Homeopathy for Chronic Non-specific Low Back Pain: Study Protocol for a Randomized, Double-Blind, Crossover, Placebo-Controlled Clinical Trial Investigating the Efficacy of the Biotherapic Lumbar Vertebra (The BIOVERT Trial).

BACKGROUND: Chronic non-specific low back pain (CNSLBP) lacks identifiable anatomical pathology and effective pharmacological treatment. Alternative approaches in homeopathy, specifically clinical homeopathy, utilize ultra-diluted (potentized) biological products. In Brazil, standardized biotherapics from sheep tissues, particularly fifty-millesimal (LM) potencies of sheep Lumbar Vertebra, have shown promise in alleviating CNSLBP. OBJECTIVES: Our objective is to present the study protocol of a clinical trial that will assess the efficacy and safety of the biotherapic Lumbar Vertebra LM2 in the short-term management of CNSLBP and to estimate its therapeutic duration. METHODS: A randomized, double-blind, crossover, placebo-controlled clinical trial spanning 8 weeks per participant was designed. Participants will include 120 individuals (aged 20 to 60 years) with clinically diagnosed CNSLBP by the study's physiotherapist. Exclusion criteria are radicular pain, signs of radiculopathy, specific lumbar spine disorders, pregnancy, or puerperium (up to 60 days after delivery). The medical intervention includes participants being randomly assigned to one of two treatment sequences: homeopathy-placebo or placebo-homeopathy. The treatments will consist of Lumbar Vertebra LM2 oral solution, topical cream, and indistinguishable placebos. Each treatment period will span 2 weeks, with a 4-week washout interval between them. Primary outcome is the assessment of changes in self-reported pain levels using the numeric rating scale (NRS) score, analyzed with a random effects model across both treatment periods. Secondary outcomes are assessment of changes in self-reported disability levels using the Oswestry Disability Index (ODI), analyzed with a random effects model across both treatment periods, and pain and disability variations, evaluated by the NRS score and ODI respectively, after the first and second treatment periods. Adverse events will be assessed at weeks 2 and 8. Pain medications will be used concomitantly. Adherence will be evaluated by the weight of medication returned/standard weight. DISCUSSION: The BIOVERT (Bioactive Vertebra) trial protocol is designed to investigate a homeopathic strategy for short-term CNSLBP treatment. Favorable outcomes for homeopathy could prompt subsequent studies evaluating the long-term effectiveness of LM potencies of Lumbar Vertebra for CNSLBP. TRIAL REGISTRATION: UMIN Clinical Trials Registry - ID: UMIN000051957.

Barriers and facilitators to utilizing digital health technologies by healthcare professionals.

Digital technologies change the healthcare environment, with several studies suggesting barriers and facilitators to using digital interventions by healthcare professionals (HPs). We consolidated the evidence from existing systematic reviews mentioning barriers and facilitators for the use of digital health technologies by HP. Electronic searches were performed in five databases (Cochrane Database of Systematic Reviews, Embase®, Epistemonikos, MEDLINE®, and Scopus) from inception to March 2023. We included reviews that reported barriers or facilitators factors to use technology solutions among HP. We performed data abstraction, methodological assessment, and certainty of the evidence appraisal by at least two authors. Overall, we included 108 reviews involving physicians, pharmacists, and nurses were included. High-quality evidence suggested that infrastructure and technical barriers (Relative Frequency Occurrence [RFO] 6.4% [95% CI 2.9-14.1]), psychological and personal issues (RFO 5.3% [95% CI 2.2-12.7]), and concerns of increasing working hours or workload (RFO 3.9% [95% CI 1.5-10.1]) were common concerns reported by HPs. Likewise, high-quality evidence supports that training/educational programs, multisector incentives, and the perception of technology effectiveness facilitate the adoption of digital technologies by HPs (RFO 3.8% [95% CI 1.8-7.9]). Our findings showed that infrastructure and technical issues, psychological barriers, and workload-related concerns are relevant barriers to comprehensively and holistically adopting digital health technologies by HPs. Conversely, deploying training, evaluating HP's perception of usefulness and willingness to use, and multi-stakeholders incentives are vital enablers to enhance the HP adoption of digital interventions.

Clinical Evolution of Preschool Picky Eater Children Receiving Oral Nutritional Supplementation during Six Months: A Prospective Controlled Clinical Trial.

OBJECTIVE: To determine if oral nutritional supplementation of picky eater children has a beneficial effect in addition to nutritional guidance on anthropometric parameters, nutrient intake, appetite, physical activity, and health complications. METHODS: This is a randomized, single-blind, controlled clinical trial that included Brazilian picky eater children aged 24 to 60 months. The individuals were randomized into a control group (CG) (n = 17) and an intervention group (IG) (n = 18), and were followed up in seven meetings for 180 days (baseline plus one meeting every 30 days). The CG received nutritional guidance for food selectivity, while the IG received the same guidance plus oral nutritional supplementation. Anthropometric and nutrient intake assessments were carried out, and appetite, physical activity and health complications were investigated. RESULTS: In the IG, the z-score of weight and height increased significantly over time (p < 0.05), while the body fat percentage (BFP) and BMI z-score remained unchanged. The percentage of inadequate intake of vitamins D, C and folate reduced in the IG over time compared to the CG (p < 0.05). In the IG, the score assigned by parents to the appetite scale increased over time (p < 0.05). There was no difference between the groups in the scores on the physical activity and global health scales, and in the number of health complications. CONCLUSIONS: Picky eater children that were supplemented increased their weight not by gaining fat, but due to an increase in stature, as shown by BMI z-score and BFP, that remained unchanged. Furthermore, they showed a decrease in inadequate micronutrient intake during the intervention. An improvement in appetite was also observed over time, attesting to the benefit of supplementation.

