Assessment of the treatment effectiveness of men with mild and medium degree of erectile dysfunction.

OBJECTIVE: . Aim: To assess the effectiveness of monotherapy and complex treatment of patients with erectile dysfunction depending on its severity. PATIENTS AND METHODS: Materials and Methods: Men with moderate and mild erectile dysfunction took part in the study, who, in turn, were divided into groups, depending on the treatment, with the evaluation of the results of the International Index of Erectile Function (MIEF-15), the state of cavernous hemodynamics and the function of the vascular endothelium before and after treatment. RESULTS: Results: In patients with an average degree of severity, who received complex treatment including a course of low-energy shock wave therapy, against the background of taking sildenafil and L-arginine, the best results were obtained in the quality of erection and increased cavernous blood flow, which positively affected satisfaction with sexual intercourse and overall satisfaction. It has also been proven that the function of the endothelium was improved in patients receiving L-arginine, due to which there was a probable decrease in endothelin-1. A probable improvement of erectile function was obtained in the group of patients with a mild degree who received L-arginine, and there was no statistical difference from the indicators in the group who received sildenafil, which was confirmed by the data of dopplerography. CONCLUSION: Conclusions: Patients with an average degree of erectile dysfunction require comprehensive treatment. The use of L-arginine can be an alternative to phosphodiesterase type 5 inhibitors in the treatment of mild erectile dysfunction.

Epidemiology, methods of diagnosis, and clinical management of patients with arginase 1 deficiency (ARG1-D): A systematic review.

BACKGROUND: Arginase 1 Deficiency (ARG1-D) is a rare, progressive, metabolic disorder that is characterized by devastating manifestations driven by elevated plasma arginine levels. It typically presents in early childhood with spasticity (predominately affecting the lower limbs), mobility impairment, seizures, developmental delay, and intellectual disability. This systematic review aims to identify and describe the published evidence outlining the epidemiology, diagnosis methods, measures of disease progression, clinical management, and outcomes for ARG1-D patients. METHODS: A comprehensive literature search across multiple databases such as MEDLINE, Embase, and a review of clinical studies in ClinicalTrials.gov (with results reported) was carried out per PRISMA guidelines on 20 April 2020 with no date restriction. Pre-defined eligibility criteria were used to identify studies with data specific to patients with ARG1-D. Two independent reviewers screened records and extracted data from included studies. Quality was assessed using the modified Newcastle-Ottawa Scale for non-comparative studies. RESULTS: Overall, 55 records reporting 40 completed studies and 3 ongoing studies were included. Ten studies reported the prevalence of ARG1-D in the general population, with a median of 1 in 1,000,000. Frequently reported diagnostic methods included genetic testing, plasma arginine levels, and red blood cell arginase activity. However, routine newborn screening is not universally available, and lack of disease awareness may prevent early diagnosis or lead to misdiagnosis, as the disease has overlapping symptomology with other diseases, such as cerebral palsy. Common manifestations reported at time of diagnosis and assessed for disease progression included spasticity (predominately affecting the lower limbs), mobility impairment, developmental delay, intellectual disability, and seizures. Severe dietary protein restriction, essential amino acid supplementation, and nitrogen scavenger administration were the most commonly reported treatments among patients with ARG1-D. Only a few studies reported meaningful clinical outcomes of these interventions on intellectual disability, motor function and adaptive behavior assessment, hospitalization, or death. The overall quality of included studies was assessed as good according to the Newcastle-Ottawa Scale. CONCLUSIONS: Although ARG1-D is a rare disease, published evidence demonstrates a high burden of disease for patients. The current standard of care is ineffective at preventing disease progression. There remains a clear need for new treatment options as well as improved access to diagnostics and disease awareness to detect and initiate treatment before the onset of clinical manifestations to potentially enable more normal development, improve symptomatology, or prevent disease progression.

Effects of arginine-based immunonutrition on inpatient total costs and hospitalization outcomes for patients undergoing colorectal surgery.

