Widely prescribed opioid painkiller tramadol not that effective for easing chronic pain

The strong opioid painkiller, tramadol, is not that effective at easing chronic pain for which it’s widely prescribed, finds a pooled data analysis of the available research, published online in BMJ Evidence Based Medicine.

And it likely increases the risk of serious side effects, including heart disease, the findings indicate, prompting the researchers to conclude that the potential harms of tramadol probably outweigh its benefits, and that its use should be minimised.

Tramadol is a dual action opioid widely prescribed for the treatment of moderate to severe acute and chronic pain. As such, it’s recommended in several medical guidelines for pain management, note the researchers.

Its use has surged in recent years, and it’s now among the most commonly prescribed opioids in the US, possibly because of its perceived lower risk of side effects and the widespread belief that it is safer and less addictive than other short-acting opioids, they add.

Although tramadol has been included in previous systematic reviews, none has provided a comprehensive assessment of tramadol’s efficacy and safety in a range of chronic pain conditions, they say.

In a bid to plug this knowledge gap, the researchers scoured research databases for randomised clinical trials published up to February 2025 that compared tramadol with placebo (dummy treatment) for patients with chronic pain, including cancer pain.

Nineteen clinical trials involving 6506 participants with chronic pain were eligible for inclusion in the analysis. Five looked at the impact of tramadol on neuropathic pain; nine focused on osteoarthritis; four looked at chronic low back pain; and one focused on fibromyalgia.

The average age of the trial participants was 58, but ranged from 47 to 69. Tablets were the primary formulation used; only one trial included topical cream. Length of treatment ranged from 2 to 16 weeks while length of follow up ranged from 3 to 15 weeks.

Pooled data analysis of the trial results showed that while tramadol eased pain, the effect was small and below what would be considered clinically effective.

Eight of the trials reported on the proportion of serious side effects arising after treatment during follow up periods of between 7 and 16 weeks.

Statistical analysis of these trials results indicated a doubling in the risk of harms associated with tramadol compared with placebo, mainly driven by a higher proportion of ‘cardiac events,’ such as chest pain, coronary artery disease, and congestive heart failure.

Use of tramadol was also associated with a heightened risk of some cancers, although the follow up period was short, making this finding “questionable,” say the researchers.

Pooled data analysis of all the trial results indicated that tramadol treatment was associated with a heightened risk of several milder side effects, including nausea, dizziness, constipation, and sleepiness.

The researchers acknowledge that the outcome results were at high risk of bias, but this increases the likelihood that the findings overestimate the beneficial effects and underestimate the harmful effects of tramadol, they suggest.

They point out: “Approximately 60 million individuals worldwide experience the addictive effects of opioids. In 2019, drug use was responsible for approximately 600,000 deaths, with nearly 80% of these fatalities associated with opioids and approximately 25% resulting from opioid overdose.

“In the United States, the number of opioid-related overdose deaths increased from 49,860 in 2019 to 81,806 in 2022. Given these trends and the present findings, the use of tramadol and other opioids should be minimised to the greatest extent possible.”

They conclude: “Tramadol may have a slight effect on reducing chronic pain (low certainty of evidence) while likely increasing the risk of both serious (moderate certainty of evidence) and non- serious adverse events (very low certainty of evidence). The potential harms associated with tramadol use for pain management likely outweigh its limited benefits.”

Reference:

Barakji JA, Maagaard M, Petersen JJ, et alTramadol versus placebo for chronic pain: a systematic review with meta-analysis and trial sequential analysisBMJ Evidence-Based Medicine Published Online First: 07 October 2025. doi: 10.1136/bmjebm-2025-114101

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No benefit of Morphine on chronic dyspnea among patients with cardiorespiratory disease: ERS Study

A new study published in The Lancet Respiratory Medicine found that morphine did not reduce chronic dyspnea in patients with cardiorespiratory disease, but online group singing improved quality of life. 

Consenting adults (1:1, stratified by site and causal disease) with a modified Medical Research Council breathlessness score of 3 or higher due to cardiorespiratory conditions were randomly assigned to receive 5–10 mg twice daily oral long-acting morphine or placebo (as well as a blinded laxative) for 56 days in this trial conducted across 11 centers.

Using a numerical rating scale (NRS; 0 = not breathless at all; 10 = worst conceivable breathlessness), the main result was the worst breathlessness score for the previous 24 hours on day 28. Quality of life, morphine-related toxicities, physical activity levels, and worst cough NRS were secondary outcomes. The patients were eligible to be included in effectiveness and safety analyses if they received at least one dosage of the trial medication.

