Good Quality RCTs Research Articles

Systematic review of the literature about immunogenity and antibodies persistance of Tdap vaccination

Abstract Introduction In industrialized countries, routine use of pertussis vaccines has shifted the burden of pertussis disease from children to infants, adolescents and adults, leading to the necessity of booster doses. Materials and methods We prepared the review following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) with the aim of a) to describe the immunogenity of the main available vaccines for adolescents and adults b) to describe antibodies persistance after immunization with the main vaccines available in childhood and adults and, also, possible co-administration and c) to identify the gold standard for adolescent and adult immunizations. Results Of 6906 records identified, after removing duplicate records, 12 RCT were included (people aged 11-73): of these 7 studies had only 1 control group, 4 studies had 2 control group and 1 had 5 control group; moreover, of the 12 studies included only 2 regarding co-administration and all were about immunogenity. 9 out 12 studies had a Jadad score above 3 points and 10 out 12 meet the criteria of Cocrane Back Review Group Criteria List for Methodological Quality Assessment. Discussion and conclusions We found a limited number of good-quality RCTs investigating our object. The five component vaccines, although containing a lower dosage of antigen, are found to be more effective than one components vaccines for prevention. Evidences support the use of 5- components vaccines for booster sessions in adolescence and adulthood. Key messages • Although 3-component and 5-component vaccines contain a lower dose of antigen, they are more effective than 1-component vaccines in the prevention of diphtheria-tetanus and Bordetella pertussis. • The robustness of the data and the analytical tests support the use of vaccines with reduced antigen concentration for decennial booster sessions in adolescence and adulthood.

MINIMALLY INVASIVE GLAUCOMA SURGICAL TECHNIQUES FOR OPEN-ANGLE GLAUCOMA : A SYSTEMATIC REVIEW

Background: Glaucoma affects more than 75 million people worldwide. Intraocular pressure (IOP) lowering surgery is an important treatment for this disease. Interest in reducing surgical morbidity has led to the introduction of minimally invasive glaucoma surgeries (MIGS). Understanding the comparative effectiveness and safety of MIGS is necessary for clinicians and patients. Methods: By comparing itself to the standards set by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) 2020, this study was able to show that it met all of the requirements. So, the experts were able to make sure that the study was as up-to-date as it was possible to be. For this search approach, publications that came out between 2013 and 2023 were taken into account. Several different online reference sources, like Pubmed and SagePub, were used to do this. It was decided not to take into account review pieces, works that had already been published, or works that were only half done. Result: In the PubMed database, the results of our search brought up 318 articles, whereas the results of our search on SagePub brought up 34 articles. The results of the search conducted for the last year of 2013 yielded a total 13 articles for PubMed and 12 articles for SagePub. In the end, we compiled a total of 5 papers, 4 of which came from PubMed and 1 of which came from SagePub. We included five research that met the criteria. Conclusion: Although MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted.

Systematic review with meta-analysis: Stress-management interventions for patients with irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a common chronic gastrointestinal disorder of unknown pathological origin that is associated with psychological distress and reduced health-related quality of life (HRQoL). We investigated the effects of stress-management for adults with IBS on typical symptoms, HRQoL and mental health. With predefined criteria (patients: adults with IBS; intervention: stress-management; control: care as usual or waitlist; outcome: patient-relevant; study-type: controlled trials), we registered the study with PROSPERO (168030) and searched the main medical databases. Two researchers independently reviewed the publications and assessed the risk of bias using the Scottish Intercollegiate Guidelines Network checklist. We performed meta-analysis with homogeneous trials of acceptable quality. After screening 6656 publications, ten suitable randomized trials of acceptable (n=5) or low methodological quality (n=5) involving 587 patients were identified. Our meta-analysis showed no effect of stress-management on IBS severity 1-2months after the intervention (Hedges' g=-0.23, 95%-CI=-0.84 to -0.38, I2 =86.1%), and after 3-12months (Hedges' g=-0.77, 95%-CI=-1.77 to -0.23, I2 =93.3%). One trial found a short-term reduction of symptoms, and one trial found symptom relief in the long-term (at 6months). One of two studies that examined HRQoL found an improvement (after 2months). One of two studies that examined depression and anxiety found a reduction of these symptoms (after 3weeks). Stress-management may be beneficial for patients with IBS regarding the short-term reduction of bowel and mental health symptoms, whereas long-term benefits are unclear. Good quality RCTs with more than 6months follow-up are needed.

