Project description:ObjectivesTo determine whether patients with early rheumatoid arthritis (ERA) have cardiovascular disease (CVD) that is modifiable with disease-modifying antirheumatic drug (DMARD) therapy, comparing first-line etanercept (ETN) + methotrexate (MTX) with MTX strategy.MethodsPatients from a phase IV ERA trial randomised to ETN+MTX or MTX strategy±month 6 escalation to ETN+MTX, and with no CVD and maximum one traditional risk factor underwent cardiovascular magnetic resonance (CMR) at baseline, years 1 and 2. Thirty matched controls underwent CMR. Primary outcome measure was aortic distensibility (AD) between controls and ERA, and baseline to year 1 AD change in ERA. Secondary analyses between and within ERA groups performed. Additional outcome measures included left ventricular (LV) mass and myocardial extracellular volume (ECV).ResultsEighty-one patients recruited. In ERA versus controls, respectively, baseline (geometric mean, 95% CI) AD was significantly lower (3.0×10-3 mm Hg-1 (2.7-3.3) vs 4.4×10-3 mm Hg-1 (3.7-5.2), p<0.001); LV mass significantly lower (78.2 g (74.0-82.7), n=81 vs 92.9 g (84.8-101.7), n=30, p<0.01); and ECV increased (27.1% (26.4-27.9), n=78 vs 24.9% (23.8-26.1), n=30, p<0.01). Across all patients, AD improved significantly from baseline to year 1 (3.0×10-3 mm Hg-1 (2.7-3.4) to 3.6×10-3 mm Hg-1 (3.1-4.1), respectively, p<0.01), maintained at year 2. The improvement in AD did not differ between the two treatment arms and disease activity state (Disease Activity Score with 28 joint count)-erythrocyte sedimentation rate-defined responders versus non-responders.ConclusionWe report the first evidence of vascular and myocardial abnormalities in an ERA randomised controlled trial cohort and show improvement with DMARD therapy. The type of DMARD (first-line tumour necrosis factor-inhibitors or MTX) and clinical response to therapy did not affect CVD markers.Trial registration numberISRCTN: ISRCTN89222125; ClinicalTrials.gov: NCT01295151.
Project description:BackgroundLow-to-moderate dose statins (LMDSs) are more commonly used among Asian acute ischemic stroke (AIS) patients in clinical practice. However, the correlation between the LMDS use and prognosis has not been evaluated in AIS patients with conventional medication treatment alone. This study aimed to investigate the influence of LMDS on the prognosis of AIS patients and how prognosis and potential prognostic factors interact with different statin doses.MethodsThis retrospective cohort study included AIS patients who were admitted within 7 days after symptom onset and received conventional medication treatment alone from November 2019 to November 2020 in the Neurology, Department of West China Hospital, Sichuan University. From a total of 782 initial patients, a final cohort of 327 patients was included in the study. These patients were divided into three groups based on statin doses: non-statin (48 patients), LMDS (152 patients), and high-dose statin (HDS) (127 patients). The follow-up period was 3 months after the onset of stroke and the primary outcome was defined as a modified Rankin scale (mRS) score of 0 to 2 at 3 months, secondary outcomes were hemorrhagic transformation (HT) and death within 3 months. Stratified analysis was also conducted to test the robustness of the relationship between the use of different statin doses and functional outcomes in various subgroups.ResultsCompared with non-statin therapy, both LMDS therapy and HDS therapy were associated with good functional outcomes [odds ratio (OR) =3.68, 95% confidence interval (CI): 1.13-12.01, P=0.0309; OR =3.45, 95% CI: 1.06-11.26, P=0.0402, respectively] and a lower risk of HT (OR =0.30, 95% CI: 0.11-0.86, P=0.0253; OR =0.36, 95% CI: 0.13-0.99, P=0.0488, respectively). However, there was no significant difference in all-cause death within 3 months among the three groups (OR =0.84, 95% CI: 0.29-2.46, P=0.7468; OR =0.76, 95% CI: 0.26-2.22, P=0.6104). Additionally, no significant differences were observed between LMDS therapy and HDS therapy regarding good functional outcomes at 3 months (OR =0.94, 95% CI: 0.50-1.77, P=0.8411) and the occurrence of HT (OR =1.19, 95% CI: 0.47-3.02, P=0.7093). The results of the relationship between different statin doses and 3-month good functional outcome were consistent after interaction tests.ConclusionsOur findings provide evidence for the benefit and safety of LMDS therapy in AIS patients with medication treatment alone. LMDS therapy is associated with favorable impacts on 3-month functional outcomes and a reduced risk of HT compared to non-statin therapy. There were no significant differences in achieving 3-month good functional outcome, the risk of HT or death within 3 months were observed between LMDS and HDS therapy in our study. Further studies with prospective design and larger sample sizes are necessary to validate our results.
