Randomized Controlled-Feeding Study of Dietary Emulsifier Carboxymethylcellulose Reveals Detrimental Impacts on the Gut Microbiota and Metabolome.

BACKGROUND & AIMS: Epidemiologic and murine studies suggest that dietary emulsifiers promote development of diseases associated with microbiota dysbiosis. Although the detrimental impact of these compounds on the intestinal microbiota and intestinal health have been demonstrated in animal and in vitro models, impact of these food additives in healthy humans remains poorly characterized. METHODS: To examine this notion in humans, we performed a double-blind controlled-feeding study of the ubiquitous synthetic emulsifier carboxymethylcellulose (CMC) in which healthy adults consumed only emulsifier-free diets (n = 9) or an identical diet enriched with 15 g per day of CMC (n = 7) for 11 days. RESULTS: Relative to control subjects, CMC consumption modestly increased postprandial abdominal discomfort and perturbed gut microbiota composition in a way that reduced its diversity. Moreover, CMC-fed subjects exhibited changes in the fecal metabolome, particularly reductions in short-chain fatty acids and free amino acids. Furthermore, we identified 2 subjects consuming CMC who exhibited increased microbiota encroachment into the normally sterile inner mucus layer, a central feature of gut inflammation, as well as stark alterations in microbiota composition. CONCLUSIONS: These results support the notion that the broad use of CMC in processed foods may be contributing to increased prevalence of an array of chronic inflammatory diseases by altering the gut microbiome and metabolome (ClinicalTrials.gov, number NCT03440229).

The Emulsifier Carboxymethylcellulose Induces More Aggressive Colitis in Humanized Mice with Inflammatory Bowel Disease Microbiota Than Polysorbate-80.

Commonly used synthetic dietary emulsifiers, including carboxymethylcellulose (CMC) and polysorbate-80 (P80), promote intestinal inflammation. We compared abilities of CMC vs. P80 to potentiate colitis and impact human microbiota in an inflammatory environment using a novel colitis model of ex-germ-free (GF) IL10-/- mice colonized by pooled fecal transplant from three patients with active inflammatory bowel diseases. After three days, mice received 1% CMC or P80 in drinking water or water alone for four weeks. Inflammation was quantified by serial fecal lipocalin 2 (Lcn-2) and after four weeks by blinded colonic histologic scores and colonic inflammatory cytokine gene expression. Microbiota profiles in cecal contents were determined by shotgun metagenomic sequencing. CMC treatment significantly increased fecal Lcn-2 levels compared to P80 and water treatment by one week and throughout the experiment. Likewise, CMC treatment increased histologic inflammatory scores and colonic inflammatory cytokine gene expression compared with P80 and water controls. The two emulsifiers differentially affected specific intestinal microbiota. CMC did not impact bacterial composition but significantly decreased Caudoviricetes (bacteriophages), while P80 exposure non-significantly increased the abundance of both Actinobacteria and Proteobacteria. Commonly used dietary emulsifiers have different abilities to induce colitis in humanized mice. CMC promotes more aggressive inflammation without changing bacterial composition.

Adverse events following injection laryngoplasty: An analysis of the MAUDE database.

OBJECTIVE: Injection laryngoplasty (IL) is considered safe in both the operating room and clinical setting. However, safety data is limited to single-institution studies with reduced sample sizes. The objective of this study is to examine a national database for adverse events related to IL in an effort to further confirm the safety of this procedure and better characterize potential complications. MATERIALS AND METHODS: Retrospective analysis of the Manufacturer and User Facility Device Experience (MAUDE) database for reported adverse events of IL procedures utilizing calcium hydroxyapatite (CAHA), hyaluronic acid (HA) and carboxymethylcellulose (CMC) implants from 2009 to 2020. RESULTS AND ANALYSIS: We identified 47 reported adverse events. The average patient age was 54 years old. 59.3% of patients were female. Adverse events more frequently involved the use of CAHA compared to HA or CMC (n = 27, 57.4%, n = 13, 27.7% and n = 7, 14.9%, respectively). The most common adverse events were laryngeal edema (n = 18, 39.1%), improper placement of injected material (n = 12, 26.1%), persistent dysphonia (n = 13, 28.3%), and post-injection dysphagia or odynophagia (n = 11, 23.9%). Major events, defined as requiring emergency room treatment, hospitalization, or surgical intervention accounted for 29 (60.4%) of cases. Four cases of edema required intubation, and one patient necessitated a surgical airway. CONCLUSION: Complications arising from IL range from minor events to airway obstruction and may happen with a variety of injectable materials including CAHA, HA and CMC. Few cases of airway obstruction requiring immediate intervention were identified, confirming the safety of IL in both the operative and office setting.

