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The Cochrane Database of Systematic... Nov 2021Lamellar macular holes (LMHs) are small, partial-thickness defects of the macula defined by characteristic features on optical coherence tomography (OCT), including a... (Review)
Review
BACKGROUND
Lamellar macular holes (LMHs) are small, partial-thickness defects of the macula defined by characteristic features on optical coherence tomography (OCT), including a newly recognised type of epiretinal membrane termed 'epiretinal proliferation'. There may be a rationale to recommend surgery for individuals with LMHs, particularly those with functional or anatomical deterioration, or poor baseline vision causing significant disability, to stabilise the LMH and prevent further visual deterioration; however, there is currently no evidence-based consensus.
OBJECTIVES
To assess the effect of surgical interventions on post-operative visual and anatomical outcomes in people with a confirmed LMH.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, Scopus SciVerse, ISRCTN registry, US National Institutes of Health Ongoing Trials Register, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We also searched reference lists of included trials to identify other eligible trials which our search strategy may have missed. The date of the search was 20 July 2021.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) involving participants with a confirmed LMH diagnosis which reported one or more surgical intervention(s), alone or in combination, in at least one arm of the RCT.
DATA COLLECTION AND ANALYSIS
We used standard methods as expected by Cochrane. Two study authors independently extracted data and assessed the risk of bias for included trials. Trial authors were contacted for further information and clarification.
MAIN RESULTS
A single RCT was eligible for inclusion. Thirty-six participants were randomised in a 2:1 ratio; 24 were allocated to undergo surgery (pars plana vitrectomy, peeling of the epiretial proliferation followed by fovea-sparing removal of the internal limiting membrane) and 12 (10 following two participant dropouts) to observation. Overall, the certainty of the evidence was low for all outcomes due to selection and detection bias, and the low number of participants enrolled in the study which may affect the accuracy of results and reliability of conclusions. At six-month follow-up, change in vision was better in the surgery group (-0.27 logMAR improvement) than observation (0.02 worsening) (mean difference (MD): -0.29 logMAR, 95% confidence intervals (CI): -0.33 to -0.25). Central retinal thickness increased in the surgery group over 6 months 126 μm increase) compared with observation group (decrease by 11μm) (MD: 137 μm, 95% CI: 125.87 μm to 148.13 μm). Finally, at six-month follow-up, retinal sensitivity was better in the surgery group (3.03 dB increase) compared with the observation group (0.06 dB decrease) (MD: 3.09 dB, 95% CI: 2.07 to 4.11 dB). Vision-related quality of life and metamorphopsia were not reported. No adverse outcomes or complications were reported in the study, however, authors could not provide information on whether any individuals developed deterioration in vision of 0.2 logMAR or worse.
AUTHORS' CONCLUSIONS
The included single trial demonstrated improvements in visual and anatomical outcome measures for participants with a LMH who underwent surgery compared with observation only. Therefore, we can conclude that participants who undergo surgery may achieve superior post-operative best corrected visual acuity and anatomical outcomes compared with observation only. However, the results of a single and small RCT provides limited evidence to support or refute surgery as an effective management option for LMHs. Future RCTs with a larger number of participants and with fewer methodological limitations and biases are necessary to inform future clinical practice.
Topics: Humans; Macula Lutea; Randomized Controlled Trials as Topic; Retina; Retinal Perforations; Visual Acuity; Vitrectomy
PubMed: 34748208
DOI: 10.1002/14651858.CD013678.pub2 -
European Journal of Internal Medicine Jul 2023There is a lack of consensus regarding the best add on therapy for treatment of resistant hypertension (RH). This is likely secondary to a paucity of data on the... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
There is a lack of consensus regarding the best add on therapy for treatment of resistant hypertension (RH). This is likely secondary to a paucity of data on the comparative effectiveness of proposed therapies for RH.
METHODS
Placebo-controlled and sham-controlled randomized clinical trials testing therapies for the treatment of RH were included in this meta-analysis. Therapies with two or more studies were included as subgroups in this meta-analysis. The primary outcomes being tested were 24-hr systolic blood pressure (SBP) and office SBP.
