Blind Randomized Placebo Controlled Study Research Articles

Unlocking the psycho-social-dermal axis: A double blinded randomized placebo controlled study unveiling the influence of a novel topical formulation on skin quality, attractiveness, quality of life, and sexual satisfaction.

Improved skin appearance is closely linked to higher self-esteem, favorable first impressions, and enhanced quality of life, with skincare products often being formulated with biostimulatory and regenerative ingredients to both enhance skin health and provide psychological benefits. Certain components, such as phospholipids and botanicals, may not only improve skin quality, but also impact mood, romantic bonding, and sexual attraction. To assess whether a novel topical skin care product formulated with a proprietary combination of proteins, lipids, and botanical derivatives, can potentially result in a robust psycho-social-dermatological benefit via modulation epidermal oxytocin and pheromonal pathways. In this single-center prospective, randomized, controlled, double-blinded study, 40 female subjects were randomly assigned to use of either active novel skincare products, or placebos, for 4-8 weeks. Skin assessments, standardized photography, first impression ratings, and questionnaires on confidence and sexual satisfaction were conducted. Thirty-nine subjects completed the study and demonstrated a statistically significant improvement in skin quality following 4 and 8 weeks of use, with improvements of greater magnitude demonstrated with a longer duration of use. Product users projected a better first impression and appeared on average 3 years younger than their actual age, with 86% of subjects reporting increased confidence. Product users found random people of the opposite sex to be more attractive 88% of the time and reported improvement in sexual satisfaction in 90% of the categories. The use of this novel topical product culminated in statistically significant improvements in skin quality, confidence, sexual relationship satisfaction, perceived attractiveness, and youthfulness, highlighting its potential in anti-aging and mood enhancement.

In the article “Double blind randomized placebocontrolled study of the efficacy and safety of proroxan in the complex therapy of generalized anxiety disorder”

In the article “Double blind randomized placebocontrolled study of the efficacy and safety of proroxan in the complex therapy of generalized anxiety disorder”

Double blind randomized placebo-controlled study of the efficacy and safety of proroxan in the complex therapy of generalized anxiety disorder

Introduction. The clinical picture of generalized anxiety disorder is characterized by diffuse anxiety, muscle tension and multiple symptoms of hyperactivity of the sympathetic part of the autonomic nervous system. As an alpha-adrenoblocker, proroxan can reduce the hyperactivity of the autonomic nervous system, thereby reducing the severity of anxiety and its somatic symptoms.Aim. To evaluate the efficacy of proroxan in the correction of autonomic disorders in patients with generalized anxiety disorder compared to placebo.Materials and methods. 100 people participated in the study: 50 – in the study group received the SSRI escitalopram, 50 – in the control group received SSRI + placebo. The diagnosis of generalized anxiety disorder was made on the basis of ICD-10 criteria. Psychometric assessment using the Montgomery-Asberg scale was performed (only at the screening visit). Weekly psychometric evaluation was performed using the Hamilton anxiety scale, the SCL-90-R scale to assess somatic manifestations of anxiety, and general clinical impression scales (CGI-S disease severity and CGI-I general improvement).Results. In the course of the study, statistically significant decrease in the mean value of CGI-S scale was observed in both groups, however, more pronounced in the proroxan group (p > 0.05); in the CGI-I scale, more pronounced improvement was observed in the first week of treatment in the proroxan group (p > 0.05). The HAM-A scale also showed a more significant reduction in anxiety in the proroxan group than in the placebo group (p > 0.05). The SCL-90-R SOM scale showed a decrease in the mean value in both groups, more pronounced in the proroxan group, which confirms the effect of the drug on autonomic symptoms of anxiety (p > 0.05).Conclusions. The obtained results confirm the superiority of combination therapy with escitalopram and proroxan in the treatment of generalized anxiety disorder compared to monotherapy. The advantages of proroxan were the absence of sedative effect and, in general, good tolerability, absence of withdrawal syndrome and control of vegetative manifestations of anxiety.

