Global Symptom Score Research Articles

Prospective Controlled Study of Endoscopic Botulinum Toxin Injection for Retrograde Cricopharyngeus Dysfunction: The Inability to Belch Syndrome.

Complete inability to belch due to retrograde cricopharyngeus dysfunction (R-CPD) may lead to chronic gas-related gastrointestinal complaints. We aimed to validate high-resolution manometric (HRM) diagnostic criteria and prospectively evaluate the feasibility and efficacy of cricopharyngeal botulinum toxin injection (CBTI) by flexible endoscopy. Consecutive manometrically diagnosed patients with R-CPD were included. Asymptomatic volunteers were also included for diagnostic validation. Patients with R-CPD underwent CBTI (treatment group) or deferred/declined treatment (control group). Outcomes included ability to belch, clinical symptoms, and quality of life measured using self-report questionnaires. Sixty-five subjects were included (52 treatment group, 7 controls, and 6 asymptomatic volunteers). All patients with R-CPD had inability to belch since childhood. During HRM with carbonated drink provocative testing, all R-CPD patients demonstrated characteristic esophageal pressurization patterns associated with failure of upper esophageal sphincter relaxation; these findings were never seen in asymptomatic volunteers. At 3 months, 92% patients who received CBTI were able to belch (compared with 0 controls; P < 0.001) and experienced improved clinical symptoms (global symptom score improved from 7.3 ± 1.7 to 1.8 ± 2.3, whereas in controls was static 7.5 ± 2.1 to 7.7 ± 1.8; P < 0.0001 for comparison). Quality of life significantly improved in the treatment group but not controls ( P = 0.0002). At 3 months, 43/51 (84%) of the treatment group reported being satisfied or very satisfied with therapeutic outcome. HRM with carbonated drink provocation demonstrates pathognomonic signs of R-CPD that were not seen in health. Flexible endoscopic CBTI is highly effective for symptomatic relief compared with no treatment.

Evaluation of Add-On Individualized Homeopathic Medicines Products in the Treatment of Symptomatic COVID-19 Managed at Home: A Double Blind, Placebo-Controlled, Randomized, Exploratory Clinical Trial

Homeopathy has shown promise in fighting epidemics, leading to potential applications in the COVID-19 clinical cases. To assess the impact of add-on individualized homeopathic medicinal products (IHMP) in improving clinical outcomes and time to medical discharge in COVID-19 patients. A prospective, double-blind, randomized, placebo-controlled, parallel-group exploratory clinical trial was conducted in a São Paulo state municipality, Brazil, between February and July 2021. 82 (unvaccinated) patients with confirmed SARS-CoV-2 infection and manageable mild to moderate COVID-19 symptoms were randomly assigned to placebo or IHMP groups. Utilizing unique global COVID-19 symptom scores, a symptom assessment was performed. Statistical analysis involved 68 patients (36 IHMP; 32 placebo). No significant initial disparity existed in total COVID-19 symptom scores between the groups. The IHMP group exhibited a significantly shorter mean time from initial appointment to medical discharge compared to placebo (p &lt; 0.05: IHMP 74.5 hours (+/- 57.47, 95% CI: 55.73-93.27); placebo 137.42 hours (+/- 87.85, 95% CI: 106.98-167.86)). Employing the chi-square trend test at selected time points (74.5 and 137.42 hours, corresponding to mean discharge times), COVID-19 scores demonstrated sustained IHMP-associated reductions (p &lt; 0.05). COVID-19 symptom scores and time to medical discharge were significantly reduced by treatment with IHMP compared to placebo, suggesting a potential role for IHMP in managing mild to moderate COVID-19 symptoms at home.

Short and long-term effect of polycarbophil vaginal gel on vaginal atrophy of peri- and post-menopausal women. The TRIPLE study

