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Objectives: Cartoons, comics, and caricatures have been incorporated in health education. This trial aimed to evaluate the effectiveness of caricature‑based breastfeeding education at improving breastfeeding knowledge, attitudes, self‑efficacy, and practice among pregnant women. Materials and Methods: A randomized controlled clinical trial was carried out at Riyadh First Health Cluster in Saudi Arabia. A total of 85 pregnant women were randomly assigned to the intervention group (n = 41) or the control group (n = 44). The intervention was two caricature-based versus one standard online lecture in breastfeeding. The participants were followed up for 3 months postpartum. The primary outcome was full breastfeeding (predominant and exclusive breastfeeding) by the time infants were 3 months old. The secondary outcomes were prenatal and postnatal breastfeeding self‑efficacy, Iowa Infant Feeding Attitude Scale (IIFAS) scores, and satisfaction with the education. Results: The participants were mostly Saudi (97.6% vs. 90.9%) and housewives (79% vs. 86.4%) for the intervention and control groups, respectively. The full breastfeeding rate at 3 months postpartum was 32.5% for the intervention and 31.6% for the control (P = 0.808; 95% confidence interval 0.539–1.965; relative risk = 1.029). Prenatal breastfeeding, postnatal self‑efficacy, and IIFAS scores were compared between the intervention and control groups; no statistically significant difference was found (P > 0.05). In both arms of the study, participants’ experiences with the health education were satisfactory. Conclusion: Caricature use in antenatal breastfeeding education was a pleasant experience, but its effect on self‑efficacy, attitudes, and behavior could not be determined from this trial. Large‑scale, multi‑center, multi‑component research is recommended. [ABSTRACT FROM AUTHOR]

Background: Cerebrovascular accident dramatically impacts patients' lives. However, this chronic disease could be managed by boosting self-care and following healthy behaviors. Accordingly, this trial sought to specify the impact of a training program established on the theory of planned behavior on the self-care of clients with this condition. Materials and Methods: This trial was performed on 80 clients, who were selected using a random numbers table and divided into two equal groups to receive either usual care alone or usual care plus a training program based on the theory of planned behavior (five in-hospital individual sessions for 5 weeks and weekly phone follow-ups for 2 months after discharge). Self-care and the dimensions of the theory of planned behavior were investigated at baseline and 2 months after the last in-hospital session using the standardized Shah version of the modified Barthel index and a researcher-made questionnaire, respectively. Results: The mean score of self-care was significantly higher in the experimental arm at the posttest (Mann--Whitney = 506.00, p = 0.005). Also, the increase in mean change of self-care from baseline to posttest was significantly more in the experimental arm (t78 = -6.6, p < 0.001). Such findings were also found for all dimensions of the theory of planned behavior. Conclusions: Based on results, nurses and health policymakers can incorporate training based on the theory of planned behavior into routine care programs for patients with cerebrovascular accident to boost their self-care. The implemented intervention also could be reproduced in other contexts. Hence, further trials are requested to specify the sustainability of the findings. [ABSTRACT FROM AUTHOR]

Background: Root canal therapy (RCT) and pulpotomy are two common treatment modalities for managing dental pulp infections, but their comparative effectiveness in terms of patient outcomes remains unclear. This root canal therapy (RCT) aimed to assess and compare patient outcomes between teeth treated with traditional RCT and pulpotomy. Materials and Methods: In this single-center RCT, a total of 120 patients presenting with symptomatic dental pulp infections were randomly assigned to either the RCT group or the pulpotomy group. The RCT group received conventional root canal treatment, which involved complete removal of infected pulp and obturation of the root canals. The pulpotomy group underwent a procedure where only the coronal pulp tissue was removed, followed by the placement of a medicament. Pain levels, infection resolution, and tooth survival were assessed at 6 months and 1 year posttreatment. Results: At the 6-month follow-up, patients in the RCT group reported significantly lower pain scores (2.5 ± 0.8) compared with the pulpotomy group (4.3 ± 1.2, P < 0.001). Infection resolution was also higher in the RCT group (92%) compared with the pulpotomy group (78%) at 6 months. Tooth survival rates at 1 year were significantly higher in the RCT group (95%) compared with the pulpotomy group (81%, P < 0.05). Conclusion: This RCT demonstrates that traditional RCT is superior to pulpotomy in terms of pain reduction, infection resolution, and tooth survival. Patients who underwent RCT experienced less pain, faster infection resolution, and better tooth survival rates compared with those who received pulpotomy. These findings support the use of RCT as the preferred treatment modality for dental pulp infections. [ABSTRACT FROM AUTHOR]

The background of the study highlighted the common occurrence of post-endodontic pain and the need for effective pain management strategies. Materials and Methods: Fifty patients were randomly assigned to two groups: the cold laser therapy (CLT) group and the traditional methods group (TMG). The CLT group received laser treatment at the affected area immediately following endodontic treatment, whereas the TMG received standard pain management techniques such as analgesics. Pain levels were assessed using a visual analog scale at baseline and at 6, 12, 24, and 48 hours post treatment. Pain scores were analyzed using appropriate statistical methods, including analysis of variance, and P values were calculated to determine the significance of differences between groups. Results: This study found significant differences in post-endodontic pain levels between CLT and standard procedures. At 6 hours post treatment, the CLT group had a mean pain score of 2.1 ± 0.8, whereas the TMG had a mean pain score of 3.8 ± 1.2 (P = 0.012). Pain levels in the CLT group decreased with time, with scores decreasing to 1.5 ± 0.6 at 12 hours, 1.2 ± 0.5 at 24 hours, and 0.9 ± 0.4 at 48 hours post treatment. In contrast, the TMG had greater pain scores at each time point: 3.2 ± 1.0, 2.9 ± 1.1, 2.5 ± 0.9, and 2.1 ± 0.8 at 12, 24, and 48 hours post treatment, respectively. At 12, 24, and 48 hours post treatment, P values of 0.021, 0.036, and 0.004, respectively, indicated significant differences. Conclusion: In managing post-endodontic pain, CLT demonstrated superior efficacy compared to traditional methods. [ABSTRACT FROM AUTHOR]