Only 3 individuals did not get the allotted therapy out of the 143 people who were randomly randomized to receive either morphine or a placebo (67 participants) between March 18, 2021, and October 26, 2023. The participants were primarily White (132 [94%]), male (93 [66%]), and their mean age was 70·5 (SD 9·4) years. By day 28, 66 (99%) of the morphine group and 64 (88%) of the placebo group achieved 90% or higher adherence.

With the exception of the better cough seen on day 56, researchers did not find any indication of a difference in the worst breathlessness at day 28 (morphine 6·19 [95% CI 5·57 to 6·81] vs placebo 6·10 [5·44 to 6·76]; adjusted mean difference 0·09 [95% CI –0·57 to 0·75], p=0·78]) or any secondary measure.

After multiple-measures adjustment, the increase in moderate to vigorous physical activity at day 28 (adjusted mean difference 9·51 min/day [0·54–18·48]) was not statistically significant.

Significant adverse events (15 vs. three, of which three in the morphine group and none in the placebo group were judged to be attributable to the study), study medication withdrawals (13 vs. two), and adverse events were more common in the morphine group (251 vs. 162). No one died as a result of therapy. Overall, the findings of this study states that there is no proof that morphine lessens the severity of the severe dyspnea.

Reference: 

Johnson, M. J., Williams, B., Keerie, C., Tuck, S., Hart, S., Bajwah, S., Chaudhuri, N., Pearson, M., Cohen, J., Evans, R. A., Currow, D. C., Higginson, I. J., Hall, P., Atter, M., Norrie, J., Fallon, M. T., & MABEL collaborative. (2025). Morphine for chronic breathlessness (MABEL) in the UK: a multi-site, parallel-group, dose titration, double-blind, randomised, placebo-controlled trial. The Lancet. Respiratory Medicine. https://doi.org/10.1016/S2213-2600(25)00205-X

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Chemists Launch Indefinite Strike Over Coldrif Tragedy, Demand Action Against Manufacturers Not Sellers

Bhopal: The Chhindwara Chemist Association has launched an indefinite strike starting midnight to protest the sealing of five chemist shops linked to the Coldrif cough syrup controversy. The association called the shop closures unfair and unjust, insisting that liability should lie with the manufacturers and approving laboratories, not local chemists who merely sold the product.

For the unversed, the Coldrif cough syrup tragedy that has claimed the lives of at least 20 children across Madhya Pradesh, allegedly due to diethylene glycol (DEG) contamination. The syrup, manufactured by Chennai-based Sresan Pharmaceuticals, was found to contain toxic industrial-grade chemicals instead of pharmaceutical-grade ingredients. Following the deaths, multiple states, including Himachal Pradesh and Uttar Pradesh, banned the product, and law enforcement agencies initiated raids and arrests linked to the manufacturer and supply chain.

Lately, the Association has appealed to authorities to unseal the shops and commit to more equitable enforcement.

“We are going on strike starting midnight in protest after five chemist shops, which have been sealed and served a showcause notice. We are not objecting to the investigation, and samples should be collected. However, we do not agree with the sealing of chemist shops. Action should be taken against the medicine producers and labs that pass them,” Chore told ANI.

Santosh Chore, President of the Chemist Association, clarified that while members support the sample collection and investigation drives, “penalising chemists for actions beyond their control is unacceptable.” He demanded the immediate release of the five shop owners and urged a revision of investigation protocols, especially given that many shopkeepers are unable to clean or prep their premises ahead of Diwali.

“Today samples are being taken from our shops, we are not able to do our business and nor we are able to clean our shops for Diwali, our chemist shops are living under fear. We want the authorities to release five chemist owners and demand a change in investigation standards,” Chore added.

Also Read: 3 cough syrups recalled, none exported: CDSCO responds to WHO

Meanwhile, Madhya Pradesh Deputy Chief Minister and Health Minister Rajendra Shukla confirmed the tragic toll of the controversy: 20 children have died from consuming Coldrif syrup. Of these, 17 were from Chhindwara, two from Betul, and one from Pandhurna.

He added that police teams have been dispatched to Chennai and Kancheepuram to apprehend those responsible for manufacturing the syrup, and that all possible efforts were being made to save the children under treatment.

