Researchers used a new-user design and Cox proportional hazards models to compare treatment-related events classified with Medical Dictionary for Regulatory Activities terminology. After adjustment for measured factors, imeglimin was associated with a substantially higher risk of gastrointestinal events than sitagliptin, with an adjusted hazard ratio of 5.44 and a 95% confidence interval of 3.44–8.61. The strongest associations involved nausea, for which the adjusted hazard ratio was 15.34 (95% confidence interval, 3.50–67.23); diarrhea, with an adjusted hazard ratio of 7.90 (95% confidence interval, 2.54–24.62); and abdominal discomfort, with an adjusted hazard ratio of 6.02 (95% confidence interval, 1.47–24.58).

No statistically significant difference in hypoglycemia risk was observed between the groups. The adjusted hazard ratio for hypoglycemia with imeglimin relative to sitagliptin was 0.66, but its wide 95% confidence interval of 0.20–2.22 indicated substantial uncertainty. The authors cautioned that the limited number of hypoglycemia events reduced confidence in this comparison, meaning that the nonsignificant result should not be interpreted as proof that the drugs have identical risks.

A sensitivity analysis restricted to patients receiving monotherapy produced a similar association: the hazard ratio for gastrointestinal events with imeglimin was 5.36, with a 95% confidence interval of 2.63–10.92. The findings concern Japanese clinical practice and selected patients who received newly prescribed medicine through community pharmacies during 2022–2024. Because the study was retrospective and observational, it can identify associations but cannot establish that imeglimin caused the additional events; unmeasured differences between patient groups may also have contributed. Nevertheless, the data indicate that gastrointestinal adverse events were more common among imeglimin users than among comparable new users of sitagliptin, while the evidence was insufficient to draw a firm conclusion about hypoglycemia.

Subject of Research: Comparative real-world safety of imeglimin and sitagliptin in Japanese patients with type 2 diabetes

Article Title: Comparative safety of imeglimin versus sitagliptin in Japanese patients with type 2 diabetes: A pharmacy-based retrospective cohort study

Article References: Suzuki, N., Ooba, N., Nakajima, R., Takabatake, K., Saita, M., Kawakami, E., Kawana, M., Watanabe, D., & Hashiba, H. (2026). Comparative safety of imeglimin versus sitagliptin in Japanese patients with type 2 diabetes: A pharmacy-based retrospective cohort study. PLOS One, 21(10), e0359960. https://doi.org/10.1371/journal.pone.0359960

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DOI: 10.1371/journal.pone.0359960

Keywords: imeglimin, sitagliptin, type 2 diabetes, adverse events, gastrointestinal events, hypoglycemia, pharmacy records, Japan, retrospective cohort, drug safety, Comparative, safety

The findings describe the experience of this hospitalized cohort and do not establish that dexmedetomidine caused the observed outcomes or was safer or more effective than another sedative. The analysis included patients admitted between June 1 and December 30, 2022, who received dexmedetomidine while receiving non-invasive respiratory support through either continuous positive airway pressure or high-flow nasal cannula. High-flow oxygen therapy was delivered through a nasal cannula, and continuous positive airway pressure was delivered with a nasal mask.

Dexmedetomidine was administered by infusion at 0.1–0.6 micrograms per kilogram per hour without a loading dose. The study used descriptive statistics and examined variables including age, dexmedetomidine dose, adverse effects, sex, heart rate and respiratory rate. Because the investigation was retrospective and did not include a randomized comparison group, it cannot separate the effects of dexmedetomidine from those associated with respiratory support, changes in illness or other aspects of clinical care.

The cohort included 46% females and 54% males. Patients aged 1–12 months accounted for 55.8% of the group, those aged 13–36 months represented 34.5%, and 9.72% were older than 36 months. Non-invasive respiratory support is frequently used in pediatric patients with moderate to severe acute respiratory failure, but non-compliance can reduce treatment success.

Dexmedetomidine is widely used in adults for its sedative and anxiolytic properties, although its use in pediatric populations has been more limited. The research therefore focused on documenting the clinical feasibility, physiological trends and adverse events associated with its use alongside non-invasive support, rather than directly comparing it with a control treatment. Following initiation of combined non-invasive respiratory support and dexmedetomidine therapy, researchers observed statistically significant reductions in respiratory rate and heart rate, with p-values below 0.001 for both measures.

These were observed changes during treatment, not evidence of a causal effect or a prespecified comparison between groups. The respiratory rate and heart rate findings also applied to the overall cohort, which comprised patients treated for acute respiratory failure and a smaller post-extubation group. Documented adverse effects occurred in five of the 113 children: bradycardia in two, elevated liver enzyme levels in two and hypotension in one.

No adverse events were reported in the remaining 108 patients. The source did not classify these events as serious adverse events, so their frequency should not be interpreted as a formal serious-adverse-event rate. In the stratified analysis, 100 of 102 children, or 98%, in the primary non-invasive support subgroup completed treatment without escalation to invasive ventilation; that subgroup was intended to prevent intubation.

