Treatment of Recurrent Urinary Tract Infection Symptoms with Urinary Antiseptics Containing Methenamine and Methylene Blue: Analysis of Etiology and Treatment Outcomes.

PURPOSE: Urinary antiseptics including methenamine and methylene blue are used in the symptomatic treatment of urinary tract infections (UTIs). PATIENTS AND METHODS: This was a prospective, double-blind, randomized, double-dummy safety and efficacy study of 2 urinary antiseptic combinations in the symptomatic treatment of recurrent cystitis: methenamine 120mg + methylene blue 20mg (Group A) versus acriflavine 15mg + methenamine 250mg + methylene blue 20mg + Atropa belladonna L. 15mg (Group B). All subjects underwent pretreatment urine culture and antibiotic sensitivity tests prior to 3-day oral treatment with study drug, followed by 3 days of antibiotic therapy (based on urine culture) + study drug treatment. Efficacy was evaluated using the Urinary Tract Infection Symptoms Assessment Questionnaire (UTISA). The primary endpoint was the percentage of patients presenting improvement in cystitis manifestations on the UTISA domain "Urination Regularity" at Visit 2. The primary safety variable was the incidence of treatment-related adverse events. RESULTS: A total of 144 subjects were randomized per group and 272 completed the study. Primary endpoint analysis demonstrates homogeneity between treatment groups, with 69.4% and 72.2% subjects, respectively, showing improvement in the score of the urinary regularity UTISA domain after 3 days of treatment (p= 0.87). At Visit 2, incidence of treatment-related adverse events was higher in Group B (Group A: n= 11, Group B: n= 31, p= 0.0057). CONCLUSION: Both treatments were effective in reducing UTI symptoms assessed by UTISA questionnaire after 3 days of treatment. The two regimens were comparable in incidence of adverse events, but the combination of methenamine + methylene blue resulted in fewer treatment-related adverse effects.

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).

S. maltophilia pneumonia: A case report.

Case report of Community-acquired pneumonia in a male patient without co-morbidities. Empiric antibiotic treatment did not resolve the clinical picture of productive cough, and a chest computerized tomography and sputum culture with antibiogram were performed, identifying S. maltophilia infection with sensitivity to levofloxacin and sulfamethoxazole/trimethoprim. Treatment with levofloxacin (500 mg/day for 15 days) resulted in resolution of the clinical picture.

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.

Comparison of the action of diclofenac alone versus diclofenac plus B vitamins on mobility in patients with low back pain.

Objective: To assess results of the finger-to-floor distance (FFD) and the Schober test performed during the DOLOR study, and to verify correlation between Visual Analog Pain Scale scores (VAS) with these measures. Research design and methods: Previously tabulated data from the Clinical Research Forms of the DOLOR study were analyzed (statistical significance defined with a two-tailed p value < 0.05 and confidence interval of 95%). For continuous variables, the Student's T- test or analysis of variance (ANOVA) was used, and differences between pre-treatment and Visits 2, 3, and 4 in the absolute number and percentage of patients with no change, improvement, or worsening of the Schober test and the FFD test scores were calculated, and the results were analyzed with the Chi-squared test. Spearman non-parametric correlation was used for correlating VAS scores with FFD and Schober test scores at each study visit. Main outcome measures: FFD, measured in centimeters; Schober test scores. Results: Throughout the treatment period, there was a statistically significant correlation between the VAS scores and the FFD in the total patient population and within treatment groups. This was not observed for the correlation between the Schober's test scores and the VAS scores. FFD scores within treatment groups improved progressively at each study visit, as did the Schober Test scores. Conclusions: The results of this post-hoc analysis show that combination therapy with diclofenac plus vitamins B1, B6, and B12 had additional positive effects on mobility restoration among the patients of the DOLOR study and serve to highlight the correlation between mobility and pain intensity among patients presenting with low back pain. The two fundamental goals of low back pain therapy are to provide improvements in pain and function. In this sense, the combination of diclofenac with the B vitamins was particularly effective in achieving both of these goals.

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.