The effectiveness of home-based phototherapy for vitiligo: Asystematic review of randomised controlled trials.

Vitiligo may be treated with hospital-based phototherapy, but this requires long-term frequent appointments. Self-treatment using home-based phototherapy is a convenient alternative, which may improve adherence and results, but evidence is limited, and so it is not routinely recommended. This systematic review aims to assess the effectiveness and safety of home-based phototherapy for vitiligo. Searches were conducted on Medline, Scopus and The Cochrane Library for randomised controlled trials comparing home-based phototherapy with institution-based phototherapy or placebo/no phototherapy for vitiligo. The primary outcome was treatment effectiveness. CASP criteria were used for quality assessment. Data were synthesised in a meta-analysis where appropriate. Three studies (195 participants) were included: two compared home-based with institution-based phototherapy, and one compared home-based phototherapy with placebo. Studies were of mixed quality. Therapy regimes varied across studies. Findings on effectiveness were contradictory across studies with variable rates of repigmentation. There was no significant difference in repigmentation rates between the groups, although adherence to treatment schedules was significantly better in home-based groups. Adverse effects were significantly higher in home-based groups. No long-term data were reported on maintenance of treatment benefits. Although adherence to treatment was significantly better with home-based phototherapy, data were insufficient to form conclusions on effectiveness. Home-based phototherapy had a significantly higher risk of adverse effects, making it difficult to recommend in clinical practice. However, as it offers logistical advantages for patients, its effectiveness alongside additional safety measures should be explored further in large-scale, good-quality RCTs, with standardised outcome measures, including patient-reported outcomes.

Do bisphosphonates alter the clinico-radiological profile of children with Perthes disease? A systematic review and meta-analysis.

This meta-analysis is aimed to analyze the efficacy of bisphosphonates in the management of Perthes disease. A total of 8 animal and 7 human studies have been shortlisted for this analysis. In human studies, common variables for pain, Harris Hip Score (HHS), propensity for femoral head collapse, and total hip arthroplasty (THA), were assessed. In contrast, in animal studies, the data was recorded for epiphyseal quotient, trabecular volume, trabecular separation, trabecular thickness, and trabecular number. Meta-analysis of human studies on ONFH (Osteo-Necrosis of Femoral Head) revealed a statistically significant outcome in HHS [p<0.001; (95% CI: 4.79 - 8.87)], collapse of the femoral head [p=0.079; (95% CI: -0.16 - 0.01)], and THA [p=0.002; (95% CI: -0.19 - -0.04)] whereas the pain score showed an insignificant outcome [p=0.067; (95% CI: -0.62 - 0.04)]. The meta-analysis of selected variables in animal studies revealed a noteworthy outcome in bone volume (p<0.001, 95% Cl), trabecular number (p<0.001, 95% Cl), trabecular thickness (p<0.013, 95% Cl) and trabecular separation (p<0.026, 95% Cl) but not in epiphyseal quotient. Further, analysis of stratified datasets in animal studies revealed a contradictory outcome with significant observations described later in the paper. The use of bisphosphonates holds a promising treatment option in Perthes disease. Although, good quality RCTs are needed to validate it further.

Vitamin D: Magic Bullet or Much to Do About Nothing

ABSTRACT Vitamin D is a generic term that encompasses a group of fat-soluble compounds. Very few foods naturally contain vitamin D. Assessing serum 25-hydroxy-vitamin D (25(OH)D) is the only way to make the diagnosis of vitamin D deficiency, whose prevalence varies based on how deficiency is defined. Given the current evidence, the benefits of large screening programs to detect vitamin D deficiency are not recommended. The clinical manifestations of vitamin D deficiency depend upon the severity and duration of the deficiency and appears restricted to the muscular-skeletal system. Two treatment modalities currently exist for vitamin D deficiency: sunlight and vitamin D supplementation. With regards to SARS-CoV-2 infection there is no clear evidence that supplementation reduces the risk, severity of infection, length of hospital stay or mortality. Due to the lack of good quality RCTs, routine supplementation of vitamin D for extra-skeletal benefits is NOT recommended.

