Effects of greens+® A Randomized, Controlled Trial

2004 ◽  
Vol 65 (2) ◽  
pp. 66-71 ◽  
Author(s):  
Heather Boon ◽  
Joyce Clitheroe ◽  
Tonia Forte

Greens+® is a popular natural health product marketed as energy-enhancing; however, no objective data substantiate this claim. The study objective was to determine if ingestion of greens+® 1. increases vitality, energy, and perception of wellbeing; 2. increases overall mental health and general health, and 3. decreases the incidence of colds and flus in an otherwise healthy female population. A total of 105 women were enrolled in this 12-week, randomized, double-blind, placebo-controlled clinical trial; 63 (60%) completed the treatment protocol. Both treatment and placebo groups showed a significant time trend effect, scoring better on all outcome measures as the trial progressed. Compared with the placebo group, the greens+® group scored marginally higher on vitality, the primary outcome measure (p=0.055), and significantly higher on energy (a secondary outcome measure, p=0.018). Findings were based on repeated measures analysis of variance; baseline scores were used as covariates. Although a trend toward greater improvement in the greens+® group was noted in the other secondary outcome measures, this trend did not reach statistical significance. Overall, our findings were positive but not conclusive that greens+® increases vitality and energy. These results provide justification for further study of the effects of greens+®.

2010 ◽  
Vol 125 (1) ◽  
pp. 22-26 ◽  
Author(s):  
D Thornton ◽  
T P C Martin ◽  
P Amin ◽  
S Haque ◽  
S Wilson ◽  
...  

AbstractObjectives:To determine the frequency of cholesteatoma in a population of patients with chronic suppurative otitis media, and to determine whether this frequency is affected by ethnicity.Patients:The study included 6005 patients with chronic suppurative otitis media seen during the course of 30 charitable surgical ‘ear camps’ in Nepal.Main outcome measures:Proportion of patients with each subtype of disease, and their ethnicity. A secondary outcome measure was concordance of surname with Nepalese ethnic affiliation.Results:A total of 762 patients were grouped as being of Tibeto-Mongolian origin, and 4875 as Indo-Caucasian. The rate of chronic suppurative otitis media with cholesteatoma, expressed as a proportion of the rate of all chronic suppurative otitis media subtypes, was 17.8 per cent in Tibeto-Mongolian patients and 18.6 per cent in Indo-Caucasian patients (p > 0.05). The effect of other risk factors (i.e. age, gender and geographical district) on disease distribution was also non-significant. Analysis of secondary outcome measures indicated that patients' surnames were a reliable predictor of ethnicity in this Nepalese population.Conclusion:There is almost complete concordance in proportions of patients with significant genetic, cultural, and even geographical heterogeneity, suggesting that, in Nepal, the aetiology of cholesteatoma owes little to these factors.


BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048126
Author(s):  
Sarah-Maria Thumbeck ◽  
Philipp Schmid ◽  
Sophie Chesneau ◽  
Frank Domahs

IntroductionAt least 68% of persons with aphasia (PWA) experience reading difficulties. Even though strategy-based interventions are a promising treatment approach for text level reading comprehension deficits in PWA, empirical evidence for their efficacy remains rare. The primary objective of this study is the analysis of the efficacy of a strategy-based intervention on text-level reading comprehension and on reading activities in PWA.Methods and analysisIn a repeated measures trial, 24 PWA will first participate in a waiting period and then in a strategy-based intervention (14 face-to-face-sessions, 60 min each). We will apply two combinations of strategies to treat either the microstructure or the macrostructure, respectively. Participants will be randomly allocated to two parallel groups that will receive these combinations in interchanged sequences. Assessments will be implemented before and after each period as well as 3 and 6 months after the intervention. The primary outcome measure is text-level reading comprehension measured with a German version of the Test de Compréhension de Textes (TCT-D) and represented by the score TCT-D Total . A non-blinded and a blinded rater will evaluate the primary outcome measure. Secondary outcome measures will address specific reading functions, reading activities and cognitive functions. The sample size was determined with an a priori power analysis. For statistical analysis, we will use contrast analyses within repeated measures analysis of variance models. We expect significant improvements in primary and secondary outcome measures during the intervention as compared with changes during the waiting period.Ethics and disseminationThis study was approved by the ethics committee of Deutscher Bundesverband für akademische Sprachtherapie und Logopädie (20–10074-KA-MunmErw+Ko). Results and relevant data will be disseminated in peer-reviewed journals, at conferences and on the Open Science Framework.Trial registration numberDRKS00021411 (see Supplementary Table 1).


