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Endocrine ◽  
2021 ◽  
Mariangela Rondanelli ◽  
Simone Perna ◽  
Zahra Ilyas ◽  
Gabriella Peroni ◽  
Philip Bazire ◽  

Abstract Purpose This study aims to evaluate the effects of a VLCKD combined with omega-3 supplementation (VLCKD diet only lasted for some weeks, and it was followed by a non-ketogenic LCD for the rest of the study period) on body composition, visceral fat, satiety hormones, inflammatory and metabolic markers. Methods It has been performed a pilot open label study lasted 90 days, in a cohort of 12 women with class I obesity aged 18 to 65 years. Data on body composition (evaluated by Dual X-Ray Absorptiometry—DXA), visceral fat, satiety hormones, inflammatory and metabolic markers were recorded. Results This study showed a body weight reduction mean difference over time of −13.7 kg and the waist circumference mean difference decrease of −13.3 cm. Also, the fat mass (FM) decreased—9.1 kg and visceral adipose tissue (VAT)—0.41 kg. No effects on fat-free mass (FFM) have been reported. Improvements were observed in the satiety hormones, with increased ghrelin and decreased leptin, and also in the metabolic profiles. Conclusions A VLCKD combined with omega-3 supplementation appears to be an effective strategy for promoting an high loss of FM with preservation of FFM in patients with class I obesity.

2021 ◽  
pp. 036354652110382
Joy C. MacDermid ◽  
Dianne Bryant ◽  
Richard Holtby ◽  
Helen Razmjou ◽  
Kenneth Faber ◽  

Background: Patients with complete rotator cuff tears who fail a course of nonoperative therapy can benefit from surgical repair. Purpose: This randomized trial compared mini-open (MO) versus all-arthroscopic (AA) rotator cuff repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with rotator cuff tears were randomized to undergo MO or AA repair at 9 centers by 23 surgeons. The primary outcome (Western Ontario Rotator Cuff Index [WORC]) and secondary outcomes (American Shoulder and Elbow Surgeons [ASES] score, Shoulder Pain and Disability Index [SPADI] pain subscale, 12-Item Short Form Health Survey [SF-12], reported medication use, adverse events), as well as measurements of range of motion and strength, were collected at 1 month before surgery; at 2 and 6 weeks postoperatively; and at 3, 6, 12, 18, and 24 months postoperatively. A blinded radiologist evaluated rotator cuff integrity on magnetic resonance imaging (MRI) at baseline and 1 year. Intention-to-treat analysis of covariance with the preoperative WORC score, age, and tear size as covariates assessed continuous outcomes. Sex differences were assessed. A meta-analysis synthesized the primary outcome between MO and AA repair with previous trials. Results: From 954 patients screened, 411 were ineligible (276 because of recovery with physical therapy), 449 were screened at surgery (175 ineligible), and 274 completed follow-up (138 MO and 136 AA). The AA and MO groups were similar before surgery. WORC scores improved from 40 preoperatively to 89 (AA) and 93 (MO) at 2 years, for an adjusted mean difference of 3.4 (95% CI, –0.4 to 7.2). There were no statistically significant differences between the AA and MO groups at any time point. All secondary patient-reported outcomes were not significantly different between the MO and AA groups, except the 2-year SPADI pain score (8 vs 12, respectively; P = .02). A similar recovery in range of motion and strength occurred in both groups over time. MRI indicated minimal improvement in muscle relative to fat (AA: n = 3; MO: n = 2), with most worsening (AA: n = 25; MO: n = 24) or remaining unchanged (AA: n = 70; MO: n = 70). Opioid use was significantly reduced after surgery (from 21% to 5%). The meta-analysis indicated no significant standardized mean difference between groups in the primary outcome across all pooled studies (standardized mean difference, –0.06 [95% CI, –0.34 to 0.22]). Conclusion: Both AA and MO rotator cuff repair provide large clinical benefits, with few adverse events. There is strong evidence of equivalent clinical improvements. Trial Registration: NCT00128076.

2021 ◽  
Vol 17 ◽  
Elena Vakali ◽  
Dimitrios Rigopoulos ◽  
Andres E. Carrillo ◽  
Andreas D. Flouris ◽  
Petros C. Dinas

