mRNA-1083 Effective and Safe for Adults Aged 50+ Against Flu and COVID-19, Phase 3 Trial Reveals

USA: A new phase 3 clinical trial has found that a single multi-component mRNA vaccine targeting both seasonal influenza and COVID-19 is not only well-tolerated but also produces immune responses on par with, or even better than, current standard vaccinations in adults aged 50 years and older.

The findings were published online in the Journal of the American Medical Association (JAMA) on May 7, 2025.

Despite strong recommendations, the uptake of seasonal influenza and COVID-19 vaccines continues to remain below optimal levels, particularly among older adults. To address this gap and simplify immunization strategies, Amanda K. Rudman Spergel, Moderna Inc, Cambridge, Massachusetts, and colleagues evaluated the immunogenicity and safety of an investigational multicomponent vaccine, mRNA-1083, designed to protect against both seasonal influenza and SARS-CoV-2.

The investigational vaccine, mRNA-1083, was evaluated in a randomized, observer-blinded study conducted at 146 sites across the United States. The trial enrolled over 8,000 participants between October and November 2023, including two distinct age groups: individuals aged 50–64 years and those aged 65 years or older. The primary aim was to determine if mRNA-1083 could generate immune responses that were at least as strong as those produced by the currently licensed influenza and COVID-19 vaccines.

Participants in the study were randomly assigned to receive either the mRNA-1083 vaccine with a placebo or a combination of licensed influenza and COVID-19 vaccines. Those aged 65 years and older received the high-dose quadrivalent inactivated influenza vaccine (HD-IIV4), while those aged 50–64 received the standard-dose version (SD-IIV4), along with an mRNA COVID-19 vaccine (mRNA-1273) in both groups.

The key findings of the study were as follows:

  • mRNA-1083 generated noninferior immune responses against all influenza and SARS-CoV-2 strains compared to standard vaccines.
  • In adults aged 50–64, the vaccine produced stronger antibody responses than the standard-dose influenza vaccine for all four flu strains.
  • Among participants aged 65 and older, mRNA-1083 outperformed the high-dose flu vaccine for three flu strains: A/H1N1, A/H3N2, and B/Victoria.
  • The vaccine also showed a superior immune response against SARS-CoV-2 in both age groups.
  • Mild to moderate side effects, such as pain at the injection site, fatigue, and headache, were more frequently reported with mRNA-1083 but resolved quickly.
  • No serious safety concerns were observed during the trial.

The authors concluded, “The phase 3 trial demonstrated that a single dose of the multicomponent mRNA-1083 vaccine is at least as immunogenic as the currently recommended influenza and COVID-19 vaccines in adults aged 50 and above.”

They stressed that the vaccine not only met noninferiority criteria but also elicited stronger immune responses against multiple influenza strains and SARS-CoV-2, with a favorable safety and tolerability profile, supporting its potential as a convenient and effective dual-protection option for older adults.

Reference:

Rudman Spergel AK, Wu I, Deng W, et al. Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial. JAMA. Published online May 07, 2025. doi:10.1001/jama.2025.5646

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Veterans with depression have increased risk of heart failure: JAMA

U.S. veterans with depression had a 14% higher risk of heart failure, a new Vanderbilt University Medical Center-led study found, even after adjusting for traditional risk factors.

The study, “Depression and Heart Failure in U.S. Veterans,” was published May 8 in the journal JAMA Network Open.

Corresponding author Evan Brittain, MD, MSCI, professor of Medicine, said the study suggests implications for patient care.

“Patients and clinicians have another reason to screen for and treat depression in order to prevent potential future heart failure,” he said.

Brittain, who holds the Cardiology Division Directorship, noted the study is the largest of its kind, analyzing a sample of 3.4 million veterans from 2000 to 2015, who received care at Veterans Administration facilities. Participants were born between 1945 and 1965, met a medical home definition (had three outpatient visits within five years), and were free of heart failure at baseline. Participants were excluded if they were younger than 18, had unknown sex data, had death within one year of meeting the definition of medical home, or had received a heart transplant before or within one year of meeting that definition.

In addition to finding that patients with depression were 14% more likely to have heart failure, the study showed depressed veterans had a higher prevalence of chronic obstructive pulmonary disease (12.9% vs. 7.1%), smoking status (43.2% vs. 34.7%) and alcohol use disorder (35.4% vs. 11.3%.)

“Among adults without significant health problems, depression was associated with an even higher risk (58%) of new heart failure during follow-up,” Brittain said.

The study concluded that further study is warranted to determine whether earlier diagnosis and treatment for depression can reduce the risk of heart failure.

“It is important to focus on assessment of depression treatment and its impact on heart failure or other cardiovascular diseases to further clarify this relationship and advise treating clinicians,” Brittain said.