Intranasal oxytocin increases respiratory rate and reduces obstructive event duration and oxygen desaturation in obstructive sleep apnea patients: a randomized double blinded placebo controlled study

BackgroundActivation of the oxytocin network has shown benefits in animal models of Obstructive Sleep Apnea (OSA) as well as other cardiorespiratory diseases. We sought to determine if nocturnal intranasal oxytocin administration could have beneficial effects in reducing the duration and/or frequency of obstructive events in obstructive sleep apnea subjects. MethodsTwo sequential standard “in-lab” polysomnogram (PSG) sleep studies were performed in patients diagnosed with OSA that were randomly assigned to initially receive either placebo or oxytocin (40 i.u.) administered intranasally in this double blinded randomized placebo controlled study. Changes in cardiorespiratory events during sleep, including apnea and hypopnea durations and frequency, risk of event-associated bradycardias, arterial oxygen desaturation and respiratory rate were assessed in 2 h epochs following sleep onset. Oxytocin significantly decreased the duration of obstructive events, as well as the oxygen desaturations and incidence of bradycardia that were associated with these events. Notably, oxytocin increased respiratory rate during non-obstructive periods. There were no significant changes in sleep architecture and no adverse effects were reported. ConclusionsOxytocin administration can benefit OSA subjects by reducing the duration and adverse consequences of obstructive events. Oxytocin could also be beneficial in situations involving respiratory depression as oxytocin increased respiratory rate. Additional studies are needed to further understand the mechanisms by which oxytocin promotes these changes in cardiorespiratory function. The long-term efficacy and optimal dose of intranasal oxytocin treatment should also be determined in OSA subjects.ClinicalTrials.gov NCT03148899.

Rocuronium versus dexmedetomidine as an adjuvant to local anesthetics in peribulbar block: A double blind randomized placebo controlled study

ObjectiveTo compare the use of rocuronium with that of dexmedetomidine as an adjuvant to the local anesthetic mixture in peribulbar anesthesia for cataract surgery.DesignA double blind, prospective, randomized controlled study.MethodsNinety patients with cataract in the age group 18–80 years of American Society of Anesthesiologists (ASA) physical status I–III scheduled for elective cataract surgery under regional anesthesia were randomly divided into three groups; Group C (control) received peribulbar anesthesia using a mixture of 4 ml lidocaine 2%, 4 ml bupivacaine 0.5%, and 1 ml normal saline. Group R received a mixture of 4 ml lidocaine 2%, 4 ml bupivacaine 0.5%, and 0.06 mg/kg rocuronium (maximum 5 mg) in 1 ml saline. Group D received a mixture of 4 ml lidocaine 2%, 4 ml bupivacaine 0.5%, and dexmedetomidine 50 μg (1 ml). Patients were assessed for onset and duration of corneal anesthesia and globe akinesia, postoperative pain using visual analog score (VAS), intraocular pressure (IOP), and sedation level using modified Ramsay sedation score (RSS). Patient and surgeon satisfaction score were also assessed.ResultsCorneal anesthesia was achieved more rapidly in groups D and R than group C (P < 0.01). Akinesia was achieved more rapidly in the group R than both group D and group C. Akinesia was achieved more rapidly in group D than the control group. Intraocular Pressure was significantly lower in group D compared to both the control group and group R. Ramsay sedation score was significantly higher in group D compared to both the control group and D. Patient and surgeon satisfaction was significantly higher in group R and D compared to the control group.ConclusionAdding 5 mg rocuronium to local anesthetic mixture provides more rapid onset of corneal and globe akinesia than 50 μg dexmedetomidine. Adding dexmedetomidine decreases IOP and provides sedation.

Comparison of Intranasal Dexmedetomidine with Intranasal Clonidine as a Premedication in Surgery.

To compare effectiveness of intranasal dexmedetomidine and clonidine as anxiolytics and sedatives in pediatric patients undergoing various surgeries. This double blind randomized placebo controlled study was conducted on 105 surgical patients of American Society of Anesthesiologist (ASA) physical status І-ІІ, aged between 2 and 9 y in a tertiary-care hospital (February 2014 to September 2015). Participants were randomly allocated to three groups to receive either intranasal dexmedetomidine 2μg/kg (Group І) or intranasal clonidine 3μg/kg (Group ІІ) or intranasal saline 0.5ml (Group ІІІ). The primary outcome measure was proportion of patients with satisfactory anxiolysis and sedation at 30min after drug administration. Secondary outcome measures included time taken to achieve Aldrete score of 9 and number of doses of rescue analgesia required in 12 h after surgery. Satisfactory anxiolysis was achieved by 88.5% in Group І vs. 60% in Group ІІ (p=0.001) and satisfactory sedation by 57.1% in Group І vs. 25.7% in Group ІІ (p=0.001) 30min after premedication. Rescue analgesia requirement was significantly less in Group І as compared to Group ІІ (p=0.001) while time taken to achieve Aldrete score was comparable between the study groups (p=0.185). Intranasal dexmedetomidine is a better anxiolytic and sedative as compared to clonidine. Postoperative analgesic requirement was also significantly decreased after intranasal dexmedetomidine. Thus, it can be preferred as compared to clonidine for premedication in pediatric surgical patients.

