Sildenafil for adult Asian patients with pulmonary arterial hypertension: a systematic review and meta-analysis.
Annals of palliative medicine. 2022;(1):339-351
BACKGROUND The prognosis of patients with untreated pulmonary arterial hypertension (PAH) has historically been poor. Previous studies have recommended that sildenafil was beneficial, but the dose varies greatly. In this study, we aimed to evaluate the safety and effectiveness of sildenafil [dose: 20 mg/three times a day (TID)] for adult Asian PAH patients. METHODS Electronic databases (MEDLINE, Embase, Web of Science, the Cochrane Library, CBM, CNKI, and Wanfang Data) were searched from their inception to January 2022. We recruited all randomized controlled trials and non-randomized studies of interventions that compared sildenafil (20 mg/TID) versus placebo or symptomatic treatment for adult Asian PAH patients. RESULTS A total of 10 studies involving 480 participants were included. Compared to symptomatic treatment, sildenafil-treated patients were more likely to walk 57.68 meters further in six-minute walk distance [mean difference (MD) =57.68 m, 95% confidence interval (CI): 41.55 to 73.81], achieve an improvement in systemic arterial oxygen saturation (MD =2.48%, 95% CI: 1.26 to 3.71), and increase the score of the Borg scale for dyspnea (MD =-0.99 points, 95% CI: -1.45 to -0.53). The total number of patients with World Health Organization class III and IV also exhibited a downtrend. Compared to the placebo, sildenafil was associated with a reduction in the mean pulmonary artery pressure (MD =-4.13 mmHg, 95% CI: -6.52 to -1.74) and the level of brain natriuretic peptide (MD =-86.16 pg/mL, 95% CI: -103.39 to -68.93). The most common adverse events were headache, flushing, dyspepsia, and diarrhea, which were relatively mild. DISCUSSION Sildenafil at a dose of 20 mg/TID is well tolerated in adult Asian PAH patients, and is associated with statistically significant improvements in exercise capacity, cardio-pulmonary function, and haemodynamic indices. The long-term prognosis still needs to be evaluated and confirmed by further trials.
Association of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases: A Systematic Review and Meta-analysis of Randomized Clinical Trials.
JAMA internal medicine. 2022;(5):513-519
Importance: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have been widely recommended for glucose control and cardiovascular risk reduction in patients with type 2 diabetes, and more recently, for weight loss. However, the associations of GLP-1 RAs with gallbladder or biliary diseases are controversial. Objective: To evaluate the association of GLP-1 RA treatment with gallbladder and biliary diseases and to explore risk factors for these associations. Data Sources: MEDLINE/PubMed, EMBASE, Web of Science, and Cochrane Library (inception to June 30, 2021), websites of clinical trial registries (July 10, 2021), and reference lists. There were no language restrictions. Study Selection: Randomized clinical trials (RCTs) comparing the use of GLP-1 RA drugs with placebo or with non-GLP-1 RA drugs in adults. Data Extraction and Synthesis: Two reviewers independently extracted data according to the PRISMA recommendations and assessed the quality of each study with the Cochrane Collaboration risk-of-bias tool. Pooled relative risks (RRs) were calculated using random or fixed-effects models, as appropriate. The quality of evidence for each outcome was assessed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) framework. Main Outcomes and Measures: The primary outcome was the composite of gallbladder or biliary diseases. Secondary outcomes were biliary diseases, biliary cancer, cholecystectomy, cholecystitis, and cholelithiasis. Data analyses were performed from August 5, 2021, to September 3, 2021. Results: A total of 76 RCTs involving 103 371 patients (mean [SD] age, 57.8 (6.2) years; 41 868 [40.5%] women) were included. Among all included trials, randomization to GLP-1 RA treatment was associated with increased risks of gallbladder or biliary diseases (RR, 1.37; 95% CI, 1.23-1.52); specifically, cholelithiasis (RR, 1.27; 95% CI, 1.10-1.47), cholecystitis (RR, 1.36; 95% CI, 1.14-1.62), and biliary disease (RR, 1.55; 95% CI, 1.08-2.22). Use of GLP-1 RAs was also associated with increased risk of gallbladder or biliary diseases in trials for weight loss (n = 13; RR, 2.29; 95% CI, 1.64-3.18) and for type 2 diabetes or other diseases (n = 63; RR, 1.27; 95% CI, 1.14-1.43; P <.001 for interaction). Among all included trials, GLP-1 RA use was associated with higher risks of gallbladder or biliary diseases at higher doses (RR, 1.56; 95% CI, 1.36-1.78) compared with lower doses (RR, 0.99; 95% CI, 0.73-1.33; P = .006 for interaction) and with longer duration of use (RR, 1.40; 95% CI, 1.26-1.56) compared with shorter duration (RR, 0.79; 95% CI, 0.48-1.31; P = .03 for interaction). Conclusions and Relevance: This systematic review and meta-analysis of RCTs found that use of GLP-1 RAs was associated with increased risk of gallbladder or biliary diseases, especially when used at higher doses, for longer durations, and for weight loss. Trial Registration: PROSPERO Identifier: CRD42021271599.
