scholarly journals Is There Clinical Improvement Associated With Intradiscal Therapies? A Comparison Across Randomized Controlled Studies

2020 ◽  
pp. 219256822096305
Author(s):  
Derek G. Ju ◽  
Linda E. Kanim ◽  
Hyun W. Bae
Keyword(s):  
Stem Cells ◽  
Growth Factor ◽  
Randomized Controlled Trials ◽  
Fibrin Sealant ◽  
Controlled Trials ◽  
Single Center ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Patient Reported ◽  
Post Hoc

Study Design: Post hoc comparison using single-site data from 4 multicenter randomized controlled trials. Objectives: Discogenic back pain is associated with significant morbidity and medical cost. Several terminated, unreported randomized controlled trials have studied the effect of intradiscal biologic injections. Here we report single-center outcomes from these trials to determine if there is clinical improvement associated with these intradiscal injections. Methods: Post hoc comparison was performed using single-site data from 4 similar multi-center randomized controlled trials. All trials evaluated an injectable therapy (growth factor, fibrin sealant, or stem cells) for symptomatic lumbar disc disease with near-identical inclusion and exclusion criteria. Demographics and patient reported outcomes were analyzed across treatment arms postinjection. Results: A total of 38 patients were treated with biologic agents and 12 were treated with control saline injections. There was a significant decrease in visual analogue score (VAS) pain for both the investigational and saline groups up to 12 months postinjection ( P < .01). There was no significant difference in VAS scores between the saline and investigational groups at 12 months. Similarly, there was significant improvement in patient-reported disability scores in both the investigational and saline groups at all time points. There were no significant differences in disability score improvement between the saline and investigational treatment groups at 12 months postinjection. Conclusions: A single-center analysis of 4 randomized controlled studies demonstrated no difference in outcomes between therapeutic intradiscal agents (growth factor, fibrin sealant, or stem cells) and control saline groups. In all groups, patient reported pain and disability scores decreased significantly. Future studies are needed to evaluate the therapeutic benefit of any intradiscal injections.

scholarly journals The Efficacy and Safety of Fibrin Sealant Versus Tranexamic Acid Administration in Patients Undergoing Hip Arthroplasty: A Meta-analysis

2020 ◽  
Author(s):  
Fan Yong Yong ◽  
deng bo ◽  
Hong Hai Nan ◽  
Zhu Zhong
Keyword(s):  
Blood Loss ◽  
Tranexamic Acid ◽  
Randomized Controlled Trials ◽  
Hip Arthroplasty ◽  
Fibrin Sealant ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Transfusion Rate ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract PurposeThe efficacy and safety of topical fibrin sealant (FS) compared with tranexamic acid (TXA) to reduce blood loss after total hip arthroplasty (THA) is not clear. A meta-analysis was conducted to evaluate the efficacy and safety of topical FS versus topical or intravenous TXA for treatment of primary THA.MethodWe searched electronic databases, including PubMed, Embase, and the Cochrane Library to identify studies up to March 2020. The references included in articles were also checked for additional potentially-relevant studies. The language of publication was limited to English. The endpoints included the mean difference (MD) of blood loss, hemoglobin value, and odds ratios (ORs) of transfusion requirements and thrombotic events. Our meta-analysis was performed according to the Guidelines of the Cochrane Reviewer's Handbook and the PRISMA statement. The data of the included studies were analyzed using RevMan 5.3.ResultsA total of four studies (two randomized controlled trials and two non-randomized controlled trials) met the inclusion criteria. Our meta-analysis demonstrated that TXA administration led to significantly different outcomes in terms of transfusion rate (RD = -0.12, 95% CI (-0.23, -0.00), P = 0.05, I2 = 74%) and postoperative hemoglobin levels (WMD = -0.47, 95% CI (-0.74, -021), P = 0.0005, I2 = 3%) compared with topical application of FS in patients undergoing THA. No significant difference was seen in total calculated blood loss (WMD = -86.22, 95% CI (-99.13, -73.31), P < 0.00001, I2 = 96%) or complication rate (RR = 0.98, 95% CI (-99.13, -73.31), P = 0.45, I2 = 0%) between the two groups.ConclusionsTXA administration can effectively decrease the transfusion rate and result in higher postoperative hemoglobin levels without increasing the rate of infection.

