Trial characteristics and treatment effect estimates in randomized controlled trials of Chinese herbal medicine: A meta-epidemiological study

Background:Previously published meta-epidemiological studies focused on Western medicine have identified some trial characteristics that impact the treatment effect of randomized controlled trials(RCTs).Nevertheless,it remains unclear if similar associations exist in RCTs on Chinese herbal medicine(CHM).Further,Chinese medicine-related characteristics have not been explored yet.Objective:To investigate trial characteristics related to treatment effect estimates on CHM RCTs.Search strategy:This meta-epidemiological study searched 5 databases for systematic reviews on CHM treatment published between January 2011 and July 2021.Inclusion criteria:An eligible systematic review should only include RCTs of CHM and conduct at least one meta-analysis.Data extraction and analysis:Two reviewers independently conducted data extraction on general characteristics of systematic reviews,meta-analyses and included RCTs.They also assessed the risk of bias of RCTs using the Cochrane risk of bias tool.A two-step approach was used for data analyses.The ratio of odds ratios(ROR) and difference in standardized mean differences (dSMD) with 95%confidence interval (CI) were applied to present the difference in effect estimates for binary and continuous outcomes,respectively.Results:Ninety-one systematic reviews,comprising 1338 RCTs were identified.For binary outcomes,RCTs incorporated with syndrome differentiation (ROR:1.23;95%CI:[1.07,1.39]),adopting Chinese medicine formula (ROR:1.19;95%CI:[1.03,1.34]),with low risk of bias on incomplete outcome data (ROR:1.29;95%CI:[1.06,1.52]) and selective outcome reporting (ROR:1.12;95%CI:[1.01,1.24]),as well as a trial size≥100 (ROR:1.23;95%CI:[1.04,1.42]) preferred to show larger effect estimates.As for continuous outcomes,RCTs with Chinese medicine diagnostic criteria (dSMD:0.23;95%CI:[0.06,0.41]),judged as high/unclear risk of bias on allocation concealment (dSMD:-0.70;95%CI:[-0.99,-0.42]),with low risk of bias on incomplete outcome data (dSMD:0.30;95%CI:[0.18,0.43]),conducted at a single center (dSMD:-0.33;95%CI:[-0.61,-0.05]),not using intention-to-treat analysis (dSMD:-0.75;95%CI:[-1.43,-0.07]),and without funding support (dSMD:-0.22;95%CI:[-0.41,-0.02]) tended to show larger effect estimates.Conclusion:This study provides empirical evidence for the development of a specific critical appraisal tool for risk of bias assessments on CHM RCTs.

Postoperative subacute static progressive stretch does not increase the risk of distal lower limb venous thromboembolism

Purpose:Static progressive stretch(SPS)can be applied to treat chronic joint stiffness.However,the impacts of subacute application of SPS to the distal lower limbs,where deep vein thrombosis(DVT)is common,on venous thromboembolism remain unclear.This study aims to explore the risk of venous thromboembolism events following subacute application of SPS.Methods:A retrospective cohort study was conducted on patients diagnosed with DVT following a lower extremity orthopedic surgery before being transferred to the rehabilitation ward from May 2017 to May 2022.Patients with unilateral lower limb comminuted para-articular fractures,transferred to rehabilitation ward for further treatment within 3 weeks after operation,followed up more than 12 weeks since initial manual physiotherapy,and diagnosed DVT by ultrasound before rehabilitation course were included in the study.Patients with polytrauma,without evidence of previous peripheral vascular disease or incompetence,had medication for thrombosis treatment or prophylaxis before the operation,detected with paralysis due to nervous system impairment,infected after operation during the regime,or with acute progression of DVT were excluded.The included patients were randomized to the standard physiotherapy and the SPS integrated groups for observation.Associated DVT and pulmonary embolism data were collected during the physiotherapy course to compare the groups.SSPS 28.0 and GraphPad Prism 9 were used for data processing.Ap<0.05 was set significant difference.Results:In total of 154 patients with DVT participating in this study,75 of them were treated with additional SPS for postoperative rehabilitation.The participants in the SPS group showed improved range of motion(12.3°±6.7°).However,in the SPS group,there was no difference in thrombosis volume between the start and termination(p=0.106,p=0.787,respectively),although difference was seen intra-therapy(p<0.001).Contingency analysis revealed the pulmonary embolism incidence(OR=0.703)in the SPS group compared to the mean physiotherapy.Conclusion:The SPS technique is a safe and reliable option to prevent potential joint stiffness without aggravating the risk of distal DVT for postoperative patients suffering from relevant trauma.