scholarly journals Clinical Efficacy of Intra-Articular Injection With P-PRP Versus That of L-PRP in Treating Knee Cartilage Lesion: A Randomized Controlled Trial.

2021 ◽  
Author(s):  
Yiqin Zhou ◽  
Haobo Li ◽  
Shiqi Cao ◽  
Yaguang Han ◽  
Jiahua Shao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Efficacy ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Womac Pain ◽  
Knee Cartilage ◽  
Cartilage Lesions ◽  
Randomized Controlled

Abstract Background: To evaluate the clinical efficacy and safety of intra-articular injection with pure platelet-rich plasma (P-PRP) versus those of leukocyte platelet-rich plasma (L-PRP) in treating knee cartilage lesions, we conducted a double-blind, randomized controlled clinical trial with a larger sample and longer follow-up period.Methods: From October 2019 to October 2020, 95 patients were invited to participate in our study, and 60 (63.2%) were randomized to P-PRP (n = 30) or L-PRP (n = 30) groups. Patients from the two groups were treated with knee intra-articular injections of P-PRP or L-PRP. Visual analog scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores were assessed preoperatively and at 6 weeks, 12 weeks, 6 months, and 12 months after intervention.Results: We followed up 27 cases in the P-PRP group and 26 cases in the L-PRP group. No significant differences in VAS and WOMAC scores were found between the two groups before the intervention (P>0.05). The WOMAC Pain and VAS-Motions scores of the P-PRP group were significantly lower than those of the L-PRP group at 6 weeks after the intervention (P<0.05). While the long-term clinical efficacy of both injections was similar and weakened after 12 months, more adverse events were found in the L-PRP group.Conclusions: The short-term results of our study are encouraging and demonstrate that both L-PRP and P-PRP intra-articular injections reduce pain and improve function in patients with knee cartilage lesions. Compared with the L-PRP injection, the P-PRP injection (which had a lower risk of early inflammation caused by leukocytes) showed better clinical efficacy in the early phase of postoperative rehabilitation and resulted in fewer adverse events. However, long-term clinical efficacy for both injections were similar and weakened after 12 months.Trial registration: ChiCTR1900026365. Registered on 3 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=43911.

scholarly journals Long-Term Influence of Platelet-Rich Plasma (PRP) on Dental Implants after Maxillary Augmentation: Retrospective Clinical and Radiological Outcomes of a Randomized Controlled Clinical Trial

2020 ◽  
Vol 9 (2) ◽  
pp. 355 ◽  
Author(s):  
Sameh Attia ◽  
Clara Narberhaus ◽  
Heidrun Schaaf ◽  
Philipp Streckbein ◽  
Jörn Pons-Kühnemann ◽  
...  
Keyword(s):  
Dental Implants ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Long Term Results ◽  
Control Group ◽  
Iliac Crest Bone Graft ◽  
Controlled Clinical Trial ◽  
Positive Effects ◽  
Randomized Controlled

The long-term clinical and radiological outcomes of dental implants inserted in augmented bone treated with platelet-rich plasma (PRP) has not been well addressed in the literature yet. This study is based on a collection of patients from a randomized controlled trial (RCT) that did not report any short-term positive effects of PRP on bone healing after sinus lift surgery using autologous iliac crest bone graft. This study aimed to evaluate the long-term impact of PRP regarding clinical and radiological outcomes on the inserted implants in the previous RCT. For this evaluation, we considered the following variables: plaque index, probing depth, bleeding index, mobility grade, Periotest® values, and radiological bone loss. Out of 53 patients (n = 306 implants) included in the previous study we were able to reinvestigate 37 patients (n = 210 implants) in two centers (31 in Giessen, Germany and 6 in Erlangen, Germany). Clinical and radiographic parameters suggested overall healthy conditions of the peri-implant tissue. The PRP-group and the control group did not differ significantly in the majority of the parameters. The overall evaluation showed that result data of the PRP-group was inferior to the control group in 64 percent of the evaluated parameters. The present study cannot provide evidence of a positive effect of PRP on the long-term implant clinical and radiological outcomes. In fact, a tendency towards inferior long-term results in the PRP-group was detected without reaching a significant threshold. Further controlled trials need to be conducted to investigate this correlation.