Impact of Blinding on Patient-Reported Outcome Differences Between Treatment Arms in Cancer Randomized Controlled Trials

2021 ◽  
Author(s):  
Fabio Efficace ◽  
David Cella ◽  
Neil K Aaronson ◽  
Melanie Calvert ◽  
Francesco Cottone ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Experimental Treatment ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Open Label ◽  
Multivariable Logistic Regression Model ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Independent Variable ◽  
Outcome Differences

Abstract Some concerns have been raised about potential bias in patient-reported outcome (PRO) results from open-label cancer randomized controlled trials (RCTs). We investigated if open-label trials favor the experimental treatment over the standard treatment more frequently than blinded trials. We also examined if the effect of blinding differs for distal vs more proximal PROs. We assessed 538 RCTs with a PRO endpoint conducted in the most prevalent cancers, of which 366 (68.0%) were open-label, 148 (27.5%) were blinded, and 24 (4.5%) were categorized as unclear. In our multivariable logistic regression model, we did not observe a statistically significant association of the independent variable treatment concealment (blinded vs open-label) on the dependent variable measuring the proportion of trials favoring the experimental treatment (adjusted odds ratio = 1.19, 95% confidence interval = 0.79 to 1.79; 2-sided P = .40). This was also the case when comparing distal and proximal PROs. Our findings provide novel evidence-based data that support the validity of PRO results from open-label cancer RCTs.

A Meta-Analysis of randomized controlled trials: Efficiency and safety of ondansetron in preventing post-anesthesia shivering during cesarean section

2021 ◽  
Author(s):  
Guanghao Zheng ◽  
Jianpin Liu ◽  
Jieyu Zhang ◽  
Fei Cao
Keyword(s):  
Cesarean Section ◽  
Randomized Controlled Trials ◽  
Subgroup Analysis ◽  
Lower Incidence ◽  
Meta Analysis ◽  
Neuraxial Anesthesia ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Randomized Controlled Studies

Abstract Objective Although ondansetron was considered to prevent post-anesthesia shivering during cesarean section, its efficiency remained controversial. Our review was conducted to estimate the efficiency and safety of ondansetron in preventing post-anesthesia shivering during cesarean section. Methods: The literature were searched from their inception to October 2020 without restriction of language. All randomized controlled trials investigating the efficacy of ondansetron versus placebo in preventing shivering during cesarean section under neuraxial anesthesia were included. The meta-analysis was conducted using Stata software. Results: Eleven randomized controlled studies with a total of 748 individuals were finally included in our meta-analysis. Our results manifested that intravenous ondansetron compared with intravenous placebo significantly reduced the incidence of PAS (RR: 0.53, 95% CI: 0.14 to 0.68). Subgroup analysis according to doses of ondansetron indicated that the efficacy of 4 mg doses of ondansetron(RR: 0.37, 95% CI: 0.21 to 0.64) is equivalent to that of 8 mg doses of ondansetron(RR: 0.61, 95% CI: 0.47 to 0.81) in preventing PAS. In addition, the intravenous ondansetron led to a lower incidence of hypotension than intravenous placebo(OR: 0.47, 95% CI: 0.32 to 0.70). We could not demonstrate differences in the incidence of bradycardia between intravenous ondansetron and intravenous placebo. Conclusion: Our results found that intravenous ondansetron was effective in preventing shivering during cesarean section under neuraxial anesthesia, and had an advantage in reducing the incidence of hypotension compared with intravenous placebo.

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