Cramps Research Articles

Non-pharmacological Interventions for Muscle Cramps and Pain in Patients With Cirrhosis: A Systematic Review.

Despite the high prevalence of pain and challenges associated with traditional pharmacological pain management in patients with cirrhosis, little is known about the safety and effectiveness of non-pharmacological management of pain in this patient population. A systematic literature search of published studies was conducted in nine databases from inception through January 11, 2023, including any clinical trial, cohort, or case-control study of non-pharmacological pain interventions in adult patients with cirrhosis. Studies using nutritional supplements were included. The primary and secondary outcomes for this review were pain/analgesic effect and safety, respectively. Two reviewers independently performed data extraction and risk of bias assessment. Of the 4,087 studies initially screened, 11 studies representing 340 patients ultimately met inclusion criteria, including seven observational and four randomized controlled trials. Five studies reported muscle cramp severity, four reported muscle cramp frequency, and two reported non-cramp pain. Oral zinc sulfate, L-carnitine, and taurine were reported to decrease cramp frequency. Oral vitamin E, oral zinc sulfate, L-carnitine, taurine, and pickle juice decreased cramp severity. Curcumin supplementation, resistance training, and stretching and walking programs improved non-cramp pain. Mild adverse events were reported in four studies. The risk of bias was moderate to high for all studies, largely due to missing data, study design, and a lack of blinding of participants. Numerous nutritional and non-pharmacological interventions have been reported to be safe and effective for the treatment of pain and painful muscle cramps in patients with cirrhosis. However, further research is needed to better determine the efficacy, safety, and optimal frequency and dosage of interventions.

Stress level and interdialytic weight gain (IDWG) in hemodialysis patients

Stress has various impacts on hemodialysis patients. Stress in hemodialysis patients can cause physical symptoms (fatigue, muscle cramps, nausea, and vomiting), a decrease in quality of life, and non-compliance with self-management, one of which is compliance related to limiting fluid intake, thus adversely affecting on the patient's IDWG. IDWG is an important indicator for fluid monitoring in hemodialysis patients. Increasing IDWG that exceeds the tolerance limit can have a negative impact and can even cause mortality. This study aimed to determine the correlation between stress level and IDWG among hemodialysis patients. This study was conducted in the hemodialysis unit of RSD Mangusada, involving 95 respondents. This study was quantitative, with non-experimental research using a cross-sectional approach. Data collection was carried out with DASS questionnaires for stress and observation sheets for the IDWG. The data was analyzed using Pearson's Spearman Rank (α<0.05). Respondents with IDWG within tolerance limits were the majority unstressed, and none experienced severe stress or very severe stress. There is a positive and weak correlation between stress and IDWG among patients undergoing hemodialysis. The findings from this study may provide useful information in reviewing existing nursing care and standards of care provided in hemodialysis units, including the need to consider psychological assistance services in the care of hemodialysis patients. Qualitative research is needed to explore the in-depth experience of stress in hemodialysis patients and the factors associated with it.

Reliability study for the Japanese version of the Columbia Muscle Cramp Scale in amyotrophic lateral sclerosis

AbstractBackgroundThe Columbia Muscle Cramp Scale (CMCS) is a useful tool for evaluating muscle cramps commonly observed in patients with amyotrophic lateral sclerosis (ALS). The CMCS comprises five subdomains: triggering factors, frequency, location, severity, and the degree to which cramps affect overall daily living.AimThis study aimed to evaluate the reliability of the CMCS, which was translated into Japanese.MethodsThirty patients with ALS (17 men and 13 women) from seven facilities were evaluated twice by two different evaluators (doctors, nurses, physical therapists, occupational therapists, and speech‐language‐hearing therapists). The degree of inter‐ and intra‐rater agreement was evaluated using kappa statistics. Weighted kappa statistics and 95% confidence intervals accounted for multiple‐order responses.ResultsThe average age was 60.4 (standard deviation: 10.4, range: 39–77) years. The kappa statistics for the inter‐rater reliability of the CMCS items showed moderate to very good agreement, ranging from 0.56 (cramp triggering) to 0.91 (daily activity) at visit 1 and 0.51 (severity) to 0.96 (daily activity) at visit 2. The kappa statistics for the intra‐rater reliability of the CMCS items also showed moderate to good agreement, ranging from 0.45 (frequency) to 0.79 (cramp triggering).ConclusionThe Japanese version of the CMCS demonstrated intra‐ and inter‐rater reliability agreement and is expected to be useful for evaluating muscle cramps in patients with ALS.