Background: Diabetic nephropathy (DN) is a kidney dysfunction, which occurs due to elevated urine albumin excretion rate and reduced glomerular filtration rate. Studies in animals have shown that alpha-lipoic acid (ALA) supplementation can reduce the development of DN. Objectives: We performed a systematic review and meta-analysis to examine the effects of ALA supplementation on biological indices (albumin, creatinine etc.) indicative of human DN. Methods: The searching procedure included the databases PubMed Central, Embase, Cochrane Library (trials) and Web of Science, (protocol registration: INPLASY 202060095). Results: We found that ALA supplementation decreased urine albumin 24h excretion rate in patients with diabetes [standardized mean difference=-2.27; confidence interval (CI)=(-4.09)–(-0.45); I2=98%; Z=2.44; p=0.01]. A subgroup analysis revealed that the studies examining only ALA, did not differ from those examined ALA in combination with additional medicines (Chi-squared=0.19; p=0.66; I2=0%), while neither ALA nor ALA plus medication had an effect on urine albumin 24h excretion rate (p>0.05). Also, ALA supplementation decreased urine albumin mg/l [mean difference (MD)=-12.95; CI=(-23.88)–(-2.02); I2=44%; Z=2.32; p=0.02] and urine albumin to creatinine ratio [MD=-26.96; CI=(-35.25)–(-18.67); I2=0%; Z=6.37; p<0.01] in patients with diabetes. When the studies that examined ALA plus medication were removed, ALA supplementation had no effect on urine albumin mg/l (p>0.05), but did significantly decrease urine albumin to creatinine ratio [MD=-25.88, CI=(34.40–(-17.36), I2=0%, Z=5.95, p<0.00001]. Conclusion: The available evidence suggests that ALA supplementation does not improve biological indices that reflect DN in humans. Overall, we identified limited evidence and therefore, the outcomes should be considered with caution.

2021 ◽  
Kusum K Rohilla ◽  
C Vasantha Kalyani ◽  
Amit Gupta ◽  
Sweety Gupta ◽  
Manoj Gupta ◽  

Abstract People living with cancer benefit greatly from informal caregivers. There has never been a previous meta-analysis on the quality of life of cancer caregivers or the efficacy of caregiver intervention programmes. The goal of this meta-analysis was to look at the quality of life of cancer caregivers and the impact of various initiatives aimed at improving it. From January 2006 to April 2021, a comprehensive literature search was conducted using PubMed, PubMed Central, Clinical Key, Google Scholar and Cochrane database. The effect of caregiver interventional programs on quality of life was evaluated using a mean difference between experimental and control groups. A random-effect model was used to measure the risk ratio (RR) for calculating the quality of life of cancer caregivers. The final report comprised eight trials with a total of 1142 participants. The caregiver intervention programme was found to improve the quality of life of cancer caregivers, but not statistically significantly (mean difference=0.10; p<0.00001). A caregiver interventional program had a positive effect on the quality of life of cancer caregivers, according to this meta-analysis. To prove that caregiver interventional programs are successful strategies for improving the quality of life of cancer caregivers, further randomised controlled trials are required.

2021 ◽  
pp. 174239532110397
Sungha Kim ◽  
Ying Xu ◽  
Kelly Dore ◽  
Rebecca Gewurtz ◽  
Nadine Larivière ◽  

Objective The aim of this study was to investigate the effectiveness of occupational therapist-/physiotherapist-guided fatigue self-management for individuals with chronic conditions. Methods Eight databases, including MEDLINE and EMBASE, were searched until September 2019 to identify relevant studies. Randomised controlled trials and quasi-experimental studies of self-management interventions specifically developed or delivered by occupational therapists/physiotherapists to improve fatigue symptoms of individuals with chronic conditions were included. A narrative synthesis and meta-analysis were conducted to determine the effectiveness of fatigue self-management. Results Thirty-eight studies were included, and fatigue self-management approaches led by occupational therapists/physiotherapists were divided into six categories based on the intervention focus: exercise, energy conservation, multimodal programmes, activity pacing, cognitive-behavioural therapy, and comprehensive fatigue management. While all exercise programmes reported significant improvement in fatigue, other categories showed both significant improvement and no improvement in fatigue. Meta-analysis yielded a standardised mean difference of the overall 13 studies: 0.42 (95% confidence interval:−0.62 to − 0.21); standardised mean difference of the seven exercise studies was −0.55 (95% confidence interval: −0.78 to −0.31). Discussion Physical exercises inspired by the self-management principles may have positive impacts on fatigue symptoms, quality of life, and other functional abilities.

