission of diabetes, as well as the efficacy, safety, and dietary satisfaction of longer term LCDs. Systematic review registration PROSPERO CRD42020161795.


PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248484
Author(s):  
Ena Bula-Oyola ◽  
Juan-Manuel Belda-Lois ◽  
Rosa Porcar-Seder ◽  
Álvaro Page

Introduction People with ulnar, radial or median nerve injuries can present significant impairment of their sensory and motor functions. The prescribed treatment for these conditions often includes electrophysical therapies, whose effectiveness in improving symptoms and function is a source of debate. Therefore, this systematic review aims to provide an integrative overview of the efficacy of these modalities in sensorimotor rehabilitation compared to placebo, manual therapy, or between them. Methods We conducted a systematic review according to PRISMA guidelines. We perform a literature review in the following databases: Biomed Central, Ebscohost, Lilacs, Ovid, PEDro, Sage, Scopus, Science Direct, Semantic Scholar, Taylor & Francis, and Web of Science, for the period 1980–2020. We include studies that discussed the sensorimotor rehabilitation of people with non-degenerative ulnar, radial, or median nerve injury. We assessed the quality of the included studies using the Risk of Bias Tool described in the Cochrane Handbook of Systematic Reviews of Interventions and the risk of bias across studies with the GRADE approach described in the GRADE Handbook. Results Thirty-eight studies were included in the systematic review and 34 in the meta-analysis. The overall quality of evidence was rated as low or very low according to GRADE criteria. Low-level laser therapy and ultrasound showed favourable results in improving symptom severity and functional status compared to manual therapy. In addition, the low level laser showed improvements in pinch strength compared to placebo and pain (VAS) compared to manual therapy. Splints showed superior results to electrophysical modalities. The clinical significance of the results was assessed by effect size estimation and comparison with the minimum clinically important difference (MCID). Conclusions We found favourable results in pain relief, improvement of symptoms, functional status, and neurophysiological parameters for some electrophysical modalities, mainly when applied with a splint. Our results coincide with those obtained in some meta-analyses. However, none of these can be considered clinically significant. Trial registration PROSPERO registration number CRD42020168792; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=168792.


BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e045819
Author(s):  
Jinhui Ma ◽  
Megan Cheng ◽  
Lehana Thabane ◽  
Caihong Ma ◽  
Ning Zhang ◽  
...  

IntroductionThe aetiology of sleep disruptions is unknown, but hormonal fluctuations during the menstrual cycle, pregnancy and menopause have been shown to potentially affect how well a woman sleeps. The aim of this systematic review was to investigate whether hormonal contraceptives are associated with a decreased quality of sleep and increased sleep duration in women of reproductive age.MethodsThis review will analyse data from randomised controlled trials or non-randomised comparative studies investigating the association between hormonal contraceptives and sleep outcomes among women of reproductive age. Reviews addressing the same research question with similar eligibility criteria will be included. A literature search will be performed using the MEDLINE, Embase and Cochrane Central Register of Controlled Trials databases from inception to 7 March 2021. The Cochrane Collaboration’s Risk of Bias for Randomised Trials V.2.0 and The Risk of Bias for Non-randomised Studies of Interventions tool will be used to assess risk of bias for each outcome in eligible studies. Two reviewers will independently assess eligibility of studies and risk of bias and extract the data. All extracted data will be presented in tables and narrative form. For sleep measures investigated by two or more studies with low heterogeneity, we will conduct random-effects meta-analysis to estimate the magnitude of the overall effect of hormonal contraceptives. If studies included in this systematic review form a connected network, a network meta-analysis will be conducted to estimate the comparative effect of different contraceptives. The Grading of Recommendations, Assessment, Development, and Evaluation approach will be used to summarise the quality of evidence. Our protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols 2015 guidelines.Ethics and disseminationEthics approval is not required as data were sourced from previously reported studies. The findings of this review will be published in a peer-reviewed journal and presented at relevant conferences.PROSPERO registration numberCRD42020199958.


2021 ◽  
pp. archdischild-2020-320389
Author(s):  
Sarah Nicolas ◽  
Yohan Gallois ◽  
Marie-Noëlle Calmels ◽  
Olivier Deguine ◽  
Bernard Fraysse ◽  
...  