Direct oral anticoagulant versus low-molecular-weight heparin for treatment of venous thromboembolism in cancer patients: An updated meta-analysis of randomized controlled trials

BackgroundCancer associated venous thromboembolism (VTE) results in significant morbidity and mortality. Low molecular weight heparin (LMWH) has been standard of care for treatment of cancer-associated VTE, however direct oral anticoagulants (DOACs) are emerging as alternative treatment options. ObjectiveTo compare the benefits and harms of DOACs versus LMWH for treatment of VTE in cancer. Data sourcesMEDLINE, Embase, and the Cochrane Collaboration Central Register of Controlled Trials from inception to April 2020. Study selectionRandomized controlled trials (RCT) comparing DOACs with LMWH for treatment of VTE in cancer patients. Data synthesisFour good-quality RCTs, met inclusion criteria. Compared with LMWH, DOACs were associated with lower rates of VTE recurrence (RR 0.62; 95% CI: 0.44–0.87; P = 0.006), and DVT recurrence (RR 0.61; 95% CI: 0.4–0.94; P = 0.02) but not PE recurrence (RR 0.73; 95% CI: 0.51–1.04; P = 0.08), in cancer patients. However, the risk of clinically relevant non-major bleeding (CRNMB) (RR 1.58; 95% CI: 1.11–2.24; P = 0.01), and major bleeding in gastrointestinal cancer (RR 2.55; 95% CI 1.24–5.27, P = 0.01), were higher with DOACs. The risk of overall major bleeding (RR 1.33; 95% CI: 0.84–2.1; P = 0.22), all-cause mortality (RR 0.99; 95% CI: 0.84–1.17; P = 0.92), VTE-related mortality (RR: 1; 95% CI: 0.29–3.44; P = 1) and bleeding-related mortality (RR: 0.71; 95% CI: 0.17–2.91; P = 0.63), were similar in both treatment groups. ConclusionAmong cancer patients with VTE, treatment with DOACs is associated with a significant reduction of VTE and DVT recurrence, compared to LMWH. These benefits were offset by an increased risk of CRNMB, and major bleeding in gastrointestinal cancer.

Guidelines for the Management of Pediatric Severe Traumatic Brain Injury, Third Edition: Update of the Brain Trauma Foundation Guidelines.

Severe Traumatic Brain Injury in Infants, Children, and Adolescents in 2019: Some Overdue Progress, Many Remaining Questions, and Exciting Ongoing Work in the Field of Traumatic Brain Injury ResearchIn this Supplement to Pediatric Critical Care Medicine, we are pleased to present the Third Edition o

Systematic review of recovery protocols for athletes following ACL injuries: Surgical vs. conservative treatment

Injuries to anterior cruciate ligament (ACL) are common in sports. The treatments prescribed for torn ACL are surgical reconstruction (ACLr) and conservative management. While both treatments do not offer relief from long-term osteoarthritis (OA), the choice of the best treatment for athletes remains unclear. To assess the effectiveness of surgical versus conservative treatment for treating torn ACL in sports, a literature search in PubMed, MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, and Cochrane Library Central Register of Controlled Trials was done for randomized controlled trials/quality randomized controlled trials (RCTs/QRCTs) that compared surgical reconstruction with conservative treatment of ACL rupture in active participants. Studies were assessed for quality using PEDro clinical appraisal tool. Since the studies were heterogeneous, meta-analysis was not performed, and a “best evidence synthesis” was reported. There were four studies (RCTs/QRCTs), which met the inclusion criteria. The mean age of participants in ACLr group ranged 25.3–45.8 years, while in CON group, it was 25.5–49.3 years. Tibiofemoral OA ranged from 23% to 80% in surgery group and 28%–68% in conservative group. Three studies reported no difference between surgical and conservative group in terms of long-term OA at 10–20 years' follow-up. When assessed in terms of functional knee outcomes (Lysholm score, IKDC score, and Tegner score) and knee laxity, ACLr group showed significantly better outcomes. Thus, it may be suggested, based on functional knee outcome scores, that ACLr may help athletes resume their sporting career postinjury. Further good quality RCTs involving a large number of participants are required to strengthen the claim.