Homeopathy for COVID-19 in primary care: A randomized, double-blind, placebo-controlled trial (COVID-Simile study).

BACKGROUND: Different homeopathic approaches have been used as supportive care for coronavirus disease 2019 (COVID-19) cases, but none has been tested in a clinical trial. OBJECTIVES: To investigate the effectiveness and safety of the homeopathic medicine, Natrum muriaticum LM2, for mild cases of COVID-19. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS: A randomized, double-blind, two-armed, parallel, single-center, placebo-controlled clinical trial was conducted from June 2020 to April 2021 in São-Carlos, Brazil. Participants aged > 18 years, with influenza-like symptoms and positive result from a real-time polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 were recruited and randomized (1:1) into two groups that received different treatments during a period of at-home-isolation. One group received the homeopathic medicine Natrum muriaticum, prepared with the second degree of the fifty-millesimal dynamization (LM2; Natrum muriaticum LM2), while the other group received a placebo. OUTCOME MEASURES: The primary endpoint was time until recovery from COVID-19 influenza-like symptoms. Secondary measures included a survival analysis of the number and severity of COVID-19 symptoms (influenza-like symptoms plus anosmia and ageusia) from a symptom grading scale that was informed by the participant, hospital admissions, and adverse events. Kaplan-Meier curves were used to estimate time-to-event (survival) measures. RESULTS: Data from 86 participants were analyzed (homeopathy, n = 42; placebo, n = 44). There was no difference in time to recovery between two groups among participants who were reporting influenza-like symptoms at the beginning of monitoring (homeopathy, n = 41; placebo, n = 41; P = 0.56), nor in a sub-group that had at least 5 moderate to severe influenza-like symptoms at the beginning of monitoring (homeopathy, n = 15; placebo, n = 17; P = 0.06). Secondary outcomes indicated that a 50% reduction in symptom score was achieved significantly earlier in the homeopathy group (homeopathy, n = 24; placebo, n = 25; P = 0.04), among the participants with a basal symptom score ≥ 5. Moreover, values of restricted mean survival time indicated that patients receiving homeopathy might have improved 0.9 days faster during the first five days of follow-up (P = 0.022). Hospitalization rates were 2.4% in the homeopathy group and 6.8% in the placebo group (P = 0.62). Participants reported 3 adverse events in the homeopathy group and 6 in the placebo group. CONCLUSION: Results showed that Natrum muriaticum LM2 was safe to use for COVID-19, but there was no statistically significant difference in the primary endpoints of Natrum muriaticum LM2 and placebo for mild COVID-19 cases. Although some secondary measures do not support the null hypothesis, the wide confidence intervals suggest that further studies with larger sample sizes and more symptomatic participants are needed to test the effectiveness of homeopathic Natrum muriaticum LM2 for COVID-19. TRIAL REGISTRATION: UMIN Clinical Trials Registry ID: JPRN-UMIN000040602.

Prevalence of childhood anaemia in Brazil: still a serious health problem: a systematic review and meta-analysis.

OBJECTIVE: To estimate the prevalence of anaemia in Brazilian children up to 83·9 months old. DESIGN: Systematic review and meta-analysis, using databases PubMed, Scopus, SciELO, Lilacs, Google Scholar, Periódicos Capes, Arca, Biblioteca Virtual em Saúde, Microsoft Academic Search and Cochrane Library using search terms: anaemia, prevalence, child and Brazil. PROSPERO Registration number: CRD42020208818. SETTING: Cross-sectional, cohort, case-control and intervention studies published between 2007 and 2020 were searched, excluding those who assessed children with an illness or chronic condition. The main outcome was anaemia prevalence. Random effects models based on the inverse variance method were used to estimate pooled prevalence measures. Sensitivity analyses removed studies with high contribution to overall heterogeneity. PARTICIPANTS: From 6790 first screened, 134 eligible studies were included, totalling 46 978 children aged zero to 83·9 months analysed, with adequate regions representativeness. RESULTS: Pooled prevalence of anaemia was 33 % (95 % CI 30, 35). Sensitivity analyses showed that withdrawal of studies that contributed to high heterogeneity did not influence national average prevalence. CONCLUSIONS: Childhood anaemia is still a serious public health problem in Brazil, exposing 33 % of Brazilian children to the anaemia repercussions. The main limitation of the study is the estimation of national prevalence based on local surveys, but a large number of studies were included, with representation in all regions of the country, giving strength to the results. In Brazil, more public policies are needed to promote supplementation, fortification and access to healthy eating to reduce the high level of anaemia among children.

