Standardized Protocols for Clinical and Histopathological Characterization of Hidradenitis Suppurativa Tissue Specimens.

Methods for describing and reporting the clinical and histologic characteristics of cutaneous tissue samples from patients with hidradenitis suppurativa (HS) are not currently standardized, limiting clinicians' and scientists' ability to uniformly record, report, and communicate about the characteristics of tissue used in translational experiments. A recently published consensus statement outlined morphological definitions of typical HS lesions, but no consensus has been reached regarding clinical characterization and examination of HS tissue samples. In this study, we aimed to establish a protocol for reporting histopathologic and clinical characteristics of HS tissue specimens. This study was conducted from May 2023 to August 2023. Experts in clinical care, dermatopathology, and translational research were recruited, and a modified Delphi technique was used to develop a protocol for histologic reporting and clinical characterization of submitted tissue specimens from patients with HS. A total of 27 experts participated (14 dermatologists, 3 fellowship-trained dermatopathologists, 3 plastic surgeons, 3 general surgeons, and 4 research scientists) in creating and reviewing protocols for the clinical and histopathological examination of HS tissue specimens. The protocols were formatted as a synoptic report and will help to consistently classify specimens in biobanks on the basis of histologic features and more accurately report and select samples used in translational research projects.

Patient and Family Mistreatment of Residents in the Surgical Learning Environment.

OBJECTIVE: Identify the frequency and types of mistreatment experienced by residents from patients and their families (P&F) and determine whether the types and frequency varied based on resident gender. DESIGN: An anonymous survey was distributed to residents to assess the types of P&F mistreatment toward residents and the association with resident gender. SETTING: The survey was distributed to the general surgery and urology programs at a large academic medical center in the mid-Atlantic. Participants: 23 of 53 residents (43% response rate) participated in the anonymous survey. Residents: 15 male residents (65%), 8 female residents (35%). Results: 12 of 23 responding residents (52%) indicated they experienced at least one form of mistreatment from P&F. Women were more likely to experience mistreatment (88% vs. 33%), with verbal assault was the most frequent (50% for female residents, 33% for male residents). Patients were more often the source than families (52% vs. 41%); verbal assault or threats of physical harm were the most common (50% for female residents, 33% for male residents). CONCLUSIONS: Residents experience mistreatment from multiple sources. This paper provides insight into the experiences of surgical residents with mistreatment from their P&F, with differences in frequency of behaviors dependent upon the perpetrator group and resident gender. Patients and their family mistreatments are likely underreported and may be more difficult to prevent. It is important to identify mitigation strategies and ensure resources are available for those residents experiencing mistreatment. A strong culture against mistreatment and providing specific resources may minimize the experience and negative effects of mistreatment.

Surgical Procedural Definitions for Hidradenitis Suppurativa Developed by Expert Delphi Consensus.

Importance: Various surgical approaches for hidradenitis suppurativa (HS) have been described in the literature, but the nomenclature is inconsistent. Excisions have been described as wide, local, radical, and regional with variable descriptions of margins. Deroofing procedures have been described with various approaches though descriptions of the approach are generally more uniform. No international consensus has been formed to globally standardize terminology for HS surgical procedures. Lack of such agreement may contribute to misunderstanding or misclassification in HS procedural research studies and impair clear communication among clinicians or between clinicians and patients. Objective: To create a set of standard definitions for HS surgical procedures. Design, Setting, and Participants: This consensus agreement study was conducted from January to May 2021 using the modified Delphi consensus method to reach agreement among a group of international HS experts regarding standardized definitions for an initial set of HS surgical terms, including "incision and drainage," "deroofing/unroofing," "excision," "lesional excision," and "regional excision," ultimately expanded to 10 terms. Provisional definitions were drafted based on existing literature and discussion among an expert 8-member steering committee. Online surveys were disseminated to members of the HS Foundation, direct contacts of the expert panel, and the HSPlace listserv to reach physicians with considerable experience with HS surgery. Consensus was defined as greater than 70% agreement to accept a definition. Results: In the first and second modified Delphi round, 50 and 33 experts participated, respectively. Ten surgical procedural terms and definitions reached consensus with greater than 80% agreement. Overall, the term "local" excision was abandoned and replaced with the descriptors "lesional" or "regional" excision. Of note, "regional" replaced the terms "wide" and "radical" excision. Furthermore, modifiers such as "partial" vs "complete" should also be included when describing surgical procedures. A combination of these terms helped formulate the final glossary of HS surgical procedural definitions. Conclusion and Relevance: An international group of HS experts agreed on a set of definitions describing surgical procedures frequently used by clinicians and in the literature. The standardization and application of such definitions are vital to allow for accurate communication, reporting consistency, and uniform data collection and study design in the future.

