Protocol for The International Cohort on Lifestyle Determinants of Health Study: A Longitudinal Investigation of Complementary and Integrative Health Utilization in Postsecondary Education Students.

Objectives: The specific aims are: 1) To characterize the health, wellness, and lifestyle of graduate and undergraduate students, and how these characteristics change over time; 2) To evaluate associations between lifestyle factors and gut microbiota populations and diversity; and 3) To evaluate associations between stress and stress management practices with sleep habits, quality of life, and overall health. Design: The International Cohort on Lifestyle Determinants of Health (INCLD Health) longitudinal cohort study is designed to assess health behaviors and lifestyle practices amongst adults studying complementary and integrative health (CIH) and higher-education students more generally after at least one to six years of exposure to CIH education. INCLD Health will adhere to the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines. Settings/Location: Colleges and universities with a CIH focus or interest with the flagship site being the National University of Natural Medicine. Participants: Adults currently enrolled in a college or university with a CIH focus or interest. Outcome Measures: Study visits will be conducted at baseline, 6 months, then every 12 months until the end of each participants' degree program. Measures include anthropometrics; serum and salivary biomarkers of cardiovascular risk, reproductive hormones, and cortisol; nutritional intake measured by a digital food frequency questionnaire; sequencing of fecal microbiota; plus validated questionnaires investigating mood, perceived stress, stress management practices, physical activity, sleep, and wellness. Conclusions: The INCLD Health Study, approved by the NUNM IRB in late 2018, will enroll a unique cohort of adults to characterize the use of CIH practices in relation to short- and long-term health. Our study design provides a breadth of information that could be implemented at multiple sites internationally allowing for comparisons across diverse student cohorts with relatively low cost and personnel.

Metabolites, Nutrients, and Lifestyle Factors in Relation to Coffee Consumption: An Environment-Wide Association Study.

Coffee consumption has been inversely associated with various diseases; however, the underlying mechanisms are not entirely clear. We used data of 17,752 Third National Health and Nutrition Examination Survey participants to investigate the association of 245 metabolites, nutrients, and lifestyle factors with coffee consumption. We used data from the first phase (n = 8825) to identify factors with a false discovery rate of <5%. We then replicated our results using data from the second phase (n = 8927). Regular coffee consumption was positively associated with active and passive smoking, serum lead and urinary cadmium concentrations, dietary intake of potassium and magnesium, and aspirin intake. In contrast, regular coffee consumption was inversely associated with serum folate and red blood cell folate levels, serum vitamin E and C, and beta-cryptoxanthin concentrations, Healthy Eating Index score, and total serum bilirubin. Most of the aforementioned associations were also observed for caffeinated beverage intake. In our assessment of the association between coffee consumption and selected metabolites, nutrients, and lifestyle factors, we observed that regular coffee and caffeinated beverage consumption was strongly associated with smoking, serum lead levels, and poorer dietary habits.

Design and methods of Shape Up Under 5: Integration of systems science and community-engaged research to prevent early childhood obesity.

Shape Up Under 5 (SUU5) was a two-year early childhood obesity prevention pilot study in Somerville, Massachusetts (2015-2017) designed to test a novel conceptual framework called Stakeholder-driven Community Diffusion. For whole-of-community interventions, this framework posits that diffusion of stakeholders' knowledge about and engagement with childhood obesity prevention efforts through their social networks will improve the implementation of health-promoting policy and practice changes intended to reduce obesity risk. SUU5 used systems science methods (agent-based modeling, group model building, social network analysis) to design, facilitate, and evaluate the work of 16 multisector stakeholders ('the Committee'). In this paper, we describe the design and methods of SUU5 using the conceptual framework: the approach to data collection, and methods and rationale for study inputs, activities and evaluation, which together may further our understanding of the hypothesized processes within Stakeholder-driven Community Diffusion. We also present a generalizable conceptual framework for addressing childhood obesity and similar complex public health issues through whole-of-community interventions.

A prospective field study of U.S. Army trainees to identify the physiological bases and key factors influencing musculoskeletal injuries: a study protocol.