Homeopathy for Covid-19 in Primary Care: A structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: To investigate the effectiveness and safety of homeopathic medicine Natrum muriaticum (LM2) for mild cases of COVID-19 in Primary Health Care. TRIAL DESIGN: A randomized, two-armed (1:1), parallel, placebo-controlled, double-blind, clinical trial is being performed to test the following hypotheses: H0: homeopathic medicines = placebo (null hypothesis) vs. H1: homeopathic medicines ≠ placebo (alternative hypothesis) for mild cases of COVID-19 in Primary Care. PARTICIPANTS: Setting: Primary Care of São Carlos - São Paulo - Brazil. One hundred participants aged 18 years or older, with Influenza-like symptoms and a positive RT-PCR for SARS-CoV-2. Willingness to give informed consent and to comply with the study procedures is also required. Exclusion criterium: severe acute respiratory syndrome. INTERVENTION AND COMPARATOR: Homeopathy: 1 globule of Natrum muriaticum LM2 diluted in 20 mL of alcohol 30% and dispensed in a 30 ml bottle. Placebo: 20 mL of alcohol 30% dispensed in a 30 ml bottle. Posology: one drop taken orally every 4 hours (6 doses/day) while there is fever, cough, tiredness, or pain (headache, sore throat, muscle aches, chest pain, etc.) followed by one drop every 6 hours (4 doses/day) until the fourteenth day of use. The bottle of study medication should be submitted to 10 vigorous shakes (succussions) before each dose. Posology may be changed by telemedicine, with no break in blinding. Study medication should be maintained during home isolation. According to the Primary Care protocol, the home isolation period lasts until the 10th day after the appearance of the first symptom, or up to 72 hours without symptoms. MAIN OUTCOMES: The primary endpoint will be time to recovery, defined as the number of days elapsed before all COVID-19 Influenza-like symptoms are recorded as mild or absent during home isolation period. Secondary measures are recovery time for each COVID-19 symptom; score of the scale created for the study (COVID-Simile Scale); medicines used during follow-up; number of days of follow-up; number of visits to emergency services; number of hospitalizations; other symptoms and Adverse Events during home isolation period. RANDOMISATION: The study Statistician generated a block randomization list, using a 1:1 ratio of the two groups (denoted as A and B) and a web-based tool ( http://www.random.org/lists ). BLINDING (MASKING): The clinical investigators, the statistician, the Primary Care teams, the study collaborators, and the participants will remain blinded from the identity of the two treatment groups until the end of the study. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): One hundred participants are planned to be randomized (1:1) to placebo (50) or homeopathy (50). TRIAL STATUS: Protocol version/date May 21, 2020. Recruitment is ongoing. First participant was recruited/included on June 29,2020. Due to recruitment adaptations to Primary Care changes, the authors anticipate the trial will finish recruiting on April 10, 2021. TRIAL REGISTRATION: COVID-Simile Study was registered at the University Hospital Medical Information Network (UMIN - https://www.umin.ac.jp/ctr/index.htm ) on June 1st, 2020, and the trial start date was June 15, 2020. Unique ID: UMIN000040602. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Aloysia polystachya (Griseb.) Moldenke (Verbenaceae) powdered leaves are effective in treating anxiety symptoms: A phase-2, randomized, placebo-controlled clinical trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Aloysia polystachya (Griseb.) Moldenke (Verbenaceae) is a plant traditionally used as medicine for anxiety symptoms. This activity was confirmed in preclinical studies. However, its efficacy was never studied in human clinical trials. AIM OF THE STUDY: We aimed to test the hypothesis that the herbal medicine of A. polystachya is superior to placebo for the treatment of anxiety-related symptoms in adults after 8 weeks. PATIENTS AND METHODS: This was a randomized, double-blind, placebo-controlled, phase-2 clinical trial. Fifty-four adults with self-reported anxiety symptoms were randomly allocated to receive either capsules containing A. polystachya powdered leaves (300 mg, twice a day) or placebo (maltodextrin), for 8 weeks. The intensity of anxiety symptoms was assessed by the Hamilton Anxiety Ranking Scale (HAM-A) at baseline and after 2, 4 and 8 weeks. All analyses were adjusted for physical activity (assessed by the International Physical Activity Questionnaire [IPAQ], short version) and gender. RESULTS: We confirmed the presence of acteoside (chromatographic analysis) and carvone and limonene (gas chromatography) as major constituents in our plant material. Only patients that received A. polystachya experienced a significant decrease in their HAM-A scores, with none or mild side-effects. CONCLUSION: Administration of powdered leaves of A. polystachya, rich in acteoside, carvone and limonene, to adults with anxiety symptoms was significantly superior to placebo in decreasing HAM-A scores after 8 weeks. This finding confirms the ethnopharmacological use of this plant for anxiety symptoms.

Efficacy of a Homeopathic Medicine of Capsicum frutescens L. (Solanaceae) in the Treatment of Hot Flashes in Menopausal Women: A Phase-2 Randomized Controlled Trial.