Comparison of two otologic suspensions of ciprofloxacin 2 mg/mL and hydrocortisone 10 mg/mL in the treatment of otitis externa: a multicenter, double-blind, randomized study / Comparação de duas suspensões otológicas de ciprofloxacino 2 mg/mL e hidrocortisona 10 mg/mL no tratamento da otite externa: um estudo multicêntrico, duplo-cego e randomizado

This was Phase III multicenter, double-blind, randomized, comparative safety and efficacy study in parallel groups of subjects, assessing non-inferiority between two commercially available otologic suspensions containing ciprofloxacin 2mg/mL and hydrocortisone 10mg/mL (Otociriax and Cipro HC®) in the treatment of acute diffuse otitis externa. Following screening and informed consent, subjects were randomly allocated into two treatment groups: Group A (treated with Otociriax) and Group B (treated with Cipro HC®). Treatment regimen in both groups was three drops, twice daily for seven days. The primary study endpoint was otitis cure, defined as elimination of pain, edema, and otorrhea. The secondary study endpoint was presence of side effects. Efficacy assessments included presence and intensity of otitis externa manifestations. Safety assessments included vital signs and physical examination, as well as adverse event monitoring. Study data analysis was performed using GraphPad Prism 5.0...

Doenças pulmonares interticiais: linfangioliomiomatose em questão / Intertitial pulmonary diseases: lymphangioleiomyomatosis in question

As doenças pulmonares intersticiais (DPIs) são conceituadas como distúrbios que acometem o parênquima pulmonar - o endotélio cailar, os alvéolos, o epitélio alveolar e os espaços entreestas estruturas, bem como os tecidos perivasculares e linfáticos - , podendo ser classificadas segundo critérios histopatológicos, distinguindo-se dois grandes grupos: 1. das associadas à inflamação e fibrose; e 2. daquelas com reação granulomatosa predominante na área intersticial u vasculas. A linfangioliomiomatose (LAM) é uma rara DPI, idiópática, e com altas taxas de morbimortalidade, sendo caracterizada por uma multiplicação acelerada de células musculares lisas imaturas em qualquer estrutura pulmonar. No presente artigo apresentar-se-á uma revisão da literatura enfocando a etiopatogenia, a epidemiologia, o quadro clínico, o diagnóstico - procedimentos, critérios e diagnóstico diferencial - o tratamento e o prognóstico da LAM.

The interstitial pulmonary diseases (IPDs) are a range of disorders that affect the pulmonary parenchyma - the capillary endothelium, alveoli, alveolar epithelium and the spaces between thesestructures, as well as the perivascular and lymphatic tissues. The IPDs may be classified according to histopathologic criteria, and are divided into two large groups: 1. those associated with inflammation and fibrosis; and 2. those associated with granulomatous reactions predominantly in the interstitial or vascular area. Lymphangioleiomyomatosis (LAM) ia a rare, idiopathic IPD with high morbimortality rates, which is characterized by an accelerated multiplication of immature smooth muscle cellsin any pulmonary structure. In this article, we present a review of the literature onthe etiopathogenesis, epidemiology, clinical picture, diagnosis and differential diagnosos, treatment, and prognosis of this condition.

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.

Quality-of-Life assessment and clinical-laboratory response to use of the combination of menthol, guaiacol, terpineol, eucalyptol, gomenol, and camphor in patients presenting persistent cough / Avaliação da qualidade de vida e resposta clínico-laboratorial ao uso da associação de mentol, guaiacol, terpinol, eucaliptol, gomenol e cânfora em pacientes apresentando tosse persistente

We evaluated the use of a combination of menthol, guaiacol, terpineol, eucalyptol, gomenol, and camphor injection in patients presenting persistent cough who were submitted to a 7-day treatment regimen with daily doses of the medication and a series of clinical and laboratory evaluations, including a quality-of-life questionnaire, spirometry, and assessments of overall condition by the patient and the physician, performed prior to the first dose of medication, after three days of treatment, and at the end of the 7-day treatment period. The use of concomitant medications and the incidence, severity and duration of adverse events were also evaluated. A total of sixty-one patients were included in the study. There were no clinically significant changes in vital signs, laboratory tests, or spirometry throughout the treatment period. A statistically significant improvement (p<0.0001) in the assessments of overall condition by the patient and physician was observed, and there was a statistically significant improvement in the scores of the quality-of-life questionnaire (p<0.0001). While adverse events were recorded, none were serious and all were resolved by the end of the treatment period. Based on the results of this study, we conclude that the combination of menthol, guaiacol, terpineol, eucalyptol, gomenol, and camphor in the form of an intramuscular injection was safe and effective ameliorating the effects of persistent cough in the quality of life of the patient population evaluated.