BACKGROUND: Musculoskeletal injuries (MSKIs) are common in military trainees and present a considerable threat to occupational fitness, deployability, and overall military readiness. Despite the negative effects of MSKIs on military readiness, comprehensive evaluations of the key known and possible risk factors for MSKIs are lacking. The U.S. Army Research Institute of Environmental Medicine (ARIEM) is initiating a large-scale research effort, the ARIEM Reduction in Musculoskeletal Injury (ARMI) Study, to better understand the interrelationships among a wide range of potential MSKI risk factors in U.S. Army trainees in order to identify those risk factors that most contribute to MSKI and may be best targeted for effective mitigation strategies. METHODS: This prospective study aims to enroll approximately 4000 (2000 male and 2000 female) U.S. Army trainees undergoing Basic Combat Training (BCT). Comprehensive in-person assessments will be completed at both the beginning and end of BCT. Participants will be asked to complete surveys of personal background information, medical history, physical activity, sleep behaviors, and personality traits. Physical measurements will be performed to assess anthropometrics, tibial microarchitecture and whole body bone mineral density, muscle cross-sectional area, body composition, and muscle function. Blood sampling will be also be conducted to assess musculoskeletal, genetic, and nutritional biomarkers of risk. In addition, participants will complete weekly surveys during BCT that examine MSKI events, lost training time, and discrete risk factors for injury. Participants' medical records will be tracked for the 2 years following graduation from training to identify MSKI events and related information. Research hypotheses focus on the development of a multivariate prediction model for MSKI. DISCUSSION: Results from this study are expected to inform current understanding of known and potential risk factors for MSKIs that can be incorporated into solutions that optimize Soldier health and enhance military readiness.

Laser acupuncture protocol for essential systemic arterial hypertension: randomized clinical trial.

OBJECTIVES: to evaluate the efficacy of a laser acupuncture protocol developed and applied by nurses in arterial hypertension patients. METHOD: randomized, multicenter, triple-blind and two-armed clinical trial. The sample consisted of 102 participants, 51 per arm, both sexes, aged between 30 and 75 years, undergoing drug therapy for a year or more, with difficulty to control blood pressure, maintaining regular measures >140x90 mmHg. Participants underwent six standard or simulated laser-acupuncture sessions, for 24 minutes, within a period of six weeks. Descriptive analyzes expressed as frequencies of occurrences, means and medians were used, and analysis of the association between variables was performed using Student's t-test and Anova, using Statistica® software, version 12.0. The significance level was set at 5% (alpha=0.05). The comparison between blood pressure measurements was performed using Student's t-test for paired samples and Anova for repeated measures. RESULTS: a significant reduction in systolic (p<0.001) and diastolic (p<0.001) blood pressure was observed among participants in the intervention arm, which was not observed in the simulation arm. CONCLUSION: the results have demonstrated the efficacy of the protocol. Reduction and control of blood pressure have been demonstrated, indicating the possibility of using this technology for the care of patientes with essential systemic arterial hypertension. Brazilian Registry of Clinical Trials. UTN: U1111-1177-1811. Clinical Trials NCT02530853.

Adjunctive Vitamin D in the treatment of non-remitted depression: Lessons from a failed clinical trial.

BACKGROUND: Many patients with depression fail to achieve remission after several consecutive treatments. Vitamin D deficiency is prevalent and new research suggests that it may have an impact on mood, primarily through an effect on neurotransmitters. Numerous observational studies suggest a relationship between low levels of vitamin D and increased incidence and severity of mood disorders. A small number of pilot studies have been undertaken but lack rigorous methodology required to draw conclusions about a clinical role for this nutrient in treatment resistant depression. METHODS: This study was designed as a randomized, double-blind, placebo controlled intervention study administering a weekly (bolus) dose of 28 000IU of Vitamin D3 or placebo to 125 patients with non-remitted depression adjunct to current antidepressant medication. Patients were followed weekly for eight weeks plus a one month follow up. Outcomes measured included depression severity, serum vitamin D levels and safety. Due to slow recruitment during the first season, amendments were made. These included extending the age range to 18-75 and removing the requirement for failing to respond to one pharmacologic antidepressant agent. The protocol was amended to reduce the burden on participants by changing the in-office visits to bi-weekly. Three additional tertiary psychiatric clinics were also added as trial sites. RESULTS: Over three recruitment period years (fall/winter), a total of 148 participants completed screening, 24 (16.2%) of whom qualified to participate in the study. Use of too many or no psychiatric medications, comorbid exclusionary psychiatric conditions, current use of a vitamin D supplement, and lack of participant compensation were the predominant reasons for ineligibility or unwillingness to participate. 9 participants were successfully enrolled in the study, 7 (77.8%) of whom completed the trial as per the protocol. After the third season, futility was declared based on inability to enroll participants. The sample size of enrolled participants (7/125, 5.6%) lacks power to conduct a full assessment of findings. DISCUSSION: High accessibility of vitamin D, as well as a growing lack of equipoise in patients and clinicians about the potential ubiquitous benefits of vitamin D for Canadians, not just for mood disorders, resulted in a large proportion of ineligible potential participants. Limited funding provided to studies on natural health products hampered recruitment. The labile and fluctuating nature of non-remitted depression as well as frequent co-morbid conditions creates additional challenges for conducting trials in this population. Future studies assessing vitamin D in depression should consider our experiences in design and conduct of research. Innovations in clinical trial design such as preference trials or accepting patients already using vitamin D but not achieving an optimal target value are potential solutions to some of these challenges.

