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Extracorporeal Shockwave Therapy Versus Platelet Rich Plasma Injection in Patients of Chronic Plantar Fasciitis: A Randomized Controlled Trial From a Tertiary Center of Eastern India
Pandey S, Kumar N, Kumar A, Biswas A, Sinha U, Pandey J, Ghosh S, Das S, Johnson RA, Kumar R, et al
Cureus. 2023;15(1):e34430
Abstract
Introduction Plantar fasciitis is a degenerative condition of the plantar fascia that leads to heel and sole pain. Physical modalities, physiotherapy, medication, and orthoses have been tried before as treatments. Extracorporeal shockwave therapy (ESWT) and the injection of autologous platelet-rich plasma (PRP) are generally effective in the treatment of plantar fasciitis, which might be resistant to other conservative measures. The present study compares the efficacy of ESWT and PRP injection in respect of symptomatic relief, functional improvement, and change in plantar fascia thickness (PFT). Methods Seventy-two patients were enrolled and randomized into two groups. Patients in the first group received ESWT, whereas patients in the second group received PRP injections. Patients were evaluated using the Visual Analog Scale (VAS) and the American Orthopedic Foot and Ankle Society (AOFAS) score, along with PFT measurement (using ultrasonography) before the treatment and at days 15, 30, and 90 after the treatment. The X(2) test was used to compare qualitative variables, and the paired T-test was used to evaluate quantitative data. Quantitative variables had a normal distribution with a standard deviation, and the significance level was set at P-value=0.05. Results On day 0, the mean VAS of the ESWT and PRP groups were 6.44±1.11 and 6.78±1.17, respectively (p=0.237). On day 15, the mean VAS of the ESWT and PRP groups were 4.67±1.45 and 6.67±1.35, respectively (p<0.001). At day 30, the mean VAS of the ESWT and PRP groups were 4.97±1.46 and 4.69±1.39, respectively (p=0.391). On day 90, the mean VAS of the ESWT and PRP groups were 5.47±1.63 and 3.36±0.96 (p<0.001). On day 0, the mean PFTs of the ESWT and PRP groups were 4.73±0.40 and 5.19±0.51, respectively (p<0.001). At day 15, the mean PFT of the ESWT and PRP groups were 4.64±0.46 and 5.11±0.62, respectively (p<0.001) which changed to 4.52±0.53 and 4.40±0.58 at day 30 (p<0.001), and to 4.40±0.50 and 3.82±0.45 at day 90 (p<0.001). The mean AOFAS of the ESWT and PRP groups were 68.39±5.88 and 64.86±8.95 on day 0 (p=0.115), 72.58±6.26 and 67.22±10.47 on day 15 (p=0.115), 73.22±6.92 and 74.72±7.52 on day 30 (p=0.276), and 72.75±7.90 and 81.08±6.01 on day 90, respectively (p<0.001). Conclusion Both PRP injection and ESWT are very effective methods to improve pain and cause reduced plantar fascia thickness in patients with chronic plantar fasciitis non-responsive to other conservative measures. PRP injection is more effective at a longer duration as compared to ESWT.
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Standard-Volume Plasma Exchange Improves Outcomes in Patients With Acute Liver Failure: A Randomized Controlled Trial
Maiwall R, Bajpai M, Singh A, Agarwal T, Kumar G, Bharadwaj A, Nautiyal N, Tevethia H, Jagdish RK, Vijayaraghavan R, et al
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2022;20(4):e831-e854
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Editor's Choice
Abstract
BACKGROUND High volume plasma-exchange (HVPE) improves survival in patients with acute liver failure (ALF), but apprehension regarding volume overload and worsening of cerebral edema remain. METHODS In an open-label randomized controlled trial, 40 consecutive patients of ALF were randomized 1:1 to either standard medical treatment (SMT) or SMT with standard-volume plasma-exchange (SVPE). SVPE was performed using centrifugal apheresis [target volume of 1.5 to 2.0 plasma volumes per session] until desired response was achieved. Cerebral edema was assessed by brain imaging. Results were analyzed in an intention-to-treat analysis. Primary outcome was 21-day transplant-free survival. The levels of cytokines, damage-associated molecular patterns (DAMPs) and endotoxins were analyzed at baseline and day 5. RESULTS ALF patients [aged 31.5 ± 12.2 years, 60% male, 78% viral, 83% hyperacute, 70% with SIRS were included. At day 5, SVPE [mean sessions 2.15 ± 1.42, median plasma volume replaced 5.049 L] compared to SMT alone, resulted in higher lactate clearance (p = .02), amelioration of SIRS (84% vs. 26%; P = .02), reduction in ammonia levels [(221.5 ± 96.9) vs.(439 ± 385.6) μg/dl, P = .02) and SOFA scores [9.9(±3.3) vs. 14.6(±4.8); P = .001]. There were no treatment related deaths. SVPE was associated with a higher 21-day transplant free-survival [75% vs. 45%; P = .04, HR 0.30, 95%CI 0.01-0.88]. A significant decrease in levels of pro-inflammatory cytokines and an increase in anti-inflammatory cytokines along with a decrease in endotoxin and DAMPs was seen with SVPE. CONCLUSION In ALF patients with cerebral edema, SVPE is safe and effective and improves survival possibly by a reduction in cytokine storm and ammonia. CLINICALTRIAL gov (identifier: NCT02718079).
PICO Summary
Population
Patients with acute liver failure (n= 40).
Intervention
Standard medical treatment with standard volume plasma exchange (SVPE), (n= 20).
Comparison
Standard medical treatment (n= 20).