All 11 children in the post-extubation subgroup, intended to prevent re-intubation, also completed non-invasive support without escalation. The post-extubation estimate is based on a particularly small group and therefore has greater uncertainty than the overall cohort result. Overall, the study supports the limited conclusion that dexmedetomidine monotherapy can be administered feasibly in a pediatric intensive care setting alongside non-invasive respiratory support, with lower heart and respiratory rates observed and only a small number of patients experiencing documented adverse effects.

The descriptive results do not show that dexmedetomidine prevents intubation or re-intubation, improves survival, or offers advantages over alternative sedatives. The authors called for prospective comparative trials to investigate the safety and effectiveness of the approach. Until such evidence is available, the reported success rate should be viewed as an observation from one retrospective cohort rather than a treatment-effect estimate.

Subject of Research: Retrospective evaluation of dexmedetomidine sedation during pediatric non-invasive respiratory support

Article Title: Safety and feasibility of dexmedetomidine for sedation in pediatric patients receiving non-invasive respiratory support: a descriptive study

Article References: Yavuz, S., & Avci, A. (2026). Safety and feasibility of dexmedetomidine for sedation in pediatric patients receiving non-invasive respiratory support: a descriptive study. BMC Pediatrics. https://doi.org/10.1186/s12887-026-07603-x

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DOI: 10.1186/s12887-026-07603-x

Keywords: dexmedetomidine, pediatric sedation, non-invasive respiratory support, pediatric intensive care, acute respiratory failure, continuous positive airway pressure, high-flow nasal cannula, retrospective study, adverse events, clinical feasibility, Safety, feasibility

The central problem was the way non-jaw osteonecrosis appeared in the reporting vocabulary. FAERS has no preferred term for avascular necrosis, so extra-oral cases are often recorded under the site-unspecified term “osteonecrosis.” That term is also used for osteonecrosis of the jaw, a complication closely associated with bisphosphonates and denosumab. The researchers therefore constructed cases at the report level, beginning with explicit non-jaw terms and adding site-unspecified reports only when they lacked evidence of jaw involvement, such as an oral or dental co-event or an indication referring to an oral malignancy or dental procedure. This adjudicated approach identified 24,087 cases, compared with 1,521 under a conservative definition limited to explicit non-jaw terms and 33,964 under a more permissive definition. A further 73 reports were removed because the suspected drug appeared to have been prescribed for osteonecrosis itself.

An initial scan of 432 suspect-drug ingredients produced 47 signals under four complementary disproportionality criteria: reporting odds ratio, proportional reporting ratio with chi-square testing, the multi-item gamma-Poisson shrinker, and the Bayesian confidence propagation neural network. A new descriptive measure, the jaw-propensity index, calculated the share of each drug’s osteonecrosis-family reports explicitly coded to the jaw. Six drugs with established jaw-centered osteonecrosis clustered at the high end: denosumab had an index of 0.94, risedronate 0.78, zoledronic acid 0.71, ibandronate 0.65, pamidronate 0.55 and alendronate 0.502. By contrast, tenofovir disoproxil had an index of 0.001, and the glucocorticoid signals ranged from 0 to 0.28. The final glucocorticoid-and-asparaginase core did not change classification when the threshold was varied from 0.30 to 0.70.

Jaw exclusion removed 41 of the 47 signals, but the study also found that litigation-related reporting could independently magnify associations. Restricting the analysis to health-professional reports sharply reduced the tenofovir disoproxil reporting odds ratio from 157.9, with a 95% confidence interval of 153.4 to 162.6, to 6.33, with an interval of 5.38 to 7.45. Of 7,027 US tenofovir disoproxil osteonecrosis cases, 5,937, or 84.5%, carried a lawyer reporter code. Emtricitabine and efavirenz showed similar patterns. Lawyer-coded reports represented 25.8% of all adjudicated cases but only 2.6% of the deduplicated FAERS corpus. The researchers treated the lawyer code as a lower bound on solicitation, because recruited reports may also enter through consumers or manufacturers with no occupation recorded.

Independent comparisons supported the view that the extreme US antiretroviral estimates reflected reporting structure rather than a comparable signal in every jurisdiction. Canada Vigilance produced a tenofovir disoproxil reporting odds ratio of 6.24, with a wide 95% interval of 2.00 to 19.4, based on only three cases. JADER produced 10.5, with an interval of 6.60 to 16.8, from 18 cases. Both were far below the all-reporter FAERS estimate and closer to its health-professional estimate. Within reports carrying an HIV indication, the Japanese estimate was 2.75, with an interval of 1.26 to 6.00, whereas the corresponding US estimate remained 27.5, with an interval of 25.2 to 30.1, because 94% of US HIV-indication cases named tenofovir disoproxil or a co-formulated partner. These findings do not exclude a modest tenofovir–osteonecrosis association, but they do not support the magnitude seen in the unfiltered US data.