Project description:BackgroundThe aim of this study was to assess the prospective, longitudinal outcome after arthroscopically assisted open reduction and internal fixation (AORIF) and to compare the results with open reduction and internal fixation (ORIF) in complex ankle fractures.MethodsAcute, closed, bimalleolar equivalent, bimalleolar, or trimalleolar ankle fractures were included. The AORIF cohort was enrolled prospectively. The ORIF group was identified from a retrospective database. The same inclusion and exclusion criteria were applied. The only difference was the additional arthroscopy in the AORIF cohort. The patient-reported outcome measurement (PROM) following AORIF was assessed at 1 and 4 years of follow-up using the Olerud and Molander Ankle Score (OMAS) and Tegner activity scale (TAS). The AORIF cohort was propensity score matched (nearest-neighbor matching) to the ORIF database. The OMAS and Foot and Ankle Ability Measure (FAAM) were compared between the resulting groups. Nonparametric statistics were applied; values are presented as median (interquartile range). Twenty-six AORIF patients had a prospective 4-year follow-up.ResultsNo significant differences (1 year vs 4 years) were identified for the OMAS (90 [10] vs 90 [11]) and TAS (4 [2] vs 5 [2]). The severity of the cartilage lesions (International Cartilage Repair Society [ICRS] grade <4 vs ICRS of 4) had no significant influence on the PROMs. Twenty-five patients per cohort (AORIF vs ORIF) were matched. The OMAS (90 [13] vs 75 [40]; P = .008) and FAAM Activities of Daily Living (ADL; 96 [11] vs 88 [30]; P = .034) revealed significantly better outcomes for AORIF. More patients in the AORIF cohort returned to sport (96% vs 77%; P = .035), with a higher FAAM Sports score (88 [37] vs 56 [47]; P = .008).ConclusionAORIF for complex ankle fractures led to consistently good to excellent results. The propensity score-matched analysis revealed a significantly better outcome 4 years after surgery for AORIF compared with ORIF.Level of evidenceLevel III, retrospective comparative study.
Project description:Background/objectivesRestricted mean survival time (RMST) summarizes treatment effect in terms of a gain or loss in the event-free days. It remains uncertain whether communicating treatment benefit and harm using RMST-based summary is more effective than conventional summary based on absolute and relative risk reduction. We compared the effect of RMST-based approach and conventional approach on decisional conflict using an example of intensive versus standard blood pressure-lowering strategies.DesignOn-line survey.SettingA convenience sample of patients in the United States.ParticipantsTwo hundred adults aged 65 and older with hypertension requiring anti-hypertensive treatment (response rate 85.5%).InterventionsParticipants were randomly assigned to either RMST-based summary or conventional summary about the benefit and harm of blood pressure-lowering strategies.MeasurementsDecisional Conflict Scale (DCS), ranging from 0 (no conflict) to 100 (high conflict), and preference for intensive blood pressure-lowering strategy.ResultsParticipants assigned to RMST-based approach (n = 100) and conventional approach (n = 100) had similar age (mean [standard deviation, SD]: 72.3 [5.6] vs 72.8 [5.5] years) and proportions of female (50 [50.0%] vs 61 [61.0%]) and white race (92 [92.0%] vs 92 [92.0%]). The mean (SD) DCS score was 25.2 (15.0) for RMST-based approach and 25.6 (14.1) for conventional approach (p = 0.84). The number (%) of participants who preferred intensive strategy was 10 (10.0%) for RMST-based approach and 14 (14.0%) for conventional approach (p = 0.52). The results were consistent in subgroups defined by age, sex, education level, cardiovascular disease status, and predicted mortality risk categories.ConclusionIn a sample of relatively healthy older adults with hypertension, RMST-based approach was as effective as conventional approach on decisional conflict about choosing a blood pressure-lowering strategy. This study provides proof-of-concept evidence that RMST-based approach can be used in conjunction with absolute and relative risk reduction for communicating treatment benefit and harm in a decision aid.