Efficacy of Sodium Carboxymethylcellulose Compared to Sodium Hyaluronate as Submucosal Injectant for Gastric Endoscopic Submucosal Dissection: A Randomized Controlled Trial.

INTRODUCTION: Sodium hyaluronate (SH) is a useful submucosal injectant for gastric endoscopic submucosal dissection (ESD). On the other hand, sodium carboxymethylcellulose (SCMC), which has high viscosity, has also been applied clinically. We evaluated the efficacy of SCMC compared to that of SH in gastric ESD. METHODS: A prospective randomized controlled trial was conducted to assess the efficacy of 1.0% SCMC as the injectant (SCMC group) compared to 0.4% SH (SH group) for ESD of gastric neoplasms. The primary end point was the procedure time of ESD. Secondary end points were treatment outcomes such as en bloc and R0 resection rates, number of hemostases, amount of injectant, ease of treatment (visual analog scale, 1-10 points), adverse events, and rate of ulcer healing 8 weeks after ESD. RESULTS: A total of 60 patients were enrolled between October 2014 and October 2018, and 30 patients were allocated in each group. The procedure time (mean ± SD, minutes) was not significantly different between the SCMC (74.7 ± 54.5) and SH groups (67.1 ± 41.4) (p = 0.547). Furthermore, there were no differences between the 2 groups in terms of en bloc and R0 resection rates, number of hemostases, amount of injectant, ease of treatment, and rate of ulcer healing. No serious adverse events were observed in either group. CONCLUSION: SCMC was comparable to SH in terms of procedure time, treatment outcome, and ease and safety of treatment in gastric ESD. Further studies are needed to demonstrate the differences between the 2 injectants.

Trial to evaluate the immunogenicity and safety of a melanoma helper peptide vaccine plus incomplete Freund's adjuvant, cyclophosphamide, and polyICLC (Mel63).

BACKGROUND: Peptide vaccines designed to stimulate melanoma-reactive CD4+ T cells can induce T cell and antibody (Ab) responses, associated with enhanced overall survival. We hypothesized that adding toll-like receptor 3 agonist polyICLC to an incomplete Freund's adjuvant (IFA) would be safe and would support strong, durable CD4+ T cell and Ab responses. We also hypothesized that oral low-dose metronomic cyclophosphamide (mCy) would be safe, would reduce circulating regulatory T cells (T-regs) and would further enhance immunogenicity. PARTICIPANTS AND METHODS: An adaptive design based on toxicity and durable CD4+ T cell immune response (dRsp) was used to assign participants with resected stage IIA-IV melanoma to one of four study regimens. The regimens included a vaccine comprising six melanoma peptides restricted by Class II MHC (6MHP) in an emulsion with IFA alone (Arm A), with IFA plus systemic mCy (Arm B), with IFA+ local polyICLC (Arm C), or with IFA+ polyICLC+ mCy (Arm D). Toxicities were recorded (CTCAE V.4.03). T cell responses were measured by interferon γ ELIspot assay ex vivo. Serum Ab responses to 6MHP were measured by ELISA. Circulating T-regs were assessed by flow cytometry. RESULTS: Forty-eight eligible participants were enrolled and treated. Early data on safety and dRsp favored enrollment on arm D. Total enrollment on Arms A-D were 3, 7, 6, and 32, respectively. Treatment-related dose-limiting toxicities (DLTs) were observed in 1/7 (14%) participants on arm B and 2/32 (6%) on arm D. None exceeded the 25% DLT threshold for early closure to enrollment for any arm. Strong durable T cell responses to 6MHP were detected ex vivo in 0%, 29%, 67%, and 47% of participants on arms A-D, respectively. IgG Ab responses were greatest for arms C and D. Circulating T-regs frequencies were not altered by mCy. CONCLUSIONS: 6MHP vaccines administered with IFA, polyICLC, and mCy were well tolerated. The dRsp rate for arm D of 47% (90% CI 32 to 63) exceeded the 18% (90% CI 11 to 26) rate previously observed with 6MHP in IFA alone. Vaccination with IFA+ polyICLC (arm C) also showed promise for enhancing T cell and Ab responses.