Reference:

Pfaff JL, Eden SK, Kundu S, et al. Depression and Heart Failure in US Veterans. JAMA Netw Open. 2025;8(5):e259246. doi:10.1001/jamanetworkopen.2025.9246.

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Study Exploring Benefits and Risks of Exercise During Pregnancy

Recent research study aimed to describe the exercise levels, pregnancy, and maternal and neonatal health outcomes in elite and recreational athletes who exceed the general physical activity recommendations during pregnancy. The study was part of the larger Strong Mama research project and included 60 pregnant elite (n=10) and recreational (n=50) athletes between 26-35 weeks gestation.

Exercise Patterns

The elite athletes exercised on average 11.6 hours per week during pregnancy, comprising mainly endurance exercise at low to moderate intensities. The recreational athletes exercised on average 7.0 hours per week, with similar amounts of resistance training as the elite group. After birth, both groups resumed exercise within the first 6 weeks postpartum, with the elite athletes exercising more hours per week than the recreational athletes.

Maternal Health

In terms of maternal health, a small number of elite athletes experienced pregnancy complications like gestational diabetes and hypertension, while none of the recreational athletes reported any complications. Most athletes in both groups were satisfied with their lives and rated their health as very good or excellent during and after pregnancy. One recreational athlete showed signs of an eating disorder during pregnancy. Regarding delivery outcomes, the majority of athletes had spontaneous vaginal births, with a slightly higher rate of vacuum deliveries compared to the general population. However, the rates of cesarean sections were similar to population data. The athletes also reported high levels of labor pain and exertion. Neonatal outcomes were generally positive, with no low birth weights and only one preterm birth. A higher percentage of recreational athletes had babies over 4000g compared to population data, but this did not seem to negatively impact delivery. The authors noted that while the small sample size precludes statistical comparisons, the findings suggest that high-volume, high-intensity exercise during pregnancy may not pose significant risks to maternal and neonatal health in this group of highly fit athletes. However, they emphasize the need for more research in this understudied population to confirm these observations.

Key Points

1. The study aimed to describe the exercise levels, pregnancy, and maternal and neonatal health outcomes in elite and recreational athletes who exceed the general physical activity recommendations during pregnancy.

2. The elite athletes exercised on average 11.6 hours per week during pregnancy, primarily engaging in endurance exercise at low to moderate intensities, while the recreational athletes exercised on average 7.0 hours per week, with similar amounts of resistance training as the elite group. Both groups resumed exercise within the first 6 weeks postpartum, with the elite athletes exercising more hours per week than the recreational athletes.

3. Regarding maternal health, a small number of elite athletes experienced pregnancy complications like gestational diabetes and hypertension, while none of the recreational athletes reported any complications. Most athletes in both groups were satisfied with their lives and rated their health as very good or excellent during and after pregnancy. One recreational athlete showed signs of an eating disorder during pregnancy.

4. The majority of athletes had spontaneous vaginal births, with a slightly higher rate of vacuum deliveries compared to the general population, but the rates of cesarean sections were similar to population data. The athletes also reported high levels of labor pain and exertion.

5. Neonatal outcomes were generally positive, with no low birth weights and only one preterm birth. A higher percentage of recreational athletes had babies over 4000g compared to population data, but this did not seem to negatively impact delivery.

6. The authors noted that while the small sample size precludes statistical comparisons, the findings suggest that high-volume, high-intensity exercise during pregnancy may not pose significant risks to maternal and neonatal health in this group of highly fit athletes, but more research is needed to confirm these observations.

Reference –

Emilie Mass Dalhaug et al. (2025). Exceeding The Guidelines: A Descriptive Study Of Exercise, Pregnancy, Maternal And Neonatal Health Outcomes In Elite And Recreational Athletes. *BMC Pregnancy And Childbirth*, 25. https://doi.org/10.1186/s12884-025-07572-6.

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Lower Blood Pressure May Offer Benefits Even for Very Elderly: Study

Adults aged 80 and older experience the highest prevalence of cardiovascular disease, yet the optimal blood pressure targets for this group have been unclear in clinical guidelines. Now, a new study from Yale School of Medicine (YSM) suggests that intensive blood pressure management may offer important benefits for very elderly patients.

As the American population rapidly ages, the proportion of adults aged 80 and above is expected to significantly increase over the next few decades. But despite their growing numbers, this population has been understudied and often excluded from clinical trials investigating blood pressure management. The American Heart Association’s current blood pressure guidelines for all adults call for blood pressure of 130/80 mmHg or below, but it’s unclear if this range is appropriate for the very elderly.

