Beneficial effect of Burdock complex on asymptomatic Helicobacter pylori‐infected subjects: A randomized,double‐blind placebo‐controlled clinical trial

Background

Burdock complex (BC) constitutes of burdock (Arctium lappa), angelica (Angelica sinensis), gromwell (Lithospermum erythrorhizon), and sesame (Sesamum indicum) oil, which are commonly used in traditional Chinese medicine (TCM) for treating various disorders. This study intended to examine the anti‐H. pylori activity of BC on AGS cell model as well as in asymptomatic H. pylori‐infected subjects.

Materials and Methods

AGS cell incubated with H. pylori and treated with BC to evaluate the minimum inhibition concentration (MIC), cell viability (MTT) anti‐adhesion activity, and inflammatory markers. In case of clinical trial, H. pylori‐positive subjects (urea breath test [UBT] >10%, n = 36) were enrolled and requested to intake BC (n = 19) or placebo (n = 17) for 8 weeks. Antioxidant capacity, total phenol, UBT, inflammatory markers were analyzed at the initial, 4th, 8th, and 10th weeks. Moreover, the endoscopic examination was carried out on baseline and 10th week.

Results

In vitro studies showed that BC treatment significantly inhibited (P < .05) the inflammatory markers and adhesion of H. pylori to AGS cell. However, H. pylori‐infected subject ingested with BC for 8 weeks significantly decreased (P < .05) the UBT value, inflammatory markers with improved antioxidant activity, and phenolic levels as compared to placebo. Also, consumption of BC considerably healed the ulcer wound.

Conclusion

Overall, the BC could attenuate H. pylori infection by inhibiting H. pylori adhesion and subsequent inflammatory response on the gastric epithelial cell (AGS) as well as clinically ameliorated UBT, antioxidant capacity, and alleviated inflammation to display its anti‐H. pylori activity.     

A natural fiber complex reduces body weight in the overweight and obese: A double‐blind,randomized, placebo‐controlled study

Objective:

A proprietary natural fiber complex (Litramine IQP G‐002AS) derived from Opuntia ficus‐indica, and standardized on lipophilic activity, was previously shown in preclinical and human studies to reduce dietary fat absorption through gastrointestinal (GI) fat binding. Here, we investigated the efficacy and safety of IQP G‐002AS in body weight reduction.

Design and Methods:

One hundred twenty‐five overweight and obese adults participated in the study. Subjects were advised on physical activity, and received nutritional counseling, including hypocaloric diet plans (30% energy from fat and 500 kcal deficit/day). After a 2‐week placebo run‐in phase, subjects were randomized to receive either 3 g/day of IQP G‐002AS (IQ) or a placebo. The primary endpoint was change in body weight from baseline; secondary endpoints included additional obesity measures and safety parameters.

Results:

One hundred twenty‐three subjects completed the 12‐week treatment phase (intention‐to‐treat (ITT) population: 30 male and 93 female; mean BMI: 29.6 ± 2.8 kg/m² and age: 45.4 ± 11.3 years). The mean body weight change from baseline was 3.8 ± 1.8 kg in IQ vs. 1.4 ± 2.6 kg in placebo (P < 0.001). More IQ subjects lost at least 5% of their initial body weight compared to placebo (P = 0.027). Compared with placebo, IQ also showed significantly greater reduction in BMI, body fat composition, and waist circumference. IQ was well tolerated with no adverse reactions reported.

Conclusions:

These results suggest that the natural fiber complex Litramine IQP G‐002AS is effective in promoting weight loss.     