Prolonged Glycemic Adaptation Following Transition From a Low- to High-Carbohydrate Diet: A Randomized Controlled Feeding Trial.
Diabetes care. 2022;(3):576-584
OBJECTIVE Consuming ≥150 g/day carbohydrate is recommended for 3 days before an oral glucose tolerance test (OGTT) for diabetes diagnosis. For evaluation of this recommendation, time courses of glycemic changes following transition from a very-low-carbohydrate (VLC) to high-carbohydrate diet were assessed with continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS After achieving a weight loss target of 15% (±3%) on the run-in VLC diet, participants (18-50 years old, BMI ≥27 kg/m2) were randomly assigned for 10 weeks to one of three isoenergetic diets: VLC (5% carbohydrate and 77% fat); high carbohydrate, high starch (HC-Starch) (57% carbohydrate and 25% fat, including 20% refined grains); and high carbohydrate, high sugar (HC-Sugar) (57% carbohydrate and 25% fat, including 20% sugar). CGM was done throughout the trial (n = 64) and OGTT at start and end (n = 41). All food was prepared in a metabolic kitchen and consumed under observation. RESULTS Glucose metrics continued to decline after week 1 in the HC-Starch and HC-Sugar groups (P < 0.05) but not VLC. During weeks 2-5, fasting and 2-h glucose (millimoles per liter per week) decreased in HC-Starch (fasting -0.10, P = 0.001; 2 h -0.10, P = 0.04). During weeks 6-9, 2-h glucose decreased in HC-Starch (-0.07, P = 0.01) and fasting and 2-h glucose decreased in HC-Sugar (fasting -0.09, P = 0.001; 2 h -0.09, P = 0.003). The number of participants with abnormal glucose tolerance by OGTT remained 10 (of 16) in VLC at start and end but decreased from 17 to 9 (of 25) in both high-carbohydrate groups. CONCLUSIONS Physiological adaptation from a low- to high-carbohydrate diet may require many weeks, with implications for the accuracy of diabetes tests, interpretation of macronutrient trials, and risks of periodic planned deviations from a VLC diet.
A prospective on multiple biological activities of lactoferrin contributing to piglet welfare.
Biochemistry and cell biology = Biochimie et biologie cellulaire. 2021;(1):66-72
Piglets, especially weaning piglets, show a lower level of immunity and higher morbidity and mortality, owing to their rapid growth, physiological immaturity, and gradual reduction of maternal antibodies, which seriously affects their growth and thus, value. It is important that piglets adapt to nutrient digestion and absorption and develop sound intestinal function and colonization with gut microbiota as soon as possible during their early life stage. Lactoferrin is a natural glycoprotein polypeptide that is part of the transferrin family. It is widely found in mucosal secretions such as saliva and tears, and most highly in milk and colostrum. As a multifunctional bioactive protein and a recommended food additive, lactoferrin is a potential alternative therapy to antibiotics and health promoting additive for piglet nutrition and development. It is expected that lactoferrin, as a natural food additive, could play an important role in maintaining pig health and development. This review examines the following known beneficial effects of lactoferrin: improves the digestion and capacity for absorption in the intestinal tract; promotes the absorption of iron and reduces the incidence of iron deficiency anemia; regulates intestinal function and helps to balance the microbial biota; and enhances the resistance to disease of the piglets via modulating and enhancing the immune system.