OBJECTIVE: The aim of this study was to assess the effects of an arginine-based immunonutrition intervention for patients undergoing elective colorectal surgery on postsurgical utilization and cost outcomes. METHODS: This analysis was based on data from two Washington State databases: Surgical Care and Outcomes Assessment Program (SCOAP) linked to the Comprehensive Hospital Abstract Reporting System (CHARS). The sample (N=722) comprises adult patients who underwent elective colorectal surgery with anastomosis in a Washington State hospital that participated in the Strong for Surgery (S4S) initiative between January 1, 2012, and December 31, 2013. A generalized linear model was used to predict the outcomes, adjusting for demographic characteristics and patient health conditions within a multivariate regression framework. RESULTS: Findings from this study demonstrated significantly fewer readmissions and hospital days for the intervention group during the 180 d after index hospitalization. Clinical benefits included decreased risk for infections and venous thromboembolism. There was a similar pattern toward lower total costs in the immunonutrition patient group; however, these were not statistically different compared with the control group at any time point. Savings in the immunonutrition group were substantial-mean total costs per patient were less by ∼$2500 at index hospitalization, $3500 less through 30 d of follow-up, and $5300 less over 180 d compared with the control group. CONCLUSION: These findings suggest that arginine-based immunonutrition should be thoroughly evaluated for incorporation into clinical practice for patients undergoing elective surgery. Moreover, there is a need to assess the effects of the intervention in other hospitals both within and outside Washington.

[ASSESSMENT OF SPECIFIC PHARMACOLOGIC ACTIVITY OF UNIFUSOL ON ENDOTHELIUM DYSFUNCTION MODEL INDUCED BY N-NITRO-L-ARGININE METHYL ETHER.]

Specific pharmacologic activity of sodium-L-arginine succinate (unifusol) was studied on endothelium dysfunction model (EDM) in rats. EDM was induced by daily administration of N-nitro-L-arginine methyl ether (L-NAME). The effectiveness of experimental therapy with unifusol was assessed by changes in the arterial pressure level, duration of endothelium-dependent and -independent vasodilation, and the blood concentration of endothelial dysfunction markers including VEGF, NO, endothelin-I and the number of desquamated endotheliocytes. Administration of unifusol favors correction of blood vessel endothelium state manifested by normalization of its functional activity and reduction of the apoptosis of endotheliocytes. In addition, the obtained results unambiguously confirm considerable vasodilating and antihypertensive effects of unifusol.

Clinical assessment of a new dentifrice with 8% arginine and calcium carbonate on dentin hypersensitivity in an Indian population using a new measuring device: the Jay Sensitivity Sensor Probe.

PURPOSE: To compare a new tactile hypersensitivity testing device [Jay Sensitivity Sensor (Jay) Probe] to three currently available methods of hypersensitivity testing: tactile hypersensitivity by the Yeaple probe, air blast (Schiff's Scale), and their overall hypersensitivity in the absence of any stimuli using the visual analog scores (VAS) during a clinical trial comparing the desensitizing potential of a dentifrice containing 8% arginine, calcium carbonate, and 1,000 ppm MFP (Colgate Sensitive Pro-Relief; Test) against a commercially available fluoride dentifrice (Colgate Cibaca; Negative control). METHODS: This 8-week clinical study enrolled 100 adults with dentin hypersensitivity (DH) to evaluate the desensitizing potential of a dentifrice with 8% arginine, calcium carbonate, and 1000 ppm MFP against a commercially available fluoride dentifrice, on an Indian population. This study included a new DH testing device (Jay Probe) in addition to the current three methods of dentin hypersensitivity testing. Subjects were randomly assigned a dentifrice and were evaluated for DH after 2-week, 4-week and 8-week use of assigned dentifrice. RESULTS: At the end of the 8-week period, the results showed a significant improvement in dentin hypersensitivity in the Test group as compared to the Negative control group. The mean tactile hypersensitivity scores at the 8-week examinations were 39.67 and 38.33 by the Yeaple and Jay Probes, respectively, for the Test group and 15.72 and 15.00 for the Negative control group. These observations were consistent with the other hypersensitivity examinations by air blast and VAS.

Clinical assessment of a supplement of Pycnogenol® and L-arginine in Japanese patients with mild to moderate erectile dysfunction.