A gluten-free diet for endometriosis patients lacks evidence to recommend it

Endometriosis, an estrogen-dependent chronic disease that is characterized by the presence of endometrium-like tissue outside the uterus, is often associated with symptoms like dysmenorrhea, dysuria, dyschezia, chronic pelvic pain and infertility. Women diagnosed with endometriosis can also report gastro-intestinal symptoms, including bloating, constipation or diarrhea and abdominal cramping, that can be associated with Irritable Bowel Syndrome (IBS) and can result in misdiagnosing endometriosis as IBS at first. Treatment usually involves hormonal therapy, pain management, surgery and/or assisted reproductive techniques in case of infertility. Nonetheless, these treatment methods can be insufficient in alleviating symptoms, or can cause unacceptable side effects leading to non-compliance. Therefore, women often apply self-management strategies including dietary interventions. One of the diets frequently suggested as a tool to manage endometriosis-related symptoms on social media and patient forums, is a gluten-free diet. While a gluten-free diet has been proven effective in managing non-celiac wheat sensitivity or celiac disease, its effectiveness for endometriosis remains uncertain. The Nurses’ Health study II found it unlikely that gluten intake was a strong factor in endometriosis etiology and symptomatology. The most frequently cited and sole published intervention study, to our knowledge, on the efficacy of a gluten-free diet for endometriosis has several important limiting factors, including the absence of a control group. Additionally, gluten consumption is highly susceptible to a placebo- and nocebo effect, where women might experience symptom relief when eliminating gluten, and return of symptoms when they consume gluten again, solely because they believe gluten are bad for them. Despite the inverse association between BMI and endometriosis and between a gluten-free diet and increased BMI, this is an association and no causality was proven. Other factors should be taken into account. Finally, a gluten-free diet is expensive with a limited availability, has a great impact on Quality of Life and without proper dietary guidance may adversely affect the gastro-intestinal microbiome. Therefore, a scientifically substantiated advice regarding the use of a gluten-free diet for endometriosis-related symptoms is currently not available and a gluten-free diet should therefore be discouraged unless there is an additional diagnosis of non-celiac wheat sensitivity or celiac disease.

Prevalence and Impact of Poly cystic Ovary Syndrome and Its Associated Irritable Bowel Syndrome among the Students: A Cross Sectional Study

To determine the prevalence and impact of poly cystic ovary syndrome (PCOS) and its associated irritable bowel syndrome (IBS) among college students. Materials and Methods: A cross-sectional study involving 280 female college students aged 17 to 28 years was conducted. Data collection was carried out using a structured questionnaire administered through Google Forms. The questionnaire gathered information on the following aspects: Demographic characteristics: Age at menarche. PCOS status: Presence or absence of PCOS diagnosis, family history of PCOS or infertility. Menstrual cycle characteristics: Duration of Menstrual bleeding, flow of menstrual bleeding, severity of menstrual pain. Hyper androgenic symptoms : Acne score, hirsutism score. IBS symptoms: Abdominal pain, cramping, diarrhoea, constipation, and psychological distress. Statistical analysis: The collected data was analyzed using descriptive statistics, including frequencies and percentages. Chi-square tests were used to assess the association between PCOS and IBSsymptoms.

The RELAX randomized controlled trial: Stretching versus meditation for nocturnal muscle cramps.

Muscle cramps are common among persons with cirrhosis and are associated with poor health-related quality of life (HRQOL). Treatment options are limited. We compared stretching or meditation in a randomized-controlled trial (RCT). We enrolled 98 patients with a history of >4 muscle cramps in the prior month from 7/22-7/23. We randomized patients 1:1 to stretching versus meditation for 35 days. Our primary outcome was the change in cramp severity measured by the visual analogue scale for cramps (VAS-cramps, scaled 0-10). Secondary outcomes included a patient global impression of change (PGIC), change in sleep quality and global HRQOL measured using the EQ-5D and VAS-global HRQOL. Overall, 48% of patients had cirrhosis, 40% had diabetes, 16% the median age was 63, most were women (67%) and 81% were college educated. Both arms experienced a reduction in cramp severity-a median of 1.44 (.58-2.29) points for stretching and 1.97 (1.01-2.93) points for meditation. These changes were significant changes from baseline (p = .001 for stretching, p < .0001 for meditation) but these changes were equivalent between arms (p = .4). The PGIC was improved: 1.33 (1.02-1.65) for stretching, 1.05 (.70-1.41) for meditation, p-difference .2. Sleep was also improved for both. HRQOL did not change according to the Eq5D; according to the VAS, HRQOL rose for meditation by 6 (.1-11.8) points but not for stretching. More patients recommended stretching than meditation (79.2% vs. 55.3%, p = .02). In a randomized trial, stretching and meditation both reduced cramp severity and improved sleep quality and global impression of change. While patients preferred stretching, there was no difference in effect between arms.

Shiga toxin-producing Escherichia coli O157:H7 outbreak associated with school field trips at a farm animal exhibit-Tennessee, September-October 2023.

In October 2023, the Tennessee Department of Health identified an outbreak of Shiga toxin-producing Escherichia coli (STEC) O157:H7 infections among elementary school students who attended school field trips to the same farm animal exhibit. Our aim was to determine STEC source and prevent additional illnesses by initiating epidemiologic, laboratory and environmental investigations. We identified cases using laboratory-based surveillance and by surveying caregivers of children who attended the exhibit. Probable cases were defined as illness with abdominal cramps or diarrhoea after attendance; confirmed cases were laboratory-confirmed STEC infection in an attendee or household contact. A site visit was conducted, and event organizers were interviewed. Human stool, animal faeces and environmental samples were tested for STEC O157:H7 by real-time polymerase chain reaction (PCR), culture and whole-genome sequencing (WGS). Approximately 2300 elementary school students attended the animal exhibit during 2 days. Field trip activities included contact with different farm animal species, drinking pasteurized milk outside animal enclosures and eating lunch in a separate building onsite. We received survey responses from 399 caregivers for 443 (19%) animal exhibit attendees. We identified 9 confirmed and 55 probable cases with illness onset dates during 26 September to 12 October. Seven children aged 1-7 years were hospitalized. Four children aged 1-6 years experienced haemolytic uraemic syndrome; none died. Laboratory testing identified STEC O157:H7 by culture from eight human stool samples with 0-1 allele difference by WGS. Three environmental samples had Shiga toxin (stx 2) genes detected by PCR, but no STEC isolates were recovered by culture. This is the largest reported STEC O157:H7 outbreak associated with an animal exhibit in Tennessee. We identified opportunities for educating school staff, event organizers and families about zoonotic disease risks associated with animal contact and published prevention measures.

