Gastric Discomfort Research Articles

Daily yerba mate (Ilex paraguariensis A.St.-Hil.) intake does not affect gastric mucosa of rats

Yerba mate (Ilex paraguariensis A.St.-Hil.) is a plant which is widely consumed in South America as an infusion. In recent years, scientific reports have demonstrated the beneficial pharmacological properties of yerba mate on health, particularly its antioxidant effects due to polyphenols content mainly chlorogenic acid and rutin. Nevertheless, several effects on the gastrointestinal system, like gastric discomfort, heartburn, or esophageal reflux, have been suggested by consumers. However, an association between usual intake of yerba mate and the pathogenesis of gastrointestinal disorders has never been demonstrated. We conducted a study to assess the effects of daily intake of yerba mate infusions on gastric mucosa and plasmatic antioxidant properties in rats. Experiments were carried out in 30-day-old female Sprague-Dawley rats. Two different infusions with different concentrations of commercial yerba mate (YM and YM+) were used as ad libitum drinks for 90 days. Macroscopic and microscopic evaluation of gastric mucosa was assessed. In plasma, the total content of polyphenols, the antioxidant capacity and lipid peroxidation were determined. The groups who drank YM and YM+ infusion showed a mucosa with normal characteristics, both macro and microscopically, similar to control animals. Levels of total polyphenols content in plasma were higher in YM+ group compared to controls and both YM groups had lower lipid peroxidation levels. The present study demonstrated that daily intake for 90 days of an infusion of YM would not produce deleterious effects on the gastric mucosa in the absence of concomitant potential harmful factors for the gastric mucosa.

6372 Changes in Blood Steroid Hormone Profile after Switching from Metyrapone to Osilodrostat

Abstract Disclosure: K. Yokozeki: None. H. Kameda: None. A. Miya: None. H. Nomoto: None. A. Nakamura: None. S. Jin: None. K. Matoba: None. T. Atsumi: None. Background: The new steroidogenesis inhibitor osilodrostat has recently been approved for use in Cushing's syndrome. However, there are limited studies on changes in blood steroid hormone profiles after switching from existing drugs including metyrapone. Purpose: To study the changes in steroid hormone profiles with switching from metyrapone to osilodrostat in patients with Cushing's disease and to examine the differences in clinical efficacy. Case 1: A woman in her 40s underwent transsphenoidal pituitary tumor surgery (TSS) for Cushing's disease in X-12, but was not in remission and was treated with 1000 mg/day of metyrapone and oral hydrocortisone. In X-3, the patient complained of masculinization and was started pasireotide LAR 10 mg per month, which was subsequently increased to 30 mg. Despite the addition of 240 mg/day of trilostane in X-2, the patient did not show improvement. Switched the steroidogenesis inhibitors to osilodrostat 4 mg/day in year X, blood cortisol and testosterone levels decreased and the symptoms of virilization disappeared.Case 2: A woman in her 40s experienced edema in her face and limbs, increased appetite and weight gain since Y-13. After endocrinological examination, she was diagnosed with Cushing's disease. TSS was performed and she was in remission. However, she suffered a relapse in Y-4 and was started on metyrapone, which was titrated up to 4,000 mg/day. Due to gastric discomfort, metyrapone was switched to osilodrostat 52 mg/day in year Y, leading to an improvement of her gastric symptoms and stabilized blood cortisol level. Case 3: A woman in her 70s underwent TSS for Cushing's disease in Z-6, but the tumor remained and she was prescribed metyrapone 1,500 mg/day. The disease was stable and complications were under control with metyrapone. In Z-1, the patient developed elevated blood pressure and worsening leg edema, and metyrapone was switched to osilodrostat 3 mg/day in year Z, resulting decreased blood cortisol level and blood pressure. Results: Liquid chromatograph mass spectrometry (LC-MS) analysis of blood steroid hormone profiles in above three cases demonstrated a decrease in 17-OH pregnenolone, 17-OH progesterone, and 11-deoxycorticosterone after switching the steroidogenesis inhibitors. Discussion and Conclusion: It has been noted that osilodrostat lowers serum cortisol in a shorter period of time compared to metyrapone and may also decrease the number of antihypertensive medications used. Under metyrapone administration, hypertrichosis, hypertension, and hypokalemia are often observed with increased mineralocorticoid precursors, but osilodrostat may have a different clinical effect as a result of its different pattern of steroid hormone synthase inhibition. Presentation: 6/2/2024

