Efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser and placebo in the treatment of striae gravidarum: A randomized clinical trial
Journal of cosmetic dermatology. 2022
BACKGROUND Striae gravidarum (SG) is a connective tissue disorder seen commonly in primigravidas. It is associated with impairment in the quality of life. OBJECTIVE To determine the efficacy of ablative fractional carbon dioxide (CO2) laser combined with autologous platelet-rich plasma (PRP) versus ablative fractional CO2 laser and placebo in the treatment of SG. STUDY DESIGN Randomized, double-blinded, placebo-controlled trial METHODOLOGY The study was conducted in 16 patients with SG. The assigned treatment area (abdomen) was divided into two sides and was randomly assigned to the PRP side and the control side. All patients received ablative fractional CO2 laser. Immediately after each laser procedure, the PRP side received autologous PRP, while the control side received plain normal saline solution (pNSS) as a placebo. The study was done for three sessions, at intervals of 4 weeks. An independent assessor used the photographs taken at weeks 6, 10, 14 and 16 to assess the clinical improvement. The patient satisfaction was reported at the same intervals. A quartile grading scale was used to measure both the clinical improvement and patient satisfaction. Data were analyzed using the Jonckheere-Terpstra test. Histopathology was done before treatment, and at the end of the study period. RESULTS The combination of ablative fractional CO2 laser and autologous PRP had better clinical improvement and patients' satisfaction compared to ablative fractional CO2 laser and placebo. However, both outcome measures were not statistically significant. CONCLUSION Ablative fractional CO2 laser combined with autologous PRP appears to be an effective treatment in SG.
The Statistical Fragility of Platelet-Rich Plasma as Treatment for Chronic Noninsertional Achilles Tendinopathy: A Systematic Review and Meta-analysis
Foot & ankle orthopaedics. 2022;7(3):24730114221119758
BACKGROUND Randomized controlled trial (RCT) outcomes reaching statistical significance, frequently determined by P <.05, are often used to guide decision making. Noted lack of reproducibility of some RCTs has brought special attention to the limitations of this approach. In this meta-analysis, we assessed the robustness of RCTs evaluating platelet-rich plasma (PRP) for the treatment of chronic noninsertional Achilles tendinopathy (AT) by using fragility indices. METHODS The present study was a systematic review and meta-analysis of RCTs comparing outcomes after PRP injection vs alternative treatment in patients with AT. Representative data sets were generated for each reported continuous outcome event using summary statistics. Fragility indices refer to the minimal number of patients whose status would have to change from a nonevent to an event to turn a statistically significant result into a nonsignificant result, or vice versa. The fragility index (FI) and continuous FI (CFI) were determined for dichotomous and continuous outcomes, respectively, by manipulating each data set until reversal of significance (a=0.05) was achieved. The corresponding fragility quotient (FQ) and continuous FQ (CFQ) were calculated by dividing FI/CFI by sample size. RESULTS Of 432 studies screened, 8 studies (52 outcome events) were included in this analysis. The 12 dichotomous outcomes had a median FI of 4.5 (FQ: 0.111), and the 40 continuous outcomes had a median CFI of 5 (CFQ: 0.154). All 52 outcome events included lost-to-follow-up data, and 12 (23.1%) indicated a greater number of patients lost to follow-up than the FI or CFI. CONCLUSION Our findings suggest that RCTs evaluating PRP for AT therapy lack statistical robustness, because changing only a small number of events may alter outcome significance. LEVEL OF EVIDENCE Level II, therapeutic study.
