Isolated systolic hypertension is common in the elderly, but decreasing systolic blood pressure (SBP) without lowering diastolic blood pressure (DBP) remains a therapeutic challenge. Although stress management training, in particular eliciting the relaxation response, reduces essential hypertension its efficacy in treating isolated systolic hypertension has not been evaluated. We conducted a double-blind, randomized trial comparing 8 weeks of stress management, specifically relaxation response training (61 patients), versus lifestyle modification (control, 61 patients). Inclusion criteria were Ն55 years, SBP 140-159 mm Hg, DBP Ͻ90 mm Hg, and at least two antihypertensive medications. The primary outcome measure was change in SBP after 8 weeks. Patients who achieved SBP Ͻ140 mm Hg and Ն5 mm Hg reduction in SBP were eligible for 8 additional weeks of training with supervised medication elimination. SBP decreased 9.4 (standard deviation [SD] 11.4) and 8.8 (SD 13.0) mm Hg in relaxation response and control groups, respectively (both ps Ͻ 0.0001) without group difference (p ϭ 0.75). DBP decreased 1.5 (SD 6.2) and 2.4 (SD 6.9) mm Hg (p ϭ 0.05 and 0.01, respectively) without group difference (p ϭ 0.48). Forty-four (44) in the relaxation response group and 36 in the control group were eligible for supervised antihypertensive medication elimination. After controlling for differences in characteristics at the start of medication elimination, patients in the relaxation response group were more likely to successfully eliminate an antihypertensive medication (odds ratio 4.3, 95% confidence interval 1.2-15.9, p ϭ 0.03). Although both groups had similar reductions in SBP, significantly more participants in the relaxation response group eliminated an antihypertensive medication while maintaining adequate blood pressure control. 129
Purpose: This document describes the consensus process and intervention for a National Institutes of Health (NIH)-funded multi-site feasibility study utilizing acupuncture for ACUte paIn in The EmergencY Department (ACUITY). The acupuncture intervention is designed to be flexible and responsive to the most common Emergency Department (ED) scenarios, including trauma, acute pain of the low back, abdomen and/or musculoskeletal system, renal colic and headache. Background: Opioids remain a primary treatment for acute ED pain with attendant risk of adverse effects, addiction liability, diversion and death. Effective/safer options for acute pain are needed. Although acupuncture therapy has shown promise for acute pain in the ED alone or in conjunction with usual care, pragmatic trials are needed to obtain definitive and generalizable evidence. Methods: An Acupuncture Advisory Panel was convened that included nine acupuncture experts with 5–44 years of experience in practice and 2–16 years of experience in the acute pain care setting. A modified Delphi process was used with provision of a literature review, surveys of our panel members, three online discussions and email discussion as needed. The STandards for Reporting Interventions in Controlled Trials (STRICTA) checklist was used as a guide. Results: A responsive acupuncture intervention was agreed on for ACUITY. Session forms were fashioned in REDCap (Research Electronic Data Capture program to capture essential treatment data, assess fidelity and inform our design for a future pragmatic multi-site randomized controlled trial (RCT) of acupuncture in the ED, and for use by other future researchers. Conclusion: Development of a responsive manualization intervention provides the appropriate framework for conducting a future, pragmatic, multi-site, definitive RCT of acupuncture in the ED. Trial registration number: NCT04880733 (ClinicalTrials.gov).
ObjectivesChiropractic spinal manipulative therapy (CSMT) and lumbar discectomy are both used for lumbar disc herniation (LDH) and lumbosacral radiculopathy (LSR); however, limited research has examined the relationship between these therapies. We hypothesised that adults receiving CSMT for newly diagnosed LDH or LSR would have reduced odds of lumbar discectomy over 1-year and 2-year follow-up compared with those receiving other care.DesignRetrospective cohort study.Setting101 million patient US health records network (TriNetX), queried on 24 October 2022, yielding data from 2012 query.ParticipantsAdults age 18–49 with newly diagnosed LDH/LSR (first date of diagnosis) were included. Exclusions were prior lumbar surgery, absolute indications for surgery, trauma, spondylolisthesis and scoliosis. Propensity score matching controlled for variables associated with the likelihood of discectomy (eg, demographics, medications).InterventionsPatients were divided into cohorts according to receipt of CSMT.Primary and secondary outcome measuresORs for lumbar discectomy; calculated by dividing odds in the CSMT cohort by odds in the cohort receiving other care.ResultsAfter matching, there were 5785 patients per cohort (mean age 36.9±8.2). The ORs (95% CI) for discectomy were significantly reduced in the CSMT cohort compared with the cohort receiving other care over 1-year (0.69 (0.52 to 0.90), p=0.006) and 2-year follow-up (0.77 (0.60 to 0.99), p=0.040). E-value sensitivity analysis estimated the strength in terms of risk ratio an unmeasured confounding variable would need to account for study results, yielding point estimates for each follow-up (1 year: 2.26; 2 years: 1.92), which no variables in the literature reached.ConclusionsOur findings suggest receiving CSMT compared with other care for newly diagnosed LDH/LSR is associated with significantly reduced odds of discectomy over 2-year follow-up. Given socioeconomic variables were unavailable and an observational design precludes inferring causality, the efficacy of CSMT for LDH/LSR should be examined via randomised controlled trial to eliminate residual confounding.
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