Possibilities of preventive treatment of tension-type headache in children and adolescents

To study clinical characteristics mechanisms and pathogenesis of the tension-type headache (TTH) in children and adolescents treated with nooclerin. The blind randomized placebo-controlled study of the efficacy of nooclerin (deanol aceglumate) indicated during 2 months as a preventive treatment of TTH was performed. Forty patients (15 male and 25 female), aged 9-16 years, were randomized into two equal groups to receive either nooclerin or placebo. Nooclerin significantly reduced the frequency, duration and intensity of TTH. The treatment resulted in positive dynamics in daily activities, regression of fatigue symptoms and normalization of the sleep-wake cycle.

Preoperative Prevention of Heart Failure in Noncardiac Surgery

Congestive heart failure is consistently associated with adverse outcomes, and is characterized by a twofold increase in mortality in noncardiac surgery. In this regard, developing the methods aimed to prevent and treatacute heart failure (AHF) in the intraoperative period remain a challenging problem. Objective. To evaluate the efficacy of preoperative levosimendan infusion in reduction both mortality and duration of treatment of elderly patients with reduced left ventricular ejection fraction in noncardiac surgery. Material and Methods . Design: Multicenter blind randomized placebocontrolled study. Patients: 81 patients operated on abdominal organs. The main endpoint of the study: The length of stay in the Intensive Care Unit (ICU) and at the hospital were chosen as the primary endpoints. The secondary endpoints of the study were 30 day and annual mortality, the rate of acute myocardial infarction and stroke. Results. Levosimendan infusion at a rate of 0,05 μg/kg/min — 0,1 μg/kg/min to patients with low left ven tricular ejection fraction just before the surgery reduced the length of stay in ICU for 2 days and required hospital stay for 3 days. NTproBNP showed the best ratio of sensitivity/specificity in predicting 30day mortality in cumulative group: AUC=0,86 (90,77 to 0,93), P&lt;0,0001. From other indicators the most informative were the Inotropes scoring, no change or decrease of a left ventricular ejection fraction, and cardiac index. Conclusion. To reduce perioperative mortality, the intravenous infusion of levosimendan at a rate of 0,05—0,1 μg/kg/min in elderly patients with low left ventricular ejection fraction is recommened as a preoperative preparation the day before the alleged noncardiac surgery.

Pidotimod for the prevention of acute respiratory infections in healthy children entering into daycare: A double blind randomized placebo-controlled study

Acute respiratory tract infections (ARTIs) are very common in pediatric age and reach a peak in the first 4 years of life, especially in children attending daycare. Pidotimod, a synthetic immunostimulant, may reduce the incidence of ARTIs in children with predisposing risk factors. Nevertheless studies on healthy children are presently lacking. We performed a double-blinded randomized placebo-controlled trial study to assess the efficacy of Pidotimod in a population of 3-year-old healthy children who just entered kindergarten. The main outcome was the incidence of respiratory infections in this population and the secondary outcome was the prescription of antibiotics.The study group consisted of healthy 3-year-old children who had not yet attended day-care centers. Patients were enrolled by a convenience sample of 17 family pediatricians (FP). Children were randomized to receive either Pidotimod 400mg per os or placebo twice daily for the last 10 days of each month from October 2013 to April 2014. Any time a child presented to his/her FP with fever and ARTI was diagnosed, clinical and therapeutic data were collected.A total of 800 children were pre-screened, 733 did not meet the inclusion criteria and 10 refused to participate. Of the 67 eligible subjects, 57 were successfully enrolled within the study recruitment period and randomized to receive Pidotimod (n=29) or placebo (n=28). Eight children were lost to follow-up. In the final analysis were thus included 24 children who received Pidotimod and 25 who received placebo. The incidence rate ratio for respiratory infections was 0.78 (95%CI 0.53 to 1.15, p=0.211) for Pidotimod vs. placebo. The corresponding risk ratio for antibiotic usage was 0.56 (95%CI 0.27 to 1.16, p=0.120).In our trial, Pidotimod did not prove to be statistically superior to placebo for the prevention of ARTI in a population of healthy children who entered kindergarten. However, Pidotimod showed some potential as a means for reducing antibiotic usage in these children.

