Nevin Manimala

Circulation. 2022 Sep 13:101161CIRCULATIONAHA122059755. doi: 10.1161/CIRCULATIONAHA.122.059755. Online ahead of print.

ABSTRACT

BACKGROUND: Women and men with heart failure (HF) and preserved ejection fraction may differ in their clinical characteristics and their response to therapy. The aim of this study was to evaluate the influence of sex on the effects of empagliflozin in patients with HF and preserved ejection fraction enrolled in the EMPEROR-Preserved trial (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction).

METHODS: The effects of empagliflozin on the primary outcome of cardiovascular death or hospitalization for HF and on secondary outcomes (including total HF hospitalization, cardiovascular and all-cause mortality, and Kansas City Cardiomyopathy Questionnaire scores) were compared in women and men in the overall cohort and in subgroups defined by left ventricular ejection fraction (41%-49%, 50%-59%, and ≥60%). The effects of empagliflozin on physiological measures, including changes in systolic blood pressure, uric acid, hemoglobin, body weight, and natriuretic peptide levels, were also assessed.

RESULTS: Of the 5988 patients randomized, 2676 (44.7%) were women. In the placebo arm, women tended to have lower risk for adverse outcomes, including a lower risk of all-cause mortality (hazard ratio, 0.69 [95% CI, 0.56, 0.84]). Compared with placebo, empagliflozin reduced the risk of cardiovascular death or hospitalization for HF to a similar degree in both sexes (hazard ratio, 0.81 [95% CI, 0.69, 0.96] for men; and hazard ratio, 0.75 [95% CI, 0.61, 0.92] for women; P_interaction=0.54). Sex did not modify the relationship between empagliflozin and outcomes across ejection fraction groups. Similar results were seen for secondary outcomes and physiological measures. Compared with placebo, empagliflozin improved the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score to a similar extent in both sexes (1.38 for men versus 1.63 for women at 52 weeks; P_interaction=0.77); the results were similar for Kansas City Cardiomyopathy Questionnaire overall summary score and total summary score.

CONCLUSIONS: Empagliflozin produced similar benefits on outcomes and health status in women and men with HF and preserved ejection fraction.

REGISTRATION: URL: https://www.

CLINICALTRIALS: gov; Unique identifier: NCT03057951.

PMID:36098051 | DOI:10.1161/CIRCULATIONAHA.122.059755

Eur J Prev Cardiol. 2022 Sep 13:zwac208. doi: 10.1093/eurjpc/zwac208. Online ahead of print.

ABSTRACT

BACKGROUND: The relationship between vegetable consumption and hypertension occurrence remains poorly characterized in sub-Saharan Africa.

AIM: This study assessed the association of vegetable consumption with odds of hypertension among indigenous Africans.

METHODS: We harmonized data on prior vegetable consumption and hypertension occurrence (defined as one of the following conditions; systolic blood pressure ≥140 or diastolic blood pressure ≥90mmHg or previous diagnosis or use of antihypertensive medications) from 16,445 participants across five African countries (Nigeria, South Africa, Kenya, Ghana and Burkina Faso) from the SIREN and AWI-Gen studies. Vegetable consumption (in servings/week) was classified as ‘low’ (<6). ‘moderate’ (6-11), ‘sufficient’ (12-29) and ‘high’ (≥30). Odds ratios (OR) and 95% confidence interval (CI) of hypertension were estimated by categories of vegetable consumption (using ‘low’ consumption as reference), adjusting for sex, age in years, family history of cardiovascular diseases, education, smoking, alcohol use, physical inactivity, body mass index, diabetes mellitus and dyslipidaemia using logistic regressions at P < 0.05.

