Significant Difference In Adverse Effects Research Articles

Efficacy and safety of ephedra-containing oral medications: a systematic review, meta-analysis, and exploratory dose-response analysis for weight reduction.

Despite the widespread use of ephedra in various forms, including food supplements and herbal prescriptions, comprehensive studies reviewing its efficacy and safety across different countries are lacking. We systematically searched 5 electronic databases and conducted a meta-analysis of 16 randomized controlled trials (RCTs) on ephedra-containing oral medications (EOMs), performing a dose-response analysis for weight loss. The meta-analysis results revealed a statistically significant reduction in the body mass index (BMI) (MD: 1.5kg/m2; 95% CI: -2.46 to -0.54) and secondary outcomes like body weight (BW) and waist circumference (WC). The dose-response analysis indicated a correlation between ephedra and weight reduction. The safety analysis showed no significant difference in adverse effects between the treatment and control groups (RR = 0.99, 95% CI = 0.80 ∼ 1.21, and p = 0.90). In conclusion, EOMs demonstrated effectiveness in promoting weight loss, and the dose-response analysis indicated a correlation between ephedra and weight reduction. However, additional research is necessary due to the limited number of studies and inconsistent results among the assessment criteria. Moreover, if prescribed by traditional medicine physicians within the permissible daily ephedrine dosage range of 150mg set by the Food and Drug Administration (FDA) and monitored by healthcare professionals, the risk of severe adverse events is likely to be minimal. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387895, identifier CRD42023387895.

Disability and Adverse Effects of Oral Versus Long-Acting Injectable Antipsychotics in Schizophrenia-Spectrum and Bipolar Disorder: A Comparison Based on Data-Driven Taxonomy.

Patients undergoing antipsychotic treatment for psychiatric disorders may experience challenges in functioning, either stemming from the severity of the illness or from the tolerability issues of prescribed medications. The aims of this cross-sectional study are to investigate the impact of adverse effects of antipsychotic drugs on patients' daily life functioning, comparing oral and long-acting injectable (LAI) antipsychotics, and further dividing antipsychotics by receptor-binding profiles based on recently defined data-driven taxonomy. This study involved patients with schizophrenia and bipolar spectrum disorders taking oral or LAI antipsychotics. Disability and functioning levels were assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS), and the adverse effects of medications were evaluated using the Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale and its subscales. The total sample consisted of 126 participants with a diagnosis of schizophrenia-spectrum or bipolar disorder, and included 54 males and 72 females ranging from 18 to 78 years of age (mean45.1, standard deviation 14); 78 patients were taking oral antipsychotics and 48 were taking LAI antipsychotics, with subcategories of muscarinic (31), adrenergic/low dopamine (25), serotonergic/dopaminergic (23), dopaminergic (1), LAI muscarinic (15), LAI adrenergic (6), and LAI serotonergic/dopaminergic (25). The UKU total score for adverse effects showed significant correlations with WHODAS total score (ρ=0.475; p<0.001). Compared with oral antipsychotics, LAIs showed significantly lower scores in psychological (p=0.014), autonomic (p=0.008), other (p=0.004), and sexual adverse effects (p=0.008), as well as the UKU total score (p=0.002). The Kruskal-Wallis test showed a significant difference in adverse effects between LAI and oral muscarinic subgroups, with LAIs having lower scores compared with antipsychotics binding to muscarinic receptors (p=0.043). These findings indicate clinically relevant differences in adverse effects among formulations, warranting further investigation for future observational studies.

Efficacy and Safety of Allopurinol on Chronic Kidney Disease Progression: A Systematic Review and Meta-Analysis.

Hyperuricemia is associated with the progression of chronic kidney disease (CKD). Whether urate-lowering treatment with allopurinol can delay disease progression remains controversial. Relevant databases were searched. Randomized clinical trials comparing the efficacy and -safety of allopurinol in patients with CKD were selected. The primary outcomes were changes in serum uric acid concentration and estimated glomerular filtration rate (eGFR). Random-effects modeling was used to -calculate the standard mean difference (SMD) with 95% CIs. Four trials enrolling 698 participants were included. All were 2-arm parallel trials with a mean duration follow-up of 22.5 months. Congenital anomalies of the kidney and urinary tract were the most common cause of CKD in children, whereas diabetes was the leading cause of CKD in adults. Allopurinol significantly increased the eGFR compared with control groups (SMD, 2.04; 95% CI, 0.60-3.49; p = 0.005; I2 = 98.23%). Allopurinol led to a significant decrease in serum uric acid concentration compared with the control group (SMD, -5.16; 95% CI, -8.31 to -2.01; p = 0.001; I2 = 98.80%). No significant difference in adverse effects was identified between treatment and control groups. Allopurinol treatment in patients with CKD and hyperuricemia slows the decline in eGFR as compared with placebo, without risk of increased adverse effects.