Abstract 19419: A Phase IIa Randomized Double-Blind, Placebo Controlled Study to Evaluate Plasmid Stromal Cell-Derived Factor-1 for Treatment of Critical Limb Ischemia - The STOP-CLI Trial

Background: Stromal cell-derived factor-1 (SDF-1) promotes tissue repair by increasing cell survival, endogenous stem cell recruitment and vasculogenesis. Preclinical studies demonstrated that non-viral DNA plasmid encoding human SDF-1 (pSDF-1) is safe and increased vessel density in animal models of hindlimb ischemia versus placebo. Additionally, clinical studies have demonstrated safety of pSDF-1 and evidence of neovascularization at the microvascular level. A Phase IIa multi-center double blind randomized placebo-controlled dose escalation study (STOP-CLI) was initiated to evaluate the safety and efficacy of pSDF-1 administered via direct intramuscular injection in patients with critical limb ischemia (CLI). Methods: Forty eight CLI (Rutherford 4 or 5) patients who were poor candidates for surgical revascularization on stable medical therapy with ankle systolic pressure ≤70 mmHg or toe systolic pressure ≤50 mmHg were enrolled into 4 cohorts (n=12 each). Within each cohort, subjects were randomized 3:1 to receive a single set of direct intramuscular injections (8 or 16) to the ischemic limb of escalating doses of 1 mg/ml pSDF-1 (4, 8, 8 or 16mg) or placebo and were followed for 12 months post-dosing. Efficacy endpoints include: quality of life via SF-36, visual analog scale (VAS), Rutherford class, time to first/number of amputations, wound healing, and survival. Results: Enrollment was completed in July 2013. At baseline, patients were, 58.6±13.7 years, 88% male, and had an equal number of Rutherford 4 and 5 (n=24 each). To date, 482 follow up months have been completed with 36 Serious Adverse Events reported, none drug-related. Interim 12 month efficacy results show patients who received 8 injections (8 x 1 mg) totaling 8 mg pSDF-1 improved in rest pain (VAS -3.3±2.5 cm vs. -0.8±2.4 cm; 8 x 1 mg injections vs. placebo, p=0.12) and demonstrate improvements in SF-36 Overall Physical (22.4 ± 27 vs. -2.6 ± 29.7, p=0.22) and Mental (21.0 ± 12.7 vs. 0.26 ± 28.2, p=0.16) Health. Final 12 month data will be available in September 2014. Conclusions: STOP-CLI tests the hypothesis that delivery of pSDF-1 is safe and will improve the clinical status of patients with CLI. The interim results of STOP-CLI demonstrate safety and bioactivity of pSDF-1 for treatment of CLI.

Standardized cranberry capsules for radiation cystitis in prostate cancer patients in New Zealand: a randomized double blinded, placebo controlled pilot study.

Acute radiation cystitis, inflammation of the bladder, is a common side effect in men receiving external beam radiation for prostate cancer. Although several treatments provide symptomatic relief, there is no effective treatment to prevent or treat radiation cystitis. Cranberry products have been associated with urinary tract health. This study aimed to determine the effect of highly standardized cranberry capsules (containing 72 mg proanthocyanidins [PACS]) compared with that of placebo capsules on the incidence and severity of radiation cystitis. Forty-one men with prostate cancer participated in a double blinded randomized placebo controlled study. Men took one capsule a day at breakfast during treatment and for 2 weeks after treatment completion. Severity of urinary symptoms and the bother these caused were measured using the individual items of the urinary domain of the Modified Expanded Prostate Index Composite (EPIC). The incidence of cystitis was lower in men taking cranberry capsules (65%) compared with those that took placebo capsules (90%) (p = 0.058); severe cystitis was seen in 30% of men in the cranberry arm and 45% in the placebo arm (p = 0.30). Overall, the incidence of pain/burning was significantly lower in the cranberry cohort (p = 0.045). Men on the low hydration regimen who took cranberry had less pain/burning (p = 0.038), stronger urine steam (p = 0.030) and used significantly fewer pads/liners (p = 0.042), which was significantly different from those on the high hydration regimen (p = 0.028). Men receiving radiation therapy for prostate cancer may benefit from using cranberry capsules, particularly those on low hydration regimens or with baseline urinary symptoms.

