A Combination of Gamma-Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine, and Cyanocobalamin vs Ginger Extract in the Management of Chronic Motion Sickness: A Clinical Evaluation.

Background: Motion sickness (kinetosis) is a common and temporarily incapacitant ailment, manageable with behavioral as well as pharmacological measures. Objective: To assess the effectiveness and safety of a combination of gamma-aminobutyric acid, glutamic acid, calcium, thiamine, pyridoxine, and cyanocobalamin (Group A) (n = 170) and extract of Zingiber officinale (ginger) (Group B) (n = 165) in the management of chronic complaints consistent with motion sickness. Methods: Both groups were tested according to the following end points, under self-paired as well as comparative study designs: reduction of ≥20 score points in the total motion sickness assessment questionnaire (MSAQ) score, percentage of patients presenting a reduction of the total MSAQ score, absolute MSAQ score reduction, physician's assessment scores, final overall assessment of study medication, and willingness to continue treatment. Safety was also evaluated. Results: There was a statistically significant better performance under both study designs for Group A (P = 0.05 using different statistical tests) in all end points. Both regimens were safe, with different neurological and gastrointestinal tolerability outcomes. Conclusions: Group A and Group B regimens were effective and safe in the management of chronic complaints consistent with motion sickness and the Group A regimen was more effective than Group B.

Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study.

PURPOSE: We report the results of low back pain treatment using a combination of nucleotides, uridine (UTP), cytidine (CMP) and vitamin B12, vs a combination of vitamins B1, B6, and B12. PATIENTS AND METHODS: Randomized, double-blind, controlled trial, of a 60-day oral treatment: Group A (n=317) receiving nucleotides+B12 and Group B (n=317) receiving B vitamins. The primary endpoint was the percentage of subjects in each group presenting adverse events (AEs). Secondary endpoints were visual analog scale (VAS) pain scores at Visit 2 (day 30) and Visit 3 (day 60) in relation to pretreatment values, Roland-Morris Questionnaire (RMQ) scores and finger-to-floor distance (FFD) (percentage of subjects per group presenting improvement ≥5 points and ≥3cm, respectively). RESULTS: Seventy-five (24%) and 105 (33%) subjects (P=0.21) presented 133 and 241 AEs, with 3159% of subjects presenting ≥2 AEs (P=0.0019) in Group A and Group B, respectively. Twenty-four subjects in Group B were discontinued due to AEs, while no AE-related discontinuations occurred in Group A (P<0.0001). VAS score reduction after 30 and 60 days of treatment was statistically significant (P<0.0001) in both groups, with Group A showing greater reduction at Visit 2 (P<0.0001). RMQ score improvement ≥5 points occurred in 99% of subjects from each group, and FFD improvement ≥3 cm occurred in all subjects. CONCLUSION: Treatment with nucleotides+B12 was associated with a lower number of total AEs, fewer AEs per subject, and no AE-related treatment discontinuation. Pain intensity (VAS) reduction was superior at 30 days of treatment in the nucleotides+B12 group and equivalent between groups at 60 days of treatment. Improvements in efficacy measures RMQ and FFD were observed in both groups at treatment days 30 and 60.

Clinical Evaluation of the Use of Ginger Extract in the Preventive Management of Motion Sickness.