“I met five children who are undergoing treatment in Nagpur, two at Government Medical College, two at AIIMS and one in a private hospital and their families. The management and doctors are making all efforts to save the lives of children undergoing treatment,” Shukla was quoted as saying by the Republic World.

Chief Minister Mohan Yadav announced that the Madhya Pradesh government will cover the full cost of treatment for nine children undergoing care in Nagpur for kidney infections linked to the contaminated cough syrup. A joint team of executive magistrates and doctors has been stationed in Nagpur to oversee medical arrangements and ensure continuous health monitoring of the affected children, the Chief Minister’s Office stated on X.

Also Read: Inside Coldrif Scandal: Tamil Nadu Plant Used Paint-Grade Chemicals, Violated 300+ Drug Norms

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3% Hypertonic Saline Nasal Irrigation Eases Allergic Rhinitis Symptoms but Not Superior to Isotonic Saline: Study

A new study published in the journal of Allergologia et immunopathologia showed that although there was no discernible improvement over isotonic saline, 3% hypertonic saline nasal irrigation decreased nasal symptoms and antihistamine usage in individuals with allergic rhinitis.

There is ongoing discussion on the relative effectiveness of 0.9% isotonic saline and 3% hypertonic saline nasal irrigation (HSNI). Thus, this study evaluated the effectiveness of HSNI as a therapeutic strategy for both adults and children with AR.

From the beginning until May 8, 2024, a comprehensive search of Scopus, PubMed, and Cochrane Central was conducted to find randomized controlled trials (RCTs) that compared 3% HSNI with control. Antihistamine usage and overall nasal symptom ratings were the main outcomes. They used a random effects model to pool mean differences and odds ratios (OR) with 95% CI, and they used I2 to measure heterogeneity. The inclusion criteria were satisfied by 9 RCTs with 645 patients. The follow-up period was 4 weeks to 2 months.

Adults were 35.49 years old on average, while children were 9.3 years old. In both adults (MD = −2.09; 95% CI: −3.86 to −0.33; P = 0.02; I2 = 97%) and children (MD = −0.97; 95% CI: −1.51 to −0.44; P = 0.0004; I2 = 42%), HSNI substantially decreased nasal symptom ratings when compared to control.

While there was no discernible difference between HSNI and isotonic saline alone (OR = 0.69; 95% CI: 0.41–1.16; P = 0.16; I2 = 0%), antihistamine usage was likewise lower with HSNI than control (OR = 0.39; 95% CI: 0.21–0.70; P = 0.002; I2 = 14%). Across all age categories, HSNI seems to be successful in lowering allergic rhinitis symptoms and medication use.

Overall, the potential advantages of HSNI in managing AR are highlighted by this systematic review and meta-analysis, especially in terms of lowering nasal symptoms and perhaps lowering the need for antihistamines. Because HSNI is nonpharmacological and has a good safety record, it might be a useful therapy adjunct.

To standardize irrigation procedures, identify ideal saline concentrations, and elucidate the function of HSNI in conjunction with traditional pharmaceutical therapies, large-scale randomized controlled studies are required in the future. Clinicians may provide AR patients a straightforward, efficient, and well-tolerated intervention to enhance their quality of life by honing nasal irrigation techniques.

Source:

Singh, N., Singh, S., Sharma, A. K., Singh, U., Bhatnagar, V., & Singh, V. (2025). Efficacy of hypertonic saline nasal irrigation in allergic rhinitis: A systematic review and meta-analysis. Allergologia et Immunopathologia, 53(5), 164–178. https://doi.org/10.15586/aei.v53i5.1409

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Infants with Sleep-Disordered Breathing and Severe Laryngomalacia Face Higher Surgery Risk: Study Suggests

USA: A new study published in the International Journal of Pediatric Otorhinolaryngology has highlighted clinical factors that can help predict the need for surgical intervention in infants with laryngomalacia. The findings offer valuable insights for clinicians aiming to optimize care and improve outcomes in affected infants.