Sedation with Chloral Hydrate and Melatonin in Childhood Electroencephalography

Objective: Recording an electroencephalography (EEG) in children is challenging due to their restlessness during the procedure and inability to follow the required instructions. Sleep deprivation and the use of sedative agents are necessary to perform the recording. This study aims to compare the success of sedation with chloral hydrate and melatonin. Methods: Patients who underwent EEG recording between December 2023 and March 2024 were retrospectively evaluated. The chloral hydrate and melatonin groups were formed for the patients requiring sedation. According to the protocol applied in our clinic, chloral hydrate was administered orally at a dose range of 30-50 mg/kg (max 1500 mg), while melatonin was given orally at a dose of 1-3 mg. The sociodemographic information of the patients was recorded from hospital charts, sleeping rates and EEG recording duration were compared. Results: Of the 471 patients EEG performed, 240 (51%) were female and 231 (49%) were male. The mean age was 9.1±5.1 years, with a median age of 9.5 years. Sleep deprivation was appropriately carried out in 434 patients (92.3%), while 37 patients did not achieved sleep deprivation. Among the 76 patients who received sedation, chloral hydrate was used in 45 (59.2%) and melatonin in 31 (40.8%). Sleeping ratio were 82.2% and 80.6% in the chloral hydrate and melatonin groups respectively; there was no statistically significant difference in sleeping rates (p: 0.86). No serious drug-related side effects were observed in either group. Rare gastric complaints, such as gastric discomfort and nausea/vomiting were noted in the chloral hydrate group. Conclusion: Melatonin and chloral hydrate provided similar rates of sedation. This study showed either drug can be choosen for the sedation in pediatric EEG recordings.

The Beneficial Effects of Regular Intake of Lactobacillus paragasseri OLL2716 on Gastric Discomfort in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Study.

We investigated the effects of Lactobacillus paragasseri OLL2716 on gastrointestinal symptoms in healthy adults with gastric complaints. In this randomized, double-blind, placebo-controlled trial, 174 healthy Japanese adults were randomly assigned to an OLL2716 or placebo group, and each group consumed 85 g of yogurt containing L. paragasseri OLL2716 or placebo yogurt daily for 12 weeks. The primary endpoint was the change in gastric symptoms from baseline as per the participants' questionnaires at 6 and 12 weeks. The secondary endpoints were changes from baseline in the short-form Nepean Dyspepsia Index (SF-NDI), the Gastrointestinal Symptom Rating Scale (GSRS), and the Council on Nutrition Appetite Questionnaire-Japanese (CNAQ-J) scores at 6 and 12 weeks. The primary endpoint data showed that the changes in "epigastric pain" at 6 and 12 weeks were significantly decreased in the OLL2716 group compared with those in the placebo group. Additionally, the changes in "epigastric pain syndrome-like symptoms" were significantly decreased in the OLL2716 group compared with those in the placebo group at 6 weeks. The SF-NDI items that improved at 6 weeks were "irritable, tense, or frustrated", "enjoyment of eating or drinking", and "tension", which are sub-scales related to mental stress. The items "Over-all" in the GSRS and "feeling hungry" in the CNAQ-J significantly improved in the OLL2716 group compared with the placebo group at 12 weeks. The results suggest that regular intake of L. paragasseri OLL2716 may improve both gastric discomfort and mental stress in healthy adults with gastric complaints, such as postprandial fullness or early satiety.