Effect of tramadol gargle on postoperative sore throat: A double blinded randomized placebo controlled study

BackgroundPostoperative sore throat is an undesirable complaint after general anesthesia with laryngeal mask airway. Tramadol is a synthetic codeine analogue with NMDA receptor antagonist and local anesthetic effects. We compared tramadol gargle to placebo given 5 min before surgery on attenuating postoperative sore throat for 24 postoperative hours.MethodIn a prospective randomized double blind study, fifty patients of ASA I and II, undergoing elective moderate urological surgery under general anesthesia using laryngeal mask airway were allocated into two groups (25 patients each); all patients were asked to gargle for 1 min with 30 ml apple juice containing tramadol 2 mg/kg in group (T), and nothing in group (P) 5 min before surgery. The incidence and the severity of postoperative sore throat were graded at 2, 6, 12, and 24 h after surgery using a four-point scale.ResultIncidence and severity of postoperative sore throat were significantly less in tramadol treated group compared to placebo group at 2, 6, 12, and 24 h (p < 0.05).ConclusionPreoperative gargling with tramadol reduced the incidence and severity of POST compared to placebo group in patients undergoing elective moderate urological surgery, during general anesthesia with laryngeal mask airway for up to 24 h postoperatively.

The Effect of Short Term Vitamin D Supplementation on the Inflammatory and Oxidative Mediators of Arterial Stiffness.

BackgroundVitamin D deficiency has been implicated as a potential risk factor for cardiovascular disease. The high rate of vitamin D deficiency (<30 ng/ml) exhibited by African Americans may account for some of the excess prevalence of cardiovascular morbidity and mortality in this vulnerable US population. Vitamin D supplementation may reduce the risk of cardiovascular disease by ameliorating the onset and progression of arterial stiffness, a strong predictor of cardiovascular mortality, usually assessed by pulse wave velocity and augmentation index. Very few prospective studies have evaluated the effect of vitamin D supplementation on the inflammatory and oxidative stress mediators of arterial stiffness.MethodIn a double blind randomized placebo controlled study we evaluated the effect of a monthly dose of 100,000IU of vitamin D3 for three months on the level of serum 25(OH)D, intact parathyroid hormone (PTH), urinary isoprostane, adipocyte cytokine expression and arterial stiffness among 130 overweight and obese (BMI > 25) African Americans with elevated blood pressure (130 - 150/85 - 100 mmHg) and low serum vitamin D level (10 - 25 ng/ml).ResultsThere was a significant increase in the serum 25(OH)D levels to a mean level of 34.5 ng/ml (SD = 7.1) with the intervention (p < 0.001). The increase in 25(OH)D levels was associated with a significant decrease in the serum level of intact PTH (p = 0.02), mean urinary isoprostane (p = 0.02) and adipocyte cytokine expression. Although the increase in the 25(OH)D levels was not associated with any significant change in the Pulse Wave Velocity (PWV) in the overall study sample, it was associated with a significant decrease in the augmentation index among the participants with the highest tertile of urinary isoprostane (p = 0.007).ConclusionWe concluded that vitamin D supplementation increased serum 25(OH)D levels, decreased intact PTH level and the levels of select inflammatory and oxidative stress mediators of arterial stiffness. Longer term prospective studies are warranted to evaluate the effect of high dose vitamin D supplementation on arterial stiffness.

LB0001 Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24 week results of a phase 3 double blind randomized placebo-controlled study (rapid-PSA)

BackgroundCertolizumab pegol (CZP) is a PEGylated humanized Fc-free anti-TNF that is clinically effective in rheumatoid arthritis [1]; this is the first report of clinical efficacy and safety of CZP in...