A meta-analysis of recombinant human endostatin combined with NP regimen for treating non-small cell lung cancer.

The aim of this study was to evaluate the efficacy and safety of recombinant human endostatin in combination with vinorelbine + cisplatin (NPE) for the treatment of advanced non-small cell lung cancer (NSCLC). Randomized controlled trials (RCTs) of NPE for advanced NSCLC in PubMed, Cochrane Library, EMBASE, Web of Science, China National Knowledge Infrastructure, and Wanfang databases were searched using a computerized search of the database from the time of creation to May 2023. Two investigators independently extracted literature information and assessed the quality of the included literature. Meta-analysis was performed using RevMan 5.4.0 software. A total of 24 RCTs with 2114 patients with advanced NSCLC were finally included. The results of meta-analysis showed that the total effective rate in the group received NPE regimen was significantly higher than those in the group without NPE regimen (RR = 1.70, 95% CI: 1.48-1.95, P < .00001). Meanwhile, the clinical benefit rate in the group received NPE regimen was also significantly higher than those in the group without NPE regimen (RR = 1.22, 95% CI: 1.15-1.29, P < .00001). However, there was no significant difference in the incidence of adverse event rate between the 2 groups (RR = 0.98, 95% CI: 0.76-1.27, P = .88). Compared with NP (vinorelbine + cisplatin) regimens for patients with advanced NSCLC, NPE regimens improve the total effective rate and clinical benefit rate of treatment, but there can be no significant difference in adverse effects. Prospective randomized trials are needed to further validate the safety and efficacy of this treatment modality.

(108) Evaluation the Efficacy and Safety of Hyperbaric Oxygen Therapy in Sildenafil Citrate Non Responder Organic Erectile Dysfunction Patients: a Randomized Double Blinded Controlled Clinical Trial

Abstract Introduction Although the phosphodiesterase 5 inhibitors (PDE5i) are the first-line oral agents for erectile dysfunction (ED) treatment, there is growing number of PDE5i- non responder patients. Management of those patients is challenging and one of the new suggested regenerative therapies is the hyperbaric oxygen therapy (HBOT). HBOT is the application of oxygen under pressure to increase tissue oxygen levels. Few clinical reports were published about HBOT and ED. Objective To evaluate the efficacy and safety of HBOT in sildenafil citrate non- responder organic ED patients. Methods The current study included 30 sildenafil citrate non-responder ED patients. Patients were divided into two groups (randomly assigned and comparably cross-matched for age). Both patients and the investigators were blinded as regards the treatment until the end of the study. Group 1: Patients assigned to the HBOT group (20 patients) were treated with (30) sessions in 5 days/week (90 minutes of 100% oxygen at 2.2 ATA); Group 2: Patients assigned to the control group (10 patients) were exposed to (30) sessions of air oxygen tension at 1 ATA with room oxygen. Baseline laboratory investigations were done (random blood sugar, lipid profile, total &amp; free testosterone). All patients were evaluated with the sexual health inventory for men (SHIM), erection hardness score (EHS), the sexual health encounter profile (SEP), and penile color Doppler initially, at 1 &amp; 3 months after the end of treatment. Results The age mean ± SD in the HBOT group was 56.35±7.43 years and in the control group was 61.7±7.14 years. The current study showed that sildenafil citrate non-responders ED patients with 30 sessions of HBOT in 5 days/week, demonstrated a significant improvement of the total SHIM score, EHS, and SEP after 1 month of stoppage of treatment as compared to the control group. Also, penile color Doppler evaluation showed a significant improvement of 10 &amp;20 minutes peak systolic velocity (PSV) between patients receiving HBOT compared to the control after 1 month of stoppage of treatment. More interestingly, the improvement of the total SHIM score, EHS, and SEP continued after 3 months of stoppage of the HBOT treatment as compared to the baseline evaluation. In addition, 10 &amp;20 minutes PSV with penile color Doppler evaluation demonstrated maintained improvement after 3 months of stoppage of the HBOT treatment as compared to the baseline evaluation. In addition, the linear regression analysis was done for factors affecting SHIM score improvement (1 month/baseline) in the HBOT treatment group, revealing that hypertension was an independent predictor for SHIM score improvement. Hypertensive patients showed 4.6 times more SHIM score improvement as compared to non-hypertensive patients. As regards HBOT safety, there was no significant difference in adverse effects between the HBOT treatment group and the control group. Conclusions HBOT might be a potential therapeutic modality for sildenafil citrate non-responder ED patients especially in hypertensive patients with good safety profile. Further a multi-centric trial with a larger sample size and a longer follow-up period is recommended. Disclosure No.

