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Recent randomised controlled trials (RCTs) have investigated the analgesic activity of sesame oil among patients with limb trauma; nevertheless, their findings are inconsistent. Hence, this review aimed to clarify the impact of topical administration of sesame oil on acute pain of adult outpatients with minor limb trauma. The online databases (e.g., Scopus, PubMed, Web of Science) were searched up to 31 January 2024. The RCTs were included if they compared the effect of applying standard treatments plus topical sesame oil to administering standard treatments alone or with a placebo/sham treatment. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) and the Cochrane Collaboration's risk of bias tool were applied to address the evidence quality and the study's methodological rigour, respectively. Four RCTs had the inclusion criteria, and their findings were pooled in a meta-analysis employing a random-effects approach. According to the pooled analysis, the reduction in mean change of the pain score from baseline to the second/third intervention day was significantly higher in favour of clients who received standard care plus daily massage of the trauma site with sesame oil compared to those who received a control condition (weighted mean difference: -1.10; 95% confidence interval [-1.62, -0.57]; p < 0.001). However, the evidence quality was moderate, and only two studies had good methodological rigour. Hence, more high-quality studies are needed to make a solid evidence-based conclusion about the favourable consequence of topical sesame oil on alleviating acute traumatic limb pain.
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Administración Tópica , Ensayos Clínicos Controlados Aleatorios como Asunto , Aceite de Sésamo , Humanos , Aceite de Sésamo/uso terapéutico , Aceite de Sésamo/administración & dosificación , Manejo del Dolor/métodos , Manejo del Dolor/normas , Adulto , Femenino , Masculino , Analgésicos/administración & dosificación , Analgésicos/uso terapéutico , Dimensión del Dolor/métodos , Persona de Mediana Edad , Extremidades/lesionesRESUMEN
This systematic review aimed to qualitatively synthesize recent randomized controlled trials (RCTs) regarding the effect of topical application and oral intake of herbal products on the healing of diabetic foot ulcer (DFU). Also, we sought to pool the obtained findings in a meta-analysis using a random-effects model, if RCTs were relatively comparable and homogenous. A comprehensive search was performed on five electronic data sources from their inception through 23 January 2024. The RCTs, without restriction on the country of origin, were included if they compared the effect of administering standard treatments and/or placebo (i.e. control condition) to applying standard treatments and/or herbal products in topical or oral routes (i.e. experimental condition). Out of 1166 retrieved records, 28 RCTs were included. Studies used different poly and single herbal formulations. Based on the meta-analysis, administration of standard care plus daily dressing of the ulcer site with olive oil for 28 days significantly increased the total ulcer healing score (3 RCTs; weighted mean difference [WMD] = 89.30; p < 0.001), raised frequency of complete ulcer healing (2 RCTs; risk ratio [RR] = 12.44; p = 0.039) and declined ulcer degree (3 RCTs; WMD = -22.28; p = 0.002). Also, daily use of the bitter melon leaf extract in oral form for 28 days significantly increased the total ulcer healing score (2 RCTs; WMD = 0.40; p = 0.001). Additionally, based on qualitative synthesis, the adjuvant use of herbal agents seems an intriguing choice to manage DFU. Nonetheless, considering the undesirable methodological quality of most studies and the high heterogeneity in administered herbal formulations, more robust trials are required to build a solid conclusion regarding the use of herbal products for healing DFU.
