Higher TyG Index Linked to Increased H. pylori Infection Risk and Mortality: Study

China: A higher triglyceride-glucose (TyG) index was significantly linked to an elevated risk of Helicobacter pylori (H. pylori) infection and all-cause mortality among those with the infection, compared to those without, a recent study has revealed.

“Each increase in the TyG index was associated with a greater risk of H. pylori infection, with an odds ratio of 1.189,” the researchers reported in Diabetology & Metabolic Syndrome.

The TyG index is a measure derived from triglyceride and glucose levels that is increasingly recognized for its potential role in assessing metabolic health and predicting cardiovascular risk. However, research into the potential link between the TyG index and mortality, particularly among individuals with H. pylori infection, has been limited. To fill this knowledge gap, Lili Huo, Capital Medical University, Beijing, People’s Republic of China, and colleagues seek to examine the relationship between the TyG index and H. pylori infection and determine whether H. pylori infection mediates the association between TyG index levels and all-cause mortality.

For this purpose, the researchers used data from the National Health and Nutrition Examination Survey (NHANES) 1999–2018, involving a final sample of 2,187 participants. They employed univariable and multivariable-adjusted logistic regression analyses to explore the relationship between H. pylori infection and relevant covariates.

To evaluate the association between the TyG index and all-cause mortality among individuals with or without H. pylori infection, they implemented Cox regression analysis and restricted cubic spline analysis.

The following were the key findings of the study:

  • There was a significant positive correlation between the TyG index and an elevated risk of H. pylori infection [OR 1.157]. This correlation persisted even after adjusting for confounding factors [OR 1.189].
  • In patients with positive H. pylori infection, a noteworthy nonlinear correlation between the TyG index and all-cause mortality was identified.
  • With an increase in the TyG index, all-cause mortality exhibited a corresponding rise, particularly following adjustment for all potential confounding factors.
  • In patients with negative H. pylori infection, there was no significant association between the TyG index and all-cause mortality after adjusting for potential confounding factors.

The findings showed that a higher TyG index was associated with an increased risk of H. pylori infection. Participants in the higher quantile of the TyG index had a greater risk of all-cause mortality than those in the same quantile who were H. pylori-positive, as opposed to H. pylori-negative participants.

“The study’s observational design limits causality inference, necessitating confirmation through larger prospective studies. Additionally, NHANES participants may not represent the global population, raising questions about the applicability of our findings to diverse ethnic groups,” the researchers concluded.

Reference:

Zhu, XY., Xiong, YJ., Meng, XD. et al. Association of triglyceride-glucose index with helicobacter pylori infection and mortality among the US population. Diabetol Metab Syndr 16, 187 (2024). https://doi.org/10.1186/s13098-024-01422-9

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Karnataka to enhance security for women doctors: Minister Sharan Prakash Patil

Bengaluru: In the wake of growing concerns following the rape and murder of a postgraduate trainne doctor at RG Kar Medical College Hospital in kolkata, Karnataka Minister for Medical Education and Skill Development, Dr Sharan Prakash Patil, announced that the state government is committed to enhancing security measures for women doctors.

Dr Sharan Prakash Patil, held a crucial meeting with officials and key stakeholders at the Bangalore Medical College and Research Institute (BMC&RI) on Tuesday.

The discussions focused on bolstering security across medical institutions, following national outrage over the recent rape and murder of a woman doctor in Kolkata.

Minister Patil emphasized the government’s commitment to safeguard the medical professionals, particularly women, by enhancing existing security measures.

Also Read:Stipend hike of 25 percent for Resident Doctors in Karnataka

According to an ANI news report, speaking to the reporters, Dr Patil said, “We are fully committed to ensuring the safety of women doctors. Based on the feedback from today’s meeting, we will implement additional security measures, including more streetlights, CCTV cameras, and trained security personnel at all medical colleges, super-specialty hospitals, and hostels. We are also prioritizing safety in women’s restrooms.”

He further assured that the measures would be in line with guidelines set by the Central Government and the Supreme Court.

Additionally, the Minister highlighted the importance of the internal complaints committees established under the PoSH Act (Prevention of Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) , stressing that these bodies will rigorously address any grievances brought forward by women in the medical field.