Objective: In this study, the retention rates of four different pit and fissure sealant materials on the first permanent molars were clinically assessed and compared. Materials and Methods: A total of 120 kids aged 7 to 10 participated in a randomized controlled experiment. On their first permanent teeth, the subjects each got one of the four sealant materials (A, B, C, or D). Over the course of 24 months, the retention rates were evaluated every 6 months. The Chi-square test and Kaplan–Meier survival analysis were used for statistical analysis. Results: At 6, 12, 18, and 24 months, the following retention rates were observed overall: A (85%, 78%, 65%, 52%), B (90%, 82%, 70%, 60%), C (78%, 70%, 55%, 42%), and D (95%, 88%, 75%, 62%). At each time point, the sealant materials showed significant variations in retention rates (P 0.05). While sealants A and C showed lower retention rates, sealant D showed the best retention rates, followed by sealant B. Conclusion: This study shows that different materials have different retention rates for pit and fissure sealants on first permanent molars. Higher retention rates for sealants D and B suggest that they may be superior than sealants A and C. These results highlight how crucial it is to choose the right sealant materials to guarantee long-term retention and effectiveness in avoiding dental cavities. [ABSTRACT FROM AUTHOR]

Background: Orthodontic treatment planning involves the precise assessment of dental and skeletal anomalies, which can be facilitated by AI-enhanced diagnostic tools. Materials and Methods: A total of 100 orthodontic cases were included in this RCT. Patients were randomly assigned to two groups: an AI-enhanced diagnostic group and a traditional diagnostic group. The AI-enhanced diagnostic group underwent orthodontic assessment with the aid of AI-powered software, which provided automated cephalometric analysis, 3D model evaluations, and treatment suggestions. The traditional diagnostic group received conventional diagnostic assessments by orthodontists. The primary outcome measures included treatment planning accuracy, treatment time, and patient satisfaction. Secondary outcomes included the number of appointments required and treatment cost. Results: The AI-enhanced diagnostic group demonstrated a significantly higher accuracy in treatment planning compared to the traditional diagnostic group (P < 0.05). The AI group also required fewer appointments (mean ± SD: 10.2 ± 2.1 vs. 12.8 ± 3.4) and had a shorter treatment time (mean ± SD: 14.6 ± 3.2 months vs. 18.9 ± 4.5 months) (P < 0.001 for both comparisons). Additionally, patient satisfaction scores were higher in the AI group (mean ± SD: 9.2 ± 0.6 vs. 8.1 ± 0.8) (P < 0.001). However, the AI-enhanced diagnostic group had a slightly higher treatment cost. Conclusion: AI-enhanced diagnostic tools significantly enhance the accuracy of treatment planning in orthodontic cases, leading to reduced treatment time, fewer appointments, and increased patient satisfaction. [ABSTRACT FROM AUTHOR]

Background: Periodontal disease, characterized by inflammation and infection of the supporting structures of teeth, poses a significant oral health challenge. Traditional periodontal surgery and non-surgical therapy, such as scaling and root planing, are established treatment approaches for addressing periodontal disease. Materials and Methods: The study enrolled 120 adult patients diagnosed with moderate to severe periodontal disease. Participants were randomly allocated to one of two groups: the traditional surgery group (TSG) or the non-surgical therapy group (NSTG). In the TSG, patients underwent traditional periodontal surgery, which included flap surgery and grafts when deemed necessary. The surgical procedures were performed by experienced periodontal surgeons. In contrast, the NSTG received non-surgical therapy in the form of scaling and root planing administered by trained dental hygienists. Outcome measures encompassed clinical parameters and patient-centered outcomes. Periodontal pocket depth and clinical attachment level, both measured in millimeters, were assessed at baseline, 3 months, and 6 months. Patient-reported outcomes, including pain, discomfort, and satisfaction, were collected through standardized questionnaires at each follow-up visit. Results: Patients in the TSG experienced a notable reduction in pocket depth from a baseline of 6.8 mm to 3.7 mm at the 6-month mark, resulting in a change of -3.1 mm. Conversely, the NSTG exhibited a reduction from 6.7 mm to 4.0 mm, with a change of -2.7 mm. In the TSG, the baseline attachment level of 7.2 mm decreased to 5.1 mm at 6 months, indicating a change of -2.1 mm. In the NSTG, the attachment level decreased from 7.1 mm to 5.5 mm, resulting in a change of -1.6 mm. Patients in the TSG reported an average pain score of 3.6 on a 1–10 scale, discomfort of 4.2, and satisfaction of 7.8. In contrast, patients in the NSTG reported lower pain (2.1) and discomfort (2.9) scores but similar satisfaction levels (8.4). Conclusion: In this randomized controlled trial (RCT), both traditional periodontal surgery and non-surgical therapy demonstrated improvements in clinical parameters and patient-reported outcomes. Traditional surgery resulted in greater reductions in periodontal pocket depth and clinical attachment loss at the 6-month follow-up. [ABSTRACT FROM AUTHOR]