RESULTS
Eight studies were identified that tested mineralocorticoid receptor antagonist (MRA) including 1,414 participants. The raw mean difference (RMD) between MRA and placebo control was statistically significant for 24-hour SBP (-10.56 mmHg; 95% confidence interval (CI) -12.82 to -8.30), 24-hour diastolic (DBP) (-5.48 mmHg; 95% CI -8.48 to -2.58), office SBP (-11.97 mmHg; 95% CI -16.41 to -7.54), and office DBP (-4.14 mmHg; 95% CI -5.62 to -2.65). Six studies were identified that tested renal denervation (RD) including 989 participants. The RMD between RD and sham control was not statistically significant for 24-hour SBP (-1.84 mmHg; 95% CI -3.92 to 0.24), 24-hour DBP (-0.66 mmHg; 95% CI -1.85 to 0.54), office SBP (-1.57 mmHg; 95% CI -6.04 to 2.89), and office DBP (-1.49 mmHg; 95% CI -3.52 to 0.55). Four studies were identified that tested endothelin receptor antagonists (ERA) including 1,193 participants. The raw mean difference (RMD) between ERA and placebo control was statistically significant for 24-hr systolic (SBP) (-7.02 mmHg; 95% CI -9.15 to -4.90, 24-hr diastolic (DBP) (-6.22 mmHg; 95% CI -7.61 to -4.82), office SBP (-5.84 mmHg; 95% CI -10.08 to -1.60), and office DBP (-3.73 mmHg; 95% CI -5.87 to -1.59).
DISCUSSION
MRA lowers BP in patients with RH more than RD, which seems to have little to no effect in RH. ERAs lead to a statistically significant reduction in BP but the confidence in efficacy is limited due to the low number of studies and differences in trial population. Individual factors and their impact on treatment response in RH should be investigated in future research.
Topics: Humans; Hypertension; Blood Pressure; Kidney; Antihypertensive Agents; Randomized Controlled Trials as Topic
PubMed: 37150718
DOI: 10.1016/j.ejim.2023.04.021 -
Medicine Dec 2021Acupuncture is widely used for oligospermia and asthenozoospermia in China, but its effect is unclear. We aimed to determine the effectiveness and safety of acupuncture... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Acupuncture is widely used for oligospermia and asthenozoospermia in China, but its effect is unclear. We aimed to determine the effectiveness and safety of acupuncture in treating oligospermia and asthenozoospermia.
METHODS
An electronic search for randomized controlled trials evaluating acupuncture treatment in patients with oligospermia and asthenozoospermia published from database inception to October 2018 was conducted in PubMed, EMBASE, the Chinese Biomedical Literature Database, the Chinese Scientific Journal Database (VIP Database), the Wan-Fang Database, the China National Knowledge Infrastructure and the Cochrane Library. We established search terms related to 3 areas (oligospermia, asthenozoospermia, and acupuncture). Two authors independently screened all identified citations and extracted the data. The methodological quality of the included trials was assessed using the Cochrane criteria.
RESULTS
Seven studies with a total of 527 subjects were screened according to inclusion and exclusion standards, and most of the studies had significant methodological weaknesses. Seven randomized controlled trials tested the effects of acupuncture compared with placebo acupuncture and conventional medications in patients with oligospermia and asthenozoospermia. The results of this study suggest that acupuncture alone has no clear superiority in improving sperm motility (standard mean difference [SMD] = 1.13, 95% confidence interval [CI]: -0.64 to 2.89), the sperm concentration (SMD = 0.32, 95% CI: 0.27-0.92) or semen volume compared with placebo acupuncture. No significant difference was found between acupuncture alone and conventional medications in improving sperm motility (SMD = -0.53, 95% CI: -2.54 to 1.48), the sperm concentration (SMD = -1.10, 95% CI: -1.48 to -0.72) or semen volume. However, adjuvant acupuncture may enhance the effect of medications on improving sperm motility (SMD = 4.10, 95% CI: 1.09-7.12) and the sperm concentration (SMD = 1.07, 95% CI: 0.739-1.40), but the study heterogeneity was too high to establish robust conclusions.