Treatment of acute, non-traumatic pain using a combination of diclofenac-cholestyramine, uridine triphosphate, cytidine monophosphate, and hydroxycobalamin.

This randomized, controlled, double-blind clinical study in parallel groups evaluated the safety and efficacy of an oral combination diclofenac-cholestyramine, nucleotides (uridine and cytidine) and vitamin B12 versus the oral combination of nucleotides and vitamin B12 in the treatment of acute, non-traumatic pain. Subjects received twice-daily, 10-day oral administration of diclofenac-cholestyramine + uridine + cytidine + vitamin B12 (Group DN, n=40) or uridine + cytidine + vitamin B12 (Group NB, n=41). The primary study endpoint was the number of subjects with VAS reduction of >30mm after 10 days of treatment. Secondary endpoints included the number of patients with improvement >5 points in the Patient Functionality Questionnaire after 10 days of treatment, and the number of subjects presenting adverse events. Treatment with the combination of diclofenac-cholestyramine, nucleotides and Vitamin B12 resulted in a higher number of subjects with VAS score reductions >30mm after 10 days of treatment (87.5% subjects) than in the control group administered nucleotides and Vitamin B12 (51.23% of subjects), (p>0.0006). A significantly higher number of subjects in the DN group (80%) had a score reduction of >5 points in the Patient Functionality Questionnaire at after 10 days of treatment compared to Group NB (29.3%), (p<0.001). The number of subjects presenting AEs did not vary significantly between treatment groups (p=0.587). The combination of diclofenac-cholestyramine with uridine, cytidine and vitamin B12 was well-tolerated over a 10-day treatment period. The combination reduced pain and improved functionality among subjects presenting acute, non-traumatic pain in the lower back, hips, and neck.

Osteoarthritis: clinical evaluation of diclofenac combined with the B complex vitamins / Osteoartrite: avaliação clínica da ação do diclofenaco com as vitaminas do complexo B

A double-blind, placebo controlled evaluation was performed on parallel groups of patients presenting osteoarthritis of the knee, hip or hand. The study aimed to evaluate the use of a combination of sustained-release diclofenac and vitamins B1, B6 and B12 in the treatment of the signs and symptoms of osteoarthritis. After screening and informed consent, randomized subjects underwent a 7-day treatment period with twice-daily oral therapy. Osteoarthritis pain, mobility and satisfaction assessments by both the subjects and the investigating physician were performed at each of the three visits to the study center before, during and at the end of the treatment period, along with physical examinations, laboratory evaluations and monitoring of adverse events and concomitant medications. Results were compared between the active and placebo treated groups (Group A and Group B, respectively).The active treatment was found to be superior to placebo in all of the pain, mobility and satisfaction assessments. Patients treated with the active substance were more willing to continue treatment at the end of the study. No significant difference was observed between the treatment groups in the physical examinations and laboratory evaluations performed.Based on the results observed in this double-blind clinical evaluation, we conclude that the combination of sustained-release diclofenac and vitamins B1, B6 and B12 is both well-tolerated and superior to placebo in the treatment of the signs and symptoms of OA in the study population evaluated.