Comparison of the efficacy of steroid-free versus classic steroid-containing regimens in primary membranous nephropathy.

Objective: To compare the efficacy of a steroid-free regimen with steroid-based treatment in managing primary membranous nephropathy (PMN) and investigate the potential benefits of steroid-free regimens in PMN therapy. Methods: This was a single-centre prospective cohort study. A total of 81 patients were divided into two groups according to their medication regimen: a rituximab (RTX)/tacrolimus (TAC) group (low-dose RTX combined with low-dose TAC group, without steroids, n = 31) and a prednisone (P)/TAC group (P combined with TAC group, n = 61). The changes in 24-h urine protein quantification, levels of blood albumin, blood creatinine, total cholesterol, triglyceride and fasting blood glucose as well as anti-phospholipase A2 receptor antibody titres were observed in both groups before treatment and after 1, 3, 6 and 12months of treatment. Clinical remission (complete and partial remission), serological remission and recurrence were assessed in both groups after treatment, and the occurrence of adverse reactions was observed. Results: 1) Before treatment, there was no significant difference in baseline values between the two groups (p > 0.05). 2) After 12months of treatment, the 24-h proteinuria and total cholesterol levels in the RTX/TAC group were significantly lower than those in the P/TAC group (p < 0.05). 3) After 6months of treatment, the clinical remission rate of the RTX/TAC group was significantly higher than that of the P/TAC group (p < 0.05). After 12months of treatment, the clinical remission rate of the RTX/TAC group was significantly higher than that of the P/TAC group (p < 0.05). (4) After 3, 6 and 12months of treatment, serological remission rates in the RTX/TAC group were significantly higher than those in the P/TAC group (p < 0.05). During treatment, the anti-PLA2R antibody titres in the RTX/TAC group remained lower than those in the P/TAC group (p < 0.05). Conclusion: The low-dose RTX combined with low-dose TAC steroid-free regimen induces serological remission in patients with PMN earlier than the classic regimen of P combined with TAC, and there was no significant difference in adverse effects between the two groups. Besides, the long-term clinical remission effect of low-dose RTX combined with low-dose TAC is better than that of P combined with TAC.

Effectiveness and safety of acupuncture in treatment of pregnancy-related symptoms: a systematic review and Meta-analysis.

To systematically evaluate the efficacy and safety of acupuncture (AM) in the treatment of pregnancy-related symptoms such as acute vomiting during pregnancy. We comprehensively searched the available literature up to November 2021, including PubMed, Embase, Cochrane Library, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure Database, for randomized controlled trials (RCTs) on AM for the treatment of severe vomiting, insomnia, pharyngeal and pelvic pain, mood abnormalities, and dyspepsia during pregnancy. Sixteen RCTs with a cumulative sample size of 1178 cases were included. Of these, 964 patients were included in the Meta-analysis. The Meta-analysis results showed that AM was more efficient than Western medicine in treating discomfort during pregnancy [odds ratio (OR) = 1.19, 95% confidence interval (CI) (1.11, 1.28), P < 0.01]. AM was better than the control group in improving the visual analog scale scores [standard mean difference (SMD) = 0.62, 95% CI(0.53, 0.71), P < 0.01]. AM was superior to the control group in improving Numerical Rating Scale (NRS) symptom scores [OR = 7.31, 95% CI(3.36, 15.94), P < 0.01]. There was no significant difference in adverse effects between the AM and sham-AM groups and the analgesic drug group [OR = 0.70, 95% CI(0.39, 1.28), P = 0.25], but the treatment and control groups had mild adverse effects with a low incidence. AM is more effective than other treatments or pharmacotherapy alone in the treatment of pregnancy-related symptoms, and is relatively safe. However, the quality of the included trials was rather poor, and high-quality studies are required to confirm our findings.

Comparison of efficacy of nalbuphine-levobupivacaine combination with levobupivacaine alone in ultrasound-guided supraclavicular brachial plexus block in upper limb orthopedic surgeries