BACKGROUND: Hot flashes are common in women during menopause, and are an important cause of discomfort, increasing the number of medical appointments. Hormone replacement therapy is an effective treatment, but it can bring undesirable consequences. Alternative treatments exist but they are not universally accepted or effective. The ingestion of malagueta peppers (popular name for fruits of Capsicum frutescens L., Solanaceae) causes sensations similar to those experienced by women during hot flashes. Using the homeopathic law of similars (let like be cured by like), we hypothesized that a homeopathic remedy made of malagueta peppers can be effective in alleviating menopausal hot flashes. We named this remedy Malagueta. METHODS: This randomized, placebo-controlled, double-blind, phase-2 clinical trial was designed to test the hypothesis that, in menopausal women, the homeopathic medicine Malagueta (30 CH), compared with placebo, will significantly reduce the intensity of hot flashes, after 4 weeks of treatment. The primary outcome was the intensity of hot flashes, measured by the Measure Yourself Medical Outcome Profile (MYMOP) instrument. A total of 40 women were enrolled in the study, 20 in each group. RESULTS: The effect of Malagueta on the primary outcome, the intensity of hot flashes, assessed by MYMOP, was superior to that of placebo over the 4 weeks of treatment, with worsening in both groups after treatment was interrupted (after week 4, p < 0.001 in ordinal logistic regression). The odds ratio for treatment response (reduction of at least three MYMOP categories) was 2.78 (95% confidence interval, 0.77 to 10.05). Treatment with Malagueta, compared with placebo, also reduced the intensity of the secondary symptoms (p = 0.001) and improved level of activity (p = 0.025) and well-being (p = 0.008). CONCLUSION: The homeopathic medicine of Capsicum frutescens (Malagueta) was superior to placebo in reducing the intensity of hot flashes in menopausal women after 4 weeks of treatment.

Double-blind evaluation of homeopathy on cocaine craving: a randomized controlled pilot study.

BACKGROUND: Brazil is among the nations with the greatest rates of annual cocaine usage. Pharmacological treatment of cocaine addiction is still limited, opening space for nonconventional interventions. Homeopathic Q-potencies of opium and Erythroxylum coca have been tested in the integrative treatment of cocaine craving among homeless addicts, but this setting had not proven feasible, due to insufficient recruitment. OBJECTIVE: This study investigates the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS: A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence (F14.2). The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group). MAIN OUTCOME MEASURES: The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were reported in both groups. RESULTS: The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% (standard deviation (SD): 22.3%), compared to 29.8% (SD: 30.6%) in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients' appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group (P = 0.41). CONCLUSIONS: A psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention. TRIAL REGISTRATION: RBR-2xzcwz (http://www.ensaiosclinicos.gov.br).

Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

INTRODUCTION: Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma. OBJECTIVE: The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol (Organon.modus) on perennial asthma in adolescents. METHODS: Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. Patients: 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. Setting: a secondary care medical specialist centre. Intervention: continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. Primary outcome: number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit. RESULTS: Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 (p = 0.18); median number of days of fenoterol use per patient: 3 versus 5 (p = 0.41); visits to an emergency room: 1 versus 6 (p = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% (p = 0.05). Few Adverse Events were reported. CONCLUSIONS: This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating homeopathy on teenage asthma, when performed by specialists following a standardised clinical-pharmaceutical homeopathic protocol. CLINICAL TRIAL REGISTRATION: RBR-6XTS8Z.

Availability of herbal medicines and medicinal plants in the primary health facilities of the state of São Paulo, Southeast Brazil: results from the National Program for Access and Quality Improvement in Primary Care. / Disponibilidade de medicamentos fitoterápicos e plantas medicinais nas unidades de atenção básica do Estado de São Paulo: resultados do Programa Nacional de Melhoria do Acesso e da Qualidade da Atenção Básica (PMAQ).

This study aims to describe the availability of herbal medicines and medicinal plants in the primary care facilities in the state of São Paulo, Southeast Brazil, from the results of the first cycle of the National Program for Access and Quality Improvement in Primary Care (PMAQ). The PMAQ uses a national cross-sectional multicenter design, with data from 4,249 health facilities distributed among 645 municipalities of the state of São Paulo. Of these facilities, 467 (11%) had herbal medicines and/or medicinal plants. Among the 645 municipalities, 104 (16.1%) had at least one health facility that provided these drugs. We observed that the availability of herbal medicines is greater in larger cities with better social and economic conditions. Furthermore, we found that use of industrialized herbal medicines prevailed over that of vegetal drugs or compounded herbal medicines.

Disponibilidade de medicamentos fitoterápicos e plantas medicinais nas unidades de atenção básica do Estado de São Paulo: resultados do Programa Nacional de Melhoria do Acesso e da Qualidade da Atenção Básica (PMAQ) / Availability of herbal medicines and medicinal plants in the primary health facilities of the state of São Paulo, Southeast Brazil: results from the National Program for Access and Quality Improvement in Primary Care

Resumo Este estudo objetiva descrever a utilização e a disponibilidade de medicamentos fitoterápicos e plantas medicinais nas unidades de atenção básica do estado de São Paulo, a partir dos resultados do primeiro Ciclo do Programa Nacional de Melhoria do Acesso e da Qualidade da Atenção Básica (PMAQ). O PMAQ utiliza um desenho transversal e multicêntrico, de abrangência nacional, sendo utilizados no presente estudo os dados de 4.249 unidades de saúde, distribuídas entre os 645 municípios do estado de São Paulo. Dentre este total de unidades, em 467 (11%) foi constatada a disponibilidade de medicamentos fitoterápicos e/ou plantas medicinais. Dentre os 645 municípios paulistas, em 104 (16,1%) havia ao menos uma unidade de saúde que disponibilizava estes fármacos. Observou-se que a disponibilidade da fitoterapia é maior em municípios mais populosos e com melhores condições sociais e econômicas. Além disso, foi constatado que medicamento fitoterápico industrializado tem sido mais utilizado do que a droga vegetal ou medicamento fitoterápico manipulado.

