Double-blind Case-control Study Research Articles

Chronic Kidney Disease and Dietary Supplementation: Effects on Inflammation and Oxidative Stress.

Chronic kidney disease (CKD) causes an irreversible loss of kidney functioning in dogs. This double-blind case-control study evaluates the efficacy of a dietary supplement, which contains calcium carbonate, calcium lactate-gluconate, chitosan, sodium bicarbonate, Lactobacillus acidophilus D2/CSL, Olea europaea L. extract, and fructooligosaccharides, in dogs in advanced CKD stage. Thirty dogs were enrolled in the study; half were administered the new dietary supplementation for 90 days, while the others were used as controls. Hematologic, biochemical, and urinalysis were performed. This novel dietary supplement mainly reported a good control of uremia, phosphate, acid-base balance, blood pressure, inflammation, and oxidative stress in dogs with advanced stages of CKD.

The Effect of Zinc and Nano Zinc Supplementation on Serum Testosterone and Testicular Histology in Male Rats

Background : Infertility is a universal medical problem, 50% was contributed to male factors. Zinc is an important elements for all living cells and it is one of the most important trace elements in our bodies. Nanoparticles, are mall particles, that have a large surface area if compared to their size, this small size, help them to enter into living cells easily. This makes them an essential participant in all biological interactions and their modern applications. The aim was to evaluate the effects of Zinc and Nano zinc on male gonads histology and function. Methods: A double blind case control study, designed to test the effects of Zinc oxide and Nano zinc oxide on 20 rats that were divided randomly into 4 equal groups. Control, Zinc, Nano zinc, and hybrid (zinc and Nano zinc) group. The dose was 0.11mg/kg. Results: There was significant change in in serum Zinc and testosterone, more in ZnNPs containing groups. While the histological picture of testis ameliorated in zinc arm, but worsen in ZnNPs arm of experiment. These results lead to the Conclusion that Nano zinc though improve S. testosterone, it can damage the testicular tissues in certain doses.

Low dose spinal anaesthesia for caesarean section in parturients having pregnancy induced hypertension: Effect on haemodynamicre sponse and vasopressor requirement: A prospective randomized double blind case control study

Currently, the safety of spinal anaesthetic techniques is well established for caesarean section in pregnancy induced hypertension (PIH) patient. Addition of fentanyl to local anaesthetic allows achievement of adequate anaesthesia with lower dose of local anaesthetic in spinal anaesthesia, thereby reducing the occurence of hypotension and need for vasopressor. A prospective, randomized, double blind, case control study was carried out in 80 parturients having PIH undergoing caesarean section in spinal anaesthesia were randomized into 2 groups depending on intrathecal drug received by them as Group C (Conventional dose group- received hyperbaric bupivacaine 10 mg)and Group L{low dose group, hyperbaric bupivacaine (7.5 mg) with fentanyl (25 mcg)} and compared regarding sensory- motor block characteristics, incidence of hypotension (fall in MAP > 25% from baseline) vasopressor requirement Phenylephrine and Ephedrine. Patient in Group L had significantly less number of hypotension episodes as compared to Group C(20 vs 31, p= 0.011). Hence vasopressor requirement was also significantly less in Group L than in Group C [Phenylephrine (1600 mcg vs 2500 mcg, p=0.044), Ephedrine (66 mg vs 18 mg, p= 0.030)].Low dose spinal anaesthesia using 7.5 mg hyperbaric bupivacaine with 25 mcg fentanyl seems to be superior alternative to conventional dose of 10 mg hyperbaric bupivacaine for caesarean section in parturients having pregnancy induced hypertension, because it was associated with better hemodynamic stability, reduced vasopressor requirement.

Myocardial protection technique structured on cardiac mass.