Is sodium carboxymethyl cellulose (CMC) really completely innocent? It may be triggering obesity.

The toxicity of sodium carboxymethyl cellulose (CMC), which has GRAS status and has been determined as "ADI non specified", was re-evaluated with a new modelling and molecular-based data. For this purpose, CMC, a food additive, was injected to the yolk sac (food) of the zebrafish embryo by the microinjection method at the 4th hour of fertilization at different concentrations. As a result, it was found that CMC showed no toxic effects within the framework of the parameters studied. But, we determined increasing lipid accumulation in zebrafish embryos exposed to CMC in a dose-dependent manner. To elucidate the mechanism underlying this lipid accumulation, the expression levels of genes related to obesity-linked lipid metabolism were examined. Our findings show that while CMC does not cause a toxic effect in zebrafish embryos, it can lead important effects on lipid metabolism by causing changes in the expression of some genes associated with obesity.

Emulsifiers Impact Colonic Length in Mice and Emulsifier Restriction is Feasible in People with Crohn's Disease.

There is an association between food additive emulsifiers and the prevalence of Crohn's disease. This study aimed to investigate: (i) the effect of different classes of emulsifiers on markers of intestinal inflammation in mice and (ii) the feasibility, nutritional adequacy and symptom impact of restricting all emulsifier classes in Crohn's disease. Mice were exposed to different classes of emulsifiers (carboxymethycellose, polysorbate-80, soy lecithin, gum arabic) in drinking water for 12-weeks, after which markers of inflammation and metabolism were measured. A low emulsifier diet was developed to restrict all classes of emulsifiers and its feasibility measured over 14-days in 20 participants with stable Crohn's disease. Crohn's disease-related symptoms, disease control, body weight and composition, nutrient intake and food-related quality of life (QoL) were measured. All emulsifiers resulted in lower murine colonic length compared with control (mean 9.5 cm (SEM 0.20)), but this only reached significance for polysorbate-80 (8.2 cm (0.34), p = 0.024) and carboxymethylcellulose (8.0 cm (0.35), p = 0.013). All 20 participants completed the feasibility study. The frequency of consuming emulsifier-containing foods decreased by 94.6% (SD 10.3%). Food-related QoL improved between habitual (median 81.5 (IQR 25.0)) and low emulsifier diet (90.0 (24.0), p = 0.028). Crohn's disease-related symptoms reduced (median 3.0 (IQR 5.3) vs. 1.4 (3.9), p = 0.006), and disease control scores improved (13.5 (IQR 6.0) vs. 15.5 (IQR 3.0), p = 0.026). A range of emulsifiers may influence intestinal inflammation in mice, and dietary restriction of emulsifiers is feasible. Trials investigating the efficacy of a low emulsifier diet in Crohn's disease are warranted.

Cerebrospinal fluid neurotransmitter levels and central nervous system depression in a rat drug overdose model.