2021 ◽  
Vol 11 (1) ◽  
Cristan A. Farmer ◽  
Audrey E. Thurm ◽  
Bianca Honnekeri ◽  
Paul Kim ◽  
Susan E. Swedo ◽  

AbstractBrain-derived neurotrophic factor (BDNF), a key peptide in neurocognitive development, has been reported to be elevated in the serum of children with autism spectrum disorder (ASD). In a few studies, however, no differences or the converse have been documented. As a secondary analysis of a natural history study, we examined differences in ELISA serum BDNF between a group of children aged 1 to 9 years (69% white) with ASD (n = 94) and those with typical development (n = 52) or non-ASD developmental delay (n = 21), while accounting for the potential confounding effects of platelet quantity. Platelet counts were measured within 4 h of blood draw using an automated cell counter. Taqman single nucleotide polymorphism (SNP) assays were used to genotype 11 SNPs within the BDNF locus. Unadjusted mean BDNF concentration was higher in children with ASD than in children with typical development (standardized mean difference = 0.23; 95% CI 0.07, 0.38), but not children with non-ASD developmental delay. The magnitude of this difference was reduced after adjusting for platelet count (standardized mean difference = 0.18; 95% CI 0.02, 0.33). Although some BDNF SNPs were related to BDNF concentration, the distributions of these genotypes did not differ across diagnostic groups. This study replicates previous work suggesting that average serum BDNF concentration is higher in ASD compared to typical development, and extends that work by highlighting the potentially confounding role of platelet counts. The etiology of platelet count differences warrants further elucidation. Nonetheless, our results suggest that elevation in BDNF may be partially explained by higher platelet counts in children with ASD, an association that should be considered in future analysis and interpretation.Registration: NCT00298246

2021 ◽  
pp. 1-16
S. Zaki ◽  
J.A. Moiz ◽  
P. Bhati ◽  
G.R. Menon

The study aims to investigate the literature on the effect of high-intensity interval training (HIIT) on cardiac autonomic function in individuals with cardiovascular disease (CVD) and lifestyle disorders. We performed electronic database search from CENTRAL, WoS, Scopus, Pubmed, and PEDro up to 25th February 2021. Randomised control trials/quasi-experimental trials/cross-over trials that assessed the effects of HIIT with control/alternative treatment on cardiac autonomic control were included in this review. A total of 11 studies were included for qualitative analysis and among them, 8 were quantitatively analysed. A random-effect model of standardised mean difference (SMD) and mean difference of the respective outcome measures for cardiac autonomic control was determined. The findings of the qualitative analysis revealed the beneficial effects of HIIT on cardiac autonomic modulation. However, the majority of the studies had an unclear or high risk of bias for randomisation, concealment methods, and blinding of participants to the intervention that could have influenced the interpretation of the findings. The SMD revealed a significant effect of HIIT on standard deviation of N-N intervals (SDNN) (ms) [SMD: 0.40, 95% confidence interval (CI): -0.001 to 0.80, P=0.05], high frequency power (HF) (ms2) [0.46, 95% CI: 0.17 to 0.76, P=0.002], and ratio of low and high frequency power, (LF/HF) [-0.80, 95% CI: -1.27 to -0.33, P=0.0008]. In conclusion, HIIT may effectively modulate cardiac autonomic function by increasing parasympathetic dominance, sympathetic withdrawal, and sympathovagal balance in individuals with CVD and lifestyle disorders. The study has a PROSPERO registration number: CRD42021231225

2021 ◽  
pp. 159101992110399
Daizo Ishii ◽  
Mario Zanaty ◽  
Jorge A Roa ◽  
Luyuan Li ◽  
Yongjun Lu ◽  

Objective Post operative cognitive dysfunction (POCD) has been widely observed after major surgery, particularly in elderly patients with general anesthesia (GA). However, a specific unanswered question is whether different approaches to anesthetic managements are associated with different cognitive outcomes after endovascular treatments for unruptured intracranial aneurysms (UIAs). The purpose of this study is to assess the correlation of POCD with GA versus monitored anesthesia care (MAC). Methods We performed a pragmatic, prospective study to assess the association between different anesthetic approaches and POCD. We compared the pre- and post-procedural Montreal Cognitive Assessment (MoCA) scores in patients with normal cognition who underwent treatments of UIAs with various endovascular methods, using either GA or MAC. Results A total of 23 patients with UIAs were enrolled in the study. Seven (30.4%) and sixteen (69.6%) UIAs were treated without perioperative complications under GA or MAC, respectively. There was a significant decline in the post-procedural MoCA score under GA (mean difference  =  1.14; 95% confidence interval  =  [0.42–1.87], P < 0.01). By contrast, there was no significant difference of MoCA score between pre- and post-procedure under MAC (mean difference  =  0.19; 95% confidence interval  =  [−0.29–0.67], P  =  0.59). Conclusions Treating UIAs using MAC was associated with a decrease in POCD as compared to GA in patients undergoing endovascular treatments for UIAs with normal cognition. Larger randomized studies are needed to confirm these findings.

