Blind Randomized Control Trial Research Articles

Impact of Nutrition Supplementation on Linear Growth Among 12-18 months Children of Belagavi City: A Randomized Control Trial

BackgroundAdequate nutrition is one of the most important factors influencing growth & immunity. Bovine colostrum (BC) is the first milk produced after birth of a calf and is a rich natural source of macronutrients, micronutrients, immunoglobulins, growth factors and peptides with anti-microbial activity. ObjectiveThe current study was conducted to test the hypothesis whether BC supplementation would lead to an increase in linear growth of children of age 12-18 months. The secondary objectives were 1) To measure biomedical parameters among 12-18 months children in the 2 groups, i.e., BC and control group. 2) To assess the acceptability and tolerability of BC among children. Materials & MethodsA double blinded randomized control trial was conducted among children in the age group of 12- 18 months. A total of 78 participants were included and were randomly divided into experiment and control groups. Anthropometric measurements and biochemical parameters were measured before and after intervention. The acceptability and tolerability of BC was assessed through a questionnaire filled by the mothers of study participant. ResultsThere was a significant difference observed in Body mass index (BMI), Chest circumference and Mid upper arm circumference in the BC group but there was not any significant difference found in biochemical parameters. Mothers of study participant reported high acceptability and no side effects of the intervention. ConclusionSupplementation of BC in children’s diet lead to improved anthropometric outcomes in children of Belagavi city and was acceptable by them.

Comparison of Milrinone with Sildenafil for the Treatment of Persistent Pulmonary Hypertension of the Newborn

Objective: To compare milrinone with sildenafil for the treatment of persistent pulmonary hypertension of the newborn. Methodology: A single blinded randomized control trial was conducted in Department of Pediatrics, Aziz Fatima Hospital Faisalabad from October 2022 to September 2023. 160 infants of persistent pulmonary hypertension were included through non probablity consecutive sampling. Group 1 infants (n = 80) received a loading dose of milrinone intravenously administered over a 60-minute period at a dose of 50 µg/kg. Group 2 infants (n = 80) received sildenafil (2mg per kg per dose three times a day). The medication was continued until extubation. The primary outcome variables were the mortality and duration of hospital stay. Results: Ninety two(57.5%) of the one hubdred & sixty newborns in total were male. 111(69.4%) of the total, were full-term babies. In 114(71.2%) infants, the mode of delivery was C-section. Mortality was observed in 7 (8.8%) patients in milrinone group and 17 (21.2%) patients in sildenafil group with p-value = 0.027. Duration of hospital stay was less in milrinone group as compared to sildenafil group (14.22±3.75 days vs 17.72±5.7 days) with p-value = 0.0001. Conclusion: Milrinone has been proven to be a promising therapeutic choice for persistent pulmonary hypertension in neonates, and it is effective in doing so in low resource settings.

Effects of short foot exercises with ultrasound bio-feedback on motor learning and foot alignment: A double blinded randomized control trial.

Short foot exercises (SFE) take a long time to master and require a feedback tool to improve motor learning. This study aimed to investigate the effect of bio-feedback of talonavicular joint movements in learning SFE with ultrasound (US) imaging. This study included thirty-one healthy volunteers and was designed as a double-blind randomized control trial. Subjects were randomly assigned to one of two groups: the control group, which performed SFE under verbal instruction, and the US bio-feedback (USBF) group, which performed SFE with real-time bio-feedback of the talonavicular joint alignment. All subjects underwent two sessions of 5 minutes each, and SFE was performed as a self-exercise, between sessions, for one week. The difference in foot length and navicular height were assessed at baseline, after Session1, before Session2, and one week after Session2. These differences were compared between the two groups using the Mann-Whitney U test. In terms of navicular height change, the USBF group (7.5 ± 4.3 mm) was significantly higher than the control group (4.2 ± 3.3 mm) one week after session 2 (p= 0.04, effect size = 0.86). SFE with USBF is an effective intervention for performing SFE.