Laryngomalacia, the most common congenital laryngeal anomaly in infants, is characterized by floppy supraglottic structures that collapse during inspiration, leading to airway obstruction. While many infants exhibit mild symptoms that can be managed conservatively, others require supraglottoplasty to address severe airway compromise, support growth, and maintain respiratory function. Identifying which infants are likely to need surgery remains a key challenge for pediatric otolaryngologists.
Robert Brinton Fujiki, PhD, CCC-SLP, from Indiana University School of Medicine, and Michael D. Puricelli, MD, from the University of Wisconsin-Madison, conducted a retrospective cohort study using electronic medical records from a tertiary children’s hospital. The study included 144 infants diagnosed with laryngomalacia, categorized into those who did not require surgery (n=82) and those who underwent supraglottoplasty (n=62). Diagnosis was confirmed by pediatric otolaryngologists using distal chip fiberoptic laryngoscopy. Researchers collected data on demographics, medical history, symptom severity, comorbidities, feeding assessments, and previous respiratory illnesses.
The analysis revealed the following findings:
  • Infants with severe laryngomalacia symptoms were nearly three times more likely to require supraglottoplasty (adjusted odds ratio [aOR] 2.8).
  • Sleep-disordered breathing increased the likelihood of surgery 5.6-fold.
  • Infants with uncoordinated suck-swallow-breathe patterns during feeding had a 2.5 times higher risk of needing surgical intervention.
  • A history of respiratory illnesses, including pneumonia or respiratory syncytial virus infection, significantly increased the probability of surgery.
  • Infants who underwent surgery typically exhibited earlier symptom onset compared with those managed conservatively.
According to the authors, these findings highlight the importance of early and careful assessment of infants with laryngomalacia. “By recognizing symptom severity, sleep-disordered breathing, feeding coordination issues, and past respiratory illnesses, clinicians can more accurately identify infants who would benefit from timely supraglottoplasty,” the researchers noted.
The study emphasizes that while mild to moderate laryngomalacia is often monitored before deciding on surgery, early identification of these key predictors can help tailor management strategies and potentially prevent complications such as poor weight gain, chronic hypoxia, or failure to thrive.
“The study provides strong evidence that symptom severity, history of respiratory illness, sleep-disordered breathing, and feeding coordination patterns are critical predictors for surgical intervention in infants with laryngomalacia. Incorporating these indicators into clinical evaluations can support personalized care plans, ensuring infants receive the appropriate level of intervention at the right time,” the authors concluded.
Reference:
Fujiki, R. B., & Puricelli, M. D. (2025). Predicting Surgical Intervention in Infants with Laryngomalacia. International Journal of Pediatric Otorhinolaryngology, 112582. https://doi.org/10.1016/j.ijporl.2025.112582

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FDA Approves new Lasix injection for Edema in Chronic Heart Failure

FDA has approved the new furosemide injection for treating edema in adults with chronic heart failure.

Lasix ONYU was developed to enable subcutaneous infusion of furosemide outside the healthcare setting for selected patients, as prescribed by a clinician without the need for a healthcare professional to administer the drug.

About 6.7 million Americans suffer from heart failure, with the prevalence expected to rise to 8.7 million by 2030. Heart failure is a leading cause of hospitalizations for individuals aged 65 and older with approximately 1.2 million hospitalizations per year.

Lasix ONYU consists of a novel high-concentration formulation of furosemide combined with a state-of-the-art small Infusor for treatment at home. The innovative design includes a reusable unit that can be used for 48 treatments and a plastic sterile single-use unit that is discarded after treatment. The two-component design reduces manufacturing complexity and cost, allowing the product to be offered at a different, more favorable price point which is expected to reduce barriers to widespread adoption.

“Lasix ONYU has the potential to be transformative in the care of patients experiencing worsening heart failure due to fluid overload,” said Pieter Muntendam, MD, founder, President and CEO of SQ Innovation. “Treating selected patients at home offers important benefits to patients, health systems and payors. We look forward to launching Lasix ONYU with leading health systems in the 4th quarter of 2025.”

Bioavailability and diuretic response were determined in a clinical study in which Lasix ONYU demonstrated complete bioavailability (112%) resulting in similar diuresis (115%) and natriuresis (117%) when compared to the same dose given by IV bolus. The biphasic delivery of furosemide by the Infusor resulted in a tempered diuretic response while IV bolus administration led to a shorter period of more intense diuresis. The results of the study were published in a leading cardiovascular journal.

“Heart failure is the most common serious medical condition in the U.S. and affects about one in four Americans during their lifetime. The number of patients affected is expected to double over the next 20 years and we currently already often lack adequate resources to take care of the 6.7 million patients affected presently – there are not enough beds, clinicians and funds”, said Dr. Javed Butler, Professor of Medicine at University of Mississippi and President, Baylor Scott and White Research Institute. “The only two actionable solutions now are more widespread adoption of guideline directed medical therapy (GDMT) and treating more patients at home with products such as subcutaneous diuretics instead of hospitalization for intravenous diuretics.”

