Tissue Sodium in Patients With Early Stage Hypertension: A Randomized Controlled Trial.
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ABSTRACT:
SUBMITTER: Alsouqi A
PROVIDER: S-EPMC9238458 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:There is sound evidence showing the efficacy of non-pharmacological interventions in lowering blood pressure (BP); however, adherence is usually poor. Interventions to induce behavioral changes aim to improve the ability to read labels, choose foods, and eat low-sodium meals, reinforcing adherence to sodium restriction. In this randomized parallel-controlled trial, we assessed the effectiveness of an educational intervention using the Dietary Sodium Restriction Questionnaire (DSRQ) scores. A follow-up period of 6 months was conducted. Participants were randomized into (1) an educational intervention provided by a registered dietitian on individual visits and dietary planning; (2) a control group with the usual care and dietary recommendations. Patients underwent 24-h ambulatory BP monitoring, 12-h fasting blood tests, spot urine collection, and assessment using DSRQ. We randomized 120 participants (67.5% women and 68.3% Caucasians), and 25 participants were lost to follow-up. The 24-h sodium urinary excretion changed in the control (Δ -1610 mg/day; 95% confidence interval [CI] -1800 to -1410) and intervention groups (Δ -1670 mg/day; 95% CI -1800 to -1450) over time. There was no significant difference in the 24-h estimated sodium between groups. In hypertensive patients, DSRQ-based educational intervention is effective for improving the ability to detect and overcome obstacles to a low-sodium restriction diet but is as effective as dietary recommendations for lowering sodium.
| S-EPMC10180840 | biostudies-literature
Project description:BackgroundPrehypertension and hypertension are associated with cardiovascular disease, ischemic heart disease, and stroke morbidity. The purpose of this study is to evaluate the effectiveness and safety of moxibustion in patients with prehypertension or hypertension.MethodsForty-five subjects with prehypertension or stage I hypertension were randomized into three groups: moxibustion treatment group A (2 sessions/week for 4 weeks), moxibustion treatment group B (3 sessions/week for 4 weeks), and control group (nontreated group). The primary outcome measure was the change in blood pressure after 4 weeks of treatment. Safety was assessed at every visit.ResultsThere were no significant differences in systolic blood pressure (SBP) or diastolic blood pressure (DBP) among three groups after 4 weeks of treatment (p = 0.4798 and p = 0.3252, respectively). In treatment group B, there was a significant decrease in SBP and DBP from baseline to 4 weeks of treatment (mean difference (MD) -9.55; p = 0.0225, MD -7.55; p = 0.0098, respectively). There were no significant differences among groups in secondary outcome measures after 4 weeks of treatment. Six adverse events (AEs) in the treatment group A and 12 AEs in the treatment group B occurred related to the moxibustion treatment.ConclusionIn conclusion, the results of this study show that moxibustion (3 sessions/week for 4 weeks) might lower blood pressure in patients with prehypertension or stage I hypertension and treatment frequency might affect effectiveness of moxibustion in BP regulation. Further randomized controlled trials with a large sample size on prehypertension and hypertension should be conducted.Trial registrationThis study was registered with the 'Clinical Research Information Service (CRIS)', Republic of Korea (KCT0000469), and the protocol for this study was presented orally at the 15th International Council of Medical Acupuncture and Related Techniques (ICMART) in Athens, 25-27 May 2012.
| S-EPMC6309023 | biostudies-literature
Project description:Acupuncture may be beneficial for patients with mild hypertension, but the evidence is not convincing. We aimed to examine the effect of acupuncture on blood pressure (BP) reduction in patients with mild hypertension. We conducted a multicenter, single-blind, sham-controlled, randomized trial in eleven hospitals in China. The trial included 428 patients with systolic blood pressure (SBP) from 140 to 159 mm Hg and/or with diastolic blood pressure (DBP) from 90 to 99 mm Hg. The patients were randomly assigned to receive 18 sessions of affected meridian acupuncture (n = 107) or non-affected meridian acupuncture (n = 107) or sham acupuncture (n = 107) during 6 weeks, or to stay in a waiting-list control (n = 107). All patients received 24-hour ambulatory blood pressure monitoring at weeks 6, 9, and 12. We included 415 participants in the intention-to-treat analysis. The two acupuncture groups were pooled in the analysis, since they had no difference in all outcomes. SBP decreased at week 6 in acupuncture group vs sham acupuncture vs waiting-list group (7.2 ± 11.0 mm Hg vs 4.1 ± 11.5 mm Hg vs 4.1 ± 13.2 mm Hg); acupuncture was not superior to sham acupuncture (mean difference 2.7 mm Hg, 95% CI 0.4 to 5.9, adjusted P = 0.103) or waiting-list control (2.9 mm Hg, 95% CI -0.2 to 6.0, adjusted P = 0.078). However, acupuncture was superior to sham acupuncture (3.3 mm Hg, 95% CI 0.2 to 6.3, adjusted P = 0.035) and waiting-list control (4.8 mm Hg, 95% CI 1.8 to 7.8, P < 0.001) at week 9. Acupuncture had a small effect size on the reduction of BP in patients with mild hypertension.
