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Dietary supplements for aggressive behaviour in people with intellectual disabilities: A randomised controlled crossover trial.
Gast, DAA, Didden, R, Westera, JJ, van de Rest, O, van Hemert, AM, Giltay, EJ
Journal of applied research in intellectual disabilities : JARID. 2023;(1):122-131
Abstract
BACKGROUND Aggressive incidents are common in people with intellectual disabilities. Therefore, we aimed to assess whether supplementation of multivitamins, minerals, and omega-3 fatty acids (FA) reduces aggressive incidents. METHODS We conducted a randomised, triple blind, placebo controlled, single crossover intervention trial. People with intellectual disabilities or borderline intellectual functioning, between 12 and 40 years of age, and showing aggressive behaviour were included. Participants received either a daily dose of dietary supplements, or placebo. Primary outcome was the number of aggressive incidents, measured using the Modified Overt Aggression Scale (MOAS). RESULTS there were 113 participants (placebo, n = 56), of whom 24 (placebo, n = 10) participated in the crossover phase of the trial. All 137 trajectories were included in the analyses. There was no significant difference in mean number of aggressive incidents per day between those assigned to supplements and those who received placebo (rate ratio = 0.93: 95% Confidence Interval [CI] = 0.59-1.45). CONCLUSION In this pragmatic trial, we did not find significant differences in the outcomes between the supplement and placebo arms. The COVID-19 pandemic started midway through our trial, this may have affected the results.
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Clinical efficacy of Jingyin granules, a Chinese patent medicine, in treating patients infected with coronavirus disease 2019.
Chen, B, Yu, X, Zhang, L, Huang, W, Lyu, H, Xu, Y, Shen, J, Yuan, W, Fang, M, Li, M, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2023;:154496
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BACKGROUND Jingyin granules (JY), one patented Chinese herbal formula, have been advised for treating coronavirus disease 2019 (COVID-19) in China. As of now, the safety and effectiveness of JY in treating COVID-19 patients were still to be evaluated. PURPOSE To investigate the safety and clinical effectiveness of JY in treating mild COVID-19 patients. STUDY DESIGN We carried out a prospective cohort study, as the highly infectious COVID-19 omicron variant ranged in Shanghai (ClinicalTrial.gov registration number: ChiCTR2200058692). METHODS Participants infected with COVID-19, who were diagnosed as mild cases, were assigned to receive either JY (JY group) or traditional Chinese medicine placebo (placebo group) orally for 7 days. The primary clinical indicators were the RNA negative conversion rate (NCR) and the incidence of severe cases. The secondary clinical indicators were the negative conversion time (NCT), inpatient length of stay (ILOS), and the disappearance rates of clinical symptoms. RESULTS Nine hundred participants were recruited in this clinical trial study, and 830 patients met the eligibility criteria. Seven hundred and ninety-one patients, accomplished the following-up assessment, including 423 cases of JY group and 368 cases of placebo group. NCR in JY group at 7-day posttreatment was considerably greater compared with placebo group (89.8% [380/423] vs 82.6% [304/368], P = 0.003). None of the patients with mild COVID-19 developed into severe cases. The median NCT of SARS-CoV-2 and ILOS in JY group were lesser than that in placebo group (4.0 [3.0,6.0]vs 5.0 [4.0,7.0] days, P < 0.001; 6.0 [4.0, 8.0] vs 7.0 [5.0, 9.0] days, P < 0.001). In both groups, the obvious improvement in clinical symptoms was observed, but the difference was not significant. In the subgroup of age ≤ 60 years, JY promoted SARS-CoV-2 RNA negative conversion (HR=1.242; 95% CI: 1.069-1.444, P < 0.001). No patients in both groups were reported as the case of serious adverse event. CONCLUSION JY maybe the potential medicine for treating mild COVID-19 patients, which had beneficial effects on increasing NCR, and shortening NCT and ILOS.
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Efficacy and safety of Reyanning mixture in patients infected with SARS-CoV-2 Omicron variant: A prospective, open-label, randomized controlled trial.