“Decongestion through use of IV diuretics has been the cornerstone of treatment for reducing edema and hypervolemia in heart failure patients for over five decades,” stated S. Craig Thomas, Immediate Past President of the American Association of Heart Failure Nurses (AAHFN), an organization dedicated to advancing nursing education, clinical practice, and research to improve outcomes for heart failure patients. “The availability of accessible, affordable, and novel options that do not require the presence of a healthcare professional allows for transformative new clinical care-delivery. This means patients who now would typically need to be hospitalized for several days of IV treatment can instead remain home, supported by periodic or remote monitoring. The significance of this shift away from inpatient care for patients, hospitals, and payers cannot be overstated.”

Starting this quarter, Lasix ONYU will be available from leading pharmaceutical distributors enabling timely availability at participating medical facilities and affiliated retail pharmacies.

SQ Innovation is hosting a Conference Call and Webcast on Thursday October 9, at 4:30pm ET to introduce the product and answer questions from the community. Participating in the conference call will be:

• Pieter Muntendam, MD, President and CEO of SQ Innovation

• Mustafa M. Ahmed, MD, Professor of Medicine, Section Chief, Heart Failure, University of Florida Health, Gainesville, FL

• S. Craig Thomas, Nurse Practitioner, Advanced Heart Failure Center, University of Virginia Health System, Charlottesville, VA and Immediate Past President American Association of Heart Failure Nurses (AAHFN).

About Lasix ONYU

Lasix® ONYU is a drug-device combination that was approved by the U.S. Food and Drug Administration on October 7, 2025 for the treatment of edema in adult patients with chronic heart failure. The pharmaceutical component of Lasix ONYU is a novel, high-concentration formulation of the diuretic furosemide, at 30 mg/mL. It comes in a pre-filled glass cartridge containing 80 mg of furosemide in 2.67 mL. The Lasix ONYU Infusor consists of two main parts: the Reusable Unit and the Disposable Unit. The Reusable Unit is an electromechanical device that contains the battery, motor, and electronic components necessary for operation and safety functions. It can be used up to 48 times before it can be recycled. The Disposable Unit is a sterile, single-use plastic component that holds the drug cartridge. It includes a micropiston pump, fluid path, needle insertion and retraction mechanism, and a 29-gauge needle. After placement on the abdomen, the needle penetrates the skin when the device is activated. The Lasix ONYU Infusor slowly administers 80 mg furosemide over a period of five hours. This method results in significant diuresis similar to IV, but in a more controlled manner. This avoids the brief, intense diuretic effect that occurs with rapid IV infusion or injection. The advanced two component design offers benefits for patients, healthcare providers, payers, and the environment.

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Intensity modulated radiotherapy matches proton beam therapy for head and neck cancer: Study

Intensity-modulated radiotherapy is as good as proton beam therapy for treating people with head and neck cancer, according to the results of a Cancer Research UK-funded clinical trial.

The TORPEdO trial funded by Cancer Research UK and The Taylor Family Foundation, led by The Christie NHS Foundation Trust and sponsored by the Institute of Cancer Research, London, compared two forms of highly targeted radiotherapy for head and neck cancer – proton beam therapy (PBT) and intensity-modulated radiotherapy (IMRT).

Presented at the American Society of Radiation Oncology (ASTRO) Annual Meeting in San Francisco, California, the initial results of this multi-centre trial found that there was no need for PBT for most people with head and neck cancer. Similar levels of side-effects from the treatment were observed in both groups.

PBT directs a beam of highly charged particles called protons onto a tumour to destroy the cancerous cells. IMRT uses advanced computer programmes to create a beam of radiation that matches the shape of a patient’s tumour, which the computer then directs onto the tumour using a machine called a linear accelerator (LINAC). Both forms of radiotherapy can be customised to maximise the radiation delivered to tumours and minimise damage to nearby healthy cells.

PBT is available in the UK at The Christie NHS Foundation Trust in Manchester and University College London Hospital. It is currently used routinely to treat brain tumours and cancers affecting children and young people in England, where it successfully reduces damage to the brain, spinal cord and developing cells in children and young people.

Further clinical trials are underway to find out if proton beam therapy should be used to treat cancers where it could reduce damage to sensitive tissues near the tumour site. This includes breast cancer, liver cancer and lung cancer.

IMRT is more widely available, with the Royal College of Radiologists estimating that there are around 340 linear accelerator (LINAC) machines in England*. However, many of these machines are outdated and require upgrading to deliver cutting-edge radiotherapy like IMRT.