“The key challenge is the lack of strong evidence for this age group,” says Yuan Lu, ScD, assistant professor of medicine (cardiology) at YSM, and the senior author of the study published in the Journal of the American College of Cardiology. “Much of the scientific evidence in the hypertension guidelines is based on clinical trials, but these studies have often excluded adults aged 80 and older. When they are included, their numbers are usually too small to draw clear conclusions for this age group.”

To address this evidence gap, Lu and her team used data from the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey and National Death Index to investigate the association between blood pressure and death from cardiovascular disease in adults aged 80 and above who had been actively treated with hypertension medication. Despite previous conjecture that higher blood pressure might be acceptable in this age group due to concerns such as increased fall risk and other side effects when blood pressure is too low, Lu and her team found evidence suggesting that lower blood pressure and more intensive management may be associated with better outcomes for these patients.

Evidence-based guidelines for blood pressure management

With little evidence to guide hypertension treatment for this age group, physicians have often relied on experience, expert opinions, and observational studies. This has frequently led to the idea that higher blood pressure might be acceptable for very elderly patients.

“There’s concern that lowering blood pressure too much in very elderly patients could cause side effects like dizziness, falls, or other injuries,” Lu explains. “That’s why there’s still uncertainty among doctors about how aggressively to manage blood pressure in this age group. We simply don’t have enough data to say what the ideal target should be. Should we aim for 120 or 130? Or is 140 to 150 still acceptable for elderly patients?”

Lu and her team sorted data from over 1,500 patients aged 80 and above who had been treated for hypertension into three groups: those with systolic blood pressure lower than 130, those between 130 and 160, and those above 160. They found that those with systolic blood pressure below 130 had the lowest risk of dying from heart disease and stroke, even after accounting for factors such as frailty that could potentially moderate the benefits of aggressive blood pressure management. They also found that systolic blood pressure even in the range of 145 held significant cardiovascular disease mortality risk for these patients.

Balancing blood pressure management in the elderly

While these results challenge earlier suggestions that higher blood pressure might be acceptable in this age group, Lu emphasizes the importance of individualized care. “Blood pressure management in this age group should involve thoughtful conversations between patients and their physicians,” she explains. “It’s essential to consider each patient’s overall health, potential side effects, and personal preferences.”

Although the study found that lower blood pressure was associated with reduced cardiovascular mortality, Lu cautions that given the multiple comorbidities in very elderly patients, antihypertensive medications may increase the risk of additional complications-factors that need to be carefully weighed when making treatment decisions.

“Physicians need to engage in shared decision making and consider the full medical history of the patient. Starting medication slowly and closely monitoring their patient’s progress and symptoms as they reach blood pressure targets may help find the right balance,” says Lu, who is also an assistant professor of biomedical informatics and data science at YSM and of chronic disease epidemiology at Yale School of Public Health. “If there are no side effects, the benefits may outweigh the risks. If there are side effects, physicians may need to reassess and weigh the trade-offs.”

Ultimately, Lu believes that both this shared decision-making and follow-up research in the form of randomized control trials will be important moving forward.

“These findings provide evidence and support for more aggressive treatment among elderly patients, but at the same time, we also want to raise the point that the treatment decision would need to be personalized for frail patients and those with multiple comorbidities,” Lu says.

Reference:

Huanhuan Yang, Chenxi Huang, Mitsuaki Sawano, Jeph Herrin, Guochong Chen, Zhihui Li, Erica S. Spatz, Harlan M. Krumholz, and Yuan Lu, Systolic Blood Pressure and Cardiovascular Mortality in U.S. Adults Aged 80+ Taking Antihypertensive Medications, Journal of the American College of Cardiology, https://www.jacc.org/doi/10.1016/j.jacc.2025.01.033.

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Tegoprazan Shows Superior Efficacy and Safety in Treating Esophageal Conditions in Phase 3 trial

In a phase 3 trial Tegoprazan Shows Superior Efficacy and Safety in Treating Esophageal Conditions. It was found that Tegoprazan acted faster and was more effective than lansoprazole (a PPI), achieving all primary and secondary endpoints during the healing phase. It showed superior healing at weeks 2 and 8 across all EE grades. Further the drug met all key endpoints, significantly improving 24-hour and overnight heartburn and regurgitation compared to placebo.Tegoprazan’s safety and tolerability were on par with both placebo and lansoprazole. Serum gastrin levels stayed within normal limits for all groups.

Across both the EE and NERD pivotal studies known as TRIUMpH, tegoprazan achieved significance in all primary and secondary endpoints tested. This included statistical superiority over a PPI (lansoprazole) in achieving complete esophageal healing at weeks 2 and 8 across all grades of EE, including the significant cohort of patients with severe disease (LA Grades C & D). In the NERD trial, tegoprazan demonstrated complete symptom relief for both heartburn (overnight and heartburn free days) and regurgitation.