Xu, X, Zhou, S, Chen, C, Li, J, Wu, H, Jin, G, Zhou, J, Wang, G, Cao, M, Sun, D, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2023;:154514
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BACKGROUND A wave of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant rapidly resulted in a steep increase in the infected population and an overloaded healthcare system. Effective medications for Omicron are currently limited. The previous observational study supports the efficacy and safety of Reyanning (RYN) mixture in the treatment of coronavirus disease 2019 (COVID-19). PURPOSE To evaluate the efficacy of RYN in asymptomatic and mildly infected patients with SARS-CoV-2 infection. STUDY DESIGN AND METHODS This study was a prospective, open-label, randomized controlled trial. We consecutively recruited 2830 patients from Shanghai New International Expo Center mobile cabin hospital and randomized them in a 1:1 ratio to receive RYN plus standard care or receive standard care alone. The primary outcomes were the negative conversion of nucleic acid. Secondary outcomes included the hospital duration, new-onset symptoms, proportion of disease progression, and the viral load measured by the cycle threshold (Ct) value. RESULTS A total of 1393 patients in the intervention group and 1407 patients in the control group completed the study. The negative conversion time of nucleic acid was significantly shortened in the intervention group (median: 6 d vs. 7 d, Hazard ratio: 0.768, 95CI %: 0.713-0.828, p < 0.0001). The negative conversion rate of nucleic acid was significantly higher in the intervention group (Day 3: 32.4% vs. 18.3%; Day7: 65.3% vs. 55.2%, p < 0.001). The hospitalization duration was significantly shortened in the intervention group (median: 8 d vs. 9 d, Hazard ratio: 0.759, 95% CI: 0.704-0.818, p < 0.0001). The proportion of new-onset fever (2.4% vs. 4.1%, p = 0.012), coughing (12.2% vs. 14.8%, p = 0.046), and expectoration (6.0% vs. 8.0%, p = 0.032) in the intervention group was significantly lower. RYN treatment increased Ct values and reduced the viral load. No disease progression and serious adverse events were reported during the study. CONCLUSION RYN is a safe and effective treatment that can accelerate virus clearance and promote disease recovery in asymptomatic and mild Omicron infections.
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A nutritional web-based approach in obesity and diabetes before and during the COVID-19 lockdown.
Fraticelli, F, Nicola, MD, Vitacolonna, E
Journal of telemedicine and telecare. 2023;(2):91-102
Abstract
INTRODUCTION Obesity and type 2 diabetes (T2D) are two closely related pandemic conditions. Novel technologies represent promising tools for their management, the use of which has been greatly encouraged during the COVID-19 pandemic. The aim of the present study is to compare a web-based nutritional intervention versus a traditional one, before and during the Italian 'lockdown' period due to the COVID-19 outbreak, in overweight and obese subjects affected by T2D or impaired glucose regulation (IGR). METHODS For the study, 36 subjects were randomly allocated into two arms: a traditional arm, providing face-to-face individual and group-based intervention; and a web arm, deploying the in-presence traditional approach with intervention provided through web technologies. The outcomes were the data resulting from the comparison between the subjects' anthropometric and clinical parameters as well as PREDIMED scores at baseline with those at 3 months (T3), 6 months (T6) and at lockdown. RESULTS In the web arm we detected a progressive reduction in weight and body mass index (BMI) from baseline to T6 and a minimal increase of both parameters during the lockdown. Improvement of these parameters compared with baseline was observed in controls during the lockdown. The PREDIMED score improved at T6 compared with baseline in both arms. Significant variations were observed considering weight (p < 0.001), BMI (p = 0.001) and PREDIMED scores (p = 0.023) over time. DISCUSSION The study showed the effectiveness and feasibility of a short-term nutritional web-based intervention in patients affected by T2D or IGR before and during the COVID 19 pandemic.Clinical Trial registration number: NCT04386200, ClinicalTrials.gov.
