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The Influence of Industry Affiliation on Randomized Controlled Trials of Platelet-Rich Plasma for Knee Osteoarthritis
Ta CN, Vasudevan R, Mitchell BC, Keller RA, Kent WT
The American journal of sports medicine. 2023;:3635465221140917
Abstract
BACKGROUND Industry funding and corporate sponsorship have played a significant role in the advancement of orthopaedic research and technology. However, this relationship raises concerns for how industry association may bias research findings and influence clinical practice. PURPOSE To determine whether industry affiliation plays a role in the outcomes of randomized controlled trials (RCTs) investigating platelet-rich plasma (PRP). STUDY DESIGN Meta-analysis; Level of evidence, 2. METHODS A search of the PubMed, Cochrane, and MEDLINE databases for RCTs published between 2011 and the present comparing PRP versus hyaluronic acid, corticosteroid, or placebo for the treatment of knee osteoarthritis was performed. To determine industry affiliation, the conflict of interest, funding, and disclosure sections of publications were assessed, and all authors were assessed through the American Academy of Orthopaedic Surgeons disclosure database and the Centers for Medicare & Medicaid Services open payments database. Studies were classified as industry affiliated (IA) or non-industry affiliated (NIA). The outcomes of each study were rated as favorable, analogous, or unfavorable according to predefined criteria. RESULTS A total of 37 studies (6 IA and 31 NIA) were available for analysis. Overall, 19 studies (51.4%) reported PRP as favorable compared with other treatment options, while 18 studies (48.6%) showed no significant differences between PRP and other treatment methods. There was no significant difference in qualitative conclusions between the IA and NIA groups, with the IA group having 3 favorable studies and 3 analogous studies and the NIA group having 16 favorable studies and 15 analogous studies (P = .8881). When comparing IA versus NIA studies using 6- and 12-month Western Ontario and McMaster Universities Arthritis Index and International Knee Documentation Committee scores, there were no significant differences in outcomes. CONCLUSION The results of this study demonstrated that qualitative conclusions and outcome scores were found to not be associated with industry affiliation. Although the results of this study suggest that there is no influence of industry involvement on RCTs examining PRP, it is still necessary to carefully evaluate pertinent commercial affiliations when reviewing recommendations from studies before adopting new treatment approaches, such as the use of PRP for knee osteoarthritis.
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Three doses of PRP therapy may be more effective than one dose of Platelet-Rich Plasma (PRP) in the Treatment of Knee Osteoarthritis: A Systematic Review and Meta-analysis
Xinyu TAO, Ai Ling AA, Jie LJ, Rahmatullah Bin Abd Razak H
Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association. 2023
Abstract
PURPOSE This study aims to compare the efficacy of a single dose of Platelet-Rich Plasma (PRP) with multiple doses of PRP therapy in the treatment of knee osteoarthritis (KOA). METHODS PubMed, Embase, CINAHL, SCOPUS, Cochrane Library, grey literature and bibliographic references were searched from inception to May 2022. Only randomized controlled trials (RCTs) comparing the effect of single versus multiple doses of PRP for KOA were included. Literature retrieval and data extraction were conducted by three independent reviewers. Inclusion and exclusion criteria were based on type of study, research subjects, intervention, outcome, language and availability of data. Pooled analysis of Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores and adverse events were conducted. RESULTS Seven studies (all RCTs) of high methodological quality involving 575 patients were included. Age of patients included in this study ranged from 20 to 80, with a balanced gender ratio. Single dose PRP therapy resulted in significantly better VAS scores compared to triple dose PRP therapy at 12 months (P<0. 0001), with no significant change in VAS scores between double and single dose PRP at 12 months. Regarding adverse events, double dose (P=0.28) and triple dose (P=0.24) therapy had no significant differences in safety from single dose therapy. CONCLUSION While there is a paucity of large high-quality Level I studies, current best evidence suggests that two or three doses of PRP for KOA are as effective as one dose of PRP at providing pain relief and improvement in function up to 1 year following administration.