The maintenance phase of the EE study will complete in Q3 2025 with a New Drug Application inclusive of both the EE and NERD indications planned for filing with FDA in Q4 2025. Braintree® intends to submit results from the TRIUMpH Phase 3 studies to a high impact, peer reviewed journal along with presentation of this data at a leading gastroenterology conference in the future.

“We are delighted with tegoprazan’s Phase 3 clinical results. Across both our EE and NERD trials, tegoprazan achieved all primary and secondary endpoints tested. This includes superior EE healing for all patients over lansoprazole at weeks 2 and 8 of treatment” said Alan Cooke, President and CEO of Sebela Pharmaceuticals®. “For over 40 years we have been committed to the gastroenterology therapeutic area and to patients affected by GI diseases. Tegoprazan offers an exciting new treatment option for individuals suffering from GERD, helping to address the substantial unmet need of patients not well-controlled by conventional PPI therapy.”

Felice Schnoll-Sussman, MD, Professor of Clinical Medicine at Weill Cornell Medical College®, Director of the Jay Monahan Center for Gastrointestinal Health, commented, “The data for tegoprazan for erosive esophagitis proves that the P-CAB class can outperform PPIs and suggests that tegoprazan may offer advantages over other agents.”

“Both heartburn and regurgitation are the cardinal symptoms of GERD, but we only typically talk about heartburn resolution. Probably because previous studies on medical therapies have not been able to show or measure reduction in regurgitation like the P-CAB tegoprazan,” said Prateek Sharma, MD, Professor at the University of Kansas School of Medicine, Current President of the American Society of Gastrointestinal Endoscopy®.

In addition, a US-based Phase 1 pharmacodynamic study has demonstrated that tegoprazan can provide more rapid acid control (pH>4) within 45 minutes, with no food effect, offering patients a truly differentiated therapeutic option.

Individual treatment-emergent adverse events occurred at a rate of < 3% in the TRIUMpH studies and were generally mild and transient. The overall rate of serious treatment-emergent adverse events in each study was < 2% and similar between tegoprazan and the PPI and placebo comparator groups. Mean serum gastrin for tegoprazan and lansoprazole remained within the normal range (0-180 pg/ml) throughout the relevant treatment periods in the TRIUMpH studies.

About TRIUMpH

The TRIUMpH program comprises two Phase 3 studies of tegoprazan in US patients with gastroesophageal reflux disease (GERD), including erosive esophagitis (EE) and non-erosive reflux disease (NERD). The Phase 3 studies were conducted entirely in the US and are representative of the demographically diverse US population.

The Phase 3 EE study consisted of a large, multi-center, double-blind study (n=1,250, including 463 patients with LA Grade C/D esophagitis) evaluating the safety and efficacy of tegoprazan versus lansoprazole for indications including the healing of all grades of EE, maintenance of EE healing and relief of heartburn.

The primary and secondary efficacy endpoints in the EE healing phase were hierarchically structured, with secondary endpoint testing commencing and continuing only if the preceding endpoints were statistically significant. All pre-specified efficacy endpoints (Table 1) were tested and achieved statistical significance.

The Phase 3 NERD study consisted of a large, multicenter, double-blind study (n=800) designed to demonstrate the safety and efficacy of tegoprazan versus placebo. The primary endpoint for the placebo-controlled treatment phase was the percentage of 24-hour heartburn-free days. Additional key endpoints included percentage of days without overnight heartburn and percentage of days without regurgitation.

About Tegoprazan

Tegoprazan is a novel agent in development for the treatment of acid-related gastrointestinal diseases. It is a member of a class of oral medications known as P-CABs, or potassium-competitive acid blockers, which have been shown to have rapid onset of action and the ability to control gastric pH for longer periods of time than proton pump inhibitors (PPIs). Tegoprazan has already received marketing authorization in 19 countries.

About GERD

GERD is a chronic and highly prevalent disorder affecting approximately 65 million people in the US. It is characterized by a wide variety of symptoms, including heartburn and acid regurgitation. The main phenotypic presentations of GERD include non-erosive reflux disease (NERD) and erosive esophagitis (EE). NERD is defined by reflux-related symptoms without esophageal erosions. In addition to reflux-related symptoms, EE is defined by erosions in the esophagus caused by acid reflux from the stomach. While proton pump inhibitors are the mainstay of therapy for both EE and NERD, 35% to 54% of patients fail to achieve complete relief of symptoms, highlighting a significant unmet need in this population.

 

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Elderly Individuals Have Threefold Higher Prevalence of Tuberculosis, Confirms Study

Researchers have determined in a new study that the elderly in Tamil Nadu have a three times greater incidence of tuberculosis (TB) than young adults. The State government of Tamil Nadu conducted a large-scale TB survey and screened more than 130,000 persons, identifying major risk factors for TB, including male gender, undernutrition, smoking, and previous history of TB. The study was published in the Indian Journal of Medical Research conducted by Prathiksha G. and colleagues.