The effect of exercise on gastrointestinal symptoms and body composition at different phases of the menstrual cycle

Women commonly experience bloating, stomach cramps, water retention, and weight gain at the beginning of their menstrual cycle, which cause fluctuations in body composition through extracellular changes, this may affect osmotic pressure, leading to gastrointestinal (GI) symptoms. The aim of this study was to investigate the effect of the menstrual cycle phase on extracellular changes and GI symptoms in females in response to exercise. Seven healthy premenopausal female recreational athletes (maximal O2 consumption: 50 ± 5.8 ml·kg-1) performed two running trials in an experimental crossover design during two distinct phases of the menstrual cycle, early follicular phase (EFP) and the mid-luteal phase (MLP). Each trial consisted of 120 min of running, 60 min at 110% lactate threshold and 60 min at 90%. Determination of cycle was calculated from calendar-based counting and urinary ovulation detection kits. The EFP was determined by self-reporting onset of menses. The day before each trial, participants followed a low FODMAP diet and completed a gastrointestinal symptom rating scale questionnaire. On the morning of the trial, a standard breakfast was consumed, upon arrival at the laboratory, body composition was recorded. Each hour, finger prick samples were taken to measure lactate and ensure performance did not exceed maximum, every 15 minutes, a visual analog scale (VAS) of subjective ratings between 0-10 cm of gut comfort was taken. Data was analysed using mean and standard deviation (subsequent statistical analysis will be conducted if an n = 10 is reached prior to the conference). During exercise, participants experienced a higher prevalence of GI issues throughout the EFP compared with the MLP. The most common complaints reported from the VAS were nausea; EFP 1 ± 1 cm, MLP 0 ± 0 cm. Flatulence; EFP 4 ± 3 cm, MLP 1 ± 1 cm, and stomach cramps; EFP 3 ± 2 cm, MLP 1 ± 1 cm. Total body weight (TBW) differences were noted between the EFP and MLP. TBW EFP pre-exercise was higher than MLP pre-exercise phase EFP pre-exercise: 38.7 ± 2.8 L compared to MLP pre-exercise at 35.8 ±5.5 L. Similar differences were demonstrated with extra cellular water pre-exercise EFP; 16.1 ± 1.1 L MLP; 15.2 ±1.0 L. During the EFP fluid retention is known to be higher than the MLP, and results are as expected. While the data suggests a seemingly minimal variation in Gl symptoms, individually, there appears to be a higher level of difference. More gastrointestinal symptoms were reported during exercise, which is consistent with the findings. There is a slight difference in GI symptoms between the EFP and MLP at this stage, indicating a slight shift in total body water.

Effect of frozen gloves on chemotherapy-induced neurotoxicity in breast cancer patients: a systematic review and meta-analysis.

Chemotherapy-induced peripheral neurotoxicity (CIPN) is a dose-limiting side effect observed in breast cancer patients. Its primary clinical manifestations include limb numbness, tingling sensations, hypoesthesia, or paresthesia. In severe instances, some patients may also encounter muscle cramps, weakness, and pain, leading to potential paralysis. The onset of CIPN significantly impacts the quality of life for cancer patients. Hence, it is imperative to explore preventive strategies for managing CIPN. We searched for relevant randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) in several databases. The primary outcome measures encompassed the Patient Neurotoxicity Questionnaire (PNQ), the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane), and the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Secondary outcomes aimed to evaluate the quality of life and the tolerability of ice gloves. Meta-analysis was conducted using RevMan 5.3 software to determine the relative risk ratio (RR) and 95% confidence interval (CI). We conducted an analysis involving 372 patients across seven trials. In our meta-analysis, the use of ice gloves demonstrated non-significant results in reducing the incidence of both motor and sensory neuropathy, as assessed through CTCAE (sensory: RR: 0.94; 95% CI: 0.85 to 1.02; P = 0.15; motor: RR: 1.04; 95% CI: 0.88 to 1.22; P = 0.64). Similarly, when evaluated using the PNQ, there was no significant reduction observed in the incidence of sensory and motor neuropathy (sensory: RR: 0.49; 95% CI: 0.20 to 1.20; P = 0.12; motor: RR: 0.71; 95% CI: 0.26 to 1.99; P = 0.52). Consistently, our conclusions remained unchanged when employing the FACT-Taxane assessment. Regarding the evaluation of the quality of life, our observations suggested a potential improvement with the use of ice gloves, and participants exhibited moderate tolerance towards them. Ice gloves are a reasonable option for the treatment of CIPN in patients undergoing chemotherapy for breast cancer. However, the effectiveness of ice gloves in combating CIPN remains inconclusive at this time due to the low quality and limited number of clinical trials on this topic. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023457045, identifier CRD42023457045.