Effectiveness of Phloroglucinol in Shortening the Active Phase of the First Stage of Labour in Term Pregnancies

Background: Labour is a normal physiological process, involving increasing myometrical contractions, cervical dilation and effacement resulting in delivery of the fetus and placenta and the initiation of the process of lactation. First Stage of labour lasts for 12-16hrs in primigravida and 6-8 hrs in multigravida. Two important characteristics of labour are uterine contractions and cervical effacementObjectives: To determine the effectiveness of phloroglucinol in shortening the 1st stage of labour in term pregnancies.Material and Methods: It was a double blinded randomized control trial (RCT) conducted in Obs and Gynae department of Hayatabad Medical Complex, MTI, Peshawar Pakistan, over a period of 6 months from 20th October 2022 to 20th April 2023. Patients were selected randomly for placebo and pluroghlucinol group and recorded on structured proforma. Total 375 women were selected in first stage of labour. In which 187 were given Phloroglucinol and 188 women received placebo. Results: The mean age of patients in phloroglucinol group was 28.3 ± 4.01 and in control group was 26.6 ± 6.8 years. The mean period of gestation in Phloroglucinol group was 37.3 ± 4.0 while in control group was 38.6 ± 2.08 weeks. The mean BMI of patients in Phl group was 22.12 ± 1.4 while in control group was 21.6 2 ± 1.5. The mean duration of active phase of 1st stage of labour in Phl group was 290.4 ± 29.7 minutes while in control group was 402.4 ± 29.7 minutes. Conclusion: Phloroglucinolhas significant effect in shortening the 1st stage of labour.Keywords: Active phase, Labour, Phloroglucinol, Pregnancy.

The impact of blinding on estimated treatment effects in randomized clinical trials on acupuncture: A meta-epidemiological study.

To evaluate the sole impact of blinding patients and outcome assessors in acupuncture randomized controlled trials (RCTs) on treatment effects while considering the type of outcome measures. We searched databases for the meta-analyses on acupuncture with both blinded and non-blinded RCTs. Mixed-effects meta-regression models estimated the average ratio of odds ratios (ROR) and differences in standardized mean differences (dSMD) for non-blinded RCTs versus blinded mixed-effects meta-regression model. The study included 96 meta-analyses (1012 trials). The average ROR for lack of patient blinding was 1.08 (95% confidence intervals 0.79-1.49) in 18 meta-analyses with binary patient-reported outcomes. The average ROR for lack of outcome assessor blinding was 0.98 (0.77-1.24) in 43 meta-analyses with binary subjective outcomes. The average dSMD was -0.38 (-0.96 to 0.20) in 10 meta-analyses with continuous patient-reported outcomes. The average dSMD was -0.13 (-0.45 to 0.18) in 25 meta-analyses with continuous subjective outcomes. The results of the subgroup analysis were consistent with the primary analysis findings. Blinding of participants and outcome assessors does not significantly influence acupuncture treatment efficacy. It underscores the practical difficulties of blinding in acupuncture RCTs and the necessity to distinguish between trials with and without successful blinding to understand treatment expectations' effects. Enhancing blinding procedures' quality and assessment in future research is crucial for improving RCTs' internal validity and reliability.

Are the results of open randomised controlled trials comparing antipsychotic drugs in schizophrenia biased? Exploratory meta- and subgroup analysis

A recent meta-epidemiological study did not reveal major differences between the results of blinded and open randomised-controlled trials (RCTs). Fewer patients may consent to double-blind RCTs than to open RCTs, compromising generalisability, making this question very important. However, the issue has not been addressed in schizophrenia. We used a database of randomised, acute-phase antipsychotic drug trials. Whenever at least one open and one blinded RCT was available for a comparison of two drugs, we contrasted the results by random-effects meta-analysis with subgroup tests. The primary outcome was overall symptoms as measured by the Positive and Negative Syndrome Scale, supplemented by seven secondary efficacy and side-effect outcomes. We also examined whether open RCTs were biased in favour of more recently introduced antipsychotics, less efficacious or more prone to side-effects antipsychotics, and pharmaceutical sponsors. 183 RCTs (155 blinded and 28 open) with 34715 participants comparing two active drugs were available. The results did not suggest general differences between open and blinded RCTs, which examined two active drugs. Only 12 out of 122 subgroup tests had a p-value below 0.1, four below 0.05, and if a Bonferroni correction for multiple tests had been applied, only one would have been significant. There were some exceptions which, however, did not always confirm the originally hypothesized direction of bias. Due to the relatively small number of open RCTs, our analysis is exploratory, but this fundamental question should be given more scientific attention. Currently, open RCTs should be excluded from meta-analyses, at least in sensitivity analyses.