Cannabinoid syndrome in cannabis dependence: a case report

IntroductionA 36-year-old man with a history of cannabis use disorder since age 16, consuming 8-10 units/day, experienced irritability and tremors upon reducing consumption. His psychiatric issues emerged in 2020, marked by anxiety, abdominal pain, and severe vomiting, leading to a dyspepsia diagnosis. Subsequently, he received psychiatric care at CAS Hospitalet, diagnosed with severe cannabis use disorder. No prior inpatient admissions occurred.Objectives Our project aims to show a case report and summarize the available evidence on cannabinoid hyperemesis syndrome (CHS).MethodsIn May 2023, he voluntarily sought admission to Barcelona’s “Hospital Sant Pau,” aiming for cannabis detox and treatment of cannabinoid hyperemesis. He’d endured years of intense abdominal pain, nausea, and vomiting, worsening over the last two years, with uncontrollable vomiting hindering daily life. Admission saw reduced cannabis use to 3-4 units/day. Inpatient care revealed anticipatory anxiety, rumination, and somatic anxiety, accompanied by distal tremors and internal restlessness due to abdominal discomfort, partially alleviated by 5-10 mg of diazepam.ResultsTreatment included domperidone 10mg/8h, haloperidol drops (5-10 drops/8h), capsaicin ointment, hot showers, and cryotherapy, resulting in gradual relief from abdominal pain. Moderate cravings for tobacco and cannabis led to acetylcysteine 600mg/12h and gabapentin up to 1200mg/8h. Gastric discomfort with SSRIs led to vortioxetine 10 mg/day, well-tolerated with a positive response. Consultation with the GI department confirmed the treatment’s efficacy, emphasizing cannabis abstinence. Upon discharge, cannabinoid hyperemesis symptoms markedly improved, and the patient was referred to “Hospital de Dia.”Conclusions CHS is a cyclic vomiting syndrome, preceded by daily to weekly chronic longstanding use of cannabis that can be difficult to diagnose and treat(1,3,4). It is unique in presentation, because of the cannabis’s biphasic effect as anti-emetic at low doses and pro-emetic at higher doses, and the association with pathological hot water bathing (2). The major characteristics are as follows: history of regular cannabis for any duration of time (100%), cyclic nausea and vomiting (100%), resolution of symptoms after stopping cannabis (96.8%), compulsive hot baths with symptom relief (92.3%), male predominance (72.9%), abdominal pain (85.1%), and at least weekly cannabis use (97.4%)(1). Treatments such as topical capsaicin, haloperidol, benzodiazepines, and propranolol have shown symptom relief (3) whereas opioids should be avoided (4). Cannabis cessation appears to be the best treatment (1,3).

On-Demand PrEP: Clinical Report of Pharmaceutical Care in HIV Pre-Exposure Prophylaxis

Introduction: Pre-Exposure Prophylaxis (PrEP) for HIV involves the combined use of antiretrovirals for individuals frequently exposed to HIV. Initially implemented in Brazil in 2018 with a daily dosing regimen of one pill, on-demand usage was recently (2022) incorporated into routine practice. Aim: To report the experience of providing pharmaceutical care to an on-demand PrEP patient in an outpatient pharmacy within Brazil's Unified Health System. Outlining: This experience report details of pharmaceutical care that included reception of the patient, conducting anamnesis, legally and technically prescription evaluation, dispensing PrEP with verbal guidance on potential adverse events related to pharmacotherapy, and scheduling a return visit to the service. Results: The patient was initially prescribed a daily regimen of PrEP. During the first return consultation, 30 days after starting PrEP, the patient reported adverse effects related to the gastrointestinal tract, leading to the recommendation of an on-demand PrEP regimen. Implications: As of the last pharmaceutical consultation (June 21, 2022), the patient maintained a negative HIV serology, was accustomed to the newly prescribed dosage, and reported reduced gastric discomfort associated with the use of on-demand PrEP. This facilitated adherence to pharmacotherapy and improved the preventive efficacy against HIV infection.