Treatment of inflammatory neuropathy with dexamethasone plus B-vitamins: a clinical evaluation / Tratamento de neuropatia inflamatória com a associação de dexametasona e vitaminas B: uma avaliação clínica

We evaluated the use of a combination of vitamins B1, B6, and B12 with dexamethasone in the treatment of the signs and symptoms of inflammatory neuropathy of the upper and lower limbs, in an open-label clinical trial. Patients were submitted to a 9-day treatment period with three doses of study medication at three day intervals, and a series of clinical and laboratory assessments, prior to the first dose of study medication and at each of the following three visits to the study center. Efficacy evaluations at each study visit included a 100mm VAS pain scale and global and satisfaction surveys completed by the patient and the investigating physician. Safety evaluations included a comparison of changes in laboratory evaluations at each visit and the incidence, severity, duration, and outcome of adverse events. A total of sixty-one patients were enrolled in the trial. A clinically significant improvement in all of the efficacy measures was observed from the pre-treatment to end-of-study evaluations. No clinically significant alterations in clinical assessments were observed during the treatment period. Based on the results of this clinical study, we conclude that the combination of dexamethasone with the B-vitamins is safe and effective in the treatment of the signs and symptoms of inflammatory neuropathy.

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.

Non-acute congestive heart failure with and without primary sodium retention: evaluation of laboratory and clinical parameters following treatment with furosemide and potassium chloride

Introduction: Congestive heart failure (CHF) is defined by a cardiac deficit in supplying normal oxygen and nutrient demands to the body. Among the many drug therapies for relief of CHF symptoms are diuretics in the treatment of edemas associated with this condition, which prevent fluid accumulation in tissues, and relieve the symptoms. Furosemide is a loop diuretic that is commonly used to this end, whose most common side effect is electrolyte imbalance, particularly hypokalemia. Potassium supplementation during treatment is recommended at a preventive measure. Objectives: To evaluate the clinical response to the use of the combination of furosemide and potassium chloride in patients presenting non-acute CHF, with respect to: 1) Signs and symptoms of CHF 2) Serum sodium and potassium levels registered in the patient chart 3) Incidence of laboratory alterations 4) Incidence of adverse events.Materials and Methods: This was a descriptive, analytic, retrospective study performed at Hospital Universitário Constantino Otaviano, UNIFESO, evaluating medical charts of patients presenting non-acute CHF who were treated with the combination of furosemide and potassium chloride. Only patients presenting laboratory data from before and after treatment were included. For each patient, the hospital chart was analyzed in order to complete the Clinical Research Form (CRF). The CRFs were filled, stored, coded, and the data were analyzed using GraphPad Prism 5.0 software. Results: There was a clinically significant decrease from pretreatment in the number of patients presenting all signs and symptoms of CHF, with the exception of nausea. Vital signs improved significantly in relation to pretreatment values. Sodium and potassium levels decreased, but remained within reference range, as did other laboratory evaluations performed. In addition to the furosemide + potassium chloride treatment, 59/60 patients were prescribed additional medications. A total of 35 adverse events were...

Efficacy and tolerability of a combination of uridine, cytidine, and vitamin B12 in anemia. A double-blind, comparative study versus nucleotide monotherapy