Abstract 18858: At Heart , a Progressive Web App for Women With Heart Disease: A Pilot Randomized Controlled Trial

Introduction/Background: At heart ’s novel core feature set includes a Heart Check, Wellness Check, and a Library, with an interactive Chatbot to manage its content and conversations. at heart is the first of its kind; there are no previous trials of an intervention rigorously developed and tested. Goals/Aims: The overall goal of this study was to develop and evaluate a digital health intervention for women with heart disease. Specific aims of the pilot randomized controlled trial (RCT) were to examine: 1) the feasibility of randomization, recruitment, and retention, 2) acceptability and barriers to implementation (including the symptom triage algorithms), and 3) engagement with the intervention. Methods/Approach: This was a two-group parallel single blind pilot RCT. Women greater than 18 years of age with heart disease were recruited, all women spoke and read English. Following completion of baseline measures, participants were randomized to either an intervention or a usual care group. Participants randomized to the intervention group used at heart for 3 months. Recruitment, retention, and adverse events were tracked and engagement was assessed using Google Analytics . Acceptability was assessed with a six-item modified Acceptability e-Scale (AES), yielding a total acceptability score of 6-30. Results/Data: A total of 98 women were assessed for eligibility, 18 were excluded. Eighty women were randomized, 40 allocated to usual care and 40 to receive the intervention. Attrition was low. Mean age was 57 years (SD 13), 32% (n=27) were employed full time, and 48% (n=41) had a post-secondary diploma/certificate. There were 226 heart checks; 1-15 per participant, most symptoms were triaged as low risk (n=176, 78%). There were 198 wellness checks, 1-12 per participant. The mean number of articles accessed in the library was 8 per participant. The mean acceptability score was 23.46 (SD 4.87), there were no barriers to implementation, and no adverse events were reported. Conclusion(s): The at heart intervention is feasible; women were engaged and reported high acceptability scores. A larger, powered RCT is necessary.

Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection (DEFeND): A Randomised External Pilot Trial.

High-quality randomised controlled trials (RCT) to support the use of Fibrin Sealants (FS) in neck dissection (ND) are lacking. The DEFeND trial assessed critical pilot/feasibility questions and signals from clinical outcomes to inform a future definitive trial. The study design piloted was a blinded surgical RCT. All participants underwent unilateral ND for head and neck cancer. Interventional arm: ND with application of FS. ND alone. Feasibility outcomes included recruitment, effectiveness of blinding, protocol adherence and evaluating administrative processes. Clinical outcomes included surgical complications (primary outcome), drainage volume, time to drain removal, length of hospital stay, pain and the Neck Dissection Impairment Index. Recruitment completed ahead of time. Fifty-three patients were recruited, and 48 were randomised at a rate of 5.3 patients/month. Blinding of patients, research nurses and outcome assessors was effective. Two protocol deviations occurred. Two patients were lost to follow-up. The mean (SD) Comprehensive Complication Index in the interventional arm was 6.5 (12.8), and it was 9.9 (14.2) in the control arm. The median (IQR) time to drain removal (days) was shorter in the interventional arm (2.67 (2.42, 3.58) vs. 3.40 (2.50, 4.27)). However, this did not translate to a clinically significant reduction in median (IQR) length of hospital stay in days (intervention: 3.48 (2.64, 4.54), control: 3.74 (3.11, 4.62)). The proposed trial design was effective, and a definitive surgical trial is feasible. Whilst there was a tendency for FS to improve clinical outcomes, the effect size did not reach clinical or statistical significance. (ISRCTN99181100).

Lansoprazole plus levosulpiride versus esomeprazole in participants with gastroesophageal reflux disease and erosive esophagitis: a double blinded randomized control trial.