Abstract This study aims to describe the availability of herbal medicines and medicinal plants in the primary care facilities in the state of São Paulo, Southeast Brazil, from the results of the first cycle of the National Program for Access and Quality Improvement in Primary Care (PMAQ). The PMAQ uses a national cross-sectional multicenter design, with data from 4,249 health facilities distributed among 645 municipalities of the state of São Paulo. Of these facilities, 467 (11%) had herbal medicines and/or medicinal plants. Among the 645 municipalities, 104 (16.1%) had at least one health facility that provided these drugs. We observed that the availability of herbal medicines is greater in larger cities with better social and economic conditions. Furthermore, we found that use of industrialized herbal medicines prevailed over that of vegetal drugs or compounded herbal medicines.

Effects of zinc supplementation on fatigue and quality of life in patients with colorectal cancer.

OBJECTIVE: To investigate the effects of oral zinc supplementation on fatigue intensity and quality of life of patients during chemotherapy for colorectal cancer. METHODS: A prospective, randomized, double-blinded, placebo-controlled study was conducted with 24 patients on chemotherapy for colorectal adenocarcinoma in a tertiary care public hospital. The study patients received zinc capsules 35mg (Zinc Group, n=10) or placebo (Placebo Group, n=14) orally, twice daily (70mg/day), for 16 weeks, from the immediate postoperative period to the fourth chemotherapy cycle. Approximately 45 days after surgical resection of the tumor, all patients received a chemotherapeutic regimen. Before each of the four cycles of chemotherapy, the Functional Assessment of Chronic Illness Therapy-Fatigue scale was completed. We used a linear mixed model for longitudinal data for statistical analysis. RESULTS: The scores of quality of life and fatigue questionnaires were similar between the groups during the chemotherapy cycles. The Placebo Group presented worsening of quality of life and increased fatigue between the first and fourth cycles of chemotherapy, but there were no changes in the scores of quality of life or fatigue in the Zinc Group. CONCLUSION: Zinc supplementation prevented fatigue and maintained quality of life of patients with colorectal cancer on chemotherapy. OBJETIVO: Investigar os efeitos da suplementação oral de zinco sobre a intensidade da fadiga e a qualidade de vida de pacientes durante a quimioterapia para neoplasia colorretal. MÉTODOS: Estudo prospectivo, randomizado, controlado e duplo-cego conduzido em um hospital universitário público terciário, com 24 pacientes em regime quimioterápico para adenocarcinoma colorretal. Os pacientes receberam cápsulas de zinco 35mg (Grupo Zinco, n=10) ou placebo (Grupo Placebo, n=14) por via oral, duas vezes ao dia (70mg/dia), durante 16 semanas, desde o período pós-operatório imediato até o quarto ciclo de quimioterapia. Todos os pacientes receberam quimioterapia por aproximadamente 45 dias após a ressecção cirúrgica do tumor. A escala Functional Assessment of Chronic Illness Therapy-Fatigue foi preenchida antes de cada um dos quatro ciclos de quimioterapia. Utilizou-se o modelo de regressão linear misto para dados longitudinais para análise estatística. RESULTADOS: Os escores de qualidade de vida e de fadiga foram semelhantes entre os grupos de estudo durante os ciclos de quimioterapia. O Grupo Placebo apresentou piora da qualidade de vida e da fadiga entre o primeiro e o quarto ciclos de quimioterapia, mas não houve mudança nos escores de qualidade de vida e fadiga no Grupo Zinco. CONCLUSÃO: A suplementação com zinco previne a fadiga e preserva a qualidade de vida de pacientes em quimioterapia para neoplasia colorretal.

Effects of zinc supplementation on fatigue and quality of life in patients with colorectal cancer / Efeitos da suplementação de zinco na fadiga e na qualidade de vida de pacientes com câncer colorretal

ABSTRACT Objective To investigate the effects of oral zinc supplementation on fatigue intensity and quality of life of patients during chemotherapy for colorectal cancer. Methods A prospective, randomized, double-blinded, placebo-controlled study was conducted with 24 patients on chemotherapy for colorectal adenocarcinoma in a tertiary care public hospital. The study patients received zinc capsules 35mg (Zinc Group, n=10) or placebo (Placebo Group, n=14) orally, twice daily (70mg/day), for 16 weeks, from the immediate postoperative period to the fourth chemotherapy cycle. Approximately 45 days after surgical resection of the tumor, all patients received a chemotherapeutic regimen. Before each of the four cycles of chemotherapy, the Functional Assessment of Chronic Illness Therapy-Fatigue scale was completed. We used a linear mixed model for longitudinal data for statistical analysis. Results The scores of quality of life and fatigue questionnaires were similar between the groups during the chemotherapy cycles. The Placebo Group presented worsening of quality of life and increased fatigue between the first and fourth cycles of chemotherapy, but there were no changes in the scores of quality of life or fatigue in the Zinc Group. Conclusion Zinc supplementation prevented fatigue and maintained quality of life of patients with colorectal cancer on chemotherapy.