Dealing with the Unexpected: Stercoral Perforation – A Surgical Conundrum

Stercoral colon perforation is a rare surgical emergency primarily linked to chronic constipation and advanced age. Diagnosis is challenging and requires established criteria and imaging. Urgent surgery is the modality of choice, typically involving Hartmann's procedure. Mortality rates can be as high as 60%, emphasising the need for early diagnosis and intervention. We presented a case of a 71-year-old bedridden female with a history of stroke, diabetes, and hypertension presenting with abdominal pain, fever and diarrhoea. Initial evaluation indicated dehydration, sepsis, and abdominal tenderness. An urgent imaging revealed a suspected rectal perforation, prompting emergency surgery. Intraoperatively, stercoral perforation due to impacted hard faeces was identified. Despite prompt and intensive treatment, the patient's condition deteriorated, ultimately resulting in her demise. Stercoral colon perforation is a critical condition requiring rapid diagnosis. Symptoms include abdominal distension, tenderness, cramps, fever, and anorectal pain. Healthcare providers should consider the possibility of stercoral perforation in individuals exhibiting these symptoms alongside a background of persistent constipation. Treatment involves peritoneal lavage and surgery. Early recognition is vital for proper management and improved outcomes.

Pengaruh Latihan Peregangan Otot Intradialisis terhadap Kram Otot

This study aims to describe the effect of muscle stretching exercises during hemodialysis on muscle cramps. The research method uses an integrative review approach by searching articles using 6 databases, namely ProQuest, ClinicalKey Nursing, Sage Journals, ScienceDirect, Scopus, and ResearchGate. Article searches were carried out from March 5 2024 to March 25 2024. Article searches used the keywords stretching intradialysis, cramps intradialysis, exercises intradialysis, and muscle cramps. Preferred reporting items for systematic reviews and Meta-analysis (PRISMA) were used in the review. Results: From the results of the article search, it was found that muscle stretching exercises during hemodialysis carried out at the end of the HD session were proven to be able to prevent and reduce the intensity of muscle cramps in hemodialysis patients. Conclusion: Muscle stretching exercises performed during hemodialysis have been proven to prevent and reduce the intensity of muscle cramps during hemodialysis Keyword: Muscle cramps, Stretching intradialysis, Muscle stretching

Frequency of dose reductions of abemaciclib in metastatic and early-stage hormone positive, HER2 negative breast cancer.

e13099 Background: Abemaciclib is a CDK4/6 inhibitor which in combination with endocrine therapy (ET) improves progression-free survival in hormone receptor (HR)-positive, HER2 negative advanced breast cancer, as well as invasive disease free-survival in high-risk early-stage breast cancer. However, abemaciclib is associated with adverse events which may limit treatment adherence. In this single-center study, we describe real-world safety outcomes of early-stage and advanced HR-positive, HER2 negative breast cancer patients prescribed abemaciclib in conjunction with ET. Specifically, we analyze the frequency of adverse events and dose reductions (DR). Methods: We conducted a retrospective study of patients treated at Scripps Clinic between 1/1/2019-1/1/2023 with HR-positive, HER2 negative breast cancer prescribed abemaciclib with ET. Primary analyses were performed to discern clinical characteristic differences between groups. Categorical variables were summarized as frequencies and compared between arms by Chi-Square tests or Fisher’s Exact Tests. All continuous variables were summarized as means and standard deviations and compared between arms by T-Tests if normally distributed or summarized as medians and compared between arms by Mann-Whitney Tests otherwise. Statistical significance was set to 0.05 and all analyses were conducted in R. Results: A total of 77 patients were analyzed including 62% in the adjuvant setting and 38% in the metastatic setting. 51% of patients required DR. Patients requiring DR were older relative to those not requiring DR (59 vs 52 years of age, p=0.019). Those requiring DR remained on abemaciclib longer relative to those without DR (509 vs 350 days, p=0.057). Among those requiring DR, there were higher rates of grades II-IV diarrhea (p&lt;0.001) and Loperamide use (p=0.083). Those requiring DR also had higher rates of neutropenia (54% vs 29%, p=0.027), abdominal cramping (39% vs 8%, p=0.002), nausea (39% vs 13%, p=0.011), and fatigue (51% vs 32%, p=0.079). Among 9 patients who expired on abemaciclib, 7 were in the metastatic setting and 1 was linked to an adverse effect from abemaciclib; none required DR (24% vs 0%, p&lt;0.001). Finally, patients in the adjuvant setting remained on abemaciclib longer relative to those in the metastatic setting (526 vs 281 days, p=0.01). 95% of patients experienced symptom improvement with DR (p&lt;0.001). Conclusions: Our study describes real-world safety outcomes of patients with HR-positive, HER2 negative breast cancer treated with abemaciclib and ET. More than half of patients required DR. Those who reduced their abemaciclib dose had improvement of clinical symptoms and remained on therapy longer. Based on our findings and given the importance of adherence in treatment efficacy, a lower starting dose of abemaciclib may be a more tolerable strategy, especially among older patients who required more DR in our study.

A phase II study of cabozantinib and pembrolizumab in advanced gastric/gastroesophageal adenocarcinomas resistant or refractory to immune checkpoint inhibitors.