Effects of crocin in reducing DNA damage,inflammation, and oxidative stress in multiple sclerosis patients: A double‐blind,randomized, and placebo‐controlled trial

Multiple sclerosis (MS) is an autoimmune disease in which the immune system attacks the nerve cells, resulting in neurological disorders. Oxidative stress, free radicals, and neuritis have important roles in MS pathogenesis. Here, we aim to evaluate the effect of crocin on inflammatory markers, oxidative damage, and deoxyribonucleic acid (DNA) damage in the blood of patients with MS. A total of 40 patients were divided into two groups, drug and placebo‐treated groups, using random assignment. Participants of the intervention and control groups received two crocin capsules or placebo per day for 28 days, respectively. Findings revealed a significant decrease in the level of important pathogenic factors in MS, including lipid peroxidation, DNA damage, tumor necrosis factor‐alpha, and interleukin 17 as well as a significant increase in the total antioxidant capacity in the serum of patients treated with crocin compared with the placebo group. Our results suggest the beneficial and therapeutic effects of crocin in MS.     

Short‐term side effects of 0.2% alcohol‐free chlorhexidine mouthrinse in geriatric patients: a randomized,double‐blind,placebo‐controlled study

doi: 10.1111/j.1741‐2358.2012.00671.x Short‐term side effects of 0.2% alcohol‐free chlorhexidine mouthrinse in geriatric patients: a randomized, double‐blind, placebo‐controlled study Objective: To determine the effects of a 0.2% alcohol‐free chlorhexidine mouthwash applied twice a day during 30 days in patients over 65 years of age. Materials and methods: A randomized, double‐blind, placebo‐controlled study was made of 70 denture wearers over 65 years of age. The study subjects were randomly assigned to one of the two groups (chlorhexidine or placebo). The patients were instructed to complete a first whitening phase with a duration of 1 week, followed by a 30‐day treatment period. The following data were collected: Silness and Löe plaque index, gingival index, the number of colony‐forming units of Candida albicans at the start and end of treatment and the possible adverse effects of chlorhexidine. Results: Significant differences were observed in the evolution of the Silness and Löe plaque index and gingival index in the two groups, as well as in the number of colony‐forming units of C. albicans between the start and end of treatment. Conclusions: These results suggest that the clinical benefits of antiplaque, antigingivitis mouthrinses in both study groups.     

Experimental chronic low‐frequency resistance training produces skeletal muscle hypertrophy in the absence of muscle damage and metabolic stress markers

Volitional animal resistance training constitutes an important approach to modeling human resistance training. However, the lack of standardization protocol poses a frequent impediment to the production of skeletal muscle hypertrophy and the study of related physiological variables (i.e., cellular damage/inflammation or metabolic stress). Therefore, the purposes of the present study were: (1) to test whether a long‐term and low frequency experimental resistance training program is capable of producing absolute increases in muscle mass; (2) to examine whether cellular damage/inflammation or metabolic stress is involved in the process of hypertrophy. In order to test this hypothesis, animals were assigned to a sedentary control (C, n = 8) or a resistance trained group (RT, n = 7). Trained rats performed 2 exercise sessions per week (16 repetitions per day) during 12 weeks. Our results demonstrated that the resistance training strategy employed was capable of producing absolute mass gain in both soleus and plantaris muscles (12%, p < 0.05). Furthermore, muscle tumor necrosis factor (TNF‐α) protein expression (soleus muscle) was reduced by 24% (p < 0.01) in trained group when compared to sedentary one. Finally, serum creatine kinase (CK) activity and serum lactate concentrations were not affected in either group. Such information may have practical applications if reproduced in situations where skeletal muscle hypertrophy is desired but high mechanical stimuli of skeletal muscle and inflammation are not. Copyright © 2010 John Wiley & Sons, Ltd.     