Background: Dental restorations play a crucial role in preserving the structural integrity and function of posterior teeth. However, wear resistance remains a significant concern for these restorations. Materials and Methods: In this RCT, 120 participants with posterior tooth restoration needs were randomly assigned to two groups. Group A received conventional composite restorations, while Group B received NanoFilled Composite restorations. The restorations were placed according to standardized protocols. Wear resistance was assessed using a custom-designed chewing simulator, and the material wear was quantified using a profilometer. Patient-reported outcomes and clinical evaluations were also recorded at regular intervals over a 24-month follow-up period. Results: The wear resistance of the NanoFilled Composite restorations (Group B) was significantly higher than that of the conventional composite restorations (Group A) after 24 months of follow-up (P < 0.05). Profilometer measurements revealed that Group B had an average wear depth of 0.15 mm, while Group A had an average wear depth of 0.25 mm. Patient-reported outcomes indicated higher satisfaction and comfort in Group B. Clinical evaluations also demonstrated that Group B restorations had better retention and marginal integrity. Conclusion: This RCT demonstrates that NanoFilled Composite restorations exhibit superior wear resistance compared to conventional composite restorations when used in posterior teeth. [ABSTRACT FROM AUTHOR]

Background: Dental caries is a prevalent oral health issue, often diagnosed through intraoral radiographs. The accuracy of Artificial Intelligence (AI) in diagnosing dental caries from these radiographs is a subject of growing interest. Materials and Methods: In this RCT, 200 intraoral radiographs were collected from patients seeking dental care. These radiographs were independently evaluated by both AI-based software and experienced human dentists. The software utilized deep learning algorithms to analyze the radiographs for signs of dental caries. The performance of both AI and human interpretations was compared by calculating sensitivity, specificity, and overall accuracy. Arbitrary values of 85% sensitivity, 90% specificity, and 88% overall accuracy were set as benchmarks. Results: The AI-based software demonstrated a sensitivity of 88%, a specificity of 91%, and an overall accuracy of 89% in diagnosing dental caries from intraoral radiographs. Human interpretation, however, yielded a sensitivity of 84%, a specificity of 88%, and an overall accuracy of 86%. The AI-based software performed consistently close to or above the predefined benchmarks, while human interpretation showed slightly lower accuracy rates. Conclusion: This RCT suggests that AI-based software is a valuable tool for diagnosing dental caries from intraoral radiographs, with performance comparable to or exceeding that of experienced human dentists. The consistent accuracy of AI in this context highlights its potential as an adjunctive diagnostic tool, which can aid dental professionals in more efficient and precise caries detection. [ABSTRACT FROM AUTHOR]

Background: The interaction between type 2 diabetes and periodontal disease underscores the importance of exploring dietary interventions that could mitigate inflammation and improve periodontal health in diabetic patients. Materials and Methods: This randomized controlled trial included 100 patients with type 2 diabetes who were equally divided into two groups: Group A (low-carbohydrate diet) and Group B (control group). Patients in Group A followed a low-carbohydrate diet for 12 weeks, while Group B maintained their regular dietary habits. Periodontal health was assessed using clinical parameters such as probing depth (PD) and clinical attachment level (CAL), and inflammation was measured by analyzing levels of C-reactive protein (CRP) and interleukin-6 (IL-6). Statistical analyses were performed using appropriate tests. Results: After 12 weeks, Group A exhibited significant improvements in periodontal health compared to Group B. The mean PD reduction was 0.5 mm in Group A and 0.1 mm in Group B, with a corresponding mean CAL gain of 0.3 mm in Group A and no significant change in Group B. Inflammatory markers also showed favorable outcomes in Group A, with a decrease of 1.2 mg/L in CRP levels and 20% reduction in IL-6 levels. In contrast, Group B demonstrated minimal changes in inflammatory markers. The differences in PD, CAL, CRP, and IL-6 levels between the two groups were statistically significant (P < 0.05). Conclusion: The adoption of a low-carbohydrate diet for 12 weeks demonstrated significant improvements in periodontal health and reduction of inflammation in patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Purpose: Substandard quality across published randomized controlled trials (RCTs) is a major concern. Imperfect reporting has the potential to distort the evidence landscape and waste valuable health-care resources. In this study, we aim to assess the current quality of reporting in the field of spine using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist. Materials and Methods: A list of published RCTs in the field of spine disease from January 1, 2013, to December 31, 2020, was built. Two reviewers scored the published RCTs against a modified CONSORT checklist. The mean adjusted CONSORT scores for each study, reporting category, and checklist item were calculated. Results: The mean and median scores across all of the RCTs were 0.72 and 0.74 out of 1.00, respectively. The spectrum of scores was wide, ranging from 0.45 to 0.94. The reporting categories with the lowest score included randomization, blinding, and abstract. The items which were most under-reported included allocation sequence generation, type of randomization used, full trial protocol details, and abstract methodology. The inter-rater reliability between our reviewers was substantial (κ = 0.7, κ = 0.71). Conclusion: Our findings correlate with only a moderate level of compliance to the CONSORT criteria on the quality of reporting for RCTs in spinal conditions. This is in line with previous reports on compliance, both within and outside the field of spinal conditions. Further continued and sustained efforts are still required to enhance the quality and consistency of RCT reporting, ultimately reducing health-care resource wastage and improving patient safety. [ABSTRACT FROM AUTHOR]

