Single-blind Randomized Study Research Articles

Effect of Zingiber Cassumunar Roxb. Phonophoresis Versus Aqua Sonic Gel on Pain, Range of Motion, and Functional Disability in Patients With Osteoarthritis of Knee: A Randomized Controlled Trial.

The aim of this trial was to collate, analyze, and compare the effectiveness of phonophoresis and ultrasound adjunct to Otago exercise program for pain, knee range of motion, and functional disability in patients with grades I and II of knee osteoarthritis. This is a single-blind randomized control study. A total of 52 patients with pre-diagnosed osteoarthritis on radiological investigation were included in the study. They were then randomly assigned into two groups: group A (n=26) received the experimental treatment, which included phonophoresis, and group B (n=26) subjects were treated with conventional physiotherapy. The interventions were given for six days/week for two weeks. Pain via the visual analog scale, knee range of motion via a goniometer, level of functional disability through the Western Ontario and McMaster Universities Osteoarthritis Index, and balance through the star excursion balance test were evaluated. Measurements of the outcome were taken prior to initiation of intervention and on the day of the last session, succeeding the treatment. Statistically, both the groups showed significant improvement in pain, range, dynamic balance, and functioning. Between the two groups, no clinically significant difference was present for balance, but the intergroup comparison for pain and functions was statistically and therefore clinically significant. Phonophoresis treatment was observed to be effective in treating pain in osteoarthritis. Combined Otago exercises and phonophoresis with modified gel can be used to achieve superior clinical results.

INTERNAL JUGULAR VEIN CATHETERIZATION “A COMPARATIVE STUDY OF REAL-TIME ULTRASOUND - GUIDED TECHNIQUE VERSUS CONVENTIONAL LANDMARK GUIDED TECHNIQUE.”

Background and Aim: Central venous catheter placement is a frequently performed procedure in emergency and intensive care units. we aimed to compare real-time ultrasound guided (USG) and the conventional anatomical landmark (LM) technique for the insertion of internal jugular vein catheters. Materials and method: Patients requiring IJV catheterization were prospectively recruited over a period of 1 and half year. It is a single blinded prospective randomised study involving total of 48 cases meeting inclusion criteria were randomly allocated in two groups, 24 patients to each group. Number of attempts, success rate, venous access time, IJV catheterization time and complications were observed in each group. All data were analysed by proper statistical test using SPSS-29 software. The data was analysed by computing percentages and descriptive statistics as mean, standard deviation and standard error of mean. The difference of mean between two techniques is tested using independent Student t-test. For all tests, p value of <0.05 was considered signicant. The nding of this study indicates that internal jugular vein catheterization gui Conclusion: ded by real-time USG results in higher 1st pass success rate, reduced number of cannulation attempt and fewer complication

Angioplasty of Dysfunctional Dialysis Fistula or Graft with Resveratrol-Excipient and Paclitaxel-Coated Balloon Improves Primary Patency Rates Compared to Plain Angioplasty Alone.

In this prospective randomized single-blinded study (reg. ISRCTN11414306), 76 patients with a dysfunctional dialysis fistula or graft due to a single de novo or recurrent stenosis in the access circuit were randomized to receive either conventional PTA (POBA) as a standard of care (n = 38) or PTA + adjunctive PTA with a drug-coated (paclitaxel-resveratrol matrix) SeQuent® Please OTW balloon (n = 38, DCB). Patients were scheduled for follow-up PTA at 3, 6, 9, and 12 months. The time of clinically driven target-lesion reintervention rate (primary patency rate) after the index procedure was analyzed using the log-rank test. The primary patency rates at 12 months after the index procedure were 17% (DCB) vs. 11% (POBA). At 3 months, they were 87% vs. 74%, at 6 months they were 53% vs. 26%, and at 9 months they were 22% vs. 11%. The hazard ratio for DCB was 0.55 (95%CI 0.32 to 0.95). The median time needed for target-lesion reintervention was longer in the DCB group (181 days) than in the conventional PTA group (98 days, p = 0.019). We conclude that PTA with the paclitaxel-resveratrol drug-coated SeQuent® Please OTW balloon in patients with de novo or recurrent stenosis in dialysis arteriovenous fistulas or grafts prolongs the time needed for target lesion reintervention and improves primary patency rates in the first year after the index procedure.