The aim was to compare the efficacy and safety of lansoprazole plus levosulpiride over esomeprazole. This randomized control trial recruited 1000 participants having symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis and they were blindly randomized into two groups in a 1:1 ratio with appropriate concealment. Group 1 was given lansoprazole plus levosulpiride combination twice daily whereas group 2 was prescribed only esomeprazole twice daily. The primary efficacy endpoint was the healing of erosive esophagitis and GERD at week 49. Secondary assessments included improvement in quality of life. Participants' quality of life was assessed before starting the treatment and post-treatment using a short-form health survey questionnaire (SF-36). The lansoprazole plus levosulpiride group had significantly lower rates of positive postintervention GERD and erosive esophagitis status, and higher rates of sustained resolution of heartburn compared to the esomeprazole alone group. However, the lansoprazole plus levosulpiride group also had a higher risk of nausea. Lansoprazole plus levosulpiride is a more effective and safe treatment for GERD than esomeprazole alone. Participants in the lansoprazole plus levosulpiride group showed a significantly higher rate of sustained resolution of GERD, lower rates of postintervention GERD and erosive esophagitis status, and a higher incidence of nausea compared to the esomeprazole alone group. Although quality of life worsened in both groups, adverse effects did not significantly differ. These findings strongly support the use of lansoprazole plus levosulpiride as a preferred treatment option for GERD and erosive esophagitis, which could have significant clinical implications for managing this common condition.

Intrapartum use of sildenafil citrate to prevent fetal compromise and emergency operative birth in term pregnancies in the United Kingdom and Australia: Apreliminary cost-effectiveness analysis.

To compare cost-effectiveness of oral sildenafil citrate, administered after onset of labor, with standard care to health system funders in the UK and Australia. We conducted a modeled cost-effectiveness analysis, measuring costs and quality adjusted life years (QALYs), using a decision-analytic model covering onset of labor to 1 month post-birth. The relative risk of emergency cesarean section and operative vaginal birth was taken from a Phase 2 placebo controlled double blinded randomized control trial. Both options of care resulted in the same QALYs gained over the model time period (0.08). Sildenafil citrate was cost-saving compared with standard care, saving £92 per birth in the UK (AU$303 per birth in Australia). Sensitivity analyses did not identify any areas of uncertainty that stopped sildenafil citrate being cost saving compared with standard care. Threshold analysis revealed that sildenafil citrate would be cost saving up to a per birth drug or administration cost of £152.32 in the UK (AU$333.61 in Australia). Oral sildenafil citrate may be cost saving compared with standard care; however, the effects on neonatal outcomes still need to be demonstrated in large randomized trials.

The Effects of Radial Extra Corporeal Shock Wave and Low-power Laser Therapies on Clinical and Electrophysiological Parameters in Moderate Carpal Tunnel Syndrome: A Blinded Randomized Control Trial

Objectives: Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy with squeezing of the median nerve and the patient is unable to function properly. There are different physiotherapy interventions for the management of these patients and recently, shock wave therapy and low-power laser (LPL) have been widely used, but there is no strong evidence comparing the effect of shock wave therapy and LLLT. Therefore, this trial was designed to compare the effect of extracorporeal shock wave therapy (ESWT), LPL, and routine interventions on clinical outcomes and electrophysiological parameters in patients with moderate CTS. Methods: Fifty-four patients were randomly assigned to the control (routine interventions), ESWT, and LPL therapy groups. All participants received transcutaneous electrical nerve stimulation (TENS) therapeutic ultrasound, hot pack, mobilization, and stretching for ten sessions over two weeks. Additionally, the ESWT group received radial ESWT in four sessions, and the LPL therapy group received laser in ten sessions. The primary outcomes were pain (assessed by the visual analog scale), function (assessed using the Boston questionnaire (BQ)), hand grip, and finger pinch strength. Secondary outcomes were electrophysiological parameters (distal motor and sensory latency and nerve conduction velocity (NCV) of the median nerve. Results: Time group interactions were significant for pain, the symptom severity subscale of BQ, finger pinch, and hand grip strength (p<0.001). Significant improvements were seen in clinical and sensory latency and motor NCV of the median nerve (p<0.05). The ESWT group experienced significant improvements with a large effect size in pain, function, and finger pinch strength compared to the control group (p<0.01). Additionally, the LPL therapy group showed significant changes in the function and finger pinch and hand grip strength compared to the control group. There were no significant differences between the LPL therapy and ESWT groups except for pain in favor of the ESWT group. No significant differences were found among the three groups in electrophysiological parameters (p>0.05). Discussion: Although laser therapy increased the efficacy of routine interventions, it seems adding ESWT to the routine treatment may be superior for the management of moderate CTS patients.