Dr. Patil issued a stern warning against perpetrators of violence and sexual assault, stating that the government will take stringent action against such offenses.

“We will leave no stone unturned in our efforts to protect our medical professionals, particularly women,” he affirmed, news agency ANI reported.

The meeting was attended by director of Medical education Dr Sujatha Rathod, the Dean and Director of BMC&RI, Dr Ramesh Krishna, Principal of BMC&RI Dr Asima Banh and others from the Medical Education Department, directors of medical institutions and super-specialty hospitals, as well as representatives of senior resident doctors, undergraduate and postgraduate students, paramedical staff, and other stakeholders.

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Crinecerfont therapy tied to reduced adrenal androgen production and lower glucocorticoid administration in CAH patients: NEJM

USA: A Phase 3 clinical trial has demonstrated that crinecerfont, a novel therapeutic agent, significantly reduces glucocorticoid doses in adults with congenital adrenal hyperplasia (CAH). This promising outcome marks a significant step forward in managing CAH, a genetic disorder characterized by enzyme deficiencies that lead to excess adrenal androgens and require lifelong glucocorticoid treatment.

In patients with congenital adrenal hyperplasia, crinecerfont treatment led to a more substantial reduction from baseline in the mean daily glucocorticoid dose, including a decrease to the physiological range, compared to placebo, following the assessment of adrenal androgen levels, the researchers wrote in the New England Journal of Medicine.

In patients with classic 21-hydroxylase deficiency CAH, adrenal insufficiency is managed with glucocorticoid replacement therapy. To control excess adrenal-derived androgens, patients often require supraphysiologic glucocorticoid doses, which can lead to complications related to glucocorticoid use. In Phase 2 trials, crinecerfont, an oral antagonist of the corticotropin-releasing factor type 1 receptor, demonstrated efficacy by lowering androstenedione levels in individuals with CAH.

Against the above background, Richard J. Auchus, University of Michigan Medical School, Ann Arbor, Michigan, and colleagues randomly assigned adults with CAH in a 2:1 ratio to receive crinecerfont or placebo for 24 weeks. Glucocorticoid treatment was held at a constant level for four weeks to assess androstenedione levels. Following this period, the glucocorticoid dose was gradually reduced and optimized over 20 weeks to find the lowest effective dose that kept androstenedione levels under control (≤120% of baseline or within the reference range).

The primary efficacy endpoint was the percentage change in the daily glucocorticoid dose from baseline to week 24 while maintaining control of androstenedione levels.

The following were the key findings of the study:

  • In the 24-week analysis, all 182 patients who underwent randomization (122 to the crinecerfont group and 60 to the placebo group) were included, with the imputation of missing values; 97% remained in the trial at week 24.
  • The mean glucocorticoid dose at baseline was 17.6 mg per square meter of body-surface area per day of hydrocortisone equivalents; the mean androstenedione level was elevated at 620 ng per deciliter.
  • At week 24, the change in the glucocorticoid dose (with androstenedione control) was −27.3% in the crinecerfont group and −10.3% in the placebo group.
  • A physiologic glucocorticoid dose (with androstenedione control) was reported in 63% of the patients in the crinecerfont group and 18% in the placebo group.
  • At week 4, androstenedione levels decreased with crinecerfont (−299 ng per deciliter) but increased with placebo (45.5 ng per deciliter).
  • Fatigue and headache were the most common adverse events in the two trial groups.

The findings of the study offer hope for a new therapeutic approach for CAH patients, who have traditionally relied on high doses of glucocorticoids with significant potential for adverse effects.

The researchers concluded that crinecerfont’s potential to reduce these doses while effectively managing the disease marks a significant advancement in the field.

Reference:

Auchus RJ, Hamidi O, Pivonello R, Bancos I, Russo G, Witchel SF, Isidori AM, Rodien P, Srirangalingam U, Kiefer FW, Falhammar H, Merke DP, Reisch N, Sarafoglou K, Cutler GB Jr, Sturgeon J, Roberts E, Lin VH, Chan JL, Farber RH; CAHtalyst Adult Trial Investigators. Phase 3 Trial of Crinecerfont in Adult Congenital Adrenal Hyperplasia. N Engl J Med. 2024 Jun 1. doi: 10.1056/NEJMoa2404656. Epub ahead of print. PMID: 38828955.