Effect of Functional Electrical Stimulation on Gait Restoration After Stroke - A Review

Stroke is one of the leading cause of disability and death throughout the world. Among the hospitalized neurological patients, 60% acquire gait disturbance. Functional electrical stimulation (FES) is a form of electrical current which helps to contract the weak muscles in the patient with stroke. Several studies were conducted to identify the effectiveness of FES on gait performance. Therefore the purpose of the article was to identify the good quality RCTs and find their results regarding the effectiveness of FES on gait performance of stroke patient. 5 randomized control trials were identified from the Physiotherapy Evidence Database (PEDro) and their score was 5 and above. A careful analysis was performed to make synopsis of those articles and presented in table with description. The first 4 studies found that a combination approach such as Mirror Therapy, Action Observational Training, Brain-computer interface and standard rehabilitation along with FES is effective in gait performance than the FES alone. One study compared the effectiveness of dual and four channels FES where they found 4 channels FES is more effective than dual channel. Therefore the review concluded that FES combined with other treatment modalities is beneficial to restore gait performance of patient with stroke.

Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis.

BackgroundMIGS have been developed as a surgical alternative for glaucomatous patients.PurposeTo analyze the change in intraocular pressure (IOP) and glaucoma medications using different MIGS devices (Trabectome, iStent, Excimer Laser Trabeculotomy (ELT), iStent Supra, CyPass, XEN, Hydrus, Fugo Blade, Ab interno canaloplasty, Goniscopy-assisted transluminal trabeculotomy) as a solo procedure or in association with phacoemulsification.MethodsRandomized control trials (RCT) and non-RCT (non randomized comparative studies, NRS, and before-after studies) were included. Studies with at least one year of follow-up in patients affected by primary open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma were considered. Risk of Bias assessment was performed using the Cochrane Risk of Bias and the ROBINS-I tools. The main outcome was the effect of MIGS devices compared to medical therapy, cataract surgery, other glaucoma surgeries and other MIGS on both IOP and use of glaucoma medications 12 months after surgery. Outcomes measures were the mean difference in the change of IOP and glaucoma medication compared to baseline at one and two years and all ocular adverse events. The current meta-analysis is registered on PROSPERO (reference n° CRD42016037280).ResultsOver a total of 3,069 studies, nine RCT and 21 case series with a total of 2.928 eyes were included. Main concerns about risk of bias in RCTs were lack of blinding, allocation concealment and attrition bias while in non-RCTs they were represented by patients’ selection, masking of participants and co-intervention management. Limited evidence was found based on both RCTs and non RCTs that compared MIGS surgery with medical therapy or other MIGS. In before-after series, MIGS surgery seemed effective in lowering both IOP and glaucoma drug use. MIGS showed a good safety profile: IOP spikes were the most frequent complications and no cases of infection or BCVA loss due to glaucoma were reported.ConclusionsAlthough MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted.

Zinc supplementation as an adjunct to standard therapy in childhood nephrotic syndrome - a systematic review.

AIMTo evaluate the role of zinc as add on treatment to the “recommended treatment” of nephrotic syndrome (NS) in children.METHODSAll the published literature through the major databases including Medline/Pubmed, Embase, and Google Scholar were searched till 31st December 2015. Reference lists from the articles were reviewed to identify additional pertinent articles. Retrieved papers concerning the role of zinc in childhood NS were reviewed by the authors, and the data were extracted using a standardized data collection tool. Randomized trials (RCTs) comparing zinc vs placebo was included. Effect of zinc was studied in both steroid sensitive and steroid dependent/frequent relapsing NS. The primary outcome measure was the risk of relapse in 12 mo. The secondary outcome measures were mean relapse rate per patient in 12 mo, mean relapse rate per patient in 6 mo, risk of infection associated relapse in 12 mo, cumulative dose of steroids in two groups, mean length of time to next relapse, adverse effects of therapy, and change in serum zinc levels.RESULTSOf 54 citations retrieved, a total of 6 RCTs were included. Zinc was used at a dose of 10-20 mg/d, for the duration that varied from 6-12 mo. Compared to placebo, zinc reduced the frequency of relapses, induced sustained remission/no relapse, reduced the proportion of infection episodes associated with relapse with a mild adverse event in the form of metallic taste. The GRADE evidence generated was of “very low-quality”.CONCLUSIONZinc may be a useful additive in the treatment of childhood NS. The evidence generated mostly was of “very low-quality”. We need more good quality RCTs in different country setting as well different subgroups of children before any firm recommendation can be made.

