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Reporting Bias is Highly Prevalent in Systematic Reviews and Meta-Analyses of Platelet Rich Plasma Injections for Hip Osteoarthritis
Kim, D., Bashrum, B. S., Kotlier, J. L., Mayfield, C. K., Thompson, A. A., Abu-Zahra, M., Hwang, M., Bolia, I. K., Petrigliano, F. A., Liu, J. N.
Arthroscopy, sports medicine, and rehabilitation. 2024;6(1):100851
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Abstract
PURPOSE To describe the incidence and types of spin in systematic reviews of platelet-rich plasma (PRP) injections for hip osteoarthritis (OA) and to determine whether patterns in study characteristics could be identified among studies with identifiable spin. METHODS The PubMed, Scopus, and SPORTDiscus databases were queried. Inclusion criteria were systematic reviews or meta-analyses that included an assessment of intra-articular PRP injections as a stand-alone treatment for hip OA. Two authors independently assessed the presence of spin in the included studies and recorded general study characteristics. The prevalence of the 15 different categories of spin was quantified using descriptive statistics. RESULTS Fifteen studies met inclusion criteria for this study. All studies contained at least two types of spin (range 2-9), with a median of 2. The most common type of spin was type 14 ("Failure to report a wide confidence interval of estimates"), which was observed in 10 studies. The second most common type of spin was type 13 ("Failure to specify the direction of the effect when it favors the control intervention"), found in 6 studies. CONCLUSIONS Spin is highly prevalent in abstracts of systematic reviews of PRP in the treatment of hip OA. Several associations were found between spin types and the study characteristics of AMSTAR 2 rating, Scopus CiteScore, journal impact factor, and PROSPERO preregistration. When present, spin in the abstracts of reviewed studies tended to favor the use of PRP in hip osteoarthritis. CLINICAL RELEVANCE It is important to understand the prevalence of spin in published abstracts, especially in areas of great impact or interest, so authors and readers can have a greater awareness of this potential form of bias.
PICO Summary
Population
Patients with hip osteoarthritis (15 systematic reviews).
Intervention
Systematic review to describe the incidence and types of spin bias in systematic reviews of platelet-rich plasma injections for hip osteoarthritis and to determine whether patterns in study characteristics could be identified among studies with identifiable spin.
Comparison
Outcome
All studies contained at least two types of spin (range 2-9), with a median of 2. The most common type of spin was type 14 ("Failure to report a wide confidence interval of estimates"), which was observed in 10 studies. The second most common type of spin was type 13 ("Failure to specify the direction of the effect when it favors the control intervention"), found in 6 studies. Several associations were found between spin types and the study characteristics of AMSTAR 2 rating, Scopus CiteScore, journal impact factor, and PROSPERO preregistration.
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Comparative effectiveness of intra-articular therapies in knee osteoarthritis: a meta-analysis comparing platelet-rich plasma (PRP) with other treatment modalities
Khalid, S., Ali, A., Deepak, F., Zulfiqar, M. S., Malik, L. U., Fouzan, Z., Nasr, R. A., Qamar, M., Bhattarai, P.
Annals of medicine and surgery (2012). 2024;86(1):361-372
Abstract
INTRODUCTION Knee osteoarthritis (KOA) is a progressive joint disease commonly treated with intra-articular injections, including platelet-rich plasma (PRP), hyaluronic acid (HA), or corticosteroids (CS). This updated meta-analysis aims to enhance the statistical power of the results and provide comprehensive clinical evidence that reflects the most current research. By doing so, the authors aim to suggest a reliable estimate for the development of guidelines, addressing the pressing need for effective and minimally invasive treatment options. METHODS PubMed, Scopus, clinicaltrials.gov, Cochrane Central were searched until March 2023, for randomized controlled trials (RCTs) comparing the effectiveness of intra-articular injectable therapies, including PRP, HA, CS, and placebo, in KOA. Data extraction involved baseline characteristics and outcome measures [Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores, Visual Analog Scale (VAS) pain scores, KOOS, and IKDC scores] at 1, 3, 6 and 12 months. Statistical analysis, including subgroup analysis, assessment of heterogeneity, and publication bias, was conducted using Review Manager. RESULTS Our meta-analysis of 42 studies involving 3696 patients demonstrated that PRP treatment resulted in significant pain relief compared to HA injections, as evidenced by improved WOMAC pain (MD: -0.74; 95% CI: -1.02 to -0.46; P≤0.00001; I (2)=94%) and VAS pain (MD: -0.65; 95% CI: -1.24 to -0.06; P=0.03; I(2)=97%) outcomes. Similarly, PRP showed greater efficacy in reducing WOMAC pain (MD: -8.06; 95% CI: -13.62 to -2.51: P=0.004; I (2)=96%) and VAS pain (MD: -1.11; 95% CI: -1.64 to -0.59; P≤0.0001; I (2)=68%) compared to CS injections, with the most significant improvement observed at 6 months. CONCLUSIONS PRP is an effective treatment for KOA. It provides symptomatic relief, has the potential to reduce disease progression, and has sustained effects up to 12 months. PRP offers superior pain relief and functional enhancement compared to CS and HA injections.