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Bran-Enriched Corn Flour Reduces LDL Cholesterol in Adults with Elevated Levels, claims study

A study published recently in The Journal of Nutrition showed that, against a background of high cholesterol, bran-enriched corn flour has a low-density lipoprotein (LDL) cholesterol-lowering effect in adults. According to a group of researchers led by Liedike B., it suggests a potential benefit of consuming the bran-enriched corn products to those people who wish to improve their overall cardiometabolic outcomes by reducing their cholesterol through dietary means. The findings indicate that bran-enriched corn meal reduced LDL cholesterol by a difference of more than 5% in about 70% of the participants, thus making this dietary intervention very promising.

It is already known that whole grains have many health-promoting benefits, which lower the risks for chronic diseases: it reduces the risk of cardiovascular disease, diabetes, and cancer. The health benefits of whole grains have been observed because they are rich in dietary fiber and bioactive compounds like polyphenols. Foods made from whole wheat have vastly been studied, while other grains, such as corn, have not been put into the limelight as much, even though corn contains almost the same amount of fiber as wheat. Present in corn are metabolites of hemicellulose, cellulose, arabinoxylan, and ferulic acid; these all reduce LDL cholesterol. The mechanisms by which corn influences cardiometabolic health and gut microbiota remain poorly understood and, therefore, warrant additional research.

The subjects were healthy men and women between the ages of 18 to 70 years, whose mildly to moderately elevated LDL cholesterol levels ranged from ≥110 mg/dl. Inclusion of those individuals with LDL cholesterol above 190 mg/dL required physician clearance. People who had recent weight changes, special diets, food allergies, recent antibiotic use, or those with certain medical conditions, such as those on lipid-lowering medications, were excluded in this study. In addition, pregnant or lactating women were not eligible for this study. The eligible participants were prescreened, followed by fasting blood tests and the collection of informed consent, baseline health data, and fecal samples for gut microbiota analysis.

Participants ingested 48 g/d of whole-grain corn meal (WCM), refined corn meal with bran (RCM + B), or refined corn meal (RCM) for four weeks with two-week washout periods between each phase. Participants added corn-based foods to the diet in the form of muffins and pita bread and replaced other grain products in their diet. Compliance, gastrointestinal symptoms and dietary intake were monitored throughout. Blood lipids were determined by auto-analyzers, while stool samples were processed for sequencing of the microbiota. Mixed-effects modeling, Analysis of Variance (ANOVA), and permutational multivariate ANOVA (PERMANOVA) were conducted in the analysis of data.

Key Findings

  • The RCM + B significantly reduced LDL cholesterol by about 10 mg/dL over time.

  • Approximately 70% of individuals’ reductions were larger than 5%.

  • This was not reflected for WCM or RCM, underlining the additional benefit of bran in a cholesterol-reducing effect.

  • There were no significant treatment, time, or period main effects for total cholesterol across the groups despite the reduction in LDL cholesterol.

  • A significant difference in high density lipoprotein cholesterol wasobserved between WCM and RCM + B although there were no differences between WCM and RCM or RCM + B and RCM.

  • The gut microbiota composition analysis did not show an alteration of any α or β diversity metrics between the different treatments. In contrast, differential abundance analysis showed an increased Agathobaculum in WCM compared to RCM. The increase was independent of cholesterol reduction. Compliance of participants was above 95% for all treatment groups. The gastrointestinal symptoms, stool characteristics, and product satisfaction did not differ across the treated groups.

  • Testing their reception of corn-based products, offering many opportunities for its consumption, pita and muffins were best served and seen as “good” in terms of appearance, texture, flavour, and satisfaction.

The study gives insight into the effects of different types of corn flour on cardiometabolic outcomes and gut microbiota in adults with high LDL cholesterol. In particular, the corn bran-enriched meal appeared to be rather effective, showing high reductions in LDL cholesterol levels in most participants. This therefore could be an indication that adding bran to corn products might be a very practical means of improving cholesterol profiles and reducing cardiovascular risk.

Although the study did not show changes in total cholesterol and gut microbiota diversity, the targeted reduction in LDL using RCM + B supports its potential as a dietary intervention for the management of high cholesterol. Minimal changes in gut microbiota suggest that while the corn products influence cholesterol, they likely do not grossly perturb the gut ecosystem in the short term.