Measurement of Vitamin D for Epidemiologic and Clinical Research: Shining Light on a Complex Decision.

Vitamin D is a fat-soluble vitamin that is synthesized in the skin with exposure to sunlight or is ingested from dietary supplements or food. There has been a dramatic increase in research on vitamin D, linking it with health outcomes as varied as reproductive function, infection, cardiovascular disease, and cancer. The study of vitamin D has generated much excitement, partly because there is an ideal intervention: Low levels may be common and can be remedied with widely available supplements. Determination of vitamin D status is complex and has advanced dramatically in the past 5 years. In this paper, we begin by describing important considerations for measurement of total 25-hydroxyvitamin D (25(OH)D), the biomarker traditionally assessed in epidemiologic studies. While 25(OH)D remains the most commonly measured biomarker, emerging evidence suggests that other related analytes may contribute to the characterization of an individual's vitamin D status (e.g., vitamin D-binding protein, bioavailable and free 25(OH)D, the C-3 epimer of 25(OH)D, 1,25-dihydroxyvitamin D, and 24,25-dihydroxyvitamin D). The measurement of these analytes is also complex, and there are important considerations for deciding whether their measurement is warranted in new research studies. Herein we discuss these issues and provide the reader with an up-to-date synthesis of research on vitamin D measurement options and considerations.

Laser acupuncture protocol for essential systemic arterial hypertension: randomized clinical trial / Protocolo de laser-acupuntura para hipertensão arterial sistêmica primária: ensaio clínico randomizado / Protocolo de láser-acupuntura para la hipertensión arterial sistémica primaria: ensayo clínico aleatorizado

ABSTRACT Objectives: to evaluate the efficacy of a laser acupuncture protocol developed and applied by nurses in arterial hypertension patients. Method: randomized, multicenter, triple-blind and two-armed clinical trial. The sample consisted of 102 participants, 51 per arm, both sexes, aged between 30 and 75 years, undergoing drug therapy for a year or more, with difficulty to control blood pressure, maintaining regular measures >140x90 mmHg. Participants underwent six standard or simulated laser-acupuncture sessions, for 24 minutes, within a period of six weeks. Descriptive analyzes expressed as frequencies of occurrences, means and medians were used, and analysis of the association between variables was performed using Student's t-test and Anova, using Statistica® software, version 12.0. The significance level was set at 5% (alpha=0.05). The comparison between blood pressure measurements was performed using Student's t-test for paired samples and Anova for repeated measures. Results: a significant reduction in systolic (p<0.001) and diastolic (p<0.001) blood pressure was observed among participants in the intervention arm, which was not observed in the simulation arm. Conclusion: the results have demonstrated the efficacy of the protocol. Reduction and control of blood pressure have been demonstrated, indicating the possibility of using this technology for the care of patientes with essential systemic arterial hypertension. Brazilian Registry of Clinical Trials. UTN: U1111-1177-1811. Clinical Trials NCT02530853.