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Effectiveness of Injectable Platelet-Rich Fibrin in the Treatment of Oral Lichen Planus: A Systematic Review and Meta-Analysis
Gupta, N., Bhargava, A., Saigal, S., Sharma, S., Patel, M., Prakash, O.
Cureus. 2024;16(1):e51626
Abstract
Oral lichen planus (OLP) is a chronic inflammatory condition affecting the oral mucosa. The current review investigated the potential effectiveness of injectable platelet-rich fibrin (i-PRF) as a treatment for OLP when compared to other interventions. The current review adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search strategy was implemented across databases such as PubMed, Embase, Scopus, Web of Science, CINAHL, and Google Scholar. The search utilized a combination of Boolean operators (AND, OR) and Medical Subject Headings (MeSH) terms to capture relevant studies. Comparative clinical studies focusing on i-PRF as a treatment for OLP and other interventions were included. Outcomes assessed were pain, surface area of lesions, and patient satisfaction. Review Manager 5.4 was used for statistical analysis. The Risk of Bias 2.0 (RoB 2.0) tool was used to assess the methodological quality of the studies. Three studies were included for the final analysis. The findings indicated that both the i-PRF and comparison treatment groups demonstrated reductions in pain and lesion size. The post-treatment Visual Analogue Scale (VAS) scores showed a decrease in pain intensity, and there was an improvement in lesion extension in the i-PRF-treated sites. The results also revealed increased patient satisfaction with i-PRF treatment. Adverse effects were not reported or specified in the included studies. Quantitative analysis for pain (VAS) showed a mean difference of 0.38 (95% CI: 0.63-1.40), but there was no significant difference between the i-PRF and control groups at p=0.46. Though intragroup differences showed statistically significant differences between pre and post intervention, intergroup differences were not significant for any of the assessed outcomes. The findings from this study suggest that i-PRF holds promise as a potential treatment for OLP. The use of i-PRF resulted in pain reduction, lesion size improvement, and increased patient satisfaction. However, it is important to consider the limitations of the included studies, such as variability in study designs, small sample sizes, and the limited number of studies.
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Autologous platelet-rich plasma (APRP) in diabetes foot disease: a meta-analysis
Ruiz-Muñoz, M., Martinez-Barrios, F. J., Fernandez-Torres, R., Lopezosa-Reca, E., Marchena-Rodriguez, A.
Journal of diabetes and its complications. 2024;38(2):108690
Abstract
INTRODUCTION This study will explore the effectiveness of autologous platelet-rich plasma in the treatment of diabetic foot disease compared to conventional treatments, based on the ulcer healing rate. METHODS The electronic databases of PubMed, EMBASE, and WOS internet were searched. Evaluated outcome rate of complete ulcer healing. Statistical analysis was performed with RevMan 5.0 software and SPSS 25.0. RESULTS Eleven RCTs with 828 patients were included in this study. The meta-analysis showed a higher complete ulcer healing rate (OR = 3.69, 95 % CI 2.62 to 5.20, P < 0.01, I(2) = 0 %) in growth factors based in autologous platelech-rich plasma (aPRP) group compared with control. Mixed evidence was seen for publication bias, but analyses by using the trim-and-fill method did not appreciably alter results. CONCLUSION Autologous platelet-rich plasma can improve the complete healing rate of the ulcer compared to current conventional treatments in diabetic foot ulcer patients.
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Esophageal Stent in Acute Refractory Variceal Bleeding: A Systematic Review and a Meta-Analysis
Songtanin, B., Kahathuduwa, C., Nugent, K.