The current randomized crossover study demonstrated that the consumption of 48 g/day of corn meal enriched with bran significantly decreased LDL cholesterol in adults with high cholesterol and that 70% of the participants had reductions greater than 5%. The results support the recommendation for corn bran-enriched corn products as part of cholesterol-lowering diets and as easily accessible dietary solutions for individuals seeking to lower the risk for cardiometabolic diseases. Further research will be needed to catch the whole spectrum of long-term benefits and mechanisms behind these effects.

Reference:

Liedike, B., Khatib, M., Tabarsi, B., et al. (2024). Evaluating the Effects of Corn Flour Product Consumption on Cardiometabolic Outcomes and the Gut Microbiota in Adults with Elevated Cholesterol: A Randomized Crossover. The Journal of Nutrition. doi:10.1016/j.tjnut.2024.06.003.

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Bivalirudin helps reduce major bleeding and prevent stent stenosis during PCI in patients with ACS: Study

A systematic meta-analysis from multiple studies revealed that, compared with unfractionated heparin, bivalirudin showed less of a risk of major bleeding during percutaneous coronary interventions in patients with acute coronary syndromes. This finding finds bivalirudin one of the safer agents to be used for anticoagulation during percutaneous coronary intervention (PCI) procedures. The paper was published in the journal Critical Pathways in Cardiology by Krittanawong and colleagues.

Acute coronary syndromes often mandate percutaneous coronary interventions to restore blood flow in the coronary arteries. A choice of anticoagulant used during PCI can make all the difference in outcomes. The two commonly used anticoagulants are unfractionated heparin and bivalirudin, although comparative effectiveness between these agents was debatable. More recently, evidence appears to point to advantages of bivalirudin over heparin on bleeding risks.

In this systematic review, studies comparing outcome data for unfractionated heparin versus bivalirudin during PCI were compared. Comprehensive databases including Ovid MEDLINE, Ovid Embase, Ovid Cochrane Database of Systematic Reviews, Scopus, and Web of Science—have been searched from 1966 to January 2024. Ten prospective trials involving 42,253 participants suffering from ACS have been included in this pooling analysis. Data review and analysis were performed by two independent reviewers. All discrepancies between the reviewers were resolved through consensus. Meta-analyses were done using random effects methods.

Key Findings

  • The use of heparin was associated with a higher risk of major bleeding compared to bivalirudin (RR 1.68; 95% CI 1.29-2.20).

  • Heparin also led to a higher risk of non-access site complications (RR 4.6; 95% CI 1.75-12.09).

  • The risk of TIMI major bleeding was greater with heparin (RR 1.70; 95% CI 1.20-2.41).

  • Overall major bleeding risks were increased with heparin (RR 1.87; 95% CI 1.49-2.36).

  • Heparin use was associated with a higher risk of cardiovascular disease death (RR 1.26; 95% CI 1.02-1.57).

  • Heparin was linked to a higher incidence of thrombocytopenia (RR 1.67; 95% CI 1.07-2.62).

  • There were no statistically significant differences between heparin and bivalirudin for all-cause mortality, major adverse cardiovascular events (MACE), stroke, reinfarction, target vessel revascularization, or acute or stent thrombosis.

This meta-analysis has shown, based on the results, that bivalirudin is a much better option than unfractionated heparin for anticoagulation during PCI in patients with ACS. It was found to be associated with a decreased risk of major bleeding. Of note, bivalirudin did not increase the risk of stent thrombosis or MACE. The findings are strongly supportive of bivalirudin as the safer alternative in PCI procedures and will probably allow bettering patient outcome by reducing complications due to anticoagulation.

This meta-analysis demonstrates that bivalirudin significantly decreases the risk of major bleeding compared to unfractionated heparin in PCI for acute coronary syndrome patients. Furthermore, there is no increased risk for stent thrombosis or MACE with bivalirudin, which suggests additional benefits as an anticoagulant during PCI.