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Diabetes Mellitus , Pie Diabético , Humanos , Pie Diabético/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Úlcera/tratamiento farmacológico , Vendajes , Administración Oral , Diabetes Mellitus/tratamiento farmacológicoRESUMEN
BACKGROUND: Recent reviews have reported inconclusive results regarding the usefulness of consuming dates (Phoenix dactylifera L. fruit) in the peripartum period. Hence, this updated systematic review with meta-analysis sought to investigate the efficacy and safety of this integrated intervention in facilitating childbirth and improving perinatal outcomes. METHODS: Eight data sources were searched comprehensively from their inception until April 30, 2023. Parallel-group randomized and non-randomized controlled trials published in any language were included if conducted during peripartum (i.e., third trimester of pregnancy, late pregnancy, labor, or postpartum) to assess standard care plus oral consumption of dates versus standard care alone or combined with other alternative interventions. The Cochrane Collaboration's Risk of Bias (RoB) assessment tools and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) were employed to evaluate the potential RoB and the overall quality of the evidence, respectively. Sufficient data were pooled by a random-effect approach utilizing Stata software. RESULTS: Of 2,460 records in the initial search, 48 studies reported in 55 publications were included. Data were insufficient for meta-analysis regarding fetal, neonatal, or infant outcomes; nonetheless, most outcomes were not substantially different between dates consumer and standard care groups. However, meta-analyses revealed that dates consumption in late pregnancy significantly shortened the length of gestation and labor, except for the second labor stage; declined the need for labor induction; accelerated spontaneity of delivery; raised cervical dilatation (CD) upon admission, Bishop score, and frequency of spontaneous vaginal delivery. The dates intake in labor also significantly reduced labor duration, except for the third labor stage, and increased CD two hours post-intervention. Moreover, the intervention during postpartum significantly boosted the breast milk quantity and reduced post-delivery hemorrhage. Likewise, dates supplementation in the third trimester of pregnancy significantly increased maternal hemoglobin levels. The overall evidence quality was also unacceptable, and RoB was high in most studies. Furthermore, the intervention's safety was recorded only in four trials. CONCLUSION: More well-designed investigations are required to robustly support consuming dates during peripartum as effective and safe integrated care. TRIAL REGISTRATION: PROSPERO Registration No: CRD42023399626.
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Trabajo de Parto , Phoeniceae , Femenino , Humanos , Recién Nacido , Embarazo , Frutas , Parto , Periodo Periparto , LactanteRESUMEN
BACKGROUND: "Partnership Care Model (PCM)", which is the first partnership conceptual framework founded on the Iranian culture to control chronic diseases, has been recently used in different fields of nursing research with no levels of valid evidence to support its application. Therefore, this systematic review and meta-analysis sought to clarify the impacts of interventions developed based on PCM on quality of life (QoL), sleep quality, anxiety, and depression among adults and children with chronic diseases. METHODS: International data sources (e.g., PubMed, Web of Science, Scopus) and national databases (e.g., SID, MagIran, IranDoc, IRCT) were searched from 2001 to September 23, 2023, to find Randomized Controlled Trials (RCTs) on PCM-driven interventions for the experimental groups versus no intervention or standard care groups. The studies' methodological quality and evidence quality were rated utilizing the Cochrane risk of bias instruction and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Data were pooled by a random-effects approach employing STATA (vers. 11.2). RESULT: Eighteen RCTs, reported in 22 publications, were qualified. The PCM compared to the standard care significantly improved the QoL among both adults (10 effect sizes [ESs], mean difference [MD]: 3.17, P < 0.001) and children (4 ESs, MD: 4.45, P < 0.001). Likewise, the intervention enhanced adults' sleep quality (3 ESs, MD: 7.15, P < 0.001). The anxiety of adults and children was also significantly lower in the PCM group (4 ESs, MD: -4.52, P = 0.001; 2 ESs, MD: -4.04, P < 0.001, respectively). However, regarding depression, a significant effect of PCM was found only among children (3 ESs, MD: -7.99, P = 0.011). The methodological quality of the studies and the evidence quality were undesirable. CONCLUSION: The PCM had a promising influence on the caring of adults and children suffering from chronic diseases. However, additional high-quality RCTs are needed to generate a higher quality of evidence concerning the clinical benefits of the PCM. PROSPERO NO: CRD42021253790.