RESUMO Objetivos: avaliar a eficácia de um protocolo para laser-acupuntura, desenvolvido e aplicado por enfermeiros em pacientes com hipertensão arterial. Método: ensaio clínico randomizado, multicêntrico, triplo-cego, dois braços. A amostra foi composta por 102 participantes, 51 por braço, ambos os sexos, idade entre 30 e 75 anos, em tratamento medicamentoso há um ano ou mais, com dificuldades para controle da pressão arterial, mantendo medidas regulares >140x90 mmHg. Os participantes foram submetidos a seis sessões de laser-acupuntura, padrão ou simulada, com duração de 24 minutos, no decorrer de seis semanas. Empregaram-se análises descritivas por frequências de ocorrências, médias e medianas, e de associação entre variáveis por teste t de Student e Anova, empregando o software Statistica®, versão 12.0. O nível de significância adotado foi de 5% (alpha=0,05). A comparação entre resultados da pressão arterial foi pelo teste t de Student para amostras pareadas e Anova para medidas repetidas. Resultados: observou-se redução significativa da pressão arterial sistólica (p<0,001) e diastólica (p<0,001) dos participantes do braço intervenção, evento não verificado no braço simulado. Conclusão: pelos resultados constatou-se eficácia do protocolo. Houve redução e controle da pressão arterial, indicando seu emprego como possibilidade de tecnologia para o cuidado de pessoas com hipertensão arterial sistêmica primária. Registro Brasileiro de Ensaios Clínicos. UTN: U1111-1177-1811. Clinical TrialsNCT02530853.

RESUMEN Objetivos: evaluar la eficacia de un protocolo de láser-acupuntura, desarrollado y aplicado por enfermeros en pacientes con hipertensión arterial. Método: ensayo clínico aleatorizado, multicéntrico, triple-ciego, de dos brazos. La muestra quedó conformada por 102 participantes, 51 por brazo, ambos sexos, con edades comprendidas entre los 30 y los 75 años, sometidos a tratamiento con medicamentos durante un año o más, con dificultades para controlar la presión arterial, manteniendo medidas regulares >140x90 mmHg. Los participantes se sometieron a seis sesiones de láser-acupuntura, estándar o simulada, durante 24 minutos, a lo largo de seis semanas. Se utilizaron análisis descriptivos expresados como frecuencias de ocurrencias, medias y medianas, y el análisis de la asociación entre variables se realizó mediante la prueba t de Student y Anova, utilizándose el software Statistica®, versión 12.0. El nivel de significación se fijó en un 5% (alfa=0,05). La comparación entre los resultados de la presión arterial se realizó utilizándose la prueba t de Student para muestras pareadas y Anova, para medidas repetidas. Resultados: se observó una reducción significativa de la presión arterial sistólica (p<0,001) y diastólica (p<0,001) entre los participantes en el brazo intervención, lo que no se observó en el brazo simulado. Conclusión: los resultados han comprobado la eficacia del protocolo. Se ha demostrado la reducción y el control de la presión arterial, lo que indica la posibilidad de utilizar esta tecnología para la atención de pacientes con hipertensión arterial sistémica primaria. Registro Brasileño de Ensayos Clínicos. UTN: U1111-1177-1811. Clinical TrialsNCT02530853.

[Epidemiology, knowledge and practices: a critical analysis]. / Epidemiología, saberes y prácticas: un análisis crítico.

If research companies need to permanently review their theoretical foundations and objects of study, evidently epidemiology should also consider these demands to pursue a transdisciplinary dialogue, as required by the study of the Health-Disease process. This dialogue should begin with a critique of its theoretical and methodological assumptions. Here, we discuss the concept of causality in epidemiology, exploring the "notions system" that has served as an original matrix for knowledge and practice. We analyze its close links with clinical knowledge, its dominant empirical-analytical orientation with a particular view of "the social", and finally, we present some critiques of the casual-inferential model, which is key in contemporary epidemiology.

Si cada empresa de investigación necesita revisar permanentemente sus supuestos teóricos y su propio objeto de estudio, es evidente que, en el caso de la Epidemiología, estas demandas también deben estar presentes en el interés por un diálogo transdisciplinario, tal como requiere el estudio del proceso salud-enfermedad. Este diálogo debe comenzar con una crítica de sus supuestos teóricos y metodológicos. Aquí discutimos el concepto de causalidad en la epidemiología, explorando el "sistema de nociones" que sirvió, en su evolución, como una matriz original para su conocimiento y práctica. Analizamos sus estrechos vínculos con el conocimiento clínico, su orientación empírico-analítica dominante con su visión particular "de lo social".