This TRIPLE study was aimed to evaluate the efficacy of polycarbophil vaginal gel (PCV) in treating symptoms of vaginal atrophy (VA) of peri- and post-menopausal women. Sexually active women in peri- (n=29) and post-menopause (n=54) suffering from VA, were progressively enrolled and treated for 30days with PCV. Those wishing to continue (n=73) were treated for additional 180days. PCV was administered as one application twice a week. The vaginal health index (VHI; range 5 to 25) and the visual analogue score (VAS range for 0 to 100mm for each item) for vaginal dryness, irritation, and pain at intercourse, along with the global symptoms score (GSS; range 1 to 15) and treatment safety, were evaluated at baseline and after 30days. In those continuing the treatment an evaluation was performed after additional 180days. Women in peri and post-menopause were of 48.7±3.3years and 57.5±5.7years old., respectively. At baseline all outcomes were significantly worse (p<0.002) in postmenopausal group, except the VHI (p<0.056). After 30days VHI increased (p<0.001) of 4.1±0.5 (mean±SE), and 5.1±0.4 in peri- and post-menopausal women respectively. VAS of vaginal dryness decreased (p<0.001) of -24.4±3.6, and -52.7±2.6 (p<0.001), VAS of irritation decreased (p<0.001) of -18.6±4.4 and -47.8±3.2, VAS of pain decreased (p<0.001) of -26.2±4.3 and -55.6±3.1 and the GSS decreased (p<0.001) of -3.9±0.3, and -4.9±0.2, in peri and post-menopausal women, respectively. All the modifications were significantly greater (p<0.001)(p<0.032 for GSS) in postmenopausal women, and after 30days all outcomes were similar in the two groups of women. In comparison to baseline, after 210days of treatment VHI increased of 7.7±0.3 (p<0.001), VAS of vaginal dryness decreased of -53.6±1.9 (p<0.001) VAS of irritation of -42.6±1.4 (p<0.001) VAS of pain of -46.7±2.3 (p<0.001) and the GSS of -6.5±0.2±0.2 (p<0.001). All outcomes improved (p<0.001) over the values observed after 30days of treatment (p<0.001). No side effect was reported. In peri- and post-menopausal women PCV administration rapidly improves VA symptoms, and its prolongation up to 6months further increases its efficacy.

Relationships between the global symptom score and electrophysiological findings after surgical release for carpal tunnel syndrome: Indications and outcomes.

Regarding surgical indications for carpal tunnel syndrome (CTS), the hypothesis that the recovery processes of subjective symptoms differ among pain, sensory, and motor symptoms and correlate with recovery in objective nerve conduction studies was examined in the present study. The global symptom score (GSS) is a method used to assess clinical outcomes and covers subjective symptoms, including pain (pain and nocturnal awakening), sensory (numbness and paresthesia), and motor (weakness/clumsiness) symptoms. The relationships between long-term changes in GSS and recovery in nerve conduction studies were investigated. Forty patients (40 hands) were included (mean age 65years; 80% female; 68% with moderate CTS: sensory nerve conduction velocity < 45m/s and motor nerve distal latency > 4.5ms). Pain and nocturnal awakening rapidly subsided within 1month after surgery and did not recur in the long term (median 5.6years). Paresthesia significantly decreased 3months after surgery and in the long term thereafter. Weakness/clumsiness significantly decreased at 1year. Sensory nerve distal latency, conduction velocity, and amplitude significantly improved 3months and 1year after surgery, and correlated with nocturnal awakening in the short term (3months) in moderate CTS cases. The patient satisfaction rate was 91%. Rapid recovery was observed in pain and nocturnal awakening, of which nocturnal awakening correlated with the recovery of sensory nerve conduction velocity. Patients with pain symptoms due to moderate CTS may benefit from surgical release.

Quality of Life in Patients Undergoing Emergency Surgery for Complex Colorectal Cancer: Protocol and Piloting of the Surgical Utilization and Recovery Patterns for Advanced Stage Colorectal Cancer Study.

Introduction: Globally, cancer is the leading cause of mortality, with colorectal neoplasia ranking third in terms of incidence and mortality worldwide. Patients face disease- and treatment-specific impacts, which can significantly influence their quality of life (QoL). Aim: This study aimed to propose a protocol to measure in-hospital and long-term QoL in patients with complicated colorectal cancer (CRC). Material and Methods: multicenter prospective observational cohort study. Results: QoL is a multidimensional concept that includes criteria for physical, mental, emotional, and social functionality as perceived by the patient. Periodically evaluating QoL offers measurable and objective tools to intervene at the appropriate time to decrease the Years of Life Lost and Years Lived with Disabilities for CRC patients. However, a structured and functional system requires dedicated and common institutional effort. A pilot study using this protocol included 69 patients, 65.12+-10.92 years, M:F ratio = 56.5:43.5%. Surgical procedure was right hemicolectomy, left colectomy, transverse colectomy, sigmoidectomy, total colectomy, rectal resection, and colorectal resection with stoma (ileostomy or colostomy) in 21.7%, 11.6%, 2.9%, 11.6%, 1.4%, 23.2%, and 27.5% of the cases, respectively. The mean Global Health Status Score, Symptom Score, and Functional Score was 82.36+-18.60, 11.89+-10.27, and 86.27, 74.50-94.11, respectively. Conclusions: CRC diagnosis has major effects on patients physical and psychological status, and concentrated efforts should be made by the involved medical team and healthcare systems to improve QoL throughout the treatment pathway.