RESULTS: The mean age of participants was 53·0 (+/-10·7) years, and 7,552 (45·9%) were males, while 7,070 (42·9%) had hypertension. Also, 6,672(40·6%) participants had ‘low’ vegetable consumption, and 1,758(10·7%) had ‘high’ vegetable consumption. Multivariable-adjusted OR for hypertension by distribution of vegetable consumption (using ‘low’ consumption as reference), were 1·03 (95% CI: 0·95, 1·12) for ‘moderate’ consumption; 0·80 (0·73, 0·88) for ‘sufficient’ and 0·81 (0·72, 0·92) for ‘high’ consumption, P-for-trend <0·0001.

CONCLUSION: Indigenous Africans who consumed at least twelve servings of vegetables per week were less likely to be found hypertensive, particularly among males and young adults.

PMID:36098047 | DOI:10.1093/eurjpc/zwac208

Lancet Healthy Longev. 2021 Nov;2(11):e712-e723. doi: 10.1016/S2666-7568(21)00248-8. Epub 2021 Oct 22.

ABSTRACT

BACKGROUND: Integrating primary prevention into care pathways for older adults is a core strategy of healthy ageing, but evidence remains limited. We aimed to determine whether incorporating a multidomain intervention into primary health care could improve standard value-based health outcomes and quality of life.

METHODS: For this Taiwan Integrated Geriatric Care (TIGER) study, a pragmatic randomised controlled trial, we recruited community-dwelling outpatients aged 65 years or older with at least three chronic medical conditions. We excluded people with malignancies undergoing chemotherapy, people with a life expectancy of less than 12 months, or people who were insufficiently able to communicate with study staff. Participants were randomly assigned (1:1) to usual care or to the integrated multidomain intervention using block randomisation. The integrated multidomain intervention entailed 16 2-h sessions per year, comprising communal physical exercise, cognitive training, nutrition and disease education, plus individualised treatment by specialists in integrated geriatric care. The primary outcome was changes from baseline quality of life, based on 36-item Short Form Health Survey (SF-36) scores, at 3, 6, 9, and 12 months. Intervention effects were analysed per protocol using a generalised linear mixed model. This trial is registered with ClinicalTrials.gov, NCT03528005.

FINDINGS: Between June 25, 2018, and Feb 15, 2019, 628 participants were screened, of whom 398 were assigned to the integrated multidomain intervention (n=199) or to usual care (n=199). 335 (84%) participants completed the 12-month follow-up. Compared with the usual care group, the integrated multidomain intervention group had significantly higher mean SF-36 physical component scores across all timepoints (overall difference 0·8, 95% CI 0·2-1·5; p=0·010), but differences at 3, 6, 9, and 12 months did not reach statistical significance. The SF-36 mental component scores did not differ significantly overall, but were significantly higher in the integrated multidomain intervention group at the 12-month follow-up (55·3 [SD 7·6] vs 57·2 [7·0]; p=0·019). No serious adverse events occurred.

INTERPRETATION: Incorporating multidomain interventions into integrated health care improved quality of life. Our standardised protocol is amenable to inclusion in policies to promote value-based care and healthy ageing.

FUNDING: National Health Research Institutes, Taiwan, and Ministry of Science and Technology, Taiwan.

PMID:36098028 | DOI:10.1016/S2666-7568(21)00248-8

Pain Manag. 2022 Sep 13. doi: 10.2217/pmt-2022-0053. Online ahead of print.

ABSTRACT

Aim: The current study compared the effectiveness of remote electrical neuromodulation (REN) to that of standard-care medications for acute treatments of migraine, using a within-subjects design. Materials & methods: Post-hoc within-subject analysis was performed on data from 78 adult chronic migraine patients who participated in a clinical trial with REN, on four end points: single-treatment pain relief, single-treatment pain freedom, consistency of pain relief and consistency of pain freedom. Results: No statistical differences were found between REN and the tested medications, in any of the effectiveness outcomes: single-treatment pain relief p = 0.056, single-treatment pain freedom p = 0.532, consistency of pain relief p = 0.369, consistency of pain freedom p = 1.00. Conclusion: The results suggest that REN may provide an effective non-pharmacological alternative for standard care abortive medications in individuals impacted by chronic migraine.