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Efficacy and Safety of the Adjuvant Use of Probiotic Bacillus clausii Strains in Pediatric Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study.
Vázquez-Frias, R, Consuelo-Sánchez, A, Acosta-Rodríguez-Bueno, CP, Blanco-Montero, A, Robles, DC, Cohen, V, Márquez, D, Perez, M
Paediatric drugs. 2023;(1):115-126
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OBJECTIVES Current irritable bowel syndrome (IBS) treatments have limited efficacy and probiotics like Bacillus clausii (B. clausii) were found to be effective in the management of several gastrointestinal disorders. This phase III trial assessed the efficacy and safety of adding B. clausii (four strains: O/C, N/R, SIN, T), versus placebo, to conventional treatment of pediatric IBS in Mexico. METHODS Patients aged 6-17 years 11 months with IBS (Rome IV) for at least 2 months were randomized to receive either B. clausii (oral suspension, total dose 4 billion spores/day) or placebo once daily for 8 weeks. All patients also received conventional treatment. The primary endpoint was the difference in the proportion of patients with clinical improvements at Week 8 (Global Assessment Questions [GAQ]). Secondary endpoints included responders by Subject's Global Assessment of Relief for Children with IBS (SGARC); number/consistency of stools; abdominal distention/bloating; abdominal pain/intensity; and IBS behavior. RESULTS 73.6% (95% confidence interval [CI] 67.3-80.0; B. clausii n = 129) and 78.5% (95% CI 72.5-84.4; placebo n = 130) of patients had symptom improvement (p = 0.8182). For Week 8 SGARC, 19.2% (B. clausii) and 20.9% (placebo) reported complete symptom relief. Stool evaluations, bloating, abdominal pain/intensity, and IBS behavior were similar between groups. Both treatments were well tolerated. CONCLUSION No significant differences in efficacy between B. clausii and placebo were demonstrated in addition to conventional treatment. The sample size calculation was based on an expected placebo/conventional treatment response of 30-40%. However, the actual treatment response observed was 80% and, thus, a study with larger population would be warranted. In addition, this study was conducted during the COVID-19 pandemic, when such controlled social conditions may have resulted in better diet, greater family stability, less psychological stress, and lower risk of infections exacerbating IBS, thereby improving symptoms in both groups. EUDRACT NUMBER 2018-004519-31.
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Efficacy of an adjuvant non-face-to-face multimodal lifestyle modification program for patients with treatment-resistant major depression: A randomized controlled trial.
Garcia, A, Yáñez, AM, Bennasar-Veny, M, Navarro, C, Salva, J, Ibarra, O, Gomez-Juanes, R, Serrano-Ripoll, MJ, Oliván, B, Gili, M, et al
Psychiatry research. 2023;:114975
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BACKGROUND The high prevalence of depression is partly attributable to the poor response of patients to first-line antidepressants. Multimodal programs that promote a healthy lifestyle are successful in treating depression when used as a complementary therapy, but their medium- and long-term benefits have not been demonstrated for patients with treatment-resistant depression (TRD). The main aim of this study was to compare the effectiveness of a lifestyle modification program (LMP) with mindfulness-based cognitive therapy (MBCT) and a placebo-control (written suggestions for lifestyle changes) in Spanish patients with TRD. METHODS This controlled clinical trial randomized 94 patients with TRD into 3 arms. The primary outcome was the Beck Depression Inventory-II (BDI-II) score at baseline, 2, 6 and 12 months. The secondary outcomes were changes in scores that evaluated quality-of-life, adherence to the Mediterranean diet, physical activity, and social support. RESULTS Relative to the placebo group, the LMP and MBCT groups had significantly better quality of life (p = 0.017; p = 0.027), and the LMP group had significantly better adherence to the Mediterranean diet (p<0.001) and reduced use of antidepressants (p = 0.036). However, the three groups showed no significant differences in BDI-II score. LIMITATIONS Only about half of the planned 180 patients were recruited, in part due to the COVID-19 pandemic. CONCLUSIONS There was no evidence that the LMP treatment significantly reduced symptoms of depression relative to the other groups during the COVID-19 lockdown.