| S-EPMC8030314 | biostudies-literature
Project description:The effectiveness of nonpharmacological interventions in blood pressure reduction has been evidenced by several studies. Nevertheless, as adherence to a low-sodium diet is poor, interventions regarding habit changing should be of a motivational nature in order to develop the ability of overcoming obstacles regarding sodium-restriction behavior. The present study aims to describe the protocol and randomization of a clinical trial design in order to evaluate the effectiveness of an educational intervention based on Dietary Sodium Restriction Questionnaire (DSRQ) scores. The effectiveness measures are the DSRQ score variation and reduction in urinary sodium values from baseline to after 2 and 6 months.This parallel, randomized clinical trial will include 120 participants, recruited and randomized as follows: 60 of them to be allocated to a sodium-restriction educational intervention group whose results are based on the DSRQ application; and the other 60 allocated to a control group with usual care. Educational orientation and usual care sessions will be conducted once a month for a period of 6 months. Both spot urine collection - estimating sodium intake - and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. There will also be blood collection and 24-h ambulatory blood pressure monitoring (ABPM) at the beginning and end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-h food recall will be collected during follow-up.The study "The effectiveness of an educational intervention to sodium restriction in patients with hypertension" is based on the results of the DSRQ application, whose objective is to evaluate aspects related to nonadherence to the recommendation of a low-sodium diet, identifying adherence barriers and facilitators, contributing to the planning of interventions for improving the adoption of a low-sodium diet and, consequently, hypertension control.ClinicalTrials.gov, Identifier: NCT02848690 . Registered retrospectively on 27 July 2016.
| S-EPMC5521063 | biostudies-literature
Project description:Aims/hypothesis: Dietary restriction (DR) reduces adiposity and improves metabolism in patients with one or more symptoms of the metabolic syndrome. Nonetheless, it remains elusive whether the benefits of DR in humans are mediated by calorie or nutrient restriction. This study was conducted to identify whether isocaloric dietary protein restriction is sufficient to confer the beneficial effects of dietary restriction in patients with metabolic syndrome. Methods: We performed a prospective, randomized controlled dietary intervention under constant nutritional and medical supervision. A total of 21 individuals diagnosed with the metabolic syndrome was randomly assigned for caloric restriction (CR; n = 11, mean age 49 ± 8.5 years, female 63%; diet of 5,941 ± 686 KJ per day) or isocaloric dietary protein restriction (PR; n = 10, mean age 51.6 ± 8.9 years, female 50%; diet of 8,409 ± 2,360 KJ per day) and followed for 27 days. Results: Like CR, PR promoted weight loss (-6.6%, P= 0.0041) due to reduction in adiposity (-9.9%, P= 0.0007), associated with reductions in blood glucose (-52.7%, P= 0.0002), lipid levels (cholesterol, -35.4%, P= 0.0010; triglycerides, -39.5% P= 0.0022) and blood pressure (systolic, -37.7 P< 0.0001; diastolic, -73.2% P< 0.0001). PR resulted in enrichment of metabolic pathways related to the immune system such as B cell proliferation, lymphocyte proliferation and leukocyte proliferation in subcutaneous adipose tissue. Hence, a reduction in calorie intake or changes in the gut microbiome are not necessary to confer the metabolic benefits of DR. Instead, a reduction in protein intake with a mild increase in carbohydrate intake to maintain the isocaloric balance of the diet is sufficient to improve metabolic control. Conclusions/interpretation: Protein restriction is sufficient to confer almost the same clinical outcomes as calorie restriction without the need for a reduction in calorie intake. The isocaloric characteristic of the PR intervention makes this approach a more attractive and less drastic dietary strategy in clinical settings and has greater potential to be used as adjuvant therapy for people with the metabolic syndrome.
2022-06-20 | GSE192587 | GEO
Project description:BackgroundHypertension is a major pathogenic factor of cardiovascular diseases. Insufficient blood pressure control rate and sub-optimal medication adherence remain challenges for effective management of hypertension. Transcutaneous electrical acupoint stimulation (TEAS) has been used to treat various diseases, including hypertension, but the scientific evidence for its benefit remains insufficient. Therefore, we will perform a randomized, controlled clinical trial in patients with stage 1 hypertension to evaluate the effect of TEAS.Methods/designThe study will be a two-arm parallel, randomized controlled trial. Sixty patients with stage 1 hypertension will be randomly assigned to the TEAS group and the control group in a 1:1 ratio. The participants in the TEAS group will receive non-invasive acupoint electrical stimulation for 30 min at four acupoints in the upper and lower extremities at home, 4 times weekly for 12 weeks for a total of 48 sessions. Participants in the control group will not receive any form of acupoint stimulation. All participants in both groups will receive lifestyle education on how to control high blood pressure, including diet, weight control, and exercise. The primary outcome measure will be the change of the mean systolic blood pressure from baseline to 12 weeks. Secondary outcomes include the change of mean diastolic blood pressure, quality of life, body mass index, and physical activity level.DiscussionThis pilot, randomized, controlled trial will explore the feasibility of TEAS. It will also provide potential clinical evidence for the efficacy and safety of TEAS in the treatment of patients with stage 1 hypertension. The results of this study will be published in peer-reviewed journals. Furthermore, this pilot trial as the precursor of a large scale randomized controlled trial will inform the sample size of the subsequent trial.Trial registrationChinese clinical trial registry, ChiCTR1900025042, Registered on 8 August 2019 (http://www.chictr.org.cn/showproj.aspx?proj=41496).