Efficacy and safety of probiotics in irritable bowel syndrome: A systematic review and meta-analysis

Irritable bowel syndrome (IBS) is a common gastrointestinal disease characterized by abdominal pain, distension, and altered bowel habits. Probiotics may alleviate IBS symptoms, but clinical trials remain conflicting. To conduct a systematic review and meta-analysis of clinical trials to evaluate the efficacy and safety of probiotics for IBS patients. We searched relevant trials in PubMed, Web of Science, Embase, Cochrane Library, and Google Scholar from 2000 to June 2023. Standardized mean difference (SMD) and 95% confidence interval (CI) were calculated for continuous outcomes. A risk ratio (RR) and a 95% CI were calculated for dichotomous outcomes. A total of 20 studies involving 3011 patients were obtained. The results demonstrated that probiotics are more effective than placebo in reducing global IBS symptoms improvement rate (RR=1.401, 95% CI 1.182-1.662, P<0.001) and quality of life scores (SMD=0.286, 95% CI=0.154-0.418, P<0.001). Subgroup analyses showed that a shorter treatment time (less than eight weeks) could reduce distension scores (SMD=0.197, 95% CI=0.038-0.356, P=0.015). High doses (daily dose of probiotics ≥ 10ˆ10) or multiple strains of probiotics exhibit beneficial effects on abdominal pain (SMD=0.412, 95% CI=0.112-0.711, P=0.007; SMD=0.590, 95% CI=0.050-1.129, P=0.032; respectively). However, there was no significant benefit on global symptom scores (SMD=0.387, 95% CI 0.122 to 0.653, P=0.004) with statistically high inter-study heterogeneity (I2=91.9%, P<0.001). Furthermore, there was no significant inter-group difference in terms of adverse events frequency (RR=0.997, 95% CI 0.845-1.177, P=0.973). Probiotics are effective and safe for IBS patients. High doses or multiple probiotic strains seem preferable, but definite conclusions are challenging due to the high heterogeneity. Large-scale, well-designed, and rigorous trials are needed to confirm their effectiveness.

The role of nutritional support with probiotics in outpatients with symptomatic acute respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled dietary study

BackgroundA number of laboratory data and clinical studies have shown that probiotic bacteria may be beneficial in respiratory viral diseases. We investigated the role of probiotics in coronavirus disease-19 (COVID -19), post-disease symptoms, and humoral immune responses to viral antigens.MethodsThis was a randomized, double-blind, placebo-controlled, prospective, multicenter study. We included symptomatic patients aged 18–65 years without risk of severe disease, and positive antigen/PCR test for SARS-CoV-2. Patients received (Bifidobacterium (B.) lactis BI040, B. longum BL020, Lactobacillus (L) rhamnosus LR110, L. casei LC130, L. acidophilus LA120, 5 billion CFU total) or placebo 1 capsule a day for 28 days and recorded symptoms. Three months later patients completed Post-COVID-19 Questionnaire (PCQ-19). On days 0–5 and 28–35, blood was sampled for IgG to nucleocapsid protein (NCP) and receptor binding domain (RBD)/spike 1 (S1) protein. The primary outcome measure was a patient global symptom score on day 10 of observation. The difference between groups was assessed using the Mann–Whitney U test.ResultsSeventy-three patients were assessed for clinical endpoints and 44 patients were evaluated for antibody production. At day 10, the median global symptom score (interquartile range) was lower in the probiotic group (0.0 (0.0–2.0) vs. 2.0 (1.0–5.0), P < 0.05). The probiotic group had a shorter duration of fatigue and anxiety after COVID -19 (P < 0.05) and a greater change in IgG concentration on RBD/S1 (225.9 vs. 105.6 binding antibody units/mL, P < 0.05).ConclusionsUse of probiotics alleviates acute and post-disease symptoms, and improves humoral immune response to viral antigens.Trial registrationRegistered at clinicaltrials.gov as NCT04907877, June 1, 2021.