The external databases more consistently reproduced the glucocorticoid pattern. The pooled glucocorticoid reporting odds ratio was 10.3, with a 95% interval of 8.28 to 12.8, in Canada and 54.4, with an interval of 48.3 to 61.3, in Japan. In JADER, individual estimates included 39.3 for prednisolone, based on 729 cases, 28.7 for methylprednisolone, based on 207 cases, and 13.0 for dexamethasone, based on 184 cases. Asparaginase also replicated strongly in Japan, with a reporting odds ratio of 75.7, an interval of 61.4 to 93.3 and 103 cases. Rankings of drugs by jaw-propensity index were highly concordant across databases, with Pearson correlations of 0.985 for Canada and 0.960 for Japan, although this comparison was supported largely by separation into jaw-dominated and non-jaw clusters rather than by identical values for every drug.

Restricting each non-glucocorticoid signal to the disease for which the drug was prescribed separated additional drug-like signals from indicators of an underlying condition. Mycophenolate mofetil initially had a reporting odds ratio of 2.58, with an interval of 2.21 to 3.01, and remained elevated when only health professionals were considered and when glucocorticoid-unexposed reports were examined. Yet within transplant or immunosuppression indications, its ratio fell to 0.89, with an interval of 0.68 to 1.16, leaving no detected excess beyond the disease baseline. Voxelotor similarly fell from 5.06 overall to 0.97, with an interval of 0.71 to 1.32, within sickle-cell disease. Among 20 non-glucocorticoid drugs evaluated within their home indications, 14 had no residual excess, five met the study’s residual criterion, and one was not evaluable. The five residuals were asparaginase, pegaspargase, testosterone, arsenic trioxide and imiglucerase.

Asparaginase had the strongest case because it combined statistical, mechanistic and cross-jurisdiction evidence. Its within-leukemia reporting odds ratio was 7.14, with a 95% interval of 5.10 to 10.0, while pegaspargase had a lower but directionally consistent ratio of 2.00, with an interval of 1.26 to 3.17. The source article describes mechanisms through which asparaginase can promote hypercoagulability and hypertriglyceridemia, both established osteonecrosis risk factors, and notes experimental evidence that it can potentiate glucocorticoid-induced osteonecrosis. By comparison, the residuals for testosterone in hypogonadism, arsenic trioxide in acute promyelocytic leukemia and imiglucerase in Gaucher disease were modest and could plausibly reflect treatment of patients with more severe disease, greater exposure to co-therapies or unmeasured differences in severity and duration. The spontaneous reports did not contain enough information to distinguish these explanations from a drug contribution.

Timing provided a further separation between the major signal clusters. Weibull models gave glucocorticoids a subacute onset profile, with shape parameters from 0.44 to 0.74 and fitted median times to onset of 71 to 265 days. Several antiresorptives had increasing-hazard profiles, consistent with delayed jaw osteonecrosis, although the antiresorptive class as a whole was heterogeneous. The litigation-heavy antiretrovirals had especially delayed patterns: tenofovir disoproxil had a fitted median of 1,292 days, emtricitabine 1,244 days and efavirenz 1,438 days. A separate machine-learning check, which did not receive the disproportionality results, also ranked consumer reporting, lawyer reporting and glucocorticoid co-exposure as the leading predictors of case status. Its area under the receiver-operating-characteristic curve was 0.765. This exercise used the same reports, so it was an internal consistency check rather than independent validation.

The study’s conclusions are constrained by the nature of spontaneous reporting. Missing concomitant medications can hide glucocorticoid exposure; adverse events are under-reported; notoriety can increase reporting; and large clusters of reports can depress the apparent ratios of less frequently reported drugs. Indeed, all 34 negative-control drugs had ratios below 1, with a median of 0.16. Removing antiresorptive and litigated-antiretroviral reports raised that median to 0.38, and removing glucocorticoid reports as well raised it to 0.44, while most remaining drug ratios increased by roughly 2.35-fold. The analysis also used external case definitions that only approximated the primary adjudication, and the secondary analyses were exploratory rather than multiplicity-adjusted. The researchers concluded that, after accounting for jaw misclassification, litigation-related reporting and confounding by indication, the reproducible spectrum is glucocorticoid-centered, with asparaginase as the best-supported residual. Three additional drugs remain unresolved, and cohort studies would be required to determine whether the residual associations reflect causation.

Subject of Research: Pharmacovigilance analysis of drug reporting signals for non-jaw osteonecrosis

Article Title: Glucocorticoid-centered drug spectrum of non-jaw osteonecrosis, a FAERS pharmacovigilance study with independent validation in Canada Vigilance and JADER

Article References: Qi, L., Qiu, Y., Wang, X., Zhang, T., & Jiang, H. (2026). Glucocorticoid-centered drug spectrum of non-jaw osteonecrosis, a FAERS pharmacovigilance study with independent validation in Canada Vigilance and JADER. Frontiers in Pharmacology, 17, Article 1977191. https://doi.org/10.3389/fphar.2026.1977191

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DOI: 10.3389/fphar.2026.1977191

Keywords: non-jaw osteonecrosis, FAERS, pharmacovigilance, glucocorticoids, asparaginase, reporting bias, jaw osteonecrosis, adverse events, disproportionality analysis, Canada Vigilance, JADER, Glucocorticoid-centered

The review, published in Frontiers in Physiology, searched PubMed, Embase, Web of Science and the Cochrane Library from database inception through August 30, 2025. Seventeen reports describing 14 independent randomized trials were eligible, after duplicate publications and linked reports from the same trial were combined. The participants had a mean age of approximately 59 years; 516 were assigned to neuromuscular training and 513 to control interventions. These controls included rehabilitation exercise, quadriceps or progressive strength training, proprioceptive exercises, medication, education, usual care or no exercise. Training lasted from four weeks to 12 weeks and generally involved two or three sessions per week.