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Ansiedad , Depresión , Humanos , Adulto , Niño , Ensayos Clínicos Controlados Aleatorios como Asunto , Enfermedad Crónica , Irán , Calidad de VidaRESUMEN
Background: Since the release of previous meta-analyses, some studies on the associations between fruit and vegetable intake with gastric cancer risk have been published. Therefore, we aimed to update the previous meta-analyses on these associations by including recently published studies as well as considering the main limitations of those meta-analyses. Methods: A comprehensive search was conducted in online databases including PubMed, Scopus, ISI Web of Science, and Google Scholar to detect relevant prospective cohort studies published up to October 2021. Summary relative risks (RRs) were estimated using a random-effects model. Results: Overall, 17 articles containing 18 prospective studies with a total sample size of 1,527,995 participants, aged between 18 and 90 years, were included in the current meta-analysis. During the follow-up periods ranging between 4.5 and 21 years, 8,477 cases of gastric cancer were diagnosed. A higher intake of total fruit [RR: 0.87, 95% confidence interval (CI): 0.80 to 0.94, I 2 = 0%] and total fruit and vegetable (RR: 0.75, 95% CI: 0.61 to 0.93, I 2 = 55.2%) were associated with a lower risk of gastric cancer. For total vegetable intake, a significant inverse association was found among the studies that controlled their analysis for energy intake. Based on the linear dose-response analysis, each 100 g/day increase in total fruit intake (Pooled RR: 0.95, 95% CI: 0.90 to 0.99, I 2 = 49%) and 200 g/day increase in total fruit and vegetable intake (RR: 0.94, 95% CI: 0.88 to 0.99, I 2 = 37.6%) were associated with a 5 and 6% lower risk of gastric cancer, respectively. Conclusion: Fruit and vegetable consumption has a protective association with gastric cancer risk.
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Findings on the association between abdominal obesity and hip fracture were summarized in a meta-analysis in 2017; however, no study has examined the dose-response association between abdominal fat indices and hip fracture. Also, we found no meta-analysis investigating other types of bone fractures including any vertebral fractures in relation to abdominal obesity. Therefore, the present systematic review and dose-response meta-analysis of prospective cohort studies were conducted to examine the association between abdominal obesity and different types of bone fractures. A comprehensive literature search was done by searching PubMed, Scopus, Web of Science, and Google Scholar until October 2021. In total, 23 articles from prospective cohort studies with a total sample size of 3,456,631 participants were included. During the follow-up periods ranging between 4 and 26 years, 137,989 cases of bone fracture were recorded. After comparing the highest and lowest categories of abdominal fat indices, the summary relative risks (RRs) of any, hip, and vertebral fractures were 0.99 (95% CI: 0.81-1.20), 1.09 (95% CI: 0.82-1.43), and 1.18 (95% CI: 1.05-1.33), respectively, indicating a significant positive association between abdominal obesity and risk of vertebral fracture. In the non-linear dose-response analysis, abdominal obesity based on the waist-to-hip ratio (WHR) was positively associated with an increased risk of hip fracture from 0.7 to 1.1 units of WHR. In the linear analysis, a 10 cm increase in waist circumference (WC) was associated with a 3% higher risk of vertebral fracture. We found no other dose-response association for other types of bone fractures. In conclusion, abdominal obesity may be associated with a higher risk of hip and vertebral fractures.
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We examined the association between soy isoflavone intake and risk of cardiovascular disease (CVD) outcomes in adults. We searched the online databases for relevant studies published up to September 2021. In total, 13 publications were included in the systematic review and 12 in the meta-analysis. We found that a high intake of soy isoflavones was significantly associated with a lower risk of coronary heart disease (CHD) among whole populations (Pooled RR: 0.92, 95% CI: 0.85-0.99, I2 = 41.0%, Pheterogeneity = 0.10) and a lower risk of overall CVD (Pooled RR: 0.91, 95% CI: 0.84-0.98, I2 = 30.7%, Pheterogeneity = 0.19) and CHD (Pooled RR: 0.89, 95% CI: 0.83-0.96, I2 = 14.4%, Pheterogeneity = 0.32) among Western population. In the linear dose-response analysis, a 3 mg/day increase in soy isoflavone intake was associated with 16% and 14% lower risks of overall CVD and CHD, respectively, among Western population. In conclusion, we found that soy isoflavone intake was associated with a lower risk of overall CVD and CHD in adults, particularly among Western population.