Introduction: Despite the increasing number of mental health professionals in Malaysia, many have yet to receive adequate treatment for common mental illnesses such as depression and anxiety. Coupled with the increasing number of mobile phone users globally, smartphone-based intervention can be a promising mental health intervention. Thus, this study aims to investigate the efficacy of using a smartphone-based mental health application in addition to treatment-as-usual (TAU) in outpatients with depressive and/or anxiety symptoms. Methods: Psychiatric outpatients that fulfill the selection criteria were recruited and randomized into two groups, the intervention group (n = 24) and the control group (n = 24). Those in the intervention group received MoodMission in addition to TAU, while those in the control group received TAU. Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scores were assessed at baseline and after four weeks. Results: A total of 48 participants were recruited, randomized, and completed the study. Baseline characteristics for both groups were comparable. There is no significant mean difference between-group comparison of PHQ-9 (1.31, 95% CI -1.35, 3.98) and GAD-7 (0.02, 95% CI -2.01, 2.05) scores at four weeks. However, for the intervention group, there was a significant improvement in the PHQ-9 score at four weeks [mean difference 2.58 (95% CI 1.16, 4.01), P = 0.001)]. Conclusion: This study showed no significant improvement in anxiety symptoms after four weeks. Use of smartphonebased mental health applications led to significant reduction of depressive symptoms. [ABSTRACT FROM AUTHOR]

Introduction: Therapy of proliferative lupus nephritis (PLN) is yet to be optimized. Standard of care for induction consists of intravenous (IV) cyclophosphamide (CYC) and steroids, which shows an improved outcome, but end-stage renal disease (ESRD) progression, increased mortality, and therapy-related adverse effects remain a major concern. The other treatment reported to induce early remission was the multitarget therapy comprising tacrolimus, mycophenolate, and steroid, but infections were high in the multitarget therapy. Considering azathioprine as a potentially safer and effective alternative anti-B-cell therapy, modified multitarget therapy (MMTT) was planned replacing mycophenolate with azathioprine. Material and Methods: A single-center, 24-week, open-label, randomized controlled trial comprising adults of age 18-65 years with biopsy-proven PLN was carried out. The intervention groups were 1) MMTT: tacrolimus 0.075 mg/kg/day and azathioprine 2 mg/kg/day and 2) IV CYC group with a starting dose of 0.75 (adjusted to 0.5-1.0) g/m² every 4 weeks for 6 months. Both groups received 3 days of pulse methylprednisolone followed by a tapering course of oral prednisone therapy. Results: Among 100 randomized patients, 48 were in MMTT arm and 52 were in IV CYC arm. At the end of 24 weeks, overall remission (complete and partial) was comparable in both the arms: MMTT (86.36%) and IV CYC (87.75%). There was comparable proteinuria reduction and systemic lupus erythematosus disease activity index (SLEDAI) score improvement with recovery of complement level C3 in both groups. Major adverse events were numerically more in the IV CYC group, including one death from pneumonia. Conclusion: The MMTT arm is as effective as IV CYC in improving short-term outcome in PLN, with a comparable safety profile. [ABSTRACT FROM AUTHOR]

Background: Dementia is characterized by neurocognitive decline which interferes with daily function and independence. Cognitive stimulation therapy (CST) is an evidence-based cognitive psychosocial intervention for people with dementia. Materials and Methods: A prospective interventional study of single-blind RCT design conducted in the Department of Neurology at ABVIMS and Dr RML Hospital amongst patients with DSM-V major neurocognitive disorder aged more than 50 years. Participants were randomized to CST and control groups using a block-randomized design. The control group participants received treatment as usual while the CST group delivered 45-min virtual group CST sessions for a total of 14 sessions over seven weeks. All participants in both groups were assessed at baseline and eight weeks using the Montreal Cognitive Assessment Scale (MoCA), Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog), neuropsychiatric inventory, instrumental activities of daily living, and Zarit Burden Interview for Caregiver Burden (ZBI) by a rater blind to group randomization. Results: Total MoCA scores improved significantly in the CST group, compared to the control group which showed a statistically significant decrease. The mean total ADAS-Cog score in the CST group improved significantly compared to controls. The Lawton Instrumental Activities of Daily Living Scale showed a statistically significant change in the control group compared to the intervention group. From the comparison of the mean total neuropsychiatric inventory scale, it was observed that there was a statistically significant decrease in the severity of Behavioural and Psychological Symptoms of Dementia (BPSD) symptoms in the CST group. The mean total ZBI score decreased significantly in the CST group favoring less caregiver burden. Conclusion: This study proved that CST has a significant impact on cognitive outcomes in dementia and it also proved its effectiveness in controlling the BPSD outcomes and caregiver burden in dementia. [ABSTRACT FROM AUTHOR]

Background': India is ranked second in the world in terms of tobacco use and tops the list of eight high-burden countries that account for two-thirds of the new tuberculosis (TB) cases globally. As tobacco smoking among TB patients is associated with unsuccessful TB treatment outcomes, effective smoking cessation interventions for TB patients is essential to combat this double pandemic. Aim: The study determined the effectiveness of nicotine replacement therapy (NRT) on smoking reduction and cessation among pulmonary TB patients. Settings and Design: The study included 300 pulmonary TB patients undergoing antitubercular treatment in government health care centers of Dakshina Kannada district in southern India. Materials and Methods: The participants in this two-armed, single-blinded, placebo-controlled, block-randomized trial were divided equally (n = 150) for experimental arm (brief advice + NRT) and control arm (brief advice + placebo). The total duration of treatment and follow-up was 6 months. Unadjusted relative risk (URR) and adjusted relative risk (ARR) were calculated for treatment outcomes at 95% confidence interval (CI). Generalized linear regression analysis was performed upon variables with P value less than 0.2. Results: After 6 months of intervention including follow up, there was a significant reduction in self-reported smoking (ARR = 1.08, 95% CI 1.01-1.17, P = 0.03) in the experimental arm compared with the control arm. Biochemically verified smoking abstinence was not significantly different between the two arms (ARR = 1.01, 95% CI 0.72-1.38, P = 0.97). Conclusion: The study showed statistically significant effectiveness of NRT for self-reported smoking reduction. [ABSTRACT FROM AUTHOR]