scholarly journals Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse

2021 ◽  
Author(s):  
Nadim Bikhazi ◽  
Randall A. Ow ◽  
Ellen M. O'Malley ◽  
Nora Perkins ◽  
Douglas M. Sidle ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Controlled Trial ◽  
Nasal Valve ◽  
Time Points ◽  
Randomized Controlled ◽  
Nasal Implant ◽  
Nasal Valve Collapse

AbstractWe report the long-term safety and efficacy outcomes of the treatment and crossover arms of a randomized controlled trial evaluating an absorbable nasal implant to address dynamic nasal valve collapse. Participants were adults with severe/extreme nasal airway obstruction primarily due to nasal valve insufficiency who had implant placement. Follow-up visits were at 3, 6, 12, 18, and 24 months post implant. Visits included collection of the following patient-reported outcome measures: nasal obstructive symptom evaluation (NOSE), nasal obstruction visual analog scale (VAS), and the Epworth Sleepiness Scale (ESS). Adverse events were evaluated at each visit. One-hundred-eleven participants with implants were followed. Of the 111, 90 completed the 12-month visit and 70 completed the 24-month visit. NOSE responder rates are greater than 80% at all follow-ups through 24 months. Mean reduction from baseline in NOSE scores is ≥30 points and statistically significant (p <0.001) at all time points through 24 months. Mean VAS score reduction is ≥29.7 points and statistically significant (p <0.001) at all time points. The subgroup of participants with baseline ESS values >10 experienced statistically significant (p <0.001) and clinically meaningful reductions at all postimplant periods, suggesting that the reduction in nasal symptoms may reduce daytime sleepiness for patients who have problems with sleep quality. No serious device-/procedure-related adverse events were reported. Implant migration/retrieval rate was 4.5% (10/222) of total implants or 9% of participants (10/111). The implant is safe and effective for dynamic nasal valve collapse in patients with severe/extreme nasal obstruction and provides durable symptom improvement 24 months after placement.

Electroacupuncture for Knee Osteoarthritis Based on Different Meridian Syndrome: A Randomized Controlled Pilot Trial

2021 ◽  
Vol 46 (3) ◽  
pp. 247-258
Author(s):  
Tian-Qi Wang ◽  
Wan-Ting Lu ◽  
Jia Yang
Keyword(s):  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Womac Pain ◽  
Randomized Controlled ◽  
End Of Treatment ◽  
Multicenter Randomized Controlled Trial ◽  
Registration Number

Background: We aimed to explore the feasibility of evaluating effectiveness and safety of electroacupuncture (EA) for the treatment of knee osteoarthritis (KOA) based on different meridian syndromes. Methods: A multicenter randomized controlled trial was conducted in Beijing from January 2019 to December 2019. Sixty KOA participants were randomly allocated to either EA (n=30) or SA (n=30) groups. Participants in EA group were treated with semi-standardized on different meridian syndrome, including five obligatory acupoints and three adjunct acupoints. Eight non-acupoints that were separated from conventional acupoints or meridians were used for the SA group. Both groups received 24 sessions within eight weeks. The primary outcome was response rate, defined as a change of ≥50% from baseline in total scores of Western Ontario and McMaster Universities osteoarthritis index (WOMAC) at the end of treatment. Secondary outcomes included function, pain, stiffness, quality of life and acupuncture-related adverse events at four and eight weeks. Results: Of 60 participants randomized, 56 (93.3%) completed the study. Response rates were 60% for the EA group and 30% for the SA group after eight weeks. Significant differences were observed in WOMAC pain and total scores within two groups (P =0.026, P =0.043). Rates of adverse events were low and similarly distributed between groups. Conclusion: EA intervention based on meridian differentiation in KOA was feasible and appeared safe, having a stronger impact on pain than SA. Future studies can be designed with larger sample size, adequately powered, randomization design and less biases. Trial registration number: NCT03274713.