2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Yu Tat Chan ◽  
Hong Wei Zhang ◽  
Yuan Qi Guo ◽  
Zhi-Xiu Lin

Background. Dysphagia is one of the most common complications of stroke. Acupuncture is widely employed to treat poststroke dysphagia in East Asia. No evidence is established to support such treatment approach. This proposed study aims to evaluate the effectiveness and safety of acupuncture for the treatment of poststroke dysphagia. Methods and Design. This is a multicenter, pragmatic, single-blinded, nonrandomized controlled clinical trial. A total of 140 eligible patients will be enrolled in the study. Subjects who are eligible in study but refuse to have acupuncture treatment will be put on the no-acupuncture control arm. Both groups of patients will receive standard routine care, while the patients of intervention group will receive add-on standardized acupuncture treatment. Each participant in intervention group will receive a total of 24 sessions of acupuncture treatment (three times per week). The primary outcome measure is the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS). Secondary outcome measures include functional oral intake scale, swallow quality-of-life questionnaire in Chinese version, BMI of the participant, and adverse events. All outcome measures will be assessed at baseline, at the end of acupuncture treatment (month 2), and at two months after treatment (month 4). Ethics and Dissemination. The ethics approval of clinical research study was granted by the Research Ethics Committee of both New Territories East and West Cluster of Hong Kong. Written informed consent will be obtained from all participants and the study will be undertaken according to the ICH-GCP Guidelines. Trial Registration. This trial is registered with chictr.org (registration number: ChiCTR-TRC-12002621 and registration date: 2012-10-26).


2016 ◽  
Vol 44 (7) ◽  
Author(s):  
Edwin Eseoghene Omih ◽  
Stephen Lindow

AbstractAim:Pregnancy in women of advancing maternal age is linked to incrementally worsening perinatal outcome. The aim of this study is to assess the impact of maternal age on delivery outcome in women that spontaneously labour at term.Methods:This was a retrospective study of women that spontaneously labour at term. Women with singletons in spontaneous onset labour beyond 37 weeks of gestation were divided into five maternal age groups: <19 years, 20–24 years, 25–29 years, 30–34 years and >35 years by their age at delivery. The main outcome variables are augmentation of labour, caesarean section, assisted vaginal delivery, and perineal trauma, while admission of the newborn into the neonatal unit within 24 h following delivery was the secondary outcome measure.Results:A total of 30,022 met the inclusion criteria with primiparae and multiparae accounting for 46 and 54%, respectively. Increasing age in primiparae was associated with; augmentation of labour OR 2.05 (95% CI 1.73–2.43), second degree perineal tear 1.35 (1.12–1.61), assisted vaginal delivery 1.92 (1.53–2.41) and caesarean section 4.23 (3.19–5.12). While that for multiparae; augmentation of labour OR 1.93 (1.05–3.52), perineal trauma 2.50 (1.85–3.34), assisted vaginal delivery 4.95 (91.82–13.35) and caesarean section 1.64 (1.13–2.38). The secondary outcome measure did not reach statistical significance.Conclusion:Increasing maternal age is an independent risk factor for operative delivery, and perineal trauma. However, maternal age has no significant effect on admission of infants into the NICU during the first 24 h following delivery.


2007 ◽  
Vol 35 (05) ◽  
pp. 725-733 ◽  
Author(s):  
Sang Pil Yun ◽  
Woo Sang Jung ◽  
Sung Uk Park ◽  
Sang Kwan Moon ◽  
Jung Mi Park ◽  
...  

This study was to test the importance of patterns identification (PI) and the effectiveness of Hwangryunhaedogtang (Huanglianjiedutang) (HT) treatment for patients with post stroke pathological laughter (PL). Fourteen subjects were enrolled. Eight subjects diagnosed with Yang Excess patterns (YEP) were assigned into group A and 6 subjects who had no YEP to group B. HT was administrated 3 times a day for 14 days to both groups. The duration of PL at one time, the frequency of PL in a day, and pathological laughter scale (PLS) were the primary outcome measures. Barthel index (BI) was the secondary outcome measure. The duration and the frequency of PL in group A were significantly decreased from 10.88 ± 4.67 to 6.63 ± 4.07 sec and from 6.38 ± 2.72 to 3.00 ± 1.77 times, respectively (p = 0.01) after 14 days administration of HT. PLS in group A was also significantly lowered from 9.13 ± 1.73 to 4.75 ± 0.71 points (p = 0.01). However, significant differences were not observed in BI in group A and in the primary and secondary outcome measures in group B. The duration and the frequency of PL and PLS were more markedly reduced in group A than in group B (p = 0.01, 0.02, and < 0.01, respectively). These results suggested that HT could be effective on subjects with post stroke PL diagnosed as YEP and PI, that prescription of herbal medications to such patients should be considered.


BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044986
Author(s):  
Chris Skedgel ◽  
Eleanor Ralphs ◽  
Elaine Finn ◽  
Jennifer A Whitty ◽  
Marie Markert ◽  
...  

ObjectivesTo understand attitudes towards infertility and willingness to pay (WTP) towards a publicly funded national assistive reproductive therapies (ART) programme.DesignAttitudes survey with dichotomous and open-ended WTP questions.SettingOnline survey administered in the USA, UK, Spain, Norway, Sweden, Finland, Denmark and China.Participants7945 respondents, analysed by country. Nordic respondents were pooled into a regionally representative sample.Primary and secondary outcome measuresPrimary outcome measures were proportion of sample agreeing with different infertility-related and ART-related value statements and supporting a monthly contribution to fund a national ART programme, expressed in local currency. Secondary outcome measure was maximum WTP.ResultsAcross the nationally representative samples, 75.5% of all respondents agreed with infertility as a medical condition and 82.3% and 83.7% with ART eligibility for anyone who has difficulty having a baby or a medical problem preventing them from having a baby, respectively. 56.4% of respondents supported a defined monthly contribution and 73.9% supported at least some additional contribution to fund a national ART programme. Overall, converting to euros, median maximum WTP was €3.00 and mean was €15.47 (95% CI 14.23 to 16.72) per month. Maximum WTP was highest in China and the USA and lowest in the European samples.ConclusionsThis large, multicountry survey extends our understanding of public attitudes towards infertility and fertility treatment beyond Europe. It finds evidence that a majority of the public in all sampled countries/regions views infertility as a treatable medical condition and supports the idea that all infertile individuals should have access to treatments that improve the chance of conception. There was also strong agreement with the idea that the desire for children is a basic human need. WTP questions showed that a majority of respondents supported a monthly contribution to fund a national ART programme, although there is some evidence of an acquiescence bias that may overstate support among specific samples.


Spinal Cord ◽  
2021 ◽  
Author(s):  
Helge Kasch ◽  
Uffe Schou Løve ◽  
Anette Bach Jønsson ◽  
Kaare Eg Severinsen ◽  
Marc Possover ◽  
...  

Abstract Study design 1-year prospective RCT. Objective Examine the effect of implantable pulse generator and low-frequency stimulation of the pelvic nerves using laparoscopic implantation of neuroprosthesis (LION) compared with neuromuscular electrical stimulation (NMES) in SCI. Methods Inclusion criteria: traumatic spinal cord injury (SCI), age 18–55 years, neurological level-of-injury Th4–L1, time-since-injury >1 year, and AIS-grades A–B. Participants were randomized to (A) LION procedure or (B) control group receiving NMES. Primary outcome measure: Walking Index for Spinal Cord Injury (WISCI-II), which is a SCI specific outcome measure assessing ability to ambulate. Secondary outcome measures: Spinal Cord Independence Measure III (SCIM III), Patient Global Impression of Change (PGIC), Penn Spasm Frequency Scale (PSFS), severity of spasticity measured by Numeric Rating Scale (NRS-11); International Spinal Cord Injury data sets-Quality of Life Basic Data Set (QoLBDS), and Brief Pain Inventory (BPI). Results Seventeen SCI individuals, AIS grade A, neurological level ranging from Th4–L1, were randomized to the study. One individual was excluded prior to intervention. Eight participants (7 males) with a mean age (SD) of 35.5 (12.4) years were allocated to the LION procedure, 8 participants (7 males) with age of 38.8 (15.1) years were allocated to NMES. Significantly, 5 LION group participants gained 1 point on the WISCI II scale, (p < 0.013; Fisher´s exact test). WISCI II scale score did not change in controls. No significant changes were observed in the secondary outcome measures. Conclusion The LION procedure is a promising new treatment for individuals with SCI with significant one-year improvement in walking ability.


2018 ◽  
Vol 103 (10) ◽  
pp. 1395-1400 ◽  
Author(s):  
Rashmi G Mathew ◽  
Sahar Parvizi ◽  
Ian E Murdoch