ObjectiveTo evaluate the treatments’ consequences for unilateral hearing loss in children.DesignSystematic review and meta-analysis (CRD42018109417). The MEDLINE, CENTRAL, ISRCTN and ClinicalTrials databases were searched between September 2018 and May 2019. Articles were screened and data were collected independently by two authors following the Cochrane and Preferred Reporting Items for Systematic review and Meta-Analysis guidelines. The risk of bias was evaluated using the Cochrane tool, the Newcastle-Ottawa Scale, the National Institute of Health, USA tool and considering the risk of confounding. In the studies with the lowest risk of bias, a meta-analysis was conducted.InterventionsValidated hearing rehabilitation devices.Patients6–15 years old children with moderate to profound unilateral hearing loss.Main outcome measuresThe primary study outcome was children’s quality of life. Academic performances were studied as an additional outcome.Results731 unique articles were identified from the primary search. Of these, 18 articles met the Population, Intervention, Control, Outcomes and Study design selection criteria. In the eight studies with the lowest risk of bias, two meta-analysis were conducted. There was not enough data on academic results to conduct a meta-analysis. In 73 children included in a fixed effect meta-analysis (two studies), no effect of treatment could be shown (g=−0.20, p=0.39). In 61 children included in a random-effect meta-analysis (six studies), a strong positive effect of hearing treatment on quality of life was demonstrated (g=1.32, p<0.05).ConclusionsThe treatment of unilateral hearing loss seems to improve children’s quality of life. Further research is needed to identify the most effective treatment and its corresponding indications.


2020 ◽  
Author(s):  
Tahereh Mokhtarian-Gilani ◽  
Nourossadat kariman ◽  
Hamid Sharif-Nia ◽  
Mahbobeh Ahmadi-Doulabi ◽  
Malihe Nasiri

Abstract Background:The postpartum quality of life refers to women's understanding of their standing in the postpartum crisis that differs depending on their health status, social support, cultural status and values, attitudes, goals and standards. The present systematic review will identify, describe, and critically assess the psychometric properties of postpartum quality of life questionnaires.Methods/Design:A systematic review will be conducted in databases including PubMed, Embase, Scopus, Web of Science, PsycINFO, and CINAHL from January 2000 to January 2020. The psychometric properties (validity and reliability) of the instruments used in the primary studies will be assessed, and the selection, methodological quality assessment and data extraction processes of the studies will be independently assessed by two reviewers with expertise in conducting systematic reviews, so as to minimize potential personal bias. Eligible resources are selected after any lack of consensus is put to debate.The risk of bias is assessed using the COSMIN RISK of Bias checklist, and to evaluate the quality of the studies, the protocol is written based on the PRISMA-P1 standards. The results of the studies will be judged based on good measurement properties, and the results of all the studies are qualitatively summarized to produce a reference for the general quality of the results. The general quality of the evidence will be determined using a modified GRADE method.Discussion:This study assessed the psychometric properties of questionnaires used for assessing postpartum quality of life and its results can be used to identify the most appropriate tool for health applications in measuring postpartum quality of life. Systematic review registration: reference number in PROSPRO CRD42020166301


2020 ◽  
Vol 29 (155) ◽  
pp. 190057 ◽  
Author(s):  
Roeland Vis ◽  
Ewoudt M.W. van de Garde ◽  
Jan C. Grutters ◽  
Ingrid H.E. Korenromp

AimsMany sarcoidosis patients experience a reduction in health-related quality of life (HRQoL) and a majority of patients report fatigue. Historically, drug trials in sarcoidosis have focused on changes in chest radiographs, lung function parameters and biomarkers, while HRQoL and fatigue have not been the main outcomes examined. We performed a systematic review of the literature to evaluate the existing evidence on the effects of pharmacological interventions on HRQoL and fatigue outcomes.MethodsThe systematic search was performed in Medline and Embase and yielded 15 records covering seven randomised controlled trials and seven single-arm open label studies, which were included in a qualitative synthesis (the results of one study were included in two publications). 12 studies evaluated immunosuppressive and/or immunomodulatory therapies and two studies evaluated stimulants.ResultsNine out of the 14 studies observed positive treatment effects from the interventions on HRQoL and/or fatigue, exceeding the minimal important difference. The risk of bias was generally high with only three studies rated as having a low risk of bias. The results suggest a potential for improvement in HRQoL and/or fatigue in patients with active disease who are either untreated or treated but not yet fully stabilised or therapy refractory.ConclusionMore randomised, double-blind and placebo-controlled trials are needed to expand the evidence base on these important outcome parameters.


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