Comparative evaluation of efficacy of diclofenac and ketoprofen administered using transdermal drug delivery route in management of post endodontic pain: A randomized controlled clinical trial.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently used as a postoperative medication after endodontic treatment. The introduction of transdermal patches aided in reducing the discomfort caused by medication prescribed through the oral route. This study aims to compare the efficacy of transdermal patches of diclofenac and ketoprofen for postendodontic pain control. Thirty patients with symptomatic irreversible pulpitis in singlerooted teeth of either arch were endodontically treated by a single endodontist. Oral diclofenac for Group I and transdermal diclofenac patch for Group II and transdermal ketoprofen patch for Group III were administered as postendodontic analgesics. Visual Analog Scale chart was used to record pain intensity preoperatively and at intervals of 4, 8, and 24 h postoperatively. Paracetamol 500 mg tablets were provided as rescue medication. Repeated Measure ANOVA. There was a significant decrease in the postoperative pain intensity scores for both transdermal groups. The postoperative scores gradually decreased from day 1 to day 2. Six out of ten patients who had received diclofenac tablets complained of gastric discomfort. Both transdermal ketoprofen and diclofenac patches were effective than oral diclofenac tablet and can be used as an alternative and effective analgesic for postendodontic pain management, especially in patients with gastric discomfort.

Assessment of oral methotrexate intolerance in Japanese adult patients with rheumatoid arthritis.

The objective of this study was to assess the gastrointestinal side (GI) effects of oral methotrexate (MTX) in Japanese adult patients with rheumatoid arthritis (RA). In this single-center retrospective study, 112 Japanese adult patients (over 18 years old) with RA were examined by Methotrexate Intolerance and Severity assessment in Adults (MISA) questionnaire. Forty-five (40.2%) of patients were MTX intolerant (MISA score ≥1). Twelve patients (11.2%) were moderate-to-severe MTX intolerant (MISA cross-product score ≥4). The most common GI side effects of MTX were gastric discomfort (26.8%), followed by loss of appetite or dysgeusia (14.3%), fatigue and lethargy (12.5%), and nausea (10.7%). Japanese adult patients with RA showed a high prevalence of MTX intolerance even in low-dose oral MTX. The MISA questionnaire was practical for finding patients with MTX intolerance.

Diagnosis of Celiac Disease in a Patient with Isolated Refractory Dyspepsia and GERD: A Case Report

Celiac disease is a chronic autoimmune illness that develops in genetically susceptible persons who consume gluten that causes damage to the small intestine. The average global prevalence of CD is between 0.5 and 1%, despite regional variations in the disease's frequency. In this report, we present a 34-year-old patient with a complaint of epigastric pain and burning with a history of nausea and vomiting. She complained of severe gastric pain, bloating, discomfort, burning, and digestive problems. Endoscopy and colonoscopy were performed due to her lower abdominal pain and it showed that the asymptomatic with isolated dyspepsia patient was diagnosed with celiac disease. Every six months, anti-TCG, IgG, and IgA levels were monitored and they improved at the same time that the patient's symptoms did. Endoscopy must be performed in young patients, who have no signs of celiac disease and have a positive laboratory test.

Study of the Effect of Preoperative Dietary Intervention on Gastrointestinal Reaction of Microparticle TACE

Objective: To evaluate the effect of preoperative dietary intervention on the gastrointestinal reaction of microparticle transcatheter arterial chemoembolization (TACE). Methods: A total of 60 patients with primary liver cancer who were treated in our hospital from January 2018 to October 2018 were selected for this study. The random sampling method was used to divide the patients into an intervention group (30 cases) and a control group (30 cases). The control group received routine intervention, whereas the intervention group received optimized nursing intervention. The incidence of gastrointestinal reactions, the vomiting frequency, the average vomiting volume, the incidence of stomach discomfort, the quality of life, and the anxiety and depression indicators of both groups were compared. Results: The results of all indicators of the intervention group were better than those of the control group. The incidence of gastrointestinal reactions in the intervention group was 13.9%, which was lower than 43.3% of the control group. The scores of QLQ-C30 of the intervention group were higher than those of the control group; the SAS and SDS scores in the intervention group were lower than those of the control group. Conclusion: Preoperative dietary intervention can reduce the incidence of gastrointestinal reactions of microparticle TACE and improve the symptoms of gastric discomfort among patients.