Efficacy and safety of rifaximin in patients with chronic intestinal pseudo-obstruction: a randomized, double-blind, placebo-controlled, phase II—a exploratory trial

Chronic intestinal pseudo-obstruction (CIPO) is a rare intractable disease with limited treatment options. Small intestinal bacterial overgrowth (SIBO) often co-occurs with several diseases, including CIPO. While rifaximin (RFX) is effective in treating SIBO, its efficacy for CIPO remains unclear. Here, we aimed to investigate the efficacy and safety of RFX in adult patients with CIPO. Twelve patients were randomly assigned to receive RFX (400 mg three times daily, n=8) or a placebo (PBO, n=4) for 4 weeks. The global symptom score for abdominal bloating (GSS-bloating) and an original whole gastrointestinal symptoms score (O-WGSS) were collected, and a glucose hydrogen breath test (GHBT) and abdominal computed tomography (CT) were performed. No significant differences were observed in the primary endpoint. GSS-bloating improved by 75% and 25% in the PBO and RFX groups, respectively, and O-WGSS improved by 25% in both groups. No significant differences were observed in secondary and other endpoints, including the SIBO eradication rate in the GHBT and small intestinal volume on CT. In a post hoc analysis of SIBO-positive patients with CIPO (4/4 and 4/8 in the PBO and RFX groups), SIBO was eradicated in 25% and 75% of the patients (PBO and RFX groups, respectively) at the end of treatment, indicating a high eradication rate in the RFX group. Furthermore, the small intestinal gas volume decreased in the RFX group, and no severe adverse events occurred. Although no significant improvements were observed in subjective indicators, RFX may be beneficial in alleviating SIBO and reducing the small intestinal gas volume in SIBO-positive patients with CIPO.

Intolerance upon statin rechallenge: A systematic review and meta-analysis of randomized controlled trials.

Although statins are often discontinued when myalgia arises, a causal relationship may not always exist. How well-tolerated statins are when rechallenge is blinded and controlled is unclear. We performed a systematic review and meta-analysis (PROSPERO CRD42023437648) to evaluate the success of statin rechallenge versus matched placebo in those who were previously statin intolerant. Our primary outcome was intolerance; our secondary outcome was the myalgia or global symptom score. Medline, Embase, CINAHL Plus, Scopus, and CENTRAL were searched from inception to May 1, 2023. Eligible trials were randomized controlled trials with parallel or crossover designs examining statin rechallenge in statin-intolerant adults. Two independent reviewers selected studies, extracted data, and assessed risk of bias (Cochrane Collaboration's risk-of-bias tool 1). Relative risk (RR) and mean difference (MD) were estimated using fixed effect Mantel-Haenszel statistics. Of 1,941 studies screened, 8 met our inclusion criteria (8 to 491 participants from Asia, Europe, North America, and Oceana). Compared to placebo, intolerance was more common in statin users [325/906 (36%) vs 233/911 (26%), RR 1.40, 95% CI, 1.23 to 1.60, I2 = 0%, 7 trials, number needed to harm 10] and there was no statistically significant difference in myalgia or global symptom score on a 100-point scale [MD 1.08, 95% CI, -1.51 to 3.67, I2 = 0%, 5 trials]. Limitations include only 1 trial asking participants about intolerable symptoms (vs inferring intolerance from discontinuation or trial withdrawal); the small number of trials; the possibility of attrition bias; and the potential for carryover effects in crossover/n-of-1 trial designs. Of those previously intolerant of statins who were rechallenged with a statin and compared to placebo recipients, medication intolerance was more common amongst statin recipients. However, there was no significant difference in mean myalgia or global symptom score between statin and placebo, and only one-third of those previously believed to be statin intolerant were unable to tolerate a statin on blinded rechallenge; one-quarter were intolerant of placebo.

A comparison of different symptomatic reflux esophagitis treatments: A real-world study.