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Patients with COVID-19 have shown melatonin deficiency. We evaluated the efficacy and safety of administration oral melatonin in patients with COVID-19-induced pneumonia. Patients were randomly assigned in a 1:1 ratio to receive melatonin plus standard treatment or standard treatment alone. The primary outcomes were mortality rate and requirement of IMV. The clinical status of patients was recorded at baseline and every day over hospitalization based on seven-category ordinal scale from 1 (discharged) to 7 (death). A total of 226 patients (109 in the melatonin group and 117 in the control group) were enrolled (median age; in melatonin group: 54.60 ± 11.51, in control group: 54.69 ± 13.40). The mortality rate was 67% in the melatonin group and 94% in the control group (OR; 7.75, 95% CI, 3.27-18.35, P < 0.001). The rate of IMV requirement was 51.4% in the melatonin group and 70.9% in the control group, for an OR of 2.31 (95% CI, 1.34-4.00, P < 0.001). The median number of days to hospital discharge was 15 days (13-17) in the melatonin group and 21 days (14-24) in the control group (OR; 5.00, 95% CI, 0.15-9.84, P = 0.026). Time to clinical status improvement by ≥ 2 on the ordinal scale in was 12 days (9-13) in the melatonin group and 16 days (10-19) in the control group (OR; 3.92, 95% CI, 1.69-6.14, P = 0.038). Melatonin significantly improved clinical status with a safe profile in patients with severe COVID-19 pneumonia.
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COVID-19 , Melatonina , Humanos , SARS-CoV-2 , Resultado del TratamientoRESUMEN
Cancer is known as one of the leading causes of death in the world. In addition to early mortality, cancer is associated with disability in affected patients. Among environmental risk factors, special attention has been paid to the role of dietary factors. In recent decades, the consumption of sugar-sweetened beverages (SSBs) and natural fruit juices has increased. Several studies have assessed the effects of these beverages on human health and found that a higher intake of SSBs is associated with a greater risk of obesity, diabetes, cardiovascular diseases, hypertension, and non-alcoholic fatty liver disease. However, current evidence for cancer incidence and mortality is not conclusive. In the current review, we concluded that SSBs intake might be positively associated with cancer incidence/mortality through their increasing effects on obesity, inflammatory biomarkers, serum levels of insulin-like growth factor-I (IGF-I), and advanced glycation end-products. Such a positive association was also seen for natural fruit juices. However, types of natural fruit juices were not considered in most previous studies. In addition, some types of cancer including brain, lung, and renal cancers were not assessed in relation to SSBs and natural fruit juices. Therefore, further studies are needed in this regard.
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BACKGROUND: Game-based training is increasingly implemented in different nursing fields, as it allows students to learn experientially, with the flexibility to regulate their training based on their personal progresses and abilities. This study aimed to compare the effects of virtual training by the "Playing with Surgical Instruments (PlaSurIn)" game and the lecture on the surgical instruments setup knowledge and performance of Operating Room (OR) novices. METHODS: This study was conducted on 51 s-semester undergraduate OR technology students taking the course "An Introduction to Surgical Instruments and Equipment." An additional virtual training session was held via a learning management system using two different methods. The students of the Game Training Group (GTG, n = 27) played individually with the "PlaSurIn" game during a week, while the students of the Lecture Training Group (LTG, n = 24) received the lecture-based training during a week. To measure knowledge, all the students participated in a theoretical test with 10 multiple-choice questions before and immediately after the training. They also participated in an Objective Structured Clinical Examination (OSCE) after the training, and their performance was evaluated by the remained time for setup completion and the scores, errors, and bonuses. RESULTS: The mean score of the theoretical test was significantly higher in the GTG than in the LTG after the training (p = 0.040). Additionally, the GTG participants had higher scores (p = 0.016), fewer errors (p = 0.001), and higher bonuses (p = 0.011) compared to the LTG ones. The remained time for setup completion was also significantly longer in the GTG than in the LTG (p < 0.001). CONCLUSION: Virtual training by "PlaSurIn" was superior to the lecture-based method for the enhancement of surgical instruments setup knowledge and performance amongst OR novices.