Project description:Purpose of reviewGiven the emerging knowledge that circadian rhythmicity exists in every cell and all organ systems, there is increasing interest in the possible benefits of chronotherapy for many diseases. There is a well-documented 24-h pattern of blood pressure with a morning surge that may contribute to the observed morning increase in adverse cardiovascular events. Historically, antihypertensive therapy involves morning doses, usually aimed at reducing daytime blood pressure surges, but an absence of nocturnal dipping blood pressure is also associated with increased cardiovascular risk.Recent findingsTo more effectively reduce nocturnal blood pressure and still counteract the morning surge in blood pressure, a number of studies have examined moving one or more antihypertensives from morning to bedtime dosing. More recently, such studies of chronotherapy have studied comorbid populations including obstructive sleep apnea, chronic kidney disease, or diabetes. Here, we summarize major findings from recent research in this area (2013-2017). In general, nighttime administration of antihypertensives improved overall 24-h blood pressure profiles regardless of disease comorbidity. However, inconsistencies between studies suggest a need for more prospective randomized controlled trials with sufficient statistical power. In addition, experimental studies to ascertain mechanisms by which chronotherapy is beneficial could aid drug design and guidelines for timed administration.
Project description:BackgroundThis study investigated the hypothesis that the efficacy of blade needle therapy for the treatment of knee osteoarthritis (KOA) is superior to that of conventional acupuncture. In addition, the efficacy of blade needle therapy versus conventional acupuncture for the treatment of KOA was analyzed in a meta-analysis.MethodsRandomized controlled trials (RCTs) of blade needle therapy and conventional acupuncture for treating KOA were retrieved from the electronic databases CNKL, Wanfang, VIP, PubMed, EMBASE and the Cochrane Library from the commencement of each database to July of 2021. Data were extracted and evaluated by 2 reviewers independently. RevMan 5.3 software was used to conduct the meta-analysis after the studies were evaluated.ResultsA total of 11 RCTs were included, all from China, involving 1142 patients. The meta-analysis results showed that the effective rate of the blade needle group was better than that of the conventional acupuncture group (OR = 3.61, 95% CI [2.56-5.10], P < .00001).ConclusionThe efficacy of blade needle treatment for KOA is superior to that of conventional acupuncture, but more high-quality studies are needed for future validation due to the low proportion of high-quality studies included and the possible bias factor.
Project description:PurposeMany brain tumor patients suffer from radiation-induced toxicities. Chronotherapy is a treatment modality that utilizes circadian rhythms to optimize the effect on tumor while minimizing negative outcomes on healthy tissue. This review aims to systematically examine the literature on the application of a radiation chronotherapeutic for all cancers and determine the possible advantages of incorporating a circadian-based fixed time-of-day for radiotherapy into CNS cancers.MethodsA systematic review of the literature was conducted in two electronic databases from inception to February 1, 2019. Primary research manuscripts were screened for those related to adult human subjects exposed to ionizing radiation using the chronotherapy technique.ResultsNine manuscripts were included in the review from 79 eligible articles. Three were prospective randomized trails and 6 were retrospective reviews. This survey revealed that overall survival and tumor control do not have consistent effects with only 60% and 55.5% of paper which included the variables having some significance, respectively. Treatment symptoms were the primary endpoint for both the prospective trials and were examined in 3 of the retrospective reviews; effects were observed in sensitive tissue for all 5 studies including mucosal linings and skin basal layer.ConclusionsExisting literature suggests that the application of radiation chronotherapy may reduce negative symptom outcome within highly proliferative tissues. Further examination of radiation chronotherapy in well-designed prospective trials and studies in brain tumor patients are merited.
Project description:As chronic pain affects 115 million people and costs $600B annually in the US alone, effective noninvasive nonpharmacological remedies are desirable. The purpose of this study was to determine the efficacy and the generalisability of Noxipoint therapy (NT), a novel electrotherapy characterised by site-specific stimulation, intensity-and-submodality-specific settings and a immobilization period, for chronic neck and shoulder pain. Ninety-seven heavily pretreated severe chronic neck/shoulder pain patients were recruited; 34 and 44 patients were randomly allocated to different treatment arms in two patient-and-assessor-blinded, randomised controlled studies. The participants received NT or conventional physical therapy including transcutaneous electrical nerve stimulation (PT-TENS) for three to six 90-minute sessions. In Study One, NT improved chronic pain (-89.6%, Brief Pain Inventory, p?<?0.0001, 95% confidence interval), function (+77.4%, range of motion) and quality of life (+88.1%) at follow-up (from 4 weeks to 5 months), whereas PT-TENS resulted in no significant changes in these parameters. Study Two demonstrated similar advantages of NT over PT-TENS and the generalisability of NT. NT-like treatments in a randomised rat study showed a similar reduction in chronic hypersensitivity (-81%, p?<?0.01) compared with sham treatments. NT substantially reduces chronic neck and shoulder pain, restores function, and improves quality of life in a sustained manner.