Proton pump inhibitors (PPIs) are currently the reference drugs for gastroesophageal reflux disease (GERD), but symptoms often recur after their withdrawal. Moreover, whether prokinetics or barrier drugs used alongside PPIs are more effective remains under debate. The aim of the study was to assess the efficacy of different therapeutic approaches to GERD treatment. We enrolled 211 grade A reflux esophagitis patients who consented to participate in this non-randomized, open-label trial. The study consisted of 6 sequentially administered medical treatments for GERD, lasting 2 months, with a 3-week washout period between each drug schedule: Group A: PPI (esomeprazole 40 mg/day before breakfast); Group B: mucosal protective drugs (a combination of hyaluronic acid, chondroitin sulfate and poloxamer 407, or a combination of hyaluronic acid, chondroitin sulfate and aluminum, 3 times daily after a meal); Group C: prokinetics (levosulpiride 25 mg or domperidone 10 mg, 3 times daily before a meal); Group D: barrier drug (alginate 3 times daily after a meal); Group E: PPI (esomeprazole 40 mg/day before breakfast) and mucosal protective drugs (a combination of hyaluronic acid, chondroitin sulfate and poloxamer 407, or a combination of hyaluronic acid, chondroitin sulfate and aluminum, before sleep); Group F: PPI (esomeprazole 40 mg/day before breakfast) and prokinetics (levosulpiride 25 mg or domperidone 10 mg before lunch and dinner). Symptoms were evaluated using the visual analogue scale (VAS) and global symptomatic score (GSS), as follows: heartburn: 0-3; retrosternal chest pain: 0-3; regurgitation: 0-3. All but 2 treatments (groups C and D) significantly improved VAS and GSS, with group E showing the most significant GSS improvement. Group C had the highest number of dropouts due to treatment failure and reported more side effects. Using PPIs and mucosal protective drugs resulted in significant symptom alleviation. However, the administration of prokinetics caused higher dropouts due to treatment failure.

&lt;italic&gt;Yukgunja-tang&lt;/italic&gt; for Irritable Bowel Syndrome: A Protocol for a Systematic Review and Meta-Analysis

Background: Irritable bowel syndrome (IBS) is a digestive disorder characterized by abdominal discomfort or pain accompanied by a change in stool condition. Owing to its complicated mechanisms, a standard treatment for IBS has not yet been established. &lt;i&gt;Yukgunja-tang&lt;/i&gt; (YGT) is a Korean herbal medicine known in Asia to be effective in the treatment of gastrointestinal symptoms. In this study, we will conduct a systematic review of randomized controlled trials (RCTs) to assess the efficacy and safety of YGT in IBS treatment.Methods and analysis: English databases, such as Embase, Medline (via PubMed), Allied and Complementary Medicine Database, and Cochrane Central Register of Controlled Trials, will be searched for articles published up to April 2023. Additional databases, such as five Korean, one Chinese, and one Japanese database, will be included. RCTs and quasi-RCTs will also be included in the assessment of the efficacy of YGT. The overall efficacy rate will be the primary outcome, and data such as IBS quality-of-life measurements, global symptom scores, and adverse events will be the secondary outcomes. Review Manager Version 5.3 will be used for evaluation, and the risk of bias (RoB) will be evaluated using Cochrane Collaboration’s RoB tool. The Grading of Recommendations Assessment, Development, and Evaluation approach will be used to score the quality of evidence.Conclusion: This study will demonstrate the efficacy and safety of YGT for treating patients with IBS.

Fecal microbiota transplantation for the treatment of irritable bowel syndrome: A systematic review and meta-analysis.

Irritable bowel syndrome (IBS) is the most prevalent gastrointestinal disorder in developed countries and reduces patients' quality of life, hinders their ability to work, and increases health care costs. A growing number of trials have demonstrated an aberrant gut microbiota composition in IBS, also known as 'gut dysbiosis'. Fecal microbiota transplantation (FMT) has been suggested as a treatment for IBS. To assess the efficacy and safety of FMT for the treatment of IBS. We searched Cochrane Central, MEDLINE, EMBASE and Web of Science up to 24 October 2022 for randomised controlled trials (RCTs) investigating the effectiveness of FMT compared to placebo (including autologous FMT) in treating IBS. The primary outcome was the number of patients with improvements of symptoms measured using a validated, global IBS symptoms score. Secondary outcomes were changes in quality-of-life scores, non-serious and serious adverse events. Risk ratios (RR) and corresponding 95%CI were calculated for dichotomous outcomes, as were the mean differences (MD) and 95%CI for continuous outcomes. The Cochrane risk of bias tool was used to assess the quality of the trials. GRADE criteria were used to assess the overall quality of the evidence. Eight RCTs (484 participants) were included in the review. FMT resulted in no significant benefit in IBS symptoms three months after treatment compared to placebo (RR 1.19, 95%CI: 0.68-2.10). Adverse events were reported in 97 participants in the FMT group and in 45 participants in the placebo group (RR 1.17, 95%CI: 0.63-2.15). One serious adverse event occurred in the FMT group and two in the placebo group (RR 0.42, 95%CI: 0.07-2.60). Endoscopic FMT delivery resulted in a significant improvement in symptoms, while capsules did not. FMT did not improve the quality of life of IBS patients but, instead, appeared to reduce it, albeit non significantly (MD -6.30, 95%CI: -13.39-0.79). The overall quality of the evidence was low due to moderate-high inconsistency, the small number of patients in the studies, and imprecision. We found insufficient evidence to support or refute the use of FMT for IBS. Larger trials are needed.