Conservative Therapies for TMJ Closed Lock: A Randomized Controlled Trial.

Background. Acute anterior disc displacement without reduction (ADDWoR) is characterized by permanent TMJ disc displacement, pain and functional limitations. Occlusal appliances (OA) are among the therapies of choice. Methods. A single-blind randomized study was carried out to compare the therapeutic success of two different types of splints in patients with ADDWoR. A total of 30 subjects were eligible for the study out of the 330 screened. Group I (n = 15) received RA.DI.CA splint therapy and Group II (n = 15) received stabilization splint therapy. Temporomandibular pain, headache, neck pain and functional excursions were evaluated at baseline (T0), after 4 weeks (T1) and after 6 months (T2). Descriptive and inferential statistics were performed. Results. There was a significant increase in maximum jaw opening and a reduction in pain in both groups (p < 0.05), except for neck pain in Group II. Significant differences in between- and within-subject factors emerged in all of the parameters evaluated, especially between T1 and T2 scores, with a greater trend of improvement in Group I than Group II. Conclusion. RA.DI.CA splints were found to be more effective for the considered sample, especially in the treatment of comorbidities and functional movements, probably due to the greater orthopedic action and joint mobilization.

Piperacillin-Tazobactam as an Adjuvant in the Mechanical Treatment of Patients with Periodontitis: A Randomized Clinical Study.

In this study, the aim was to evaluate the effects of the adjuvant piperacillin-tazobactam solution in the mechanical treatment of periodontitis. A single-blind split-mouth randomized study, it included 24 participants. All of them presented periodontitis stage III according to the 2018 World Workshop classification and the presence of at least one of the following periodontal pathogens: Aggregatibacter actinomycetemcomitans; Porphyromona gingivalis; Treponema denticola; Tannerella forsythia; Prevotella intermedia. The study established two groups: a control group (SRP: scaling and root planing) and a test group (SRP plus local piperacillin-tazobactam). The final recruitment included 11 women (45.8%) and 13 men (54.2%). The age range was between 25 and 72 years, and the mean age was 57 ± 10.20 years. Clinical controls were performed at 2 weeks, 3 months, and 6 months, repeating the SRP and applying the piperacillin-tazobactam solution again at the 3-month appointment. The clinical attachment level decreased by a mean of 2.13 ± 0.17 mm from the baseline to 6 months in the test group versus 1.63 ± 0.18 mm in the control group. The mean probing pocket depth decreased from 1.32 ± 0.09 mm in the test group, versus from 0.96 ± 0.14 mm on the control side. The plaque index in the test group decreased by 0.46 ± 0.04, while it decreased by an average of 0.31 ± 0.04 in the control group. In conclusion, the local use of piperacillin-tazobactam as complementary therapy produces better clinical results in patients with periodontitis. However, these results are not maintained over time, and so a more persistent local application is necessary.

The effect of varying inhaled oxygen concentrations of high-flow nasal cannula oxygen therapy during gastroscopy with propofol sedation in elderly patients: a randomized controlled study

BackgroundDespite evidence that high-flow nasal cannula oxygen therapy (HFNC) promotes oxygenation, its application in sedated gastroscopy in elderly patients has received little attention. This study investigated the effect of different inhaled oxygen concentrations (FiO2) of HFNC during sedated gastroscopy in elderly patients.MethodsIn a prospective randomized single-blinded study, 369 outpatients undergoing regular gastroscopy with propofol sedation delivered by an anesthesiologist were randomly divided into three groups (n = 123): nasal cannula oxygen group (Group C), 100% FiO2 of HFNC group (Group H100), and 50% FiO2 of HFNC (Group H50). The primary endpoint in this study was the incidence of hypoxia events with pulse oxygen saturation (SpO2) ≤ 92%. The secondary endpoints included the incidence of other varying degrees of hypoxia and adverse events associated with ventilation and hypoxia.ResultsThe incidence of hypoxia, paradoxical response, choking, jaw lift, and mask ventilation was lower in both Group H100 and Group H50 than in Group C (P < 0.05). Compared with Group H100, Group H50 showed no significant differences in the incidence of hypoxia, jaw lift and mask ventilation, paradoxical response, or choking (P > 0.05). No patients were mechanically ventilated with endotracheal intubation or found to have complications from HFNC.ConclusionHFNC prevented hypoxia during gastroscopy with propofol in elderly patients, and there was no significant difference in the incidence of hypoxia when FiO2 was 50% or 100%.Trial registrationThis single-blind, prospective, randomized controlled trial was approved by the Ethics Committee of Nanjing First Hospital (KY20201102-04) and registered in the China Clinical Trial Center (20/10/2021, ChiCTR2100052144) before patients enrollment. All patients signed an informed consent form.