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Competencia Clínica , Quirófanos , Humanos , Aprendizaje , Instrumentos QuirúrgicosRESUMEN
OBJECTIVE: To summarize available findings on the effect of Chlorella vulgaris supplementation on lipid profile in adults. DESIGN: Systematic review and meta-analysis of randomized controlled trials (RCTs). SETTING: This study followed 2020 PRISMA guideline. We performed a systematic search in the online databases to identify relevant articles and then, extracted required data from each paper for the meta-analysis. Random-effects models were used to obtain overall mean difference (MD) comparing Chlorella vulgaris supplementation with a control group. MAIN OUTCOME MEASURES: Blood lipids including triglyceride (TG), total cholesterol (TC), LDL-C, and HDL-C. RESULTS: In total, 10 RCTs with a total sample size of 539 adults (264 in the Chlorella vulgaris group and 275 in the control group) were included. Of the 10 RCTs, four had a low risk of bias for all aspects of the Cochrane risk of bias tool. Also, only two studies determined the chlorella content, purity, potency, and contamination of the supplements used in the intervention. Combining results from these studies showed a summary MD of -2.11 mg/dL (95% CI: -7.28 to 3.06) for TG, -7.47 mg/dL (95% CI: -12.98 to -1.96) for TC, -7.71 mg/dL (95% CI: -14.05 to -1.37) for LDL-C, and -0.45 mg/dL (95% CI: -0.67 to 1.57) for HDL-C, indicating a beneficial effect of Chlorella vulgaris supplementation on TC and LDL-C levels. Based on the dose-response analysis, the reducing effect of Chlorella vulgaris supplementation on LDL-C levels was seen at the dosages between zero and 1500 mg/d (P for non-linearity= 0.01), whereas in higher amounts, this effect was not significant. CONCLUSION: We found that Chlorella vulgaris supplementation had a beneficial effect on TC and LDL-C levels with no significant effect on TG and HDL-C levels.
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Chlorella vulgaris , Adulto , Suplementos Dietéticos , Humanos , Lípidos , Ensayos Clínicos Controlados Aleatorios como Asunto , TriglicéridosRESUMEN
BACKGROUND AND AIMS: The current study was done to examine the efficacy of naproxen in the management of patients with COVID-19 infection. METHODS: This randomized, double-blind, placebo-controlled, clinical trial was done on hospitalized adult patients with confirmed COVID-19 infection. Patients were randomly assigned to receive either naproxen (two capsules per day each containing 500 mg naproxen sodium) or placebo (containing starch) for five days along with the routine treatment that was nationally recommended for COVID-19 infection. Clinical symptoms of COVID-19 infection, the time to clinical improvement, blood pressure, laboratory parameters, and death due to COVID-19 infection were considered as the outcome variables in the present study. RESULTS: Treatment with naproxen improved cough and shortness of breath in COVID-19 patients; such that, compared with placebo, naproxen intake was associated with 2.90 (95% CI: 1.10-7.66) and 2.82 (95% CI: 1.05-7.55) times more improvement in cough and shortness of breath, respectively. In addition, naproxen administration resulted in a significant increase in mean corpuscular volume (MCV) and had a preventive effect on the reduction of systolic blood pressure in COVID-19 patients. CONCLUSION: Treatment with naproxen can improve cough and shortness of breath in COVID-19-infected patients. Further studies are required to confirm our findings.