A Randomized Control Study of Oral Itraconazole versus Itraconazole with Terbinafine in the Treatment of Dermatophytosis

Background: Dermatophyte infections are one of the first known fungal infections of humankind and are most common throughout the world. The antifungal therapies over the past 30 years have improved, but the phenomenon of antifungal resistance is still of major concern. Combination therapies can show great promise in overcoming this problem to broaden the spectrum of activity, enhance the rate or extent of killing, and minimize the development of resistance. Objectives: To find out the therapeutic efficacy of itraconazole versus itraconazole with terbinafine for the treatment of dermatophytosis. Materials and Methods: A prospective study was conducted for a duration of 1 year on 64 patients diagnosed with dermatophytosis and was randomly divided into two groups. Group A was given oral itraconazole whereas Group B received oral itraconazole and oral terbinafine for 4 weeks along with levocetirizine daily for 2 weeks and miconazole 2% topically for 6 weeks. The measurability criteria were done on detailed clinical examination (itching, erythema, size, number, scaling, and margin) and through photographic assessment. Results: The mean difference and standard deviation of total scores for group A were 10.12 ± 4.09 and for group B were 9.94 and 3.75, respectively. The P value was not significant (P = 0.78). Out of 64 cases, 3 (5%) patients complained of gastric discomfort, 2 (3%) patients complained of nausea, and 1 (1%) of dizziness. Conclusion: This study revealed that there was a highly significant improvement in both groups with no significant difference in their clinical criteria.

#4383 WHEN SHOULD WE TRY TREATMENT FOR PERITONEAL SCLEROSIS?

Abstract Background and Aims Although it is very important to detect patients at increased risk of developing encapsulating peritonitis (EPS), there are not established predictors which would promote early diagnosis and treatment of EPS ensuring sustainability of peritoneal dialysis (PD). D-Dimers are considered a significant test in evaluation of peritoneal fibrinolysis activity and Ca 125 is used as an alternative marker for the integrity of peritoneal membrane.[1] We examined prospectively a combination of these surrogate markers both in serum and effluent to discern early peritoneal sclerosis. Method In a cohort of 39 PD patients D-Dimers, Ca 125, CRP along with a complete biochemical profile were tested both in serum and overnight effluent dialysate at the beginning of the study. In 9 patients, who presented with recurrent gastrointestinal symptoms, such as mild nausea, incidence of gastric discomfort or sense of bloating, CT imaging was performed for evaluation of potent EPS and thickening of the bowel wall was measured. The latter group of nine patients received tamoxifene for a period of approximately one year and both serum/effluent biomarkers and CT imaging were repeated at the end of this period. Results In Table 1 characteristics of patients are shown. At the beginning of the study CRP was the only biomarker that was different between the group with or without gastrointestinal symptoms (4±6mg/dl vs 0.8±1.1mg/dl, p = 0.04). In patients, who received tamoxifene gastrointestinal symptoms improved. In these patients follow up with CT imaging demonstrated amelioration of bowel wall thickening compared to the beginning (3±1.2mm vs 2.1±0.4mm), which was not statistically significant. Moreover, Ca 125 in dialysate decreased (60.4±74 U/ml vs 27±27 U/ml, p = 0.04). No side effects were recorded. Five patients are still on PD, 3 patients died from unrelated causes and 1 was transferred to hemodialysis. Conclusion In this study neither D-Dimers, a test for the assessment of the peritoneal fibrinolysis activity, nor Ca 125 an alternative marker for assessing the integrity of peritoneal membrane helped us to distinguish patients at risk for EPS. In fact Ca 125 levels in the effluent were higher in the treated group just before initiation of treatment, although in some references it is proposed that it is minimized.[1,2] Clinical evaluation along with radiologic findings led us to the decision to treat patients with tamoxifene, which exerts a protective effect on the peritoneal membrane during both early and late stages of fibrotic disorders.[3] Despite the small number of patients in this study, bowel wall thickening showed a tendency to decrease and symptoms improved.

Determination of Physicochemical, Textural, and Sensory Properties of Date-Based Sports Energy Gel.