| S-EPMC7310085 | biostudies-literature
Project description:ObjectivesThis article describes results of a randomized controlled trial comparing a time-limited early-stage memory loss (ESML) support group program conducted by a local Alzheimer's Association chapter to a wait-list (WL) control condition.MethodsOne hundred and forty-two dyads were randomized in blocks to ESML (n = 96) or WL (n = 46). Mean age of participants was 74.9 years, and mean Mini-Mental State Examination was 23.4. The primary outcome was participant's quality of life; secondary outcomes included mood, family communication, and perceived stress.ResultsOn the intent-to-treat (ITT) pre-post analysis, significant differences were seen in participant quality of life (p < .001), depression (p < .01), and family communication (p < .05). Within the care partner groups, there was no significant difference between ESML and WL in the ITT analysis. A post hoc exploratory examination of changes that were associated with improved quality of life in ESML participants revealed significant reductions of depressive symptoms and behavior problems (p < .05), improved family communication (p < .05), self-efficacy (p < .01), Medical Outcomes Study short form (SF-36) role-emotional (p < .05), SF-36 social functioning (p < .05), and SF-36 mental health components (p < .01) in improvers.DiscussionThese results support the efficacy of ESML support groups for individuals with dementia.
| S-EPMC2954328 | biostudies-literature
Project description:BACKGROUND AND OBJECTIVES:The US Centers for Medicare and Medicaid Services have mandated reducing early (30-day) hospital readmissions to improve patient care and reduce costs. Patients with ESKD have elevated early readmission rates, due in part to complex medical regimens but also cognitive impairment, literacy difficulties, low social support, and mood problems. We developed a brief family consultation intervention to address these risk factors and tested whether it would reduce early readmissions. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:One hundred twenty hospitalized adults with ESKD (mean age=58 years; 50% men; 86% black, 14% white) were recruited from an urban, inpatient nephrology unit. Patients were randomized to the family consultation (n=60) or treatment-as-usual control (n=60) condition. Family consultations, conducted before discharge at bedside or via telephone, educated the family about the patient's cognitive and behavioral risk factors for readmission, particularly cognitive impairment, and how to compensate for them. Blinded medical record reviews were conducted 30 days later to determine readmission status (primary outcome) and any hospital return visit (readmission, emergency department, or observation; secondary outcome). Logistic regressions tested the effects of the consultation versus control on these outcomes. RESULTS:Primary analyses were intent-to-treat. The risk of a 30-day readmission after family consultation (n=12, 20%) was 0.54 compared with treatment-as-usual controls (n=19, 32%), although this effect was not statistically significant (odds ratio, 0.54; 95% confidence interval, 0.23 to 1.24; P=0.15). A similar magnitude, nonsignificant result was observed for any 30-day hospital return visit: family consultation (n=19, 32%) versus controls (n=28, 47%; odds ratio, 0.53; 95% confidence interval, 0.25 to 1.1; P=0.09). Per protocol analyses (excluding three patients who did not receive the assigned consultation) revealed similar results. CONCLUSIONS:A brief consultation with family members about the patient's cognitive and psychosocial risk factors had no significant effect on 30-day hospital readmission in patients with ESKD.
| S-EPMC5989676 | biostudies-literature
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:The prevalence of prehypertension and Stage 1 hypertension continues to increase despite being amenable to non-pharmacologic interventions. Iyengar yoga (IY) has been purported to reduce blood pressure (BP) though evidence from randomized trials is lacking. We conducted a randomized controlled trial to assess the effects of 12 weeks of IY versus enhanced usual care (EUC) (based on individual dietary adjustment) on 24-h ambulatory BP in yoga-naïve adults with untreated prehypertension or Stage 1 hypertension. In total, 26 and 31 subjects in the IY and EUC arms, respectively, completed the study. There were no differences in BP between the groups at 6 and 12 weeks. In the EUC group, 24-h systolic BP (SBP), diastolic BP (DBP) and mean arterial pressure (MAP) significantly decreased by 5, 3 and 3?mmHg, respectively, from baseline at 6 weeks (P < .05), but were no longer significant at 12 weeks. In the IY group, 24?h SBP was reduced by 6?mmHg at 12 weeks compared to baseline (P = .05). 24?h DBP (P < .01) and MAP (P < .05) decreased significantly each by 5?mmHg. No differences were observed in catecholamine or cortisol metabolism to explain the decrease in BP in the IY group at 12 weeks. Twelve weeks of IY produces clinically meaningful improvements in 24?h SBP and DBP. Larger studies are needed to establish the long term efficacy, acceptability, utility and potential mechanisms of IY to control BP.
| S-EPMC3145370 | biostudies-literature