Double Blinded Randomized Controlled Trial Comparing Budesonide and Saline Nasal Rinses in the Post-operative Management of Chronic Rhinosinusitis.

Post-operative management of chronic rhinosinusitis is very crucial for outcomes following surgery, Normal saline nasal irrigation and steroid spray form the standard treatment of care in this period. However nasal irrigation may not be adequate and spray is usually started after 2weeks of surgery which in any case does not deliver optimum dosage of drug to the paranasal sinus mucosa. Budesonide nasal irrigation in a high-volume low-pressure system could be the solution for a better outcome. A double blinded randomized control trial with 88 patients in 2 groups of 44 each received normal saline or Budesonide nasal irrigation (0.5mg in 200ml) twice daily. Patients were followed up at 2weeks post-operatively and 3months, a SNOT 22 and Lund Kennedy Endoscopic scores were assessed for subjective and objective assessment. Subset analysis of only CRS patients (55) were done, and results presented. Patient reported subjective score at 3months post operatively, SNOT22 was significantly (p < 0.0001) improved with the use of Budesonide irrigation (26.69 ± 2.92) as compared to Normal saline (30.54 ± 2.81) and objective assessment score, LKES was significantly (p = 0.0031) better in Budesonide group (4.06 + 0.74) in comparison to Normal saline in the saline (4.50 + 0.67) respectively. The mean scores 3months post op visit was significantly lower for both subjective SNOT (p < 0.001) and objective score LKES (p < 0.0001) in Budesonide groups. Budesonide nasal irrigation with positive pressure high volume device has better patient benefits and wound healing when compared to normal saline irrigation in the post-operative management of chronic rhinosinusitis.

Analgesic Potency Of Ibuprofen, Paracetamol, And Mephenamic Acid: A Randomized Controlled Trial

BACKGROUND: Analgesics are a group of drugs to relieve pain. The use of analgesics is quite high, around 22.8% is used per year. Selection of analgesic drugs having adequate potency and minimal side effects is needed. Common analgesics publicly known involve paracetamol 500 mg, mefenamic acid 500 mg, and ibuprofen 400 mg. This study aims to compare the analgesic potency of paracetamol 600 mg, ibuprofen 600 mg and mefenamic acid 500 mg. METHODS: This study used a double blind randomized control trial. The study population was healthy subjects. The study sample consisted of 30 subjects with the inclusion criteria involve normal vital signs, while the exclusion criteria involve history of allergy to NSAID class drugs. This study consisted of three groups namely group 1 (K1)= paracetamol 600 mg, group 2 (K2)= mefenamic acid 500 mg, group 3 (K3)= ibuprofen 600 mg. Each subject was given medication according to the group and their pain latency (the time of onset of constant and unbearable pain) was measured every 30 minutes RESULTS: The repeated ANOVA test shows P= 0.1507 meaning that no significantly different analgesic potency was found between groups. CONCLUSION: Paracetamol 600 mg, mefenamic acid 500 mg and ibuprofen 600 mg have equal analgesic potency.

Acupuncture effect on dumping syndrome in esophagus cancer patients with feeding jejunostomy: A study protocol for a single blind randomized control trial.