AimsTo compare success proportions at 5 years in three surgical groups: group 1, trabeculectomy alone; group 2, trabeculectomy followed by cataract surgery within 2 years; and group 3, trabeculectomy performed on a pseudophakic eye.MethodsA retrospective cohort study. 194 eyes of 194 patients were identified with at least 5 years’ follow-up post trabeculectomy (N=85, 60 and 49 in groups 1, 2 and 3, respectively).Main outcome measures1. Primary outcome measure: intraocular pressure (IOP) at 5 years post-trabeculectomy surgery, 2.Secondary outcome measure: change in visual acuity at 5 years.ResultsAt 5 years, the mean IOP (SD) was 12.9 (3.5), 12.5 (4.8) and 12.7 (4.8) mm Hg in groups 1, 2 and 3, respectively. Overall success was almost identical, 58%, 57% and 59% in groups 1, 2 and 3, respectively. There was no significant difference between the groups in terms of percentage IOP reduction, number of medications, proportion restarting medication and reoperation rates at 5 years. Logistic regression for an outcome of failure showed men to be at increased risk of failure OR 1.97 (95% CI 1.10 to 3.52, p=0.02). Nearly 80% of patients retained or improved their vision following their initial trabeculectomy.ConclusionsThe sequence in which surgery is carried out does not appear to affect trabeculectomy function at 5 years, success being similar to trabeculectomy alone. In our study, men may be at increased risk of failure.


2019 ◽  
Vol 13 (11) ◽  
pp. 961-967 ◽  
Author(s):  
Cem Karaali ◽  
Mustafa Emiroglu ◽  
Sabri Atalay ◽  
Ismail Sert ◽  
Ayberk Dursun ◽  
...  

Introduction: This study aims to evaluate the efficacy of a new antimicrobial stewardship program (ASP) on surgical antibiotic prophylaxis (SP) and antibiotics in discharge prescriptions used as a continuation of SP. Methodology: The study included elective patients with clean and clean-contaminated wounds. The accuracy of the assigned SP was evaluated according to international guidelines. Primary outcome measures comprised appropriateness of prophylactic antibiotic indication, correct timing of initial dose, discontinuation of SP within 24 hours, and antibiotic prescription at discharge. A secondary outcome measure was to determine whether the effect of ASP was sustained long-term. Results: The total compliance rate for all stages of SP increased from 8% to 52.1% after the intervention (p < 0.05). When analyzed according to individual SP components, it was found that although ASP did not change first dose timing rates, it did affect the rates of prophylactic antibiotic indication, discontinuation of SP within 24 hours and antibiotic prescription at discharge, with statistical significance (p < 0.05). In addition, ASP continued to increase its effectiveness throughout the 3rd year. Conclusions: Based on the findings of our study, it seems clear that the modified ASP introduced in our general surgery clinic can be used effectively and simply; in addition, this ASP increases its efficacy with time.


2021 ◽  
Vol 3 ◽  
Author(s):  
Moa Jederström ◽  
Sara Agnafors ◽  
Christina Ekegren ◽  
Kristina Fagher ◽  
Håkan Gauffin ◽  
...  

Introduction: Although figure skating attracts several hundred thousand participants worldwide, there is little knowledge about physical health and sports injuries among young skaters. The present study aimed to describe the health status of a geographically defined Swedish population of licensed competitive figure skaters and to examine injury determinants.Methods: All licensed competitive skaters in the southeastern region of Sweden were in April 2019 invited to participate in a cross-sectional study using an online questionnaire. Multiple binary logistic regression was used for the examination of injury determinants. The primary outcome measure was the 1-year prevalence of a severe sports injury episode (time loss &gt;21 days). The secondary outcome measure was the point prevalence of an ongoing injury. The determinants analyzed were age, skating level, relative energy deficiency indicators, and training habits.Results: In total, 142 (36%) skaters participated, 137 (96%) girls [mean (SD) age: 12.9 (SD 3.0) years]. Participating boys (n = 5) were excluded from further analysis. The 1-year prevalence of a severe sports injury episode was 31%. The most common injury locations for these injuries were the knee (25%), ankle (20%), and hip/groin (15%). In the multiple model, having sustained a severe injury episode was associated with older age (OR 1.2, 95% CI 1.1–1.4; p = 0.002) and an increased number of skipped meals per week (OR 1.1, 95% CI 1.0–1.3; p = 0.014). The point prevalence of an ongoing injury episode was 19%. The most common locations were the knee (24%), ankle (24%), and foot (24%). Having an ongoing injury episode was associated with older age (OR 1.4, 95% CI 1.2–1.7; p &lt; 0.001) and an increased number of skipped meals per week (OR 1.1, 95% CI 1.0–1.3; p = 0.049).Conclusion: One-third of young female Swedish competitive figure skaters had sustained a severe injury episode during the past year, and a fifth reported an ongoing episode. Older age and an increased number of skipped meals per week were associated with a sports injury episode. Long-term monotonous physical loads with increasing intensity and insufficient energy intake appear to predispose for injury in young female figure skaters. Further examination of injury determinants among competitive figure skaters is highly warranted.


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