Reference:

Krittanawong, C., Ahuja, T., Wang, Z., Qadeer, Y. K., Moras, E., Virk, H. U. H., Alam, M., Jneid, H., & Sharma, S. (2024). Bivalirudin versus heparin in patients undergoing percutaneous coronary intervention in acute coronary syndromes. Critical Pathways in Cardiology. https://doi.org/10.1097/HPC.0000000000000372

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Strategy of mass distribution of Azithromycin shows Potential in Reducing Childhood Mortality: NEJM

A recent study highlighted a promising intervention to combat childhood mortality in sub-Saharan Africa through the mass distribution of azithromycin. The study was conducted in rural communities in Niger and suggests that twice-yearly distributions of the antibiotic to children between 1 to 59 months old can significantly reduce mortality rates when compared to more limited distribution among infants.

The study has come at a time when childhood mortality remains a critical public health challenge in the region, it was designed to test the efficacy of azithromycin distribution across different age groups. The World Health Organization (WHO) had previously recommended limiting the distribution to infants aged 1 to 11 months to curb the rise of antimicrobial resistance. However, this restriction had not been tested on a large scale, prompting the need for this study.

This randomized trial involved nearly 1,273 communities across Niger. These communities were divided into 3 groups, where one received azithromycin for children aged 1 to 59 months (the child azithromycin group), another received the drug for infants aged 1 to 11 months only (the infant azithromycin group), and a control group received a placebo for children aged 1 to 59 months. The trial spanned for 2 years and the mortality data was carefully monitored.

In the communities where azithromycin was administered to children aged 1 to 59 months, the mortality rates were significantly lower than in the placebo group. Also, there were 11.9 deaths per 1,000 person-years in the child azithromycin group when compared to 13.9 deaths per 1,000 person-years in the placebo group. This represents a 14% reduction in mortality, with a confidence interval of 7% to 22%, which makes it a statistically significant finding.

On the other hand, the results from the infant azithromycin group were less conclusive. The study observed a slight reduction in mortality among infants aged 1 to 11 months, with 22.3 deaths per 1,000 person-years when compared to 23.9 deaths per 1,000 person-years in the placebo group. This reduction translated to a 6% decrease in mortality and was not statistically significant. Thus, this indicated that the impact of azithromycin may be more pronounced in older children.

The study also monitored adverse events, reporting 5 serious cases which was 3 in the placebo group and 1 each in the infant and child azithromycin groups. This suggested that the treatment was generally well-tolerated. Overall, the distribution of azithromycin to children aged 1 to 59 months in Niger significantly reduced mortality rates, proving more effective than limiting the treatment to infants. 

Reference:

O’Brien, K. S., Arzika, A. M., Amza, A., Maliki, R., Aichatou, B., Bello, I. M., Beidi, D., Galo, N., Harouna, N., Karamba, A. M., Mahamadou, S., Abarchi, M., Ibrahim, A., Lebas, E., Peterson, B., Liu, Z., Le, V., Colby, E., Doan, T., … Lietman, T. M. (2024). Azithromycin to Reduce Mortality — An Adaptive Cluster-Randomized Trial. In New England Journal of Medicine (Vol. 391, Issue 8, pp. 699–709). Massachusetts Medical Society. https://doi.org/10.1056/nejmoa2312093

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Anakinra Plus Zinc May Cause More Kidney Damage in Severe Alcohol Hepatitis, Study Reveals

USA: A recent study has revealed concerning findings regarding the treatment of severe alcohol-associated hepatitis with anakinra plus zinc (A+Z). The research indicates that patients receiving this combination therapy experienced a higher frequency and severity of acute kidney injury (AKI) compared to those treated with prednisone.

“Those receiving A+Z who developed AKI exhibited elevated levels of urine-neutrophil-gelatinase-associated lipocalin, indicating that A+Z may have nephrotoxic effects in patients with severe alcohol-associated hepatitis,” the researchers wrote in the journal Hepatology.

A recent trial had shown lower survival and higher acute kidney injury rates versus prednisone (PRED) in patients with severe alcohol-associated hepatitis treated with anakinra plus zinc. Kavish R. Patidar, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Indiana University, Indianapolis, Indiana, USA, and colleagues characterized the clinical factors and potential mechanisms associated with AKI development in that trial.