Effects of a 12-Week Transtheoretical Model-Based Exercise Training Program in Chinese Postoperative Bariatric Patients: a Randomized Controlled Trial.
Obesity surgery. 2021;(10):4436-4451
PURPOSE This study aims to investigate the effectiveness of the transtheoretical model (TTM)-based exercise training on TTM variables, exercise adherence, and physical function in patients in the early stages after bariatric surgery (BS). MATERIALS AND METHODS We conducted a single-blinded, prospective, randomized controlled trial (RCT) to evaluate the effects of TTM-based exercise training on BS patients immediately after surgery. Participants (n = 120) were randomized into a TTM-based exercise training group (n = 60) and a control group (n = 60). Main outcomes included TTM variables (measured by exercise stages of change (ESCs), exercise self-efficacy (ESE), and decisional balance), exercise adherence, and physical function (determined by the 6-min walk distance (6MWD)). Secondary outcomes were physical activity, anthropometrics, and body composition. We performed all analyses in accordance with the intention-to-treat principle. RESULTS Retention rates for the interventions were 91.7% for the intervention group and 90.0% for the control group. Compared with the control group, the 12-week TTM-based intervention significantly helped participants advance through ESCs, demonstrate higher ESE, perceive more benefits and fewer barriers to exercise, and show higher exercise adherence and better physical function afterward (all P < 0.05). However, we observed no statistically significant difference between the two groups in anthropometric parameters or body composition after intervention. CONCLUSION The TTM-based exercise intervention had significant positive effects on the TTM variables, which could further help increase patients' exercise adherence and physical function immediately after BS. TRIAL REGISTRATION This study was retrospectively registered at the Chinese Clinical Trial Registry (website: www.chictr.org.cn , registry number: ChiCTR2000039319).
Efficacy of acupuncture for urinary incontinence in middle-aged and elderly women: A systematic review and meta-analysis of randomized controlled trials.
European journal of obstetrics, gynecology, and reproductive biology. 2021;:138-143
OBJECTIVES Our aim was to generalize the available evidence and evaluate the effectiveness of acupuncture for urinary incontinence in middle-aged and elderly women. METHODS Six databases including VIP, CNKI, Wan Fang, Web of Science, PubMed and The Cochrane Library were systematically searched to retrieve similar studies updated to December 2019 to gather RCTs regarding the effectiveness of acupuncture for middle-aged and elderly women with urinary incontinence. Two researchers independently performed the whole process of retrieving the studies, extracting the data and assessing the risk of bias of the included studies. The current meta-analysis was performed using RevMan 5.3 software. RESULTS A total of eight studies with 607 patients were included in the evaluation. The current meta-analysis showed that Compared with rehabilitation exercise or medication, acupuncture intervention significantly improved the clinical effectiveness (OR = 5.52, 95 % CI, 3.13-9.73), reduced the urine leakage in pad test (SMD = -2.67, 95 % CI, -4.05 to -1.29) and decrease the ICIQ-SF score (MD = -3.46, 95 % CI, -3.69 to -3.22). The results indicated that acupuncture intervention can help the patients alleviate the symptoms effectively. CONCLUSION Based on this study, acupuncture intervention of stress urinary incontinence in middle-aged and elderly women can improve the clinical effectiveness, reduce the urine leakage in pad test and ICIQ-SF score. More high-quality studies with large sample size are required for further verification.
Effect of laparoscopic sleeve gastrectomy on drug pharmacokinetics.