Abstract Background and Aims: Brachial plexus block is a widely used approach for upper limb surgeries as an alternative to general anesthesia to achieve ideal operating conditions by providing adequate muscle relaxation and maintaining intraoperative hemodynamic stability. Ultrasound-guided supraclavicular brachial plexus block provides intraoperative anesthesia and postoperative analgesia. It reduces many complications such as intravascular injection pneumothorax. Levobupivacaine is preferable over bupivacaine due to its lower cardiotoxicity, prolonged sensory block, and shorter duration of motor block. Materials and Methods: A prospective, hospital-based, double-blinded, randomized, controlled, comparative study was planned on 80 adult patients of either sex belonging to the American Society of Anesthesiologists Class 1 and 2 undergoing upper limb orthopedic surgeries. Group L – 24 mL levobupivacaine 0.375% (90 mg) + NS (1 mL) (total volume 25 mL) and Group LN – 24 mL levobupivacaine 0.375% (90 mg) +5 mg nalbuphine diluted with NS to 1 mL volume (total volume 25 mL). Duration of analgesia, onset, and duration of sensory block and motor block, hemodynamic changes, and total doses of rescue analgesia in 24 h were noted in both groups. Results: The duration of analgesia was significantly longer in Group LN (749.80 ± 9.70 min) as compared to Group L (641.20 ± 12.71 min) (P &lt; 0.001). Onset of sensory block in Group LN (11.15 ± 0.83 min) is faster than in Group L is (13.30 ± 0.52 min) (P &lt; 0.001). Onset of motor block in Group LN (13.68 ± 0.73 min) is faster than in Group L (16.33 ± 0.89 min) (P &lt; 0.001). Hemodynamic parameters were comparable in both groups. There was no significant difference in adverse effects and complications. Conclusion: The addition of nalbuphine to levobupivacaine provides a longer duration of analgesia as compared to levobupivacaine alone.

Efficacy and safety of vericiguat in heart failure: a meta-analysis.

This study aimed to investigate the safety and efficacy of vericiguat in patients with heart failure (HF). We conducted a comprehensive literature review of the PubMed, Embase, and Cochrane Library databases up to 14 December 2022 for studies comparing vericiguat with placebo in patients with HF. Clinical data were extracted and cardiovascular deaths, adverse effects, and HF-related hospitalization were analyzed using Review Manager software (version 5.3), after quality assessment of the enrolled studies. Four studies (6705 patients) were included in this meta-analysis. There were no significant differences in the basic characteristics of the included studies. There was no significant difference in adverse effects between the vericiguat group and placebo group, and no significant differences between the groups in terms of cardiovascular death and HF hospitalization. This meta-analysis indicated that vericiguat was not an effective drug for HF; however, more clinical trials are required to verify its efficacy.

Safety and Efficacy of Lactobacillus rhamnosus GG (ATCC 53103) in Children with Functional Abdominal Pain: A Randomised, Doubleblinded, Placebo-controlled Trial

Introduction: Functional Abdominal Pain (FAP) is a major concern in developing countries, especially in school-going children. Recently, some probiotics have shown clinical evidence in managing abdominal diseases. The role of Lactobacillus rhamnosus GG (LGG) (ATCC 53103) for FAP in children has not been studied in India. Aim: To evaluate the safety and efficacy of LGG (ATCC 53103) in children with FAP in terms of frequency, severity, and adverse effects. Materials and Methods: This double-blinded, placebocontrolled study was conducted at Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India, from February 2021 to July 2022, after obtaining permission from the Institutional Ethical Committee (IEC). Children aged 5-18 years with FAP were included in the study. A total of 82 children were included in the study and were randomised into the LGG group and placebo group. The LGG group received LGG (ATCC 53103), and the placebo group received sugar powder for a period of four weeks. These patients were followed-up after 2, 4, and 8 weeks for evaluation. Student’s t-test (unpaired) was used for quantitative data, and Chi-square test was used for qualitative data. Statistical Package for the Social Sciences (SPSS) PC-20.0 version was used to evaluate the data. Results: Out of 82 children, a total of 77 children were enrolled during the study period, with 38 in the LGG group and 39 in the placebo group. The severity of abdominal pain at four weeks and eight weeks was significantly less compared to placebo (p-value=0.009 and p-value=0.01, respectively). The frequency of abdominal pain at four weeks and eight weeks was also significantly less compared to placebo (p-value ≤0.001 and p-value≤0.001, respectively). There was no statistically significant difference in adverse effects between the two groups (p-value =0.115). Conclusion: This study concluded that LGG decreases both the severity and frequency of abdominal pain in children aged 5-18 years without any significant side-effects. Thus, it can be safely used in the management of childhood FAP.

ERECTOR SPINAE PLANE BLOCK CATHETER: A GOAL STANDARD FOR THORACIC ANAESTHESIA?

