ABSTRACT
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 (300â¯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.
Subject(s)
Anti-Anxiety Agents/therapeutic use , Anxiety/drug therapy , Plant Preparations/therapeutic use , Verbenaceae , Adult , Anti-Anxiety Agents/chemistry , Capsules , Double-Blind Method , Female , Glucosides/analysis , Glucosides/therapeutic use , Humans , Male , Middle Aged , Oils, Volatile/analysis , Oils, Volatile/therapeutic use , Phenols/analysis , Phenols/therapeutic use , Phytotherapy , Plant Leaves/chemistry , Plant Preparations/chemistry , PowdersABSTRACT
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.
Subject(s)
Capsicum , Hot Flashes/drug therapy , Menopause , Phytotherapy , Plant Preparations/therapeutic use , Double-Blind Method , Female , Homeopathy , Humans , Middle Aged , Quality of Life , Severity of Illness Index , Treatment OutcomeABSTRACT
Introduction: Comorbidities are thought to have prognostic impact on outcomes of patients submitted to noninvasive ventilation (NIV). Our goal was to determine if age-adjusted Charlson comorbidity index (ACCI) could predict outcomes in patients undergoing NIV due to acute respiratory failure. Methods:Patients in respiratory failure submitted to NIV were prospective evaluated comparing patien's characteristics and outcomes according to ACCI ≤ median vs. ACCI > median. Each comorbidity composing the index was tested as predictor of NIV failure and readmission/mortality risk at 30 and 90 days, using logistic regression analysis. NIV failure was defined as need for invasive mechanical ventilation and/or death. Results: 177 patients were enrolled. Median ACCI score was 5 points. Comparing patients with ACCI > 5 with ACCI ≤ 5, the former group was older but APACHE II was similar. Time to first NIV disconnection was inferior for ACCI > 5 patients (OR 0.46, 95% CI 0.23-0.89, p = 0.021), after gender and age adjustment. No differences were found in length of stay, time on NIV, NIV complications or failure, and 30 and 90-day hospital readmission or death, before and after adjustment. None of the single comorbidities was predictive of NIV failure and readmission risk, when adjusted to sex and age. Conclusion: ACCI is not a good predictor for short and medium-term outcomes in patients submitted to NIV
Introducción: Las comorbilidades parecen tener un impacto en el pronóstico de los resultados de pacientes sometidos a ventilación no invasiva (VNI). Nuestro objetivo fue determinar si el ajuste por edad del índice de comorbilidad de Charlson (ICC) podía predecir los resultados de aquellos pacientes sometidos a VNI por insuficiencia respiratoria aguda. Métodos: Se evaluaron de forma prospectiva pacientes con insuficiencia respiratoria sometidos a VNI, comparando las características de los pacientes y sus resultados valorados como ICC
Subject(s)
Humans , Male , Female , Middle Aged , Aged , Aged, 80 and over , Comorbidity , Pulmonary Ventilation , Noninvasive Ventilation/methods , Noninvasive Ventilation/trends , Respiratory Insufficiency/therapy , Tidal Volume , Prospective StudiesABSTRACT
INTRODUCTION: Comorbidities are thought to have prognostic impact on outcomes of patients submitted to noninvasive ventilation (NIV). Our goal was to determine if age-adjusted Charlson comorbidity index (ACCI) could predict outcomes in patients undergoing NIV due to acute respiratory failure. METHODS: Patients in respiratory failure submitted to NIV were prospective evaluated comparing patient's characteristics and outcomes according to ACCI≤median vs. ACCI>median. Each comorbidity composing the index was tested as predictor of NIV failure and readmission/mortality risk at 30 and 90 days, using logistic regression analysis. NIV failure was defined as need for invasive mechanical ventilation and/or death. RESULTS: 177 patients were enrolled. Median ACCI score was 5 points. Comparing patients with ACCI>5 with ACCI≤5, the former group was older but APACHE II was similar. Time to first NIV disconnection was inferior for ACCI>5 patients (OR 0.46, 95% CI 0.23-0.89, p=0.021), after gender and age adjustment. No differences were found in length of stay, time on NIV, NIV complications or failure, and 30 and 90-day hospital readmission or death, before and after adjustment. None of the single comorbidities was predictive of NIV failure and readmission risk, when adjusted to sex and age. CONCLUSION: ACCI is not a good predictor for short and medium-term outcomes in patients submitted to NIV.
Subject(s)
Noninvasive Ventilation , Respiratory Insufficiency/complications , Respiratory Insufficiency/therapy , Acute Disease , Adult , Age Factors , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Prognosis , Prospective Studies , Severity of Illness Index , Treatment OutcomeABSTRACT
INTRODUCTION: Neurosarcoidosis occurs in about 5% to 15% of patients with sarcoidosis. The purpose of this study was to identify and characterize a cohort of neurosarcoidosis patients and to review the largest previously reported neurosarcoidosis case series. METHODS: This retrospective study enrolled all patients with the diagnosis of probable or definitive neurosarcoidosis according to Zajicek and Scolding criteria, followed at the neurology department of a tertiary center in Portugal from January 1989 to December 2015. RESULTS: A total of 15 patients presented a diagnosis of probable or definitive neurosarcoidosis, with a mean age at time of diagnosis of 38.5years. The presenting neurologic syndrome was isolated cranial neuropathy, aseptic meningitis, myelitis, brain parenchymal lesion, myelorradiculitis and meningomyelorradiculitis. MRI study most often presented different enhancing lesions and the CSF analysis commonly revealed a lymphocytic pleocytosis and raised proteins. Thirteen patients had histopathology confirmation of systemic sarcoidosis and one preformed a spinal cord biopsy. Corticosteroids was the most often used treatment alone or in combination with immunosuppressive drugs. After a mean follow-up of 86.1months, the majority of patients fully recovered to a mRankin 0. DISCUSSION: Fully comprehension of neurosarcoidosis is still a challenge due to its rarity and limited number of large published series, which renders the epidemiological study of this disease very difficult. In this study, the thoroughly medical records review and the summarize of previous published cohorts allow to add some information in the epidemiological and clinical knowledge of this entity.