Expert review of clinical pharmacology. 2021;(12):1481-1495
INTRODUCTION Given its feasibility and efficacy, laparoscopic sleeve gastrectomy (LSG) has become a widely accepted bariatric surgery for patients with clinically diagnosed severe obesity. LSG induces anatomical changes and subsequent weight loss which may affect drug pharmacokinetics (PK) and consequently impact dosing regimens. This review aims to examine the effect of LSG on drug PK and identify relevant gastrointestinal physiological alterations. AREAS COVERED PubMed, Embase, Scopus, and the Cochrane Library were searched for articles related to drug PK and LSG from inception to July 2021. Moreover, literature concerning postoperative physiological conditions in the gastrointestinal tract, such as gastric pH, gastric emptying, and small bowel transit time, etc., which may affect the PK profile of drug products was also reviewed. EXPERT OPINION Although LSG is classified as having restrictive property without malabsorptive bypass, postoperative changes in gastrointestinal physiology and subsequent weight loss may also lead to increased, decreased or unaltered drug exposure levels. General monitoring on drug efficacy or safety using biomarkers is proposed. In addition, therapeutic drug monitoring for those drugs when it is applicable and available is recommended to ensure efficient drug dosing and avoid adverse effects. Further research into many individual drugs are warranted.
A Low-Carbohydrate Diet Realizes Medication Withdrawal: A Possible Opportunity for Effective Glycemic Control.
Frontiers in endocrinology. 2021;12:779636
Plain language summary
Many studies have shown that diet restrictions can help glycemic control and reduce metabolic risks in patients with type 2 diabetes mellitus (T2DM). The aim of this study was to look at the efficacy of two diets, the LCD and the low-fat diet (LFD), on glycemic control and clinical treatment. The study was a prospective, open-label, double-arm, randomized controlled trial conducted from March 2019 to December 2020 in China. 134 T2DM participants took part and they were randomly assigned to the LCD group or the low -fat diet (LFD) group. The following were measured at the beginning and end of each intervention: weight, fasting blood glucose (FBG), postprandial 2-h blood glucose (PPG), glycosylated haemoglobin (HbA1c), antiglycemic medications, and medications for other diseases and emerging diseases. The effect of decreasing blood glucose control with the LCD is superior to that of the LFD for Chinese patients with T2DM. It also led to a lower medication effects score (MES). It can reduce body weight, BMI, and lipid-lowering agents. Strict diet control and monitoring are the keys to managing diabetes. Further larger scale studies are needed to obtain more evidence.
Objective: Multiple studies have confirmed that diet restrictions can effectively realize glycemic control and reduce metabolic risks in patients with type 2 diabetes mellitus (T2DM). In 2018, the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) stated that individuals can select a low-carbohydrate diet (LCD) according to their needs and preferences. Owing to the influence of Chinese traditional eating habits, only a small portion of patients in China have achieved their blood glucose goals. As a result, the Chinese government will incur huge expenditures. Method: This study recruited 134 T2DM participants and randomly assigned them to the LCD group (n = 67) or the low-fat diet (LFD) group (n = 67). All of the patients had a fixed amount of exercise and were guided by clinicians. After a period of dietary washout, all of the patients received corresponding dietary education according to group. The follow-up time was 6 months. The indicators for anthropometry, glycemic control, and medication application parameters were collected and compared between the two groups. Results: There were 121 participants who finally entered the study. The proportions of calories from three major nutrients the participants consumed met the requirements of LCD and LFD. Compared with baseline, the pre-postdifferences of body weight, BMI, and several other indicators were significant except for dosages of insulin used in the LCD group and MES in the LFD group. After the intervention, body weight, body weight index (BMI), fasting blood glucose (FBG), postprandial 2-h blood glucose (PPG), and glycosylated hemoglobin (HbA1c) levels in the LCD group decreased significantly (p < 0.05) compared with the LFD group. The number of patients using lipid-lowering agents was significant higher in the LCD group and lower in the LFD group. However, there was no significant difference between the two groups for antihypertensive, hormone-replacement, and other agents. Conclusions: The LCD diet can decrease body weight, glycemic levels, MES, and lipid-lowering agents more than the LFD diet, thus decreasing cost burden in Chinese patients with T2DM. Strict diet control and monitoring are the keys to managing diabetes.
Persistent effect at 30-month post intervention of a community-based randomized trial of KM2H2 in reducing stroke and heart attack among senior hypertensive patients.