Implementation of Early Intervention Services (OPUS) in Denmark and results of 20 year follow-up of the OPUS trial

Abstract: BackgroundThe OPUS trial is the largest randomized controlled trial (RCT) testing early intervention services with 20-years of follow-up among individuals with a first episode of psychosis in the schizophrenia spectrum.MethodsA total of 547 individuals with first episode psychosis in the schizophrenia spectrum were included into the OPUS I trial between January 1998 - December 2000 and allocated to either two years of early intervention services or treatment as usual. Clinical and trained staff, blinded to the original treatment allocation, performed the five, ten and 20-year follow-up assessments.The early intervention service consisted of two years of assertive community treatment including social skill training, psychoeducation and family involvement delivered by a multi-disciplinary team (staff patient ratio 1:10). The standard treatment was based on the available community mental health treatment (1:20 –1:30).ResultsA total of 164 participants (30%) of 547 were interviewed at the 20-year follow-up. No significant differences were found between the early intervention group (OPUS-group) compared to the Treatment As Usual group (TAU-group) on global functional levels, psychotic and negative symptom scores after 20 years. Likewise, no differences was found ten to 20-years after randomization between the OPUS-group and TAU-group on days of psychiatric hospitalizations (Incidence Rate Ratio (IRR), 1.202, 95% CI 0.733 - 1.997, P=0.46), or number of outpatient contacts (IRR: 1.197, 95% CI 0.889 - 1.612, P=0.24). Of the entire cohort, 40% were in symptom remission and 18% were in clinical recovery at the 20-year follow-up. The mortality rate 20 years after randomization was 13.1% in the OPUS-group and 15.1% in the TAU group, P=.47.Conclusions and RelevanceNew initiatives are needed to maintain the positive outcomes achieved after two years of early intervention servicesDisclosure of InterestNone Declared

The impact of chemo-induced menopause on the quality of life of young women with non-metastatic breast cancer in Algeria

Background: Breast cancer is the most common cancer in females worldwide. Young women with breast cancer are treated with chemotherapy, which may exhibit gonadotoxicity thus inducing chemo- induced menopause with a risk of deterioration in their quality of life.&#x0D; Method: A prospective study first of its kind in Algeria was carried out on 57 patients aged between 30 and 49 years that went for consultation at the oncology department of Pierre and Marie Curie Medical Centre Algiers. The medical files obtained and criteria of questionnaires: Quality of Life Questionnaire for Breast Cancer (QLQ-BR23) and the Quality of Life Questionnaire-Core 30 (QLQ-C30) were used to assess the quality of life in patients.&#x0D; Results: From the medical files, patients had a dominant histological type of invasive ductal carcinoma at 96% and Scarff-Bloom-Richardson (SBR) II grade and luminal B profile were the most frequent. The (QLQ-C30) having averages of global health status, symptom score, and functional score with 56.34, 63.7, and 45.75 respectively. QLQ-BR23 having averages for symptom, functional score of 61.6 and 49.71 respectively.&#x0D; Conclusion: Chemotherapy induces gonadotoxicity, which results in chemo-induced menopause that has a negative impact on the quality of life of young women. QLQ-BR23 is more suitable than QLQ-C30 to access the context of this study.