High-dose versus standard-dose vitamin D supplementation in older adults with COVID-19 (COVIT-TRIAL): A multicenter,open-label,randomized controlled superiority trial

BackgroundVitamin D supplementation has been proposed as a treatment for Coronavirus Disease 2019 (COVID-19) based on experimental data and data from small and uncontrolled observational studies. The COvid19 and VITamin d TRIAL (COVIT-TRIAL) study was conducted to test whether a single oral high dose of cholecalciferol (vitamin D3) administered within 72 hours after the diagnosis of COVID-19 improves, compared to standard-dose cholecalciferol, the 14-day overall survival among at-risk older adults infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).Methods and findingsThis multicenter, randomized, controlled, open-label, superiority trial involved collaboration of 9 medical centers in France. Patients admitted to the hospital units or living in nursing homes adjacent to the investigator centers were eligible if they were ≥65 years, had SARS-CoV-2 infection of less than 3 days, and at least 1 COVID-19 worsening risk factor (among age ≥75 years, SpO2 ≤94%, or PaO₂/FiO₂ ≤300 mm Hg). Main noninclusion criteria were organ failure requiring ICU, SpO2 ≤92% despite 5 L/min oxygen, life expectancy <3 months, vitamin D supplementation >800 IU/day during the preceding month, and contraindications to vitamin D supplements. Eligible and consenting patients were randomly allocated to either a single oral high-dose (400,000 IU) or standard-dose (50,000 IU) cholecalciferol administered under medical supervision within 72 hours after the diagnosis of COVID-19. Participants and local study staff were not masked to the allocated treatment, but the Steering Committee and the Data and Safety Monitoring Board were masked to the randomization group and outcome data during the trial. The primary outcome was 14-day overall mortality. Between April 15 and December 17, 2020, of 1,207 patients who were assessed for eligibility in the COVIT-TRIAL study, 254 met eligibility criteria and formed the intention-to-treat population. The median age was 88 (IQR, 82 to 92) years, and 148 patients (58%) were women. Overall, 8 (6%) of 127 patients allocated to high-dose cholecalciferol, and 14 (11%) of 127 patients allocated to standard-dose cholecalciferol died within 14 days (adjusted hazard ratio = 0.39 [95% confidence interval [CI], 0.16 to 0.99], P = 0.049, after controlling for randomization strata [i.e., age, oxygen requirement, hospitalization, use of antibiotics, anti-infective drugs, and/or corticosteroids] and baseline imbalances in important prognostic factors [i.e., sex, ongoing cancers, profuse diarrhea, and delirium at baseline]). The number needed to treat for one person to benefit (NNTB) was 21 [NNTB 9 to ∞ to number needed to treat for one person to harm (NNTH) 46]. Apparent benefits were also found on 14-day mortality due to COVID-19 (7 (6%) deaths in high-dose group and 14 (11%) deaths in standard-dose group; adjusted hazard ratio = 0.33 [95% CI, 0.12 to 0.86], P = 0.02). The protective effect of the single oral high-dose administration was not sustained at 28 days (19 (15%) deaths in high-dose group and 21 (17%) deaths in standard-dose group; adjusted hazard ratio = 0.70 [95% CI, 0.36 to 1.36], P = 0.29). High-dose cholecalciferol did not result in more frequent adverse effects compared to the standard dose. The open-label design and limited study power are the main limitations of the study.ConclusionsIn this randomized controlled trial (RCT), we observed that the early administration of high-dose versus standard-dose vitamin D3 to at-risk older patients with COVID-19 improved overall mortality at day 14. The effect was no longer observed after 28 days.Trial registrationClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT04344041","term_id":"NCT04344041"}}NCT04344041.

In a randomized trial, Cedric Annweiler and colleagues evaluate whether a single high dose of vitamin D3 improves survival among older adults in France with SARS-CoV-2 infection.     