PMID:36097974 | DOI:10.2217/pmt-2022-0053

J Clin Lab Anal. 2022 Sep 13:e24702. doi: 10.1002/jcla.24702. Online ahead of print.

ABSTRACT

BACKGROUND: COVID-19 is a newly discovered infectious disease that spread and caused a global health problem. Medical students, especially those in clinical stages are among groups exposed to the disease. The study aimed to show the impact of social distancing on the mental health of Iraqi medical students.

METHOD: A convenient sampling technique involved 105 participants was obtained through a questionnaire. The participants were from all stages of College Of Medicine. Questions were regarding the mental health status of the students, which included sleeping hours, nightmares, eating habits, weight problems, relationship with the family, starting to have bad habits, memory loss, attention problems, irritability, and study rank affect.

RESULTS: Of about 105 participants, 64 (60.9%) of them were females and 41 (39.1%) were males. The mean age of the participants was (21.26 ± 1.065) ranging from 19 to 24 years. Feeling stressful when hearing news about COVID-19″ found in 82 (78.1%) of the participants. A high statistical significant difference (p = 0.035) among feeling isolated. About 77 (73.3%) of the participants had become easily irritable and angry. About 82 (78.1%) student started for having calculation problems. The stress with sleeping hours (p = 0.019), sleeping disturbance (p = 0.022), eating habit (p = 0.015), weight problems (p = 0.002), fear of familiar places (p = 0.004), recent memory loss (p = 0.034) and being easily irritable or angry (p = 0.0001), revealed a statistical significant association, respectively.

CONCLUSION: COVID-19 news and social distancing had made medical students more stressed and irritable, affecting their sleeping hours and pattern with a general tendency for weight gain and recent memory loss in stressful students.

PMID:36097972 | DOI:10.1002/jcla.24702

Int J Dermatol. 2022 Sep 13. doi: 10.1111/ijd.16409. Online ahead of print.

ABSTRACT

BACKGROUND: Hidradenitis suppurativa (HS) is associated with substantial morbidity. Few studies have addressed the natural history and mortality rates associated with HS. A higher risk of cardiovascular death in patients with HS has been reported. We investigated whether patients with HS have an increased overall risk of death compared with age- and gender-matched referents.

METHODS: We performed a retrospective cohort study of residents of Olmsted County, Minnesota, with incident HS between January 1, 1980, and December 31, 2008, and age- and gender-matched referents. The main outcomes and measures were the overall and cause-specific risks of death.

RESULTS: We identified 226 incident cases of HS and 678 age- and gender-matched referents among Olmsted County residents during the study period. Compared to referents, patients with HS had a significantly higher risk of all-cause death (hazard ratio [HR, 2.48; 95% CI, 1.53-4.03, P < 0.001) and cardiovascular- or cerebrovascular-related death (HR, 2.85; 95% CI, 1.10-7.40, P = 0.03). However, these risks were attenuated by adjusting for smoking history: all-cause HR, 1.65 (95% CI, 0.97-2.82, P = 0.07) and cardiovascular- or cerebrovascular-related HR, 2.03 (95% CI, 0.71-5.81, P = 0.18). The 71% of patients were former or current smokers at the time of HS diagnosis.

CONCLUSIONS: Hidradenitis suppurativa patients have a substantially increased risk of death from any cause, including cardiovascular or cerebrovascular causes; the risk is especially dependent on smoking history.

PMID:36097962 | DOI:10.1111/ijd.16409

Zhonghua Kou Qiang Yi Xue Za Zhi. 2022 Sep 9;57(9):946-952. doi: 10.3760/cma.j.cn112144-20220302-00087.