The international journal of behavioral nutrition and physical activity. 2018;(1):1
BACKGROUND The effect of the Keep Moving toward Healthy Heart and Healthy Brain (KM2H2) program at 6-month post intervention has been assessed. The purpose of this study is to evaluate the KM2H2 program at 30-month post intervention. METHODS A total of 450 senior hypertensive patients from 12 community health centers were randomized by center to either receive KM2H2 plus standard care (6 centers, n = 232) or standard care only (6 centers, n = 218). Data for outcome measures at 30-month post intervention were analyzed. New cases of stroke and heart attack were verified with medical records; levels of physical activity were assessed using self-reported questionnaire. In addition to comparative analysis, adjusted incidence rate and program effects were determined using mixed effects modeling method. RESULTS At the 30-month follow-up, the adjusted incidence rate [95% CI] of stroke was 11.81% [5.90, 17.72] for patients in the intervention group and 19.78% [14.07, 25.50] (p = 0.03) for the control group. The adjusted incidence rate of heart attack was 3.34% [1.91, 8.58] and 6.68% [1.64, 11.73] for the intervention and control groups (p = 0.16), respectively; the proportion and the duration of engaging in regular physical activity were significantly greater for the intervention group than the control group. The reductions in blood pressure between the intervention and the control was not statistically significant. CONCLUSIONS The KM2H2 program showed a persistent effect up to 30 months post intervention in enhancing physical activity and reducing the risk of cardio-cerebrovascular events, particularly stroke. These findings demonstrate the persistent effect of the KM2H2 and suggest the need for a full-scale evaluation of the intervention program for practical use. TRIAL REGISTRATION ISRCTN Register ISRCTN12608966 . Registered 03 March 2015. Retrospectively registered.
Tai Chi Exercise for the Quality of Life in a Perimenopausal Women Organization: A Systematic Review.
Worldviews on evidence-based nursing. 2017;(4):294-305
BACKGROUND Improvement of the quality of life in perimenopausal women has recently become an important global health issue. Extensive research reports provide evidence of Tai Chi for the quality of life, but no systematic review has individually investigated Tai Chi as a main intervention on the quality of life in perimenopausal women. OBJECTIVE To assess clinical evidence of Tai Chi for the quality of life in perimenopausal women. METHODS Studies related to the effect of Tai Chi on the quality of life in perimenopausal women in the databases of China and abroad were searched. RevMan version 5.2 software was used, and the Medical Outcomes Study 36-item short form health survey (SF-36) and bone mineral density (BMD) were selected as evaluation indices. RESULTS Five trials were included. The results of this study showed that Tai Chi had a significant effect on bodily pain, general health, vitality, mental health of SF-36, and the spine dimension of BMD, as supported by the following data: bodily pain (Standard Mean Difference [SMD] = -3.63; 95% confidence interval [CI] [-6.62, -0.64]; p = .02); general health (SMD = -5.08; 95% CI [-7.60, -2.56]; p < .0001); vitality (SMD = -5.67; 95% CI [-8.54, -2.81], p = .0001); mental health (SMD = -2.51; 95% CI [-4.82, -0.20], p = .03); and spine dimension of BMD (SMD = -0.06; 95% CI [-0.10, -0.01]; p = .01). However, Tai Chi had no effect on physical function, emotional health, social function, role-physical of SF-36, and the hip dimension of BMD, as supported by the following data: physical function (SMD = -1.79; 95% CI [-5.15, 1.57]; p = .30); emotional health (SMD = -2.90; 95% CI [-7.23, 1.43], p = .19]; social function (SMD = -2.23, 95% CI [-5.08, 0.61], p = .12; role-physical (SMD = - 1.18; 95% CI [-4.84, 2.47], p = .53; and hip dimension of BMD (SMD = -0.01; 95% CI [-0.03, 0.01]; p = .31). LINKING EVIDENCE TO ACTION This systematic review found significant evidence for Tai Chi improving bodily pain, general health, vitality, mental health of SF-36, and the spine dimension of BMD in patients with perimenopausal syndrome. Findings suggest that Tai Chi might be recommended as effective and safe adjuvant treatment for patients with perimenopausal syndrome. More high-quality randomized controlled trials are urgently needed to confirm these results.