A neuropsychiatric drug overdose impairs physiological function via central nervous system (CNS) depression. In drug-related deaths, only the drug concentration can currently provide information regarding CNS depression in victims. In this study, using a drug overdose model, we investigated the ability of neurotransmitters in the cerebrospinal fluid (CSF) to serve as biomarkers for CNS depression. Four groups of rats were orally administered diazepam (200 mg/kg) and/or phenobarbital (100 mg/kg) or vehicle. In a hot plate test performed to assess physiological impairment, drug-administered animals showed prolongation of the response latency. Serum drug concentrations were also sufficient to observe the effect of drug overdose. The levels of benzoyl-derivatized neurotransmitters were measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis. Noradrenaline, adrenaline, serotonin, melatonin, phosphoethanolamine, and histamine levels in the CSF decreased as the response latencies in the hot plate test increased. These reduced CSF neurotransmitter levels may represent physiological dysfunction through CNS depression.

Lactic acid 5% mouth wash vs Kenalog in Orabase 0.1% for treatment and prophylaxis of recurrent aphthous ulcer.

BACKGROUND: The outcomes of most therapeutic modalities for recurrent aphthous ulcer (RAU) are still unsatisfactory. AIM: To evaluate lactic acid 5% mouth wash vs Kenalog in Orabase for treatment and prophylaxis of RAU. PATIENTS/METHODS: Forty cases with early-onset idiopathic RAU were enrolled in this study. Patients were divided into two equal groups; group A patients had used Kenalog in Orabase twice daily, and group B patients had used lactic acid 5% mouth wash 3 times daily. All patients had used the therapy for 1-2 weeks according to patients' clinical response that was evaluated according to oral clinical manifestations index (OCMI); before therapy, during course of treatments and in follow-up visits. RESULTS: At the ends of both first and second weeks, from beginning of therapy, OCMI was reduced more in group B patients than in group A with statistically significant results. These results revealed that group B achieved more reduction in the size, pain, and healing time of RAU. During the follow-up period, group A showed 40% recurrence rate while group B showed 5% only. CONCLUSIONS: Lactic acid 5% mouth wash is natural, safe, and effective so it is better alternative to corticosteroids for treatment and prophylaxis of RAU without any side effects.

A multipeptide vaccine plus toll-like receptor agonists LPS or polyICLC in combination with incomplete Freund's adjuvant in melanoma patients.

BACKGROUND: Cancer vaccines require adjuvants to induce effective immune responses; however, there is no consensus on optimal adjuvants. We hypothesized that toll-like receptor (TLR)3 agonist polyICLC or TLR4 agonist lipopolysaccharide (LPS), combined with CD4 T cell activation, would support strong and durable CD8+ T cell responses, whereas addition of an incomplete Freund's adjuvant (IFA) would reduce magnitude and persistence of immune responses. PATIENTS AND METHODS: Participants with resected stage IIB-IV melanoma received a vaccine comprised of 12 melanoma peptides restricted by Class I MHC (12MP), plus a tetanus helper peptide (Tet). Participants were randomly assigned 2:1 to cohort 1 (LPS dose-escalation) or cohort 2 (polyICLC). Each cohort included 3 subgroups (a-c), receiving 12MP + Tet + TLR agonist without IFA (0), or with IFA in vaccine one (V1), or all six vaccines (V6). Toxicities were recorded (CTCAE v4). T cell responses were measured with IFNγ ELIspot assay ex vivo or after one in vitro stimulation (IVS). RESULTS: Fifty-three eligible patients were enrolled, of which fifty-one were treated. Treatment-related dose-limiting toxicities (DLTs) were observed in 0/33 patients in cohort 1 and in 2/18 patients in cohort 2 (11%). CD8 T cell responses to 12MP were detected ex vivo in cohort 1 (42%) and in cohort 2 (56%) and in 18, 50, and 72% for subgroups V0, V1, and V6, respectively. T cell responses to melanoma peptides were more durable and of highest magnitude for IFA V6. CONCLUSIONS: LPS and polyICLC are safe and effective vaccine adjuvants when combined with IFA. Contrary to the central hypothesis, IFA enhanced T cell responses to peptide vaccines when added to TLR agonists. Future studies will aim to understand mechanisms underlying the favorable effects with IFA. TRIAL REGISTRATION: The clinical trial Mel58 was performed with IRB (#15781) and FDA approval and is registered with Clinicaltrials.gov on April 25, 2012 (NCT01585350). Patients provided written informed consent to participate. Enrollment started on June 24, 2012.