In the TORPEdO trial, 205 patients with head and neck cancer were randomly assigned to either PBT or IMRT at centres across the UK between 2020 and 2023.

One year after treatment, no differences were observed between the PBT and IMRT groups in terms of key side effects. Both groups reported similar outcomes in taste, chewing, swallowing, speech, saliva function and appearance post-treatment.

Clinical lead for head and neck cancer at the Christie NHS Foundation Trust and Chief Investigator of the TORPEdO trial, Professor David Thomson, said:

“What our trial shows is that high quality radiotherapy is essential to give people with head and neck cancer the best possible treatment. This trial compared two sophisticated forms of radiotherapy which deliver targeted doses of radiation.

“For most people with head and neck cancer, IMRT and proton beam therapy are equally effective treatments, giving similar results in terms of survival and quality of life afterwards. But as IMRT can be delivered with more widely available equipment, this trial provides reassurance that people with head and neck cancer can more readily access the best treatments in their local area.”

Professor of Oncology Trials at the Institute of Cancer Research, London, and TORPEdO trial co-lead, Professor Emma Hall, said:

“The TORPEdO trial has demonstrated the importance of conducting randomised clinical studies to inform how we guide treatment decisions and deliver cancer care. For most people with head and neck cancer, proton beam therapy did not reduce side effects compared to IMRT.

“These findings reinforce the importance of ensuring that high-quality IMRT is accessible to patients across the UK, which will require further investment in modern linear accelerator machines.”

Tex Leece, a 52-year-old married father of two from Rivington in Bolton, received curative treatment on the TORPEdO clinical trial at The Christie NHS Foundation Trust in Manchester for oropharynx (throat) cancer and is cancer free more than three years later.

Tex, a Warburton’s delivery driver, who walked his daughter Holly down the aisle just six weeks after finishing cancer treatment and getting the all-clear in May 2022, was randomised to the standard radiotherapy arm of the trial.

The nine times triathlete, who now enjoys cycling and DIY, having just built a log cabin in his garden, said:

“I’m really well, and still super active thanks to the treatment I received. I’m not surprised by the results of the trial as I’d done so well with the standard radiotherapy I was given.

“I was very happy to be part of the TORPEdO trial and saw it as a bit of an adventure as you know you’re contributing to science and helping future patients in the process. It’s a way of giving back. I’d say to anyone thinking of taking part in a trial to stay as positive as you can, although it’s not going to be easy, having a good mental attitude really helps.”

Director of Research at Cancer Research UK, Dr Catherine Elliott, said:

“The results of the TORPEdO trial show how important it is for people with cancer to have access to the best quality radiotherapy. Modern radiotherapy is now far more advanced, far more targeted and far more effective than ever before.

“The UK Government’s recent commitment to fund new LINAC machines to replace outdated ones is welcome, but it is a one-off commitment. Between now and 2040, we expect 6 million new cancer cases to be diagnosed across England, and we will need to ensure that health services are prepared for the increased capacity this will require.

“If we are to continue to deliver the best outcomes for people with cancer, the UK Government needs to tackle staff shortages in radiology and there needs to be sustained investment in equipment. The upcoming National Cancer Plan for England is the perfect opportunity to unlock better access to a wider range of cutting-edge treatments, which ensure that more people will live longer, better lives, free from the fear of cancer.”

The TORPEdO trial tested the two radiotherapy regimes in combination with cisplatin chemotherapy. Whether proton beam therapy selectively improves patient outcomes in other tumour types or when combined with immunotherapy or molecular targeted therapies, is the subject of ongoing and future clinical trials.

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IBS Patients Face Higher Risk of Developing IBD, suggests study

Researchers have discovered in a new study that irritable bowel syndrome (IBS) patients have a much greater long-term risk of acquiring inflammatory bowel disease (IBD) than the general population. The study concluded that IBS patients, particularly those with the diarrhea-predominant subtype (IBS-D), had a higher risk of developing ulcerative colitis (UC) or Crohn’s disease (CD) in the long run. The study was published in the Journal of Gastroenterology by Huixin S. and colleagues.

IBS and IBD are two prevalent but different gastrointestinal disorders. IBS is defined as a functional disorder in which there is abdominal pain, bloating, diarrhea, or constipation, whereas IBD, encompassing UC and CD, is a chronic inflammatory bowel disease of the gastrointestinal tract with ongoing complications. This UK Biobank large-scale study gives the strongest evidence to date that IBS patients are at a significantly increased risk of developing IBD.