Platelet-Rich Plasma Versus Microfragmented Adipose Tissue for Knee Osteoarthritis: A Randomized Controlled Trial
Orthopaedic journal of sports medicine. 2022;10(9):23259671221120678
BACKGROUND Platelet-rich plasma (PRP) has been established as safe and effective for knee osteoarthritis (OA). Another orthobiologic therapy, microfragmented adipose tissue (MFAT), has gained attention because of its heterogeneous cell population (including mesenchymal stem cells). However, prospective comparative data on MFAT are lacking. Because of the safety, efficacy, and simplicity of PRP, new therapeutics such as MFAT should be compared directly with PRP. PURPOSE To compare patient-reported outcomes of a single injection of PRP versus MFAT for knee OA. STUDY DESIGN Randomized controlled trial; Level of evidence, 2. METHODS A total of 58 patients with symptomatic knee OA (Kellgren-Lawrence grades 1-4) were randomized to receive a single injection of either leukocyte-rich PRP or MFAT under ultrasound guidance. PRP was created by processing 156 mL of whole blood. MFAT was created by harvesting 30 mL of adipose tissue via standard lipoaspiration. Scores for the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales and visual analog scale for pain with Activities of Daily Living (VAS-ADL) were recorded at baseline and at 1, 3, and 6 months after the injection. The primary outcome was the KOOS-Pain subscore at 6 months after the injection. RESULTS The PRP group (n = 30) had a mean volume of 5.12 ± 1.12 mL injected. This consisted of a mean platelet count of 2673.72 ± 1139.04 × 10(3)/µL and mean leukocyte count of 25.36 ± 13.27 × 10(3)/µL (67.81% lymphocytes, 18.66% monocytes, and 12.33% neutrophils). The MFAT group (n = 28) had a mean volume of 7.92 ± 3.87 mL injected. The mean total nucleated cell count was 3.56 ± 4.62 million/mL. In both groups, KOOS subscale and VAS-ADL scores improved from baseline, and there was no significant difference between the PRP and MFAT groups in the final KOOS-Pain subscore (80.38 ± 16.07 vs 81.61 ± 16.37, respectively; P = .67) or any other outcome score. CONCLUSION A single injection of either PRP or MFAT resulted in a clinically meaningful improvement for patients with knee OA at 6 months, with no difference between treatment groups. REGISTRATION NCT04351087 (ClinicalTrials.gov identifier).
Erythropoietin in Acute Kidney Injury (EAKI): a pragmatic randomized clinical trial
BMC nephrology. 2022;23(1):100
BACKGROUND Treatment with erythropoietin is well established for anemia in chronic kidney disease patients but not well studied in acute kidney injury. METHODS This is a multicenter, randomized, pragmatic controlled clinical trial. It included 134 hospitalized patients with anemia defined as hemoglobin < 11 g/dL and acute kidney injury defined as an increase of serum creatinine of ≥ 0.3 mg/dL within 48 h or 1.5 times baseline. One arm received recombinant human erythropoietin 4000 UI subcutaneously every other day (intervention; n = 67) and the second received standard of care (control; n = 67) during the hospitalization until discharge or death. The primary outcome was the need for transfusion; secondary outcomes were death, renal recovery, need for dialysis. RESULTS There was no statistically significant difference in transfusion need (RR = 1.05, 95%CI 0.65,1.68; p = 0.855), in renal recovery full or partial (RR = 0.96, 95%CI 0.81,1.15; p = 0.671), in need for dialysis (RR = 11.00, 95%CI 0.62, 195.08; p = 0.102) or in death (RR = 1.43, 95%CI 0.58,3.53; p = 0.440) between the erythropoietin and the control group. CONCLUSIONS Erythropoietin treatment had no impact on transfusions, renal recovery or mortality in acute kidney injury patients with anemia. The trial was registered on ClinicalTrials.gov (NCT03401710, 17/01/2018).