Efficacy of an antiadhesive agent for the prevention of intra-abdominal adhesions after radical gastrectomy: A prospective randomized, multicenter trial.

BACKGROUND: Guardix-SG is a poloxamer-based antiadhesive agent. The aim of this study was to investigate its efficacy in preventing abdominal adhesions in gastric cancer patients undergoing gastrectomy. Few clinical studies have reported that antiadhesive agent reduces the incidence of adhesion after gastrectomy. METHODS: We conducted a multicenter trial from June 2013 and August 2015 in patients with gastric adenocarcinoma undergoing radical gastrectomy. Patients were randomly assigned to the Guardix treatment or control group. Postoperative adhesions were diagnosed based on postoperative symptoms, plain x-ray films, and computed tomography. The primary endpoint of the study was the incidence of small bowel obstruction in the first postoperative year. The secondary end-point was the safety of Guardix-SG. RESULTS: The study included 109 patients in the Guardix group and 105 patients in the control group. The groups were similarly matched with pathological stage, operation type, anastomosis method, midline incision length, and the extent of lymph node dissection. Eight in the Guardix group and 21 in the control group experienced intestinal obstruction during the 1-year follow-up period. The cumulative incidence of small bowel obstruction was significantly lower in the Guardix group compared to that seen in the control group (4.7% vs 8.6% at 6 months and 7.3% vs 20% at 1 year; P = .007, log-rank test). There were no differences in postoperative complications and adverse events. CONCLUSION: Guardix-SG significantly decreased the incidence of intestinal obstruction without affecting the incidence of postoperative complications.

Xenoenxerto (pele da Tilápia-do-Nilo) e hidrofibra com prata no tratamento das queimaduras de II grau em adultos / Nile tilapia skin xenograft versus silver-based hydrofiber dressing in the treatment of second-degree burns in adults

Introdução: Estudos recentes apontam a utilização do curativo biológico com base em animais aquáticos como biomaterial na medicina regenerativa, apresentando boa aderência ao leito das feridas. O objetivo foi avaliar a eficácia da utilização da pele da Tilápia-do-Nilo (Oreochromis niloticus) como curativo biológico oclusivo, no manejo/tratamento de queimaduras de 2º grau em adultos. Métodos: Estudo clínico com 30 pacientes aleatoriamente tratados com pele da Tilápia-do-Nilo (n = 15) e hidrofibra com prata Aquacel Ag® (n =1 5). Resultados: Em relação à duração, o tratamento com a pele da Tilápiado-Nilo obteve uma média de dias de tratamento (9,6 ± 2,4) similar ao material comparativo (10,7 ± 4,5). Quanto ao relato de dor durante a troca de curativos, não houve diferença estatisticamente significante (p > 0,68) entre os grupos. Após a troca do curativo, não houve inferioridade no registro do valor na escala analógica de dor, em que 66,7% dos tratados com pele da Tilápia-do-Nilo relataram diminuição dos eventos álgicos. Constatou-se ainda que 60% dos pacientes tratados com a pele da Tilápia-do-Nilo não tiveram seus curativos substituídos em qualquer momento do tratamento. Para o curativo Aquacel AG®, 53,3% dos pacientes tiveram mais de uma substituição de curativos. Conclusões: Com base na pesquisa, pode-se concluir que a pele da Tilápia-do-Nilo é eficaz como curativo biológico oclusivo. Houve similaridade entre os grupos para a média de dias de tratamento (completa cicatrização da ferida) e para o relato de dor durante a realização do curativo. Também, a não inferioridade relacionada a dor após os curativos e suas trocas (quando existentes) e na quantidade de substituições destes.