<h3>Background</h3> Recent advances in Enhanced Recovery post Thoracic surgery has introduced various fascial plane blocking techniques that block dorsal, lateral, and anterior cutaneous nerves of the thorax and abdomen. Erector spinae plane (ESP) block is a relatively novel truncal nerve plane block increasing used in thoracic analgesia. Blockage of dorsal and ventral rami of the thoracic nerves allows for effective pain management post open thoracotomies and video assisted thoracic surgery. Due to limitation by duration of action of single shot nerve blocks,(paravertebral and ESP block), continuous pain relief using catheters have been widely used with good patient outcome. <h3>Method</h3> Patients undergoing elective and urgent thoracic surgeries under general anaesthesia in a single thoracic and trauma unit in the United Kingdom were appropriately selected based on comorbidities, performance status, and indication plus duration of thoracic surgery. Retrospective data on single shot nerve block injections and patient-controlled analgesia (PCA) use was collected for fifty patients. Prospectively, ESP catheter was inserted in fifty patients by consultant anaesthetist or thoracic surgeon pre procedure and post routine intraoperative anaesthesia care and multimodal analgesia. We compared total opioid consumption, postoperative pain scores (visual analog scale), mobility with physiotherapy, complications, and length of stay. <h3>Results</h3> Forty patients were included in both groups. Five cases were removed due to incomplete data. Total opioid consumption over 24 hours and 48 hours was measured. Total opiod consumption was significantly low in patients receiving continuous ESP catheters. Pain score was lower in the recovery and post operative ward in patients with ESP catheters. Pain nurse review in ESP catheter group day 1 postoperatively allowed for better optimisation of analgesia, improved adherence to documentation of acute pain observation chart. ESP catheter did not affect physiotherapy care and patients completed 100m in less than 48 hours. There was no statistically significant difference in adverse effects between single shot vs catheter patients, however, increased PCA use in single shot blocks contributed to post operative drowsiness and nausea in five patients. <h3>Conclusion</h3> ESP catheter has shown to provide safe and effective analgesia post thoracic surgery while decreasing opioid consumption. We could demonstrate a significant improvement in patient outcome, with the ESP catheters when compared to single shot blocks. Early physiotherapy and good analgesics provided early mobilization and less days in hospital stay and reduced complications. On account of technical ease and low procedural risk of ESP block under ultrasound guidance, it is favorable for use in thoracic surgery compared to more invasive nerve blocks. More education, compliance and multimodal care is required to utilize ESP catheter for successful postoperative pain management.

Selective serotonin reuptake inhibitors combined with traditional Chinese medicine for premature ejaculation: A systematic review and meta-analysis.

Premature ejaculation (PE) is still a tough problem in drug treatment. Many clinical trials have proven that traditional Chinese medicine (TCM) has a significant effect in the treatment of PE. This article aims to provide the latest evidence for the efficacy and safety of TCM combined with selective serotonin reuptake inhibitors (SSRIs) in the treatment of PE. We looked for randomized controlled trials (RCTs) from China National Knowledge Infrastructure, Wanfang, VIP Database, MEDLINE, PubMed, Web of Science, EMBASE, and Cochrane Library until June 30, 2022. STATA 15.1 software was used to analyze all data for this article. The quality of the included articles was evaluated using the Cochrane Reviewer's Handbook 5.3. Finally, we selected 16 high-quality RCTs in our meta-analysis, which containing 889 patients. Meta-analysis suggested that, compared with SSRIs alone, combination of TCM with SSRIs increased significantly intravaginal ejaculation latencv time and the scores of ejaculation control ability, sexual life satisfaction, PE-related distress, and communication difficulties between partners related to PE. Also, there was no significant difference in adverse effects between the two groups. In addition, the results of publication bias test showed that no significant bias occurred. The combined use of TCM and SSRIs has significant effect in the treatment of PE compared with SSRIs monotherapy and was generally well tolerated. Due to the small sample size, multicenter and large sample RCT is still needed in the future to further confirm the effectiveness and safety of TCM combined with SSRIs in the treatment of PE.

Same-day single-dose vs large-volume split-dose regimens of polyethylene glycol for bowel preparation: A systematic review and meta-analysis.