Platelet-rich Plasma Injection Can Be a Viable Alternative to Corticosteroid Injection for Conservative Treatment of Rotator Cuff Disease: A Meta-analysis of Randomized Controlled Trials
Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association. 2022
PURPOSE The purpose of this study was to explore whether PRP injection can be a viable alternative to CS injection for conservative treatment of rotator cuff disease. METHODS The study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. PubMed, EMBASE, The Cochrane Library, and Web of Science were searched for English-written randomized controlled trials (RCTs) which compared PRP and CS injections for patients with rotator cuff disease from January 1, 1990, to March 20, 2022. Two evaluators independently screened the literature, extracted data, and assessed the level of evidence and methodological quality of the enrolled studies. The meta-analysis was conducted using RevMan 5.3.3 software. RESULTS Thirteen non-surgical RCTs with 725 patients were included. Compared with CS, PRP provided statistically worse short-term (＜2 months) changes (Δ) of the American Shoulder and Elbow Surgeons (ASES) assessment, Δ the Simple Shoulder Test (SST), Δ the Disability of Arm, Shoulder and Hand (DASH) questionnaires but better medium-term (2 to 6 months) Δ DASH, long-term (≥ 6 months) Δ Constant-Murley Score (CMS), Δ ASES and Δ SST. No statistical differences regarding pain reduction were found between the two groups. PRP injections led to worse short-term Δ forward flexion, Δ internal rotation but better medium-term Δ forward flexion and Δ external rotation. PRP had significantly lower rates of postinjection failure (requests for a subsequent injection or surgical intervention prior to 12 months) than CS. No outcome reached the minimal clinically important difference (MCID). After sensitivity analyses by excluding studies with substantial clinical and/or methodological heterogeneity, PRP showed better medium-term Δ ASES, Δ VAS, and long-term Δ VAS which reached the MCID. CONCLUSIONS Without the drawbacks of CS injection, PRP injection is not worse than CS injection in pain relief and function recovery at any time point of the follow-up. PRP injection may reduce rates of subsequent injection or surgery, and might provide better improvement in pain and function in the medium- to long-term. PRP injection can be a viable alternative to CS injection for conservative treatment of rotator cuff disease. LEVEL OF EVIDENCE Systematic review of Level I and II studies.
The efficacy and safety of roxadustat for the treatment of anemia in non-dialysis dependent chronic kidney disease patients: An updated systematic review and meta-analysis of randomized clinical trials
PloS one. 2022;17(4):e0266243
BACKGROUND Roxadustat (ROX) is a new medication for anemia as a complication of chronic kidney disease (CKD). Our meta-analysis aims to evaluate the efficacy and safety of ROX, especially on the cardiovascular risks, for anemia in NDD-CKD patients. METHODS Electronic databases were searched systematically from inception to July 2021 to look for randomized control trials (RCTs) that evaluated ROX NDD-CKD patients. Hemoglobin level and iron utilization parameters, including ferritin, serum iron, transferrin saturation (TSAT), total iron-binding capacity (TIBC), transferrin, and hepcidin were analyzed for efficacy. Pooled risk ratios (RRs) and standardized mean differences (SMDs) were calculated and presented with their 95% confidential intervals (CIs). RESULTS Nine RCTs included a total of 3,175 patients in the ROX group and 2,446 patients in the control group. When compared the control group, ROX increased Hb level significantly (SMD: 1.65; 95% CI: 1.08, 2.22; P< 0.00001) and improved iron utilization parameters by decreasing ferritin (SMD: -0.32; 95% CI: -0.51, -0.14; P = 0.0006), TSAT (SMD: -0.19; 95% CI: -0.32, -0.07; P = 0.003), and hepcidin (SMD: -0.74; 95% CI: -1.09, -0.39; P< 0.0001) and increasing TIBC (SMD: 0.99; 95% CI: 0.76, 1.22; P< 0.00001) and transferrin (SMD: 1.20; 95% CI: 0.70, 1.71; P< 0.00001). As for safety, ROX was associated with higher serious adverse effects (RR: 1.07; 95% CI: 1.01, 1.13; P = 0.01), deep venous thrombosis (DVT) (RR: 3.80; 95% CI: 1.5, 9.64; P = 0.08), and hypertension (HTN) (RR: 1.37; 95% CI: 1.13, 1.65; P = 0.001). CONCLUSION We concluded that ROX increased Hb level and improved iron utilization parameters in NDD-CKD patients, but ROX was associated with higher serious adverse effects, especially DVT and HTN. Our results support the use of ROX for NDD-CKD patients with anemia. However, higher-quality RCTs are still needed to ensure its safety and risk of thrombosis.
People with non-dialysis-dependent chronic kidney disease who took part in randomised controlled trials (RCTs) identified by a systematic review (n= 5,621, 9 RCTs).
Roxadustat at various doses (ROX, n= 3,175).