Neuromuscular training is an exercise-based approach that combines principles of motor control, joint biomechanics, coordination and dynamic stability rather than concentrating only on increasing muscle strength. In the meta-analysis, it produced a mean improvement of 4.44 points on the Knee injury and Osteoarthritis Outcome Score Symptoms scale, with a 95% confidence interval of 1.62 to 7.26 and P = 0.002. The difference was consistent with the direction favoring training, and statistical heterogeneity was low at I² = 23%. The Symptoms domain includes stiffness, swelling, activity limitation and mechanical discomfort, with higher scores indicating better symptom control.

Benefits also appeared in the activities-of-daily-living and quality-of-life domains, but the evidence was less uniform. Neuromuscular training was associated with a 3.94-point advantage in KOOS activities of daily living, covering activities such as standing, walking, turning, stair climbing and squatting (95% confidence interval 0.09 to 7.79; P = 0.04). This analysis had moderate heterogeneity, with I² = 54%, and its confidence interval was close to the null value. Excluding one report in sensitivity analysis strengthened the estimate to 5.44 points and reduced heterogeneity to I² = 5%, although the original result remained the primary finding.

For knee-related quality of life, the pooled mean difference was 5.59 points, with a 95% confidence interval of 0.97 to 10.21 and P = 0.02. This domain captures patients’ concerns about their knee, expectations for future function and the burden of osteoarthritis on daily life. Heterogeneity was high at I² = 71%, and a sensitivity analysis that included a trial with neuromuscular exercise in both randomized groups produced a similar estimate of 5.31 points. Broader general-health measures, including EQ-5D-3L outcomes, did not differ significantly between groups, so the finding was specific to knee-related quality of life rather than a demonstrated improvement in overall health status.

Neuromuscular training did not significantly outperform control interventions for pain. The primary KOOS Pain analysis yielded a mean difference of 1.95 points, but the 95% confidence interval ranged from −0.27 to 4.17 and P was 0.08, with no statistical heterogeneity at I² = 0%. A sensitivity analysis that included a trial comparing two neuromuscular-exercise strategies also remained nonsignificant. Additional pooled analyses of visual analogue pain scores after walking and overall pain likewise found no statistically significant differences. The pattern therefore suggests that any observed benefit is not adequately explained by a direct or consistent pain-relieving effect.

No statistically significant advantage was found in KOOS Sport and Recreation, where the mean difference was 1.64 points (95% confidence interval −2.24 to 5.53; P = 0.41; I² = 0%). Most objective performance measures also failed to show consistent between-group differences, including the 30-second chair-stand test, maximum knee bends, one-leg rises, one-leg hop, stair climbing, Timed Up and Go and walking velocity. A 20-meter walk test showed a statistically significant difference of −0.56 seconds in favor of neuromuscular training, but the clinical relevance of that small change was uncertain. Measures of knee-flexion and knee-extension peak torque, extensor and flexor strength and other biomechanical indicators likewise did not show consistent benefits.

Ten randomized trials contributed adverse-event data. The pooled relative risk was 0.83, with a 95% confidence interval of 0.50 to 1.37 and P = 0.46, indicating no statistically significant difference in reported adverse events between neuromuscular training and control groups. This result must not be read as proof that the interventions were equally safe, because studies differed in how they defined, monitored and reported adverse events. The funnel plot appeared broadly symmetrical, but Egger’s test for the adverse-event analysis gave P = 0.01, suggesting possible publication bias or small-study effects. The review’s GRADE assessment was used to evaluate certainty for primary outcomes and adverse events, recognizing factors such as risk of bias, inconsistency, indirectness, imprecision and publication bias.

Most prespecified subgroup analyses did not identify reliable effect modifiers. The reviewers examined control type, intervention duration, mean age, mean body-mass index and geographic region, and used formal interaction tests rather than treating a significant result in one subgroup as sufficient. Only mean age significantly interacted with the quality-of-life result, with P for interaction = 0.02. Although quality of life improved in groups whose mean age was at least 60 years and in those with a mean BMI of at least 28 kilograms per square metre, the limited number of studies and reliance on study-level rather than individual-participant age data make the age signal exploratory. No definitive regional, BMI, duration or control-type effect was established.