The research was a cross-sectional survey that sought to diagnose TB in adults aged 15 years and older in Tamil Nadu. The screening was conducted through digital X-ray imaging and sputum testing to detect microbiologically confirmed pulmonary tuberculosis (MCPTB). A focused sub-analysis of the elderly population (60 years and older) was done, representing a major share of the total sample. The information gathered from these individuals were compared with the findings among younger adults to determine differences in TB risk factors and prevalence.

Results

  • 130,932 participants were screened for TB, of which 16,555 (12.64%) were 60 years and older. Of the elderly, 74 individuals (0.45%) had microbiologically confirmed pulmonary tuberculosis (MCPTB), while the prevalence in adults under 60 years was 170 cases (0.15%).

  • The crude prevalence of MCPTB among the elderly age group was 447 per lakh (95% CI: 351-561).

  • The adjusted prevalence among the elderly was 482 per lakh (95% CI: 385-578).

  • The crude prevalence of MCPTB among adults was 130 per lakh (95% CI: 111-151), and the adjusted prevalence was 166 per lakh (95% CI: 137-195).

  • The adjusted prevalence ratio (aPR) for MCPTB among the elderly population was 2.99 (95% CI: 2.25-3.98, P<0.0001), showing that the elderly were almost three times more likely to develop MCPTB compared to adults younger than 60 years.

A number of risk factors were identified that raised the risk of TB among the elderly:

  • Male sex had an aPR of 2.54 (95% CI: 1.41-4.57).

  • Undernutrition had an aPR of 3.53 (95% CI: 1.65-7.54).

  • Smoking raised the aPR to 1.94 (95% CI: 1.02-3.71).

  • A history of TB raised the aPR to 2.26 (95% CI: 0.92-5.51), but the results were not significant.

The number needed to screen (NNS) to detect one case of MCPTB was estimated to be:

  • 224 among the elderly population (95% CI: 178-285).

  • For the entire population aged 15 years and older, the NNS was 537 (95% CI: 473-611).

  • Among certain subgroups of the elderly, the NNS was significantly lower in those with a history of TB (56; 95% CI: 26-152), smokers (75; 95% CI: 52-112), and a history of alcohol consumption (78; 95% CI: 55-114), showing an increased risk among these groups.

In the elderly population in Tamil Nadu, tuberculosis prevalence was significantly higher among them than in younger adults. Male sex, undernutrition, and smoking were significantly linked to higher TB prevalence in the elderly. These observations highlight the necessity of targeted screening and intervention programs for the elderly, especially in high-burden areas for TB.

Reference:

Prathiksha Giridharan1, Ariarathinam Newtonraj​2,, Kannan Thiruvengadam1, Asha Frederick3, Sriram Selvaraju1. Tuberculosis in the elderly population: Findings from a State-level TB prevalence survey (2022) from India. Indian Journal of Medical Research, published by Scientific Scholar for Director-General, Indian Council of Medical Research, 2024.

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SZC Shows Superior Efficacy and Safety Over SPS in Treating Hyperkalemia in hemodialysis patients: Study

Data from a new clinical trial revealed that compared to sodium polystyrene sulfonate (SPS) treatment, Sodium zirconium cyclosilicate (SZC) provided faster and more effective resolution of hyperkalemia, with a potentially improved safety profile and better palatability in hemodialysis patients. The findings were published in the BMC Nephrology journal.

Hyperkalemia is a frequent and potentially fatal complication in patients receiving maintenance dialysis. Despite the widespread use of potassium binders like SPS, comparative data on newer therapies has remained limited, until now.

This multicenter, double-blinded, randomized clinical trial enrolled 120 HD patients with predialysis serum potassium levels exceeding 5 mmol/L. Participants were assigned to receive either SZC (5 grams, thrice weekly on non-dialysis days, totaling 15 grams per week) or SPS (15 grams, thrice weekly, 45 grams per week) over an 8-week period. The primary outcome was the change in serum potassium levels during the treatment phase.

The results found both groups to experience a statistically significant reduction in serum potassium levels beginning in the first week and continuing throughout the study period (p < 0.001 for both groups). However, SZC outpaced SPS in bringing patients into the normal potassium range (normokalemia), achieving this milestone by the second week, whereas SPS-treated patients did not reach normokalemia until the sixth week (p < 0.001).

The rescue therapy for hyperkalemia was used when potassium levels pose an acute risk, was required less often in the SZC group (3.3%) when compared to the SPS group (6.6%), although this difference was not statistically significant (p = 0.678).