Time-restricted eating and exercise training improve HbA1c and body composition in women with overweight/obesity: A randomized controlled trial

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Cross training effects of non-paralytic dorsiflexion muscle strengthening exercise on paralytic dorsiflexor muscle activity,gait ability,and balancing ability in patients with chronic stroke: A randomized,controlled, pilot trial

Objective:To investigate the effects of non-paralytic dorsiflexion muscle strengthening exercise on functional abilities in chronic hemiplegic patients after stroke.Methods:A total of 21 patients with chronic stroke underwent dorsiflexion muscle strengthening exercise (MST) 5 times a week for 6 weeks (the experimental group, MST to non-paralytic dorsiflexion muscles, n=11; the control group, MST to paralytic dorsiflexion muscles; n=10). Paralytic dorsiflexor muscle activities (DFA) and 10 m walking tests (10MWT) and timed up and go tests (TUG) were measured before and after intervention.Results:A significant increase in DFA was observed after intervention in the experimental and control groups (p<0.05) (experimental 886.6% for reference voluntary contraction (RVC), control 931.6% for RVC). TUG and 10MWT results showed significant reductions post-intervention in the experimental and control groups (experimental group -5.6 sec, control -4.8 sec; experimental group -3.1 sec, control, -3.9 sec; respectively). No significant intergroup difference was observed between changes in DFA or between changes in TUG and 10MWT results after intervention (p>.05).Conclusion:Strengthening exercise performed on non-paralytic dorsiflexion muscles had positive cross-training effects on paralytic dorsiflexor muscle activities, balance abilities, and walking abilities in patients with chronic stroke.     

Effects of multicomponent exercise program with progressive phases on functional capacity,fitness, quality of life,dual-task and physiological variables in older adults: Randomized controlled trial protocol

IntroductionThe multicomponent exercise program must be carried out in phases, due to the low tolerance of the old adults to prolonged efforts, since their functional reserve is reduced.The aim of study is investigate the effects of Multicomponent on Progressive Phases Program on functional capacity, fitness, quality of life, dual-task and physiological variables in the elderly.MethodsThis is a randomized controlled trial protocol with blind examiners. The protocol was registered at clinictrials.gov (protocol number: NCT04118478). The experimental group will participate in a progressive multi-component program of 27 weeks divided into 3 phases of 9 weeks each of them. Primary outcomes will be determined by evaluating functional capacity using the Short Physical Performance Battery (SPPB), gait speed, and Time up and Go test. Fitness will be determined by the handgrip, 2-min step test, chair sit and reach test, and back scratch test. Quality of life will appear with the SF-36 questionnaire and dual-task with the walking-while-talking test. The physiological variables evaluated will be heart rate and blood pressure at rest, autonomic balance and forced spirometry. Secondary outcomes are determined by measuring the level of physical activity, motivation for exercise, and anthropometric variables.DiscussionThe results derived from this research will increase the knowledge about the effects of a program of this type. The possible discoveries could serve as a guide to encourage future researchers to develop similar protocols. The purpose of the program is to serve as a practical and viable tool for the benefit of older people.Clinical trial registry protocol: NCT04118478.     

Furazolidone‐containing triple and quadruple eradication therapy for initial treatment for Helicobacter pylori infection: A multicenter randomized controlled trial in China

Background

The efficacy of Helicobacter pylori (H. pylori) eradication has steadily declined, primarily because of antibiotic resistance. This study aimed to evaluate the efficacy and safety of furazolidone eradication therapies as initial treatments for H. pylori infection.

Methods

A national, multicenter, open‐label, randomized controlled trial was performed at 16 sites across 13 provinces in China to evaluate the efficacy and safety of furazolidone‐containing therapies for H. pylori infection. Treatment naïve patients were randomly assigned to: esomeprazole 20 mg, bismuth 220 mg, amoxicillin 1000 mg, and furazolidone 100 mg twice daily for 10 and 7 days (FAB 10 and FAB 7; the same therapy without bismuth (FA 10 and FA 7). The primary and secondary outcomes were the eradication rate and regimen safety, respectively. Treatment success was assessed by the ¹³C urea breath test at least 4 weeks after treatment completion.