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Phase III, Randomized, Double-blind, Placebo controlled trial of Efficacy, Safety and Tolerability of Antiviral drug Umifenovir vs Standard care of therapy in non-severe COVID-19 patients.
Ramachandran, R, Bhosale, V, Reddy, H, Atam, V, Faridi, M, Fatima, J, Shukla, V, Khan, ZA, Khan, H, Singh, V, et al
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases. 2022;:62-69
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OBJECTIVE To test efficacy, safety and tolerability of Umifenovir in non-severe COVID-19 adult patients. METHODS We carried out randomized, double-blind, placebo-controlled, multicenter, phase III trials involving adult (18-75 years), non-severe COVID19 patients, randomized 1:1 on placebo or Umifenovir (800 mg BID, maximum 14 days) respectively along with standard-of-care. The primary endpoint for Asymptotic-mild patients was time to nasopharyngeal swab RT-PCR test negativity. For Moderate patients, the average change in the ordinal scale from the baseline scores on the eight-point WHO ordinal scale was assessed. RESULTS 132 patients were recruited between 3rd October to 28th April 2021, of which 9 discontinued due to various reasons. In Mild-asymptomatic patients (n=82), we found that 73% patients in the Umifenovir arm were RT-PCR negative, while 40% patients in the placebo arm were negative (P=0.004) on day 5. However, in the moderate group (n=41), the WHO scores for the Umifenovir arm was not statistically significant (P=0.125 on day 3), while it was statistically significant in the Mild-asymptomatic group (P=0.019 on day 5). CONCLUSION Umifenovir meets the primary and secondary endpoint criteria and exhibits statistically significant efficacy for Mild-asymptomatic patients. It is efficacious, safe and well-tolerated at the tested dosage of 800mg BID, maximum 14 days.
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Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes: A Randomized Clinical Trial.
Tandon, N, Gupta, Y, Kapoor, D, Lakshmi, JK, Praveen, D, Bhattacharya, A, Billot, L, Naheed, A, de Silva, A, Gupta, I, et al
JAMA network open. 2022;(3):e220773
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IMPORTANCE Women with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes. OBJECTIVE To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia. DESIGN, SETTING, AND PARTICIPANTS This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021. Data were analyzed from April to July 2021. INTERVENTIONS A 12-month lifestyle intervention focused on diet and physical activity involving group and individual sessions, as well as remote engagement, adapted to local context and resources. This was compared with usual care. MAIN OUTCOMES AND MEASURES The primary outcome was worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes. The primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, which occurred at varying times after 12 months for each patient. Secondary outcomes included new-onset type 2 diabetes and change in body weight. RESULTS A total of 1823 women (baseline mean [SD] age, 30.9 [4.9] years and mean [SD] body mass index, 26.6 [4.6]) underwent OGTT at a median (IQR) 6.5 (4.8-8.2) months postpartum. After excluding 160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized. Subsequently, 11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care). These included 600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia. Among participants randomized to the intervention, 644 women (80.5%) received all program content, although COVID-19 lockdowns impacted the delivery model (ie, among 644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely). After a median (IQR) 14.1 (11.4-20.1) months of follow-up, 1308 participants (81.2%) had primary outcome data. The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome. CONCLUSIONS AND RELEVANCE This study found that a large proportion of women in South Asian urban settings developed dysglycemia soon after a GDM-affected pregnancy and that a lifestyle intervention, modified owing to the COVID-19 pandemic, did not prevent subsequent glycemic deterioration. These findings suggest that alternate or additional approaches are needed, especially among high-risk individuals. TRIAL REGISTRATION Clinical Trials Registry of India Identifier: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry Identifier: SLCTR/2017/001; and ClinicalTrials.gov Identifier: NCT03305939.
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Equipment-free, unsupervised high intensity interval training elicits significant improvements in the physiological resilience of older adults.