Randomized control trial of mesenchymal stem cells versus hyaluronic acid in patients with knee osteoarthritis - A Hong Kong pilot study.

ObjectiveThis pilot study evaluated the efficacy of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) versus hyaluronic acid (HA) in surgically naïve patients with knee osteoarthritis (OA).MethodsSingle-centre, single-blind randomized study of patients with knee OA. Twenty patients were randomized into groups of 10 each for intra-articular injection of cultured BM-MSCs (6 ​ml of BM-MSCs at 1 ​× ​106 ​cells/mL) or HA (6 ​ml). Clinical assessments of pain, quality of life, radiographic imaging, and magnetic resonance imaging (MRI) compositional change were performed at baseline and 12 months follow-up.ResultsCompared with HA, BM-MSCs injection resulted in significant improvement in qualify of life and reduction in pain as reflected by visual analogue scale (VAS) pain score, Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, and 36-Item Short Form Survey (SF-36) score collectively. T2-relaxation time tended to decrease more in the BM-MSCs group with a 38 ​± ​24.0% reduction in 6 out of 10 BM-MSC participants; while there was only a 12 ​± ​7.9% reduction in 4 out of 10 HA participants at the end of follow-up. The remaining participants showed either no response or had relaxation time increased on MRI assessment.ConclusionsThis pilot study found that autologous BM-MSCs significantly reduced pain, improved functional assessment score, and improved quality of life parameters comparing with HA at one year follow-up. Further clinical trial with larger sample size and longer follow up duration is warranted.The Translational Potential of this ArticleThis pilot RCT demonstrated the feasibility and potential effectiveness of BM-MSCs advanced therapy for patients with knee OA compared to HA injection. Further multi-center clinical trial with a larger sample size and longer follow up duration in accordance with latest regulatory guidelines is warranted to ascertain the long term safety and effectiveness of MSCs therapy for cartilage regeneration in OA.RegistrationThe study was registered in the Centre for Clinical Research Biostatistics - Clinical Trials Registry (CUHK_CCT00469).

Preoperative Forced-Air Warming Strategy: Is It Effective in Averting Intraoperative Hypothermia in Elderly Trauma Surgical Patients?

Background and objectivesInadvertent perioperative hypothermia is expected in the elderly during central neuraxial anesthesia. We aimed to compare the incidence of intraoperative hypothermia (< 36-degree celsius) between preoperative forced-air warming for 30 minutes and non-warming groups. Also, we compared the time to develop hypothermia, perioperative shivering, duration of intraoperative active warming, metabolic acidosis, surgical site infections, coagulation derangements, and post-anesthesia care unit (PACU) stay.Material and methodologyA total of 100 American Society of Anesthesiologists (ASA) I-III (Age > 60 years) patients scheduled to undergo femur fracture surgeries under central neuraxial anesthesia were enrolled in this single-blinded prospective randomized study. They were randomly allocated into Group A (active forced-air warming for 30 minutes in the preoperative period) and Group B (without forced-air warming). Then, patients were transferred to the operation theatre, where central neuraxial anesthesia was administered for surgery. An infrared tympanic membrane thermometer measured the core body temperature during the different study points.ResultsThe intraoperative hypothermia incidences were 26.0% and 68.0% in groups A and B, respectively. The mean time for developing hypothermia was found to be 143.08 ± 26.26 min and 25.88 ± 9.25 min in groups A and B, respectively. The mean duration of intraoperative active warming was observed to be 15.6 minutes and 103.6 minutes in groups A and B, respectively. The shivering and surgical site infection (SSI) grades were lower in group A.ConclusionA preoperative forced-air warming strategy for 30 minutes helps in reducing the incidence of intraoperative hypothermia and shivering in elderly patients undergoing femur fracture surgeries under central neuraxial anesthesia.