Keratinocytes and immune cells in the epidermis are key drivers of inflammation in hidradenitis suppurativa providing a rationale for novel topical therapies.

BACKGROUND: Hidradenitis suppurativa (HS) is a debilitating inflammatory skin disease characterized by painful nodules, drainage and scarring in skin folds. Injectable adalimumab is the only drug approved by the US Food and Drug Administration for the treatment of HS. Although systemic Janus kinase (JAK) inhibitors show promise, serious side-effects have been reported. There are no highly effective topical treatments for HS; furthermore, the contribution of epidermal keratinocytes to the intense inflammation has largely been unexplored. OBJECTIVES: We investigated the role of keratinocytes and epidermal immune cells in HS inflammation at all Hurley stages of disease severity. We aimed to determine whether ruxolitinib can mitigate inflammation from keratinocytes and to develop a better understanding of how topical therapeutics might benefit patients with HS. METHODS: We used skin samples from 87 patients with HS (Hurley stages I-III) and 39 healthy controls to compare keratinocyte- and immune cell-driven epidermal inflammation, in addition to the response of lesional HS keratinocytes to treatment with interferon (IFN)-γ and ruxolitinib. We used haematoxylin and eosin staining, immunohistochemistry, immunoblotting and quantitative reverse-transcription polymerase chain reaction assessments in whole skin, isolated epidermis, and cultured keratinocytes from healthy controls and both nonlesional and lesional HS skin to identify and define epidermal and keratinocyte-mediated inflammation in HS and how this may be targeted by therapeutics. RESULTS: HS lesional keratinocytes autonomously secreted high levels of chemokines, such as CCL2, CCL3 and CXCL3, which recruited neutrophils, CD8 T cells, and natural killer cells to the epidermis. Keratinocytes were the dominant source of tumour necrosis factor-α and interleukin (IL)-6 in HS lesions with little to no contribution from underlying dermal immune cells. In the presence of IFN-γ, which is dependent on immune cell infiltrate in vivo, keratinocytes expressed increased levels of additional cytokines including IL-1ß, IL-12, IL-23 and IL-36γ. The JAK inhibitor ruxolitinib mitigated the expression of inflammatory cytokines and chemokines in HS lesional keratinocytes, thus providing a rationale for future study as a topical treatment for HS. CONCLUSIONS: This study demonstrates that keratinocytes actively recruit immune cells to HS epidermis and interactions between these cells drive a broad inflammatory profile in HS epidermis. Targeting epidermal inflammation in HS with novel topical formulations may be highly efficacious with reduced systemic side-effects.

Core EPAs in the Acting Internship: Early Outcomes from an Interdepartmental Experience.

INTRODUCTION: The Core Entrustable Professional Activities for Entering Residency (Core EPAs) are clinical activities all interns should be able to perform on the first day of residency with indirect supervision. The acting (sub) internship (AI) rotation provides medical students the opportunity to be assessed on advanced Core EPAs. MATERIALS AND METHODS: All fourth-year AI students were taught Core EPA skills and performed these clinical skills under direct supervision. Formative feedback and direct observation data were provided via required workplace-based assessments (WBAs). Supervising physicians rated learner performance using the Ottawa Clinic Assessment Tool (OCAT). WBA and pre-post student self-assessment data were analyzed to assess student performance and gauge curriculum efficacy. RESULTS: In the 2017-2018 academic year, 167 students completed two AI rotations at our institution. By their last WBA, 91.2% of students achieved a target OCAT supervisory scale rating for both patient handoffs and calling consults. Paired sample t tests of the student pre-post surveys showed statistically significant improvement in self-efficacy on key clinical functions of the EPAs. DISCUSSION: This study demonstrates that the AI rotation can be structured to include a Core EPA curriculum that can assess student performance utilizing WBAs of directly observed clinical skills. CONCLUSIONS: Our clinical outcomes data demonstrates that the majority of fourth-year medical students are capable of performing advanced Core EPAs at a level acceptable for intern year by the conclusion of their AI rotations. WBA data collected can also aid in ad hoc and longitudinal summative Core EPA entrustment decisions. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40670-021-01208-y.