Introduction: Recent studies have suggested the use of biological dressings made of aquatic animals as biomaterials in regenerative medicine since they demonstrate good adherence to the wound bed. The objective of this study was to evaluate the efficacy of Nile tilapia skin (Oreochromis niloticus) as an occlusive biological dressing in the management and treatment of second-degree burns in adults. Methods: This clinical study included 30 patients randomly treated with Nile tilapia skin (n = 15) or Aquacel Ag® silver-based hydrofiber dressing (n = 15). Results: The Nile tilapia skin yielded a similar mean treatment time (9.6 ± 2.4 days) to that of the comparative material (10.7 ± 4.5 days). There was no statistically significant intergroup difference (p > 0.68) in pain during dressing changes. No disadvantage in pain was noted, as 66.7% of patients treated with Nile Tilapia skin reported a decrease in pain events. Moreover, 60% of the patients treated with the Nile Tilapia skin did not require dressing replacement at any time during treatment. For the Aquacel AG® dressing, 53.3% of the patients required more than one dressing replacement. Conclusions: Our findings suggest that the Nile tilapia skin is as effective as an occlusive biological dressing. The average treatment time (complete wound healing) and pain reports during dressing changes were similar between groups. Furthermore, pain after and number of dressing exchanges (when performed) were not worse.

Anaphylaxis to Carboxymethylcellulose: Add Food Additives to the List of Elicitors.

A 14-year-old girl developed 4 episodes of anaphylaxis of unknown etiology, which required intramuscular adrenaline administration each time. She had eaten pizza and a cheeseburger immediately before the first 2 episodes, respectively, but had not eaten anything for several hours before the last 2 episodes. It turned out that she had eaten the same ice lolly 4 hours before the first 3 episodes and a Café au lait Swirkle (a half-frozen beverage) 4 hours before the last episode. We detected carboxymethylcellulose sodium as the only common ingredient in all anaphylactic episodes. Skin prick tests were positive for carboxymethylcellulose solution and carboxymethylcellulose-containing food products. We obtained a custom-made carboxymethylcellulose sodium-free ice lolly from the manufacturer and confirmed that it did not induce anaphylactic reactions by a challenge test. Carboxymethylcellulose, an anionic water-soluble polymer derived from native cellulose, is considered to be unabsorbable from the human gut and has been widely and increasingly used in pharmaceutical preparations, cosmetics, and food. This article is the first report of anaphylaxis caused by carboxymethylcellulose-containing foods, whereas anaphylaxis to carboxymethylcellulose has been rarely associated with carboxymethylcellulose-containing pharmaceuticals. Although the exact mechanisms underlying the induction of late-onset anaphylaxis by carboxymethylcellulose remain unclear, a small minority of cellulose-digesting microbial flora in the human colon and contamination of food products with carboxymethylcellulose of low molecular weight might be involved. The induction of recurrent anaphylaxis by various products should be a clue that prompts physicians to suspect food additives as a cause for anaphylaxis.

Evaluation of a Shorter Follow-up Time to Capture Benefit of a Trial Vocal Fold Augmentation.

OBJECTIVE: Trial vocal fold injection (TVFI) is employed diagnostically for patients with subtle glottic insufficiency to explore potential for improvement. Clinical experience demonstrates the time to and length of peak benefit of the TVFI is variable. Previous studies collected data 4 weeks or more after TVFI. The aim of this study was to compare subjectively successful and unsuccessful TVFI patient groups. It is hypothesized that patients with subjectively reported success will also have significant improvements in Voice Handicap Index-10 (VHI-10), phase closure percentage, and aerodynamic measures 2 weeks after trial augmentation. METHODS/DESIGN: Subjects with glottic insufficiency were included in this retrospective review if they underwent office-based, per-oral vocal fold injection augmentation specifically for trial purposes. Patients were divided into "successful" and "unsuccessful" groups based on their subjective experience during the 2-week post-TVFI period. VHI-10, subjective report, phase closure evaluation using frame-by-frame analysis, and aerodynamic data were collected pre- and 2 weeks post-TVFI. RESULTS: Of the subjects, 15 of 23 (65%) reported a successful subjective improvement of their symptom, whereas 8 (35%) were unsuccessful (only partial improvement or no improvement). The number of subjects with an improvement in VHI-10 by 5 or more points was not significantly different between groups. The number of subjects that demonstrated complete, long phase closure was significantly higher in the successful group (P = 0.021). CONCLUSIONS: The understanding of how to more precisely determine the success of TVFI remains incomplete. Subjective improvement of successful TVFI was captured with basic clinical questioning, yet the VHI-10 was unable to confidently demonstrate this reported success 2 weeks after TVFI.