RESUMO Objetivo Investigar os efeitos da suplementação oral de zinco sobre a intensidade da fadiga e a qualidade de vida de pacientes durante a quimioterapia para neoplasia colorretal. Métodos Estudo prospectivo, randomizado, controlado e duplo-cego conduzido em um hospital universitário público terciário, com 24 pacientes em regime quimioterápico para adenocarcinoma colorretal. Os pacientes receberam cápsulas de zinco 35mg (Grupo Zinco, n=10) ou placebo (Grupo Placebo, n=14) por via oral, duas vezes ao dia (70mg/dia), durante 16 semanas, desde o período pós-operatório imediato até o quarto ciclo de quimioterapia. Todos os pacientes receberam quimioterapia por aproximadamente 45 dias após a ressecção cirúrgica do tumor. A escala Functional Assessment of Chronic Illness Therapy-Fatigue foi preenchida antes de cada um dos quatro ciclos de quimioterapia. Utilizou-se o modelo de regressão linear misto para dados longitudinais para análise estatística. Resultados Os escores de qualidade de vida e de fadiga foram semelhantes entre os grupos de estudo durante os ciclos de quimioterapia. O Grupo Placebo apresentou piora da qualidade de vida e da fadiga entre o primeiro e o quarto ciclos de quimioterapia, mas não houve mudança nos escores de qualidade de vida e fadiga no Grupo Zinco. Conclusão A suplementação com zinco previne a fadiga e preserva a qualidade de vida de pacientes em quimioterapia para neoplasia colorretal.

Effect of Zinc Supplementation on Antioxidant Defenses and Oxidative Stress Markers in Patients Undergoing Chemotherapy for Colorectal Cancer: a Placebo-Controlled, Prospective Randomized Trial.

The study aimed to investigate the effect of oral zinc supplementation on antioxidant defenses and oxidative stress markers during chemotherapy for colorectal cancer. Twenty-four patients who had undergone surgical resection of colorectal cancer participated in this placebo-controlled, prospective randomized study. The supplementation was started in the perioperative period, in which 10 patients received 70 mg of zinc (zinc group, n = 10) and 14 patients received placebo (placebo group, n = 14) for 16 weeks. Approximately 45 days after surgical resection of tumor, all patients received a chemotherapeutic regimen (capecitabine, capecitabine combined with oxaliplatin or 5-fluorouracil). Vitamin C, vitamin E, antioxidant enzymes superoxide dismutase (SOD) and glutathione peroxidase (GPx), and lipid peroxidation markers malondialdehyde (MDA) and 8-isoprostane were determined before the first, second, third, and fourth chemotherapy cycles. Compared with the placebo group, the zinc group presented higher SOD values before the first, second, and fourth chemotherapy cycles and lower GPx values before the third cycle. There were no statistical differences between the study groups in vitamin C, vitamin E, MDA, or 8-isoprostane plasma values. Longitudinal analysis revealed decreased vitamin E concentration in the placebo group before the second and fourth cycles as compared with the initial values. Zinc supplementation during chemotherapy cycles increased SOD activity and maintained vitamin E concentrations. Although no effect of zinc supplementation on oxidative stress markers was observed, the increase in SOD activity indicates a production of stable free radicals, which may have a positive effect in cancer treatment.

Hospital nutritional care: propositions endorsed by the scientific community / Atención nutricional hospitalaria: proposiciones aceptadas por la comunidad científica

Background/objectives: the incidence of hospital undernutrition and its consequences for both the patient and the hospital has demanded procedures that ensure the delivery of good-quality hospital nutritional care. On the basis of literature reports, this study aimed to build a hospital nutritional care propositions that the scientific community later evaluated and endorsed. Methods: forty-one propositions concerning patient clinical nutritional care and hospital food service management by the Hospital Nutrition and Food Service were designed. One hundred professionals, researchers, and professors evaluated the propositions. Agreement with the propositions was analyzed by means of a five-point Likert scale (I strongly disagree; I partially disagree; I have no opinion; I partially agree; I totally agree) associated with each proposition. Agreement was considered to occur when 70% or more of the interviewees agreed (partially or totally) with the proposition. The procedure Proc Corresp of the software SAS 10, version 8, aided descriptive statistics and correspondence analysis. Results: more than 90% of the interviewees completely or partially agreed with 85% (35) of the 41 propositions; between 80 and 90% of the interviewees totally or partially agreed with 15% (6) of the 41 propositions. All the proposed criteria had over 70% agreement (total and partial). The lowest value of total agreement was 70%, attributed to the proposition that suggested patient’s participation in nutritional intervention. Conclusions: the scientific community presented high level of agreement with the hospital nutritional care propositions, which suggested an important consensus about it (AU)