A double-blind parallel group comparison design clinical study was conducted in Japanese patients with mild to moderate erectile dysfunction to investigate the efficacy of a supplement containing Pycnogenol® and L-arginine. Subjects were instructed to take a supplement (Pycnogenol® 60 mg/day, L-arginine 690 mg/day and aspartic acid 552 mg/day) or an identical placebo for 8 weeks, and the results were assessed using the five-item erectile domain (IIEF-5) of the International Index of Erectile Function. Additionally, blood biochemistry, urinalysis and salivary testosterone were measured. Eight weeks of supplement intake improved the total score of the IIEF-5. In particular, a marked improvement was observed in 'hardness of erection' and 'satisfaction with sexual intercourse'. A decrease in blood pressure, aspartate transaminase and γ-glutamyl transpeptidase (γ-GTP), and a slight increase in salivary testosterone were observed in the supplement group. No adverse reactions were observed during the study period. In conclusion, Pycnogenol® in combination with L-arginine as a dietary supplement is effective and safe in Japanese patients with mild to moderate erectile dysfunction.

Pharmacological functional MRI assessment of the effect of ibuprofen-arginine in painful conditions.

Pharmacological functional magnetic resonance imaging (phMRI) is a valuable tool for the investigation of pharmacological effects of a drug on pain processing. We hypothesized that the ibuprofen-arginine combination, in line with its characteristic analgesic properties, may influence the phMRI response at the central level, as compared to placebo. Ten healthy subjects underwent a double-blind, placebo-controlled, randomized, cross-over phFMRI study with somatosensory painful stimulation of the right median nerve. We measured the blood oxygen level dependent (BOLD) signal variations induced in conditions of pain after oral administration of either ibuprofen-arginine or placebo formulations. Independent component analysis (ICA) was used for the analysis of the fMRI data, without assuming a specific hemodynamic response function (HRF), which may be altered by drug administration. Median nerve electrical painful stimulation mainly activated the primary contralateral and the secondary somatosensory cortices, the insula, the supplementary motor area, and the middle frontal gyrus. Placebo and ibuprofen-arginine administration induced activation bilaterally in the premotor cortex, and an overall reduction in the other pain-related areas, which was more prominent in the left hemisphere. A task-related increase of BOLD signal between drug and placebo was observed bilaterally in the primary somatosensory area and the middle frontal gyrus without any changes in subjective pain scores. Overall, our findings show that ibuprofen-arginine, in line with the characteristic analgesic properties of ibuprofen, influences the BOLD response in specific pain-related brain areas with respect to placebo, with a vasoactive effect possibly due to arginine.

Lysine, arginine, and related amino acids: an introduction to the 6th amino acid assessment workshop.

The focus of the 6th workshop is on lysine, arginine, and related amino acids. Functions, metabolic pathways, clinical uses, and upper tolerance intakes are emphasized in the articles that follow. Lysine is arguably the most deficient amino acid in the food supply of countries where poverty exists, and since the discovery of the nitric oxide synthase pathway, arginine has come into prominence clinically because of the role of nitric oxide in cardiovascular physiology and pathophysiology.

Nutritional strategies in cardiovascular disease control: an update on vitamins and conditionally essential nutrients.

Several nutritional interventions for cardiovascular disease (CVD) prevention and therapy have recently appeared in the biomedical literature. These include appropriate use of several vitamins (E, C, B6, folate) and conditionally essential nutrients (CoQ10, L-arginine, propionyl L-carnitine). Possible undesirable consequences of long term nutritional supplementation with vitamin E and of adverse drug-nutrient interactions between the statins and CoQ10 are also considered. Although additional intervention studies are needed, current scientific evidence generally supports nutritional supplementation with these nutrients as an effective adjunctive strategy for CVD control.

Leg ulceration in the sickle cell patient.

BACKGROUND: The purpose of this study was to determine cost of care for leg ulcers in sickle cell patients and suggest an improved modality in ulcer care. STUDY DESIGN: We performed a retrospective study of a group of sickle cell disease patients with leg ulcers. RESULTS: Eighteen patients with a leg ulcer (duration: mean, 53.7 months), sickle cell disease, and a mean of 20.7 years of age had various modalities of treatment with the only consistency in healing being a commercial moist-wound dressing. CONCLUSIONS: There is no consistency in the treatment of the sickle cell patient with a leg ulcer. Treatment with a moist dressing had the best results.

Early postoperative enteral immunonutrition: clinical outcome and cost-comparison analysis in surgical patients.