Background: Substance use in workplace leads to adverse effects both on the employees and on the workplace. Existing research focuses on alcohol-related harm, while workplace use of other substances has been neglected. There are no randomized controlled studies of brief interventions in Indian hospital settings. Aim: To evaluate the efficacy of World Health Organization (WHO) alcohol, smoking, and substance involvement screening test (ASSIST)-linked brief intervention (ALBI) for reducing risky patterns of substance use in male workers at a tertiary-care hospital in North India. Material and Methods: The study was conducted in two phases. In Phase-I, a random list of 400 employees was generated from the entire pool of male hospital workers, of which 360 participated. Data on the ASSIST risk categories (mild, moderate, and high) were generated from Phase I. In Phase-II, moderate- or high-risk subjects ('ASSIST screen-positive') were randomized into intervention and control groups, with 35 screen-positive subjects in each group. The intervention group was provided a 15--30-min structured session per ALBI protocol, while the control group was given a 15--30-min general talk on health-related consequences associated with substance use. The subjects were compared on ASSIST score, WHO quality-of-life brief version (WHOQOL-BREF) and readiness to change questionnaire (RCQ) at baseline and at 3-month follow up. Results: The prevalence of moderate-to-high-risk use of tobacco, alcohol, and cannabis in the total sample was 28.6%, 27.5%, and 6.9%, respectively. At 3-months postintervention follow-up of the randomized sample, recipients of ALBI had significant reduction of ASSIST scores for all substances compared to the control group (p < 0.001). More participants receiving ALBI were ready to change to RCQ action stage (p values for tobacco, alcohol, and cannabis <0.001, <0.001 and 0.007, respectively). WHOQOL-BREF scores significantly improved in ALBI group across all domains. Conclusion: ALBI was effective in reducing risky substance use, increasing readiness to change and improving the QOL of the subjects at workplace setting. [ABSTRACT FROM AUTHOR]

Background: There are randomized controlled trials (RCTs) about the zinc supplementation effect on circulating levels of brain-derived neurotrophic factor (BDNF). However, the findings of these studies are inconsistent. The purpose of this systematic review and meta-analysis was to determine the zinc supplementation effect on BDNF and zinc levels in published RCTs. Methods: We searched PubMed/Medline, Cochrane, Scopus, ISI Web of Science, EMBASE, "Clinicaltrials.gov", "Cochrane Register of Controlled Trials", "IRCT" and also key journals up to 2019. RCTs with two intervention (zinc) and control (placebo) groups that evaluated zinc supplementation efficacy on BDNF levels were included. Study heterogeneity was assessed, and then, meta-analysis was performed using the fixed-effects model. Results: Four studies were included in the present secondary analysis. Compared with placebo, zinc supplementation significantly enhanced circulating levels of BDNF [(SMD): 0.31, 95% confidence interval (CI): (0.22, 0.61)] and zinc [(SMD): 0.88, 95% CI: (0.54, 1.22)] with no considerable heterogeneity among the studies [(Q = 3.46; P = 0.32; I2% = 13.4); (Q = 2.01; P = 0, 37; I2% = 0.5), respectively]. Conclusions: Our results propose that zinc supplementation can increase the circulating levels of BDNF and zinc. This study was registered at PROSPERO as CRD42020149513. [ABSTRACT FROM AUTHOR]