Sian, TS, Inns, TB, Gates, A, Doleman, B, Bass, JJ, Atherton, PJ, Lund, JN, Phillips, BE
BMC geriatrics. 2022;(1):529
Abstract
BACKGROUND Reduced cardiorespiratory fitness (CRF) is an independent risk factor for dependency, cognitive impairment and premature mortality. High-intensity interval training (HIIT) is a proven time-efficient stimulus for improving both CRF and other facets of cardiometabolic health also known to decline with advancing age. However, the efficacy of equipment-free, unsupervised HIIT to improve the physiological resilience of older adults is not known. METHODS Thirty independent, community-dwelling older adults (71(SD: 5) years) were randomised to 4 weeks (12 sessions) equipment-free, supervised (in the laboratory (L-HIIT)) or unsupervised (at home (H-HIIT)) HIIT, or a no-intervention control (CON). HIIT involved 5, 1-minute intervals of a bodyweight exercise each interspersed with 90-seconds recovery. CRF, exercise tolerance, blood pressure (BP), body composition, muscle architecture, circulating lipids and glucose tolerance were assessed at baseline and after the intervention period. RESULTS When compared to the control group, both HIIT protocols improved the primary outcome of CRF ((via anaerobic threshold) mean difference, L-HIIT: +2.27, H-HIIT: +2.29, both p < 0.01) in addition to exercise tolerance, systolic BP, total cholesterol, non-HDL cholesterol and m. vastus lateralis pennation angle, to the same extent. There was no improvement in these parameters in CON. There was no change in diastolic BP, glucose tolerance, whole-body composition or HDL cholesterol in any of the groups. CONCLUSIONS This is the first study to show that short-term, time-efficient, equipment-free, HIIT is able to elicit improvements in the CRF of older adults irrespective of supervision status. Unsupervised HIIT may offer a novel approach to improve the physiological resilience of older adults, combating age-associated physiological decline, the rise of inactivity and the additional challenges currently posed by the COVID-19 pandemic. TRIAL REGISTRATION This study was registered at clinicaltrials.gov and coded: NCT03473990 .
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Effects of Sedentary Behavior Interventions on Mental Well-Being and Work Performance While Working from Home during the COVID-19 Pandemic: A Pilot Randomized Controlled Trial.
Falk, GE, Mailey, EL, Okut, H, Rosenkranz, SK, Rosenkranz, RR, Montney, JL, Ablah, E
International journal of environmental research and public health. 2022;(11)
Abstract
Sedentary behavior negatively impacts mental health, which can decrease employee productivity. Employee mental well-being and work performance may improve with sedentary reduction interventions, especially strategies that include environmental workplace modifications and behavior-changing strategies. However, such interventions have not been examined among employees working remotely during the COVID-19 pandemic. As part of the Stand Up Kansas program, 95 sedentary university employees working from home were randomized into one of four intervention arms: height-adjustable desk provision (Desk Only), online sedentary behavior modification program (Program Only), Desk + Program, or Control. The outcomes were measured at a baseline (November 2020) and following the 12-week intervention (February 2021). Employees reported mood (positive and negative affect), stress, fatigue (duration, interference with activities and severity) and work performance (irritability, focus, work satisfaction, non-work satisfaction and productivity) were measured using established self-report instruments. The effect sizes, by comparing the Control arm to the Desk + Program arm, revealed large improvements in mood (positive affect, d = 1.106). Moderate improvements were also seen in fatigue (duration, d = -0.533, and interference with activities, d = -0.648) and several aspects of work performance (focus, d = 0.702, work satisfaction, d = 0.751, and productivity, d = 0.572). Moderate effect sizes were also seen for positive affect (d = 0.566) and fatigue severity (d = 0.577) among the Program Only arm, whereas no noteworthy effect sizes were observed among the Desk Only arm. Combining an online sedentary behavior modification program with height-adjustable desk provisions appeared to positively affect mental well-being and work performance among remote employees.