Myocardial protection is crucial in cardiac surgery: quantification is often difficult as there is a significant mismatch between body weight and heart weight as per geometric remodeling. This study has the objective to compare two groups of patients on the administration of myocardial protection in valvular pathologies: the first group has indexed the administration with left ventricular mass index; the second has indexed it on the body weight or on the body surface area. The primary endpoint of double-blind case-control study is to detect the difference in incidence in terms of post-operative low cardiac output syndrome. A single-center double-blind case-control study in a specialized regional tertiary cardiac surgery center in Italy. Between March 2017 and September 2018, 200 adults (100 per Group A vs. Group B) were scheduled for elective procedures: Group A (50 aortic valve replacement-50 mitral valve repair in minimally invasive cardiac surgery) used blood cardioplegic solution with Saint Thomas I solution, with calculation of left ventricular mass index with echocardiographic measures (Formula Group A); Group B (50 aortic valve replacement-50 mitral valve repair in minimally invasive cardiac surgery) used blood cardioplegic solution with Saint Thomas I solution, with calculation indexed on the body surface area, Du Bois Method (Formula Group B). A statistically significant difference was found for Student's t-test in patients who used myocardial indexed protection on left ventricular mass index versus control: aortic valve replacement procedures in aortic valve stenosis-ejection fraction (24 hours, p-value = 0.046), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.043), and infusion of epinephrine after cardiopulmonary bypass (p-value = 0.033); aortic valve replacement procedures in aortic valve insufficiency-ejection fraction (24 hours, p-value = 0.044), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.046), and infusion of Epinephrine after cardiopulmonary bypass (p-value = 0.029). No statistically significant differences in patients undergoing mitral valve repair surgery. The study group in the aortic valve surgery that administered myocardial protection indexed for the left ventricular mass index and showed a statistically significant lower incidence for post-operative low cardiac output syndrome compared to the control group.

Effect of Hyperoxygenation During Surgery on Surgical Site Infection in Colorectal Surgery.

PurposeDespite the use of different surgical methods, surgical site infection is still an important cause of mortality and morbidity in patients and imposes a considerable cost on the healthcare system. Administration of supplemental oxygen during surgery has been reported to reduce surgical site infection (SSI); however, that result is still controversial. This study was performed to evaluate the effect of hyperoxygenation during colorectal surgery on the incidence of wound infection.MethodsThis study was a prospective double-blind case-control study. The main aim of the study was to evaluate the effect of hyperoxygenation during colorectal surgery on the incidence of SSI. Also, secondary outcomes, such as atelectasis, pneumonia, respiratory failure, length of hospital stay, and required hospitalization in the intensive care unit were evaluated.ResultsSSI was recorded in 2 patients (2 of 40, 5%) in the hyperoxygenation group (FiO2 80%) and 6 patients (6 of 40, 15%) in the control group (FiO2 30%) (P < 0.05). Time of hospitalization was 6 ± 6.4 days in the hyperoxygenation group and 9.2 ± 2.4 days in the control group (P < 0.05).ConclusionThis study showed a positive effect of hyperoxygenation in reducing SSI in colorectal surgery, especially surgery in an emergency setting. When the low risk, low cost, and effectiveness of this method in patients undergoing a laparotomy are considered, it is recommended for all patients undergoing colorectal surgery.

MOLAR EXTRACTION

Introduction: Dry socket (DS) or Alveolar osteitis (AO) is a common postextraction complication in third molar removal. Various techniques have been used to reducethe risk of DS. Objectives: To evaluate the effect of Chlorhexidine (CHX) gel in preventing thedevelopment of DS. Study Design: Randomized double blind case-control study. Setting: Oraland Maxillofacial Surgery Department of University College of Dentistry(UCD), The Universityof Lahore, Pakistan. Period: July 2017 to December 2017. Methodology: Patients havingimpacted mandibular 3rd molars selected for surgical extraction. Randomly selected one groupconsisted of 30 patients received CHX gel and the other group again of 30 patients consideredas the control. The outcome variable was formation of DS and the predictor variable was CHXgel application. Data were processed using chi-square test with the confidence interval of95%. Results: 60 cases (39 females and 21 males) with average age of 22 years ± 5 yearsunderwent 3rd molar extractions. Total 09 sockets (15%) developed DS. The frequency of DS inCHX gel (2 cases, 6.7%) was significantly lower than control (7 cases, 23.3%) (P-value &lt; 0.05).Conclusion: CHX gel can reduce the risk of development of DS after mandibular 3rd molarsurgical extraction.

Genistein Supplementation and Cardiac Function in Postmenopausal Women with Metabolic Syndrome: Results from a Pilot Strain-Echo Study.

Genistein, a soy-derived isoflavone, may improve cardiovascular risk profile in postmenopausal women with metabolic syndrome (MetS), but few literature data on its cardiac effects in humans are available. The aim of this sub-study of a randomized double-blind case-control study was to analyze the effect on cardiac function of one-year genistein dietary supplementation in 22 post-menopausal patients with MetS. Participants received 54 mg/day of genistein (n = 11) or placebo (n = 11) in combination with a Mediterranean-style diet and regular exercise. Left ventricular (LV) systolic function was assessed as the primary endpoint, according to conventional and strain-echocardiography measurements. Also, left atrial (LA) morphofunctional indices were investigated at baseline and at the final visit. Results were expressed as median with interquartile range (IQ). A significant improvement of LV ejection fraction (20.3 (IQ 12.5) vs. −1.67 (IQ 24.8); p = 0.040)), and LA area fractional change (11.1 (IQ 22.6) vs. 2.8 (9.5); p = 0.034)) were observed in genistein patients compared to the controls, following 12 months of treatment. In addition, body surface area indexed LA systolic volume and peak LA longitudinal strain significantly changed from basal to the end of the study in genistein-treated patients. One-year supplementation with 54 mg/day of pure genistein improved both LV ejection fraction and LA remodeling and function in postmenopausal women with MetS.