Esophagus cancer patients are at risk for malnourishment. Feeding jejunostomy is used in advanced esophagus cancer patients in order to support and supplement the patients' nutrition needs. In dumping syndrome, the food is rapidly introduced into the intestine at a rate that is faster than normal, it is associated with both digestive system and vasoactive symptoms. Dumping syndrome has an association with both esophagus cancer patients and feeding jejunostomy. In the mid and long term, dumping syndrome is an important issue that contributes to the risk of malnourishment in advanced esophagus cancer patients. In recent studies, acupuncture was effective in regulating digestive symptoms. Acupuncture is considered to be a safe intervention, that was previously shown to be effective in treating digestive-related symptoms. Sixty advanced esophageal cancer patients post-feeding jejunostomy will be divided into 2 equal groups, an intervention group (n = 30) and a control group (n = 30). Patients in the intervention group will receive acupuncture using the following acupoints: ST36 (Zusanli), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Neiguan), LI4 (Hegu), and Liv 3 (Taichung). Patients in the control group will receive shallow acupuncture on 12 non-acupoints (sham points), 1 cm from the above mention points. Patients and assessors will be blind to trial allocation. Both groups will receive acupuncture twice a week for 6 weeks. The main outcome measurements are: body weight, BMI, Sigstad's score, and the Arts' dumping questionnaire. There are no previous studies that have examined the use of acupuncture on patients with dumping syndrome. This single-blind randomized control trial will investigate the effect of acupuncture on dumping syndrome in advanced esophagus cancer patients with feeding jejunostomy. The results will determine if verum acupuncture can affect dumping syndrome and prevent weight loss.

459 Clinical Utility of Pharmacogenetic Tests When Prescribing Antidepressant Therapy for Depression, A Systematic Review and Meta-analysis of Randomised Controlled Trials

Abstract Introduction Pharmacogenetic testing when prescribing medicines has the potential to reduce harmful side effects, optimise treatment, and improve clinical outcomes. Depression is a major global disease burden with high economic costs and it’s becoming more prevalent (1). There is a growing number of clinical trials and reviews that support the use of pharmacogenetic testing for depression and more results are available from randomised controlled trials (RCTs) that were completed recently to warrant a new systematic review (2). Aim The aim was to evaluate the clinical utility of pharmacogenetic tests when prescribing antidepressant therapy for depression (including mild, moderate, and major depression) by comparing the remission rate, antidepressant response and adverse events from RCTs for the pharmacogenetic guided therapy group and the treatment as usual group (TAU) through a systematic review and meta-analysis. Methods The PICO inclusion criteria are adults with depression requiring antidepressant therapy for depression. The intervention is a pharmacogenetic gene test(s) and the comparator is usual treatment. The outcomes are depression remission, antidepressant response and adverse events. This research was undertaken between April and September 2022 by the main author (SJ). The second author (HA) peer reviewed the title/abstract screening, full text review, and the third author (PD) provided supervisory support. A systematic literature search was completed using Embase, Medline, Cochrane, and PubMed databases according to a published PROSPERO protocol. Articles published between 2000 - 2022 were eligible. Only RCTs that had TAU as the comparator were included. Bias and quality assessments were carried out using the RoB 2 tool. Studies with a high risk of bias were excluded. Heterogeneity was calculated using I2. A random effects model meta-analysis was conducted using RevMan. Results In total, 520 articles were retrieved at first search (excluding duplicates) and seven double-blinded (rater and patient blinded) RCTs were identified that met the full inclusion and exclusion criteria. The RCTs were based in North America (5), Australia (1) and Europe (1). The meta-analysis revealed the remission rate was greater for pharmacogenetic guided groups compared to the TAU groups, pooled risk ratio (RR) = 1.54 (95% CI 1.07-2.21, p = 0.02). For the response rate, results from 6 double blinded RCTs which measured this had a pooled RR= 1.23 (95% CI 0.95-1.59, p = 0.11) which indicates a greater (but not statistically significant) response rate in the pharmacogenetic guided group. Conclusion A limitation of this study is that it showed improvement in remission but not response rate, which is potentially due to response data missing from one of the seven pooled studies. Pharmacogenetic tests might have the potential to improve remission and response rates for antidepressant therapy compared to treatment as usual. However, further studies in the UK are warranted to help determine whether pharmacogenetic tests should be used in an NHS setting.