Baricitinib for the treatment of intestinal Behçet's disease: A pilot study

The pilot study aims to explore the efficacy and safety of baricitinib in treating refractory intestinal Behçet's disease (BD). We consecutively enrolled patients with refractory intestinal BD from October 2020 to September 2022. They were treated with baricitinib 2-4mg daily, with background glucocorticoids and immunosuppressants. Efficacy assessment included the global gastrointestinal symptom scores, the endoscopy scores, the Disease activity index for intestinal Behçet's disease (DAIBD), and the inflammatory parameters. Side effects were recorded. The thirteen patients (six males and seven females) had a median follow-up of eleven months, 76.92% (10/13) patients achieved complete remission of global gastrointestinal symptom scores, and 66.7% (6/9) had mucosal healing on endoscopy. The DAIBD scores decreased significantly, as well as the C-reactive protein level. Baricitinib showed a glucocorticoid-sparing effect, and the safety profile is favorable. Baricitinib might be a potential choice in treating refractory intestinal BD.

Comparison of the Results of Intragastric Gastric Balloon Application Versus Sleeve Gastrectomy on the Quality of Life in Patients Who Were Diagnosed as Asthma

Aim: We have aimed to compare the postoperative outcomes of asthmatic patients who have underwent laparoscopic sleeve gastrectomy (LSG) versus intragastric balloon(IGB) application.Materials and Methods: Total of asthmatic 84 patients who have underwent LSG versus IGB due to morbid obesity between March 2019 and February 2021 in the tertiary surgery department have retrospectively analyzed. Demographic findings, global symptom scores, and length of the stay in hospital of patients were evaluated. The patients in present resarch have similar in terms of BMI, age, and gender. Statistically significant results were accepted as p&amp;lt;0.05.Results: The mean age of the patients participating in the study were 42.32±6.51 (range 28–54), mean BMI were 42.3±6.7 kg/m² (range 41–52). There were no major complications and mortality were observed in patients. Age and gender were defined as independent risk factors by multivariant logistic regression analysis, Age, p:0.054, (OR (95%CI): 2.017), BMI, p:0.067. (OR (95%CI): 1.379), Gender was determined as p:0.110 (OR (95%CI): 0.928.Conclusion: We have concluded that although the morbidity of sleeve gastrectomy is higher than the gastric balloon application process, LSG provides more improvement in quality of life than IGB process.

Lactobacillus gasseri LA806 Supplementation in Patients with Irritable Bowel Syndrome: A Multicenter Study.

The potential benefits of Lactobacillus gasseri LA806 in IBS were previously identified in a comprehensive preclinical research program. The purpose of this multicenter study was to explore in real-life conditions changes in IBS symptoms and quality of life in patients receiving a 4-week supplementation with L. gasseri LA806. Altogether 119 patients meeting Rome IV criteria for IBS were included, of whom 118 received the supplement. The majority of patients (71.8% (95% CI 63.6−79.9%)) manifested a ≥30% decrease in abdominal pain at 4 weeks, the mean abdominal pain score diminishing by 54.2% (from 5.3 ± 2.2 to 2.2 ± 2.4, p < 0.0001). A statistically significant decrease in abdominal pain was seen as early as the first week. A decrease of ≥30% in both abdominal pain score and global IBS symptom score was attained in 61.5% of patients (95% CI 51.7−71.2%). The mean IBS-SSS score fell by 152 ± 112 points (p = 0.001), with symptoms being attenuated in 85% of patients (CGI-I). Supplementation led to a 10-fold decrease in the number of patients reporting severe IBS symptoms. The concomitant intake of antidiarrheals, antispasmodics and analgesics decreased and quality of life scores significantly improved. These preliminary results warrant confirmation by a randomized, placebo-controlled study that this study will allow a better design.

Efficacy and Safety of Inhalation of Nebulized Ethanol in COVID-19 Treatment: A Randomized Clinical Trial.

Coronavirus disease 2019 (COVID-19) is a pandemic caused by the SARS-CoV-2 virus. Many efforts have been made and are currently being made to prevent and treat this global disease. This study was designed to evaluate the efficacy and safety of nebulized ethanol (EtOH) in treating COVID-19. A randomized clinical trial (RCT)of 99 symptomatic and real-time polymerase chain reaction (RT-PCR)-positive patients admitted to a hospital receiving remdesivir-dexamethasone was conducted. They were randomly assigned to receive distilled water spray (control group (CG)) or 35% EtOH spray (intervention group (IG)). Both groups inhaled three puffs of spray (nebulizer) every six hours for a week. The primary outcome included Global Symptomatic Score (GSS) between the two groups at the first visit and on days three, seven, and 14. Secondary outcomes included the Clinical Status Scale (CSS; a seven-point ordinal scale ranging from death to complete recovery) and readmission rate. A total of 44 and 55 patients were enrolled in the IG and CG, respectively. Although there was no difference at admission, the GSS and CSS improved significantly in the IG (p = 0.016 and p = 0.001, respectively). The IG readmission rate was considerably lower (0% vs. 10.9%; p = 0.02). Inhaled-nebulized EtOH is effective in rapidly improving the clinical status and reducing further treatment. Due to its low cost, availability, and absent/tolerable adverse events, it could be recommended as an adjunctive treatment for moderate COVID-19. Further research on curative effects in more serious cases and in prevention is advisable.