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Impact of autologous platelet concentrates on wound area reduction: A meta-analysis of randomized controlled trials
Tang, B., Huang, Z., Zheng, X.
International wound journal. 2023
Abstract
This meta-analysis aimed to evaluate the impact of autologous platelet concentrates (APCs) on wound area reduction based on randomized controlled trials (RCTs). A comprehensive search was conducted in PubMed, Embase, China National Knowledge Infrastructure (CNKI), Web of Science, and the Cochrane Library to identify relevant literature. The primary outcome measure was the percentage of wound area reduction. Secondary outcome measures included wound healing time and the incidence of infection. A total of 14 studies were included in the meta-analysis. The results showed that the percentage of wound area reduction was significantly greater in the APCs group compared to conventional treatments (standardized mean difference [SMD] 1.98, 95% confidence interval [CI]: 1.27-2.68, p < 0.001). Subgroup analysis revealed that the percentage of wound area reduction varied based on wound location, follow-up duration, and type of APCs used. The healing time and incidence of infection presented no significant difference between the two groups. The findings suggest that APCs can effectively reduce wound areas when compared to conventional treatments, without increasing the risk of infection. In addition, the effectiveness of APCs in wound area reduction may vary depending on factors such as wound location, type of APCs used, and follow-up duration.
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Platelet-rich Plasma for the Treatment of Erectile Dysfunction: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
Masterson TA, Molina M, Ledesma B, Zucker I, Saltzman R, Ibrahim E, Han S, Reis IM, Ramasamy R
The Journal of urology. 2023;:101097ju0000000000003481
Abstract
PURPOSE We assessed the safety and efficacy of 2 injections of platelet-rich plasma for treating mild to moderate erectile dysfunction by conducting a prospective, randomized, double-blind, placebo-controlled clinical trial. MATERIALS AND METHODS Men with mild to moderate erectile dysfunction (International Index of Erectile Function scores 11-25) were randomized to receive either 2 injections of platelet-rich plasma or placebo separated by 1 month. Primary outcome was percentage of men meeting minimum clinically important difference at 1 month after the second injection. Secondary outcomes were change in International Index of Erectile Function at 1, 3, and 6 months, and changes in penile vascular parameters and adverse events at 6 months. RESULTS We randomized 61 men: 28 into platelet-rich plasma and 33 into placebo. There was no difference between groups in percentage of men meeting minimum clinically important difference at 1 month: 14 (58.3%) in platelet-rich plasma vs 15 (53.6%) in placebo (P = .730). Mean International Index of Erectile Function-Erectile Function domain changed from 17.4 (95% CI 15.8-19.0) to 21 (17.9-24.0) at 1 month in men receiving platelet-rich plasma, vs 18.6 (17.3-19.8) to 21.6 (19.1-24.1) in the placebo group; however, there was no significant difference between groups (P = .756). There were no major adverse events and only 1 minor adverse event in each group. There were no changes in penile Doppler parameters from baseline to 6 months. CONCLUSIONS The results of our prospective, double-blind, randomized, placebo-controlled clinical trial suggest that 2 injections of intracavernosal platelet-rich plasma separated by 1 month in men with mild to moderate erectile dysfunction is safe, but we found no difference in efficacy between platelet-rich plasma and placebo.