ABSTRACT

Objective: To investigate the project characteristics of oral clinical trials registered in Chinese Clinical Trial Registry (ChiCTR), and to provide reference for medical institutions to improve the quality of oral clinical trials and formulate management systems. Methods: The ChiCTR database was retrieved to collect all the oral-related clinical trials from the time of database establishment to July 25, 2021. Those clinical trials were analyzed statistically in respect of name of registered project, registration time, registration status, regional distribution of research institutions, approval status by ethics committee, sample size, source of funds, involved disease, research type and design, randomization method, and whether blind method was adopted. Results: A total of 778 oral clinical trials, which studied mainly in the oral and maxillofacial diseases, periodontal tissue diseases, oral implant diseases, oral mucosal diseases, and oral prosthetic diseases, were retrieved in the database. Beijing, Sichuan, Shanghai, Guangdong and Hubei were major regions where oral clinical trials were carried out, accounting for 69.68% (772/1 108) of the total. The top four funding sources were hospital finance [24.93% (186/746)], local government finance [22.39% (167/746)], self-financing [17.69% (132/746)], and national finance [12.47% (93/746)]. For the types of researches, 520 interventional studies and 244 observational studies were identified (accounting for 66.84% and 31.36%, respectively). The research designs were dominated by ways of randomized control (381, 48.97%), of which 240 (62.99%) trials were with missing or unspecified blinding methods. Conclusions: Oral clinical trials are increasing year by year, but they are regionally imbalanced, and still need to be further improved in registration information and research design. Administrative departments should pay more attention to strengthen the publicity and education on the registration and publication mechanism of clinical trials, and enhance researchers’ cognitions in clinical trials registration and clinical trials design.

PMID:36097942 | DOI:10.3760/cma.j.cn112144-20220302-00087

Zhonghua Kou Qiang Yi Xue Za Zhi. 2022 Sep 9;57(9):927-931. doi: 10.3760/cma.j.cn112144-20220126-00032.

ABSTRACT

Objective: To compare the accuracy and retention of denture bases fabricated by injection molding, milling, and three-dimensional (3D) printing fabricating, in order to provide some references for clinical practice. Methods: A maxillary edentulous jaw model made was used to duplicated 10 working casts. The casts were numbered and scanned. The wax pattern was designed by digital ways and conventional methods and then the denture bases were fabricated by injection molding, milling, and 3D printing. The tissue surface of experimental denture base was obtained using a dental laboratory scanner. The deviation between the tissue surface of the fabricated denture bases and the working model was evaluated. A digital force gauge was used to measure the traction force. Results: The milling group [(0.076±0.026) mm] was more accurate than the 3D printing group [(0.117±0.041) mm] (P<0.05) and the injection group [(0.120± 0.025) mm] (P<0.05). The accuracy of 3D printing group and that of injection group were not statistically significant (P>0.05). The milling group [(9.55±2.44) N] demonstrated greater retentive force than 3D printing group [(5.19±0.06) N] and injection molding group [(1.52±0.52) N] (P<0.05). Conclusions: The denture base fabricated by milling was more accurate and showed the greatest retentive force than the other groups. And 3D printing group showed better retentive force than the injection molding group. Both digital manufacturing methods can meet the requirements of clinical application.

PMID:36097939 | DOI:10.3760/cma.j.cn112144-20220126-00032

Zhonghua Kou Qiang Yi Xue Za Zhi. 2022 Sep 9;57(9):907-913. doi: 10.3760/cma.j.cn112144-20220127-00033.