Effect of Semont maneuver and Brandt-Daroff exercises on Benign Paroxysmal Positional Vertigo

Objective. This study aimed to examine the efficacy of single session of Semont maneuver and Brand Daroff exercises in treatment of BPPV. Methods. This controlled single blinded randomized control trial (RCT) approved by “IEC, GJUS&amp;T, Hisar” on vide letter no. PTY/2022/155 dated on 21/04/2022. 30 patients (18 years of age and above) of posterior semicircular canal BPPV divided into two groups; Group 1 (N=16) was intervention group treated with Semont maneuver &amp; Brandt-Daroff exercises and Group 2 (N=14) was control group in which Brandt-Daroff exercises were given. Subjects were diagnosed with the help of Dix-Hallpike maneuver, visual vertigo analysis scale, questionnaire for self-diagnosis of BPPV and dizziness handicap inventory score. Paired t-test was used to compare data within groups and unpaired t-test was used to compare data between intervention and control group. Results. VAS and total DHI scores at the start of the study were not statistically significant (p=0.28, p=0.80, respectively) between the treatment group and control group. VAS and DHI scores statistically significantly improved after the intervention in group 1 (VAS 6.75±.68, p&lt;0.001; Total-DHI =42.87±8.69; p&lt;0.001). On the other hand, in the group 2, no significant difference was observed (VAS 1.21±.68, p=0.56; Total-DHI =2.29±8.69; p=.67). In addition, significant improvements were observed in VAS and total DHI scores in patients who underwent the Semont maneuver and Brandt-Daroff compared to those in the group 2 (p&lt;0.01, p&lt;0.01, respectively). Conclusion. Semont maneuver and Brandt Daroff exercises are safe and more effective in treatment of BPPV in majority of patient.

Median Nerve Stimulation for Treatment of Tics: A 4-Week Open Trial with Ecological Momentary Assessment.

Median nerve stimulation (MNS) at 10-12 Hz was recently proposed as a treatment for Tourette syndrome and other chronic tic disorders (TS/CTD). We report on 31 participants ages 15-64 with TS/CTD in an open-label, comparative (within-group, several time points) study of MNS (ClinicalTrials.gov registration number NCT05016765). Participants were recruited from completers of a randomized controlled trial (RCT) of MNS and were given a transcutaneous electrical nerve stimulation (TENS) unit to use as desired for 12 Hz MNS for 4 weeks. Participants were instructed to complete surveys regarding tic symptoms and stimulation discomfort before and after stimulation, as well as twice daily when randomly prompted by text message. Participants also completed an extensive final survey. Twenty-seven participants completed the study. Median device use was 1.5 days per week and 50 min per day used. Tic frequency improved during MNS (mean improvement: 1.0 on a 0-5 scale, p < 0.001), as did tic intensity (mean improvement: 0.9, p < 0.001). Mean discomfort was mild (1.2 on a 3-point scale). In total, 21 participants (78%) planned to continue using the device. Participants' results in this study did not correlate significantly with their results in the blinded RCT. We found MNS to improve tic frequency and intensity with minimal side effects.

Comparison of Plaque Removal Efficacy of Modified Bass Technique and Charter’s Technique in Orthodontic Patients

Aim: To compare the efficacy of modified bass technique and charters technique in plaque removal among orthodontic patients. Study design: Single Blind Randomized control trial Place and duration of study: Department of Periodontology, Sardar Begum Dental College Peshawar from 1st July 2022 to 31st December 2022. Methodology: Forty six patients undergoing orthodontic treatment were enrolled. Patients were divided into two equal groups using lottery method. Group A used Modified Bass technique and Group B used Charter’s brushing technique. Plaque scores were measured by principal investigator and were recorded onthe Online Periodontal Chart of University of Berlin. Plaque score was recorded on all sides of the tooth in relation to bracket (mesial, distal, gingival, occlusal) using dental explorer after disclosing plaque by plaque disclosing tablet. Results: There were 24 (52.2%) females and 22 (47.8%) males. The mean plaque score for Group A was 25.76 and for Group B was 27.64, with no statistical difference after the test was applied. Conclusion: The modified Bass and Charters brushing techniques showed similar results in plaque removal efficacy. Scrubbing is the simplest and most often used cleaning procedure. Keywords: Plaque, Fixed appliances, Brushing techniques, Efficacy