The Catalonia WHO Demonstration Project of Palliative Care: Results at 25 Years (1990-2015).

In 2015, the World Health Organization (WHO) Demonstration Project on Palliative Care in Catalonia (Spain) celebrated its 25th anniversary. The present report describes the achievements and progress made through this project. Numerous innovations have been made with regard to the palliative care (PC) model, organization, and policy. As the concept of PC has expanded to include individuals with advanced chronic conditions, new needs in diverse domains have been identified. The WHO resolution on "Strengthening of palliative care as a component of comprehensive care throughout the life course," together with other related WHO initiatives, support the development of a person-centered integrated care PC model with universal coverage. The Catalan Department of Health, together with key institutions, developed a new program in the year 2011 to promote comprehensive and integrated PC approach strategies for individuals with advanced chronic conditions. The program included epidemiologic research to describe the population with progressive and life-limiting illnesses. One key outcome was the development of a specific tool (NECPAL CCOMS-ICO(©)) to identify individuals in the community in need of PC. Other innovations to emerge from this project to improve PC provision include the development of the essential needs approach and integrated models across care settings. Several educational and research programs have been undertaken to complement the process. These results illustrate how a PC program can respond and adapt to emerging needs and demands. The success of the PC approach described here supports more widespread adoption by other key care programs, particularly chronic care programs.

Case-centered Analysis of Optic Neuritis After Vaccines.

We evaluated the risk of optic neuritis (ON) after vaccines, using a case-centered analysis, comparing the time since vaccination for the patients with ON with that for all similar vaccinees in a large integrated health plan population. We did not detect any association between ON and receipt of any type of vaccine.

PREventing Maternal And Neonatal Deaths (PREMAND): a study protocol for examining social and cultural factors contributing to infant and maternal deaths and near-misses in rural northern Ghana.

BACKGROUND: While Ghana is a leader in some health indicators among West African nations, it still struggles with high maternal and neonatal morbidity and mortality rates, especially in the northern areas. The clinical causes of mortality and morbidity are relatively well understood in Ghana, but little is known about the impact of social and cultural factors on maternal and neonatal outcomes. Less still is understood about how such factors may vary by geographic location, and how such variability may inform locally-tailored solutions. METHODS/DESIGN: Preventing Maternal And Neonatal Deaths (PREMAND) is a three-year, three-phase project that takes place in four districts in the Upper East, Upper West, and Northern Regions of Ghana. PREMAND will prospectively identify all maternal and neonatal deaths and 'near-misses', or those mothers and babies who survive a life threatening complication, in the project districts. Each event will be followed by either a social autopsy (in the case of deaths) or a sociocultural audit (in the case of near-misses). Geospatial technology will be used to visualize the variability in outcomes as well as the social, cultural, and clinical predictors of those outcomes. Data from PREMAND will be used to generate maps for local leaders, community members and Government of Ghana to identify priority areas for intervention. PREMAND is an effort of the Navrongo Health Research Centre and the University of Michigan Medical School. DISCUSSION: PREMAND uses an innovative, multifaceted approach to better understand and address neonatal and maternal morbidity and mortality in northern Ghana. It will provide unprecedented access to information on the social and cultural factors that contribute to deaths and near-misses in the project regions, and will allow such causal factors to be situated geographically. PREMAND will create the opportunity for local, regional, and national stakeholders to see how these events cluster, and place them relative to traditional healer compounds, health facilities, and other important geographic markers. Finally, PREMAND will enable local communities to generate their own solutions to maternal and neonatal morbidity and mortality, an effort that has great potential for long-term impact.

Effectiveness of Topical Nigella sativa Seed Oil in the Treatment of Cyclic Mastalgia: A Randomized, Triple-Blind, Active, and Placebo-Controlled Clinical Trial.

