Cost-Effectiveness of Salt Substitute and Salt Supply Restriction in Eldercare Facilities: The DECIDE-Salt Cluster Randomized Clinical Trial.

Importance: Salt substitution has been reported to be a cost-saving sodium reduction strategy that has not yet been replicated in different contexts. Objective: To estimate the cost-effectiveness of sodium reduction strategies within the DECIDE-Salt trial. Design, Setting, and Participants: The DECIDE-Salt trial cluster randomized in a 1:1:1:1 ratio 48 eldercare facilities in China into 4 groups for evaluation of 2 sodium reduction strategies for 2 years: 1 with both strategies, 2 with either strategy, and 1 with neither strategy. The trial was conducted from September 25, 2017, through October 24, 2020. Interventions: The 2 intervention strategies were replacing regular salt with salt substitute and progressively restricting salt supply to kitchens. Main Outcomes and Measures: The main outcomes included per-participant costs of intervention implementation and medical treatments for hypertension and major adverse cardiovascular events (MACEs) against mean reductions in systolic blood pressure, hypertension prevalence, MACE incidence, and mortality. The incremental cost-utility ratio was then assessed as the additional mean cost per quality-adjusted life-year gained. Analyses were conducted separately for each strategy, comparing groups assigned and not assigned the test strategy. Disease outcomes followed the intention-to-treat principle and adopted different models as appropriate. One-way and probabilistic sensitivity analyses were conducted to explore uncertainty, and data analyses were performed between August 13, 2022, and April 5, 2023. Results: A total of 1612 participants (1230 males [76.3%]) with a mean (SD) age of 71.0 (9.5) years were enrolled. Replacing regular salt with salt substitute reduced mean systolic blood pressure by 7.14 (95% CI, 3.79-10.48) mm Hg, hypertension prevalence by 5.09 (95% CI, 0.37-9.80) percentage points, and cumulative MACEs by 2.27 (95% CI, 0.09-4.45) percentage points. At the end of the 2-year intervention, the mean cost was $25.95 less for the salt substitute group than the regular salt group due to substantial savings in health care costs for MACEs (mean [SD], $72.88 [$9.11] vs $111.18 [$13.90], respectively). Sensitivity analysis showed robust cost savings. By contrast, the salt restriction strategy did not show significant results. If the salt substitution strategy were rolled out to all eldercare facilities in China, 48 101 MACEs and 107 857 hypertension cases were estimated to be averted and $54 982 278 saved in the first 2 years. Conclusions and Relevance: The findings of this cluster randomized clinical trial indicate that salt substitution may be a cost-saving strategy for hypertension control and cardiovascular disease prevention for residents of eldercare facilities in China. The substantial health benefit savings in preventing MACEs and moderate operating costs offer strong evidence to support the Chinese government and other countries in planning or implementing sodium intake reduction and salt substitute campaigns. Trial Registration: ClinicalTrials.gov Identifier: NCT03290716.

Effects of Chinese heart-healthy diet on blood lipids, glucose, and estimated 10-y cardiovascular disease risk among Chinese adults: results on secondary outcomes of a randomized controlled trial.

BACKGROUND: Healthy diet is essential for cardiovascular disease risk management, but its effects among Chinese patients, whose diets differ from Western diets, remain largely unknown. METHODS: In this multicenter, patient- and outcome assessor-blind, randomized controlled feeding trial, 265 Chinese adults with baseline systolic blood pressure 130 to 159 mmHg were randomly assigned into Chinese heart-healthy (CHH) diet or usual diet for a 28-d intervention after a 7-d run-in period on usual diet. Blood lipids and glucose were measured from overnight fasting blood samples before and after the intervention. Ten-year cardiovascular disease risk was estimated using models previously developed and validated in Chinese. The changes in secondary outcomes of serum total cholesterol (TC), blood glucose, and 10-y cardiovascular disease risk over the intervention period were compared between intervention groups, adjusting for center, among participants with baseline and follow-up blood samples available. Sensitivity analyses were done with further adjustment for baseline values and covariables; missing data imputed; and among per-protocol population. RESULTS: Among 256 eligible participants (130 on CHH diet, 126 on control diet), 42% had hypercholesterolemia and 15% had diabetes at baseline. In the control group, TC and 10-y cardiovascular disease risk decreased after the intervention by 0.16 mmol/L and 0.91%, respectively, but blood glucose increased by 0.25 mmol/L. Compared with usual diet, the CHH diet lowered TC (-0.14 mmol/L, P = 0.017) and 10-y cardiovascular disease risk (-1.24%, P = 0.001) further. No effect on blood glucose was found. All sensitivity analyses confirmed the results on TC and 10-y cardiovascular disease risk, and analysis with multiple variables adjusted showed a borderline significant effect on blood glucose (-0.17 mmol/L, P = 0.051). The differences in intake of nutrients and food groups between intervention groups explained the results. CONCLUSIONS: The CHH diet reduced TC and 10-y cardiovascular disease risk and was likely to reduce blood glucose among Chinese adults with mild hypertension. Further studies with longer terms are warranted. This trial was registered at clinicaltrials.gov as NCT03882645.

A Mixed Methods Process Evaluation of a Clustered-Randomized Controlled Trial to Determine the Effects of Community-Based Dietary Sodium Reduction in Rural China.