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Effects of Platelet-Rich Plasma in Tear Size Reduction in Partial-Thickness Tear of the Supraspinatus Tendon Compared to Corticosteroids Injection
Tanpowpong T, Thepsoparn M, Numkarunarunrote N, Itthipanichpong T, Limskul D, Thanphraisan P
Sports medicine - open. 2023;9(1):11
Abstract
OBJECTIVES Corticosteroid (CS) injection is commonly used in partial-thickness rotator cuff tears to decrease pain. However, this could result in unwanted side effects, such as tendon rupture. Alternatively, platelet-rich plasma (PRP) injection is frequently used to treat tendinopathies because it enhances healing. This study aimed to compare the differences in tear size and functional scores between intralesional PRP and subacromial CS injections. METHODS Patients with symptomatic partial-thickness tears of the supraspinatus tendon who underwent conservative treatment for ≥ 3 months were enrolled. All patients underwent magnetic resonance imaging (MRI) to confirm the diagnosis. Fourteen and 15 patients were randomized to receive intralesional PRP and subacromial CS injections, respectively. Tears were measured in the coronal and sagittal planes. The patients underwent another MRI 6 months after the injection. Tear size was compared between the two MRI results. The American Shoulder and Elbow Surgeons Shoulder score (ASES) and Constant-Murley score (CMS) were also obtained. RESULTS The baseline data were similar between the groups. In the coronal plane, PRP and CS showed tear size reductions of 3.39 mm (P = 0.003) and 1.10 mm (P = 0.18), respectively. In the sagittal plane, PRP and CS showed tear size reductions of 2.97 mm (P = 0.001) and 0.76 mm (P = 0.29), respectively. Functional scores improved 6 months after injection in both groups, but PRP showed better functional scores than CS (P = 0.002 for ASES, P = 0.02 for CS). CONCLUSION Intralesional PRP injection can reduce the tear size in partial-thickness tears of the supraspinatus tendon. Subacromial steroid injection did not significantly affect the tear size. While CS improved functional scores compared with baseline, PRP resulted in better improvement 6 months post-injection. Trial registration Thai Clinical Trials Registry, TCTR20210428004. Registered 28 April 2021-retrospectively registered, TCTR20210428004 .
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Symptom duration and resolution with early outpatient treatment of convalescent plasma for COVID- 19: a randomized trial
Baksh S, Heath SL, Fukuta Y, Shade D, Meisenberg B, Bloch EM, Tobian AAR, Spivak ES, Patel B, Gerber J, et al
The Journal of infectious diseases. 2023
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Abstract
BACKGROUND COVID-19 convalescent plasma (CCP) reduces hospitalizations among outpatients treated early after symptom onset. It is unknown if CCP reduces time to symptom resolution among outpatients. METHODS We evaluated symptom resolution at day 14 by trial arm using an adjusted sub-distribution hazard model, with hospitalization as a competing risk. Additionally, we assessed prevalence of symptom clusters at day 14 between treatments. Clusters were defined based on biologic clustering, impact on ability to work, and an algorithm. RESULTS Among 1,070 outpatients followed after transfusion, 381 of 538 (70.8%) receiving CCP and 381 of 532 (71.6%) receiving control plasma were still symptomatic (p = 0.78) at day 14. Associations between CCP and symptom resolution by day 14 were not statistically different from those in controls after adjusting for baseline characteristics (adjusted sub-distribution hazard ratio: 0.99; p = 0.62). The most common cluster consisted of cough, fatigue, shortness of breath, and headache, found in 308 (57.2%) and 325 (61.1%) of CCP and control plasma recipients, respectively (p = 0.16). CONCLUSIONS In this trial of outpatients with early COVID-19, CCP was not associated with faster resolution of symptoms compared to control. Overall, there were no differences in the prevalence of each symptom or symptom clusters at day 14 by treatment.