CONCLUSION
These results suggest that the current evidence does not support acupuncture as an effective treatment for oligospermia and asthenozoospermia; therefore, acupuncture is not currently recommended as a treatment for these conditions. However, owing to the high risk of bias among the included studies, the evidence is limited, and more large-scale, high-quality clinical trials are needed in the future.
TRIAL REGISTRATION NUMBER
PROSPERO CRD42018083885.
Topics: Acupuncture Therapy; Asthenozoospermia; Humans; Male; Oligospermia; Randomized Controlled Trials as Topic; Sperm Motility; Treatment Outcome
PubMed: 35049183
DOI: 10.1097/MD.0000000000027816 -
Medicina (Kaunas, Lithuania) Oct 2022: The positive implications of using free light chains in diagnosing multiple sclerosis have increasingly gained considerable interest in medical research and the... (Meta-Analysis)
Meta-Analysis Review
: The positive implications of using free light chains in diagnosing multiple sclerosis have increasingly gained considerable interest in medical research and the scientific community. It is often presumed that free light chains, particularly kappa and lambda free light chains, are of practical use and are associated with a higher probability of obtaining positive results compared to oligoclonal bands. The primary purpose of the current paper was to conduct a systematic review to assess the up-to-date methods for diagnosing multiple sclerosis using kappa and lambda free light chains. : An organized literature search was performed across four electronic sources, including Google Scholar, Web of Science, Embase, and MEDLINE. The sources analyzed in this systematic review and meta-analysis comprise randomized clinical trials, prospective cohort studies, retrospective studies, controlled clinical trials, and systematic reviews. : The review contains 116 reports that includes 1204 participants. The final selection includes a vast array of preexisting literature concerning the study topic: 35 randomized clinical trials, 21 prospective cohort studies, 19 retrospective studies, 22 controlled clinical trials, and 13 systematic reviews. : The incorporated literature sources provided integral insights into the benefits of free light chain diagnostics for multiple sclerosis. It was also evident that the use of free light chains in the diagnosis of clinically isolated syndrome (CIS) and multiple sclerosis is relatively fast and inexpensive in comparison to other conventional state-of-the-art diagnostic methods, e.g., using oligoclonal bands (OCBs).
Topics: Humans; Oligoclonal Bands; Multiple Sclerosis; Retrospective Studies; Prospective Studies; Immunoglobulin kappa-Chains; Immunoglobulin lambda-Chains; Immunoglobulin Light Chains; Randomized Controlled Trials as Topic
PubMed: 36363469
DOI: 10.3390/medicina58111512 -
European Journal of Nutrition Feb 2023A healthy diet is fundamental for healthy growth and for future disease prevention. However, scientific consensus on how to compose healthy diets for children has not... (Meta-Analysis)
Meta-Analysis Review
Effects of foods, beverages and macronutrients on BMI z-score and body composition in children and adolescents: a systematic review and meta-analysis of randomized controlled trials.
PURPOSE
A healthy diet is fundamental for healthy growth and for future disease prevention. However, scientific consensus on how to compose healthy diets for children has not been established. Therefore, a systematic review and meta-analysis was performed to investigate if an independent effect exists between foods, beverages or the composition of macronutrients and body composition in children and adolescents.
METHODS
A systematic search was performed in four databases up to July 2021. A systematic review of randomized controlled studies (RCTs) and meta-analyses were carried out by extracting mean difference (MDs) and standard deviation (SD) and performed using the random effect model.
RESULTS
Sixteen RCTs met inclusion criteria. Beyond dairy, sugar-sweetened beverages and macronutrient composition, no trials were identified for other food groups. Based on five RCTs (n:5), a higher-dairy diet was found to reduce body fat percentage - 0.47 [- 0.92, - 0.03] (p = 0.04). A higher-dairy diet was also found to increase lean body mass (kg) 0.34 [0.06, 0.62] (p = 0.02) (n:2), but did not affect BMI z-score - 0.05 [- 0.16, 0.06] (p = 0.39) (n:4). Substituting sugar-sweetened beverage with non-caloric beverages or flavored milk reduced body fat percentage (- 0.70 [- 0.78, - 0.62] (p < 0.001)) (n:3) but did not change BMI z-score (- 0.05 [- 0.20, 0.09] (p = 0.48)) (n:2). No significant effects were found between different macronutrient compositions and BMI z-score or body fat percentage.