BACKGROUNDSplit-dose regimens (SpDs) of 4 L of polyethylene glycol (PEG) have been established as the “gold standard” for bowel preparation; however, its use is limited by the large volumes of fluids required and sleep disturbance associated with night doses. Meanwhile, the same-day single-dose regimens (SSDs) of PEG has been recommended as an alternative; however, its superiority compared to other regimens is a matter of debate.AIMTo compare the efficacy and tolerability between SSDs and large-volume SpDs PEG for bowel preparation.METHODSWe searched MEDLINE/PubMed, the Cochrane Library, RCA, EMBASE and Science Citation Index Expanded for randomized trials comparing (2 L/4 L) SSDs to large-volume (4 L/3 L) SpDs PEG-based regimens, regardless of adjuvant laxative use. The pooled analysis of relative risk ratio and mean difference was calculated for bowel cleanliness, sleep disturbance, willingness to repeat the procedure using the same preparation and adverse effects. A random effects model or fixed-effects model was chosen based on heterogeneity analysis among studies.RESULTSA total of 18 studies were included. There was no statistically significant difference of adequate bowel preparation (relative risk = 0.97; 95%CI: 0.92-1.02) (14 trials), right colon Boston Bowel Preparation Scale (mean difference = 0.00; 95%CI: -0.04, 0.03) (9 trials) and right colon Ottawa Bowel Preparation Scale (mean difference = 0.04; 95%CI: -0.27, 0.34) (5 trials) between (2 L/4 L) SSDs and large-volume (4 L/3 L) SpDs, regardless of adjuvant laxative use. The pooled analysis favored the use of SSDs with less sleep disturbance (relative risk = 0.52; 95%CI: 0.40, 0.68) and lower incidence of abdominal pain (relative risk = 0.75; 95%CI: 0.62, 0.90). During subgroup analysis, patients that received low-volume (2 L) SSDs showed more willingness to repeat the procedure using the same preparation than SpDs (P < 0.05). No significant difference in adverse effects, including nausea, vomiting and bloating, was found between the two arms (P > 0.05).CONCLUSIONRegardless of adjuvant laxative use, the (2 L/4 L) SSD PEG-based arm was considered equal or better than the large-volume (≥ 3 L) SpDs PEG regimen in terms of bowel cleanliness and tolerability. Patients that received low-volume (2 L) SSDs showed more willingness to repeat the procedure using the same preparation due to the low-volume fluid requirement and less sleep disturbance.

Efficacy of melatonin for febrile seizure prevention: A clinical trial study

Background: Prophylactic treatment for recurrence of febrile seizure generally consists of intermittent administration of diazepam or clobazam, or long-term treatment with valproic acid or phenobarbital. However, the adverse effects outweigh the benefits. A newer, effective, more tolerable drug treatment is warranted.Objective: To study melatonin efficacy in prevention of recurrence of one or more episodes of either simple or complex febrile seizure compared to a control group.Methods: A quasi-experimental study in children who were diagnosed with febrile seizure in Bhumibol Adulyadej Hospital, between 6 months to 5 years old, divided into two groups, melatonin group and control group, depending upon parental convenience. Melatonin was given 0.3 mg/kg/dose every 8 hours for 48 to 72 hours during febrile illness to melatonin group if body temperature was more than 37.5°C. Control group had no medicine. Patients were followed at 3 and 6 months.Results: The study included 23 patients in the melatonin group and 41 in the control group. Mean age of diagnosed of febrile seizure onset was 17.3 and 21.6 months, respectively. In the melatonin group, 8.7% of patients had recurrent febrile seizure compared to 36.6% in the control group, which is statistically significant (P-value 0.015, RD −0.28(95%CI: −0.46 to −0.09)). There was no statistically significant difference in adverse effects between the two groups.Conclusion: This study demonstrates the efficacy and safety of short-term melatonin use to prevent the recurrence of one or more episodes of either simple or complex-febrile seizure in children.

Comparison of inhaled salbutamol and intravenous furosemide in the treatment of transient tachypnea of the newborn regarding their safety and efficacy

Background Postnatal respiratory complications among term infants are common. The most commonly reported cause of neonatal respiratory distress is transient tachypnea of the newborn (TTN), with an estimated incidence of 0.5–2.8% of all newborns. Aim To evaluate and compare the efficacy and safety of inhaled salbutamol and intravenous (i.v.) furosemide in the treatment of TTN and to monitor of their possible adverse effects in neonates. Patients and methods This was a randomized controlled clinical trial on 100 neonates who were admitted immediately or shortly after birth owing to persistence of tachypnea to neonatal intensive care unit of pediatric hospitals, Cairo University, over a 1-year period. Our study included 100 neonates (25 in the salbutamol group, 25 in the furosemide group, and 50 in the control group) with TTN born between 35 and 39 weeks of gestational age. They were randomized in a blinded manner to receive one nebulized dose of salbutamol 0.15 mg/kg in 0.9% saline solution or i.v. furosemide 1 mg/kg once in addition to oxygen and i.v. fluids or received oxygen and i.v. fluids alone. Results The efficacy of inhaled salbutamol and furosemide was assessed by determining the respiratory rate, heart rate, TTN clinical score, and the level of respiratory support before receiving medication and 30 min, 1, and 4 h after drug therapy. The duration and level of respiratory support and the period of hospitalization were shorter in the salbutamol group. There was a significant decrease in the respiratory rate and TTN score in the salbutamol group 4 h after nebulized salbutamol. Conclusion Comparing the three groups after respiratory support, TTN score was significantly improved in the salbutamol group. The total duration of oxygen treatment in hours and total neonatal intensive care unit stay in days were significantly shorter in the salbutamol group than in furosemide and control groups. Regarding the safety of salbutamol, our study did not show a significant difference in adverse effects. Inhaled salbutamol treatment was effective in TTN without adverse events. Further studies at larger or repeated doses of furosemide may be needed.