The study team examined 447,631 baseline participants without IBD (2006–2010) for longitudinal cohort analysis and 76,992 participants who filled out the Digestive Health Questionnaire (2017–2018) for cross-sectional analysis. The main outcome in the cohort study was incident new cases of IBD, with Cox proportional hazards models calculating hazard ratios (HRs). In the cross-sectional design, prevalent IBD was taken as the outcome, and logistic regression calculated odds ratios (ORs).

Results

  • During a median follow-up of 14.2 years, the cohort study ascertained 2,916 new cases of IBD, including 2,097 ulcerative colitis (UC) and 1,015 Crohn’s disease (CD) cases.

In comparison with non-IBS participants, IBS patients exhibited:

  • 68% increased risk of IBD (HR = 1.68, 95% CI: 1.47–1.92).

  • 60% increased risk of UC (HR = 1.60, 95% CI: 1.36–1.89).

  • 104% increased risk of CD (HR = 2.04, 95% CI: 1.66–2.51).

  • Notably, the risk continued to persist in the long term, with IBS patients continuing to have a 55% increased risk of IBD at 10 years (HR = 1.55, 95% CI: 1.27–1.89).

In cross-sectional analysis, IBS patients had markedly increased odds of IBD:

  • 2.40-fold increased odds of overall IBD (OR = 2.40, 95% CI: 2.14–2.70).

  • 2.18-fold increased odds of UC (OR = 2.18, 95% CI: 1.92–2.48).

  • 3.15-fold increased odds of CD (OR = 3.15, 95% CI: 2.68–3.70).

  • Among the IBS subtypes, the IBS-D group had the highest odds with a 3.72 times higher risk of IBD (OR = 3.72, 95% CI: 3.24–4.28).

This large population study in UK Biobank produces strong evidence that IBS patients, particularly IBS-D, have a significantly higher risk of developing IBD, including UC and CD, compared to the general population. This elevated risk is maintained for more than a decade, supporting the requirement for long-term watchfulness among IBS patients. These findings suggest that IBS might not only be thought of as a functional disorder but also as an occult risk factor for the future development of inflammatory bowel diseases.

Reference:

Song, H., Zhou, Y., Liu, S. et al. Long-term risk of inflammatory bowel disease in patients with irritable bowel syndrome: the cross-sectional and longitudinal relationship. J Gastroenterol (2025). https://doi.org/10.1007/s00535-025-02304-1

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High Stress-Induced Blood Sugar Linked to Increased ARDS and Mortality in Sepsis Patients: Study

China: Researchers have found that a higher stress hyperglycemia ratio (SHR) is strongly associated with an increased risk of acute respiratory distress syndrome (ARDS) and in-hospital mortality among patients with sepsis.

The study, published in Scientific Reports, analyzed data from 1,946 sepsis patients and highlighted that individuals in the highest SHR quartile faced a 42% higher risk of developing ARDS and a 40% greater risk of dying during hospitalization compared with those in the lowest quartile.
The study, led by Xianwei Jin and colleagues from the Department of Medicine, Graduate School, Nanchang University, China, aimed to investigate the relationship between SHR—a measure comparing acute blood glucose elevation to baseline glycemic status—and ARDS risk in sepsis patients. Data were sourced from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database, a comprehensive repository of intensive care unit patient records in the United States.
Patients were stratified into four groups based on SHR quartiles. The primary outcome assessed was the occurrence of in-hospital ARDS. Researchers employed multivariate Cox proportional-hazards regression and restricted cubic spline models to examine the correlation between SHR and ARDS risk. Subgroup analyses and Kaplan-Meier survival curves further supported the findings.
The study led to the following notable findings:
  • 34% of participants developed acute respiratory distress syndrome (ARDS).
  • 13% of participants died during hospitalization.
  • The stress hyperglycemia ratio (SHR) was independently associated with both ARDS and in-hospital mortality after adjusting for confounders.
  • Risk of ARDS and mortality increased approximately linearly with rising SHR levels, especially for mild and moderate ARDS.
  • Subgroup analyses showed that the association between SHR and adverse outcomes was consistent across different patient populations.
According to the researchers, these findings suggest that SHR can serve as a valuable early indicator for identifying patients with sepsis at high risk of ARDS, potentially enabling timely interventions and improved clinical management. The study emphasizes the clinical relevance of monitoring stress-induced hyperglycemia as part of comprehensive sepsis care.
The study had some limitations: it included only U.S. patients, mostly White, limiting generalizability; its retrospective, observational design precludes causal conclusions; and as a single-center study with a modest sample size, residual confounding may still affect the results.
The authors recommend that prospective, multicenter studies be conducted to validate these results and further explore the mechanistic links between SHR and ARDS.
“Elevated SHR is significantly linked to higher in-hospital mortality and ARDS risk in patients with sepsis. Monitoring SHR could help clinicians identify high-risk individuals early, enabling better risk stratification and guiding timely interventions. Future prospective studies are necessary to confirm these findings and inform clinical strategies for managing stress hyperglycemia in sepsis patients,” the authors concluded.
Reference:
Jin, X., Deng, W., Weng, Q., Liu, F., & Min, J. (2025). Correlation between stress hyperglycemia ratio and risk of acute respiratory distress syndrome in patients with sepsis: A MIMIC-IV cohort study. Scientific Reports, 15(1), 1-13. https://doi.org/10.1038/s41598-025-18349-4