For this purpose, the researchers analyzed data from 147 participants in a multicenter randomized clinical trial, with 74 receiving A+Z and 73 receiving PRED. They compared the incidence of acute kidney injury, AKI phenotypes, and kidney injury biomarkers between participants who developed AKI and those who did not in both treatment groups.

Multivariable competing risk analyses were conducted to identify baseline risk factors for incident AKI, treating death as a competing event. The factors considered included age, sex, mean arterial pressure (MAP), white blood cell count, albumin, MELD score, ascites, hepatic encephalopathy (HE), and treatment arm.

The following were the key findings of the study:

  • At baseline, no participants had AKI; 33% (n=49) developed AKI during follow-up.
  • AKI incidence was higher in A+Z than in PRED (45% versus 22%).
  • AKI phenotypes were similar between the two treatment arms (p=0.361), but peak AKI severity was greater in A+Z than PRED (stage 3 63.6% versus 50.0%).
  • At baseline, urine-neutrophil-gelatinase–associated lipocalin levels were similar among participants who developed AKI in both treatment arms.
  • Day 7 and 14 urine-neutrophil-gelatinase–associated lipocalin levels increased significantly in participants treated with A+Z who developed AKI versus participants treated with PRED who developed AKI.
  • On multivariable competing risk analysis, only A+Z was independently associated with incident AKI (subdistribution hazard ratio 2.35).

Study limitations include a lack of data necessary to fully understand the mechanism behind AKI.

The authors concluded that “the use of A+Z might have led to a decrease in MAP, which could have triggered acute tubular injury and contributed to higher mortality rates observed in the clinical trial comparing A+Z to prednisone for severe alcohol-associated hepatitis.”

Reference:

Patidar, Kavish R.1,2; Tu, Wanzhu3; Cotter, Thomas G.4; Simonetto, Douglas A.5; Asgharpour, Amon6; Jan, Muhammad Y.7; Tang, Qing3; Yu, Yunpeng3; Li, Yang3; Taiwo, Moyinoluwa8; Thevkar Nagesh, Prashanth9; Dasarathy, Srinivasan8; Kamath, Patrick S.5; McClain, Craig J.10; Chalasani, Naga1; Szabo, Gyongyi9; Bataller, Ramon11,12; Mitchell, Mack4; Mehal, Wajahat Z.13,14; Nagy, Laura E.15; Shah, Vijay H.5; Gawrieh, Samer1; Sanyal, Arun J.6; for The AlcHepNet Investigators. Acute kidney injury in severe alcohol-associated hepatitis treated with anakinra plus zinc or prednisone. Hepatology ():10.1097/HEP.0000000000001019, July 19, 2024. | DOI: 10.1097/HEP.0000000000001019

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Nonpharmacological methods of pain relief after onco-surgeries: Study finds the answer

Postoperative pain is a common but undesirable outcome following surgery. It is crucial to effectively manage postoperative pain to facilitate proper recovery and minimize the negative effects of unmanaged pain. Recent prospective, observational study aimed to assess the use of nonpharmacological methods (NPMs) for postoperative pain management among patients following oncologic surgeries at a single center. The primary objective was to determine the incidence of NPM use, while secondary objectives were to correlate NPM use with pain scores, patient satisfaction, and physical/emotional outcomes. The study included 200 adult patients who underwent major elective surgeries and were followed for the first 72 hours after surgery. Patients were interviewed on the third postoperative day to assess their use of NPMs, beliefs about NPMs, and responses to the American Pain Society Patient Outcome Questionnaire (APS-POQ). The results showed that only 24.5% of the total study population used NPMs for postoperative pain relief. The most common NPMs used were prayer (11.5%), deep breathing (6%), and watching TV/reading (5-6%). When not in pain, 46% of patients reported using NPMs as part of their hospital routine, most commonly walking (23.5%), deep breathing (14%), and prayer (18.5%). After propensity matching patients based on surgery type and postoperative analgesia, there were no significant differences in pain scores, patient satisfaction, or physical/emotional outcomes between those who used NPMs and those who did not. Patients who did not use NPMs when in pain tended to spend less time (20% vs 30%) in severe pain compared to the NPM group, though this difference was not statistically significant. The study found that education level impacted patients’ beliefs and willingness to use NPMs, with more educated patients having a more positive view. However, overall, only 35% of patients believed in the benefits of NPMs for pain management, and 48% agreed to participate in NPMs after being informed of their potential usefulness. In conclusion, the use of NPMs for postoperative pain management was low in this patient population, with no clear benefits observed in pain scores, satisfaction, or outcomes. Lack of caregiver encouragement and low patient awareness about the benefits of NPMs appear to be key barriers. Improving education, particularly among less educated patients, may help increase the utilization of these complementary pain management techniques.