Placebo or control treatment [Darbepoetin Alfa], (n= 2,446).
When compared the control group, ROX increased Haemoglobin level significantly (standardised mean difference [SMD]: 1.65; 95% CI: 1.08, 2.22) and improved iron utilization parameters by decreasing ferritin (SMD: -0.32; 95% CI: -0.51, -0.14), transferrin saturation (SMD: -0.19; 95% CI: -0.32, -0.07), and hepcidin (SMD: -0.74; 95% CI: -1.09, -0.39) and increasing total iron binding capacity (SMD: 0.99; 95% CI: 0.76, 1.22) and transferrin (SMD: 1.20; 95% CI: 0.70, 1.71). As for safety, ROX was associated with higher serious adverse effects (RR: 1.07; 95% CI: 1.01, 1.13), deep venous thrombosis (RR: 3.80; 95% CI: 1.5, 9.64), and hypertension (RR: 1.37; 95% CI: 1.13, 1.65).
Randomized prospective comparative study of platelet-rich plasma versus conventional compression in treatment of post-phlebitic venous ulcer
OBJECTIVES to assess the safety and efficacy of platelet-rich plasma (PRP) as adjunctive to compression therapy for post-phlebitic venous ulcers. METHODS This is a single-center randomized controlled trial on patients with persistent chronic post-phlebitic lower limb venous ulcers from March 2019 to March 2020. Patients were randomly allocated to one of two equal cohort groups. Patients group in which patients underwent combined PRP with compression therapy versus control group in which patients underwent placebo+ compression therapy alone. The primary endpoint of the study was the improvement in ulcer topographic measurement. Secondary endpoints included ulcer healing parameters, possible healing factors, reduction in pain score (VAS), and the achievement of complete healing. RESULTS Forty patients were available equally for randomization and analysis in both groups. The median number of PRP applications for every patient in the patient group was 6 (ranging from 3 to 6). There was a significant decline in the median length, width, and depth of ulcers in the patients group versus control group. Consequently, there was a significant decline of the median ulcer area, in the patient group versus control group (4 (3-9) cm(2) vs. 10 (6-14) cm(2), p = .036). Also, the median volume of the ulcers showed a significant decline in the patient group versus control group (1 (.7-3) cm(3) vs 3 (2-6) cm(3), p = .008). Complete healing was achieved in 45% of patient group. There was a significant decline in pain scores at 3- and 6 months from the therapy starting point in both groups (patient group: pre-VAS = 6.5 vs. post(3 months)-VAS = 1 vs. post(6 months)-VAS = 0.5) and (control group: pre-VAS = 6.4 vs. post(3 months)-VAS = 4.5 vs. post(6 months)-VAS = 2.2), (p < .0001 for each). On the other hand, the decline in pain scores between both groups was statistically significant in favor of the patient group, (post (3 months); PRP-VAS = 1 vs. control-VAS = 4.5, and post(6 months); PRP-VAS = 0.5 vs. control-VAS = 2.2), (p < .0001). CONCLUSION Platelet-rich plasma as an adjunct to compression therapy for chronic post-phlebitic venous ulcers is safe and effective as regards the ulcer healing and improvement of pain score. PRP may be useful adjunct in treatment of post-phlebitic venous ulcer. However, larger trials are warranted.
Management of Lateral Epicondylitis: A Prospective Comparative Study Comparing the Local Infiltrations of Leucocyte Enriched Platelet-Rich Plasma (L-aPRP), Glucocorticoid and Normal Saline
Malaysian orthopaedic journal. 2022;16(1):58-69
INTRODUCTION Lateral epicondylitis is a painful condition of the elbow, characterised by pain and tenderness with resisted wrist extension. This study was carried out to evaluate the comparative efficacy of the local infiltration of L-PRP, methylprednisolone and normal saline in patients with lateral epicondylitis. MATERIALS AND METHODS Sixty adult patients, between the ages 30 to 50 years, diagnosed with lateral epicondylitis of more than 12 weeks, were enrolled in the prospective randomised study. Their medical history and previous conservative treatment were recorded; the clinical evaluation of the tendinitis was made with the visual analogue scale (VAS), the disabilities of the arm, shoulder, and hand (DASH) outcome scores, the modified elbow performance index (MEPS), the functional assessment by patient-rated tennis elbow evaluation (PRTEE), together with the laboratory investigations. The patients were randomised using the computer-generated alphabets into three groups of 20: group A received saline, group B received PRP, and group C received corticosteroids. RESULTS Patients were seen at 4, 8 and 12 weeks to evaluate the post-injection status. VAS, DASH, and PRTEE scores were significantly reduced, and MEPS was significantly improved in group B compared to group A and group C. Moreover, the reductions in VAS and PRTEE were significantly different in group C compared to group A. CONCLUSION PRP leads to superior healing with long-term therapeutic advantages compared to corticosteroids though it takes a little longer to have its effect.