Effectiveness of Partially Hydrolyzed Guar Gum in Reducing Constipation in Long Term Care Facility Residents: A Randomized Single-Blinded Placebo-Controlled Trial.

To assess the effectiveness of partially hydrolyzed guar gum (PHGG) in improving constipation and reducing the use of laxatives among long term care facility (LTCF) residents. A single-center, prospective, randomized, placebo-controlled, single-blinded parallel-group trial from September 2021 to November 2021. Four LTCF in Hong Kong. Fifty-two LTCF residents with chronic constipation (mean age: 83.9±7.6 years, male 38%). 5g PHGG mixed with 200ml water per day for 4 weeks was given to intervention group participants. Control group received 200ml water for 4 weeks. Participants continued their usual as-needed laxative (lactulose, senna or dulcolax) on their own initiative. Baseline measurements included age, gender, Charlson comorbidity index, Roackwood's Clinical Frailty Scale, body mass index and daily dietary fiber intake. Outcome measures were fecal characteristics assessed by Bristol Stool Form Scale, bowel opening frequency and laxative use frequency at baseline, first, second, third and fourth week of trial. Adverse events were measured. The study was registered on ClinicalTrial.gov; identifier: NCT05037565. There was no significant difference in bowel frequency and stool characteristics between the treatment group and control group. However, there was a significantly lower frequency of lactulose, senna, and total laxative use in the treatment group compared with controls in the third and fourth week. There was no significant difference in adverse effects between the two groups. This study showed that daily dietary fibre supplementation by using PHGG for 4 weeks in LTCF residents results in significantly less laxative use than placebo. It may be an effective way to reduce laxative dependence among older people living in LTCFs.

Peripheral Neuropathy Patients and the Effectiveness of Crocin of Saffron (Crocus Sativus L.)

Cancer patients treated with chemotherapeutic drugs often suffer from Chemotherapy-induced peripheral neuropathy (CIPN). In animal models, peripheral neuropathy has been diminished by the use of Saffron. A previous clinical trial has demonstrated that Saffron has the ability to relieve pain in patients suffering from fibromyalgia. Bozorgi and colleagues have for the very first time, studied the potential analgesic properties of an important constituent of Saffron- Crocin. Between December 2018 and March 2020, a total of 177 eligible patients suffering from mild to moderate CIPN for at least a month were recruited for the trial. The patients were categorized into two main groups: Placebo tablet and Crocin 15 mg tablet twice a day for a duration of 8 weeks. A crossover study design with a washout period of 2 weeks was adopted. Their study revealed that a significant decline in neuropathic, sensory, and motor pain was observed in the Crocin group vs the placebo group. Only mild toxicity and no significant difference in adverse effects were seen between the two groups. The authors argue that Crocin does have the ability to substantially reduced CIPN in cancer patients undergoing chemotherapy. Nonetheless, the authors also suggest further investigations, especially compared to Lamotrigine, gabapentin, and antidepressants. J Ethnopharmacol. 2021 Dec 5;281:114511.

Effectiveness and adverse effects of anakinra in treatment of rheumatoid arthritis: a systematic review.

Rheumatoid arthritis (RA) can be described as a chronic, inflammatory, progressive, autoimmune disorder characterized by generalized inflammation of the synovial joints, which hereby triggers the progressive erosion of both cartilage and bone. Anakinra is a recombinant form of human IL-1 receptor antagonist which targets the type I IL-1 receptor. In the present systematic review, we intend to evaluate the effectiveness and adverse effects of interleukin-1 antagonists in the treatment of rheumatoid arthritis. The database search was carried out using PubMed (Medline), Web of Science (Clarivate), Embase, Scopus, and Cochrane Library for the existing studies. A total of 3912 relevant articles were identified as per the search strategy. Out of them, 854 duplicate records and further 3024 records were excluded after going through their titles and abstracts. Further, out of 42 articles left, we excluded 32 more articles matching our inclusion criteria and excluding the reviews and case studies. Finally, we included 10 relevant studies that focused on both the effectiveness and adverse effects of interleukin-1 antagonists during the treatment of adult patients with rheumatoid arthritis in the present analysis. Nine out of 10 included studies are randomized trials (RCT) except for 1 study, which was an extension study. The results showed an ACR20 response at week 12 and were the most common primary outcome measure in the present review. Various secondary outcome measures studied were changed from baseline at week 24 in individual ACR components. ACR50 and ACR70 responses at subsequent weeks (12 and 24), ESR components, HAQ score, CRP levels, and ESR. Notably, more improvement was observed with anakinra in comparison to placebo for achieving ACR50 and ACR70 responses at 24 weeks. Premature withdrawal of participants was observed in almost all the studies. Adverse drug reactions were attributed to be the most common reason followed by loss of efficacy for withdrawal of patients from the treatment. The infectious episode was another common adverse effect observed in both anakinra and placebo groups. Some malignancies were also documented in the included researches of this systematic analysis. We observed a lower overall incidence of malignancies for the studies screened compared with that of the general population. This review demonstrated that anakinra is safe, effective, and well-tolerated, with no significant difference in adverse effects compared to placebo in rheumatoid arthritis patients.