Key Points

Here are the 6 key points from the research paper:

1. The study aimed to assess the use of nonpharmacological methods (NPMs) for postoperative pain management in patients following oncologic surgeries.

2. The results showed that only 24.5% of the total study population used NPMs for postoperative pain relief, with the most common methods being prayer (11.5%), deep breathing (6%), and watching TV/reading (5-6%).

3. When not in pain, 46% of patients reported using NPMs as part of their hospital routine, with the most common methods being walking (23.5%), deep breathing (14%), and prayer (18.5%).

4. There were no significant differences in pain scores, patient satisfaction, or physical/emotional outcomes between those who used NPMs and those who did not, though patients who did not use NPMs when in pain tended to spend less time in severe pain.

5. The study found that education level impacted patients’ beliefs and willingness to use NPMs, with more educated patients having a more positive view, but overall, only 35% of patients believed in the benefits of NPMs for pain management.

6. The low utilization of NPMs appears to be due to a lack of caregiver encouragement and low patient awareness about the benefits of these complementary pain management techniques, suggesting that improving education, particularly among less educated patients, may help increase their use.

Reference –

Bakshi SG, Arya K, Dhurwe B. Prevalence of use of nonpharmacological methods of pain relief among patients following onco surgeries – A prospective, observational cohort study from a single center. J Anaesthesiol Clin Pharmacol 2024 DOI: 10.4103/joacp.joacp_198_22

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Low-Dose IL-2 Therapy Improves Disease Control in Bullous Pemphigoid Patients, suggests research

A recent study published in the Journal of the American Academy of Dermatology demonstrated that low-dose IL-2 therapy may be an effective treatment for patients with moderate to severe bullous pemphigoid (BP), a chronic autoimmune blistering disorder. The research assessed the response to IL-2 therapy, suggests that it could significantly shorten the time required to achieve disease control when combined with standard corticosteroid treatment.

Bullous pemphigoid is characterized by the formation of large, fluid-filled blisters primarily affecting the elderly. Current treatments primarily rely on systemic corticosteroids, which can lead to serious side effects, especially when used long-term. The reduction of Regulatory T cells (Tregs) in both the peripheral blood and skin lesions of BP patients has been identified as a critical factor in the disease’s pathogenesis. Given that low-dose IL-2 therapy can selectively stimulate Tregs, this study wanted to find if it could offer a novel therapeutic approach for BP.

The study included a total of 43 patients with moderate to severe BP who were divided into 2 groups. Both groups received systemic corticosteroids, with the dosage tailored to disease severity of 0.5 mg/kg/day for moderate cases and 1.0 mg/kg/day for severe cases. The control group received only corticosteroids and allowed immunosuppressants, while the treatment group received an additional low-dose IL-2 therapy (half a million IU administered subcutaneously every other day for eight weeks).

The primary outcome measured was the time required to achieve disease control. The treatment group, which received IL-2, reached disease control in an average of 7.60 days, significantly faster than the control group, which took an average of 10.43 days (p=0.008). This reduction in time is clinically significant, suggesting that low-dose IL-2 therapy not only hastens the healing process but also potentially reduces the overall burden of corticosteroid use.

Also, the study found that the total amount of corticosteroids required by the treatment group was markedly lower when compared to the control group. No serious infections were reported in the IL-2 group which addresses the concerns about the safety of this approach. The findings of the study offer strong evidence that low-dose IL-2 therapy could improve current BP treatment protocols by reducing the need for high-dose corticosteroids and achieving faster disease control. Overall, this study illuminates the potential of IL-2 therapy as a promising adjunct in the management of bullous pemphigoid. 