Antecedentes/objetivos: la incidencia de desnutrición hospitalaria y sus consecuencias tanto para el paciente como para el hospital ha exigido procedimientos que aseguren un servicio de atención nutricional hospitalaria de buena calidad. Basado en los informes de la literatura, este estudio tuvo como objetivo construir proposiciones sobre los cuidados nutricionales hospitalarios, que después fueran evaluados y aprobados por la comunidad científica. Métodos: fueron desarrolladas cuarenta y una proposiciones relativas a la atención nutricional clínica del paciente y a la gestión del servicio de alimentación por el Servicio de Alimentación y Nutrición Hospitalaria. Un total de cien profesionales, investigadores y profesores evaluaron las proposiciones. Para analizar si los evaluadores estaban de acuerdo con las proposiciones se utilizó una escala Likert de cinco puntos (estoy en total desacuerdo, estoy parcialmente en desacuerdo, no tengo opinión, estoy parcialmente de acuerdo, estoy totalmente de acuerdo) asociada a cada proposición. Fue considerada concordancia cuando el 70% o más de los evaluadores estaban de acuerdo (totalmente o parcialmente) con la proposición. Para el análisis estadístico fue utilizado el procedimiento Proc Corresp del software SAS 10, versión 8, estadística descriptiva y análisis de correspondencias. Resultados: más del 90% de los entrevistados estaban total o parcialmente de acuerdo con el 85% (35) de las 41 proposiciones; entre el 80 y 90% de los entrevistados estaban total o parcialmente de acuerdo con el 15% (6) de las 41 proposiciones. Todos los criterios propuestos tuvieron más del 70% de concordancia (total y parcial). El menor valor de concordancia total fue del 70%, atribuido a la proposición que sugiere la participación del paciente en la intervención nutricional. Conclusiones: la comunidad científica presentó alto nivel de concordancia con las proposiciones para la atención nutricional hospitalaria, lo que sugiere un importante consenso al respecto (AU)

Effect of Zinc Supplementation on Serological Response to Vaccination Against Streptococcus Pneumoniae in Patients Undergoing Chemotherapy for Colorectal Cancer.

The aim of the study was to evaluate the effect of zinc supplementation on the antibody titer and the 23-valent pneumococcal seroconversion after vaccination in patients undergoing chemotherapy for colorectal cancer. The study included 25 patients undergoing postsurgery chemotherapy for colorectal adenocarcinoma (chemo group). Subjects were assessed in the perioperative period (prevaccination), before chemotherapy (4th wk) and after 3 cycles of chemotherapy (16th wk). Thirty-two healthy volunteers (control group) were included in the study. Participants received the 23-valent pneumococcal conjugate vaccine, and capsules containing zinc (Zn) sulfate (70 mg daily) or identical placebo capsules (containing wheat starch with no added Zn) for 16 wk and were randomly allocated on one of the following groups: chemo-Zn (n = 10), chemo-placebo (n = 15), control-Zn (n = 21), and control-placebo (n = 11). The antipneumococcal antibody titer against 6 polysaccharides was analyzed by ELISA and compared using linear mixed models. The seroconversion rate was compared using Fisher's exact test. An immune response to the vaccination against pneumococcus was observed in all participants. In the 16th wk, the polysaccharide 6 concentration was lower in the chemo-Zn group [2.96 (1.74-5.03) µg/mL] compared with the Chemo-Placebo group [10.75 (5.37-21.54) µg/mL] and the seroconversion rate was lower in the chemo-placebo (36%) compared with the control-placebo (85%) (P = 0.027). Zinc supplementation did not change the antibody titer after vaccination. However, the lower seroconversion rate observed in the chemo-placebo suggests an influence of zinc in the vaccinal protection.

Fraturas de fêmur em idosos no Brasil: análise espaço-temporal de 2008 a 2012 / Femoral fractures in elderly Brazilians: a spatial and temporal analysis from 2008 to 2012 / Las fracturas de fémur de ancianos en Brasil: análisis espacio-temporal de 2008 a 2012

Fraturas de fêmur em pessoas com idade igual ou superior a 60 anos (idosos) representam um grande impacto para a saúde pública, e estão associadas à elevada morbimortalidade e grandes custos socioeconômicos. Buscou-se descrever temporal e espacialmente os casos de fratura de fêmur em idosos de todas as regiões do país, por sexo, em um período de cinco anos. Foram realizadas descrições de série temporal e espacial bayesiana, baseadas em dados obtidos do Sistema de Informações Hospitalares do Sistema Único de Saúde (SIH-SUS), empregando modelo de regressão de Poisson, sobre os casos ocorridos entre os anos de 2008-2012. No período estudado ocorreram mais de 181 mil casos de fratura de fêmur, predominando o sexo feminino, sem correlações espaciais e diferenças temporais importantes. Apesar de não se observar predomínio de comportamento temporal e espacial, o número de casos de fratura de fêmur no Brasil é alto e com grandes custos financeiros e sociais. Políticas públicas de saúde visando a controlar os fatores predisponentes para esse evento devem ser urgentemente implementadas.