Results

Overall, according to intention‐to‐treat (ITT) analysis, the eradication rates for FAB 10 and FAB 7 were 86.6% (95% confidence interval [CI], 79.9%‐93.2%) and 83.6% (95% CI, 76.3%‐90.9%) and for FA 10 and FA 7 were 82.4% (95% CI, 74.9%‐89.8%) and 77.6% (95% CI, 69.4%‐85.8%), respectively. According to per‐protocol analysis, the overall eradication rates for FAB 10 and FAB 7 were 94.7% (95% CI, 90.3%‐99.1%) and 90.8% (95% CI, 85.1%‐96.5%) and for FA 10 and FA 7 were 90.6% (95% CI, 84.9%‐96.3%) and 85.1% (95% CI, 78.2%‐92.1%), respectively. The overall prevalence of side effects was 8.1%.

Conclusions

Furazolidone‐containing therapies, particularly the tested 10‐day quadruple therapy, exhibited satisfactory efficacy and safety. This 10‐day quadruple therapy represents a promising initial treatment strategy for Chinese patients.     

Pulsed electromagnetic fields on postmenopausal osteoporosis in southwest China: A randomized,active‐controlled clinical trial

A randomized, active‐controlled clinical trial was conducted to examine the effect of pulsed electromagnetic fields (PEMFs) on women with postmenopausal osteoporosis (PMO) in southwest China. Forty‐four participants were randomly assigned to receive alendronate or one course of PEMFs treatment. The primary endpoint was the mean percentage change in bone mineral density of the lumbar spine (BMDL), and secondary endpoints were the mean percentage changes in left proximal femur bone mineral density (BMDF), serum 25OH vitamin D3 (25(OH)D) concentrations, total lower‐extremity manual muscle test (LE MMT) score, and Berg Balance Scale (BBS) score. The BMDL, BMDF, total LE MMT score and BBS score were recorded at baseline, 5, 12, and 24 weeks. Serum concentrations of 25(OH)D were measured at baseline and 5 weeks. Using a mixed linear model, there was no significant treatment difference between the two groups in the BMDL, BMDF, total LE MMT score, and BBS score (P ≥ 0.05). For 25(OH)D concentrations, the effects were also comparable between the two groups (P ≥ 0.05) with the Mann–Whitney's U‐test. These results suggested that a course of PEMFs treatment with specific parameters was as effective as alendronate in treating PMO within 24 weeks. Bioelectromagnetics 34:323–332, 2013. © 2012 Wiley Periodicals, Inc.     

Sex of preceding sibling and anthropometrics of subsequent offspring at birth and in young adulthood: A population‐based study in Sweden

In many mammal species with sexual dimorphism producing sons is energetically more demanding to the mother than producing daughters. Although some studies in humans have suggested that offspring born after a brother have a smaller birth weight and adult height when compared with those born after a sister, little is known about this intergenerational cost of producing sons. We aimed to study whether the sex of preceding sibling is associated with anthropometrics of the subsequent child at birth and in young adulthood. This population‐based study was carried out on two data sets derived from the Swedish registers. Information on birth weight and length was obtained for 752,723 children of both sexes. Adult weight, height and muscle strength were available for 506,326 men. Multiple linear regression analyses showed that boys and girls born after a brother were, respectively, 18 and 9 g lighter and 0.08 and 0.03 cm (P < 0.001) shorter at birth than those born after a sister. Adjustment for gestational age decreased the magnitude of the associations [10 g and 0.04 cm (P < 0.001) in men and nonsignificant estimates in women], suggesting that part of the lower mean birth weight and length of individuals born after a brother was due to a shorter gestation. In young adulthood, men with a preceding brother showed 0.16 kg more in weight, 0.3% higher body mass index (P < 0.001) and a trend towards reduced height and muscle strength. Our results suggest that even though the sex of the previous child is associated with the anthropometrics of the subsequent child, the effect sizes are very small questioning whether this mechanism has adaptive value in contemporary humans. Am J Phys Anthropol 154:471–478, 2014. © 2014 Wiley Periodicals, Inc.