Transfusion strategies in patients with acute coronary syndrome and anemia: a meta-analysis
The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology. 2022;74(1):17
BACKGROUND Anemia is a known risk factor for ischemic heart disease and serves as an independent predictor of major adverse cardiovascular events (MACE) in patients with acute coronary syndrome (ACS). This meta-analysis pools data from randomized controlled trials (RCTs) to better define hemoglobin (Hb) thresholds for transfusion in this setting. RESULTS MEDLINE, EMBASE, and Cochrane databases were searched using the terms "Acute Coronary Syndrome" AND "Blood Transfusion" including their synonyms. A total of three randomized controlled trials were included. Restrictive transfusion strategy (RTS) was defined as transfusing for Hb ≤ 8 g/dl with a post-transfusion goal of 8 to 10 g/dl. Liberal transfusion strategy (LTS) was defined as Hb ≤ 10 g/dl and post-transfusion goal of at least 11 g/dl. The primary end point was 30-day mortality. Secondary outcomes included recurrent ACS events, new or worsening CHF within 30 days, and major adverse cardiac events (MACE). The primary analytic method used was random effects model. Out of 821 patients, 400 were randomized to LTS, and 421 to RTS. Mean age was 70.3 years in RTS versus 76.4 in LTS. There was no statistically significant difference for 30-day mortality in LTS compared to RTS [odds ratio (OR) 1.69; 95% CI 0.35 to 8.05]. Similarly, there was no difference in MACE (OR 0.74; 95% CI 0.21 to 2.63), CHF (OR 0.82; 95% CI 0.18 to 3.76), or the incidence of recurrent ACS (OR 1.21; 95% CI 0.49 to 2.95). CONCLUSIONS In the setting of ACS, there is no difference between LTS and RTS for the outcomes of mortality, MACE, recurrent ACS, or CHF at 30 days. Further evidence in the form of high-quality RCTs are needed to compare RTS and LTS.
Different platelet-rich plasma preparation protocols in Female pattern hair loss: Does it affect the outcome? A pilot study
Journal of cosmetic dermatology. 2022
BACKGROUND Platelet-rich plasma (PRP) injection is a promising modality for hair regeneration in female pattern hair loss (FPHL). A standard protocol on best methods for PRP preparation has not been established. OBJECTIVES To optimize standard PRP preparation protocols and evaluate its clinical efficacy in FPHL. METHODS Comparative study enrolled 40 female patients with FPHL divided randomly into 4 equal groups. Each group received 3 sessions of monthly intradermal injection of PRP prepared by different methods regarding number of spins, centrifugation speeds, type of the centrifuge, and the size of PRP tube. Patients were evaluated by trichoscan before and 1 month after the 3(rd) session for number of terminal, vellus hair, and average hair width. RESULTS A statistically significant increase in platelet count in PRP prepared by combination of digital centrifuge, large-sized sodium citrate tube, and low centrifugation speed (900 rpm). All patients showed statistically significant increase in percentage of terminal hair and average width of hair after treatment as assessed by trichoscan, without statistically significant difference between studied groups. CONCLUSIONS Digital centrifuge, large-sized sodium citrate tubes, and a single spin with low centrifugation speed (900 rpm) were ideal for PRP preparation. PRP is an effective and safe modality in FPHL therapy.