Applying energy supplements in gel form may circumvent gastric discomfort and thus it is a practical alternative. The main objective of this investigation was to develop date-based sports energy gels consisting of highly nutritious ingredients such as black seed (Nigella sativa L.) extract and honey. Three date cultivars (Sukkary, Medjool, and Safawi) were used and characterized for their physical and mechanical properties. The sports energy gels were prepared with addition of xanthan gum (0.5% w/w) as the gelling agent. The newly developed date-based sports energy gels were then analysed for proximate composition, pH level, colour, viscosity, and texture profile analysis (TPA). A sensory test was also conducted with 10 panellists who analysed the appearance, texture, odour, sweetness, and overall acceptability of the gel using a hedonic scale. The results showed that different types of date cultivars affect the physical and mechanical properties of the new developed gels. The outputs of the sensory evaluation revealed that the date-based sports energy gel prepared from Medjool received the highest mean score, followed closely by those prepared from Safawi and Sukkary, indicating that, overall, all three cultivars are acceptable to consumers, but the date-based sports energy gel prepared from Medjool is the most preferred one.

Gastroretentive Drug Delivery System in Cancer Chemotherapy.

Chemotherapy for stomach cancer often includes several side effects. The primary reasons for the failure of such treatment approaches are low drug concentrations in target tissues and a short stomach residence time. Gastroretentive controlled drug delivery systems improves the therapeutic performance of chemotherapeutic drugs following oral administration because of the longer gastric retention time. The goal of this study was to find suitable gastroretentive formulations that might be used for the localized treatment of stomach cancer. The purpose of this study is to summarize current advances in gastro-retentive drug administration for oral chemotherapy, with a focus on floating, mucoadhesive, and swellable systems. This article also discusses the potentials and limitations of existing gastroretentive drug delivery systems used in cancer chemotherapy. Due to increased stomach retention and modified drug release properties, gastroretentive controlled drug delivery systems improve the therapeutic performance of anti-cancer drugs used to treat stomach cancer. Gastroretentive drug delivery systems appear to be a promising carrier for localized chemotherapy with smaller doses and better patient compliance. However, selection of drug candidates, drugfood interactions and chemotherapy-induced gastric discomfort remain the key characteristics that must be addressed to improve treatment outcomes.

Evaluation of Water Quality, Urinary Mercury & Arsenic Investigation and Survey of Diseases Associated with Drinking Water Sources

Background: Contamination of freshwater sources can be caused by both anthropogenic and natural processes. WHO reported that 1.1 billion people worldwide consume contaminated water, and the majority of diarrheal diseases (88%) are caused by it. According to Central Pollution Control Board (CPCB), Maharashtra along with two other states contribute 80% of hazardous waste, including heavy metal pollution in India. Certain dissolved heavy metals are easily absorbed by aquatic organisms and can enter the body through drinking water, skin absorption, and biological chains, posing a health risk. Hence, the main objectives of the study were, (1) surface and groundwater quality assessment, (2) to determine the association of diseases/symptoms with different sources of drinking water used, and (3) urinary Mercury (Hg) and Arsenic (As) levels investigation in the study population. Methods: The cross-sectional study was conducted in the industrialized city of Solapur, Maharashtra, India. The study area was limited to 25 km around the industrial hub. A total of 557 people were randomly selected for the survey, with consumers from all four types of water sources i.e., surface, handpump, wells, and municipal water. Spot urine samples were collected for estimating Hg and As levels after considering inclusion and exclusion criteria. People under treatment for tuberculosis, cancer, and chronic heart, lung, or kidney ailments were excluded. Also, pregnant and lactating women were not included. One surface water, one municipal water, and five handpump water samples were collected for evaluating water quality. Samples were analyzed for pH, Total Dissolved Solids (TDS), Dissolved Oxygen (DO), Biological Oxygen Demand (BOD), Chemical Oxygen Demand (COD), Fluoride, Ammonia, Mercury, Arsenic, Cadmium, Lead, Nickel, Copper, Zinc, Chromium, and Manganese. Results: The water samples were observed to be neutral to slightly basic. TDS was between 410 to 1898 mg/L for groundwater whereas for surface water was 378 & 450 mg/L. F concentration ranged between 0.4 to 0.9 mg/L, Zn from 0.32 to 0.57 mg/L, and NH3 was found to be <0.1 mg/L. Out of 557 people, 43 (7.7%) used surface water, 194 (34.8%) used handpump, 64 (11.5%) used well, and 256 (46%) used municipal water. Among surface water users, 14 (32.5%) people reported frequent loose stools (p-value <0.05), and 11 (25.5%) people reported frequent abdominal pain. Handpump and well water users majorly reported frequent abdominal pain and gastric discomfort (p-value <0.05) respectively. 47 people were selected for estimating urinary Hg and As levels after considering exclusion and inclusion criteria. The mean value of urinary Hg & As are 4.91 ± 0.280 & 42.04 ± 2.635 µg/L respectively. Conclusion: In our study frequent loose stools, abdominal pain, and gastric discomfort were associated with the various sources of drinking water. Urine Hg levels were above the permissible reference value set by NHANES (USA) Survey. Additionally, it is advised that frequent drinking water monitoring be implemented in the vicinity of the industrial hub since metal accumulation may be dangerous to consumers when it is present in excess, and if found higher, necessary action should be taken to reduce exposure.