BACKGROUND: Motion sickness can be triggered in a variety of situations and is characterized primarily by nausea and vomiting. Ginger is widely used in treating conditions including chemotherapy-associated gastrointestinal symptoms, morning sickness, postoperative nausea, and motion sickness. OBJECTIVES: The primary study objective was to evaluate Zingiber officinale extract in the treatment of motion sickness. Secondary objectives were to evaluate treatment effect on Motion Sickness Assessment Questionnaire (MSAQ) score and subscores before and after treatment, and to evaluate treatment tolerability. METHODS: Open-label, single-arm study assessing motion sickness outcomes with and without pre-travel oral treatment with Zingiber officinale 160 mg extract (containing 8 mg gingerols). All patients answered the MSAQ on 4 separate occasions following a trip of at least 15 minutes in duration: Trip 1 (pretreatment) and Trips 2, 3, and 4 (after oral treatment with study medication). The primary end point was percentage of patients presenting improvement ≥20 score points on the MSAQ during Trip 2, Trip 3, and Trip 4 in comparison to pretreatment score (Trip 1). Secondary end points included percentage of patients presenting improvement in MSAQ subscores during Trips 2, 3, and 4; percentage of patients presenting treatment-related adverse events; and pre- and posttreatment physician assessment scores. RESULTS: One hundred eighty-four patients were included and 174 completed treatment. A reduction of ≥20 points in total MSAQ score points occurred in 26.52%, 29.89%, and 29.31% of patients from Trips 2, 3, and 4, respectively. There was no significant difference at Trips 2, 3, and 4 in number of patients presenting improvement ≥20 score points (P = 0.9579). There was a significant reduction in total MSAQ scores from Trips 2, 3, and 4 (P < 0.0001) compared with Trip 1. Total MSAQ scores did not vary at each trip taken under treatment (P = 0.28). There were significant (P < .001) improvements in all domain subscores from Trips 2, 3, and 4 in relation to scores from Trip 1. There was a significant improvement in physician assessment scores at Visit 2 (P < .0001). Adverse events were reported among 31 patients, mainly affecting the gastrointestinal system. Twenty-four patients (13.04%) reported 39 adverse events considered related to treatment. No significant change in physical exam was noted at Visit 2 in relation to Visit 1. CONCLUSIONS: These open label, historically controlled study results suggest the need for randomized, blinded, placebo and active substance controlled clinical trials. (Curr Ther Res Clin Exp. 2020; 81:XXX-XXX).

Treatment with Sofosbuvir and Daclatasvir (with or without Ribavirin) Improves Patient Reported Outcomes in Hepatitis C.

OBJECTIVES: To evaluate the impact of 3 treatment regimens upon health-related quality of life and work productivity using patient-reported outcomes (PROs) in chronic hepatitis C infected patients: sofosbuvir (SOF) + daclatasvir (DCV); SOF + DCV + ribavirin (RBV); SOF + simeprevir (SMV). METHODS: 4 questionnaires were used to evaluate PROs before, during and after treatment: Short Form-36 (SF-36), Chronic Liver Disease Questionnaire (CLDQ) - hepatitis C virus (HCV), Work Productivity and Activity Index, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). RESULTS: Of the global sample of 55 patients included in this study; SOF + DCV (n = 10); SOF + DCV + RBV (n = 29); SOF + SMV (n = 16) all had a statistically significant improvement in SF-36, CLDQ and FACIT-F scores during and post-treatment. No statistically significant differences in the PRO questionnaire values were observed between the distinct treatment regimens. The SOF and SMV patient groups presented higher mean PRO variations during and post-treatment, compared to the other groups: SF-36 functional capacity (16.1); SF-36 mental health (21.4); CLDQ activity (1.8); CLDQ emotional function (1.2); FACIT-F physical well-being (8.0); Total FACIT-F (21.6). CONCLUSION: Treatment with SOF + DCV, with or without RBV, results in an improved PRO similar to treatment with SOF + SMV in chronic hepatitis C patients.

A double-blind, randomized, comparative study of the use of a combination of uridine triphosphate trisodium, cytidine monophosphate disodium, and hydroxocobalamin, versus isolated treatment with hydroxocobalamin, in patients presenting with compressive neuralgias.

CONTEXT: This paper reports on the results of treatment of compressive neuralgia using a combination of nucleotides (uridine triphosphate trisodium [UTP] and cytidine monophosphate disodium [CMP]) and vitamin B12. OBJECTIVES: To assess the safety and efficacy of the combination of nucleotides (UTP and CMP) and vitamin B12 in patients presenting with neuralgia arising from neural compression associated with degenerative orthopedic alterations and trauma, and to compare these effects with isolated administration of vitamin B12. METHODS: A randomized, double-blind, controlled trial, consisting of a 30-day oral treatment period: Group A (n=200) receiving nucleotides + vitamin B12, and Group B (n=200) receiving vitamin B12 alone. The primary study endpoint was the percentage of subjects presenting pain visual analog scale (VAS) scores ≤20 at end of study treatment period. Secondary study endpoints included the percentage of subjects presenting improvement ≥5 points on the patient functionality questionnaire (PFQ); percentage of subjects presenting pain reduction (reduction in VAS scores at study end in relation to pretreatment); and number of subjects presenting adverse events. RESULTS: The results of this study showed a more expressive improvement in efficacy evaluations among subjects treated with the combination of nucleotides + vitamin B12, with a statistically significant superiority of the combination in pain reduction (evidenced by VAS scores). There were adverse events in both treatment groups, but these were transitory and no severe adverse event was recorded during the study period. Safety parameters were maintained throughout the study in both treatment groups. CONCLUSION: The combination of uridine, cytidine, and vitamin B12 was safe and effective in the treatment of neuralgias arising from neural compression associated with degenerative orthopedic alterations and trauma.