A Comparison of Intravenous Ephedrine or Phenylephrine, for Prevention of Postspinal Hypotension during Elective Lower Abdominal Surgery: A Randomized, Double-blind Case-control Study.

Background:In this randomized, double-blinded case–control study, we investigated the intravenous effects of ephedrine or phenylephrine on prevention of post–spinal hypotension in elective lower abdominal surgery under spinal anesthesia.Materials and Methods:One hundred and thirty-five patients, American Society of Anesthesiologists physical status I or II candidate for elective lower abdominal surgery under spinal anesthesia were randomized to three groups (45 each). According to their allocated group, patients received either ephedrine 2.5 mg (E group), phenylephrine (P group) 25 mic as vasopressor or the same volume of saline normal as placebo (S group) immediately after the spinal anesthesia. hemodynamic parameters, and complications were recorded.Results:Patients’ demographics were similar in all the groups. The mean systolic blood pressure (SBP), diastolic blood pressure (DBP), and MAP and also heart rate were similar over time for groups E and P (P > 0.05). The incidence of reactive hypertension was more in group E than group P and placebo (P < 0.05). The incidence of nausea and vomiting were significantly lower in groups E and P in comparison with placebo (P < 0.05).Conclusion:Although the mean fall of SBP and DBP were significantly less in groups E and P compared with placebo but we did not find significant differences in prophylactic use of ephedrine or phenylephrine for prevention of post–spinal hypotension in elective lower abdominal surgery. Vasopressors infusion have added benefit of lower incidence of nausea and vomiting.

Contraversive neglect? A modulation of visuospatial neglect in association with contraversive pushing.

Contraversive pushing (CP) is a neurologic disorder characterized by a lateral postural imbalance. Pusher patients actively push toward their contralesional side due to a misperception of the body's orientation in relation to gravity. Although not every patient with CP suffers from spatial neglect (SN), both phenomena are highly correlated in right-hemispheric patients. The present study investigates whether peripersonal visuospatial functioning differs in neglect patients with versus without CP (NP+ vs. NP- patients). Eighteen right-hemispheric stroke patients with SN were included, of which 17 in a double-blind case-control study and 1 single case with posterior pushing to supplement the discourse. A computer-based visuospatial navigation task, in which lateralized deviation can freely emerge, was used to quantify visuospatial behavior. In addition, visuospatial orienting was monitored using line bisection. Significant intergroup differences were found. The NP+ patients demonstrated a smaller ipsilesional navigational deviation and more cross-over (contralesional instead of ipsilesional deviation) in long line bisection. As such, they demonstrated a contraversive (contralesionally directed) shift in comparison with the NP- patients. These findings highlight the similarity between 2 systems of space representation. They are consistent with a coherence between the neural processing system that mainly provides for postural control, and the one responsible for nonpredominantly postural, visuospatial behavior.

Vagal Nerve Stimulation for the Treatment of Autism.