OBJECTIVE: To determine if early postoperative feeding of patients with upper gastrointestinal malignancy, using an enteral diet supplemented with arginine, dietary nucleotides, and omega-3 fatty acids (IMPACT, Sandoz Nutrition, Bern, Switzerland) results in an improved clinical outcome, i.e., reduced infectious and wound complications and decreased treatment costs when compared with an isocaloric, isonitrogenous control diet. DESIGN: A prospective, randomized, placebo-controlled, double-blind, multicenter trial of the clinical outcome and a retrospective cost-comparison analysis. SETTING: Surgical intensive care units in three different German university hospitals. PATIENTS: Of 164 patients enrolled in the study, 154 patients were eligible for analysis. They were admitted to the intensive care unit after upper gastrointestinal surgery for cancer and they received an enteral diet via needle catheter jejunostomy. Infectious complications were defined as sepsis or systemic inflammatory response syndrome, pneumonia, urinary tract infection, central venous catheter sepsis, wound infection, and anastomotic leakage. The complication events were prospectively divided into two groups: early (postoperative days 1 to 5) and late (after the fifth postoperative day) postoperative complications. The treatment costs of each complication were analyzed and compared in both groups. INTERVENTIONS: Patients were randomized to receive either the immunonutritional diet (n = 77) or an isocaloric and isonitrogenous placebo diet (n = 77). Enteral feeding was initiated 12 to 24 hrs after surgery, starting with 20 mL/hr and advanced to a target volume of 80 mL/hr by postoperative day 5. MEASUREMENTS AND MAIN RESULTS: Clinical examination and adverse gastrointestinal symptoms were recorded on a daily basis. Both groups tolerated early enteral feeding well, and the rate of tube feeding-related complications was low. Postoperative complications occurred in 17 patients in the immunonutrition group vs. 24 patients in the control group (NS). Further, in the early phase (postoperative day 1 to 5), complications occurred to a similar extent in both groups (12 patients in the immunonutritional group vs. 11 patients in the control group). However, in the late phase (after postoperative day 5), considerably fewer patients in the experimental diet group experienced complications compared with the control group (5 vs. 13, p < .05). In addition, the frequency rate of complicating events were recorded in each group. In the experimental diet group, a total of 22 complicating events were recorded vs. a total of 32 events in the placebo diet group (NS). However, the occurrence of late complicating events, i.e., complicating events after the fifth postoperative day, was significantly reduced in the immunonutrition group when compared with the control group (8 vs. 17 events, p < .05). The total costs for the treatment of the complications were 83,563 German marks in the experimental diet group vs. 122,430 German marks in the control group, resulting in a cost-reduction of 38,867 German marks. (At the end of December 1995, the conversion rate from German marks to U.S. dollars was 1.4365 German marks to $1.00.) CONCLUSIONS: Early enteral feeding with an arginine, dietary nucleotides, and omega-3 fatty acids supplemented diet, as well as an isonitrogenous, isocaloric control diet (placebo) were well tolerated in patients who underwent upper gastrointestinal surgery. In patients who received the supplemented diet, a significant reduction in the frequency rate of late postoperative infectious and wound complications was observed. Thereby, the treatment costs were substantially reduced in the immunonutrition group as compared with the control group.

Randomized trial of immune-enhancing enteral nutrition in burn patients.

BACKGROUND: "Immune-enhancing" diets (IEDs) are aimed at improving outcomes in patients suffering trauma and infection. This study was conducted to evaluate a popular IED in patients suffering burn injury. METHODS: Fifty burned patients were randomized to receive either Impact (Sandoz Nutrition, Minneapolis, Minn), an IED enhanced with omega-3 fatty acids, arginine, and RNA, or Replete (Clintec, Deerfield, Ill), our standard high-protein diet. Feedings were begun within 48 hours of injury, and continued until patients supported themselves with oral intake. RESULTS: Forty-nine patients completed the study. The two feeding groups did not differ with respect to age, burn size, incidence of inhalation injury, or the quantity of calories and protein received. There were no differences between groups in mortality, length of hospitalization, hospital charges, days of ventilator support, or incidence of complications. Patients with inhalation injuries required more ventilatory support, and had longer lengths of hospitalization and higher costs. CONCLUSIONS: Administration of an IED has no clear advantages over the use of less expensive high-protein enteral nutrition in burn patients.