Cyclic mastalgia is common in women and has no optimal therapy. Analgesic effects of Nigella sativa have been reported. Thus, the effect of a standardized N. sativa seed oil (600 mg applied to the site of pain bis in die for 2 months) on the 10-centimeter visual analog scale scores of pain severity in 52 women with cyclic mastalgia was compared to that of topical diclofenac (20 mg bis in die) (n = 51) and placebo (n = 53). There was no significant difference between the 1- and 2-month pain scores in the active treatment groups (p > 0.05). The pain scores of the active treatment groups did not differ significantly at 1 and 2 months (p > 0.05). The endpoint pain scores of the active treatment groups decreased significantly compared with the baseline (both p < 0.001). The pain scores of the active treatment groups at 1 and 2 months were significantly smaller than those of the placebo group (both p < 0.001). The pain scores of the placebo group at 1 and 2 months were not significantly different from the baseline (p > 0.05). No adverse effect was observed. In conclusion, topical N. sativa seed oil is safe, more effective than placebo, and has clinical effectiveness comparable to topical diclofenac in the treatment of cyclic mastalgia.

Assessment of environmental enteropathy in the MAL-ED cohort study: theoretical and analytic framework.

Individuals in the developing world live in conditions of intense exposure to enteric pathogens due to suboptimal water and sanitation. These environmental conditions lead to alterations in intestinal structure, function, and local and systemic immune activation that are collectively referred to as environmental enteropathy (EE). This condition, although poorly defined, is likely to be exacerbated by undernutrition as well as being responsible for permanent growth deficits acquired in early childhood, vaccine failure, and loss of human potential. This article addresses the underlying theoretical and analytical frameworks informing the methodology proposed by the Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development (MAL-ED) cohort study to define and quantify the burden of disease caused by EE within a multisite cohort. Additionally, we will discuss efforts to improve, standardize, and harmonize laboratory practices within the MAL-ED Network. These efforts will address current limitations in the understanding of EE and its burden on children in the developing world.

[Health-related quality of life in patients with bronchial asthma]. / Jakosc zycia zalezna od stanu zdrowia u chorych na astme oskrzelowa

A patient is not, or at least should not be, a passive subject, but the active participant of the process of asthma treatment. This naturally imposes covering patients with bronchial asthma with a holistic model of care. Assessment of health-related quality of life (HRQoL) is one component of this model. HRQoL of asthma patients can be determined with an array of generic instruments, e.g. Medical Outcomes Survey Short Form 36 (SF-36), EuroQoL questionnaire (EQ-5D) or World Health Organization Quality of Life Questionnaire (WHOQOL), as well as with the specific tools, among which Saint George's Respiratory Questionnaire (SGRO) and Asthma Quality of Life Questionnaire (AQLQ) belong to the most widely used. HRQoL is significantly associated with the degree of asthma control. However, literature data suggest that a determination of HRQoL alone, with either specific or generic instrument, can be insufficient, as the level of health-related quality of life turned out to be modulated by three groups of factors: 1) demographic characteristics of patients, 2) clinical parameters, and 3) personality traits of respondents. Due to particularly strong effect of psychological characteristics on the quality of life of patients with bronchial asthma, also the level of depressiveness should be examined along with the HRQoL determination. Furthermore, complex assessment of the quality of life and its determinants should be conducted longitudinally, either in individual patients or in epidemiological studies.

Clinical Effects of Portulaca Oleracea Seeds on Dyslipidemia in Obese Adolescents: a Triple-blinded Randomized Controlled Trial.

OBJECTIVE: Childhood obesity is a major public health concern worldwide while the current epidemic may be secondary to over consumption of high-fat, energy-rich foods. Purslane (Portulaca oleracea L.) has been traditionally used in medicine for several antioxidant and anti-atherogenic activities. In this study the anti-dyslipidemic effects of P.oleracea was evaluated in obese adolescents. METHODS: In this triple-blinded randomized placebo-controlled clinical trial which was done from July 2011 to June 2012, obese adolescent patients whom were referred to the Isfahan Cardiovascular Research Institute (Iran) were randomly allocated to the two arms of cases and controls. The cases group was asked to take one capsule containing powdered P. oleracea seeds (500 milligrams) two times a day for one month, and the controls group were asked to take identical but placebo (lactose) capsules in the same way. Biochemical parameters including 12-hours fasting serum levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) were measured before the initiation and after the completion of the study protocol. FINDINGS: Total cholesterol, LDL-C, and TG showed statistically significant changes over time (one month) in the P. oleracea group (p < 0.05). However, between-group analysis using general linear model (multivariate) test revealed that the differences in the mentioned parameters between two study groups were statistically significant just for LDL-C and TG, while others did not differ significantly. CONCLUSION: P. oleracea L. may have positive effects on serum lipids profile which may be attributed to its polyphenolic and antioxidant compounds. This herbal drug seems to be well-tolerated in adolescent population as well. Further studies are recommended.