Gastrointestinal side effects, a known concern with potassium binders, were reported by 5% of patients in the SZC group and 11.6% in the SPS group, a non-significant difference. However, palatability emerged as a clear differentiator. SZC was rated as significantly more palatable than SPS (p < 0.001), an advantage that could enhance patient compliance.

While both agents demonstrated safety and effectiveness in lowering potassium levels, the study’s data suggest SZC may offer a faster, better-tolerated, and more patient-friendly alternative to the traditional SPS approach.

The study data compared weekly average serum potassium levels between the two groups over the 8-week trial. SZC-treated patients saw a sharper and earlier decline in potassium, with normalization occurring by week 2. In contrast, SPS showed a more gradual decrease, achieving normokalemia only by week 6.

Additionally, gastrointestinal side effects and the need for rescue therapy were numerically lower in the SZC group. Patient-reported palatability scores strongly favored SZC, reinforcing its potential advantages in clinical practice.

Source:

Elsayed, M. M., Abdelrahman, M. A., Sorour, A. M., Rizk, I. G., & Hassab, M. A. A. (2025). Sodium zirconium cyclosilicate versus sodium polystyrene sulfonate for treatment of hyperkalemia in hemodialysis patients: a randomized clinical trial. BMC Nephrology, 26(1). https://doi.org/10.1186/s12882-025-04129-9

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Study Compares Perpendicular and Parallel Techniques of Analgesia for continuous abductor canal block

Recent study investigates the differences in anatomical dye distribution patterns and nerve blockade effectiveness between two catheter placement techniques for continuous adductor canal block (CACB) using a subsartorial approach. The comparison focuses on parallel and perpendicular orientations of catheter tips in relation to the saphenous nerve (SN) and the nerve to vastus medialis (NVM). An initial motivation for the study stems from documented complications associated with catheter dislocation, particularly during postoperative rehabilitation, which could impact analgesic outcomes.

Research has indicated that catheters placed parallel to nerves might experience less migration than traditional perpendicular placements. However, existing studies had mostly examined single nerve blocks rather than CACB, which targets multiple nerves. This study, therefore, aims to assess how variations in catheter orientation influence dye distribution to the SN and NVM and to evaluate any implications for postoperative analgesia.

Conducted with four modified Thiel soft-embalmed cadavers, the study utilized a randomized approach to assign each limb to either the parallel or perpendicular technique. Using ultrasound guidance, a dye approach involving methylene blue was employed, with both a continuous infusion method and bolus injections to visualize dye spread. The primary measurements included the dye diffusion patterns, intensity of staining on the SN and NVM, and any spread beyond the adductor canal.

Results show that both techniques led to substantial staining of the SN; however, the NVM exhibited intense staining using the perpendicular method, while staining intensity varied with the parallel technique. The dye distribution revealed a narrower downward spread with the parallel approach, contrasting with the more diffuse and extensive spread achieved with the perpendicular orientation. Notably, the parallel method demonstrated a tendency for dye penetration into the posterior knee compartment through the adductor hiatus, an occurrence not observed with the perpendicular placement.

Implications

The findings suggest that while the perpendicular catheter placement reliably targets both the SN and NVM, the parallel placement predominantly influences only the SN but allows for extended influence into the posterior compartment of the knee. This distribution pattern may have implications for pain control post-surgery, as effective analgesia often necessitates adequate blockade of nerves supplying the posterior knee region.

Limitations

The study acknowledges significant limitations, including the small sample size and the challenges of translating results from cadaveric examinations to living patients, particularly given that the opioid spread in awake subjects may vary considerably from cadaveric models. Additionally, variations in catheter usage techniques or infusion durations could also confound the results.

Conclusion

Concluding, the study emphasizes that while perpendicular catheter placements for CACB target both the SN and NVM effectively, the parallel technique might be preferred in certain clinical settings, given its potential for greater posterior compartment influence. These findings could shape future techniques in regional anesthesia, guiding clinicians toward optimal analgesic strategies and possibly reducing complications related to catheter migration. Further research in living subjects will be essential to validate these observations and improve application in clinical contexts.

Key Points

– The study investigates the anatomical dye distribution patterns and effectiveness of nerve blockade between two catheter placement techniques (parallel vs. perpendicular) for continuous adductor canal block (CACB), specifically examining their impact on the saphenous nerve (SN) and the nerve to vastus medialis (NVM).

– Existing research indicates that parallel catheter placements might reduce migration compared to traditional perpendicular placements, yet previous studies primarily focused on single nerve blocks rather than the multi-nerve targeting inherent in CACB.

– Utilizing four modified Thiel soft-embalmed cadavers, the study employed a randomized design involving ultrasound guidance to visualize dye spread from both continuous infusion and bolus injections, analyzing patterns and intensity of staining on the SN and NVM.