Fractures in the elderly (≥ 60 years) have a major public health impact and take a heavy social and economic toll. This article aimed to describe spatial and time trends in femoral fractures among elderly men and women in all regions of Brazil. Bayesian descriptive analyses of spatial and time series were performed on data obtained from the Hospital Information System of the Brazilian Unified National Health System, using Poisson regression for femoral fractures in individuals 60 years of age or older from 2008 to 2012. There were more than 181,000 femoral fractures during this period, predominantly in women, without important spatial correlations or temporal differences. Despite the lack of temporal and spatial correlations, the number of femoral fractures in elderly Brazilians was high, with heavy financial and social costs. Public health policies are urgently needed to control predisposing factors for femoral fractures in elderly Brazilians.

Las fracturas en personas mayores de 60 años (de edad avanzada) representan un impacto mayor de salud pública, se asocian con alta morbilidad y mortalidad y costos sociales y económicos importantes. El estudio trató de describir la evolución temporal y espacial de los casos de fractura de fémur en personas de edad ≥ 60 años en todas las regiones del país, por sexo. Se realizaron descripciones de serie temporales y espaciales, mediante el método bayesiano, basadas en los datos obtenidos por el Sistema de Información Hospitalaria del Sistema Único de Salud (SIH-SUS), empleando el modelo de regresión de Poisson, sobre los casos ocurridos entre los años 2008-2012. En el periodo se produjeron más de 181.000 casos de fractura de fémur, predominantemente femenino, sin correlaciones importantes diferencias espaciales y temporales. Aunque no observamos ningún predominio del comportamiento temporal y espacial, el número de casos de fractura de fémur es alto con grandes costos financieros y sociales. Las políticas de salud públicas, destinadas a controlar los factores que predisponen para este hecho, deben aplicarse urgentemente.

A homeopatia na prevenção e tratamento da dengue: uma revisão / Homeopathic medicines in the treatment and prevention of dengue: a review

Introdução: A dengue é uma importante doença tropical, com um número estimado de 50 a 100 milhões de casos a cada ano. Atualmente, não se dispõe de tratamentos específicos nem de uma vacina para a prevenção da doença, mas os praticantes da medicina homeopática sugerem que formulações homeopáticas sejam úteis como medidas profiláticas e terapêuticas para a dengue. Objetivo: Trata-se de uma revisão da literatura que busca identificar e sumarizar os estudos que investigaram medicamentos homeopáticos para o tratamento e a prevenção da dengue. Métodos: Realizou-se busca sistemática de publicações científicas nas seguintes bases de dados: PubMed, LILACS, Scopus, ISI Web of Science, The Cochrane Library, PsycInfo e SciELO, utilizando os termos "dengue" e "homeopatia" em inglês, português e espanhol. Resultados: Foi identificado um único ensaio clínico aleatorizado controlado duplo-cego, além de dois ensaios de comunidade. Entretanto, tais estudos não evidenciaram a eficácia terapêutica ou profilática das formulações homeopáticas. Conclusões: Até o momento, pela falta de ensaios clínicos randomizados, duplo-cegos e controlados bem conduzidos e em número suficiente não há evidências claras da utilidade dos medicamentos homeopáticos para o tratamento e a prevenção da dengue. Assim, as medidas usuais e já bem conhecidas empregadas na prevenção primária da doença não devem ser substituídas por formulações homeopáticas. .

Background: Dengue is an important tropical disease with an estimated number of 50 to 100 million cases per year. Currently, there are no specific treatments or a vaccine available for the control of dengue disease, but homeopathic practitioners suggest that homeopathic formulations are useful to prevent and treat symptoms of dengue. Objective: To present a review of literature that seeks to identify and summarize all studies that had investigated the utility of the homeopathic medicines in the treatment and prevention of dengue. Methods: We conducted a systematic search of published scientific articles in the following databases: PubMed, LILACS, Scopus, ISI Web of Science, The Cochrane Library, PsycInfo and SciELO, employing English, Portuguese and Spanish language. The search terms used were "dengue" and "homeopathy". Results: It was found only one randomized controlled double-blind clinical trial and two trials of community. However, these studies do not provided reliable evidences of therapeutic or prophylactic efficacy of homeopathic formulations. Conclusion: To date, due to the lack of randomized, double-blind controlled and well conducted studies in sufficient numbers, there are no clear evidences of the usefulness of homeopathic medicines for the treatment and prevention of dengue. Thus, the usual measures and well known employed in the primary prevention of disease should not be replaced by homeopathic formulations. .

[Femoral fractures in elderly Brazilians: a spatial and temporal analysis from 2008 to 2012]. / Fraturas de fêmur em idosos no Brasil: análise espaço-temporal de 2008 a 2012.

Fractures in the elderly (≥ 60 years) have a major public health impact and take a heavy social and economic toll. This article aimed to describe spatial and time trends in femoral fractures among elderly men and women in all regions of Brazil. Bayesian descriptive analyses of spatial and time series were performed on data obtained from the Hospital Information System of the Brazilian Unified National Health System, using Poisson regression for femoral fractures in individuals 60 years of age or older from 2008 to 2012. There were more than 181,000 femoral fractures during this period, predominantly in women, without important spatial correlations or temporal differences. Despite the lack of temporal and spatial correlations, the number of femoral fractures in elderly Brazilians was high, with heavy financial and social costs. Public health policies are urgently needed to control predisposing factors for femoral fractures in elderly Brazilians.