Management of normal long head of the biceps tendon in isolated grade-1 supraspinatus tear: Research protocol for a multicenter prospective single-blind randomized study

BackgroundThe long head of the biceps (LHB) tendon is a common locus of pain in rotator cuff tear and of residual pain after tendon repair. Therefore, systematic LHB tenotomy, with or without tenodesis, is usually recommended. However, the recent literature suggests that long-term functional results of supraspinatus tendon repair are comparable between conservation of a normal biceps and tenotomy. The study objective is to compare functional results between sectioning and sparing a normal LHB in treating isolated grade-1 supraspinatus tendon tear. The study hypothesis is that sparing the normal LHB is clinically preferable to sectioning in the particular case of distal supraspinatus tear. Methods and analysisA French nationwide prospective single-blind randomized clinical study will include 194 patients undergoing arthroscopic repair of grade-1 supraspinatus tear with normal LHB. They will be randomized to 2 parallel groups: LHB sparing and sectioning. The main endpoint is Constant-Murley score, and secondary endpoints comprise ASES and SSV scores, clinical assessment of the biceps, pain on VAS, ultrasound assessment of cuff repair healing and conserved LHBs, impact on return to work and sport, pathologic assessment of sectioned LHBs, and analysis of risk factors for cuff repair failure. Ethical approval and publicationThe protocol has been approved by the data protection committee (art.L.1122-1) and meets the criteria of the Declaration of Helsinki and of the SPIRIT statement defining standard protocol items for clinical trials. Results will be published in a peer-reviewed journal. Level of evidencenot applicable.

How does visual praxis based occupational therapy program effect motor skills in children with hyperactivity and attention disorder? Single blind randomized study design

Attention Deficit and Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized with problems such as; atypical attention skills increased impulsive behaviors at least two of the child’s areas of daily living. In studies investigating developmental aspect of the said problems of children with ADHD, it was stated that the children usually do not demonstrate normal development regarding the motor proficiency and may fall behind their peers in exhibiting normal motor performance. These problems in motor skills are said to cause a hindered development in complex skills which may result in; distorted body image, increased anxiety and poor social communication skills. This study’s aim was to investigate effects of a Visual-Praxis-based Occupational Therapy program (VPOT) on motor proficiency of children with ADHD. The 58 children who were included to the study were assigned numbers from 1 to 58 and randomized into two groups (the intervention group and the control group). Both groups were subjected to the Bruninks-Oserestry Test of Motor Proficiency 2–Brief Form (BOT2-BF). After the initial assessment, the participants in the intervention group were admitted into the VPOT program for a duration of 8 weeks with twice-weekly sessions of 45 minutes. End of the program, BOT2-BF was applied once more. The participants mean age was 8.44±1.39 years. There were no differences between the intervention and the control group in terms of age. When the BOT2-BF results for the intervention group were analyzed, it was found that there were significant differences between pre- and post-intervention scores of all sub-scores and the total score. Due to approaching the motor development aspect of ADHD within the context of motor proficiency and visual perception, this study can be considered to be one of the innovative and pioneer studies in the field and is positively unique regarding the usage of the intervention approach that was used.

Effect of probiotics on hemodynamic changes and complications associated with cirrhosis: A pilot randomized controlled trial.