scholarly journals Ten-Year Follow-Up of Patients Treated with Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection from a Randomized Controlled Trial and Review of the Literature

2021 ◽  
Vol 9 (3) ◽  
pp. 548
Author(s):  
R. E. Ooijevaar ◽  
E. van Nood ◽  
A. Goorhuis ◽  
E. M. Terveer ◽  
J. van Prehn ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Fecal Microbiota Transplantation ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Randomized Controlled ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection

Fecal microbiota transplantation (FMT) has become a well-established treatment for recurrent Clostridioides difficile infection (rCDI). While short-term outcomes and adverse events relating to FMT have been well documented, there still is a paucity of data with regard to long-term safety. In this report, we describe the long-term follow-up of the prospective cohort of the first randomized controlled trial of FMT for rCDI, and review the existing literature. A total of 34 patients were treated with FMT for rCDI. Seven patients were still alive after a follow-up of more than 10 years and three patients were lost to follow-up. None of the 34 patients had experienced a new-onset autoimmune, gastrointestinal, or malignant disorder during follow-up. We did not find any deterioration or amelioration of pre-existing medical conditions. Furthermore, no deaths directly attributable to FMT could be identified. These findings are in accordance with the data in available literature. In conclusion, no long-term adverse events or complications directly attributable to FMT were found in our prospective cohort. Review of the available literature does not point to long-term risks associated with FMT in this elderly population, provided that carefully screened fecal suspensions are being used. No firm conclusion on the long-term safety of FMT in younger patients could be drawn.

Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial

2018 ◽  
Vol 47 (2) ◽  
pp. 347-354 ◽  
Author(s):  
Alessandro Di Martino ◽  
Berardo Di Matteo ◽  
Tiziana Papio ◽  
Francesco Tentoni ◽  
Filippo Selleri ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hyaluronic Acid ◽  
Functional Status ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Symptomatic Relief ◽  
Randomized Controlled ◽  
Over Time

Background: Platelet-rich plasma (PRP) injections have been proposed as a new conservative option for knee degeneration to provide symptomatic relief and delay surgical intervention. Although the current literature provides some evidence on the benefits of this technique compared with viscosupplementation, no studies have been performed to compare their long-term effects. Purpose: To compare the long-term clinical outcomes provided by intra-articular injections of either PRP or hyaluronic acid (HA) to treat knee degenerative disease. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with a history of chronic symptomatic knee degenerative changes and osteoarthritis (Kellgren-Lawrence grade 0-3) were enrolled: 192 patients were randomized to undergo 3 blinded weekly intra-articular injections of either PRP or HA. Patients were prospectively evaluated before the injection and then at 2, 6, 12, and 24 months and a mean of 64.3 months (SD, 7.8 months) of follow-up. Evaluation was based on International Knee Documentation Committee (IKDC) subjective (main outcome), EuroQol visual analog scale, and Tegner scores; 167 patients reached the final evaluation. Results: Both treatments were effective in improving knee functional status and symptoms over time: Mean ± SD IKDC subjective score improved significantly for both PRP and HA groups ( P < .0005) and remained stable over time up to 24 months (from 53.3 ± 14.3 to 67.3 ± 18.1 and from 50.3 ± 13.2 to 62.1 ± 20.8 for PRP and HA groups, respectively). At final evaluation, a significant IKDC reduction was observed in both treatment groups, with the PRP group still presenting significantly higher values compared with baseline: PRP 60.5 ± 19.0 ( P < .001 vs baseline), HA 55.7 ± 18.8 (not significant vs baseline). A comparative analysis showed no significant intergroup difference in any of the clinical scores at any follow-up point. The median duration of patient subjective perception of symptomatic relief was 9 months for HA and 12 months for PRP (not significant). The only significant difference was observed in the rate of reintervention at 24 months, which was significantly lower in the PRP group (22.6% vs 37.1%, P = .036). Conclusion: Both treatments were effective in improving knee functional status and symptoms over time. PRP did not provide an overall superior clinical improvement compared with HA in terms of either symptomatic-functional improvement at different follow-up points or effect duration. Registration: NCT01670578 (ClinicalTrials.gov identifier).