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Effects of platelet-rich plasma and prolotherapy on supraspinatus tendinopathy: a double blind randomized clinical trial
Abd Karim S, Hamid MS, Choong A, Ooi MY, Usman J
The Journal of sports medicine and physical fitness. 2023;63(5):674-684
Abstract
BACKGROUND Supraspinatus tendinopathy is a significant cause of pain and function loss. It has been suggested that platelet-rich plasma (PRP) and prolotherapy are effective treatments for this condition. This study was done to assess and compare the effects of PRP and prolotherapy on shoulder function and pain. The secondary aim was to evaluate the effect of the treatment on shoulder range of motion, supraspinatus tendon thickness, patient satisfaction, and adverse effects. METHODS This was a randomized, double-blind clinical trial. The study included 64 patients over the age of 18 who had supraspinatus tendinopathy and had not responded to at least three months of conventional treatment. Patients were assigned to either receive 2 mL of PRP (N.=32) or prolotherapy (N.=32). The Shoulder Pain and Disability Index (SPADI) and the Numerical Rating Scale (NRS) were the primary outcomes. Secondary outcomes included shoulder range of motion (ROM), supraspinatus tendon thickness, and adverse effects, which were measured at baseline, 3, 6, and 6 months after injection. At six months, patient satisfaction was assessed. RESULTS Repeated measures ANOVA showed there was a statistically significant effect of time on total SPADI scores (F [2.75, 151.11], = 2.85, P=0.040) and the NRS (F [2.69, 147.86], = 4.32, P=0.008) within each group. There were no other significant changes over time or between groups. Significantly more patients in the PRP group experienced increased pain lasting less than two weeks after injection (χ(2)=11.94, P=0.030). CONCLUSIONS PRP and prolotherapy resulted in improved shoulder function and pain for patients with chronic supraspinatus tendinopathy who did not response to conventional treatment.
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Effect of convalescent plasma transfusion on outcomes of coronavirus disease 2019: a meta-analysis with trial sequential analysis
Hakim SM, Chikhouni GMA, Ammar MA, Amer AM
Journal of anesthesia. 2023;:1-14
Abstract
The aim of this review was to update evidence for benefit of convalescent plasma transfusion (CPT) in patients with coronavirus disease 2019 (COVID-19). Databases were searched for randomized controlled trials (RCT) comparing CPT plus standard treatment versus standard treatment only in adults with COVID-19. Primary outcome measures were mortality and need for invasive mechanical ventilation (IMV). Twenty-Six RCT involving 19,816 patients were included in meta-analysis for mortality. Quantitative synthesis showed no statistically significant benefit of adding CPT to standard treatment (RR = 0.97, 95% CI = 0.92 to 1.02) with unimportant heterogeneity (Q(25) = 26.48, p = .38, I(2) = 0.00%). Trim-and-fill-adjusted effect size was unimportantly changed and level of evidence was graded as high. Trial sequential analysis (TSA) indicated information size was adequate and CPT was futile. Seventeen trials involving 16,083 patients were included in meta-analysis for need of IMV. There was no statistically significant effect of CPT (RR = 1.02, 95% CI = 0.95 to 1.10) with unimportant heterogeneity (Q(16) = 9.43, p = .89, I(2) = 3.30%). Trim-and-fill-adjusted effect size was trivially changed and level of evidence was graded as high. TSA showed information size was adequate and indicated futility of CPT. It is concluded with high level of certainty that CPT added to standard treatment of COVID-19 is not associated with reduced mortality or need of IMV compared with standard treatment alone. In view of these findings, further trials on efficacy of CPT in COVID-19 patients are probably not needed.