BACKGROUNDBacterial translocation exacerbates the hyperdynamic circulation observed in cirrhosis and contributes to a more severe disease course. Probiotics may reduce bacterial translocation and may therefore be useful to redress the circulatory imbalance.AIMTo investigate the effect of probiotics on hemodynamic parameters, systemic inflammation, and complications of cirrhosis in this randomized placebo-controlled trial.METHODSThis single-blind randomized placebo-controlled study included 40 patients with Child-Pugh class B and C cirrhosis; 24 patients received probiotics (Saccharomyces boulardii) for 3 mo, and 16 patients received a placebo over the same period. Liver function and the systemic hemodynamic status were evaluated pre- and post-intervention. Echocardiography and simultaneous blood pressure and heart rate monitoring were performed to evaluate systemic hemodynamic indicators. Cardiac output and systemic vascular resistance were calculated.RESULTSFollowing a 3-mo course of probiotics in comparison to the control group, we observed amelioration of hyperdynamic circulation [a decrease in cardiac output (P = 0.026) and an increase in systemic vascular resistance (P = 0.026)] and systemic inflammation [a decrease in serum C-reactive protein levels (P = 0.044)], with improved liver function [an increase in serum albumin (P = 0.001) and a decrease in the value of Child-Pugh score (P = 0.001)] as well as a reduction in the severity of ascites (P = 0.022), hepatic encephalopathy (P = 0.048), and cholestasis [a decrease in serum alkaline phosphatase (P = 0.016) and serum gamma-glutamyl transpeptidase (P = 0.039) activity] and an increase in platelet counts (P < 0.001) and serum sodium level (P = 0.048).CONCLUSIONProbiotic administration was associated with amelioration of hyperdynamic circulation and the associated complications of cirrhosis.

Virtual Reality Therapy for the Negative Symptoms of Schizophrenia (V-NeST): A pilot randomised feasibility trial

BackgroundNegative symptoms are typically observed in people with schizophrenia and indicate a loss or reduction of normal function (e.g. reduced motivation and affect display). Despite obstructing people's recovery, intervention development has received limited attention. This study tests the feasibility and acceptability of a novel Virtual Reality Supported Therapy for the Negative Symptoms of Schizophrenia (V-NeST). MethodA single (rater) blind randomised study with two conditions; V-NeST plus treatment as-usual (TAU) vs. TAU alone, recruiting people with schizophrenia experiencing debilitating negative symptoms. Assessment was at baseline and 3-month post-randomisation. The pre-specified primary outcome was participants' goal attainment, secondary outcomes were negative symptoms and functioning. The study assessed feasibility and acceptability parameters including recruitment, eligibility, treatment adherence and retention. Acceptability was also evaluated qualitatively using a post-therapy feedback interview. Explorative therapy effect on outcomes was estimated. ResultsThe study recruited to its pre-specified target of 30 participants (15 randomised to V-Nest). Two participants in each trial arm disengaged and did not complete the study. Therapy engagement for those randomised to V-NeST was appropriate and research procedures were feasible. The experience with therapy and VR was described as positive and useful. Preliminary analysis suggested the therapy may have a large effect on participants goals and a possible effect on negative symptoms. ConclusionV-NeST is a feasible and acceptable intervention. This therapy has the potential to support people with schizophrenia achieving their recovery goals and may reduce negative symptoms. The efficacy results need to be evaluated in an appropriately powered efficacy study.

Effect of Telenursing on Caregiver Burden of Care and Incidence of some Complications in Patients with Acute Stroke Discharged from Neurological Wards: A Randomized Control Trial

Background: Brain stroke is the main cause of death and disability worldwide. This disease can cause major complications in patients and place a great burden of care on caregivers. Therefore, this study was conducted to determine the effect of telenursing on the burden of care in caregivers and the rate of complications in patients with acute brain stroke discharged from neurological wards. Methods: This two-arm parallel-group single-blind randomized clinical trial study was carried out on 72 patients with acute brain stroke discharged from neurological wards in Qom, Iran, in 2019. The patients and their caregivers were divided to control and intervention groups using random block allocation. In addition to the usual training of the ward, the intervention group received training and counseling based on their needs through phone calls for 4 weeks. However, the control group received only the usual ward training. Immediately after discharge from the hospital and 1 month later, the average care load in caregivers and urinary problems, bedsores, and the number of falls in patients were measured. A demographic questionnaire, Caregiver Burden Inventory, Braden Scale, Morse Scale, and a urinary problem checklist were used for data collection. The data were analyzed using the chi-square test, Mann-Whitney U test, independent t-test, and paired t-test by SPSS software (version 24). Results: After the intervention, the mean scores of the caregiver’s burden of care in the control and counseling groups were 35.22 ± 17.215 and 8.00 ± 7.556, respectively (P &lt; 0.001). In addition, the counseling group experienced remarkably fewer urinary problems (P &lt; 0.001) and falling (P = 0.011). Conclusions: This study showed that telenursing reduced the burden of care in caregivers and decreased urinary tract infections and the number of falls in patients with acute stroke. Therefore, nurses and healthcare providers can use this program to improve the lifestyle of patients with acute brain stroke and their caregivers.