Clinical importance remains another central limitation. The pooled differences of 4.44 points for symptoms, 3.94 for activities of daily living and 5.59 for quality of life were all below a commonly cited 8–10-point threshold for a clinically important change on KOOS, although the relevance of that threshold depends on the population and estimation method. Overall, the evidence suggests that neuromuscular training may partially ease perceived knee symptoms and support daily activity and knee-related quality of life in some people with knee osteoarthritis, but it does not establish a broad effect on pain, strength or physical performance. The investigators called for larger, adequately powered trials with standardized protocols, objective tracking of adherence and training dose, and longer follow-up to clarify the magnitude, mechanisms and long-term clinical value of these modest benefits.

Subject of Research: Effects of neuromuscular training on symptoms, function, quality of life and safety in people with knee osteoarthritis

Article Title: Rehabilitation efficacy of neuromuscular training for individuals suffering from knee osteoarthritis: a systematic review and meta-analysis based on randomized controlled trials

Article References: Bai, B., Gu, Y., Dingpeng, L., Xie, X., & Yao, F. (2026). Rehabilitation efficacy of neuromuscular training for individuals suffering from knee osteoarthritis: a systematic review and meta-analysis based on randomized controlled trials. Frontiers in Physiology, 17, Article 1892963. https://doi.org/10.3389/fphys.2026.1892963

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DOI: 10.3389/fphys.2026.1892963

Keywords: knee osteoarthritis, neuromuscular training, rehabilitation, systematic review, meta-analysis, randomized controlled trials, quality of life, exercise therapy, adverse events, efficacy, neuromuscular, training

Probiotics have long been proposed as a way to soften these side effects, potentially by attenuating antibiotic-induced disruption of the gut microbiota, reinforcing colonization resistance, and modulating mucosal immune responses. Previous meta-analyses, however, pooled trials that mixed proton pump inhibitors, vonoprazan, and other acid suppressants with different antibiotic backbones, probiotic strains, doses, and durations. That heterogeneity, the review authors argued, obscured what probiotics actually add when the underlying regimen is otherwise fixed.

To answer that narrower question, the team searched eight bibliographic databases and three trial registries from inception through mid-July 2026, with no language restrictions. Eligible studies were randomized controlled trials in adults with confirmed H. pylori infection comparing a vonoprazan-based regimen plus a probiotic against the identical regimen without one, with probiotic administration overlapping the eradication course. The searches identified 506 database records and 19 registry records; after screening, sixteen reports corresponding to nine independent randomized studies met the criteria, encompassing 1,270 participants.

All nine trials were conducted in China, one multicenter and eight single-center, published or completed between 2023 and 2026. Six evaluated vonoprazan-amoxicillin dual therapy, one vonoprazan-based triple therapy, and two bismuth-containing quadruple therapy, with treatment durations of 10 days, 14 days, or, in one atypical case, four weeks. The probiotic interventions were biologically diverse, ranging from Bacillus subtilis plus Enterococcus faecium and Saccharomyces boulardii to compound lactic acid bacteria, Bifidobacterium capsules, Bacillus licheniformis, and a Bifidobacterium tetravaccine.

Eradication was generally confirmed by urea breath testing at least four weeks after treatment. Statistically, the team pooled risk ratios using restricted maximum-likelihood random-effects models with Hartung-Knapp confidence intervals, and reported 95 percent prediction intervals to estimate what a future comparable trial might show. The primary outcome was the proportion of participants experiencing at least one adverse event, treated as a participant-level binary measure rather than a count of episodes.

The reviewers used the Cochrane Risk of Bias 2 tool for outcome-specific bias assessments and GRADE to rate certainty, and excluded studies with ambiguous adverse-event totals or serious allocation concerns from the primary analyses. The tolerability signal was striking. Across five studies involving 611 participants, adjunctive probiotics reduced the risk of experiencing at least one adverse event by roughly 70 percent (risk ratio 0.30, 95 percent confidence interval 0.17 to 0.53; P = 0.004), with zero statistical heterogeneity.

The prediction interval, 0.12 to 0.79, remained entirely below the null, suggesting benefit would be expected in a future similar trial. Translated into absolute terms, the risk fell from 261 to about 79 per 1,000 treated, meaning roughly one additional patient avoids an adverse event for every six given probiotics. Sensitivity analyses kept the estimate between 0.31 and 0.38, and GRADE certainty was rated moderate.

The efficacy picture was far less convincing. Intention-to-treat eradication across seven studies and 910 participants showed a small apparent benefit (risk ratio 1.09, 95 percent confidence interval 1.00 to 1.19), but the prediction interval of 0.92 to 1.30 crossed no effect, and statistical significance vanished in sensitivity analyses that excluded dissertation-based or methodologically atypical studies. Per-protocol eradication showed little or no difference (risk ratio 1.03), and adherence, already high at about 95 percent in control groups, was not clearly improved.

Individual symptoms such as constipation, bloating, and nausea trended in probiotics' favor, but these analyses rested on few events and were graded very-low-certainty. Discontinuation and serious adverse events were too rare to yield interpretable estimates. The authors caution that all included trials were conducted in China, and that regional differences in antimicrobial resistance, prior antibiotic exposure, diet, baseline microbiota, probiotic product quality, and symptom-reporting behavior may limit generalizability to other populations.