Journal of clinical medicine. 2024;13(2)
Abstract
Background: Acute esophageal variceal bleeding accounts for up to 70% of upper-gastrointestinal bleeding in cirrhotic patients. About 10-20% of patients with acute variceal bleeding have refractory bleeding that is not controlled by medical or endoscopic therapy, and this condition can be life-threatening. Balloon tamponade is a long-standing therapy which is only effective temporarily and has several complications, while transjugular intrahepatic portosystemic shunt (TIPS) and liver transplantation may not be readily available at some centers. The use of self-expandable metal stents (SEMSs) in refractory esophageal variceal bleeding has been studied for effectiveness and adverse events and has been recommended for use as a bridge to a more definitive treatment. Aim: To investigate the effectiveness and safety of SEMSs in managing refractory variceal bleeding. Methods: A systematic search of the MEDLINE, EMBASE, and Cochrane library databases was performed from inception to October 2022 using the following terms: "esophageal stent", "self-expandable metal stents", "endoscopic hemostasis", "refractory esophageal varices", and "esophageal variceal bleeding". Studies were included in the meta-analysis if they met the following criteria: (1) patients' age older than 18 and (2) a study (or case series) that has at least 10 patients in the study. Exclusion criteria included (1) non-English publications, (2) in case of overlapping cohorts, data from the most recent and/or most appropriate comprehensive report were collected. DerSimonian-Laird random-effects meta-analysis was performed using the meta package in R statistical software(version 4.2.2). Results: Twelve studies involving 225 patients with 228 stents were included in the analyses. The mean age and/or median age ranged from 49.4 to 69 years, with a male-to-female ratio of 4.4 to 1. The median follow-up period was 42 days. The mean SEMS dwell time was 9.4 days. The most common cause of acute refractory variceal bleeding in chronic liver disease patients included alcohol use followed by viral hepatitis. The pooled rate of immediate bleeding control was 91% (95% CI 82-95%, I(2) = 0). The pooled rate of rebleeding was 17% (95% CI 8-32%, I(2) = 69). The pooled rate of stent ulceration was 7% (95% CI 3-13%, I(2) = 0), and the pooled rate of stent migration was 18% (95% CI 9-32%, I(2) = 38). The pooled rate of all-cause mortality was 38% (95% CI 30-47%, I(2) = 34). Conclusions: SEMSs should be primarily considered as salvage therapy when endoscopic band ligation and sclerotherapy fail and can be used as a bridge to emergent TIPS or definitive therapy, such as liver transplantation.
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Efficacy and safety of platelet-rich plasma in the treatment of venous ulcers: A systematic review and meta-analysis of randomized controlled trials
Hu, Z., Wang, S., Yang, H., Xv, H., Shan, B., Lin, L., Han, X.
International wound journal. 2024;21(2):e14736
Abstract
Considering the substantial impact of venous ulcers on quality of life and healthcare systems, this study evaluated the efficacy and safety of platelet-rich plasma (PRP) in comparison to conventional therapy. A systematic review of four databases identified 16 randomized clinical trials, including 20 study groups. PRP significantly enhanced complete ulcer healing, exhibiting an odds ratio (OR) of 5.06 (95% confidence interval [CI]: 2.35-10.89), and increased the percentage of healed ulcer area by a mean difference of 47% (95% CI: 32%-62%). Additionally, PRP shortened the time required for complete healing by an average of 3.25 months (95% CI: -4.06 to -2.43). Although pain reduction was similar in both groups, PRP considerably decreased ulcer recurrence rates (OR = 0.16, 95% CI: 0.05-0.50) without increasing the risks of infection or irritative dermatitis. These results suggest PRP as a viable, safe alternative for venous ulcer treatment, providing significant improvements in healing outcomes.
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Platelet-Rich Plasma for Patients with Olfactory Dysfunction: Myth or Reality? A Systematic Review
Moffa, A., Nardelli, D., Giorgi, L., Di Giovanni, S., Carnuccio, L., Mangino, C., Baptista, P., Vacca, M., Casale, M.
Journal of clinical medicine. 2024;13(3)
Abstract
BACKGROUND With promising outcomes, platelet-rich plasma (PRP) has recently been suggested as a treatment for olfactory dysfunction (OD). METHODS Clinical studies utilizing PRP in OD caused by COVID-19, trauma, anesthetic exposure, viral infection, and chronic rhinosinusitis were included in a systematic review. RESULTS Ten clinical studies were qualitatively analyzed. Six of these studies used the PRP for OD caused by COVID-19, one on OD after functional endoscopic sinus surgery, and three on post-infectious or post-trauma OD. The population included 531 patients, ranging in age from 15 to 63. CONCLUSION The use of PRP may be a risk-free and efficient therapeutic option with very encouraging outcomes. Indeed, it enhances olfactory perception in patients who not only exhibit COVID-19 infection aftereffects, but also in those who have lost their sense of smell due to trauma, rhinosinusitis, rhinitis, or even surgery. To evaluate the PRP's therapeutic benefits in OD patients and to compare the efficacy of different therapeutic protocols with regard to treatment schedules, there is an urgent need for focused controlled trials.