Effect of intraoperative alveolar recruitment maneuver on intraoperative oxygenation and postoperative pulmonary function tests in patients undergoing robotic-assisted hysterectomy: a single-blind randomized study

BackgroundRobotic-Assisted Hysterectomies (RAH) require Trendelenburg positioning and pneumoperitoneum, which further accentuate alteration in respiratory mechanics induced by general anesthesia. The role of Recruitment Maneuver (RM) as a lung-protective strategy during intraoperative surgical settings has not been much studied. We planned this study to evaluate the effect of RM on perioperative oxygenation and postoperative spirometry using PaO2/FiO2 and FEV1/FVC, respectively in patients undergoing RAH. MethodsSixty-six ASA I‒II female patients scheduled for elective RAH were randomized into group R (recruitment maneuver, n = 33) or group C (control, n = 33). Portable spirometry was done one day before surgery. Patients were induced with general anesthesia, and mechanical ventilation started with volume control mode, with Tidal Volume (TV) of 6–8 mL.kg−1, Respiratory Rate (RR) of 12 min, inspiratory-expiratory ratio (I: E ratio) of 1:2, FiO2 of 0.4, and Positive End-Expiratory Pressure (PEEP) of 5 cmH2O. Patients in group R received recruitment maneuvers of 30 cmH2O every 30 minutes following tracheal intubation. The primary objectives were comparison of oxygenation and ventilation between two groups intraoperatively and portable spirometry postoperatively. Postoperative pulmonary complications, like desaturation, pulmonary edema, pneumonia, were monitored. ResultsPatients who received RM had significantly higher PaO2 (mmHg) (203.2+-24.3 vs. 167.8+-27.3, p < 0.001) at T2 (30 min after the pneumoperitoneum). However, there was no significant difference in portable spirometry between the groups in the postoperative period (FVC, 1.40 ± 0.5 L vs. 1.32 ± 0.46 L, p = 0.55). ConclusionThis study concluded that intraoperative recruitment did not prevent deterioration of postoperative spirometry values; however, it led to improved oxygenation intraoperatively.

Simulation-based randomized trial of medical emergency cognitive aids

BackgroundMedical emergencies are complex and stressful, especially for the young and inexperienced. Cognitive aids (CA) have been shown to facilitate management of simulated medical emergencies by experienced teams. In this randomized trial we evaluated guideline adherence and treatment efficacy in simulated medical emergencies managed by residents with and without CA.MethodsPhysicians attending educational courses executed simulated medical emergencies. Teams were randomly assigned to manage emergencies with or without CA. Primary outcome was risk reduction of essential working steps. Secondary outcomes included prior experience in emergency medicine and CA, perceptions of usefulness, clinical relevance, acceptability, and accuracy in CA selection. Participants were grouped as “medical” (internal medicine and neurology) and “perioperative” (anesthesia and surgery) regarding their specialty. The study was designed as a prospective randomized single-blind study that was approved by the ethical committee of the University Duisburg-Essen (19-8966-BO). Trial registration: DRKS, DRKS00024781. Registered 16 March 2021—Retrospectively registered, http://www.drks.de/DRKS00024781.ResultsEighty teams participated in 240 simulated medical emergencies. Cognitive aid usage led to 9% absolute and 15% relative risk reduction. Per protocol analysis showed 17% absolute and 28% relative risk reduction. Wrong CA were used in 4%. Cognitive aids were judged as helpful by 94% of the participants. Teams performed significantly better when emergency CA were available (p < 0.05 for successful completion of critical work steps). Stress reduction using CA was more likely in “medical” than in “perioperative” subspecialties (3.7 ± 1.2 vs. 2.9 ± 1.2, p < 0.05).ConclusionsIn a high-fidelity simulation study, CA usage was associated with significant reduction of incorrect working steps in medical emergencies management and was characterized by high acceptance. These findings suggest that CA for medical emergencies may have the potential to improve emergency care.