Sexual problems and post‐traumatic stress disorder following sexual trauma: A meta‐analytic review

Difficulties with sex often develop following sexual trauma, yet are rarely targeted within treatment of post-traumatic stress disorder (PTSD). Where outcomes of sexual function are included, they are secondary to other measures. This review aimed to assess whether psychological treatment for PTSD (from sexual trauma) has an effect on sexual functioning. Systematic searches of MEDLINE, PsycINFO, EMBASE, and trial registers were performed. Five studies met inclusion criteria. Pre-post treatment effect sizes were also calculated. Data from four good-quality RCTs were included in the meta-analyses. These examined females (n=799) who had experienced adult sexual trauma or child sexual abuse. Studies compared psychological treatment to control conditions, but no effect on outcomes of sexual concerns, standardized mean difference (SMD)=0.03 and dysfunctional sexual behaviour, SMD=0.02, was found. Pre-post treatment effect sizes were small to medium (SMD=0.36 and 0.47, respectively). While firm conclusions cannot be drawn, the available evidence suggests that psychological treatment for PTSD has no effect on sexual problems. Pre-post effects indicate some improvement over the course of treatment, which may be strengthened if treatment actively targeted sexual problems. The paucity of evidence in this area suggests that there is substantial need for further research in order to establish a set of evidence-based guidelines for practitioners implementing treatment in this area. The measurement of sexual problems is overlooked in psychological treatment RCTs for sexual trauma. Current treatments for post-traumatic stress disorder (PTSD) from sexual trauma do not appear to be addressing sexual problems. Integrated treatments for comorbid sexual problems and PTSD treatment may be warranted. It is imperative that in future, RCTs that examine people with PTSD from sexual trauma use outcomes of sexual problems.

Skin Substitutes and Dermatology: A Review

Death from large burn wounds has pushed the development of life-saving techniques to cover and heal these wounds as rapidly as possible, resulting in a variety of tissue engineered skin substitutes available on the market. There remains a paucity of good quality RCTs evaluating the efficacy of skin substitutes, and even fewer studies comparing products to each other. While some products have been used successfully for dermatologic applications and published in the literature, a vast majority of data that we do have on skin substitutes relates to chronic wound management and care of burn patients. Though not specific to our specialty, the use of skin substitutes for these indications can be extrapolated to dermatology. Understanding the composition, advantages/disadvantages, and risk/benefit of each product, as well as the indications for each product’s use, facilitates the selection of the appropriate substitute. This review will hopefully provide the information that makes the use of these products feasible for the appropriate defect.

