Effect of Platelet-Rich Plasma Injection vs Sham Injection on Tendon Dysfunction in Patients With Chronic Midportion Achilles Tendinopathy: A Randomized Clinical Trial
IMPORTANCE Platelet-rich plasma injections are used as a treatment for chronic midportion Achilles tendinopathy, but evidence for this treatment is limited. OBJECTIVE In adults with midportion Achilles tendinopathy, to assess the effects of a single platelet-rich plasma injection, compared with sham injection, on the outcome of the Victorian Institute of Sport Assessment-Achilles (VISA-A) score (a single composite measure of Achilles tendinopathy severity). DESIGN, SETTING, AND PARTICIPANTS A participant-blinded, multicenter randomized clinical trial that included 240 people from 24 sites assigned to either a platelet-rich plasma injection or a sham injection between April 2016 and February 2020. Final follow-up was July 2020. Participants were older than 18 years with midportion Achilles tendon pain for more than 3 months as confirmed by ultrasound, magnetic resonance imaging, or both. INTERVENTIONS A single intratendinous platelet-rich plasma injection (n = 121) or a single sham injection (insertion of a subcutaneous dry needle not entering the tendon) (n = 119). MAIN OUTCOMES AND MEASURES The primary outcome was the VISA-A score, measured 6 months after treatment allocation. The VISA-A score contains 8 questions that cover 3 domains of pain, function, and activity, analyzed as a composite score (range, 0 [worst symptoms] to 100 [no symptoms]; minimal clinically important difference in score, 12 points). The primary analysis was adjusted for laterality, age, sex, and baseline VISA-A score. RESULTS Among 240 patients assigned to a platelet-rich plasma or sham injection (mean age, 52 years; 138 [58%] women), 221 (92%) completed the trial. At 6-month follow-up, mean VISA-A score values in the plasma-rich plasma group vs the sham injection group were 54.4 vs 53.4 (adjusted mean difference, -2.7 [95% CI, -8.8 to 3.3]). The most common adverse events compared between patients in the platelet-rich plasma group vs the sham group were injection site discomfort (97 vs 73 patients), swelling (56 vs 52 patients) and bruising (48 vs 49 patients). CONCLUSIONS AND RELEVANCE Among patients with chronic midportion Achilles tendinopathy, treatment with a single injection of intratendinous platelet-rich plasma, compared with insertion of a subcutaneous dry needle, did not reduce Achilles tendon dysfunction at 6 months. These findings do not support the use of this treatment for chronic midportion Achilles tendinopathy. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN13254422.
Intrathecal Fibrinolysis for Aneurysmal Subarachnoid Hemorrhage: Evidence From Randomized Controlled Trials and Cohort Studies
Frontiers in neurology. 2019;10:885
Background: The role of intrathecal fibrinolysis for the treatment of patients with aneurysmal subarachnoid hemorrhage (aSAH) has been widely investigated; however, the results have been contradictory. In our study, we conducted a meta-analysis to evaluate the safety and efficacy of intrathecal (intracisternal or intraventricular) fibrinolysis for aSAH. Methods: PubMed, Web of Science, Embase, Medline, and the Cochrane library databases were searched up to February 1, 2019. The outcomes analyzed were neurologic recovery, delayed ischemic neurologic deficit (DIND), mortality, and the incidence of chronic hydrocephalus and hemorrhage. Results: A total of 21 studies comprising 1,373 patients were analyzed, including nine randomized controlled trials (RCTs) and 12 non-RCTs. The results showed that intracisternal fibrinolysis significantly decreased poor neurologic outcomes (RR = 0.62, 95% CI = 0.50-0.76, P < 0.001) and reduced the incidence of DIND (RR = 0.52, 95% CI = 0.41-0.65, P <0.001), chronic hydrocephalus (RR = 0.59, 95% CI = 0.42-0.82, P = 0.002) and mortality (RR = 0.58, 95% CI = 0.37, 0.93, P = 0.02). There was no significant difference in the occurrence of hemorrhage. Moreover, the results of the Egger test and Begg's funnel plot showed no evidence of publication bias. Conclusions: Current evidence suggests that intracisternal fibrinolysis has beneficial effects on the clinical outcomes of patients with aSAH. However, further well-designed randomized trials are needed to confirm the efficacy and safety of intracisternal fibrinolysis for the treatment of aSAH.
Efficacy and tolerability of intravenous iron for patients with restless legs syndrome: evidence from randomized trials and observational studies
Sleep medicine. 2019
OBJECTIVE Restless legs syndrome (RLS) is a common neurological disorder of unclear pathophysiology that appears to involve an iron deficiency in the brain. Some studies, but not others, suggest that intravenous injection of iron can reduce RLS severity. METHOD The databases Web of Science, PubMed, Embase, Chinese National Knowledge Infrastructure, Wanfang, and SinoMed were searched for randomized controlled trials, cohort studies and case-control studies of intravenous iron therapy to treat RLS. Eligible studies were meta-analyzed using Stata 12.0. RESULTS This analysis indicated that IV iron was more efficacious than placebo in treating RLS (OR: 4.71,95%CI 4.21-5.21,p < 0.0001). According to sub-group analysis, either IV ferric carboxymaltose (FCM) or iron sucrose was more efficacious than placebo in treating RLS. Adverse events did not differ significantly between patients receiving intravenous iron or placebo (OR 1.68, 95%CI 0.92-3.07, p = 0.093). The present study also indicated after accepting IV iron treatment the IRLS score in RLS patients decreased (OR = 6.75,95%CI 4.02-9.49, p < 0.0001). The subgroup analysis showed that IV iron dextran, iron sucrose, and FCM could alleviate the IRLS score. CONCLUSION The available evidence suggests that intravenous iron is effective and tolerable for patients with RLS regardless of peripheral iron status.