Aim: To study the efficacy of intravenous vitamin C in management of moderate and severe COVID-19. Objective: To determine the efficacy of intravenous vitamin C in reducing in-hospital mortality in moderate and severe cases of COVID-19. Design: Parallel, double-blinded randomized controlled trial with placebo. Ethical clearance was obtained from the institutional ethics committee, AIIMS Patna. The trial was registered with the Clinical Trials Registry – India (registration number- CTRI/2020/11/029230.) Setting: A tertiary care centre in Bihar, India Participants: All patients above the age of 18 years both males and females, admitted in ICU with a diagnosis of moderate and severe COVID-19 (on the basis of a positive reverse transcriptase polymerase chain reaction (RT–PCR) report) at our facility during the study period (01/10/2020–31/12/2020) not having any of the exclusion criteria. Intervention: The patients in the intervention arm were given 1 gram (2 ampoules of 2 ml each containing 500 mg of vitamin C mixed in 100 ml normal saline) intravenous vitamin C 8 hourly for four days. The patients in the placebo arm received similar looking ampoules (2 ampoules of 2 ml sterile water for injection mixed in 100 ml normal saline) intravenously 8 hourly for four days. The rest of the treatment was given as per the standard operating procedure (SOP) of the institute with adjustments as per treating team's judgement. Outcome Measures: Primary outcome was reduction in in-hospital mortality. Secondary outcomes were improvement in qSOFA score, pO2/fiO2 ratio, fall in inflammatory markers, need for mechanical ventilation and vasopressors. Results: Regarding primary outcome, 10 (33.3%) patients died in intervention group compared to 13 (43.3%) in placebo. Worth noting from baseline characteristics is that 86.7% in intervention arm were of severe category compared to 66.7% severe category patients in placebo group. Though number of severe cases were more in intervention arm there has been comparatively less mortality in this group. Regarding secondary outcomes, amongst 30 patients in vitamin C group, 11 (36.7%) required invasive mechanical ventilation compared to 14 (46.7%) out of 30 in placebo group but the difference was not statistically significant. Although there were a greater number of moderate cases in placebo group, invasive ventilation requirement (and NIV requirement) was more in this group, thus it could be considered that vitamin C might have a role in reducing the severity of disease. The need for vasopressor therapy was higher in intervention arm 33.3% compared to 26.7% in placebo but not significant statistically. The secondary outcomes of the study such as improvement in organ failure score (qSOFA Score), fall in level of inflammatory markers, improvement in respiratory index (pO2/fiO2 ratio), need for mechanical ventilation and need for vasopressors also shown encouraging results but not up to the statistically significant level due to moderate dosage of the drug and small sample size. Conclusion: In the current study, by the observations and results of the double-blind placebo controlled randomised trial, we concluded that as the primary outcome of the study, there was reduction in In-hospital mortality and need for mechanical ventilation in the vitamin C intervention group compared to placebo, although these results did not reach statistical significance due to small sample size and use of moderate dose of IV vitamin C. The secondary outcomes of the study such as improvement in organ failure score (qSOFA Score), fall in level of inflammatory markers, improvement in respiratory index (pO2/fiO2 ratio), need for mechanical ventilation and need for vasopressors also shown encouraging results but not up to the statistically significant level due to moderate dosage of the drug and small sample size. In summary, high dose of intravenous vitamin C may reduce inflammatory reaction, improve oxygen support status, and reduce mortality in COVID-19 patients, without adverse events. High dose intravenous vitamin C may be a promising therapy for patients of moderate to severe COVID-19. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials [RCTs] form the corner-stone of evidence-based medicine. RCTs published in high impact factor journals such as the New England Journal of Medicine [NEJM] are a key driver of clinical practice and policy decisions. RCTs are expected to report both efficacy and safety, however, safety reporting in many studies tends to be poor. The present audit was undertaken with the primary objective of evaluating safety reporting during a five-year period in all RCTs published in the NEJM. Methods: PubMed alone was searched for RCTs published in NEJM from 2013-17. Each RCT was searched for the following outcome measures –whether the trial was sponsored by pharmaceutical industry or investigator initiated, phase of trial, nature of intervention and therapeutic area in terms of reporting of safety outcomes [with 'P values' or '95% confidence interval']. Results: A total of n=623 articles reported safety outcomes of which 275/623 (44.1%) articles reported statistics for safety outcome. There was significant difference in reporting of safety statistics between investigator initiated studies and pharmaceutical industry sponsored studies, [cOR=4.0, 95% CI 2.8- 5.5 P < 0.001]; phase 3 and phase 4 trials, [cOR 0.67, 95% CI 0.5 - 0.9, P = 0.02]; trials involving drugs and surgery, [ cOR 2.07, 95% CI 1.2-3.5, P = 0.01] and in therapeutic areas, cardiovascular and oncology [cOR 0.26, 95% CI 0.1-0.4, P < 0.0001]. Conclusions: Safety reporting in RCTs continues to take a back seat relative to efficacy reporting and is worse for pharmaceutical industry funded studies. Safety reporting should be emphasized in the CONSORT guidelines. [ABSTRACT FROM AUTHOR]

The safety and efficacy of different anti-diabetic drugs are not clear because of the lack of sufficiently powered clinical trials. This network meta-analysis was conducted to compare the efficacy and safety of three anti-diabetic drugs (insulin, glyburide, and metformin), and rank them as per their efficiency to control glucose levels, pregnancy, and neonatal outcomes. The study design is a systematic review, meta-analysis, and network meta-analysis. After a systematic search of existing databases, 34 randomized controlled trials were selected for inclusion in the analysis. We did pairwise network meta-analysis to calculate standardized mean difference and odds ratio (OR) as the summary measures for numerical and dichotomous variables, respectively, by using random-effects model. Our key outcomes were incidence of neonatal hypoglycemia, respiratory distress syndrome, macrosomia, C-section, admission to neonatal intensive care unit (NICU) and mean differences in the birth weight of neonates, gestational age at birth, HbA1C levels, fasting blood sugar, large at gestational age, and post-prandial glucose. It was found that metformin significantly lowered the post-prandial levels of glucose as compared with both glyburide and insulin in pairwise analysis (SMD = 14.11 [23–4.8]; SMD = 22.45 [30–14]), respectively. There was a significant reduction in birth weights of babies whose mothers were administered metformin as compared with either glyburide or insulin. The proportion of neonates admission to NICU was significantly lower for metformin when compared with insulin [Log OR = 0.334 (0.0184, 0.6814))]. Large at gestational age was significantly lower for metformin as compared with both glyburide and insulin [log OR = 0.6882 (0.171, 1.329), log OR = 0.393 (0.00179, 0.8218)], respectively. Oral anti-diabetic drugs especially metformin performed better than both glyburide and insulin for all neonatal and maternal outcomes except that it significantly lowered the neonatal birth weight. [ABSTRACT FROM AUTHOR]

Background and Aims: Programmed intermittent epidural boluses (PIEB) may produce more extensive spread of epidural bolus rather than continuous epidural infusion (CEI). Previous studies compared PIEB with CEI and concluded that PIEB shows better outcome when combined with patient controlled epidural analgesia (PCEA), but these studies lack any comparison between PCEA and PIEB in the absence of CEI. Material and Methods: In this open labeled, prospective, randomized, controlled study 50 parturient were randomly assigned to two groups of 25 each.Group 1 received PCEA bolus of 5 ml (0.1% levobupivacaine plus 2mcg/ml fentanyl) with 15 min lockout interval with provision of rescue clinician bolus of 5 ml of same drug for breakthrough pain. Group 2 received physician‑administered PIEB with same parameters as Group 1. The primary outcome was to assess total consumption of levobupivacaine plus fentanyl mixture, in PIEB vs. PCEA group, corrected for duration of labor (ml/h) and secondary outcomes included pain score, maternal satisfaction, maternal, and neonatal characteristics. Results: The hourly mean drug consumption in the PCEA group was significantly lower as compared with the physician‑administered PIEB group (5.46 ml/h, SD 2.01 vs. 6.55 ml/h, SD 1.28; P = 0.03). The median total number of rescue boluses consumed were less in the PCEA group when compared with the PIEB group (0 vs. 1; P < 0.001). There was no significant difference between groups with regard to pain scores, maternal hemodynamics, maternal and fetal outcome and adverse effects. Conclusion: PCEA may be better than physician‑administered PIEB in providing effective labor analgesia with comparable safety. [ABSTRACT FROM AUTHOR]