– Results demonstrate that while both techniques stained the SN significantly, the perpendicular method yielded intense staining of the NVM with a more extensive dye spread, whereas the parallel technique resulted in a narrower downward spread but notable penetration into the posterior knee compartment.

– The findings imply that although the perpendicular technique effectively targets both SN and NVM, the parallel method, primarily affecting the SN, could allow for extended analgesic influence into the posterior knee compartment, which may enhance postoperative pain control.

– Limitations of the study include a small sample size, difficulties in translating findings from cadavers to live patients, and potential variations in clinical techniques affecting results; further research on living subjects is necessary to confirm these insights and enhance clinical application.

Reference –

Kampitak W, Thamrongskulsiri N, Purngpiputtrakul P, Kertkiatkachorn W. Does parallel versus perpendicular catheter placement for a subsartorius approach to a continuous adductor canal block influence injectable distribution? A comparative cadaveric study. Indian J Anaesth 2025;69:405-9.

 

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Study assesses Impact of Lingual Nerve Block on Hemodynamic Stability During Tongue Cancer Surgery: Study

Recently published randomized controlled trial involved 132 patients undergoing wide local excision of unilateral tongue cancer to evaluate the effectiveness of a lingual nerve block on managing haemodynamic surges and reducing opioid and volatile anaesthetic requirements. After recruitment, 14 patients were excluded due to protocol deviations, leaving a balanced comparison between two groups: one receiving a lingual nerve block (Group B) with 2 mL of 2% lignocaine, and the other receiving 2 mL of saline (Group A).

Results Overview

Results indicated that the maximum mean arterial pressure (MAP) and the maximum rises in systolic and diastolic blood pressure parameters were significantly higher in the control group, with p-values of 0.001 for all measurements. Although the maximum heart rate did not differ significantly between groups, the increase in heart rate from baseline was significantly greater in the control group. The total fentanyl consumption was also markedly higher in the control group compared to those receiving the nerve block, with p-values less than 0.001 for both immediate surgery and overall procedures that included neck dissection tasks.

NNT Analysis and Anaesthetic Depth

Notably, a number-needed-to-treat (NNT) analysis revealed an absolute risk reduction of 63.72%, indicating that for every 1.57 patients receiving lingual nerve blocks, one patient did not require extra fentanyl during tongue resection. In terms of anaesthetic depth, the maximum and mean minimum alveolar concentration (MAC) values used were also significantly higher in the control group (p < 0.001 and p = 0.019, respectively).

Conclusion on Effectiveness

Further, while total blood loss and Ramsay Sedation Score (RSS) in the post-anesthesia care unit were comparable across groups, the study concluded that lingual nerve block effectively mitigated increases in MAP and reduced opioid consumption during the surgical excision of tongue cancers. This aligns with previous research highlighting the advantages of regional anaesthesia in head and neck surgeries, not only improving analgesia and reducing dosages of opioids and anaesthetics but also possibly influencing postoperative recovery and cancer recurrence rates.

Discussion of Mechanism

The discussion section elaborated on the mechanism and expected benefits of lingual nerve block by noting that it targets critical innervation to the anterior two-thirds of the tongue. The common phenomenon of heightened systolic and diastolic pressure and heart rate when exising tumor tissue necessitates deeper sedation and increased opioid administration, which the nerve block addresses effectively. It cited earlier studies showing benefits of various nerve blocks in similar surgical contexts and reinforced that, unlike other blocks like the inferior alveolar nerve (IAN) and Gowgates block, the lingual nerve block offers unique advantages by minimizing unwanted sensation in adjacent areas while ensuring targeted anaesthesia.

Study Limitations

Limitations were noted, including the inability to track blood loss before and after specific phases of surgery, which might complicate interpretations of surgical blood loss comparison. There was a suggestion for further exploration of bilateral lingual nerve blocks to see if they provide improved outcomes regarding haemodynamic stability and opioid consumption.

Final Conclusion

In conclusion, using a lingual nerve block in tongue cancer surgeries proved effective in controlling haemodynamic responses while simultaneously reducing opioid and volatile anaesthetic requirements, providing a more stable surgical experience. The findings establish regional anaesthesia as a valuable adjuvant to manage perioperative risks associated with these sensitive and invasive procedures. More studies are warranted to explore implications for postoperative outcomes and longer-term cancer control related to anaesthetic strategies.

Key Points

– A randomized controlled trial involving 132 patients assessed the efficacy of lingual nerve blocks during wide local excision of unilateral tongue cancer. A total of 14 patients were excluded due to protocol deviations, resulting in two balanced groups: one receiving a lingual nerve block (Group B) and the other receiving saline as a control (Group A).