Background: Deficiency in vitamin B12 is commonly associated with pernicious anemia, presenting a number of clinical symptoms resulting from neurological alterations due to modifications in myelin formation. Treatment consists of oral or parenteral vitamin B12 supplementation. Vitamin B12 has also been shown to have analgesic action whether administered alone or in combination with other therapeutic agents. Oral or parenteral pyrimidine ribonucleotide supplementation may be advantageous in the treatment of peripheral neuropathies. Objectives: To evaluate and compare the efficacy and tolerability of an orally administered combination of vitamin B12, uridine and cytidine, versus administration of the nucleotides alone in the treatment of the signs and symptoms of anemia. Study design: Study goal was normalization of MCV and MCH and serum vitamin B12 as well as improvement in pain and paresthesia among patients presenting these symptoms at Pretreatment. The study was designed as a double-blind, randomized trial in two arms: Group A patients were treated with the vitamin + nucleotide combination Group B patients received nucleotides alone. Treatment lasted 60 days, with two interim visits at 20 and 40 days of treatment and a final evaluation after 60 days of treatment. Setting: Patients were attended in an ambulatory setting of a UNIFESO university hospital. Patients: Eligible patients were between 18-65 years of age, with clinical and laboratory presentation of anemia with or without underlying autoimmune disease, caused by vitamin B12 deficiency. Female patients were not pregnant and were required to use birth control for the duration of the treatment period. Eighty patients were randomized, with 40 patients in each treatment group. Treatment consisted of 3 daily oral doses of: 1.0 mg hydroxocobalamin acetate, 2.5 mg cytidine 5'-{sodium P'(2-(trimethylammonio)-ethyl) hydrogen diphosphate}, and 1.5 mg uridine 5'-trisodium triphosphate for Group A patients, while patients in Group B received 2.5 mg cytidine 5'-{sodium P'(2-(trimethylammonio)-ethyl) hydrogen diphosphate}, and 1.5 mg uridine 5'-trisodium triphosphate in identical capsule forms. Main outcome measure: Primary outcome measures defined in the protocol included improvements in MCV, MCH and vitamin B12 reaching laboratory reference range, 3-point improvements in Global, Pain, and Paresthesia evaluations and a 20% reduction in VAS scores. Results: Normalization of laboratory evaluations occurred only in Group A. Three-point improvement in Global evaluation by the physician was observed only in Group A, while both groups showed improvement in Global evaluation by the patient. Patient's assessment of pain improved only in Group A, although VAS score decrease was noted in both groups both groups also had improvement in paresthesia evaluations. Vital signs did not change, while weight gain was observed in both groups. Adverse events seen in both groups included nausea, diarrhea, headache and abdominal cramps. Alterations in laboratory evaluations were reported in both groups, but could be directly attributed to anemia. Conclusion: The combination of vitamin B12, uridine and cytidine was found to be safe and effective in the treatment of the signs and symptoms of anemia in the population studied. The pain reduction observed in both groups may be attributed to activity of the nucleotides.

Evaluation of the safety and efficacy of an injectable B-vitamin combination in acute neuralgias

A clinical trial evaluating the safety and efficacy of the use of an intramuscular combination of vitamins B1, B6, and B12 in the treatment of the signs and symptoms of trigeminal and plantar neuralgia was performed. Patients were submitted to a 9-day, open-label treatment period with three administrations of the study medication, and underwent a series of clinical and laboratory evaluations prior to the first treatment dose and at each of the three following visits to the study center. The incidence of adverse events and the use of concomitant medications was monitored at each study visit, when efficacy evaluations were also performed, including a 100mm VAS pain assessment and global and satisfaction surveys completed by the patients and investigating physician. Additionally, at the end of the treatment period, the patients were evaluated on their willingness to continue treatment with the study medication.

Safety and efficacy of a B-vitamin combination in the treatment of osteoarthritis-related pain / Segurança e eficácia da associação das vitaminas B1, B6, B12 na analgesia da osteoartrite

We evaluated the safety and efficacy of the use of an oral combination of vitamins B1, B6, and B12 in the treatment of osteoarthritis-related pain and loss of mobility. A 14-day, open-label treatment period was adopted for patients presenting osteoarthritis of the knee or hip. Patients underwent a series of clinical and laboratory evaluations prior to the first treatment dose, following 7 days of treatment, and at the end of the 14-day drug administration period. The incidence of adverse events and use of concomitant medication was also monitored at each study visit. At each study visit, osteoarthritis evaluations were performed, including a 100mm VAS pain assessment, and global and satisfaction surveys completed by both patients and investigating physician. At the conclusion of the study, an additional assessment was performed to evaluate the patient's willingness to continue treatment with the B-vitamin combination.Clinical safety was evaluated by comparing the differences between the pretreatment, mid-study, and end-of-study clinical and laboratory evaluations as well as the incidence and severity of any adverse events. A comparison between the patient and physician assessments at each study visit was used to evaluate efficacy.A total of 54 patients were treated with the study medication. A clinically significant change was observed from pretreatment to end-of-study efficacy evaluations, including those for pain, mobility, and global osteoarthritis condition. The physician's evaluation of global patient condition and treatment satisfaction evaluation also presented a clinically significant change from pretreatment to the final study evaluation. No clinically significant changes in the patients clinical and laboratory evaluations were observed during the study.Based on the results of this clinical study, we conclude that the combination of cyanocobalamin, thiamine mononitrate and pyridoxine chlorihydrate at the concentrations employed is safe and effective in the treatment of the pain and loss of mobility associated with osteoarthritis.