Impact of a Unit-Based Clinical Pharmacist on Communication of Medication Information in an Orthopedic Hospital.

BACKGROUND: Medication management, a complex yet essential part of patient care, requires that clinicians and patients understand indication, dosage, frequency, and adverse effects in order to maximize benefits and minimize errors, as well as to transition patients from hospital to home. Clinical pharmacists improve care transitions and safety by interacting with patients, prescribers, and nurses on medication management and self-care. However, little is known on the use of clinical pharmacists on interdisciplinary teams at the unit level within orthopedics. QUESTIONS/PURPOSES: This study sought to measure the impact of unit-based clinical pharmacists on patient perceptions of communication specific to medication during hospitalization at an orthopedic specialty hospital and on the frequency of medication errors. METHODS: A retrospective, quasi-experimental, two-group evaluative design with nonequivalent controls was used. Consumer Assessment of Healthcare Providers and Systems (HCAHPS) data on six inpatient units was analyzed 6 months before and 6 months after assignment of clinical pharmacists to half these units. Data specific to questions that measure quality of communication as well as medication understanding were analyzed. Additionally, data on medication error frequency were collected and compared between units with and without clinical pharmacists. RESULTS: A total of 2022 surveys were analyzed. The percentage of patients who reported receipt of medication information and medication understanding increased significantly after the implementation of unit-based clinical pharmacists. Comparison of intervention and non-intervention groups showed no statistically significant difference in the frequency of medication errors. CONCLUSION: Results suggest that a clinical pharmacist assigned to an inpatient unit in orthopedics significantly influences patient perceptions of communication about and understanding of their medications.

Nucleotides Cytidine and Uridine Associated with Vitamin B12 vs B-Complex Vitamins in the Treatment of Low Back Pain: The NUBES Study.

PURPOSE: We report the results of low back pain treatment using a combination of nucleotides, uridine (UTP), cytidine (CMP) and vitamin B12, vs a combination of vitamins B1, B6, and B12. PATIENTS AND METHODS: Randomized, double-blind, controlled trial, of a 60-day oral treatment: Group A (n=317) receiving nucleotides+B12 and Group B (n=317) receiving B vitamins. The primary endpoint was the percentage of subjects in each group presenting adverse events (AEs). Secondary endpoints were visual analog scale (VAS) pain scores at Visit 2 (day 30) and Visit 3 (day 60) in relation to pretreatment values, Roland-Morris Questionnaire (RMQ) scores and finger-to-floor distance (FFD) (percentage of subjects per group presenting improvement ≥5 points and ≥3cm, respectively). RESULTS: Seventy-five (24%) and 105 (33%) subjects (P=0.21) presented 133 and 241 AEs, with 3159% of subjects presenting ≥2 AEs (P=0.0019) in Group A and Group B, respectively. Twenty-four subjects in Group B were discontinued due to AEs, while no AE-related discontinuations occurred in Group A (P<0.0001). VAS score reduction after 30 and 60 days of treatment was statistically significant (P<0.0001) in both groups, with Group A showing greater reduction at Visit 2 (P<0.0001). RMQ score improvement ≥5 points occurred in 99% of subjects from each group, and FFD improvement ≥3 cm occurred in all subjects. CONCLUSION: Treatment with nucleotides+B12 was associated with a lower number of total AEs, fewer AEs per subject, and no AE-related treatment discontinuation. Pain intensity (VAS) reduction was superior at 30 days of treatment in the nucleotides+B12 group and equivalent between groups at 60 days of treatment. Improvements in efficacy measures RMQ and FFD were observed in both groups at treatment days 30 and 60.