Not required

Use of homoeopathic remedies in the management of learning disabilities

Aims: The objective of the study was to assess the therapeutic usefulness of Homoeopathy in the management of LD, viz., dyslexia and dysgraphia, to ascertain the role of homoeopathic medicines and verify their characteristic symptoms in the management of various types of LD to establish verified characteristic symptoms of medicines used in the management of various types of LD. Settings and Design: A 3-year randomised double blind case control study was carried out on 67 children between ages 8-12 years fulfilling the criteria of LD (ICD-10) for dyslexia and dysgraphia with a minimal observation period of one year. The study was conducted in three Marathi-medium schools in Mumbai. Material and Methods: 67 children between ages 8-12 years fulfilling the criteria of LD (ICD-10) for dyslexia and dysgraphia were studied for a minimal observation period of one year. All received remedial education as it is the standard mode of management. 32 children constituted Group I and were administered the indicated homoeopathic medicine in the 200 th potency in infrequent repetition while 35 children from Group II were given placebo. The children and the Remedial Educators who were the assessors were blinded for the study. Statistical Analysis Used: t-test was done for statistical analysis. Results: The children under homoeopathic treatment with remedial education showed an early response to remedial inputs and a statistically significant change in the indicators of dyslexia and dysgraphia. There was also a significant change in the co-morbid behavioural condition notably Attention Deficit Hyperactivity Disorder (ADHD). The study not only helped verify the characteristic symptoms of the remedies from Materia Medica useful in LD but also was able to report clinical symptoms which have not been reported in source books.53.12% of children needed Calcarea salts. The other significant remedy indicated in 9.3% children was Medorrhinum, Argenticum nitricum, Calc-flour, and Natrum salts were indicated in 6.25% children.Conclusion: Homoeopathic intervention when combined with standard remedial education has a definite role in bringing about an early change in all parameters of LD. It also assists in bringing about a change in treating the co-morbid conditions, commonly Attention Deficit Disorder (ADD/ADHD). The improvements started simultaneously in most of the areas except in speed of reading and reading comprehension, repetition in reading and omission of punctuation in writing.

Induction of Cross-Neutralizing Antibody Against H5N1 Virus After Vaccination with Seasonal Influenza Vaccine in COPD Patients

Archival serum samples from elderly individuals with underlying chronic obstructive pulmonary disease (COPD) who were enrolled in a double-blind case-control study of seasonal influenza vaccine efficacy were assayed for cross-neutralizing antibody formation to avian influenza A (H5N1) virus. Of 118 serum samples, 58 were collected from influenza vaccinees (mean age 68.5 y), and 60 from placebo controls (mean age 68.4 y) who received vitamin B injections. Blood samples were collected before and at 1 mo after seasonal influenza vaccination from all subjects; in addition, for a longitudinal follow-up period of 1 y paired-blood samples were collected again from subjects who developed acute respiratory illness. Hemagglutination inhibition assay for antibodies to influenza A (H1N1), influenza A (H3N2), and influenza B viruses was carried out to determine the serological response to vaccination, and to diagnose influenza viral infection, while microneutralization assays were performed to detect cross-reactive antibody to H5N1 virus. Pre-existing cross-reactive H5N1 antibody at reciprocal titer 10 was found in 6 (10.3%) vaccinees and 4 (6.7%) placebo controls. There was no change in H5N1 antibody titer in these subjects after vaccination. On the other hand, 3 (5.2%) vaccinees developed seroconversion to H5N1 virus at 1 mo after vaccination, even though they had no pre-existing H5N1 antibody in their first blood samples. No cross-neutralizing antibody to H5N1 virus was detected in the placebo controls or in the 22 influenza patients, suggesting that influenza vaccination, but not influenza virus infection, induces cross-neutralizing antibody against avian influenza H5N1 virus.

RANDOMIZED TRIAL OF BUFFERED VERSUS PLAIN LIDOCAINE FOR LOCAL ANAESTHESIA IN OPEN CARPAL TUNNEL DECOMPRESSION

We performed a randomized double-blind case–control study in 64 consecutive patients undergoing open carpal tunnel decompression under local anaesthetic to assess the pain experienced on injection of plain lidocaine (pH 6.4) compared with lidocaine buffered with sodium bicarbonate (pH 7.4). The results showed no statistical difference in the pain scores reported by patients. The mean pain scores for all patients were low, and most patients reported that they were “not at all anxious” about receiving a similar injection in the future.

Morphine sparing effect of low dose ketamine during patient controlled analgesia

AbstractObjective: To compare the quality of intravenous patient controlled analgesia (PCIA) of low dose morphine plus ketamine with morphine. Design: Double blind case control study. Setting: Academic hospital. Patients: Thirty-six patients scheduled for elective abdominal hysterectomy were randomly divided into two groups to receive patient controlled intravenous analgesia (PCIA). Interventions: Group M received morphine 21 μg/kg as a bolus, Group MK received morphine 7 μg/kg plus ketamine 14 μg/kg as a bolus. The lockout period in both groups was 7 minutes. Measurements: Morphine consumption, visual analogue pain score (VAPS), pulse oximetry oxygen saturation (SpO2), respiratory rate (RR), verbal descriptive sedation score (VDSS), nausea, pruritis, dreaming, and hallucinations were recorded at 1, 4, 24 and 48 hours. Equivalence of the two groups was assessed by comparing the 95% confidence interval (CI) for the effect with the equivalence delta (10%). Results: Morphine consumption was significantly low...

Dermatoglyphics in patients with eczema, psoriasis and alopecia areata.