Most trials were also open-label, a concern for subjectively reported adverse events, and the data cannot identify an optimal probiotic strain, dose, or timing. The reviewers conclude that probiotics are best framed as supportive care to improve tolerability during vonoprazan-based therapy, not as a means of raising cure rates, and they call for adequately powered, placebo-controlled, multicenter trials with standardized outcome definitions and strain-level reporting to confirm the findings in diverse settings.

Subject of Research: Adjunctive probiotics during vonoprazan-based Helicobacter pylori eradication therapy

Article Title: Adjunctive probiotics may reduce adverse events during vonoprazan-based Helicobacter pylori eradication: a systematic review and meta-analysis

Article References: Lin, C.-J., Ren, P.-Y., Chen, H.-Y., Zheng, M.-Q., Jiang, Y.-X., Li, G., Fu, M., & Guo, Y.-H. (2026). Adjunctive probiotics may reduce adverse events during vonoprazan-based Helicobacter pylori eradication: a systematic review and meta-analysis. Frontiers in Pharmacology, 17, Article 1946885. https://doi.org/10.3389/fphar.2026.1946885

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DOI: 10.3389/fphar.2026.1946885

Keywords: Helicobacter pylori, vonoprazan, probiotics, meta-analysis, adverse events, eradication therapy, gut microbiota, potassium-competitive acid blocker, tolerability, randomized controlled trials, GRADE certainty, gastroenterology

Participants received one of two approaches: bone marrow aspirate collected from the posterior iliac crest and combined with a scaffold, or standard treatment based on guided bone regeneration or an autogenous bone block graft. The experimental group contained 35 participants, while the standard-of-care group contained 29. The investigators used mixed models to compare outcomes between treatment groups. They also trained machine-learning models on extraction-socket and trauma or cleft-reconstruction datasets, then tested the models on trauma data to evaluate their ability to predict wound-healing index, quality of life, discomfort and whether adverse events occurred.

Discomfort increased across all groups over the four-week assessment period, indicating worsening symptoms after surgery; the change over time reached p < 0.001. The total quality-of-life score worsened with increasing age (p = 0.02). Hispanic participants recorded the highest overall quality-of-life scores (p = 0.01), while adverse events increased with age and among female participants (p < 0.001). These patterns describe associations within the analyzed population and do not establish causes. The analysis did not detect differences between the stem-cell and standard-care groups, supporting the authors’ conclusion that the two approaches had equivalent effects on the measured early outcomes.

Machine-learning approaches performed well in predicting the continuous outcomes of wound-healing index, quality of life and discomfort, particularly with nonlinear models. All tested models also predicted the binary outcome of adverse events. Together, the results suggest that computational models captured patterns in the postoperative outcome data. The analysis was limited to short-term assessments at one, two and four weeks, 64 participants pooled from three randomized studies, and several types of craniofacial procedure. As a secondary analysis of previously conducted trials, the work evaluated existing trial data rather than constituting a new randomized comparison of treatment effects.

Overall, the study found that experimental regenerative therapy did not produce detectable differences from established grafting approaches during early recovery after oral and craniofacial reconstruction. The findings support including patient-reported measures when evaluating these procedures, as the analysis evaluated recovery-related experiences in addition to wound-healing indicators. The results do not establish whether the treatments have equivalent long-term outcomes, implant success or tissue-regeneration benefits, and they cannot be extended beyond the four-week assessment period. The authors called for further research focused on patient-reported outcomes in oral and craniofacial reconstruction.

Subject of Research: Early patient-reported outcomes after experimental stem-cell therapy for craniofacial bone reconstruction

Article Title: Patient-reported outcomes following craniofacial regenerative stem cell therapy: a secondary analysis and machine learning approach

Article References: Almujaydil, R., Leow, N., Nguyen, L., Giannobile, W. V., D’Aiuto, F., & Kaigler, D. J. (2026). Patient-reported outcomes following craniofacial regenerative stem cell therapy: a secondary analysis and machine learning approach. Journal of Translational Medicine. https://doi.org/10.1186/s12967-026-09106-w

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DOI: 10.1186/s12967-026-09106-w

Keywords: stem-cell therapy, craniofacial reconstruction, patient-reported outcomes, wound healing, quality of life, bone grafting, machine learning, postoperative discomfort, adverse events, randomized trials, Patient-reported, outcomes

Of the 301 patients, 187 underwent stenting for superior vena cava syndrome and 114 for inferior vena cava syndrome. The investigators identified 34 adverse events in total, using International Classification of Diseases, 10th Revision codes. Red blood cell transfusion was required in 10 patients, representing 3.3% of the cohort.

The study did not report the frequency of every individual adverse event or identify transfusion as the most common event, so the available results support the reported counts without establishing a ranking among complications. The analysis also examined short-term mortality and differences between the two anatomical groups. Seven-day mortality after stent placement was 5.0%, while 30-day in-hospital mortality measured from hospital admission was 11.6%.