What Makes Wounds Chronic.

Chronic wounds present a unique therapeutic challenge to heal. Chronic wounds are colonized with bacteria and the presence of a biofilm that further inhibits the normal wound healing processes, and are locked into a very damaging proinflammatory response. The treatment of chronic wounds requires a coordinated approach, including debridement of devitalized tissue, minimizing bacteria and biofilm, control of inflammation, and the use of specialized dressings to address the specific aspects of the particular nonhealing ulcer.

Local Topic Mining for Reflective Medical Writing.

Reflective writing is used by medical educators to identify challenges and promote inter-professional skills. These non-medical skills are central to leadership and career development, and are clinically relevant and vital to a trainees success as a practicing physician. However, identification of actionable feedback from reflective writings can be chal- lenging. In this work, we utilize a Natural Language Processing pipeline that incorporates a seeded Term Frequency- Inverse Document Frequency matrix along with sentence-level summarization, sentiment analysis, and clustering to organize sentences into groups, which can aid educators in assessing common challenges experienced by Acting In- terns. Automated analysis of reflective writing is difficult due to its subjective nature; however, our method is able to identify known and new challenges such as issues accessing the electronic health system and adjusting to specialty differences. Medical educators can utilize these topics to identify areas needing attention in the medical curriculum and help students through this transitional time.

Physician mistreatment in the clinical learning environment.

BACKGROUND: Mistreatment has been correlated with burnout and poor well-being in medical students, but data regarding residents and faculty are limited. The objective was to investigate the prevalence of mistreatment towards surgical housestaff and faculty and characterize such experiences. METHODS: In 2018, the Department of Surgery surveyed housestaff and faculty on incidents of mistreatment. RESULTS: Clinical faculty (63%) and residents (72%) completed the mistreatment survey. Excluding public embarrassment, 48% of residents and 29% of clinical faculty experienced mistreatment. Residents experienced public embarrassment and public humiliation more frequently than faculty, however faculty were subjected to racially or ethnically offensive remarks/names more frequently than residents (p < .05). Faculty within and external to their department were most cited as instigators of mistreatment. Residents experienced mistreatment most often by faculty, co-residents, and nurses. Reporting of the behaviors was low. CONCLUSIONS: Incidents of mistreatment are frequently occurring for surgical residents and faculty.

Detecting direct oral anticoagulants in trauma patients using liquid chromatography-mass spectrometry: A novel approach to medication reconciliation.

BACKGROUND: Accurate medication reconciliation in trauma patients is essential but difficult. Currently, there is no established clinical method of detecting direct oral anticoagulants (DOACs) in trauma patients. We hypothesized that a liquid chromatography-mass spectrometry (LCMS)-based assay can be used to accurately detect DOACs in trauma patients upon hospital arrival. METHODS: Plasma samples were collected from 356 patients who provided informed consent including 10 healthy controls, 19 known positive or negative controls, and 327 trauma patients older than 65 years who were evaluated at our large, urban level 1 trauma center. The assay methodology was developed in healthy and known controls to detect apixaban, rivaroxaban, and dabigatran using LCMS and then applied to 327 samples from trauma patients. Standard medication reconciliation processes in the electronic medical record documenting DOAC usage were compared with LCMS results to determine overall accuracy, sensitivity, specificity, and positive and negative predictive values (PPV, NPV) of the assay. RESULTS: Of 356 patients, 39 (10.96%) were on DOACs: 21 were on apixaban, 14 on rivaroxaban, and 4 on dabigatran. The overall accuracy of the assay for detecting any DOAC was 98.60%, with a sensitivity of 94.87% and specificity of 99.05% (PPV, 92.50%; NPV, 99.37%). The assay detected apixaban with a sensitivity of 90.48% and specificity of 99.10% (PPV, 86.36%; NPV 99.40%). There were three false-positive results and two false-negative LCMS results for apixaban. Dabigatran and rivaroxaban were detected with 100% sensitivity and specificity. CONCLUSION: This LCMS-based assay was highly accurate in detecting DOACs in trauma patients. Further studies need to confirm the clinical efficacy of this LCMS assay and its value for medication reconciliation in trauma patients. LEVEL OF EVIDENCE: Diagnostic Test, level III.