Outcome
Compared to standard medical treatment alone, at day five SVPE resulted in higher lactate clearance, amelioration of systemic inflammatory response syndrome (84% vs. 26%), reduction in ammonia levels [(221.5 ± 96.9) vs. (439 ± 385.6) μg/dl] and sequential organ failure assessment scores [9.9(±3.3) vs. 14.6(±4.8)]. There were no treatment related deaths. SVPE was associated with a higher 21-day transplant free-survival (75% vs. 45%). A significant decrease in levels of pro-inflammatory cytokines and an increase in anti-inflammatory cytokines along with a decrease in endotoxin and damage-associated molecular patterns was seen with SVPE.
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Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19
Goligher EC, Bradbury CA, McVerry BJ, Lawler PR, Berger JS, Gong, MN, Carrier M, Reynolds HR, Kumar A, Turgeon AF, et al
The New England Journal of Medicine. 2021
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Editor's Choice
Abstract
BACKGROUND Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19. METHODS In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. RESULTS The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio <1.2], 99.9%). The percentage of patients who survived to hospital discharge was similar in the two groups (62.7% and 64.5%, respectively; adjusted odds ratio, 0.84; 95% credible interval, 0.64 to 1.11). Major bleeding occurred in 3.8% of the patients assigned to therapeutic-dose anticoagulation and in 2.3% of those assigned to usual-care pharmacologic thromboprophylaxis. CONCLUSIONS In critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin did not result in a greater probability of survival to hospital discharge or a greater number of days free of cardiovascular or respiratory organ support than did usual-care pharmacologic thromboprophylaxis. (REMAP-CAP, ACTIV-4a, and ATTACC ClinicalTrials.gov numbers, NCT02735707, NCT04505774, NCT04359277, and NCT04372589.).
PICO Summary
Population
Critically ill patients with severe COVID-19 (n= 1,098).
Intervention
Therapeutic-dose anticoagulation with heparin (n= 534).
Comparison
Usual-care pharmacologic thromboprophylaxis (n= 564).
Outcome
The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis. The percentage of patients who survived to hospital discharge was similar in the two groups (62.7% and 64.5%, respectively). Major bleeding occurred in 3.8% of the patients assigned to therapeutic-dose anticoagulation and in 2.3% of those assigned to usual-care pharmacologic thromboprophylaxis.
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Anti-Thrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC): Study design and methodology for an international, adaptive Bayesian randomized controlled trial
Houston BL, Lawler PR, Goligher EC, Farkouh ME, Bradbury C, Carrier M, Dzavik V, Fergusson DA, Fowler RA, Galanaud JP, et al
Clinical Trials (London, England). 2020;:1740774520943846
Abstract
BACKGROUND Mortality from COVID-19 is high among hospitalized patients and effective therapeutics are lacking. Hypercoagulability, thrombosis and hyperinflammation occur in COVID-19 and may contribute to severe complications. Therapeutic anticoagulation may improve clinical outcomes through anti-thrombotic, anti-inflammatory and anti-viral mechanisms. Our primary objective is to evaluate whether therapeutic-dose anticoagulation with low-molecular-weight heparin or unfractionated heparin prevents mechanical ventilation and/or death in patients hospitalized with COVID-19 compared to usual care. METHODS An international, open-label, adaptive randomized controlled trial. Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached. The trial uses response-adaptive randomization to maximize the probability that patients will receive the more beneficial treatment approach, as treatment effect information accumulates within the trial. By leveraging a common data safety monitoring board and pooling data with a second similar international Bayesian adaptive trial (REMAP-COVID anticoagulation domain), treatment efficacy and safety will be evaluated as efficiently as possible. The primary outcome is an ordinal endpoint with three possible outcomes based on the worst status of each patient through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation or death. CONCLUSION Using an adaptive trial design, the Anti-Thrombotic Therapy To Ameliorate Complications of COVID-19 trial will establish whether therapeutic anticoagulation can reduce mortality and/or avoid the need for mechanical ventilation in patients hospitalized with COVID-19. Leveraging existing networks to recruit sites will increase enrollment and mitigate enrollment risk in sites with declining COVID-19 cases.
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Role of preoperative donor-specific transfusion and cyclosporine in haplo-identical living related renal transplant recipients
Sharma RK, Rai PK, Kumar A, Kumar P, Gupta A, Kher V, Agrawal S, Bhandari M
Nephron. 1997;75((1):):20-4.
Abstract
A prospective randomized trial of use of donor-specific transfusion and cyclosporine given 24 h before operation was performed in living related renal transplant recipients. The benefits, disadvantages and effect on graft and patient outcome was analyzed. Cyclosporine was started 72 h before operation and 48 h before donor-specific transfusion (DST). Fifteen patients received DST while another 15 age- and sex-matched living related renal allograft recipients on similar immunosuppression served as controls. Patient and donor demographics were similar in the two groups. The DST group had significantly fewer rejection episodes than the control group (0.26 vs. 1.1 rejection episode per patient, p < 0.01). There were fewer episodes of acute rejection in the first 3 months posttransplant in the DST group. Hyperresponder recipients (as tested by mixed lymphocyte cultures) also benefitted by DST which significantly reduced the number of acute rejection episodes (0.25 vs. 1 episode per hyperresponder patient, DST vs. control, p < 0.05). The need for dialysis, incidence of infections and other complications were similar in the two groups. Graft function at 3, 6, 9 and 12 months after transplant was significantly better in the DST group (p < 0.05). Graft survival at 1 year in DST group (85.5%) was not statistically different than control (74.8%). In conclusion, DST and cyclosporine given 24 h before live related renal transplantation is effective in improving graft function and reducing the number of acute rejection episodes which could have a beneficial effect on long-term graft survival.