Treatment of Resistant Acne Vulgaris in Adolescents Using Dietary Supplementation with Magnesium, Phosphate and Fatty Acids (Omega 6 and 7): Comparison with 13-Cis-Retinoic Acid

The burden of disease associated with acne vulgaris has continued to increase over time in the world population. This continued growth suggests that there is an unmet dermatologic need for this condition worldwide. Potential sequelae of acne, such as scarring, depigmentation, and marked emotional and psychological problems (e.g., low self-esteem), can lead to significant morbidity. The purpose of this study was to investigate whether dietary supplementation with magnesium, phosphate, omega 6 (linoleic acid calcium salt - C18:2 fatty acid Ca salt), and omega 7 (palmitoleic acid calcium salt - C16:1 fatty acid Ca salt) would help patients with acne vulgaris, and to compare with isotretinoin (13-cis retinoic acid). Magnesium has anti-inflammatory properties. Linoleic and palmitoleic acids have bactericidal activity against Staphylococcus aureus and Cutibacterium acnes (formerly known as Propionibacterium acnes). A single-blind randomized study was conducted in which 257 patients were treated with the above dietary supplementation (group A) and 275 patients with isotretinoin (group B) for 6 months. All patients in group A (100%) reported complete regression of symptoms after 6 months of treatment. On the other hand, 187 subjects (68%) in group B reported complete resolution of symptoms during the same period. The difference between the groups (p < 0.05) was statistically significant. The study was approved by the CEP/CONEP. This natural formulation promotes regression and/or cure of acne vulgaris symptoms and has better results than drugs (such as isotretinoin), without significant side effects.

Efficacy of Diethylcarbamazine in Allergic Rhinitis as an Adjuvant to Antihistamines : A Comparative Study

Background: Allergic rhinitis is a type of inflammation in the nose that occurs when the immune system overreacts to allergens in the air. Underlying mechanism involves IgE antibodies that attach to allergen resulting in release of histamine from mast cells. Signs and symptoms include a runny or stuffy nose, sneezing, redness and watering of eyes. Symptom onset is often within minutes following allergen exposure and can affect sleep and ability to work or study. People with allergic rhinitis may have associated asthma, allergic conjunctivitis, atopic dermatitis. The study aims to know the efficacy of diethyl carbamazine in reducing the severity of symptoms in patients with allergic rhinitis when added to the antihistaminic treatment.&#x0D; Methods: This is a single blind randomized control trial study involving 50 allergic rhinitis patients between 13-60 years as cases and 50 as controls. The patients were classified as mild, moderate and severe based on the severity of symptoms. The cases were prescribed Tablet Diethyl carbamazine 300mg along with Tablet cetrizine 10mg for a period of 21 days. The controls were prescribed Tablet cetrizine 10mg with placebo. Patients were followed up for 3 months and watched for any reduction in the severity of symptoms. Results were compared between the study and control groups. &#x0D; Results: Out of 50 patients in the study group, 20 cases showed improvement, 30 cases did not show any improvement; Out of 50 controls, 6 showed improvement and 44 didn’t show any improvement. P value is significant (0.003) &#x0D; Conclusion: Diethyl carbamazine is an ant filarial drug which is found to have an effect in reducing the mediators of inflammation thereby useful in reducing the severity of symptoms in allergic rhinitis, as an adjuvant.