Effect of OTX-101 in Patients with Dry Eye Disease at Day 14 of Treatment: Ocular Surface Endpoint Results from the Phase 2b/3 Clinical Trial.

Dry eye disease (DED) is a multifactorial disorder characterized by loss of tear film homeostasis, which initiates a cycle of ocular surface inflammation and damage. As ocular discomfort symptoms associated with DED can decrease quality of life, affected patients prefer treatments that rapidly improve the underlying disease process. OTX-101 0.09% (CEQUA®) is indicated to increase tear production in patients with DED. The current analysis assessed early efficacy of OTX-101 0.09% in adult patients with bilateral DED by evaluating ocular surface endpoints after 14 days of treatment in the phase 2b/3 trial. In this randomized, double-masked, vehicle-controlled, dose-ranging study, patients received one drop of OTX-101 0.05%, OTX-101 0.09%, or vehicle per eye twice daily for 84 days. Corneal staining, conjunctival staining, tear breakup time (TBUT), and modified Symptom Assessment iN Dry Eye (SANDE) total global symptom score were assessed at baseline and Days 14, 28, 42, 56, and 84/early discontinuation. Overall, 455 patients were randomized (OTX-101 0.05%, n=151; OTX-101 0.09%, n=152; vehicle, n=152); only baseline and Day 14 results for the approved OTX-101 0.09% formulation and vehicle are presented. Least squares (LS) mean (standard error [SE]) change from baseline in conjunctival staining score was -1.3 (0.1) for OTX-101 and -1.0 (0.1) for vehicle. LS mean (SE) change from baseline in corneal staining score was -1.1 (0.17) for OTX-101 and -0.7 (0.17) for vehicle. LS mean (SE) change from baseline in TBUT was 0.52 (0.15) for OTX-101 and 0.36 (0.15) for vehicle. LS mean (SE) change from baseline in modified SANDE total global symptom score was -4.93 (1.54) for OTX-101 and -9.1 (1.54) for vehicle. OTX-101 0.09% demonstrated a numerically greater treatment effect compared with vehicle in conjunctival staining, corneal staining, and TBUT after 14 days.

Improvement of Symptoms in Patients Affected by Chronic Atrophic Gastritis Using L-Cysteine (Acetium®)

Background: Chronic atrophic gastritis (CAG) alone is a precancerous condition for gastric cancer. Achlorhydria plays an important role in the formation of a class I carcinogen, acetaldehyde. L-cysteine has been claimed to bind acetaldehyde covalently. Symptoms are present in 55% of CAG patients, of whom 70% have upper gastrointestinal complaints. The aim of this study was to investigate the properties of L-cysteine in the modification of symptom patterns in CAG patients. Methods: Consecutive patients with histological diagnosis of CAG (OLGA ≥1 with gastric corpus involvement) were evaluated with serological determination of gastric function, clinical assessment of symptoms using the visual analog score (VAS) and the global symptomatic score (GSS), and considered for therapy with L-cysteine, 300 mg daily. Data regarding symptoms were collected at enrollment and after 3, 6, 12, 18, and 24 months, with an ultimate follow-up of 2 years. Results: A total of 330 patients with CAG were divided in group 1 (77 patients treated with L-cysteine) and group 2 (50 patients who received no specific treatment – control group). A statistically significant improvement in the VAS score (7.8 at baseline vs. 4.5 after 24 months; p < 0.01) was observed in patients treated with L-cysteine, while no significant changes in symptom pattern/intensity were recorded in the 2-year follow-up of untreated patients with CAG. Conclusions: Long-term treatment with L-cysteine provides symptom improvement in CAG patients and might be proposed as maintenance therapy in such patients.