Purpose: Comparison of three ultrasound (US) frequencies for phacoemulsification of hard cataracts to determine a frequency that makes phacoemulsification more efficacious and safer.Methods: A randomized controlled trial was undertaken at a medical college and hospital. In total, 207 patients with grade 5.6-6.9 (LOCS III) senile cataract were randomized into three groups. Group I underwent phacoemulsification with 28-kHz frequency, group II with 42-kHz frequency, and group III with 53-kHz frequency. The effective phacoemulsification time (EPT) and estimated fluid usage (EFU) were compared intraoperatively. The endothelial cell parameters were analyzed for 6 months.Results: The groups were matched for age (P = 0.467), gender (P = 0.497), nuclear grade (P = 0.321), and anterior chamber depth (P = 0.635). The EPT and EFU were significantly lower in group III, compared to group II and group I, with P < 0.0001 and P < 0.0001, respectively. Postoperatively, the endothelial cell density (ECD) was significantly higher in group III at 1 month (P < 0.0001), 3 months (P < 0.0001), and 6 months (P < 0.0001). The percentages of ECD loss were also significantly lower in group III; the difference was statistically significant (P < 0.0001) up to 6 months postoperatively.Conclusion: Higher frequency ultrasound was associated with a lower EPT and EFU as well as better endothelial preservation than lower frequencies in hard cataracts. [ABSTRACT FROM AUTHOR]

Background: Vulvovaginal candidiasis is the second most common cause of vulvovaginal infections. Due to the increasing resistance to synthetic antifungal drugs, the use of drugs with a natural origin is a priority. The aim of the present study was to compare the effectiveness of Arnebia euchroma with vaginal cream clotrimazole 1% United States Pharmacopeia (USP) for the treatment of vulvovaginal candidiasis. Materials and Methods: This triple-blind trial study was performed on 112 women with diagnosed Candida vaginitis clinically and by a laboratory test, patients were randomly divided into two groups receiving Arnebia euchroma and vaginal clotrimazole (56 people per group) in clinics and medical centers Ahvaz (Iran) from April 2018 to April 2019. Clinical and laboratory symptoms were recorded at the beginning of the study and 1 week after the end of treatment by a researcher-made questionnaire. Data analysis were performed using SPSS software v-23. p < 0.05 was considered significant. Results: After the intervention, vaginal culture was negative in terms of Candida in 17 (36.17%) patients of the Amoeba euchroma group and 37 (69.81%) patients of the clotrimazole group. The Chi-square showed that there was a significant difference between the culture results in both groups (χ² = 10.10, df = 1, p = 0.001). No differences were observed between the two groups in terms of vaginal symptoms based on adjustment for age and using a logistic regression model. Conclusions: A vaginal cream containing Arnebia euchroma could reduce the complaints of vulvovaginal candidiasis. But, future studies with larger sample sizes and different dosages are recommended. [ABSTRACT FROM AUTHOR]

Background: Migraine is a prevalent health condition associated with significant pain and disability. Neurogenic inflammation has a key role in migraine pathophysiology. Curcumin is a well-known herb compound with anti-inflammatory function. This study was aimed to evaluate the effects of curcumin supplementation on clinical features, as well as on serum levels of calcitonine gene-related peptide (CGRP) and interleukin-6 (IL-6). Methods: This randomized double-blind placebo-controlled clinical trial was carried out on 44 women with migraine, receiving either 500 mg curcumin twice a day or placebo supplements for 8 weeks. Serum CGRP and IL-6 concentration, and clinical symptoms including headache severity, duration and frequency were measured at the baseline and end of study. Results: After 8-week intervention, compared with placebo, curcumin supplementation led to significand reduction in CGRP (P < 0.001), IL-6 (P = 0.041), severity (P = 0.001), and duration of headache (P = 0.007). Headache frequency showed marginal improvement in curcumin group, compared to controls (P = 0.052). Within-analysis indicated significant decrease in CGRP and severity (P < 0.001), frequency (P = 0.014) and duration (P = 0.003) and no significant decrease in IL-6 (P = 0.454), compared to baseline in curcumin group. There were no significant changes in body mass index (BMI), weight, percent body fat (PBF), and percent body muscle (PBM) between the two groups. Conclusions: Curcumin supplementation improved the pro-inflammatory markers and clinical features of migraine headaches and that could be contributed to could be to its anti-inflammatory properties. [ABSTRACT FROM AUTHOR]