Respiratory failure was reported more frequently in the superior vena cava group. Other adverse events and the mortality measures were comparable between the superior and inferior vena cava groups, according to the study. Because the research was observational, these figures describe outcomes in the treated population and do not establish that stenting caused the deaths or other recorded complications.

Underlying malignancies and treatment patterns differed between the groups. Lung tumors predominated in superior vena cava cases, whereas liver tumors predominated in inferior vena cava cases. Multiple stents were used more frequently in patients treated for inferior vena cava syndrome.

The researchers also evaluated therapeutic interventions received by patients. These findings are descriptive characteristics of the hospital population rather than evidence that a particular cancer type or stent configuration determined the likelihood of an adverse event or death. Overall, the results indicate an observed 10.6% incidence of coded adverse events after malignant vena cava stenting, with no serious adverse event requiring invasive intervention in this cohort.

Subject of Research: Safety of stent placement for malignant superior and inferior vena cava syndrome in a nationwide Japanese inpatient cohort

Article Title: Patient characteristics and the safety of stent placement for malignant vena cava syndrome in Japan: a nationwide analysis

Article References: Ozawa, M., Nakama, R., Inoue, N., Miyamoto, Y., Sone, M., & Fushimi, K. (2026). Patient characteristics and the safety of stent placement for malignant vena cava syndrome in Japan: a nationwide analysis. Supportive Care in Cancer, 34(11), Article 1129. https://doi.org/10.1007/s00520-026-11400-8

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DOI: 10.1007/s00520-026-11400-8

Keywords: vena cava syndrome, venous stenting, malignant obstruction, adverse events, stent safety, cancer care, retrospective cohort, Japan, inpatient database, patient outcomes, Patient, characteristics

Before maintenance treatment, 10 of the 13 children were in complete response and three were in partial response with marrow-confined disease; 10 had undergone autologous stem cell transplantation. At the end of immunotherapy, 11 children were classified as having complete response and two as having progressive disease. Four event-free-survival events were recorded: a pathology-confirmed parenchymal central nervous system relapse, a probable central nervous system relapse defined by MRI without histologic confirmation, non-central-nervous-system skull-base osseous progression with parameningeal extension, and abdominal nodal progression followed by death. No treatment-related deaths were reported.

Safety was summarized descriptively across 65 maintenance cycles: 41 immunotherapy-only cycles and 24 combined chemotherapy-immunotherapy cycles. Pain, cytokine release syndrome and capillary leak syndrome were predominantly low grade. Grade 3 or higher myelosuppression, neutropenia, infection and fever occurred numerically more often in combined cycles than in immunotherapy-only cycles: 83.3% versus 34.1%, 58.3% versus 9.8%, 37.5% versus 19.5%, and 37.5% versus 26.8%, respectively. The investigators did not perform formal statistical testing or within-patient adjustment to establish differences or attribute adverse events to individual treatment components.

The study included a contemporaneous 43-patient cohort—30 children who did not receive dinutuximab beta, including seven treated with naxitamab—only to provide context about treatment pathways and accessibility; it was not a comparator group. The authors cautioned that the small cohort entered maintenance with a low residual disease burden after multimodal treatment, so the observed outcomes cannot be attributed to dinutuximab beta alone. Cycle-stratified safety patterns were likewise descriptive, and the three heterogeneous cranial-region events were described as hypothesis-generating rather than evidence of an increased central-nervous-system relapse rate or a changed relapse spectrum.

Subject of Research: Single-center observational assessment of dinutuximab beta maintenance therapy in children with newly diagnosed high-risk neuroblastoma.

Article Title: Dinutuximab beta-based first-line maintenance therapy for newly diagnosed high-risk neuroblastoma following a COG-based pathway: a single-center real-world study in China

Article References: Yi, M., Chen, S., Xu, H., Liu, C., Lang, H., & Yuan, X. (2026). Dinutuximab beta-based first-line maintenance therapy for newly diagnosed high-risk neuroblastoma following a COG-based pathway: a single-center real-world study in China. BMC Cancer. https://doi.org/10.1186/s12885-026-16951-x

Image Credits: AI Generated

DOI: 10.1186/s12885-026-16951-x

Keywords: dinutuximab beta, high-risk neuroblastoma, pediatric cancer, maintenance therapy, event-free survival, adverse events, China, retrospective cohort, Dinutuximab, beta-based, first-line, maintenance

The reported population had a median age of 66 years and a median of three vaccine doses. Participants were non-hospitalized adults who met the study’s high-risk criteria. The primary outcome was a composite of all-cause hospitalization or death within 30 days. Based on the published abstract, the analysis assessed real-world clinical outcomes, tolerability and predictors of progression in a largely triple-vaccinated and frail cohort. As a retrospective observational study without an untreated or alternative-treatment comparison reported in the abstract, it establishes associations among treated patients rather than demonstrating that nirmatrelvir/ritonavir caused the low observed event rates.