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Tratamiento Farmacológico de COVID-19 , Inhibidores de la Ciclooxigenasa/uso terapéutico , Naproxeno/uso terapéutico , Adulto , Método Doble Ciego , Femenino , Humanos , Pacientes Internos , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVE: To examine the associations between dietary intake and tissue biomarkers of alpha linolenic acid (ALA) and risk of mortality from all causes, cardiovascular disease (CVD), and cancer. DESIGN: Systematic review and meta-analysis of prospective cohort studies. DATA SOURCES: PubMed, Scopus, ISI Web of Science, and Google Scholar to 30 April 2021. STUDY SELECTION: Prospective cohort studies that reported the risk estimates for death from all causes, CVD, and cancer. DATA SYNTHESIS: Summary relative risks and 95% confidence intervals were calculated for the highest versus lowest categories of ALA intake using random effects and fixed effects models. Linear and non-linear dose-response analyses were conducted to assess the dose-response associations between ALA intake and mortality. RESULTS: 41 articles from prospective cohort studies were included in this systematic review and meta-analysis, totalling 1 197 564 participants. During follow-up ranging from two to 32 years, 198 113 deaths from all causes, 62 773 from CVD, and 65 954 from cancer were recorded. High intake of ALA compared with low intake was significantly associated with a lower risk of deaths from all causes (pooled relative risk 0.90, 95% confidence interval 0.83 to 0.97, I2=77.8%, 15 studies), CVD (0.92, 0.86 to 0.99, I2=48.2%, n=16), and coronary heart disease (CHD) (0.89, 0.81 to 0.97, I2=5.6%, n=9), and a slightly higher risk of cancer mortality (1.06, 1.02 to 1.11, I2=3.8%, n=10). In the dose-response analysis, a 1 g/day increase in ALA intake (equivalent to one tablespoon of canola oil or 0.5 ounces of walnut) was associated with a 5% lower risk of all cause (0.95, 0.91 to 0.99, I2=76.2%, n=12) and CVD mortality (0.95, 0.91 to 0.98, I2=30.7%, n=14). The pooled relative risks for the highest compared with lowest tissue levels of ALA indicated a significant inverse association with all cause mortality (0.95, 0.90 to 0.99, I2=8.2%, n=26). Also, based on the dose-response analysis, each 1 standard deviation increment in blood concentrations of ALA was associated with a lower risk of CHD mortality (0.92, 0.86 to 0.98, I2=37.1%, n=14). CONCLUSIONS: The findings show that dietary ALA intake is associated with a reduced risk of mortality from all causes, CVD, and CHD, and a slightly higher risk of cancer mortality, whereas higher blood levels of ALA are associated with a reduced risk of all cause and CHD mortality only. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021229487.
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Enfermedades Cardiovasculares , Ingestión de Alimentos/fisiología , Neoplasias , Ácido alfa-Linolénico , Enfermedades Cardiovasculares/metabolismo , Enfermedades Cardiovasculares/mortalidad , Humanos , Mortalidad , Neoplasias/metabolismo , Neoplasias/mortalidad , Factores Protectores , Medición de Riesgo , Ácido alfa-Linolénico/sangre , Ácido alfa-Linolénico/metabolismoRESUMEN
BACKGROUND: Recent studies have reported inconclusive results regarding the potential effects of Rosa damascena on sleep quality. Therefore, this review aimed to summarize the findings of parallel-group and cross-over randomized controlled trials (RCTs) on the effects of aromatherapy and oral intake of Rosa damascena on adults' sleep quality. METHODS: The electronic data sources of PubMed, Scopus, Web of Science Core Collection, Embase, CENTRAL, ProQuest, CINAHL, SID, and MagIran were searched from inception to June 30, 2021. Out of 1341 publications found in the initial search, 10 RCTs were considered eligible for this review. The Cochrane risk-of-bias assessment tool was used to evaluate the risk of bias. Sufficient data were statistically pooled by a random-effects model using Stata software (version 11.2); otherwise, a narrative summary was presented. RESULTS: Based on the systematic review, the inhalation and oral intake of Rosa damascena could improve some sleep-related outcomes. The pooled analysis of seven effect sizes revealed that inhalation aromatherapy with Rosa damascena significantly improved sleep quality (standardized mean difference: 2.24; 95% confidence interval: 1.01-3.48; P < 0.001). Most RCTs had fair methodological quality, and two RCTs reported the adverse effects of treatment, including headache, nausea, vomiting, and frequent sneezing. CONCLUSIONS: The administration of Rosa damascena seems to be a promising approach in complementary and alternative medicine for the improvement of adults' sleep quality. However, considering the fair methodological quality of most RCTs and reported adverse effects, it is required to perform further high-quality RCTs to draw an evidence-based conclusion on the use of Rosa damascena for the improvement of adults' sleep quality. PROSPERO NO: CRD42020211778.