Medications and patient safety in the trauma setting: a systematic review.

Background: Medication errors account for the most common adverse events and a significant cause of mortality in the USA. The Joint Commission has required medication reconciliation since 2006. We aimed to survey the literature and determine the challenges and effectiveness of medication reconciliation in the trauma patient population. Materials and methods: We conducted a systematic review of the literature to determine the effectiveness of medication reconciliation in trauma patients. English language articles were retrieved from PubMed/Medline, CINAHL, and Cochrane Review databases with search terms "trauma OR injury, AND medication reconciliation OR med rec OR med rek, AND effectiveness OR errors OR intervention OR improvements." Results: The search resulted in 82 articles. After screening for relevance and duplicates, the 43 remaining were further reviewed, and only four articles, which presented results on medication reconciliation in 3041 trauma patients, were included. Two were retrospective and two were prospective. Two showed only 4% accuracy at time of admission with 48% of medication reconciliations having at least one medication discrepancy. There were major differences across the studies prohibiting comparative statistical analysis. Conclusions: Trauma medication reconciliation is important because of the potential for adverse outcomes given the emergent nature of the illness. The few articles published at this time on medication reconciliation in trauma suggest poor accuracy. Numerous strategies have been implemented in general medicine to improve its accuracy, but these have not yet been studied in trauma. This topic is an important but unrecognized area of research in this field.

Management of penetrating intraperitoneal colon injuries: A meta-analysis and practice management guideline from the Eastern Association for the Surgery of Trauma.

BACKGROUND: The management of penetrating colon injuries in civilians has evolved over the last four decades. The objectives of this meta-analysis are to evaluate the current treatment regimens available for penetrating colon injuries and assess the role of anastomosis in damage control surgery to develop a practice management guideline for surgeons. METHODS: Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, a subcommittee of the Practice Management Guidelines section of EAST conducted a systematic review using MEDLINE and EMBASE articles from 1980 through 2017. We developed three relevant problem, intervention, comparison, and outcome (PICO) questions regarding penetrating colon injuries. Outcomes of interest included mortality and infectious abdominal complications. RESULTS: Thirty-seven studies were identified for analysis, of which 16 met criteria for quantitative meta-analysis and included 705 patients considered low-risk in six prospective randomized studies. Seven hundred thirty-eight patients in 10 studies undergoing damage control laparotomy and repair or resection and anastomosis (R&A) were included in a separate meta-analysis. Meta-analysis of high-risk patients undergoing repair or R&A was not feasible due to inadequate data. CONCLUSIONS: In adult civilian patients sustaining penetrating colon injury without signs of shock, significant hemorrhage, severe contamination, or delay to surgical intervention we recommend that colon repair or R&A be performed rather than routine colostomy. In adult high-risk civilian trauma patients sustaining penetrating colon injury, we conditionally recommend that colon repair or R&A be performed rather than routine colostomy. In adult civilian trauma patients sustaining penetrating colon injury who had damage control laparotomy, we conditionally recommend that routine colostomy not be performed; instead, definitive repair or delayed R&A or anastomosis at initial operation should be performed rather than routine colostomy. LEVEL OF EVIDENCE: Systematic review/meta-analysis, level III.

Redefining the Acting Internship in the Era of Entrustment: One Institution's Approach to Reforming the Acting Internship.

Creating a Core Entrustable Professional Activities (Core EPA) curriculum requires a longitudinal approach. Current curricular efforts have focused primarily on the pre-clerkship and clerkship phases of training; however, the role of the Acting Internship (AI) has not been explored. The AI experience offers opportunities for students to have enhanced clinical responsibility, demonstrate proficiency, and allows for assessment of Core EPAs that are beyond the focus of clerkships. We share our experience developing an interdepartmental AI experience designed to assess designated Core EPAs and highlight tensions that should be considered when incorporating an AI experience into a longitudinal Core EPA-oriented curriculum.

Network proteomics of human dermal wound healing.