Reference:

Xue, R., Li, G., Zhou, Y., Wang, B., Xu, Y., Zhao, P., Teng, L., Zheng, J., Liu, H., Ji, S., Elston, D. M., & Liang, Y. (2024). Efficacy and safety of low-dose Interleukin-2 in the treatment of moderate to severe bullous pemphigoid: a single center perspective-controlled trial. In Journal of the American Academy of Dermatology. Elsevier BV. https://doi.org/10.1016/j.jaad.2024.08.033

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Weekly Semaglutide 2.4 mg Shows Promise in Treating Obesity and Prediabetes: Results from STEP 10 Phase 3 Trial

UK: A study published in The LANCET Diabetes and Endocrinology revealed that Semaglutide 2.4 mg led to significantly greater weight loss and a higher rate of reversion to normoglycemia compared to placebo in individuals with obesity and prediabetes.

Prof. Barbara M. McGowan, MD, Department of Diabetes and Endocrinology, Guy’s and St Thomas’ NHS Foundation Trust et. al., conducted a study to evaluate the efficacy and safety of semaglutide 2.4 mg for weight management and glycemic control in participants with obesity and prediabetes.

The STEP 10 study was a randomized, double-blind, parallel-group, phase 3 trial conducted at 30 sites across Canada, Denmark, Finland, Spain, and the UK. It included participants aged 18 and older with a BMI of 30 kg/m² or higher and prediabetes, as defined by the UK National Institute for Health and Care Excellence criteria (either an HbA1c of 6.0–6.4% [42–47 mmol/mol] or fasting plasma glucose [FPG] of 5.5–6.9 mmol/L at screening). Participants were randomly assigned in a 2:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo, alongside diet and physical activity counseling, for 52 weeks, followed by a 28-week off-treatment period. The primary endpoints were the percentage change in body weight and the proportion of participants who reverted to normoglycemia (HbA1c <6.0% [<42 mmol/mol] and FPG <5.5 mmol/L) at week 52, analyzed in all randomly assigned participants based on intention to treat. Selective safety data were collected from participants who received at least one dose of the study drug.

The key findings of the study are as follows:

  • A total of 138 participants were assigned to the semaglutide 2.4 mg group, while 69 were assigned to the placebo group. Of these, 71% were female and 29% were male, with 88% of participants identified as White.
  • Baseline characteristics of the participants included a mean age of 53 years, mean bodyweight of 111.6 kg, mean BMI of 40.1 kg/m², mean waist circumference of 120.1 cm, mean HbA1c of 5.9% (41.3 mmol/mol), and mean fasting plasma glucose (FPG) of 5.9 mmol/L.
  • The semaglutide 2.4 mg group showed a significantly greater reduction in body weight at week 52, with an average decrease of 13.9%, compared to a 2.7% reduction in the placebo group. The estimated treatment difference was –11.2%, with a 95% confidence interval (CI) of –13.0 to –9.4, and the result was statistically significant (p<0.0001).
  • A higher proportion of participants in the semaglutide 2.4 mg group reverted to normoglycemia at week 52, with 81% achieving this outcome compared to 14% in the placebo group. The odds ratio for reversion to normoglycemia was 19.8, with a 95% CI of 8.7 to 45.2, and the result was statistically significant (p<0.0001).
  • Serious adverse events were reported in 9% of participants in both the semaglutide 2.4 mg group and the placebo group. However, adverse events leading to treatment discontinuation were more common in the semaglutide group (6%) compared to the placebo group (1%). Importantly, no new safety signals were identified during the trial.

The study concluded that Semaglutide 2.4 mg led to a significantly greater reduction in body weight and a higher rate of reversion to normoglycemia compared to placebo in participants with obesity and prediabetes. The safety and tolerability profile of Semaglutide 2.4 mg was consistent with previous studies and aligned with the known characteristics of the GLP-1 receptor agonist class. These findings suggest that Semaglutide 2.4 mg could be a promising treatment option for individuals with obesity and prediabetes to help achieve reversion to normoglycemia.

Reference

McGowan BM, Bruun JM, Capehorn M, Pedersen SD, Pietiläinen KH, Muniraju HAK, Quiroga M, Varbo A, Lau DCW; STEP 10 Study Group. Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial. Lancet Diabetes Endocrinol. 2024 Jul 29:S2213-8587(24)00182-7. doi: 10.1016/S2213-8587(24)00182-7. Epub ahead of print. PMID: 39089293.

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