Randomized, Double-Blind, Double-Masked, Parallel Group Clinical Study to Compare the Effectiveness of Diclofenac Potassium 150 mg, LP OD, vs Diclofenac Potassium 50 mg, TID, Three Times a Day, in Knee Osteoarthritis

Background: Osteoarthritis is a chronic disease associated with pain, inflammation, stiffness and synovial effusion, with progressive functional limitation, compromising quality of life. It progressively leads to loss or decrease in joint function. Pharmacological and non-pharmacological therapy seeks symptomatic management, complicated by a lack of adherence. After acetaminophen, non-steroidal anti-inflammatory drugs such as diclofenac are the most widely used medications. Objectives: The primary objective compared the analgesic effect of diclofenac 150 mg once daily vs. 50 mg three times daily in patients with knee osteoarthritis. The secondary objective assessed changes in quality of life. Method: One group received diclofenac 150 mg OD with placebo TTD. Another group received placebo OD and 50 mg active diclofenac (reference) TTD, both for 30 days. The evaluation of pain was carried out by a visual analog scale (VAS), at the beginning, 2, 3, 4, 15 and 30 days, quality of life (the WOMAC scale) and adverse effects, at 15 and 30 days. Results: Pain decreased significantly on days 15 and 30, compared to day 0, in both groups, without differences between groups. The total results in the WOMAC scale showed a very marked improvement at 15 and 30 days, without differences between groups. The most frequent adverse effects were constipation 6% in the reference group, and gastric discomfort 30.3% in the reference group vs 28.1%, in the Test group. Conclusions: Prolonged-release diclofenac 150 mg OD is as effective as diclofenac 50 mg TID for the treatment of patients with knee osteoarthritis.

Design and development of montmorillonite-sodium alginate microbeads for oral sustained delivery of cefaclor

Drug administration via oral route is most suitable for drug delivery to patients. But this route is associated with several drawbacks such as high frequency of administration as well as gastric discomfort. To avoid these problems attempt was made to develop the sustained release system by using nanocomposite clay (MMT) and polymer (Na-Al) based microbeads for oral administration of CFR. The formulations were optimized and validated by using Box–Behnken design with 3 different levels of MMT, Na-Al and CaCl2 wherein the %EE and % drug release at 8 h were considered as dependent responses. The developed formulation was characterized by FT-IR, DSC as well as XRD. The optimized formulation was evaluated for % yield, swelling behavior, particle size, drug release and surface morphology by FESEM. The developed formulation showed physical interaction due to surface adsorption and intercalation of drug with that of MMT. The optimized formulation showed high yield, %EE and swelling behavior due to high amount of MMT and Na-Al. The particle size of the microbeads was below 500 µm and drug release takes place in sustained manner up to 12 h. Polymeric cross-linking and MMT stalking were observed in FESEM study indicated distinctive system. Drug release follow the non-fickian diffusion pattern coupled with matrix release as indicated by Korsemeyer-Peppas (n) value 0.72.