Most patients with metastatic gastroesophageal adenocarcinoma (mGEA) progress on immune checkpoint inhibitors (ICIs). Novel approaches to overcome resistance to ICI in mGEA are needed. Cabozantinib is a multi-tyrosine kinase inhibitor thought to enhance the immunomodulatory effects of ICI. This study evaluated the combination of cabozantinib and pembrolizumab in ICI refractory or resistant mGEA. Investigator-initiated, single-arm, single institution, and phase II study in patients with mGEA. Patients had progressed on ICI and/or had PD-L1 CPS score ≤10%. Cabozantinib dose was 40 mg p.o. daily on days 1-21 of a 21-day cycle, with pembrolizumab 200 mg i.v. on day 1. The primary endpoint was progression-free survival at 6 months (PFS-6). Twenty-seven patients were enrolled. Median age 58 years (24-87), female (n = 14), ECOG 0/1 = 13/14, GC/GEJ = 16/11, and non-Hispanic White/Hispanic/Asian = 12/8/7. The primary endpoint was met. After a median follow-up of 31.4 months (range 3.3-42.5), PFS-6 was 22.2% (95% CI 9.0-39.0). The median PFS and OS are 2.3 months (95% CI 1.7-4.1) and 5.5 months (3.1-14.0), respectively. The most common mutations were TP53 (78.3%) and CDH1/PIK3CA/CTNNB1 (17.4% each). The most common grade (G) treatment-related adverse events (TRAE) were diarrhea (25.9%), fatigue (18.5%), hypertension, and muscle cramps (14.8% each). G3-4 TRAE were seen in n = 3 patients (hypertension, thromboembolic event, esophageal perforation; each n = 1). No G5 was observed. The addition of cabozantinib to pembrolizumab shows clinical benefit in ICI-resistant or refractory mGEA with a tolerable safety profile. (ClinicalTrials.gov Identifier: NCT04164979. IRB Approved: UCI 18-124, University of California Irvine IRB#20195426.).

Updated results on multiple antigens stimulating cellular therapy (MASCT-I) in metastatic urothelial carcinoma: A randomized, open-label, phase I trial.

2545 Background: The appropriate treatment for mUC remains unmet medical needs. MASCT-I, an adoptive transfer of dendritic cells (DCs) presenting 15 types of tumor-associated antigens (TAAs), showed valuable treatment in solid tumors. We previously reported the efficacy and safety of MASCT-I alone, or plus camrelizumab or chemotherapy in mUC (NCT03034304). The biomarker analysis and long-term follow-up to for this promising approach was unknown. Methods: All enrolled patients were divided into in five groups (G) as previous reported. Patients in G2 receiving maintenance therapy of MASCT-I after first-line platinum based-chemotherapy were allowed to enter enrolled in G3 and receiving MASCT-I plus camrelizumab when disease progressed. We updated the exploratory endpoint of the IFN-γ ELISPOT assay, which was used to measure activation of the cytotoxic T Lymphocyte (CTL) response in eligible patients. Long-term follow-up results for safety, progression-free survival (PFS) and overall survival (OS) were reported. Results: 39 patients were enrolled. By January 31st, 2024, median follow-up time was 31.1 months. No new safety signals were updated. As previously reported, the most common adverse events (AEs) associated with MASCT-I included grade 1 and 2 flushing, pruritus, rash, muscle cramp, fever, and arthralgia. No MASCT-I-related death occurred. Median PFS and OS for all patients were 2.3 months, and 16.9 months, respectively. Patients in G2 presented superior OS of 41.2 months and duration of response (DOR) of 6.4 months. Nine patients treated with MASCT-I and camrelizumab after progression on MASCT-I in G2 presented a 24-month PFS rate of 55.6% and a 48-month DOR rate of 71.8%. Five patients had prolonged PFS for more than 20 months while two of them had PFS of more than 43 months. To identify the potentially beneficial population, IFN-γ ELISPOT data analysis revealed that patients who had positive TAAs ELISPOT response had significant prolonged PFS and OS compared to the non-responders (median PFS: 10.1 months vs 4.8 months, HR=0.30, 95% CI: 0.14-0.61, P&lt;0.005; median OS: not reached vs 13.6 months, HR=0.16, 95% CI: 0.05-0.57, P&lt;0.005). The Cmax value of INF-γ-positive T cells after cell infusion was also higher in patients with better PFS. In addition, we observed a significant increase in INF-γ-positive T cell activities in patients who progressed from G2 and were subsequently treated with a combination of MASCT-I and camrelizumab (Cmax mean (SD): 72 spots per million bulk PBMCs at G2 to 186 spots per million bulk PBMCs after transfer to G3, P=0.002). Conclusions: MASCT-I alone or in combination with immunotherapy or chemotherapy are safe and well tolerated, with inspiring survival benefit. The combination of PD-1 inhibitors may enhance the antitumor activity of MASCT-I. IFN-γ ELISPOT might be able to predict potentially beneficial populations. Clinical trial information: NCT03034304 .