OBJECTIVE: The healing of wounds is critical in protecting the human body against environmental factors. The mechanisms involving protein expression during this complex physiological process have not been fully elucidated. APPROACH: Here, we use reverse-phase protein microarrays (RPPA) involving 94 phosphoproteins to study tissue samples from tubes implanted in healing dermal wounds in seven human subjects tracked over two weeks. We compare the proteomic profiles to proteomes of controls obtained from skin biopsies from the same subjects. MAIN RESULTS: Compared to previous proteomic studies of wound healing, our approach focuses on wound tissue instead of wound fluid, and has the sensitivity to go beyond measuring only highly abundant proteins. To study the temporal dynamics of networks involved in wound healing, we applied two network analysis methods that integrate the experimental results with prior knowledge about protein-protein physical and regulatory interactions, as well as higher-level biological processes and associated pathways. SIGNIFICANCE: We uncovered densely connected networks of proteins that are up- or down-regulated during human wound healing, as well as their relationships to microRNAs and to proteins outside of our set of targets that we measured with proteomic microarrays.

Prevention of firearm injuries with gun safety devices and safe storage: An Eastern Association for the Surgery of Trauma Systematic Review.

BACKGROUND: Over 50,000 homicides and suicides occur each year. An estimated half of all US households are believed to have a firearm present, making them one of the most ubiquitous consumer products. Our goal was to determine if the manner of storage of a firearm in a home could potentially make a difference in the outcomes of intentional and unintentional injuries involving a firearm; specifically addressing the use of gun safes and devices that block/disable firearm function (trigger locks, cable locks, etc.). METHODS: A comprehensive review of the literature was performed. We used Grading of Recommendations Assessment, Development, and Evaluation methodology to assess the breadth and quality of the data specific to our Population, Intervention, Comparator, Outcomes (PICO) questions. RESULTS: A total of 176 studies were initially identified, then, 120 more added after a subsequent literature review, with 97 removed as duplicates. One hundred ninety-one case reports, case series, and reviews were removed because they did not focus on prevention or did not address our comparators of interest. This left a total of two studies which merited inclusion for PICO 1, should gun locks be used to prevent firearm injuries and six studies which merited inclusion for PICO 2, should safe storage for guns be used to prevent firearm injuries. CONCLUSION: PICO 1: We conditionally recommend that gun locks be used to prevent unintentional firearm injury. PICO 2: Because of the large effect size and the reasonable quality of available evidence with safe storage of firearms, we recommend safe storage prevent firearm-related injuries. LEVEL OF EVIDENCE: Systematic review, level III.

Practice Patterns for the Use of Antibiotic Agents in Damage Control Laparotomy and Its Impact on Outcomes.

BACKGROUND: The purpose of this study was to identify practice patterns associated with the use of antimicrobial agents with damage control laparotomy (DCL) and the relationship with post-operative intra-abdominal infection (IAI) rates. PATIENTS AND METHODS: The study was a retrospective review of trauma patients undergoing laparotomy at a Level 1 trauma center in 2010. Patients undergoing DCL versus those primarily closed (PCL) were compared for antimicrobial use (ABX) and its correlation with IAI rates (p < 0.05). Deaths with length of stay <5 days were excluded. RESULTS: A total of 121 patients were identified (28 DCL, 93 PCL). The DCL group was more severely injured (Injury Severity Score [ISS]: 31.4 ± 15 DCL vs. 18 ± 12.7 PCL, p < 0.001) with more small and large bowel injuries (SLBI), although not statistically significant (53.6% DCL vs. 35.5% PCL, p = 0.12). Practice patterns of ABX administration in terms of pre-operative (94.6% PCL vs. 69.2% DCL, p = 0.0012) and post-operative administration (PCL: 50.5% none, 21.5% one day, 28% long term >1 d; DCL: 21.4% none, 25.0% one day, 53.6% long term >1 day, p = 0.0130) were significant. Regression analyses demonstrated that neither ISS nor DCL was an independent predictor of infection, but pre-operative ABX was a negative predictor (odds ratio [OR] 0.20, 95% confidence interval [CI] 0.05-0.91, p = 0.037), while post-operative ABX (OR 6.7, 95%CI 1.33-33.8, p = 0.044) and SLBI (OR 3.45, CI 1.03-11.5, p = 0.02) were positive predictors of infection with an receiver operating characteristic of 0.81. CONCLUSION: Significant variations exist in the use of ABX in DCL and PCL. These variations may lead to deleterious results from both lack of initial pre-operative coverage and prolonged ABX use. The decrease in infection rates with pre-operative ABX yet significant increase with continued post-operative use even in the presence of SLBI suggests the need for a more standardized approach. With the increase in DCL and the open abdomen, more research is needed to clearly establish ABX protocols in this patient population.