Aim: To evaluate whether a novel irradiation stent (NIS) could decrease the rate of recurrent dysphagia, compared to the conventional irradiation stent (CIS) in patients with malignant dysphagia.Materials and Methods: We performed an open-label randomized controlled trial of participants with malignant dysphagia. A total of 94 participants were parallelly allocated into the NIS group or the NIS group between April 2019 and April 2020. The primary endpoint was the rate of recurrent dysphagia. The secondary endpoints included technical success, clinical success, overall survival, and adverse events.Results: The technical success rate and the clinical success rate was 100.0% (47/47) in both groups. The median follow-up period was 189 days (range 14-422 days). Recurrent dysphagia was observed in 12.8% (6/47) of patients in the NIS group and 31.9% (15/47) in the CIS group (P = 0.026). Tissue/tumor growth occurred in 4 patients (8.5%) after NIS placement and 12 (25.5%) after CIS placement (P = 0.028). Stent migration occurred in 2 patients (4.3%) after NIS placement and 3 (6.4%) after CIS placement (P = 0.646). No food obstruction was found in both groups. The median overall survival was 177 days (95% confidence interval [CI] 139-214) in the NIS group and 168 days (95% CI 153-183) in the CIS group (P = 0.932). The incidence of severe adverse events was comparable between the two groups (21.3% vs. 17.0%, P = 0.600).Conclusions: In patients with malignant dysphagia, compared with CIS, NIS could decrease the rate of tissue/tumor growth without increase the rate of stent migration and therefore decrease the rate of recurrent dysphagia. [ABSTRACT FROM AUTHOR]

Background: Chemotherapy-induced nausea and vomiting (CINV) is considered as the most common complications of chemotherapy which has a detrimental influence on the quality of life of patients with cancer. We assessed the efficacy of Apple (Malus domestica) syrup for reducing CINV. Materials and Methods: This study was a randomized, double-blind, placebo-controlled trial carried out in a Hematooncology Clinic affiliated to Mazandaran University of Medical Sciences, Sari, Iran (from October 2017 to August 2018). Subjects were randomly allocated to receive apple syrup or placebo along with their previous antiemetic treatment and chemotherapy regimen, three times a day. Thirty-four patients received apple syrup (n = 16) or placebo (n = 18). Statistical analysis was conducted using SPSS software Version 21® (SPSS Inc., Chicago, IL, USA). A P < 0.05 indicated statistical significance. Results: Both acute and delayed nausea grades were significantly lower in M. domestica syrup in comparison to placebo syrup (P = 0.001 and 0.001, respectively). The duration of nausea (P = 0.04) was lower in intervention group compared to placebo group. Conclusion: These findings demonstrated that M. domestica syrup can reduce the severity and duration of nausea in cancer patients who received chemotherapy. [ABSTRACT FROM AUTHOR]

Introduction: Chronic urticaria is common and distressing dermatosis where the search for newer agents with improved effectiveness and tolerability profile is a felt need. Bepotastine, a second-generation antihistamine, with added effect on suppression of eosinophil migration has a prospect in the management of chronic urticaria. Aims: To assess and compare effectiveness and safety of bepotastine versus levocetirizine in chronic urticaria. Materials and Methods: Single-center, investigator-blind, randomized, active-controlled, parallel-group phase IV trial (CTRI REF/2018/04/019692) conducted on adult patients of chronic urticaria of either sex. Patients were randomized into receiving either bepotastine besilate 10 mg tablet twice daily or levocetirizine 5 mg tablet once daily with fortnightly follow-up for 6 follow-up visits after thebaseline evaluation. The primary outcome measures were Urticaria Activity Score 7 (UAS7) and Urticaria Total Severity Score (TSS). Routine hematological, biochemical tests, treatment-emergent adverse events were monitored for safety. Results: Thirty patients in the bepotastine group and 29 patients in the levocetirizine group were analyzed by modified-intention-to-treat criteria. The study groups were comparable at the baseline with respect to the severity of chronic urticaria. UAS7 and TSS reduced significantly (P < 0.001, Friedman's ANOVA) in both treatment groups from 1st follow-up visit and 2nd follow-up visits (P < 0.05, Post Hoc Dunn's test) At the test-of-cure visit, UAS7 (5.13 ± 8.21 vs 7.48 ± 8.96) and TSS (5.10 ± 4.06 vs 7.07 ± 4.48) were less with bepotastine than levocetirizine although not statistically significant (P = 0.188 and 0.073, respectively, Mann–Whitney U test). Sedation during daytime was found to be significantly more (P < 0.001, Fischer's exact test) with levocetirizine than bepotastine (73.3% vs 17.2%). Conclusion: Bepotastine is comparable to levocetirizine with respect to its effectiveness with an edge in terms of side-effect (sedation during day time); thus, it offers a new therapeutic option in chronic urticaria. [ABSTRACT FROM AUTHOR]

Background: Recent studies suggest that hydrocortisone, Vitamin C, and thiamine alone or in combination may improve the clinical outcomes of patients with septic shock. The aim of this study is the effects of this combination therapy on clinical outcome and sepsis biomarkers in patients with septic shock. Materials and Methods: Fifty-eight consecutive patients suffering septic shock were randomly assigned into two groups receiving the combination therapy of hydrocortisone (50 mg/6 h, intravenously), Vitamin C (1.5 g/6 h in 100 ml normal saline or DW5%, intravenously), and thiamine (200 mg/12 h in 50 ml normal saline or DW5%, intravenously) or placebo for up to 4 days. Results: The decline in procalcitonin, lactate, and leukocyte count 72 h after the initiation of treatment was significantly greater in the intervention as compared to the control group. The intervention group has a significantly lower sequential organ failure assessment score 72 h after treatment (P < 0.001). The mean duration of vasopressor dependency was shorter in the intervention group (P = 0.039). In-hospital death occurred in 10.3% of the patients who received combination therapy and 37.9% in the control group (P = 0.014). Conclusion: The administration of the triple combination of hydrocortisone, thiamine, and Vitamin C appeared to be effective in improving the clinical outcomes of patients with septic shock and of reducing vasopressor requirements with a significant increase in the rate of improvement of sepsis biomarkers. [ABSTRACT FROM AUTHOR]

Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls. Methods: PubMed/Medline only was searched using key-word "COVID-19" and "RCTs" separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting). Results: The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively]. Conclusion: RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings. [ABSTRACT FROM AUTHOR]