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Objectives: To evaluate the effect of a single 10-minute session of Chinese head massage on the activity of the cardiac autonomic nervous system via measurement of heart rate variability (HRV). Design: In this pilot randomized crossover trial, each participant received both head massage and the control intervention in a randomized fashion. Settings/Location: The study was conducted at Children's & Women's Health Centre of British Columbia between June and November 2014. Participants: Ten otherwise healthy adults (6 men and 4 women) were enrolled in this study. Interventions: The intervention comprised 10 minutes of head massage therapy (HMT) in a seated position compared with a control intervention of sitting quietly on the same chair with eyes closed for an equal amount of time (no HMT). Outcome measures: The primary outcome measures were the main parameters of HRV, including total power (TP), high frequency (HF), HF as a normalized unit, pre-ejection period, and heart rate (HR). Results: A single short session (10 minutes) of head massage demonstrated an increase in TP continuing up to 20 minutes after massage and reaching statistical significance at 10 minutes after massage (relative change from baseline, 66% for HMT versus −6.6% for no HMT; p = 0.017). The effect on HF also peaked up to 10 minutes after massage (59.4% for HMT versus 4% for no HMT; p = 0.139). Receiving head massage also decreased HR by more than three-fold compared to the control intervention. Conclusion: This study shows the potential benefits of head massage by modulating the cardiac autonomic nervous system through an increase in the total variability and a shift toward higher parasympathetic nervous system activity. Randomized controlled trials with larger sample size and multiple sessions of massage are needed to substantiate these findings. [ABSTRACT FROM AUTHOR]

To evaluate disease-free survival (DFS) as a surrogate endpoint for overall survival (OS) using aggregate-level data from resectable esophageal or gastroesophageal junction cancer (EC/GEJC) trials assessing therapies in (neo)adjuvant and perioperative settings. A systematic literature review was conducted to identify trials reporting OS and DFS, or compatible progression-free survival (PFS). Bivariate random-effects meta-analysis was used to estimate correlation between the treatment effects on DFS/PFS and OS, and weighted linear regression models assuming trial sample sizes as weights were used to estimate surrogacy equations. The primary analysis consisted of trials across all treatment settings, and secondary analysis consisted of trials only in the adjuvant setting. Leave-one-out cross-validation (LOOCV) was performed to measure the stability and predictive accuracy of the surrogacy equations while surrogate threshold effects (STE)—the minimum treatment effect on DFS/PFS that would translate into a positive OS benefit—were derived to measure their usefulness. The primary analysis included 26 trials. The estimated correlation coefficient between the hazard ratio (HR) of DFS/PFS (HR DFS/PFS) and HR of OS (HR OS) was 0.83 (95% confidence interval [CI]: 0.70–0.90). The estimated surrogacy equation was log(HR OS) = 0.80 × log(HR DFS/PFS) with a corresponding STE of 0.82. Reported HR OS was within the 95% prediction interval of the predicted HR OS from the model for more than 95% of the trials in the LOOCV, indicating a valid model. Secondary analysis included 7 trials with an estimated correlation coefficient of 0.76 (95% CI: 0.18–0.95). Through LOOCV, the surrogacy equation in the adjuvant setting was deemed valid. Our meta-analysis suggests that HR DFS/PFS —where DFS/PFS is defined as time from resection to disease recurrence (local, locoregional, or distant) or death—is correlated to HR OS , and a valid and useful surrogate predictor for HR OS in the neoadjuvant, perioperative, or adjuvant settings. • First published DFS/OS surrogacy analysis spanning all treatment settings in EC/GEJ. • Meta-analysis of 26 trials suggests correlated hazard ratios for DFS and OS. • DFS can be a valid and useful surrogate for OS in resectable EC/GEJ. [ABSTRACT FROM AUTHOR]

Background: Direct injection of corticosteroids into the joint is a standard treatment for knee osteoarthritis (OA). However, the treatment is somewhat controversial with regard to the benefit of both single and repeated injections; evidence that they are beneficial comes from small studies that show only modest improvements. The aim of this study was to estimate the short- and long-term clinical efficacy and safety of hylan G-F 20 versus intra-articular corticosteroids (IACS) for the treatment of pain in knee OA using Bayesian network meta-analysis. Methods: Based on a pre-specified protocol, MEDLINE, Embase, and CENTRAL were searched from inception to June 2018 to identify randomized controlled trials. The Cochrane Collaboration's tool for assessing risk of bias in randomized trials was used to assess the included studies. Hylan G-F 20 and IACS were compared using Bayesian network meta-analysis. Efficacy was evaluated at 1, 3, and 6 months, and at the final follow-up for safety outcomes. A pain hierarchy was used to select 1 pain outcome per study. Results: Forty-two trials were included for analysis. The network meta-analysis of pain showed that hylan G-F 20 may be equivalent to IACS in the short-term, but by 6 months the benefit relative to IACS was statistically significant, standardized mean difference (95% credible interval): –0.13 (–0.26, –0.01). There were no statistical differences in adverse events. Conclusions: Hylan G-F 20 may perform better in relieving pain at 6 months post-injection compared to IACS. Both agents were relatively well tolerated, with no clear differences in safety. [ABSTRACT FROM AUTHOR]