Mindfulness-based cognitive therapy v. treatment as usual in people with bipolar disorder: A multicentre, randomised controlled trial

AbstractBackgroundMindfulness-based cognitive therapy (MBCT) seems a promising intervention for bipolar disorder (BD), but there is a lack of randomised controlled trials (RCT) investigating this. The purpose of this multicentre, evaluator blinded RCT was to investigate the added value of MBCT to treatment as usual (TAU) in BD up to 15 months follow-up (NCT03507647).MethodsA total of 144 participants with BD type I and II were randomised to MBCT + TAU (n = 72) and TAU (n = 72). Primary outcome was current depressive symptoms. Secondary outcomes were current (hypo)manic and anxiety symptoms, recurrence rates, rumination, dampening of positive affect, functional impairment, mindfulness skills, self-compassion, and positive mental health. Potential moderators of treatment outcome were examined.ResultsMBCT + TAU was not more efficacious than TAU in reducing current depressive symptoms at post-treatment (95% CI [−7.0 to 1.8], p = 0.303, d = 0.24) or follow-up (95% CI [−2.2 to 6.3], p = 0.037, d = 0.13). At post-treatment, MBCT + TAU was more effective than TAU in improving mindfulness skills. At follow-up, TAU was more effective than MBCT + TAU in reducing trait anxiety and improving mindfulness skills and positive mental health. Exploratory analysis revealed that participants with higher depressive symptoms and functional impairment at baseline benefitted more from MBCT + TAU than TAU.ConclusionsIn these participants with highly recurrent BD, MBCT may be a treatment option in addition to TAU for those who suffer from moderate to severe levels of depression and functional impairment.Trial registrationClinicalTrials.gov, NCT03507647. Registered the 25 April 2018, https://www.clinicaltrials.gov/ct2/show/NCT01126827.

A randomized controlled study of Ropivacaine with adjuvants in ultra sound guided supraclavicular brachial plexus blockade.

Adjuvants in brachial plexus blockade can improve the patient care by prolonging postoperative analgesia and early mobilization of patient with stable hemodynamics. Brachial plexus block has possible complications like local anaesthetic systemic toxicity, pneumothorax, nerve injury etc. These limitations can be overcome by use of ultrasound guided block with adjuvants like dexmedetomidine and clonidine to prolong the duration of block and postoperative analgesia. Ropivacaine¹ has greater degree of motor differentiation and less cardiotoxicity. Setting and Design: A prospective double – blind randomized control trial comprising of 90 subjects posted for elective upper extremity surgeries. Aim: To compare the onset, duration of sensory blockade, motor blockade and analgesia of 0.5% ropivacaine with clonidine 1mg.kg-1 and 0.5% ropivacaine with dexmedetomidine 1mg.kg-1 in upper extremity surgeries. Methods: Ninety patients aged between 18 – 60yrs of American Society of Anaesthesiology (ASA) Physical Status Class 1 and 2, scheduled for various elective upper extremity surgeries were selected and randomly allocated into two groups of 45 patients each. Group A received 20mL of 0.5% Ropivacaine with dexmedetomidine 1mg.kg-1 and Group B received 20 ml of 0.5% Ropivacaine with clonidine 1mg.kg-1 in 2mL of distilled water. Parameters were compared between the study groups. Results: In Group A, 73.3% of the patients showed onset of sensory block of 8 minutes. And 26.7% of the patients showed onset of sensory block of 10 minutes. In Group B, 44.4% of the patients showed onset of sensory block of 8 minutes, and 26.7% of the patients showed onset of sensory block of 10 min. There was a statistically significant decrease in onset of block and increase in mean duration of sensory and motor block in Group A as compared to Group B. Conclusion: Dexmedetomidine added to 0.5 % ropivacaine in supraclavicular brachial plexus block decreased the time of onset of sensory and motor block and prolonged the postoperative analgesia.