ABSTRACT

Objective: To compare the treatment effect of distraction osteogenesis (DO) and maxillomandibular advancement (MMA) for severe obstructive sleep apnea hypopnea syndrome (OSAHS) patients and to guide clinical decisions about treatment of OSAHS. Methods: Thirty-seven OSAHS patients which accepted maxillomandibular advancement (MMA) or distraction osteogenesis (DO) in Stomatological Hospital of the Department of Maxillofacial Trauma and Orthognathic Surgery, School of Stomatology, The Forth Military Medical University from June 2017 to June 2019 were collected. Their preoperative and postoperative data of cephalometry, polysomnography (PSG), Pittsburgh sleep quality index (PSQI) and Epworth sleepiness scale (ESS) scores were collected and analyzed. With propensity score matching method, the treatment effect of MMA and DO was analyzed and compared. Results: According to the statistics of MMA group, only AHI was correlated with operative successful rate and cure rate. With the increase of AHI, the treatment effect of MMA on OSAHS patients gradually decreased. The cut-off point of AHI as a predictor of MMA treatment failure was 78.2 n/h. All the matched cases were severe OSAHS patients. Statistical analysis showed that the mandibular elongation of DO patients[(24.00±4.39) mm] was significantly more than that of MMA group [(11.20±1.37) mm] (t=-6.11, P<0.001), the improvement of PSG index [including lowest oxygen saturation (LSpO₂), longest apnea (LA) and longest hypopnea (LH)] in DO group [LSpO₂=(93.40±1.82)%; LA=(18.28±8.32) s; LH=(61.84±32.94) s] was significantly higher than that in the MMA group [LSpO₂=(86.00±4.06)%, LA=(64.08±21.78) s, LH=(172.40±30.70) s](t=-3.72, P=0.005; t=4.39, P=0.003; t=5.49, P=0.004). The PSQI and the ESS scores of DO group (PSQI=4.20±0.83; ESS=3.40±1.52) were also significantly better than that of MMA group (PSQI=8.80±2.39, ESS=9.40±2.88)(t=4.07, P=0.001; t=4.12, P=0.002). Conclusions: For severe OSAHS patients, the objective and subjective indicators of DO treatment group showed a better therapeutic effect than that of MMA.

PMID:36097936 | DOI:10.3760/cma.j.cn112144-20220127-00033

Zhonghua Jie He He Hu Xi Za Zhi. 2022 Sep 12;45(9):894-903. doi: 10.3760/cma.j.cn112147-20220112-00045.

ABSTRACT

Objective: To identify the differentially expressed genes (DEGs) induced by tuberculosis peptide-based vaccine MP3RT in a humanized mouse model using transcriptomics technology. Methods: This study was conducted from August 2019 to February 2022. We used edgeR software to screen DEGs with a fold change greater than or equal to 1.5 and a P value less than 0.05 as screening conditions. Gene ontology (GO), Kyoto encyclopedia of genes and genomes (KEGG), and protein interaction network analyses were performed on the screened DEGs. Then, these DEGs were verified by RT-qPCR and statistically analyzed by GraphPad Prism 8 software. Results: A total of 367 DEGs (214 up-regulated and 153 down-regulated) were identified by transcriptomics. Bioinformatics analysis showed that the GO enrichment of the DEGs mentioned above significantly focused on cell metabolism, growth, apoptosis, inflammation, and other terms. In contrast, the KEGG enrichment significantly focused on inflammatory pathways such as the MAPK signaling pathway. Protein interaction network analysis showed that protein Abl1 had the highest aggregation, the highest aggregation coefficient, and the best connectivity. RT-qPCR results showed that gene expressions of cpne4 (t=2.48, P=0.048 0), h2-q10 (t=2.95, P=0.025 6), mef2c (t=2.87, P=0.028 4), cr2 (t=3.23, P=0.178), ablim1 (t=2.91, P=0.033 5), dll1 (t=2.70, P=0.027 3) and ms4a2 (t=3.03, P=0.019 2) genes in the MP3RT group were significantly up-regulated than those in the PBS group, while gene expressions of cd163l1 (t=2.56, P=0.043 0), il1r1 (t=2.91, P=0.022 7) and cd34 (t=2.42, P=0.046 2) genes in the MP3RT group were significantly down-regulated than those in the PBS group. Conclusions: The MP3RT vaccine induced 367 DEGs in humanized mice, which were associated with metabolic and immune responses. Furthermore, we found that p38 MAPK and JNK/MAPK signaling pathways played an important role in the molecular mechanism of the MP3RT vaccine.

PMID:36097927 | DOI:10.3760/cma.j.cn112147-20220112-00045