Interventions for HIV-associated nephropathy

Human immunodeficiency virus-associated nephropathy (HIVAN) is the most common cause of end stage kidney disease (ESKD) in human immunodeficiency virus-1 (HIV-1) serotype patients and it mostly affects patients of African descent. It rapidly progresses to ESKD if untreated. The goal of treatment is directed toward reducing HIV-1 replication and/or slowing the progression of chronic kidney disease. The following pharmacological agents have been used for the treatment of HIVAN: antiretroviral therapy, angiotensin-converting enzyme inhibitors (ACEi), steroids and recently cyclosporin. Despite this, the effect of each intervention is yet to be evaluated. To evaluate the benefits and harms of adjunctive therapies in the management of HIVAN and its effects on symptom severity and all-cause mortality. In January 2012 we searched the Cochrane Renal Group's Specialised Register, AIDS Education Global Information System (AEGIS database), ClinicalTrial.gov, the WHO International Clinical Trials Registry Portal, and reference lists of retrieved articles without language restrictions. In our original review we searched CENTRAL, MEDLINE, EMBASE, and AIDSearch, in addition to contacting individual researchers, research organisations and pharmaceutical companies. Randomised controlled trials (RCTs) and quasi-RCTs of any therapy used in the treatment of HIVAN. We independently screened the search outputs for relevant studies and to retrieve full articles when necessary. For dichotomous outcomes results were to be expressed as risk ratios with 95% confidence intervals, and for continuous scales of measurement the mean difference was to be used. We identified four relevant ongoing studies: one is still ongoing; two have completed recruitment but are yet to be published; and the fourth study was suspended for unspecified reasons. No completed RCTs or quasi-RCTs were identified. We summarised and tabulated the data from the observational studies, however no formal analyses were performed. There is currently no RCT-based evidence upon which to base guidelines for the treatment of HIVAN, however three ongoing studies have been identified. Data from observational studies suggest steroids and angiotensin-converting enzyme inhibitors appear to improve kidney function in patients with HIVAN, however no formal analyses were performed in this review. This review highlights the need for good quality RCTs to address the effects of interventions for treating this group.

TB and vitamin D

In a nutshellVitamin D levels are lower in TB, and linked with resistance to and recovery from the clinical disease. This is most likely related to the vitamin's immunological functions.Vitamin D has been used as part of clinical treatment for TB for over 50 years, but the few good quality RCTs do not collectively provide any clear answer on whether it is effective in this role.

Cranberries for preventing urinary tract infections.

Cranberries (particularly in the form of cranberry juice) have been used widely for several decades for the prevention and treatment of urinary tract infections (UTIs). The aim of this review is to assess the effectiveness of cranberries in preventing such infections. To assess the effectiveness of cranberry juice and other cranberry products in preventing UTIs in susceptible populations. Electronic databases and the Internet were searched using English and non English language terms; companies involved with the promotion and distribution of cranberry preparations were contacted; reference lists of review articles and relevant trials were searched. Cochrane Central Register of Controlled Trials (CENTRAL - the Cochrane Library, issue 1, 2003) was searched in February 2003. All randomised or quasi randomised controlled trials of cranberry juice/products for the prevention of urinary tract infections in susceptible populations. Trials of men, women or children were included. Two reviewers independently assessed and extracted information. Information was collected on methods, participants, interventions and outcomes (urinary tract infections (symptomatic and asymptomatic), side effects and adherence to therapy). RR were calculated where appropriate, otherwise a narrative synthesis was undertaken. Quality was assessed using the Cochrane criteria. Seven trials met the inclusion criteria (four cross-over, three parallel group). The effectiveness of cranberry juice (or cranberry-lingonberry juice) versus placebo juice or water was evaluated in six trials, and the effectiveness of cranberries tablets versus placebo was evaluated in two trials (one study evaluated both juice and tablets). In two good quality RCTs, cranberry products significantly reduced the incidence of UTIs at twelve months (RR 0.61 95% CI:0.40 to 0.91) compared with placebo/control in women. One trial gave 7.5 g cranberry concentrate daily (in 50 ml), the other gave 1:30 concentrate given either in 250 ml juice or in tablet form. There was no significant difference in the incidence of UTIs between cranberry juice versus cranberry capsules (RR 1.11 95% CI:0.49 to 2.50). Five trials were not included in the meta-analyses due to methodological flaws or lack of available data. However, only one reported a significant result for the outcome of symptomatic UTIs. Side effects were common in all trials, and dropouts/withdrawals in several of the trials were high. There is some evidence from two good quality RCTs that cranberry juice may decrease the number of symptomatic UTIs over a 12 month period in women. If it is effective for other groups such as children and elderly men and women is not clear. The large number of dropouts/withdrawals from some of the trials indicates that cranberry juice may not be acceptable over long periods of time. In addition it is not clear what is the optimum dosage or method of administration (e.g. juice or tablets). Further properly designed trials with relevant outcomes are needed.