scholarly journals Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Zhang Jing ◽  
Guan Liying ◽  
Wang Zhenqing ◽  
Zhang Hui ◽  
Liu Shuai ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Efficacy Rate ◽  
Efficacy And Safety ◽  
Symptom Index ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean ◽  
Hepatorenal Function

Objectives. To evaluate the efficacy and safety of Ningmitai (NMT) capsules in patients with chronic epididymitis. Methods. This prospective randomized controlled trial included 112 patients diagnosed with chronic epididymitis. The patients were randomized (1 : 1 : 1) to receive levofloxacin (LVX), NMT, or NMT combined with LVX for 4 weeks. The patients were followed up at 2 and 4 weeks after initiation of treatment and were evaluated in terms of Chronic Epididymitis Symptom Index (CESI) scores, epididymal nodules, and safety parameters. The primary endpoints were the CESI scores at the end of 2 and 4 weeks of treatment. The secondary endpoints included the mean epididymal nodule diameter and the clinical efficacy rate. Safety was evaluated by hepatorenal function tests and adverse event reports during the trial. Results. After 2 weeks of treatment, the CESI score of the NMT group was significantly lower than that of the LVX group ( P < 0.05 ). In addition, the clinical efficacy rate of the NMT group was significantly higher than that of the LVX group (55% vs. 8.33%, P < 0.0001 ), indicating that NMT has a rapid effect on chronic epididymitis. After 4 weeks of treatment, there was no significant difference in CESI scores or clinical efficacy rates between the two monotherapy regimens ( P > 0.05 ); however, the mean diameter of epididymal nodules was significantly smaller in the NMT group than in the LVX group ( P < 0.0001 ). Moreover, after 4 weeks of treatment, the patients in the LVX + NMT group, which had a clinical efficacy rate of 97.22%, had lower CESI scores (both P < 0.01 ) and a smaller epididymal nodule diameter (vs. LVX, P < 0.0001 ; vs. NMT, P < 0.05 ) than those in the other two groups. No adverse events or abnormal hepatorenal function were found during the study. Conclusion. NMT significantly improved CESI scores and epididymal nodule diameter in patients with chronic epididymitis. The combination of NMT and LVX provides a much better effect than monotherapy, and this treatment regimen was well tolerated.

scholarly journals The Efficacy and Safety of Longmu Tang Granule for Treating Atopic Dermatitis: Study Protocol for a Single-Centered, Double-Blinded, Randomized Controlled Trial

2021 ◽  
Author(s):  
YAQIN LI ◽  
TAOTAO SHEN ◽  
QINGYING WANG ◽  
MENGXI MA ◽  
FENGYAN TIAN ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Randomized Controlled ◽  
Limited Effectiveness

Abstract Background: Atopic dermatitis (AD) is a chronic relapsing skin disease that has long-term adverse effects on the physical and mental health of children. Current treatments mainly include anti-inflammatory, antibacterial, and anti-allergic interventions, systemic therapy and recently emerging targeted agents. However, these treatments have limited effectiveness and bothersome side effects. The use of traditional Chinese medicine (TCM) is associated with safety and improvements in the clinical symptoms and quality of life of AD patients. However, the poor quality and heterogeneity of studies have not led to sufficient conclusions. Therefore, we will conduct a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of Longmu Tang granule for the treatment of AD.Methods: This is a single-center, double-blind, randomized, controlled clinical trial. A total of 60 participants will be randomly assigned (1:1) to receive Longmu Tang granule or placebo granule for 8 weeks. The primary outcome is the index of Scoring Atopic Dermatitis (SCORAD). The second outcomes include the children's Dermatology Life Quality Index (CDLQI) and the Number Cancel Test (NCT), and long-term efficacy. Mechanistic outcome is the serum level of inflammatory cytokines, including IgE, tumor necrosis factor (TNF) -α, interleukin-1 (IL-1) and interleukin-6 (IL-6).Discussion: The results of this trial will provide evidence on the efficacy and safety of Longmu Tang granule and prove anti-inflammation of Longmu Tang granule for patients with AD.Trial registration: Chinese Clinical Trial Registry Chictr.org ID: ChiCTR2100041591. Registered on 1 January 2021. https://www.chictr.org.cn/showproj.aspx?proj=62586

Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis

2016 ◽  
Vol 45 (2) ◽  
pp. 339-346 ◽  
Author(s):  
Brian J. Cole ◽  
Vasili Karas ◽  
Kristen Hussey ◽  
David B. Merkow ◽  
Kyle Pilz ◽  
...  
Keyword(s):  
Outcome Measure ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Anti Inflammatory ◽  
Linear Contrasts

Background: The use of platelet-rich plasma (PRP) for the treatment of osteoarthritis (OA) has demonstrated mixed clinical outcomes in randomized controlled trials when compared with hyaluronic acid (HA), an accepted nonsurgical treatment for symptomatic OA. Biological analysis of PRP has demonstrated an anti-inflammatory effect on the intra-articular environment. Purpose: To compare the clinical and biological effects of an intra-articular injection of PRP with those of an intra-articular injection of HA in patients with mild to moderate knee OA. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 111 patients with symptomatic unilateral knee OA received a series of either leukocyte-poor PRP or HA injections under ultrasound guidance. Clinical data were collected before treatment and at 4 time points across a 1-year period. Synovial fluid was also collected for analysis of proinflammatory and anti-inflammatory markers before treatment and at 12 and 24 weeks after treatment. Several measures were used to assess results: (1) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale; (2) International Knee Documentation Committee (IKDC) subjective knee evaluation, visual analog scale (VAS) for pain, and Lysholm knee score; and (3) difference in intra-articular biochemical marker concentrations. Results: There were 49 patients randomized to treatment with PRP and 50 randomized to treatment with HA. No difference was seen between the groups in the primary outcome measure (WOMAC pain score). In the secondary outcome measure, linear contrasts identified a significantly higher IKDC score in the PRP group compared with the HA group at 24 weeks (mean ± standard error [SE], 65.5 ± 3.6 vs 55.8 ± 3.8, respectively; P = .013) and at final follow-up (52 weeks) (57.6 ± 3.37 vs 46.6 ± 3.76, respectively; P = .003). Linear contrasts also identified a statistically lower VAS score in the PRP group versus the HA group at 24 weeks (mean ± SE, 34.6 ± 3.24 vs 48.6 ± 3.7, respectively; P = .0096) and 52 weeks (44 ± 4.6 vs 57.3 ± 3.8, respectively; P = .0039). An examination of fixed effects showed that patients with mild OA and a lower body mass index had a statistically significant improvement in outcomes. In the biochemical analysis, differences between groups approached significance for interleukin-1β (mean ± SE, 0.14 ± 0.05 pg/mL [PRP] vs 0.34 ± 0.16 pg/mL [HA]; P = .06) and tumor necrosis factor α (0.08 ± 0.01 pg/mL [PRP] vs 0.2 ± 0.18 pg/mL [HA]; P = .068) at 12-week follow-up. Conclusion: We found no difference between HA and PRP at any time point in the primary outcome measure: the patient-reported WOMAC pain score. Significant improvements were seen in other patient-reported outcome measures, with results favoring PRP over HA. Preceding a significant difference in subjective outcomes favoring PRP, there was a trend toward a decrease in 2 proinflammatory cytokines, which suggest that the anti-inflammatory properties of PRP may contribute to an improvement of symptoms. Registration: ClinicalTrials.gov (Identifier: NCT02588872).

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