Use of pure diosmin 600 mg in chronic venous disease: a review of the literature / Utilização de diosmina 600 Mg na insuficiência venosa crônica: revisão da literatura

Chronic Venous Disorder (CVD) is a term used to represent all abnormal clinical changes that result from venous disease of the lower extremities, and that have a chronic pattern. This disease has a documented socioeconomic impact, involving a significant part of the western populations, and consuming 2-3% or more of societies? health budgets. This review of the literature focuses on diosmin, a benzopyrone phlebotonic, specifically mechanisms of action as well as preclinical and clinical evidence.

Colecistite alitiásica aguda: manifestação inicial de uma doença autoimune? / Acute cholecystitis alitiasica: initial manifestation of na autoimune disease?

A Colecistite Alitiásica Aguda (CAA) é uma inflamação da vesícula biliar na ausência de colelitíase. É uma forma pouco frequente de colecistite, representando cerca de 10% de todos os casos, sendo tradicionalmente descrita em pacientes graves, submetidos a grandes procedimentos cirúrgicos, queimados, sépticos, politraumatizados ou em nutrição parenteral total por tempo prolongado. Existem relatos na literatura da sua associação também com o diabetes mellitus, insuficiência cardíaca, síndrome da imunodeficiência adquirida, dentre outras patologias. Doenças autoimunes como poliarterite nodosa e Lúpus Eritematoso Sistêmico (LES) também podem se manifestar através da CAA, causada por uma lesão isquêmica na vesícula biliar. Nosso objetivo é relatar um caso clínico de Colecistite Alitiásica Aguda numa paciente sem fator de risco que, durante a evolução, apresenta quadro de rash cutâneo facial, com Fator Antinuclear (FAN) positivo, porém sem critérios diagnósticos para LES segundo os protocolos e que, após início da corticoterapia, apresentou remissão total dos sintomas.

The Acute Cholecystitis Alitiasica (CAA) is an inflammation gallbladder in the absence of cholelithiasis. It is a Uncommonly of cholecystitis, representing about 10% of all cases, traditionally described in critically ill patients undergoing to major surgical procedures, burns, sepsis, multiple trauma or parenteral nutrition total time for prolongado. There are reports in literature also its association with diabetes mellitus, heart failure, immunodeficiency syndrome acquired, among other patologias. Diseases as autoimmune lupus erythematosus and polyarteritis nodosa (SLE) may also manifest by CAA, caused by an ischemic lesion in gall biliar. Our goal is to report a case Acute cholecystitis in a patient without Alitiásica factor risk that during evolution, presents frame facial rash with antinuclear antibodies (ANA) antibody positive, but no diagnostic criteria for SLE according to protocols and that after the start of steroid therapy, showed total remission of symptoms.

Tosse persistente: qualidade de vida e avaliação clínica dos resultados de terapia com anti-sépticos pulmonares / Persistent cough: clinical assessment of quality-of-life and treatment outcome using pulmonary antiseptics