A double blind randomised placebo controlled study of propolis (bee glue) effectiveness in the treatment of severe oral mucositis in chemotherapy treated children

Chemotherapy-induced oral mucositis (OM) is a debilitating side effect. In addition to standard therapy, patients often use complementary and alternative medicine to treat OM. Double blind randomised placebo controlled study assessing propolis (bee glue) efficacy for chemotherapy-induced severe OM treatment. University Children's Hospital, University Medical Centre Ljubljana, Ljubljana, Slovenia. Paediatric patients undergoing chemotherapy were randomly assigned to propolis (n=19) or placebo groups (n=21). Patients were introduced to a unified oral care protocol and asked to apply propolis or placebo to vestibular mucosa twice daily. Oral mucosa was assessed with the Oral Assessment Guide (OAG) twice a week when the patients were in hospital. Patients were followed for the period of the chemotherapy or for the first 6 months of the chemotherapy. An OAG score of 3 was considered to be severe OM and analysed. Three dependent variables (a) OM episode frequency, (b) mean number of assessment visits, at which an OAG 3 score was noted, expressing mean OM duration, (c) mean number of OAG 3 scores expressing mean OM severity) were reduced to a single variable using principal component analysis. A new variable (FDS) was used as the dependent variable in ANCOVA model analysis to show the differences between study groups. Severe OM was seen in 42% and 48% of patients in the propolis and placebo group, respectively. FDS was not statistically significant between study groups (p=0.59). According to our study results, propolis cannot be recommended for severe OM treatment.

Metilprednisolone and dialyzable leukocytes extracts induce changes in frequency of CLA+ T cells in patients with atopic dermatitis (P4196)

Abstract Atopic dermatitis(AD) is a T cell-mediated skin disease associated with a Th2 local response and skin inflammation is associated with CLA expression. In this work we evaluated expression of CLA on CD4 and CD8 T cells in 2 groups of patients one of them received metilprednisolone(mP-Advantan-) as treatment(Group 1) and second group received mP and dialyzable leukocyte extracts(DLE-Transferon-) as immune modulator(Group 2). Methods: Double blind randomized placebo controlled study, approved by hospital ethical committee. PBMC were obtained before, during (14 day) and at the end of treatment (28 day) and CLA expression on CD4 and CD8 was evaluated by flow cytometry. Results: Group 1:Frequency of CD4+CLA+T cells before treatment 1%±0.6 vs 1.9%±0.9 p=0.02 after treatment. CD8+CLA+T cells before treatment 4.5%±0.9 vs 8.1%±1.9 p=0.0002 after treatment. Group 2: CD8+CLA+T cells before treatment 5.3%±2.1 vs 8.8%±1.8 p=0.005 after treatment. Conclusion: We treated 58 AD-pediatric patients with mP or with mP+DLE, in both groups clinical outcome was improved after therapy; mP-treated patients induced CLA on CD4+ and CD8+ Tcells, while DLE-treated patients induced only CD8+CLA+T cells. Despite CLA expression is associated with local skin inflammation, some authors have suggested that CLA expression is also induced in Tregs; it is possible that DLE- induced CD8+CLA+ T could be enriched Tregs since it has been reported a diminished frequency of AD activation after DLE immune modulation.

1406 DOUBLE BLINDED RANDOMIZED PLACEBO CONTROLLED TRIAL TO DETERMINE EFFECT OF BUPIVACAINE DORSAL PENILE BLOCK ON POSTOPERATIVE PAIN AND FOLEY DISCOMFORT FOLLOWING ROBOTIC ASSISTED RADICAL PROSTATECTOMY

INTRODUCTION AND OBJECTIVES: Urethral catheterization is a source of significant discomfort and pain after Robotic Assisted Radical Prostatectomy (RARP). Herein we present an interim analysis of a study assessing the effect of Bupivacaine dorsal penile block on postoperative pain after RARP. METHODS: Between December 2011 and October 2012 at total of 78 patients were enrolled in a prospective double blinded randomized placebo controlled study comparing bupivacaine (20cc at 0.5%) dorsal penile block injection versus normal saline injection at the conclusion of RARP. Postoperative pain and urinary symptoms were evaluated using questionnaires based on visual analog scales at multiple time points until Foley removal. In addition, patients were required to maintain a log of narcotic and pain medication use after RARP until Foley catheter removal. Student?s t test and Fisher?s exact tests were used for continuous parametric and categorical data, respectively, with p 0.05 considered to be significant. RESULTS: No complications or adverse events occurred in this study. There was no difference with respect to age, pre-operative PSA, stage, Gleason score, body mass index, operative time or history of diabetes between the two groups. There was a trend toward less inpatient narcotic use in patients receiving block vs. placebo (3.9 mg vs. 5.7 mg morphine equivalents, p .19). Outpatient narcotic use was similarly less in the patients receiving block vs. placebo (13.8 mg vs. 15mg morphine equivalents, p .77). With respect to abdominal incisional pain and bladder spasm discomfort, there was no significant difference at the 18 hour time point (average discharge time) or at the end of the follow up period on day 9. At the 18 hour time point period patients receiving penile block reported significantly less penile pain than patients receiving saline injection (1.39 vs. 2.0, p .04). At the end of the follow up period this difference remained significant in favor of penile block (.75 vs. 3.27, p .04). CONCLUSIONS: In this interim analysis, penile block with bupivacaine appears to improve penile pain score postoperatively after RARP. These results suggest that initial post-operative pain management may affect the perception of pain going forward. Further confirmation is needed to standardize penile block as a viable protocol to manage post-operative Foley discomfort after RARP.