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Anticoagulant Monotherapy alone, best for Stroke Prevention in AF with Atherosclerosis: JAMA

Researchers have found in a new study that in patients with nonvalvular atrial fibrillation (AF) and atherosclerosis, the addition of antiplatelet therapy to anticoagulants did not reduce ischemic events but significantly increased bleeding risk. Researchers conclude that anticoagulant monotherapy may be a safer option for this high-risk population. The study was published in JAMA Neurology by Shuhei O. and colleagues.

This multicenter, open-label, randomized clinical trial was conducted across 41 sites in Japan between November 2016 and March 2025, including adults with ischemic stroke or transient ischemic attack (TIA) within 8 to 360 days of onset, confirmed nonvalvular atrial fibrillation, and at least one manifestation of atherosclerotic cardiovascular disease (ASCVD) (such as carotid or intracranial artery stenosis, ischemic heart disease, peripheral artery disease, or noncardioembolic stroke). The trial was arranged to check if an antiplatelet drug added to anticoagulant therapy would enhance clinical outcomes over anticoagulant monotherapy.

316 patients were randomized and enrolled into two groups: 159 in combination therapy (anticoagulant + antiplatelet) and 157 in anticoagulant monotherapy. The mean (SD) age was 77.2 (7.4) years, and 28.5% (n = 90) were women. The data were analyzed between April and October 2024.

The main outcome was a composite of ischemic cardiovascular events and major bleeding during two years. Secondary endpoints were ischemic cardiovascular events, and safety endpoints were major and clinically relevant nonmajor bleeding. The study was prematurely stopped on July 18, 2023, after an interim analysis revealed that there was no additional benefit expected from further enrollment.

Key Findings

The outcomes showed no significant ischemic difference between the two treatment arms but a significantly higher risk of bleeding in the combination arm:

  • The main outcome occurred in 17.8% of combination therapy group patients and 19.6% of monotherapy group patients (HR, 0.91; 95% CI, 0.53–1.55; P = .64), with no significant advantage to the addition of an antiplatelet.

  • Ischemic cardiovascular events occurred in 11.1% of the patients who were on combination therapy and 14.2% of the patients on monotherapy (HR, 0.76; 95% CI, 0.39–1.48; P = .41), once more indicating no notable decrease in ischemic risk.

  • Yet, for major and clinically significant nonmajor bleeding, 19.5% of the combination therapy group experienced events in comparison to 8.6% of the monotherapy group (HR, 2.42; 95% CI, 1.23–4.76; P = .008), a greater than twofold increase in risk.

These results affirm that although theoretical benefits for dual therapy may exist in reducing thrombotic events, these do not translate to a benefit in total outcomes and significantly increase the risk of harm from bleeding.

In this randomized clinical trial of patients with ischemic stroke or TIA and concurrent nonvalvular atrial fibrillation and atherosclerotic cardiovascular disease, the addition of an antiplatelet agent to anticoagulant therapy did not enhance clinical outcomes but rather enhanced bleeding risk. This research supports maintaining the reduction of unnecessary dual therapy to weigh efficacy with safety for the patient.

Reference:

Okazaki S, Tanaka K, Yazawa Y, et al. Optimal Antithrombotics for Ischemic Stroke and Concurrent Atrial Fibrillation and Atherosclerosis: A Randomized Clinical Trial. JAMA Neurol. Published online October 06, 2025. doi:10.1001/jamaneurol.2025.3662

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