Prevalence, risk factors, and management practices of primary dysmenorrhea among young females

BackgroundPrimary dysmenorrhea (PD) is one of the most common gynecological conditions among young females, which has a significant negative impact on health-related quality of life and productivity. Despite its high prevalence, the evidence is limited regarding the management-seeking practices and its perceived effectiveness among females with PD.MethodsThis is a cross-sectional study conducted among 550 female students in six universities across Lebanon. The prevalence of PD, associated risk factors, and management-seeking practices were assessed using a self-administered questionnaire.ResultsThe prevalence of PD was 80.9%. Most of the females with PD described their menstrual pain as moderate (56%) to severe (34.6%), which significantly affected their daily activities and studying ability (P < 0.001). The major risk factors associated with PD included heavy menstrual flow (adjusted odds ratio [AOR] = 10.28), family history of PD (AOR = 2.52), history of weight loss attempt (AOR = 2.05), and medical specialization (AOR = 1.663). Only 36.9% of females with PD sought formal medical advice. Most dysmenorrheic females (76.4%) received medications for the management of PD, and remarkably none of them took hormonal contraceptives. Drugs commonly used for PD were mefenamic acid (26.2%), ibuprofen (25%), and paracetamol (11.5%), which were administered when the pain started (58.2%). All medications were significantly effective in reducing the pain score (P = 0.001), and most NSAIDs were more potent than paracetamol in managing PD (P = 0.001). However, no significant difference in adverse effects among medications was revealed. Moreover, no superiority of any individual NSAID for pain relief was established. Nevertheless, mefenamic acid was associated with the lowest risk of abdominal pain (OR: 0.03, P = 0.005) and the highest risk of flank pain (OR = 12, P = 0.02).ConclusionsSuboptimal management of PD is practiced among university students in Lebanon. Therefore, health care providers should educate dysmenorrheic females to optimize the self-management support of PD. Furthermore, future research is required to investigate females’ misconceptions about hormonal contraceptives in the management of PD, aiming to raise awareness and correct misconceptions.

Role of lactulose for prophylaxis against hepatic encephalopathy in cirrhotic patients with upper gastrointestinal bleeding: A randomized trial.

We aimed toassess the efficacy of lactulose as prophylaxis against hepatic encephalopathy (HE) in cirrhotic patients with acute upper gastrointestinal bleeding (AUGIB). We conducted a randomized, double-blinded, placebo-controlled, multicenter study from October 2012 to February 2014. Cirrhotic patients presenting with AUGIB (aged 18-80years, without HE at the time of admission) were enrolled and randomized to receive blinded medications (both physically indistinguishable), labeled "Lactulose A" and "Lactulose B" for 5days along with standard treatment depending on the type of bleeding (variceal and nonvariceal). The primary endpoint was the development of overt HE according to the West-Haven criteria. Modified intention-to-treat analysis was performed. Forty-six patients completed the protocol: Lactulose A (placebo, n= 22) and Lactulose B (lactulose, n= 24). There was no significant difference in baseline characteristics and clinical outcomes between the two groups. Nine (19.6%) patients developed HE: five (22.7%) in the placebo group and four (16.7%) in the lactulose group (p= 0.718). One patient (2.2%) died inlactulose group. All patients tolerated the medication and no significant difference in adverse effects was detected (59.1% inplacebo vs. 50.0% inlactulosegroup, p= 0.536). On multivariate analysis, increased baselineChild-Turcotte-Pugh (CTP) score (odds ratio [OR] 2.176; 95% confidence interval [CI] 1.012-4.681, p= 0.047) and presence of diarrhea (OR 16.261; 95% CI 1.395-189.608, p= 0.026) were independent risk factors for the development of HE. Five-day lactulose is ineffective as prophylaxis against HE in cirrhotic patients with AUGIB. Unnecessarytreatment with laxatives should be avoided in these patients. Clinical trial registry number TCTR20200526003 (retrospectively registered).