Prolonged pain reducing effect of sodium hyaluronate-carboxymethyl cellulose solution in the selective nerve root block (SNRB) of lumbar radiculopathy: a prospective, double-blind, randomized controlled clinical trial.

BACKGROUND: The pattern of linear graph schematized by visual analogue scale (VAS) score displaying pain worsening between 2 days and 2 weeks after selective nerve root block (SNRB) is called rebound pain. PURPOSE: The purpose of this study was to determine if sodium hyaluronate and carboxymethyl cellulose solution (HA-CMC sol) injection could reduce the occurrence of rebound pain at 3 days to 2 weeks after SNRB in patients with radiculopathy compared with injection with corticosteroids and local anesthetics alone. STUDY DESIGN/SETTING: Double blinded randomized controlled clinical trial. PATIENT SAMPLE: A total of 44 patients (23 of 24 patients in the Guardix group and 21 of 24 patients in the control group) who finished the follow-up session were subjects of this study. OUTCOME MEASUREMENT: Patients were asked to write down their average VAS pain scores daily for 12 weeks. Functional outcomes were assessed by Oswestry Disability Index, Roland Morris Disability Questionnaire , and Short Form-36. METHOD: A cocktail of corticosteroids, 1% lidocaine, 0.5% Bupivacaine, and 1 mL of normal saline was used for the control group whereas a cocktail of corticosteroids, 1% lidocaine, 0.5% Bupivacaine, and 1 mL of HA-CMC solution was used for the G group. Study participants were randomized into one of two treatment regimens. They were followed up for 3 months. RESULTS: VAS score at 2 weeks after the procedure was 4.19±1.32 in the control group, which was significantly (p<.05) higher than that (2.43±1.24) in the G group. VAS score at 6 weeks after the procedure was 4.00±1.23 in the control group and 3.22±1.45 in the G group, showing no significant (p=.077) difference between the two groups. There were no significant differences in functional outcomes at 6 or 12 weeks after the procedure. CONCLUSIONS: Compared with conventional cocktail used for SNRB, addition of HA-CMC sol showed effective control of rebound pain at 3 days to 2 weeks after the procedure.

Acute Exposure to Commonly Ingested Emulsifiers Alters Intestinal Mucus Structure and Transport Properties.

The consumption of generally regarded as safe emulsifiers has increased, and has been associated with an increased prevalence of inflammatory bowel and metabolic diseases, as well as an altered microbiome. The mucus barrier, which selectively controls the transport of particulates and microorganisms to the underlying epithelial layer, has been previously shown to be altered by dietary salts and lipids. However, the potential impact of emulsifiers on the protective mucus barrier, its permeability, and associated structural changes are not clear. In this study, we analyzed changes in the mucus barrier to both passively diffusing nanoparticles and actively swimming E. coli upon exposure to two emulsifiers, carboxymethylcellulose (CMC) and polysorbate 80 (Tween). When exposed to CMC, mucus pore size decreased, which resulted in significantly slower E. coli speed and particle diffusion rates through mucus. Tween exposure minimally impacted mucus microstructure and particle diffusion, but increased E. coli speed in mucus. Moreover, both emulsifiers appeared to alter mucus amount and thickness in rat intestinal tissue and mucus-producing cell cultures. These results indicate that acute exposure to emulsifiers impacts barrier and structural properties of intestinal mucus, modulating interactions between intestinal lumen contents, microbes, and underlying tissue, which may contribute to development of intestinal inflammation.