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Rosa , Adulto , Cefalea , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Sueño , Calidad del SueñoRESUMEN
OBJECTIVES: We investigate the effects of melatonin, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in severely ill patients with confirmed COVID-19 who are admitted to the Intensive Care Unit (ICU). TRIAL DESIGN: This is a single-center, open-label, randomized, clinical trial with a parallel-group design. This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran. PARTICIPANTS: All patients admitted to the ICU of Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria. Inclusion criteria 1. Age >20 years 2. Definitive diagnosis of COVID-19 based on RT-PCR or/and serological testing 3. Severe pneumonia and lung involvement in imaging 4. Signing informed consent Exclusion criteria 1. Underlying diseases, including convulsive disorders, chronic hepatic and renal diseases 2. Use of mechanical ventilation 3. History of known allergy to Melatonin 4. Pregnancy and breastfeeding INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education's protocol, along with Melatonin soft gelatin capsule (Danna Pharmaceutical Company) at a dose of 5 mg twice a day for a period of seven days. CONTROL GROUP: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol for a period of seven days. MAIN OUTCOMES: The primary outcomes are the recovery rate of clinical symptoms and checking arterial blood gas (ABG), C-reactive protein (C-RP), Ferritin, Lactate dehydrogenase (LDH) within seven days of randomization. The secondary outcomes are time to improvement of clinical and paraclinical features and length of stay in the ICU, need for mechanical ventilation, and mortality rate within seven days of randomization. RANDOMIZATION: Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 6 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms. BLINDING (MASKING): This is an open-label trial without blinding and placebo control. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group). TRIAL STATUS: The protocol is Version 1.0, February 16, 2021. Recruitment began February 28, 2021, and is anticipated to be completed by July 31, 2021. TRIAL REGISTRATION: The trial protocol has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is " IRCT20200506047323N7 ". The registration date was February 16, 2021. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
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Antioxidantes/uso terapéutico , Tratamiento Farmacológico de COVID-19 , Melatonina/uso terapéutico , Análisis de los Gases de la Sangre , Proteína C-Reactiva/metabolismo , COVID-19/metabolismo , COVID-19/fisiopatología , Ferritinas/metabolismo , Humanos , Unidades de Cuidados Intensivos , Irán , L-Lactato Deshidrogenasa/metabolismo , Ensayos Clínicos Controlados Aleatorios como Asunto , SARS-CoV-2RESUMEN
Data on the association of nut intake with risk of cancer and its mortality are conflicting. Although previous meta-analyses summarized available findings in this regard, some limitations may distort their findings. Moreover, none of these meta-analyses examined the dose-response associations of total nut intake with the risk of specific cancers as well as associations between specific types of nuts and cancer mortality. Therefore, this study aimed to summarize available findings on the associations of total nut (tree nuts and peanuts), tree nut (walnuts, pistachios, macadamia nuts, pecans, cashews, almonds, hazelnuts, and Brazil nuts), peanut (whole peanuts without considering peanut butter), and peanut butter consumption with risk of cancer and its mortality by considering the above-mentioned points. We searched the online databases until March 2020 to identify eligible articles. In total, 43 articles on cancer risk and 9 articles on cancer mortality were included in the current systematic review and meta-analysis. The summary effect size (ES) for risk of cancer, comparing the highest with lowest intakes of total nuts, was 0.86 (95% CI: 0.81, 0.92, P < 0.001, I2 = 58.1%; P < 0.01), indicating a significant inverse association. Such a significant inverse association was also seen for tree nut intake (pooled ES: 0.87, 95% CI: 0.78-0.96, P < 0.01, I2 = 15.8%; P = 0.28). Based on the dose-response analysis, a 5-g/d increase in total nut intake was associated with 3%, 6%, and 25% lower risks of overall, pancreatic, and colon cancers, respectively. In terms of cancer mortality, we found 13%, 18%, and 8% risk reductions with higher intakes of total nuts, tree nuts, and peanuts, respectively. In addition, a 5-g/d increase in total nut intake was associated with a 4% lower risk of cancer mortality. In conclusion, our findings support the protective association between total nut and tree nut intake and the risk of cancer and its mortality.