Short Term Outcome of Plasma Pleurodesis in Post Pulmonary Resections Persistent Air Leak

Background: Air leak is the most common morbidity after pulmonary resection surgery. It may result in prolonged duration with chest tubes with their annoying chest pain, prolonged hospital stay time with increased financial costs, pneumonia, empyema, and patient dissatisfaction. Our objective was to evaluate the efficacy of plasma pleurodesis for stoppage of air leak after lung resection, in comparison to conservative measures.&#x0D; Methods: This prospective single-blinded randomized study included 60 patients randomly divided into two groups:&#x0D; Group A: included 30 patients who received intrapleural fresh frozen plasma. One bag of FFP, contains 250 ml of plasma, matched for the ABO group was installed through the apical chest tube into the pleural cavity.&#x0D; Group B: a control group of 30 patients who did not receive any sclerosing agent. They were managed with under-water seal and observation.&#x0D; Results: This study showed that the stoppage of air leak in group A was faster “which stopped in 9-10 days” in comparison to control group B “24-25 days”, (P-value &lt;0.001). There was a significant difference between groups A and B regarding the hospital stay, which was in 9-10 days in group A in comparison to group B “26-28 days (P-value &lt;0.001).&#x0D; Conclusion: Intrapleural fresh frozen plasma appears to be a valuable option to stop persistent air leaks post pulmonary resections. It’s a cheap, available, and safe agent. It reduced hospital stay, costs and morbidities.

Randomized prospective trial of the severity of irritative symptoms after HoLEP vs ThuFLEP.

To compare the short-term postoperative functional outcomes and severity of irritative symptoms following holmium and thulium fiber laser enucleation (HoLEP and ThuFLEP). This prospective randomized single-blinded study was performed in accordance with CONSORT. The inclusion criteria were IPSS > 20 or Qmax < 10ml/s. Patients were randomized between HoLEP and ThuFLEP. Demographics, objective data (PSA, prostate volume, etc.), data on urinary and sexual function (IPSS, IIEF, QoL, QUID, Qmax, ICIQ-MLUTS) were collected. Detailed perioperative information and postoperative data on functional outcomes at 1, 2, 3, 4, 6, 8, 10, 12weeks and 6months were collected. Data on 163 participants were included (77-HoLEP, 86-ThuFLEP). No differences were found in surgery duration; number of postoperative complications (Clavien-Dindo I-III), catheterization time and hospital stay. Functional outcomes up to 6months didn't differ between the groups (IPPS, IIEF, QoL, QUID, ICIQ-MLUTS, Qmax, p > 0.05). Total ICIQ-MLUTS, bother and voiding scores at 1 and 3months significantly increased compared with the baseline in both groups (p < 0.05). No difference between the groups were observed. In HoLEP the SUI series rate was 1.3% and 1.3% after 3 and 6months following the procedure; in ThuFLEP: it was 3.5% and 2.3% respectively (p = 0.35 and p = 0.54). The preliminary results of the study showed no apparent differences in functional outcomes (IPSS, Qmax), rate of SUI or irritative symptoms.Both ThuFLEP and HoLEP are efficient ways of treating benign prostatic obstruction. Both surgeries are comparable in terms of duration and postoperative complication rates.

Effectiveness of Erector Spinae Plane Block for Post-Operative Analgesia in Breast Surgeries-A Randomized Control Study

Objectives: This study is aimed at testing the efficacy of ultra sound guided erector spinae plane block (ESPB) with 20ml of 0.2% ropivacainein providing postoperative analgesia in patients undergoing breast surgery. Materials and Methods: After seeking approval from the hospital ethics committee and obtaining written informed consent from participants, this single blinded prospective randomised control study was conducted on 60 patients posted for breast surgery under general anaesthesia. The recruited participants were randomly assigned into two equal groups B and C by closed envelope technique. Group B patients were given ultrasound-guided ESPB with 20 ml of 0.2% ropivacaine and Group C patients were given routine postoperative port site infiltration with 20 ml of 0.2% ropivacaine. Postoperative pain and need for rescue analgesics were noted. Chi-square test, independent sample t test, Mann Whitney U test was used for statistical analysis. Results: Pain score was lower in Group B patients up to 12h (P&lt;0.007). At 24h the pain scores between the two groups were comparable. The rescue analgesic requirement was also significantly less in group B compared to Group C (23.3% vs. 70%), and this difference was statistically significant (P=0.01). On comparing the incidence of postoperative nausea and vomiting, there was no significant difference between the two groups. No adverse events were noted in both groups. Conclusion: Ultrasound-guided ESPB with 20ml of 0.2% ropivacaine is superior to local infiltration in providing postoperative analgesia in patients undergoing breast surgery. It also decreases postoperative tramadol requirement.