Exploring associations between eating habits, gastrointestinal health and perceived stress and anxiety symptoms in adults

Gastrointestinal (GI) disorders are becoming increasingly common in young people in India and globally (1). Diet (eating habits, nutrient intake, and dietary diversity) and mental health (stress and anxiety levels) factors can independently and synergistically regulate gut health through dietary modulation of gut microbiota composition and gut-brain axis-related mechanistic pathways (2-3). However, few studies have investigated the associations between diet, mental health, and GI-related disturbances. Hence, this observational study was conducted to explore the possible effects of eating behaviors and stress and anxiety symptoms on self-reported measures of gastrointestinal health among 18-45-year-old adults in India.A purposive cluster sampling method guided the recruitment of participants (n=407). Two non- consecutive day 24-hour diet recalls were conducted to estimate nutrient intakes and calculate Individual Diet Diversity (IDD) and Food Variety Scores (FVS). Gastrointestinal health was assessed using a validated instrument comprising 35 items related to gastric, small intestine, and colon function, and GI inflammation. Perceived Stress Scale (PSS-10 scores 0 to 40 with higher scores representing higher levels of stress), and Generalized Anxiety Disorder Scale (GAD-7 scores &gt;5 (mild), &gt;10 (moderate), and &gt;15 (severe)) were used to evaluate perceived stress and anxiety (4-5). Socioeconomic status and eating habits were self-reported and the anthropometry measurements were recorded. Multivariable logistic regression analysis was performed using sociodemographic characteristics, anthropometry measurements, eating habits, and stress and anxiety levels as independent (predictor) variables, and composite gastrointestinal health risk scores as the dependent variables.Participants reported mild anxiety (mean (M) = 7.09, standard deviation (SD)= 3.25) and moderate stress (M=18.44; SD= 9.89) with preponderance among females, higher age groups (&gt; 35 years), and lower socioeconomic status. Overall, 38.8% and 45.3% were at high-risk score categories for gastric function and GI inflammation respectively. Higher energy and fat consumption, frequent breakfast skipping, and lower IDDS and FVS scores were associated with higher scores for stress and anxiety. Moreover, participants having moderate to severe anxiety reported a higher frequency of GI symptoms such as indigestion (M= 3.23 SD= 2.1-4.6, p= 0.023), excessive belching (M= 2.36 SD =1.21, p=0.043), and post-meal lower abdominal discomfort and cramps (M= 3.07, SD = 2.22, p &lt; 0.001) as compared to those having nominal/mild anxiety. Age-adjusted regression models showed higher waist circumference (OR= 4.69, 95% CI =1.33- 7.28, p= 0.034), and stress scores (OR= 1.66, 95% CI= 1.32-1.90, p = 0.042), lower IDDS (OR= 2.34, 95% CI=1.80- 2.91, p &lt;0.001) and presence of &gt; 2 co-morbid conditions (OR= 8.12, 95% CI = 5.34- 11.21, p &lt; 0.001) as predictors of higher GI disorder risk scores.The preliminary findings of the study highlight associations between diet, stress, and GI health, presenting opportunities to modulate diet and optimize mental health to prevent and reduce the severity of GI disorders.

First-line treatment of fecal microbiota transplantation for immune-mediated colitis.

2660 Background: The management of moderate to severe IMC includes immunosuppression with steroids and/or biologic agents. Long-term immunosuppression increases the risk for infections and steroid induced toxicities. Fecal microbiota transplantation (FMT) is increasingly used for the treatment of refractory IMC. Front-line FMT treatment has not been studied for IMC but could potentially alleviate IMC symptoms while reducing unnecessary extended exposure to steroids. In this study, we present a case series of 12 patients who received front-line FMT for the treatment of IMC as part of a clinical trial. Methods: This study reports preliminary data from a prospective clinical trial (NCT0403861) exploring the efficacy and safety of FMT as a first-line treatment for IMC. To be included, patients had to 1) have symptoms of immune-mediated diarrhea or colitis grade ≥ 2 (per Common Terminology Criteria for Adverse Events v5) within 45 days of FMT and 2) not have received any immunosuppressive treatment for IMC or any other indication around the time of FMT. Results: Twelve patients have been enrolled in the trial thus far. Patients received front-line FMT in a median of 31 days (IQR: 16-67 days) from IMC onset. 10 (83.3%) patients had symptom improvement in a median of 5 days (IQR: 1-7 days) after FMT. The only FMT-related adverse events reported were fatigue, transient fever, self-resolving abdominal cramping, and gassiness in six patients (50.0%) within the first week of FMT. One of the six patients additionally had recurrence of a previously existing frequent UTI due to bladder cancer within a week of FMT. Most patients (10, 83.3%) stopped immunotherapy due to IMC. Seven patients (63.6%) were able to resume cancer treatment after FMT, with four (33.3%) resuming checkpoint inhibitors. None of the patients that resumed ICI had recurrence of their colitis requiring immunosuppression. Nine patients (75%) had colitis remission by the end of the study period, with one additional patient showing signs of symptom improvement but passing away before his outcome could be assessed. Only two patients (16.7%) required immunosuppression for persistent colitis after FMT failure. Conclusions: This study is the first to evaluate the safety and efficacy of front-line FMT for the treatment of IMC. Our preliminary results are promising and show that FMT can be an effective first-line treatment for IMC that can quickly provide symptom relief in a majority of patients while avoiding the use of steroids. Our results also suggest that front-line FMT can be delivered in a timely manner and can allow for the safe resumption of immunotherapy in this population that typically responds well to immunotherapy. While more patients are needed before any solid conclusions may be drawn, there is mounting evidence to suggest that first-line FMT may be a safe and effective alternative to the current standard of care treatment for IMC. Clinical trial information: NCT04038619 .