CONCLUSION
Changes in diet from low to higher-dairy consumption and from sugar-sweetened beverages to non-caloric beverages or flavored milk resulted in favorable changes in body composition among children and adolescents. Eligible studies investigating other foods are lacking.
TRIAL REGISTRATION
PROSPERO registration number (CRD42020173201).
Topics: Humans; Child; Adolescent; Body Mass Index; Randomized Controlled Trials as Topic; Beverages; Body Composition; Nutrients
PubMed: 35902429
DOI: 10.1007/s00394-022-02966-0 -
Eye & Contact Lens Sep 2023To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) on the effects of orthokeratology for slowing myopia progression in children. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) on the effects of orthokeratology for slowing myopia progression in children.
METHODS
We performed a specific search on PubMed, Embase, Cochrane Library, Clinical Trials, CNKI, SinoMed, and Wanfang Data for RCTs conducted up to October 1, 2022. We pooled the weighted mean difference (WMD) between the orthokeratology and control groups for axial length (AL) elongation and the odds ratio (OR) for rates of adverse events and dropout.
RESULTS
Seven RCTs involving 655 eyes were included. There were significant differences in the effects of orthokeratology versus control in slowing AL elongation with WMD of -0.11 mm (95% confidence interval (CI), -0.13 to -0.08; P <0.01) at 6 months, -0.16 mm (95% CI, -0.18 to -0.13; P <0.01) at 12 months, -0.23 mm (95% CI, -0.29 to -0.18; P <0.01) at 18 months, and -0.28 mm (95% CI, -0.38 to -0.19; P <0.01) at 24 months, respectively. Myopia control rate declined, with 64%, 53%, 50%, and 47% recorded for 6, 12, 18, and 24 months, respectively. There was no statistical significance for adverse events between orthokeratology and control groups (OR=2.63, 95% CI, 0.72-9.61; P =0.11).
CONCLUSION
Orthokeratology can effectively slow myopia progression in children, and the efficacy of myopia control decreases with time.
Topics: Child; Humans; Randomized Controlled Trials as Topic; Myopia; Axial Length, Eye; Odds Ratio; Orthokeratologic Procedures; Refraction, Ocular
PubMed: 37284749
DOI: 10.1097/ICL.0000000000001006 -
PloS One 2023Some patients have insufficient treatment response to conventional disease-modifying antirheumatic drugs (cDMARD); although biologics have proven to be an effective... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND OBJECTIVES
Some patients have insufficient treatment response to conventional disease-modifying antirheumatic drugs (cDMARD); although biologics have proven to be an effective treatment for RA, the effects that bDMARDs have on integumentary, cardiac, and immune systems and the high costs associated with these treatments, make that mesenchymal stem cell-based therapies (MSCs) for RA are being considered potential treatment methods. This work analyses the performance in safety and efficacy terms of MSCs techniques.
METHODS AND FINDING
A literature search was performed in PubMed, EMBASE, Cochrane Library, Web of Science, and Open Grey databases from inception to October 28, 2022. Three randomized controlled trials (RCTs) and one non-randomized controlled trial (non-RCTs), including 358 patients met our inclusion criteria and were included in qualitative synthesis; only RCTs were eligible for quantitative synthesis (meta-analysis). Meta-analysis of adverse events (AE) in RCTs showed no significant differences in the incidence of AE in the MSCs group compared to the control group (Risk ratio: 2.35; 95% CI, 0.58 to 9.58; I2 = 58.80%). The pooled Risk ratio for non-serious and serious adverse events showed no statistical difference between intervention and control groups concerning the incidence of non-serious and serious adverse events (Risk ratio: 2.35; 95% CI, 0.58 to 9.51; I2 = 58.62%) and (Risk ratio: 1.10; 95% CI, 0.15 to 7.97; I2 = 0.0%) respectively. The Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS28) decreased in agreement with the decreasing values of C-reactive protein (CRP) and Erythrocyte sedimentation rate (ESR). Additionally, a trend toward clinical efficacy was observed; however, this improvement was not shown in the studies after 12 months of follow-up without continuous treatment administration.