– Results indicated significantly higher maximum mean arterial pressure (MAP) and increases in systolic and diastolic blood pressure in the control group (p = 0.001), while the heart rate increase from baseline was also notably greater in the control group, despite no significant difference in the maximum heart rate between groups.

– Total fentanyl consumption was substantially lower in the lingual nerve block group, with p-values less than 0.001 for both immediate surgery and overall procedures, implying a strong reduction in opioid requirements due to the nerve block.

– A number-needed-to-treat (NNT) analysis showed an absolute risk reduction of 63.72%, indicating that for about every 1.57 patients treated with a lingual nerve block, one patient avoided needing extra fentanyl. Furthermore, the maximum and mean minimum alveolar concentration (MAC) values were significantly higher in the control group (p < 0.001 and p = 0.019, respectively).

– While no significant differences were observed between the groups concerning total blood loss and Ramsay Sedation Score (RSS) in the post-anesthesia care unit, the study concluded that lingual nerve block effectively reduced MAP surges and opioid consumption during tongue cancer surgeries, supporting the benefits of regional anaesthesia in head and neck operations.

– Study limitations included the inability to measure blood loss accurately across different surgical phases, and there was a recommendation for further studies on bilateral lingual nerve blocks to assess enhanced haemodynamic stability and opioid use. The findings reinforce regional anaesthesia as a critical approach for managing perioperative risks in sensitive surgical contexts.

Reference –

Shalini Chaudhuri et al. (2025). Efficacy Of Lingual Nerve Block In Preventing Haemodynamic Response Due To Surgical Stimulation In Patients Undergoing Tongue Cancer Resections: A Randomised Controlled Trial. *Indian Journal Of Anaesthesia*. https://doi.org/10.4103/ija.ija_1002_24.

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Intralesional MMR Vaccine Outperforms Vitamin D in Wart Treatment, Study Finds

Egypt: A recent randomized clinical trial demonstrated that the intralesional measles, mumps, and rubella (MMR) vaccine is more effective than vitamin D3 in treating multiple warts, offering a promising alternative to traditional destructive therapies.

In the study, published in the Indian Journal of Dermatology, Venereology and Leprology, 80.4% of patients in the MMR group (0.3 mL) achieved a complete response, compared to 66.1% in the vitamin D group (0.3 mL). Although the MMR group reported higher rates of mild pain and injection site itching, the recurrence rates after six months were similar between the two groups (3.6% for MMR vs. 5.4% for vitamin D).

Warts, benign skin lesions triggered by human papillomavirus (HPV) infection, often pose cosmetic concerns and discomfort. Traditional treatment approaches, such as cryotherapy, electrocautery, and chemical cautery, although widely used, are associated with various side effects and recurrence risks. Manar Sallam, Department of Dermatology, Andrology and Sexually Transmitted Diseases, Faculty of Medicine, Mansoura University, Mansoura, Egypt, and colleagues aimed to evaluate the effectiveness, safety, and tolerability of using the intralesional measles, mumps, and rubella (MMR) vaccine in comparison to vitamin D for treating warts.

For this purpose, the researchers enrolled 112 participants with multiple warts, dividing them into two groups. Group I (56 participants) received 0.3 mL of intralesional MMR vaccine, while Group II (56 participants) received 0.3 mL of intralesional vitamin D3. Injections were given every two weeks into the most noticeable wart, with up to five sessions. The participants were followed up for six months after their final treatment.

Key findings were as follows:

  • The MMR group showed a significantly higher complete response rate (80.4%) than the vitamin D group (66.1%).
  • Both groups received an average of four treatment sessions, with no significant difference.
  • The MMR group experienced significantly higher rates of mild pain (96.4%) and injection site itching (12.5%) than the vitamin D group.
  • After six months of follow-up, the recurrence rates were similar in both groups, with 3 cases (5.4%) in the vitamin D group and 2 cases (3.6%) in the MMR group.

The researchers concluded that intralesional MMR demonstrated greater efficacy than vitamin D in treating warts, though with a higher incidence of tolerable side effects. Both treatments were safe, effective, and cost-efficient for wart therapy, offering low recurrence rates. As such, immunotherapy, including intralesional MMR and vitamin D, may be a suitable option for managing multiple, disseminated, and recalcitrant warts.

“The study, however, acknowledges certain limitations, including the lack of assessment of viral types and serum cytokine levels before and after treatment. Further studies are needed to explore the effect of these injections on cytokine serum levels,” the researchers wrote.

Reference:

Sallam M, Awad A, Hamdy S, State A. Intralesional measles, mumps, and rubella vaccine versus vitamin D for treatment of warts: A randomised clinical trial. Indian J Dermatol Venereol Leprol. doi: 10.25259/IJDVL_1669_2024

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