Ethnoveterinary Study of Medicinal Plants of District Okara, Pakistan

Background: Herbal medicines have long been integral to disease treatment, particularly in developing countries like Pakistan, where 84% of the population relies on traditional remedies. The ethnoveterinary practices in District Okara, Punjab, Pakistan, involve the use of medicinal plants for livestock health management. Objective: This study aimed to document and analyze the ethnoveterinary uses of medicinal plants in District Okara, focusing on their application in treating livestock and bird diseases. Methods: The study was conducted in District Okara, located between 31º-55’ and 32º-30’ North latitudes and 74º-35’ and 75º-21’ East longitudes. Ethnoveterinary data were collected from 150 local inhabitants through a semi-structured questionnaire during five visits from April to June 2023. Participants included 46 women and 104 men, aged 25-70 years, from diverse occupations such as hakims, merchants, shepherds, nomads, woodcutters, baildaars, instructors, cowmen, farmers, and local healers. The questionnaire gathered detailed information on livestock diseases treated, medicinal plants used, their local names, plant parts utilized, and preparation methods. Data analysis was performed using SPSS version 25, employing descriptive statistics to summarize demographic characteristics and the usage patterns of medicinal plants. The study adhered to ethical standards as per the Declaration of Helsinki, with verbal consent obtained from all participants. Results: The study identified 60 medicinal plant species from 29 families used to treat livestock ailments. Fabaceae was the largest family, with 8 species, followed by Solanaceae and Apiaceae, each with 5 species. Herbs were the predominant plant habit, comprising 39 species, followed by trees (16 species), shrubs (4 species), and herbaceous vines (1 species). The most frequently used plant parts were leaves, followed by fruits and seeds. The ethnoveterinary practices included the use of Ficus religiosa for foot and mouth disease, Brassica campestris for muscle cramps and heat stress, and Zingiber officinale for oral diseases and fever. Cross-referencing among informants validated the data. Conclusion: This study highlighted the extensive use of medicinal plants in District Okara for livestock health management, with Fabaceae being the most represented family and leaves being the most commonly used plant part. The documentation of these practices underscores the need for conservation efforts to protect these valuable plant resources from threats such as overgrazing, urbanization, and agricultural expansion. Raising awareness among the local population about the importance of medicinal plants is crucial for their preservation and sustainable use.

#2938 The association between serum iron biomarkers and health-related quality of life in patients undergoing dialysis

Abstract Background and Aims Anemia is a very common complication of chronic kidney disease, affecting most patients undergoing dialysis. Iron deficiency, one of the causes of anemia, is generally a second consideration in the management of anemia. Nephrologists mainly focus on the correction of hemoglobin, often prescribing iron therapy for this indication only. However, iron has important physiological functions besides erythropoiesis. Conversely, iron overload can lead to oxidative stress and cellular damage. Therefore, nephrologists have been cautious to prescribe iron therapy to patients with already high serum iron levels. This caution has been underscored by studies linking higher levels of iron to increased mortality. Unfortunately, evidence is lacking regarding the impact of iron on important patient-reported outcomes like health-related quality of life (HRQoL). Therefore, the aim of this study is to explore the association between serum iron biomarkers, health-related quality of life (HRQoL) and the presence of anemia-related symptoms over a one-year period in patients undergoing dialysis. Method Data were obtained from the multicenter, prospective, observational Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO). Adult patients new to dialysis were included, and had a baseline and follow-up assessments at 3, 6 and 12 months, with measurements of serum iron biomarkers ferritin and transferrin saturation (TSAT). HRQoL, encompassing physical and mental HRQoL, was measured using the validated 12-item Short Form Health Survey (SF12, summary scores ranging from 0 to 100). The presence of anemia-related symptoms: fatigue, shortness of breath, restless legs and muscle cramps were assessed using the Dialysis Symptom Index. Patients were categorized into 4 groups depending on their ferritin levels (μg/L): &amp;lt;200, 200–500 (reference), &amp;gt;500–700 and &amp;gt;700, and into 3 groups depending on their TSAT levels (%) at baseline: &amp;lt;20, 20–39 (reference), and ≥40. Longitudinal analyses were conducted using sequential conditional mean models to adjust for time-independent and time-varying confounding. All analyses captured the overall association over a one-year follow-up. Results We included 1069 patients, of whom 76% started hemodialysis, the median age was 68, 66% were male, and 32% were receiving iron therapy. Over a one-year follow-up, patients with ferritin &amp;lt;200 μg/L had similar physical HRQoL (MD=0.5 ; 95% CI –2.4 to 3.3 ) and mental HRQoL (MD=0.04 ; 95% CI -2.0 - 2.0) compared to the reference group with ferritin between 200–500 μg/L. Patients with ferritin between 501–700 μg/L also had a similar physical and mental HRQoL mental HRQoL compared to those with ferritin between 200-500 μg/L. This was also found for patients with ferritin above 700 μg/L (Fig. 1). Similarly, patients with TSAT levels below 20% and patients with TSAT levels ≥40% had comparable physical and mental HRQoL compared the reference group of patients with a TSAT between 20-39% (Fig. 2). For the secondary objectives, we found no significant differences in the anemia-related symptoms fatigue, shortness of breath, restless legs, or muscle cramps between patients with various levels of ferritin nor between the various TSAT groups. Conclusion We found that dialysis patients with higher or lower levels of ferritin or TSAT did not have a significantly different physical or mental HRQoL over a one year-follow up after starting dialysis. Similarly, no significant differences were found in the presence of fatigue, shortness of breath, restless legs, and muscle cramps between patients with these higher or lower levels of serum iron markers. And although iron levels do have impact on clinical outcomes such as mortality, these results suggest that they do not influence patient reported outcomes such as physical and mental HRQoL.