The study of patterns of fingerprints is important in anthropology and medical genetics, chiefly because of their diagnostic usefulness. In the present work, we studied the frequencies of various types of skin ridges of the first phalanx in patients with eczema, psoriasis and alopecia areata. In a double-blind case-control study, we determined the frequencies of fingerprints in 551 patients (240 cases with eczema, 164 cases with psoriasis and 147 cases with alopecia areata) as well as in general population of Hamadan City (control group: 188 males and 529 females). We compared the frequencies between various fingers, hands and sexes in all three case groups as well as between case groups and control group. The frequencies of various types of fingerprints are presented in some tables. The results showed that frequencies are not statistically different according to types of fingers, hands (left or right) and sexes as well. But they are significantly different in various case groups and between case groups and control group. We can conclude that frequencies of various patterns of skin ridges differ in eczema, psoriasis and alopecia areata from normal population.

Clinical study of the 1CU accommodating intraocular lens

Purpose To compare the near functional capacities of patients with an accommodating intraocular lens (IOL) with those of patients with a conventional monofocal IOL. Setting Department of Ophthalmology, University of Chieti, Chieti, Italy. Methods This prospective double-blind case-control study comprised 42 eyes that had phacoemulsification and implantation of 1 of 2 types of IOLs: HumanOptics accommodating 1CU® (study group) and Eurocrystal IFP 3G 6.00 (control group). The main outcome measures were subjective refraction, uncorrected distance acuity, best corrected distance acuity, distance corrected near acuity at 40 cm, best corrected near acuity at 40 cm, and subjective amplitude of accommodation. Patients were examined 7, 30, 90, and 180 days after surgery. Results Postoperatively, both groups had excellent uncorrected distance acuity, best corrected distance acuity, and best corrected near acuity. In the study group, the mean distance corrected near acuity (Jaeger) was 5.43 ± 0.98 (SD) (range 4 to 7) at 7 days, 2.33 ± 0.48 (range 2 to 3) at 1 and 3 months, and 3.66 ± 2.12 (range 2 to 7) at 6 months. In the control group, the mean distance corrected near acuity was 7.43 ± 0.50 (range 7 to 8) during the entire follow-up. The differences between the groups was statistically significant ( P<.001). The mean amplitude of accommodation was 0.00 diopter (D) in the control group and 1.14 ± 0.44 D (range 0.75 to 2.00 D) in the study group at 7 days, 2.36 ± 0.28 D (range 2.00 to 2.75 D) at 30 and 90 days, and 1.90 ± 0.77 D (range 0.75 to 2.75 D) at 6 months. Conclusions The 1CU accommodating IOL provided better useful spectacle-free near visual acuity than the conventional monofocal IOL. However, the accommodating mechanism can play a role in capsule fibrosis.

Adrenocortical, autonomic, and inflammatory causes of the metabolic syndrome: nested case-control study.

The causes of metabolic syndrome (MS), which may be a precursor of coronary disease, are uncertain. We hypothesize that disturbances in neuroendocrine and cardiac autonomic activity (CAA) contribute to development of MS. We examine reversibility and the power of psychosocial and behavioral factors to explain the neuroendocrine adaptations that accompany MS. This was a double-blind case-control study of working men aged 45 to 63 years drawn from the Whitehall II cohort. MS cases (n=30) were compared with healthy controls (n=153). Cortisol secretion, sensitivity, and 24-hour cortisol metabolite and catecholamine output were measured over 2 days. CAA was obtained from power spectral analysis of heart rate variability (HRV) recordings. Twenty-four-hour cortisol metabolite and normetanephrine (3-methoxynorepinephrine) outputs were higher among cases than controls (+ 0.49, +0.45 SD, respectively). HRV and total power were lower among cases (both -0.72 SD). Serum interleukin-6, plasma C-reactive protein, and viscosity were higher among cases (+0.89, +0.51, and +0.72 SD). Lower HRV was associated with higher normetanephrine output (r=-0.19; P=0.03). Among former cases (MS 5 years previously, n=23), cortisol output, heart rate, and interleukin-6 were at the level of controls. Psychosocial factors accounted for 37% of the link between MS and normetanephrine output, and 7% to 19% for CAA. Health-related behaviors accounted for 5% to 18% of neuroendocrine differences. Neuroendocrine stress axes are activated in MS. There is relative cardiac sympathetic predominance. The neuroendocrine changes may be reversible. This case-control study provides the first evidence that chronic stress may be a cause of MS. Confirmatory prospective studies are required.