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Impact of C-reactive protein on the effect of Roxadustat for the treatment of anemia in chronic kidney disease: a systematic review of randomized controlled trials
Luo, X., Li, G., Yang, H., Chen, L., Gao, Y., Cong, J., Luo, H., Zhang, W.
BMC nephrology. 2024;25(1):47
Abstract
BACKGROUND Chronic inflammation, reflected by an increased blood C-reactive protein (CRP) level, is common in patients with chronic kidney disease (CKD) and is involved in the development of renal anemia. This systematic review aims to investigate the impacts of CRP on the efficacy of hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHIs) in the treatment of renal anemia in patients with CKD. METHODS We conducted a comprehensive search of electronic databases including Pubmed, Web of Science, Embase, Cochrane Library, CNKI, Wanfang, and the International Clinical Trials Registry Platform (ICTRP), from their inception to May 19, 2022. We systematically reviewed evidence from randomized controlled trials using HIF-PHIs for renal anemia treatment. The mean difference (MD) in changes in hemoglobin concentration (∆Hb) before and after treatment served as the meta-analysis outcome, utilizing a random-effects model. We compared groups with CRP levels greater than or equal to the upper limit of normal (ULN) and less than the ULN. Additionally, further analysis was conducted in the CRP ≥ ULN group comparing HIF-PHIs and erythropoiesis-stimulating agents (ESA). RESULTS A total of 7 studies from 6 publications were included in the analysis. In the comparison between the CRP ≥ ULN group and the CRP < ULN group, 524 patients from 4 studies were incorporated into the analysis. All patients received roxadustat as the primary intervention. The pooled results revealed no significant difference in ΔHb between patients with CRP ≥ ULN and CRP < ULN at baseline (Mean Difference: 0.00, 95% Confidence Interval: -0.32 to 0.33, P = 0.99). Moreover, within the CRP ≥ ULN group, three studies involving 1399 patients compared the efficacy of roxadustat and erythropoiesis-stimulating agents (ESAs). The results indicated no significant difference in ΔHb between patients treated with ESAs and HIF-PHIs (Mean Difference: 0.24, 95% Confidence Interval: -0.08 to 0.56, P = 0.14). In terms of medication dosage, an increase in ESA dose over time was observed across various studies, particularly evident in the CRP ≥ ULN group, while the dose of roxadustat remains constant over time and is not influenced by the baseline levels of CRP. CONCLUSIONS Our systematic review demonstrates that roxadustat exhibits similar efficacy across different CRP levels. Moreover, within the CRP ≥ ULN group, roxadustat can maintain efficacy comparable to ESA without the necessity for dose escalation. TRIAL REGISTRATION CRD42023396704.
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Kidney disease in trials of perioperative tranexamic acid
Liu, C. W., Anih, J., Lebedeva, V., Gungor, A., Wang, C., Park, L., Roshanov, P. S.
Journal of clinical anesthesia. 2024;94:111417
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Editor's Choice
Abstract
STUDY OBJECTIVE To assess how kidney disease is handled in randomized trials evaluating the safety and efficacy of perioperative tranexamic acid, and to evaluate its effects across levels of kidney function. DESIGN Systematic review and meta-analysis of randomized controlled trials. SETTING We screened studies from a previous comprehensive systematic review, and updated its search of PubMed, Embase, and Cochrane CENTRAL to July 31, 2023. PATIENTS Patients undergoing non-obstetric surgery. INTERVENTIONS Intravenous tranexamic acid compared to placebo or usual care without tranexamic acid. MEASUREMENT We summarized the handling of kidney disease in eligibility criteria, dose adjustments for kidney function, and effects of tranexamic acid on thrombotic events, seizures, and bleeding by subgroups of kidney function. MAIN RESULTS We evaluated 300 trials with 53,085 participants; 45,958 participants (86.6%) were enrolled in 228 trials (76.0%) that explicitly excluded patients with kidney disease. Definitions of kidney diseased used for exclusion varied widely. Most were non-specific and some corresponded to mild disease. Only 5 trials adjusted dosing for kidney function. Meta-analysis of two large trials found tranexamic acid unlikely to substantially increase or decrease the occurrence of thrombotic events in patients with eGFR <60 mL/min/1.73m(2) (RR, 0.95; 95% CI: 0.83 to 1.07) or ≥ 60 mL/min/1.73m(2) (RR, 1.00; 95% CI, 0.91 to 1.11; P for subgroup difference = 0.47), but both trials excluded patients with severe kidney disease. No analysis could be performed regarding seizure risk. One large trial in noncardiac surgery reported similar reduction in bleeding across subgroups of kidney function but excluded patients with creatinine clearance <30 mL/min. CONCLUSIONS The large evidence base supporting perioperative tranexamic acid suffers from broad and unjustified exclusion of patients with kidney disease. Typical perioperative dosing of tranexamic acid is likely safe and effective in patients with creatinine clearance >30 mL/min, but effects in more severe kidney disease are unknown.