Systemic Analysis of the Anticancer Effects of Sijunzi Decoction on Gastric Cancer Based on Network Pharmacology

Objective: Sijunzi decoction (SJZD) has been used for alleviating peptic ulcer or gastric discomfort, and treating spleen disorders since the Song Dynasty, but its pharmacological effect on human gastric cancer (GC) is still unclear. In this research, a network pharmacology-based strategy was applied to explore active ingredients, potential targets, and molecular mechanisms of SJZD against GC. Methods: The active compounds and potential targets of SJZD, as well as GC-associated gene targets, were retrieved from publicly available databases. Bioinformatics approaches were used to assess the network interaction, functional regulation, and signaling pathways between SJZD ingredients and GC targets. The anticancer effects of SJZD against GC were verified in vivo by a mouse subcutaneous model. Results: The results of network analysis showed that quercetin was the most active ingredient in SJZD. Several prominent target genes of SJZD were identified, such as AKT1 and STAT3. Gene ontology analysis revealed that the core anti-GC targets of SJZD included transcription factor activity and kinase activity. Pathway enrichment analysis indicated that GC patients could be benefited from SJZD treatment via modulation of signaling pathways related to endocrine system, cancer, and infectious disease. Furthermore, in vivo experiments showed that high-dose SJZD could inhibit GC xenograft tumor growth, reduce GC cell proliferation, induce GC cell apoptosis, and decrease the expression of p-AKT1 and p-STAT3. Conclusions: Taken together, our results suggest that SJZD can serve as an effective adjuvant therapeutic agent for GC patients.

Can cyanotoxins explain the clinical features of the thermal crisis in balneotherapy?

Microbial biofilms communities in mineral waters and hot springs have a particular composition with species belonging to different groups such as epsilonproteobacteria and gammaproteobacteria or different siderobacteria and other chymoautrophic organisms, in addition to certain bacillaryophytes, chlorophytes and especially cyanobacteria. Balneotherapy can cause adverse reactions to the usual doses of application of treatments, that consists of a non-specific clinical picture, the so-called "thermal crisis” or “balneointoxication". Despite its clinical similarity (gastric discomfort, hepatic congestive outbreaks, cutaneous reactions, etc.) with that observed in acute cyanotoxin poisonings, thermal crisis has never been associated with the abundant growth of potentially toxic cyanobacteria in the mineral water sources. The aim of this work was to verify the hypothetical involvement of cyanotoxins in this clinical picture. Samples from mostly sulphurous water sources, with thermal characteristics ranging from cold to hyperthermal waters were analysed. ELISA (both in solution and in cellular matrix samples), LC-ESI-HRMS (in cellular matrix samples), and analysis of potential toxicity by means of a standardized bioassay were carried out. The toxic effect observed in the toxicity bioassays in one third of the sources may be related to the existence of microcystins and nodularins and even with other cyanobacterial peptides detected. In addition, several responses observed in the toxicity analyses reflect a pattern, probably linked to a type of hormetic response (hormesis is an adaptive response to low levels of stress, characterized by a biphasic dose-response curve).

Investigating the Influence of Early Gastric Discomfort Symptoms on Life Quality and the Interventional Effects of a Stomach-Protecting Formula

Gastroenterology Medicine & Research Investigating the Influence of Early Gastric Discomfort Symptoms on Life Quality and the Interventional Effects of a Stomach-Protecting Formula Jialun Chen, Bingqi Xie, Wanxiang Zhang, Qianying Chen and Dan Gan* Department of Research and Development, Sirio pharma Co., LTD., China *Corresponding author: Dan Gan, Department of Research and Development, Sirio pharma Co, LTD, NO.1133 Changning Road, Shanghai 200042, China Submission:February 23, 2022;Published: March 04, 2022 DOI: 10.31031/GMR.2022.06.000646 ISSN 2637-7632Volume6 Issue5