CONCLUSION
This Systematic review and meta-analysis showed a favorable safety profile, without life-threatening events in subjects with RA, and a trend toward clinical efficacy that must be confirmed through high-quality RCTs, considerable sample size, and extended follow-up in subjects with RA.
Topics: Humans; Antirheumatic Agents; Arthritis, Rheumatoid; Methotrexate; Treatment Outcome; Controlled Clinical Trials as Topic
PubMed: 37498842
DOI: 10.1371/journal.pone.0284828 -
Heart, Lung & Circulation Sep 2023Current pharmacological options for hypertrophic cardiomyopathy (HCM) are not disease-specific; while it treats symptoms, mavacamten targets the underlying pathology. We... (Review)
Review
BACKGROUND
Current pharmacological options for hypertrophic cardiomyopathy (HCM) are not disease-specific; while it treats symptoms, mavacamten targets the underlying pathology. We aim to assess the efficacy and safety of mavacamten, a first-in-class cardiac myosin inhibitor, in symptomatic obstructive HCM.
METHODS
This systematic review of the literature followed the PRISMA guidelines. Title/abstract and topics were searched using the following term: "mavacamten". The electronic research literature databases included the Cochrane Library, MedLine, and clinicaltrials.gov from July to August 2022. Primary efficacy endpoint was to assess clinical response at the end of treatment compared with baseline, defined as, at least one New York Heart Association (NYHA) class reduction. Two secondary endpoints from baseline were determined. The first was defined as improvement in mixed venous oxygen pressure (pVO). The second was defined as reduction of the post-exercise left ventricular outflow tract (LVOT) gradient.
RESULTS
We included in our analyses data from four studies that met our review eligibility criteria. There were three randomised placebo-controlled clinical trials and one non-randomised open-label clinical trial. All four studies showed a reduction in NYHA class from mavacamten use. Three out of four studies demonstrated >1 NYHA functional class improvement ranging from 34% to 80%, while only one study showed a smaller percentage of patients remaining at class 3. Three out of four studies measured pVO as an outcome, and all three studies noticed an increase in peak oxygen consumption after mavacamten treatment. Additionally, three out of four studies measured post-exercise LVOT gradient reduction as an outcome and all three found significant reduction in the post-exercise LVOT gradient after treatment. The most commonly observed adverse side effects were atrial fibrillation and decreased left ventricular ejection fraction, but all participants recovered without long-term sequelae and only one patient dropped out of the trial.
CONCLUSIONS
Mavacamten has a greater efficacy than placebo in the treatment of HCM. It also showed promising tolerability and efficacy profiles in the treatment of HCM in adults. The three endpoints used in the evaluation of studies were reduction in NYHA class, increase in pVO, and post-exercise LVOT gradient reduction. Mavacamten showed greater reduction in NYHA, larger effects on increase of pVO, and significant reduction of the LVOT gradient. Mavacamten was also found to be well tolerated, like the placebo. The side effect profile was limited for the majority of individuals taking mavacamten. In the future, authors recommended dose-optimisation studies, and studies that evaluate mavacamten both in comparison to, and in conjunction with other current treatments.
Topics: Adult; Humans; Cardiomyopathy, Hypertrophic; Heart; Stroke Volume; Ventricular Function, Left; Clinical Trials as Topic
PubMed: 37453852
DOI: 10.1016/j.hlc.2023.05.019 -
Journal of Shoulder and Elbow Surgery Sep 2023Despite advancements in the surgical techniques of rotator cuff repair (RCR), there remains a high retear rate. Biological augmentation of repairs with overlaying grafts... (Meta-Analysis)
Meta-Analysis Review
Scaffold- and graft-based biological augmentation of rotator cuff repair: an updated systematic review and meta-analysis of preclinical and clinical studies for 2010-2022.