A double-blind, randomized, comparative study of the use of a combination of uridine triphosphate trisodium, cytidine monophosphate disodium, and hydroxocobalamin, versus isolated treatment with hydroxocobalamin, in patients presenting with compressive neuralgias.

CONTEXT: This paper reports on the results of treatment of compressive neuralgia using a combination of nucleotides (uridine triphosphate trisodium [UTP] and cytidine monophosphate disodium [CMP]) and vitamin B12. OBJECTIVES: To assess the safety and efficacy of the combination of nucleotides (UTP and CMP) and vitamin B12 in patients presenting with neuralgia arising from neural compression associated with degenerative orthopedic alterations and trauma, and to compare these effects with isolated administration of vitamin B12. METHODS: A randomized, double-blind, controlled trial, consisting of a 30-day oral treatment period: Group A (n=200) receiving nucleotides + vitamin B12, and Group B (n=200) receiving vitamin B12 alone. The primary study endpoint was the percentage of subjects presenting pain visual analog scale (VAS) scores ≤20 at end of study treatment period. Secondary study endpoints included the percentage of subjects presenting improvement ≥5 points on the patient functionality questionnaire (PFQ); percentage of subjects presenting pain reduction (reduction in VAS scores at study end in relation to pretreatment); and number of subjects presenting adverse events. RESULTS: The results of this study showed a more expressive improvement in efficacy evaluations among subjects treated with the combination of nucleotides + vitamin B12, with a statistically significant superiority of the combination in pain reduction (evidenced by VAS scores). There were adverse events in both treatment groups, but these were transitory and no severe adverse event was recorded during the study period. Safety parameters were maintained throughout the study in both treatment groups. CONCLUSION: The combination of uridine, cytidine, and vitamin B12 was safe and effective in the treatment of neuralgias arising from neural compression associated with degenerative orthopedic alterations and trauma.

Comparison of the action of diclofenac alone versus diclofenac plus B vitamins on mobility in patients with low back pain.

Objective: To assess results of the finger-to-floor distance (FFD) and the Schober test performed during the DOLOR study, and to verify correlation between Visual Analog Pain Scale scores (VAS) with these measures. Research design and methods: Previously tabulated data from the Clinical Research Forms of the DOLOR study were analyzed (statistical significance defined with a two-tailed p value < 0.05 and confidence interval of 95%). For continuous variables, the Student's T- test or analysis of variance (ANOVA) was used, and differences between pre-treatment and Visits 2, 3, and 4 in the absolute number and percentage of patients with no change, improvement, or worsening of the Schober test and the FFD test scores were calculated, and the results were analyzed with the Chi-squared test. Spearman non-parametric correlation was used for correlating VAS scores with FFD and Schober test scores at each study visit. Main outcome measures: FFD, measured in centimeters; Schober test scores. Results: Throughout the treatment period, there was a statistically significant correlation between the VAS scores and the FFD in the total patient population and within treatment groups. This was not observed for the correlation between the Schober's test scores and the VAS scores. FFD scores within treatment groups improved progressively at each study visit, as did the Schober Test scores. Conclusions: The results of this post-hoc analysis show that combination therapy with diclofenac plus vitamins B1, B6, and B12 had additional positive effects on mobility restoration among the patients of the DOLOR study and serve to highlight the correlation between mobility and pain intensity among patients presenting with low back pain. The two fundamental goals of low back pain therapy are to provide improvements in pain and function. In this sense, the combination of diclofenac with the B vitamins was particularly effective in achieving both of these goals.