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Janhavi Sandeep Khandekar ◽  
Vanamala Lakshmi Vasavi ◽  
Vijay Pratap Singh ◽  
Stephen Rajan Samuel ◽  
S. G. Sudhan ◽  

Introduction. Prehypertension is a precursor for developing hypertension and is a risk factor for cardiovascular diseases. Yoga therapy may have a role in lowering the blood pressures in prehypertension and hypertension. This systematic review aims to synthesize the available literature for the same. Methodology. Databases such as PubMed, Embase, Scopus, and Web of Science were searched for randomised control trials only in the time duration of 2010–2021. The main outcome of interest was systolic and diastolic blood pressures. Articles were screened based on the inclusion criteria, and 8 articles were recruited for the review. Meta-analysis was done for suitable articles. RevMan 5.4 by Cochrane was used for meta-analysis and forest plot construction. Risk of bias was determined using the Downs and Black checklist by three independent authors. Results. The meta-analysis of the articles favoured yoga intervention over the control intervention. Yoga therapy had significantly reduced the systolic pressure (−0.62 standard mean difference, at IV fixed 95% CI: −0.83, −0.41) and diastolic pressure (−0.81 standard mean difference, at IV random 95% CI: −1.39, −0.22). Secondary outcome measures studied were heart rate, weight, BMI, waist circumference, and lipid profile. The main protocol of yoga therapy included postures, breathing exercises, and different meditation techniques. A significant reduction in secondary outcomes was observed, except for HDL values in lipid profile which showed a gradual increase in yoga group in comparison with alternative therapy. Conclusion. Yoga therapy has shown to be significant in the reduction of systolic and diastolic pressure in prehypertensive population. Supporting evidence lacks in providing a proper structured dosage of yoga asanas and breathing techniques. Considering the existing literature and evidence, Yoga therapy can be used and recommended in prehypertensive population and can be beneficial in reducing the chances of developing hypertension or cardiovascular diseases.

2021 ◽  
Vol 21 (1) ◽  
Amina Acherkouk ◽  
Nisha Patel ◽  
Andrew Butler ◽  
Pejmon Amini

Abstract Background This examiner-blind, stratified, parallel study aimed to evaluate the anti-gingivitis efficacy of a non-aqueous (anhydrous) 0.454% w/w stannous fluoride toothpaste (‘Test’) versus a sodium monofluorophosphate toothpaste (‘Control’) in people with clinically-confirmed mild-moderate gingivitis. Plaque-induced gingivitis can progress to irreversible periodontitis if left untreated. This can be controlled by an effective oral hygiene regimen such as one including toothbrushing with a toothpaste containing the chemotherapeutic agent stannous fluoride. Long-term studies over 4–12 weeks have shown the efficacy of stannous fluoride; however, shorter term studies are needed to examine if the effects on measures of gingivitis and plaque control occur sooner. Methods Eligible participants were randomised to 3 weeks’ twice-daily brushing (for 1 min) with Test or Control toothpastes. The primary efficacy variable was between-treatment difference in Bleeding Index (BI) at 3 weeks; secondary variables were between-treatment differences in number of bleeding sites, modified Gingival Index (MGI), and Turesky modification of the Quigley–Hein Plaque Index (TPI) at Weeks 2 and 3. Results A statistically significant (p < 0.0001) lower BI score was reported for Test (n = 65) versus Control (n = 65) groups at Week 2 (mean difference: − 0.07 [95% CI − 0.9, − 0.05]; 32.7% difference) and Week 3 (mean difference: − 0.06 [95% CI − 0.8, − 0.04]; 29.2% difference). The Test group also demonstrated statistically significant lower (all p < 0.0001 versus Control) number of bleeding sites (Weeks 2/3 mean difference [95% CI]: − 10.04 [− 12.3, − 7.5]/ − 8.2 [− 11.1, − 5.3] sites; 33.0%/29.3% difference); MGI score (Weeks 2/3 mean difference [95% CI]: − 0.09 [− 0.13, − 0.06]/ − 0.10 [− 0.14, − 0.06]; 4.3%/4.7% difference); overall TPI score (Weeks 2/3 mean difference [95% CI]: − 0.45 [− 0.55, − 0.35/ − 0.42 [− 0.53, − 0.30] difference; 16.0%/15.1% difference) and interproximal TPI score (Weeks 2/3 mean difference [95% CI]: − 0.42 [− 0.52, − 0.30]/ − 0.41 [− 0.52, − 0.29]; 14.6%/14.1% difference). Both toothpastes were generally well tolerated. Conclusion Three weeks’ twice-daily brushing with the 0.454% w/w stannous fluoride Test toothpaste compared to the Control toothpaste led to statistically significant lower gingival bleeding, gingival inflammation and plaque levels in adults with mild-moderate gingivitis. These results indicate that plaque and gingivitis-reducing benefits of 0.454% w/w stannous fluoride may be seen from 2 weeks’ use. Trial registration Identifier: NCT04050722; 08/08/2019.

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