Purpose: A clustered-randomized controlled trial was conducted to determine the effects of a sodium reduction program in 120 rural villages in Northern China. This mixed-methods process evaluation was used to investigate the implementation and to evaluate the feasibility of the complex intervention to translate the findings from clinical study to the real world. Methods: A convergent mixed-methods process evaluation design was used in this study. Quantitative data were collected from activity logs and routine study records. Qualitative data were collected from 53 project stakeholders and 45 villagers from 10 intervention villages. Thematic analysis of qualitative interviews facilitated integration with the descriptive quantitative data analysis based on theory-informed domains of fidelity, delivery, reach, receipt, and contextual factors of intervention from a process evaluation framework. Results: The intervention was implemented with high fidelity, delivery, reach, and receipt. A total of 5,450 sheets of posters, 31,400 calendars, and 78,000 sheets of stickers were delivered as planned, and 11 promotion activities were conducted in each village. Contextual factors hindering full uptake of the intervention included preference for salty taste, higher cost of low-sodium salt, and low education levels of villagers. Other contextual factors, positive policy support, administrative support, and staff enthusiasm were the facilitators for implementation. Conclusions: This multifaceted intervention was implemented well and effectively in rural China. This process evaluation has indicated that conducting health education interventions in rural areas requires policy and administrative support, enthusiastic staff, easy-to-understand health education materials and activities, and key persons, but tempered expectations as behavior change requires time. This project demonstrates the feasibility and benefits of using mixed-methods process evaluation in large-scale studies.

Clinical research on acupuncture and moxibustion treatment of chronic atrophic gastritis.

OBJECTIVE: To observe the clinical therapeutic effects of acupuncture and moxibustion in treating chronic atrophic gastritis. METHODS: Patients who met the criteria were randomly divided into the treatment groups consisting of the acupuncture group (30 cases) and the acupuncture-moxibustion group (30 cases), and the control group (28 cases). After two months of treatment, observed were safety and the curative effects, through general physical check ups, routine examinations of blood, urine and feces, and symptoms, pathology and gastrin before, during and after the treatment. RESULTS: (1) The treatment groups showed significant superiorities in the improvement of symptoms, with the acupuncture-moxibustion group showing the best therapeutic effects. (2) The acupuncture-moxibustion group showed marked differences before and after the treatment in the improvement of glandular atrophy and intestinal metaplasia, with a total effective rate of 66.67%. (3) After the treatment, the three groups all showed marked improvement in the level of serum gastrin, with the acupuncture-moxibustion group showing the best effects. CONCLUSION: Acupuncture and moxibustion have definite therapeutic effects for chronic atrophic gastritis, especially in improving the symptoms. Acupuncture or acupuncture combined with moxibustion can provide possibilities in reversing the pathologic changes of glandular atrophy and intestinal metaplasia for patients with chronic atrophic gastritis. Acupuncture-moxibustion is really an effective and safe therapy for chronic atrophic gastritis.

Short-Term Outcomes of Single-Incision Versus Conventional Laparoscopic Surgery for Colorectal Diseases: Meta-Analysis of Randomized and Prospective Evidence.

BACKGROUND: Conventional laparoscopic surgery (CLS) has been established as an alternative to open surgery for colorectal diseases (CRDs); simultaneously, single-incision laparoscopic surgery (SILS) is gaining popularity. OBJECTIVE: The aim of this study was to compare the short-term efficacy and safety of SILS with CLS for CRDs. METHODS: MEDLINE, EMBASE, and the Cochrane Library were searched for relevant randomized and prospective studies. Reference lists of relevant articles and reviews, conference proceedings, and ongoing trial databases were also screened. Outcome measures included surgical parameters, postsurgical recovery, pain, and adverse events. Meta-analysis was conducted where appropriate, comparing items using weighted mean differences (WMDs) and risk ratios (RRs) according to data type. RESULTS: A total of nine prospective (three randomized and six non-randomized) researches published from 2011 to 2015 were identified. The overall pooled results showed compared to CLS, SILS was associated with fewer blood transfusions, shorter incision length, and slighter postoperative pain, but more extra ports. All the other parameters were comparable. Randomized evidence supported SILS was associated with less blood loss, and shorter hospital stay, but longer operative time. For only colectomy cases, SILS was associated with more conversions to open surgery. SILS was associated with longer surgical time for Easterners, but not for Westerners. The detected differences were clinically insignificant. CONCLUSIONS: The results based on randomized and prospective evidence provide convincing support for the clinical similarity that SILS is basically as applicable, effective, and safe as CLS when dealing with colorectal lesions, but not for superiority.

Analysis of heart rate variability in masked hypertension.

To investigate heart rate variability (HRV) in patients with masked hypertension (MH), participants were classified based on clinic and 24-h ambulatory blood-pressure monitoring: essential hypertension (EH, n = 40; MH, n = 36) and normotension (NT, n = 48). The HRV parameters were observed using a 24-h Holter monitor. Compared with NT controls, the parameters of HRV (SDNN, SDANN, SDNN Index, RMSSD, HF) and parameters in EH and MH patients had significantly decreased. No statistically significant difference in the HRV parameters was found between the EH and MH groups. The changes in HRV parameters show cardiac autonomic nerve dysfunction in patients with MH.