BACKGROUND
Despite advancements in the surgical techniques of rotator cuff repair (RCR), there remains a high retear rate. Biological augmentation of repairs with overlaying grafts and scaffolds may enhance healing and strengthen the repair construct. This study aimed to investigate the efficacy and safety of scaffold-based (nonstructural) and overlay graft-based (structural) biological augmentation in RCR (excluding superior capsule reconstruction and bridging techniques) in both preclinical and clinical studies.
METHODS
This systematic review was performed in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, as well as guidelines outlined by The Cochrane Collaboration. A search of the PubMed, Embase, and Cochrane Library databases from 2010 until 2022 was conducted to identify studies reporting the clinical, functional, and/or patient-reported outcomes of ≥1 biological augmentation method in either animal models or humans. The methodologic quality of included primary studies was appraised using the Checklist to Evaluate a Report of a Non-pharmacological Trial (CLEAR-NPT) for randomized controlled trials and using the Methodological Index for Non-randomized Studies (MINORS) for nonrandomized studies.
RESULTS
A total of 62 studies (Level I-IV evidence) were included, comprising 47 studies reporting outcomes in animal models and 15 clinical studies. Of the 47 animal-model studies, 41 (87.2%) demonstrated biomechanical and histologic enhancement with improved RCR load to failure, stiffness, and strength. Of the 15 clinical studies, 10 (66.7%) illustrated improvement in postoperative clinical, functional, and patient-reported outcomes (eg, retear rate, radiographic thickness and footprint, and patient functional scores). No study reported a significant detriment to repair with augmentation, and all studies endorsed low complication rates. A meta-analysis of pooled retear rates demonstrated significantly lower odds of retear after treatment with biological augmentation of RCR compared with treatment with non-augmented RCR (odds ratio, 0.28; P < .00001), with low heterogeneity (I = 0.11).
CONCLUSIONS
Graft and scaffold augmentations have shown favorable results in both preclinical and clinical studies. Of the investigated clinical grafts and scaffolds, acellular human dermal allograft and bovine collagen demonstrate the most promising preliminary evidence in the graft and scaffold categories, respectively. With a low risk of bias, meta-analysis revealed that biological augmentation significantly lowered the odds of retear. Although further investigation is warranted, these findings suggest graft and scaffold biological augmentation of RCR to be safe.
Topics: Animals; Cattle; Humans; Arthroplasty; Arthroscopy; Rotator Cuff; Rotator Cuff Injuries; Treatment Outcome; Controlled Clinical Trials as Topic
PubMed: 37178960
DOI: 10.1016/j.jse.2023.03.031 -
The Lancet. Global Health Feb 2023Snakebite clinical trials have often used heterogeneous outcome measures and there is an urgent need for standardisation. A globally representative group of key... (Review)
Review
Snakebite clinical trials have often used heterogeneous outcome measures and there is an urgent need for standardisation. A globally representative group of key stakeholders came together to reach consensus on a globally relevant set of core outcome measurements. Outcome domains and outcome measurement instruments were identified through searching the literature and a systematic review of snakebite clinical trials. Outcome domains were shortlisted by use of a questionnaire and consensus was reached among stakeholders and the patient group through facilitated discussions and voting. Five universal core outcome measures should be included in all future snakebite clinical trials-mortality, WHO disability assessment scale, patient-specific functional scale, acute allergic reaction by Brown criteria, and serum sickness by formal criteria. Additional syndrome-specific core outcome measures should be used depending on the biting species. This core outcome measurement set provides global standardisation, supports the priorities of patients and clinicians, enables meta-analysis, and is appropriate for use in low-income and middle-income settings.
Topics: Humans; Consensus; Outcome Assessment, Health Care; Snake Bites; Surveys and Questionnaires; Treatment Outcome; Clinical Trials as Topic; Global Health
PubMed: 36669810
DOI: 10.1016/S2214-109X(22)00479-X