Safety and Effectiveness of Liv.52 DS in Patients With Varied Hepatic Disorders: An Open-Label, Multi-centre, Phase IV Study.

Background The hepatoprotective function of polyherbal formulation Liv.52 in chronic liver diseases is well recognized in published literature. The objective of this open-label, phase IV study was to further strengthen and validate its safety and effectiveness using a large patient pool in a real-world scenario and provide scientific data on symptomatic improvement and supportive treatment in liver function with improvement in quality of life. Methods Adult patients of either sex with one or more clinical symptoms like fatigue, nausea, anorexia, abdominal pain or discomfort, muscle cramps, jaundice, or any other signs and symptoms with a history suggestive of mild-to-moderate hepatic disorders like alcoholic liver disease (ALD), non-alcoholic fatty liver disease (NAFLD), drug-induced hepatotoxicity, or hepatitis were treated with two Liv.52 DS tablets (oral) twice daily for 12 weeks. Results Out of the 1000 enrolled patients, 962 (96%) completed the study with the following subgroups ALD: 375 (38.9%), NAFLD: 379 (39.3%), drug-induced hepatotoxicity: 78 (8.1%), hepatitis: 130 (13.5%). The mean age of enrolled patients was 37.7 years, and the majority of them, 785 (78.5%) were men. The common adverse events observed (with >1.5% incidence) in the study were abdominal pain: 26 (2.6%) and headache: 17 (1.7%). Liv.52 showed statistically significant improvement (P<0.0001) in various clinical signs and symptoms in the majority of patients namely, fatigue: 357/723 (49%), anorexia: 485/620 (78.2%), jaundice: 48/52 (92%). Majority of the patients showed significant improvements from baseline to end of 12 weeks in the liver function test parameters namely, aspartate aminotransferase: 633/840 (75.36%), alanine aminotransferase: 592/729 (81.21%), serum bilirubin: 244/347 (70.32%), alkaline phosphatase: 279/355 (78.59%) with P<0.0001 for all parameters. Statistically significant improvement (P<0.005) was also seen in all the components of the chronic liver disease questionnaire (CLDQ) scores from baseline to 12 weeks. Conclusions The study demonstrated that Liv.52 was hepatoprotective and well tolerated in the study population after treatment for 12 weeks. Significant improvements were seen in clinical signs and symptoms, laboratory parameters of liver function, and CLDQ scores from baseline to 12 weeks. No significant or new safety signals emerged from this study.

#2814 Characterization of cardiological manifestations in patients with sodium-wasting tubulopathies

Abstract Background and Aims Bartter (BS) and Gitelman (GS) syndromes are rare tubulopathies caused by mutations affecting renal NaCl transporters, resulting in similar symptoms like muscle weakness, cramps, and electrolyte imbalances, with GS also presenting with hypomagnesemia. Treatment focuses on electrolyte and fluid balance, using supplements and drugs to inhibit prostaglandin production and RAAS activation. Electrolyte deficits in these conditions can extend the QT interval and increase the risk of potentially fatal cardiac arrhythmias. This study aims to profile BS and GS patients followed at our hospital, focusing on cardiological phenotyping. We assessed diagnostic, clinical, and lab data, particularly examining the link between electrolyte imbalances (like hypokalemia or hypomagnesemia) and electrocardiographic changes or cardiac symptoms during follow-up. Method We screened all BS and GS patients for study inclusion, requiring a genetic diagnosis with disease-causing mutations and comprehensive clinical and electrocardiographic data. We excluded cases lacking sufficient data. We gathered demographic and health information retrospectively, categorizing patients based on electrocardiographic results into groups: 1) persistent long QT interval, 2) transient long QT interval, and 3) no long QT interval. Data were summarized with medians, interquartile ranges, and frequencies. Results A total of 27 patients were enrolled in the study, 16 with Bartter Syndrome (BS) and 11 with Gitelman Syndrome (GS); median length of follow-up was 6 years (range 3-19). Only one patient was classified in group 1, with a constant QTc prolongation (446.3 ms); 8 patients (34.8%) fell into group 2 with median QTc values of 420 ms, all exhibiting hypokalemia and hypomagnesemia. The majority (14/23, 61%) were in group 3, with a median QTc of 399.2 ms and 79% displaying hypokalemia and hypomagnesemia. All 9 patients who experienced cardiac-related symptoms were adults, with 8 presenting these symptoms during intercurrent episodes. The study also compared clinical differences between BS and GS patients, noting a higher frequency of hypokalemia and hypomagnesemia in GS, whereas BS patients had more electrocardiographic alterations, although not statistically significant. No echocardiographic abnormalities were detected from the available data, and there were no recorded incidents of malignant arrhythmias or sudden death. Conclusion Electrocardiographic abnormalities in BS and GS patients fluctuate, often related to episodic events, with QT prolongation in one-third of cases but no severe cardiac complications, indicating a generally positive prognosis.