Simplified antibiotic regimens for the management of clinically diagnosed severe infections in newborns and young infants in first-level facilities in Karachi, Pakistan: study design for an outpatient randomized controlled equivalence trial.

BACKGROUND: Infection in young infants is a major cause of morbidity and mortality in low-middle income countries, with high neonatal mortality rates. Timely case management is lifesaving, but the current standard of hospitalization for parenteral antibiotic therapy is not always feasible. Alternative, simpler antibiotic regimens that could be used in outpatient settings have the potential to save thousands of lives. METHODS: This trial aims to determine whether 2 simplified antibiotic regimens are equivalent to the reference therapy with 7 days of once-daily (OD) intramuscular (IM) procaine penicillin and gentamicin for outpatient management of young infants with clinically presumed systemic bacterial infection treated in primary health-care clinics in 5 communities in Karachi, Pakistan. The reference regimen is close to the current recommendation of the hospital-based intravenous ampicillin and gentamicin therapy for neonatal sepsis. The 2 comparison arms are (1) IM gentamicin OD and oral amoxicillin twice daily for 7 days; and (2) IM penicillin and gentamicin OD for 2 days, followed by oral amoxicillin twice daily for 5 days; 2250 "evaluable" infants will be enrolled. The primary outcome of this trial is treatment failure (death, deterioration or lack of improvement) within 7 days of enrollment. Results are expected by early 2014. DISCUSSION: This trial will determine whether simplified antibiotic regimens with fewer injections in combination with high-dose amoxicillin are equivalent to 7 days of IM procaine penicillin and gentamicin in young infants with clinical severe infection. Results will have program and policy implications in countries with limited access to hospital care and high burden of neonatal deaths.

Rationale and design of a randomized controlled trial of the effect of retinol and vitamin D supplementation on treatment in active pulmonary tuberculosis patients with diabetes.

BACKGROUND: The association between pulmonary tuberculosis (PTB) and diabetes mellitus (DM) has been previously attracted much attention. Diabetes alters immunity to tuberculosis, leading to more frequent treatment failure in TB patients with DM. Moreover, TB and DM often coincide with micronutrients deficiencies, such as retinol and vitamin D, which are especially important to immunity of the body and may influence pancreas ß-cell function. However, the effects of retinol and vitamin D supplementation in active TB patients with diabetes on treatment outcomes, immune and nutrition state are still uncertain. We are conducting a randomized controlled trial of vitamin A and/or D in active PTB patients with DM in a network of 4 TB treatment clinics to determine whether the supplementation could improve the outcome in the patients. METHODS/DESIGN: This is a 2×2 factorial trial. We plan to enroll 400 active PTB patients with DM, and randomize them to VA (2000 IU daily retinol); VD (400 IU daily cholecalciferol); VAD (2000 IU daily retinol plus 400 IU cholecalciferol) or control (placebo) group. Our primary outcome measure is the efficacy of anti-tuberculosis treatment and ameliorating of glucose metabolism, and the secondary outcome measure being immune and nutrition status of the subjects. Of the first 37 subjects enrolled: 8 have been randomized to VA, 10 to VD, 9 to VAD and 10 to control. To date, the sample is 97.3% Han Chinese and 91.9% female. The average fasting plasma glucose level is 12.19 mmol/L. DISCUSSION: This paper describes the design and rationale of a randomized clinical trial comparing VA and/or VD supplementation to active pulmonary TB patients with DM. Our trial will allow rigorous evaluation of the efficacy of the supplementation to active TB and DM therapy for improving clinical outcomes and immunological condition. This detailed description of trial methodology can serve as a template for the development of future treatment scheme for active TB patient with DM. TRIAL REGISTRATION: ChiCTR-TRC-12002546.