JUSTIFICATIVA E OBJETIVOS: A tosse persistente representa uma condição comum e causa frequente de procura por atendimento médico, podendo alterar a rotina diária do paciente afetado. O objetivo deste estudo foi avaliar a resposta clínica e laboratorial à terapia de tosse persistente, utilizando uma combinação de eucaliptol, gomenol, guaifenesina, cansilato de sódio e cloridrato de lidocaína.MÉTODO: Foram obtidos dados referentes a 60 pacientes atendidos no Serviço de Pneumologia do Hospital das Clínicas de Teresópolis Constantino Otaviano, incluindo informações demográficas, resultados de exames físicos, laboratoriais e de espirometria, avaliações do médico e do paciente, bem como uma avaliação através do Cough-specific Quality of Life Questionnaire (CQLQ) que foram analisadas antes, durante e após sete dias de terapia. RESULTADOS: Não houve alterações clinicamente significativas nos exames físicos. Os exames laboratoriais e testes de espirometria permaneceram dentro das respectivas faixas de normalidade e nenhuma diferença significativa nos valores entre as avaliações foi observada. Vinte e nove eventos adversos foram registrados em 22 pacientes, todos com gravidade leve a moderada. As pontuações das avaliações de condição geral do médico e do paciente melhoraram significativamente na Avaliação 3 em relação à Avaliação 1 (Qui-quadrado = 121,1; GL= 16; p < 0,0001, e Qui-quadrado = 61,86; GL = 16; p < 0,0001, respectivamente). As pontuações no CQLQ da Avaliação 3 melhoraram de forma significativa em relação às da Avaliação 1 (t = 6,746; GL = 58; p < 0,0001), indicando melhora substancial na qualidade de vida.CONCLUSÃO: Com base nos resultados obtidos, concluiu-se que a combinação de eucaliptol, gomenol, guaifenesina, cansilato de sódio e cloridrato de lidocaína foi segura e eficaz em pacientes com processos pulmonares produtivos acompanhados de tosse, com impacto positivo na qualidade de vida dos pacientes tratados.

BACKGROUND AND OBJECTIVES: Persistent cough represents a common ailment for which medical attention is often sought, and may cause significant disruption of the affected patient's routine. The objective of this study was to evaluate clinical and laboratory response to persistent cough therapy using a combination of eucalyptol, gomenol, guaifenesin, sodium camsilate, and lidocaine hydrochloride. METHOD: We collected data from 60 patients attended at the Pneumology Service of the Hospital de Clínicas de Teresópolis Constantino Otaviano, including demographic information, physical exams, laboratory, and spirometry exam results, physician and patient evaluations, and a quality-of-life assessment (CQLQ) which were analyzed before, during, and after seven days of therapy. RESULTS: There were no clinically significant changes regarding physical exams. Laboratory exams and spirometry tests remained within the respective normal ranges, and no statistically significant difference in values among study assessments was observed. Twenty-nine adverse events were recorded among 22 patients, all of which were mild to moderate in severity. The scores of the physician and patient evaluation of overall condition improved significantly in Assessment 3 in relation to Assessment 1 (Chi-square = 61.86; Degree of Freedom = 16; p < 0.0001 and Chi-square = 121.1; DF= 16; p < 0.0001, respectively). CQLQ total scores from Assessment 3 improved significantly in relation to those of Assessment 1 (t = 6.746; DF = 58; p < 0.0001), indicating a substantial improvement in quality-of-life. CONCLUSION: Based on the results of this analysis, we conclude that the combination of eucalyptol, gomenol, guaifenesin, sodium camsilate, and lidocaine hydrochloride, was safe and effective in patients with productive pulmonary processes accompanied by cough, positively impacting quality-of-life of the treated patients.

Neural compression-induced neuralgias: clinical evaluation of the effect of nucleotides associated with vitamin B12

The use of a combination of uridine triphosphate (UTP), cytidine monophosphate (CMP), and hydroxocobalamin was evaluated in a double-blind, randomized study in the treatment of neuralgia due to degenerative orthopedic alterations with neural compression. Following informed consent, 80 patients were randomized to a 30 day treatment period. The subjects received a thrice-daily oral treatment regimen of either the combination treatment (Group A: total daily dose of 9mg UTP, 15mg CMP, 6 mg hydroxocobalamin) or vitamin B12 alone (Group B: total daily dose of 6 mg hydroxocobalamin). Efficacy measures evaluated global patient condition from the perspective of the subject and the investigating physician pain ? measured by a visual-analog scale and functionality, using a patient-response questionnaire. The safety evaluation took into account physical evaluations and laboratory tests performed at each visit to the study center as well as the incidence and severity of adverse events. At the end of the 30-day treatment period, there were reductions in the pain scale scores in both groups, however there was a significantly larger reduction in the scores of the Group A patients. The Patient Global Evaluation scores improved in both groups but showed greater improvement in Group A, while the Physician Global Evaluation improved significantly only in Group A. A similar finding was observed in the scores of the Patient Functionality Questionnaire. Based on the findings of this clinical trial, we conclude that the combination of UTP, CMP, and vitamin B12 has a positive effect on pain and functionality improvement in the treatment of degenerative orthopedic alterations with neural compression, in the study population evaluated.