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Arachis , Neoplasias , Humanos , Incidencia , Nueces , Estudios Observacionales como Asunto , RiesgoRESUMEN
A systematic review was conducted on electronic databases of MEDLINE/PubMed, Scopus, ISI Web of Science, CINAHL, and Embase until December 2017, using relevant keywords for educational games developed for nursing students in perioperative field. To evaluate the level of strength and quality of the evidence, the Association of periOperative Registered Nurses (AORN) revised model for evidence appraisal was used. Of the 852 evidence, only 10 met the criteria and were reviewed and appraised. Educational games had focused on different learning domains, including skills, feelings, emotion, knowledge, performance, attitude, motivation, and interest. With respect to the evidence level, most evidence was categorized as V (expert opinionâ¯=â¯2, case reportâ¯=â¯2, literature reviewâ¯=â¯1, and organizational experiencesâ¯=â¯1), and only one was in level I (randomized controlled trial). The quality level of most evidence was high (nâ¯=â¯4) and low (nâ¯=â¯4), and the rating of most of them was moderate (nâ¯=â¯4) and limited (nâ¯=â¯4). Based on the findings, most evidence had inappropriate quality and was found to be weak. It seems that the investigated games are insufficient to promote the nursing students' learning outcomes in different domains. Accordingly, more high-quality studies are required to design and develop innovative and practical games for students in perioperative nursing by considering validity and reliability process.
Asunto(s)
Enfermería Perioperatoria , Juego e Implementos de Juego , Entrenamiento Simulado/métodos , Estudiantes de Enfermería , Competencia Clínica , Humanos , Aprendizaje , Investigación en Educación de Enfermería , Investigación Cualitativa , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: Postoperative nausea and vomiting (PONV), as one of the complications after laparoscopic cholecystectomy, occurs in over 40% - 77% of cases. Considering the numerous complications of synthetic drugs, there is a growing tendency towards the use of herbal medicines due to their unique features. Ginger root is one of the herbal compounds effective on nausea and vomiting. OBJECTIVES: The aim of this study was to evaluate the effect of preoperative Zintoma capsules on PONV after laparoscopic cholecystectomy. METHODS: In this quasi-experimental study, 130 eligible patients were randomly assigned to intervention (n = 65) and control (n = 65) groups using the four-block method. The intervention group received two capsules of 500 mg and one of 250 mg Zintoma. The control group received three placebo capsules. The severity of patients' PONV was recorded at 0, 2, 6, 12, and 24 hours after surgery using a checklist and a standard VAS instrument. Data were analyzed using t-test, Chi-square test, and LSD Post Hoc test (ANOVA) in SPSS 19. RESULTS: The severity of PONV and vomiting was significantly different between the two groups (P = 0.001) at the above time points. The mean severity of nausea (by VAS) changed in the intervention group from 7.92 ± 1.28 to 0.33 ± 0.67 and in the control group from 8.00 ± 1.20 to 2.11 ± 1.55. The postoperative vomiting was less frequent in the group receiving the Zintoma capsules. The postoperative use of chemical anti-vomiting and nausea drugs was significantly lower in the intervention group than in the placebo group (P = 0.001). CONCLUSIONS: Zintoma capsules can be used as a supportive treatment in the prevention of nausea and vomiting by reducing the incidence rate of PONV.