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Safety and efficacy of intra-articular injection of platelet-rich plasma for the treatment of ankle osteoarthritis: a systematic review and meta-analysis
Ding SL, Ji LF, Zhang MZ, Xiong W, Sun CY, Han ZY, Wang C
International orthopaedics. 2023
Abstract
PURPOSE To evaluate the safety and efficacy of platelet-rich plasma (PRP) intra-articular injective treatments for ankle osteoarthritis (OA). METHODS A systematic literature search was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in PubMed, Scopus, Embase, Google Scholar, and the Cochrane library until May 2022. Both randomized and non-randomized studies were included with the assessment of the risk of bias. We recorded the participant's age, gender, type of PRP, injection volume, the kit used, and activating agent. We subsequently assessed the short-term and long-term efficacy of PRP using the functional scores and visual analog scale (VAS). RESULTS We included four studies with a total of 127 patients, with a mean age of 56.1 years. 47.2% were male (60/127), according to eligibility criteria. There were three cohort studies and one randomized controlled trial (RCT) study, and no study reported severe adverse events. All included studies used the Leukocyte-poor PRP. Short-term follow-up results suggested significant improvement of the American Orthopaedic Foot and Ankle Society (AOFAS) score in the PRP injection group compared to the control group (n = 87 patients; MD: 6.94 [95% CI: 3.59, 10.29]; P < 0.01). Consistently, there was a statistical difference in AOFAS score between PRP injection and control groups in the final follow-up (≥ 6 months) (n = 87 patients; MD: 9.63 [95% CI: 6.31, 12.94]; P < 0.01). Furthermore, we found a significant reduction in VAS scores in the PRP groups at both the short-term follow-up (n = 59 patients; MD, - 1.90 [95% CI, - 2.54, - 1.26]; P < 0.01) and the ≥ six months follow-up (n = 79 patients; MD, - 3.07 [95% CI, - 5.08, - 1.05]; P < 0.01). The improvement of AOFAS and VAS scores at ≥ six months follow-up reached the minimal clinically important difference (MCID). Nevertheless, the treatment effect of AOFAS and VAS scores offered by PRP at short-term follow-up did not exceed the MCID. Substantial heterogeneity was reported at the ≥ six months follow-up in VAS scores (I(2): 93%, P < 0.01). CONCLUSION This meta-analysis supports the safety of PRP intra-articular injection for ankle OA. The improvements of AOFAS and VAS scores in the PRP group at short-term follow-up do not exceed the MCID to be clinically significant. PRP injection provides significant improvement of AOFAS score and reduced pain at ≥ six months follow-up. The efficacy of PRP should be interpreted with caution regarding the high heterogeneity and the scarcity of available literature, which urges large-scale RCTs with longer follow-up to confirm the potential efficacy of PRP injection for ankle OA.
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Effect of platelet counts and activator in platelet-rich plasma on the treatment of androgenetic alopecia, split-head comparison: A randomised, double-blind study
Singh SK, Singh S
Indian journal of dermatology, venereology and leprology. 2023;:1-9
Abstract
Background Androgenetic alopecia is a common, chronic, non-scarring alopecia. It is characterised by stepwise miniaturisation of the hair follicles, due to alteration in the hair cycle dynamics, leading to the transformation of terminal hair follicles into a vellus ones. Oral finasteride and topical minoxidil are the only approved drugs for treating this condition. Due to a limited number of effective therapies for androgenetic alopecia, platelet-rich plasma may be an effective alternative treatment. Aims To study the effect of activator in platelet-rich plasma and baseline platelet count in platelet-rich plasma on the treatment of androgenetic alopecia. Methods A randomised, double-blind split-head comparative study. The sample size was calculated and randomisation was done. Patients with androgenetic alopecia were allocated into two groups; in the first group, autologous activated platelet-rich plasma was injected in the right half of the affected scalp and autologous non-activated platelet-rich plasma was injected in the left half of the affected scalp and vice versa in the second group. Patients were also categorised on the basis of platelet counts in their platelet-rich plasma in three groups; group A (6-8 lakh/mm3), group B (8.1-10 lakh/mm3) and group C (>10 lakh/mm3). Interventions were done monthly for three months and followed up for the next three months. Effects of interventions were assessed by hair density, hair thickness, patient self-assessment and clinical photography. Results A total of 80 patients were included in the study. Activated platelet-rich plasma produced significant improvement of hair density after four months and hair thickness at 6 months. An increase in platelet count led to a significant increase in hair density and hair thickness after three and four months respectively and a highly significant increase in both parameters at the end of the study. Limitations Long-term follow-up of cases was not done and no measurement of vellus hair count was done. Conclusion There is a significant effect of activator and platelet count of the platelet-rich plasma on hair density as well as hair thickness.