Effect of Vitamin D Supplements On Hemoglobin Concentration in Patients with Iron Deficiency Anemia and Concurrent Vitamin D Deficiency:A Randomized Single Blind Placebo Controlled Trial

Abstract 5173 Background:The effect of vitamin D replacement on hemoglobin concentration in subjects with concurrent iron deficiency anemia and vitamin D deficiency is not known. Methods:In a single blinded randomized placebo controlled study, thirty subjects with iron deficiency anemia (serum ferritin < 15 ug/dl) were randomized to intervention arm (vitamin D 6 lakh IU IM once) or placebo. In all subjects, iron deficiency was corrected with parental iron. All the causes other than iron deficiency were excluded with appropriate investigation. The primary end point was rise in hemoglobin concentration. Results:Baseline age, BMI, hemogram, levels of serum ferritin, 25(OH)D and PTH were similar in both the arms. Twelve weeks after vitamin D replacement, there was significant increase in 25 (OH) D levels and decrease in PTH levels in subjects with intervention arm compared to placebo arm (p<0. 01). The increment in serum ferritin in both the group was similar. There was no further increase in hemoglobin concentration in intervention arm compared to placebo arm. Conclusion:Vitamin D replacement in subjects with iron deficiency anemia after iron correction does not improve hemoglobin concentration further. Disclosures:No relevant conflicts of interest to declare.

Improvement of accommodation with anti-oxidant supplementation in visual display terminal users.

To determine the antioxidant supplementation effect on accommodation among VDT users. A double blind randomized placebo controlled study. Registered under ClinicalTrials.gov Identifier No. NCT00877201. Fourty right eyes of 40 healthy VDT users (30 females, 10 males, mean age: 43.8±2.8 years, range: 40-49 years). 20 subjects (15 females, 5 males; mean age: 44.0±2.7 years, range: 40-49 years). Subjects were required to take an antioxidant supplement, 20 age and sex matched subjects (15 females, 5 males; mean age: 43.6±3.1 years, range: 40-49 years) were required to take placebo medication for 4 weeks. The mean of the change in accommodation power was significantly higher in the group receiving antioxidant supplements (0.20±0.50 Diopter(D)) compared to the placebo group (-0.12±0.48(D)) (p<0.05). Antioxidant supplementation was observed to improve accommodation in Japanese Visual Display Terminal (VDT) Users.

Cefuroxime as a prophylactic preoperative antibiotic in septoplasty. A double blind randomized placebo controlled study

Prophylactic antibiotics are often used in septoplasty. However, the number of controlled studies, especially randomized double blind placebo controlled studies on the effect of antibiotics in septum surgery, is very low. The PURPOSE OF THE PRESENT STUDY was to investigate if intravenous cefuroxime given as preoperative antimicrobial prophylaxis 30 minutes prior to surgery diminishes the risk of infection after septoplasty during the first postoperative month among patients with normal immune function. This study was a double-blind placebo controlled randomized study and patients were randomized to either an antibiotic prophylaxis-group or placebo-group. In the antibiotic-group, the infection rate was 2.2% (2/92) and in the placebo-group 8.3% (8/96), which is not statistically different. All three deep incisional SSI (septal abscess) occurred in the placebo-group. The preoperative crusting or purulent secretion, or Staphylococcus aureus in the bacterial swab increased the risk of postoperative infection significantly. We recommend the use of one dose of 1500 mg intravenous cefuroxime prior to septoplasty in patients having crusts or purulent secretion in the nasal cavities or if the operation is expected to be prolonged.