In adjusted multivariable analysis using backward selection, solid neoplasms, lymphoma and leukemia were the strongest independent predictors of the 30-day composite outcome. Solid neoplasms were associated with an odds ratio of 6.32 (95% confidence interval 1.91–20.87), lymphoma with an odds ratio of 14.33 (5.15–39.88), and leukemia with an odds ratio of 5.81 (1.24–27.37). These estimates identify groups with a higher observed likelihood of hospitalization or death within the treated cohort; they do not quantify the causal effect of treatment or provide comparative risks for untreated patients.

Adverse events were reported in 10.7% of participants, with dysgeusia and gastrointestinal symptoms identified as the main events. Treatment was discontinued because of toxicity in 0.7% of the cohort. Overall, the abstract reports few adverse events and very low rates of severe outcomes among the high-risk outpatients who received early nirmatrelvir/ritonavir, while active solid or hematologic malignancies remained associated with greater risk. The findings should be interpreted in light of the retrospective design, the selected high-risk population and the absence of a comparison group described in the abstract. In addition, only the abstract was supplied for this report, so the full study methods, detailed results and limitations could not be independently assessed.

Subject of Research: Clinical outcomes and progression predictors among high-risk Italian COVID-19 outpatients treated with nirmatrelvir/ritonavir

Article Title: Clinical outcomes, safety and predictors of disease progression in high-risk COVID-19 outpatients treated with nirmatrelvir/ritonavir: an Italian multicenter retrospective cohort study (PRIMA study)

Article References: Gentile, I., Buonomo, A. R., Lichtner, M., Cattelan, A., Campoli, C., Coppola, L., Tumbarello, M., Pellegrino, M. C., Mastroianni, C., Torti, C., Coppola, N., Marino, A., Cascio, A., Leone, S., Masullo, A., Codella, A. V., Nicastri, E., Borgo, C. D., Scaglione, V., … Giulia, Z. (2026). Clinical outcomes, safety and predictors of disease progression in high-risk COVID-19 outpatients treated with nirmatrelvir/ritonavir: an Italian multicenter retrospective cohort study (PRIMA study). BMC Infectious Diseases. https://doi.org/10.1186/s12879-026-14363-7

Image Credits: AI Generated

DOI: 10.1186/s12879-026-14363-7

Keywords: COVID-19, nirmatrelvir/ritonavir, outpatients, retrospective cohort, disease progression, hospitalization, mortality, malignancy, adverse events, Italy, Clinical, outcomes

Researchers searched PubMed/MEDLINE, the Web of Science Core Collection and Cochrane CENTRAL from database inception through 20 August 2026. The review included phase III randomized trials evaluating abiraterone, enzalutamide, apalutamide or darolutamide, regardless of whether the studies reported fracture outcomes. Twenty-two trials met the eligibility criteria. Thirteen trials, involving 13,712 participants, contributed data for all-grade fracture-related adverse events, while eight trials, involving 9,254 participants, contributed data for grade 3 or higher events.

Risk ratios were pooled with random-effects models using restricted maximum-likelihood estimation and a Hartung–Knapp adjustment. For all-grade fracture-related adverse events, the pooled risk ratio was 2.13 (95% confidence interval, 1.74–2.60), with statistical heterogeneity of 45.8% and a 95% prediction interval of 1.23–3.68. For grade 3 or higher events, the pooled risk ratio was 2.64 (95% confidence interval, 1.73–4.02), with heterogeneity of 11.8%. The corresponding pooled cumulative risk differences were 4.93 percentage points for all-grade events and 1.71 percentage points for grade 3 or higher events, although the abstract cautions that these estimates require caution because observation periods and baseline fracture risks differed among trials.

Exploratory analyses suggested possible differences among the four agents, but no interaction was observed by prostate cancer disease state. These subgroup findings were based on indirect comparisons and were imprecise in several groups. The direction of the associations remained statistically stable in sensitivity and rare-event analyses, but differences in fracture definitions and treatment exposure across trials remained unresolved. The findings therefore describe associations with adverse events as reported in randomized trials, rather than establishing a uniform fracture risk for every individual receiving an ARPI-containing regimen.

Subject of Research: Reported fracture adverse-event risks with androgen receptor pathway inhibitor-containing therapies for prostate cancer

Article Title: Evaluation of bone fracture risk among men with prostate cancer treated with androgen receptor pathway inhibitor-containing therapies: a systematic review and meta-analysis

Article References: Zhu, J., Zhang, A., Jing, W., & Zhang, F. (2026). Evaluation of bone fracture risk among men with prostate cancer treated with androgen receptor pathway inhibitor-containing therapies: a systematic review and meta-analysis. BMC Cancer. https://doi.org/10.1186/s12885-026-16982-4

Image Credits: AI Generated

DOI: 10.1186/s12885-026-16982-4

Keywords: prostate cancer, androgen receptor pathway inhibitors, fracture risk, adverse events, systematic review, meta-analysis, randomized trials, abiraterone, enzalutamide, apalutamide, darolutamide, Evaluation