PICO Summary
Population
Patients undergoing non-obstetric surgery (300 trials, n= 53,085).
Intervention
Intravenous tranexamic acid.
Comparison
Placebo or usual care without tranexamic acid.
Outcome
From all the included studies, 45,958 participants (86.6%) were enrolled in 228 trials (76.0%) that explicitly excluded patients with kidney disease. Definitions of kidney diseased used for exclusion varied widely. Most were non-specific and some corresponded to mild disease. Only 5 trials adjusted dosing for kidney function. Meta-analysis of two large trials found tranexamic acid unlikely to substantially increase or decrease the occurrence of thrombotic events in patients with estimated glomerular filtration rate <60 mL/min/1.73m(2) (RR 0.95; 95% CI [0.83, 1.07]) or ≥ 60 mL/min/1.73m(2) (RR 1.00; 95% CI [0.91, 1.11], but both trials excluded patients with severe kidney disease. No analysis could be performed regarding seizure risk. One large trial in non-cardiac surgery reported similar reduction in bleeding across subgroups of kidney function but excluded patients with creatinine clearance <30 mL/min.
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The Potential of Autologous Platelet-Rich Plasma Gel for Diabetic Foot Ulcer Care Among Older Adults: A Systematic Review and Meta-Analysis
Platini, H., Adammayanti, K. A., Maulana, S., Putri, P. M. K., Layuk, W. G., Lele, Jajmn, Haroen, H., Pratiwi, S. H., Musthofa, F., Mago, A.
Therapeutics and clinical risk management. 2024;20:21-37
Abstract
INTRODUCTION Poorly controlled diabetes mellitus can lead to the development of diabetic foot ulcers (DFU), which is a frequent complication in patients. However, several diabetes management guidelines for older adults do not mention the occurrence of DFUs. Nowadays, Autologous Platelet-Rich Gel (APG) is being used for treating diabetic ulcers. APG is an innovative platelet-derived product with many advantages, such as being low-cost, easy to produce, and readily available materials. Additionally, it does not lead to any rejection reaction. OBJECTIVE This study aims to assess the safety and efficacy of APG as a novel treatment of DFU compared with standard treatment in older adult patients. METHODS Randomized Controlled Trials (RCTs) were searched using PubMed, Cochrane, Google Scholar, Wiley, and PlosOne. The keywords have been arranged using the Boolean operator, including autologous platelet-rich gel, DFU, and elderly. The data was screened by inclusion and exclusion criteria. The final inclusion study was analyzed and synthesized by tabulation, clusterization, contextual and thematic approach, and assessed for risk of bias using ROB 2.0. Meta-analysis was conducted by using Review Manager 5.4 and the Mantel Haenszel method. RESULTS Eight RCTs with 598 patients were eligible for the present analysis. Compared with standard care/conventional treatment, APG could significantly improve the healing wound in patients with diabetic foot ulcers (Relative risk (RR) 1.32, 95% confidence interval (CI) 1.22-1.57, p < 0.0001), shortened the healing time (Mean difference [MD] -16.97 days (95% CI: -32.64 to -1.29; p < 0.00001), shortened the length of hospital stay (MD= -20.11, 95% CI: -38.02, -2.20; p = 0.03), and amputation rate (MD= 0.36, 95% CI: 0.16, 0.84; p = 0.02). CONCLUSION APG treatment can better treat DFU in terms of duration of healing, wound healing, length of hospital stay, and amputation prevention than the standard treatment.