Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial

Renal denervation is a promising new non-pharmacological treatment for resistant hypertension. However, there is a lack of data from Asian patients. The REQUIRE trial investigated the blood pressure-lowering efficacy of renal denervation in treated patients with resistant hypertension from Japan and South Korea. Adults with resistant hypertension (seated office blood pressure ≥150/90 mmHg and 24-hour ambulatory systolic blood pressure ≥140 mmHg) with suitable renal artery anatomy were randomized to ultrasound renal denervation or a sham procedure. The primary endpoint was change from baseline in 24-hour ambulatory systolic blood pressure at 3 months. A total of 143 patients were included (72 renal denervation, 71 sham control). Reduction from baseline in 24-hour ambulatory systolic blood pressure at 3 months was not significantly different between the renal denervation (−6.6 mmHg) and sham control (−6.5 mmHg) groups (difference: −0.1, 95% confidence interval −5.5, 5.3; p = 0.971). Reductions from baseline in home and office systolic blood pressure (differences: –1.8 mmHg [p = 0.488] and −2.0 mmHg [p = 0.511], respectively), and medication load, did not differ significantly between the two groups. The procedure-/device-related major adverse events was not seen. This study did not show a significant difference in ambulatory blood pressure reductions between renal denervation and a sham procedure in treated patients with resistant hypertension. Although blood pressure reduction after renal denervation was similar to other sham-controlled studies, the sham group in this study showed much greater reduction. This unexpected blood pressure reduction in the sham control group highlights study design issues that will be addressed in a new trial. Clinical trial registration NCT02918305 (http://www.clinicaltrials.gov).

Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial

Objective To determine the safety and efficacy of temperature-controlled radiofrequency (RF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis. Study Design A multicenter, prospective, single-blinded, randomized controlled trial, in which the control arm underwent a sham procedure. Setting Sixteen otolaryngology centers. Methods Patients with 24-hour reflective Total Nasal Symptom Score (rTNSS) ≥6, including moderate to severe rhinorrhea and mild to severe congestion, were randomized 2:1 to active treatment of the posterior nasal nerve area with a temperature-controlled RF device or a sham procedure, with no RF energy delivery. The stylus was applied bilaterally to nonoverlapping areas of the posterior middle meatus and posterior inferior turbinate in each nostril in the region of the PNN. The primary endpoint was responder rate at 3 months, where a response was defined as ≥30% improvement (decrease) in rTNSS from baseline. Results Patients had a mean baseline rTNSS of 8.3 (95% CI, 7.9-8.7) and 8.2 (95% CI, 7.6-8.8) ( P = .797) in the active treatment (n = 77) and sham control (n = 39) arms, respectively. At 3 months, responder rate was significantly higher in the active treatment arm: 67.5% (95% CI, 55.9%-77.8%) vs 41.0% (95% CI, 25.6%-57.9%) ( P = .009). The active treatment arm had a significantly greater decrease in rTNSS (mean, −3.6 [95% CI, −4.2 to −3.0] vs −2.2 [95% CI, −3.2 to −1.3]) ( P = .013). Three adverse events related to the device/procedure were reported, and all resolved. Conclusion This randomized controlled trial showed temperature-controlled neurolysis of the PNN area is free from significant adverse events and superior to a sham procedure in decreasing the symptom burden of chronic rhinitis.

The Effect of Vertebral Augmentation Procedure on Painful OVCFs: A Meta-Analysis of Randomized Controlled Trials

Study Design: Meta-analysis. Objective: To systematically compare the effectiveness and safety of vertebral augmentation procedure (VAP) with non-surgical management (NSM) for the treatment of osteoporotic vertebrate compression fractures (OVCFs). Methods: Systematic reviews and meta-analyses with the comparison between VAP and NSM were identified to extract randomized controlled trials from electronic database. Additionally, recently published RCTs were identified. Two researchers independently extracted the data. The primary outcome of this meta-analysis was pain relief evaluated by visual analogue scale (VAS). Results: Twenty RCTs involving 2566 patients with painful OVCFs were included. Significant differences were found between percutaneous vertebroplasty (PVP) and conservative treatment (CT) in VAS at each time point during follow-up period. The differences of VAS were not significant between PVP and sham procedure at most time points during follow-up period. In subgroup analysis based on fracture type and fracture location, significant differences of VAS were found between PVP and CT and were not found between PVP and sham procedure. In subgroup analysis of duration of back pain, significant differences were found between PVP and CT in VAS at 1 week, 3 month and 1 year. And the differences of VAS were not significant between PVP and CT at 1 month and 6 month. Conclusion: BKP is considered sufficient to achieve good clinical outcomes. PVP is associated with on beneficial effect on treatment of painful OVCFs compared with sham procedure. The indication and timing of VAP need further research. More independently high-quality RCTs with sufficiently large sample sizes reporting cost-effectiveness are needed.

Accelerometric Changes before and after Capacitive Resistive Electric Transfer Therapy in Horses with Thoracolumbar Pain Compared to a SHAM Procedure

Capacitive resistive electric transfer (CRET), a radiofrequency at 448 kHz, increases flexibility in quadricep muscles of human athletes. To assess whether CRET would result in clinical and biomechanical improvements in horses with thoracolumbar pain, 18 sport horses were divided into two groups: CRET (n = 9), subjected to four CRET sessions, during two consecutive weeks, and SHAM (n = 9), subjected to the same procedure with the device off. Clinical examination and accelerometry were performed before and after the four sessions. During the study, horses were in training and in active competition, and did not receive any other treatment. Mann-Whitney and a Wilcoxon matched pair tests were used to compare between the SHAM and CRET groups and before and after the intervention, respectively. CRET horses showed increased dorsoventral (p < 0.002), mediolateral and total power (p < 0.01) after the intervention, suggesting increased back flexibility. SHAM horses did not show any of these modifications after the intervention. No changes were found in the dorsoventral displacement of the gravity center in either group. Thoracolumbar pain decreased one degree after CRET (p = 0.002), and it did not change after SHAM. Epaxial muscle pain decreased two degrees after CRET (p = 0.03) and one degree after SHAM (p = 0.01). These results reflected that CRET therapy would increase back flexibility and decrease thoracolumbar and epaxial pain.