Search Results (496)

Background and Objectives: Implantation of cardiac implantable electronic devices (CIEDs) is increasingly performed in elderly and comorbid patients, for whom minimizing perioperative complications—including pain and systemic drug use—is critical. Traditional local infiltration often provides insufficient analgesia. The ultrasound-guided PECS II block, an interfascial regional technique, offers promising analgesic benefits in thoracic wall procedures but remains underutilized in cardiac electrophysiology. Materials and Methods: We conducted a prospective, controlled, non-randomized clinical study including 106 patients undergoing de novo CIED implantation. Patients were assigned to receive either a PECS II block (n = 53) or standard lidocaine-based local anesthesia (n = 53). Pain intensity was assessed using the numeric rating scale (NRS) intraoperatively and at 1, 6, and 12 h postoperatively. Secondary outcomes included the need for rescue analgesia, procedural duration, length of hospitalization, and patient satisfaction. Results: Patients in the PECS II group reported significantly lower NRS scores at all time points (mean intraoperative score: 2.1 ± 1.2 vs. 5.7 ± 1.6, p < 0.001; at 1 h: 2.5 ± 1.5 vs. 6.1 ± 1.7, p < 0.001). Rescue analgesia (metamizole sodium) was required in only four PECS II patients (7.5%) vs. 100% in the control group within 1 h. Hospital stay and procedural time were also modestly reduced in the PECS II group. Patient satisfaction scores were significantly higher in the intervention group. Conclusions: The ultrasound-guided PECS II block significantly reduces perioperative pain and the need for additional analgesia during CIED implantation, offering an effective, safe, and opioid-sparing alternative to conventional local infiltration. Its integration into clinical protocols for device implantation may enhance procedural comfort and recovery. Full article

Background: Despite significant advancements in diabetes care, many individuals with type 2 diabetes (T2D) do not receive optimal care and treatment. Digital interventions promoting behavioral changes have shown promising long-term results in supporting healthier lifestyles but are not implemented in most healthcare offerings, maybe due to lack of general practice support and collaboration. This study evaluates the efficacy of the Digital, Individualized, and Collaborative Treatment of T2D in General Practice Based on Decision Aid (DICTA), a randomized controlled trial integrating a patient-centered smartphone application for lifestyle support in conjunction with a clinical decision support (CDS) tool to assist general practitioners (GPs) in optimizing antidiabetic treatment. Methods: The present randomized controlled trial aims to recruit 400 individuals with T2D from approximately 70 GP clinics (GPCs) in Denmark. The GPCs will be cluster-randomized in a 2:3 ratio to intervention or control groups. The intervention group will receive one year of individualized eHealth lifestyle coaching via a smartphone application, guided by patient-reported outcomes (PROs). Alongside this, the GPCs will have access to the CDS tool to optimize pharmacological decision-making through electronic health records. The control group will receive usual care for one year, followed by the same intervention in the second year. Results: The primary outcome is the one-year change in estimated ten-year cardiovascular risk, assessed by SCORE2-Diabetes calculated from age, smoking status, systolic blood pressure, total and high-density lipoprotein cholesterol, age at diabetes diagnosis, HbA1c, and eGFR. Conclusions: If effective, DICTA could offer a scalable, digital-first approach for improving T2D management in primary care by combining patient-centered lifestyle coaching with real-time pharmacological clinical decision support. Full article

Objective: To compare the effect of different bone augmentation procedures, namely, autogenous bone blocks (ABBs) versus guided bone regeneration (GBR), on patient-reported outcomes (PROMs). Methods: This systematic review was conducted according to the PRISMA guidelines. A MEDLINE, Embase, and Web of Science search was conducted by two independent reviewers in combination with a free-hand search in relevant journals until June 2025. Outcomes were PROMs to enhance our understanding of the evolution of these procedures. Results: The electronic search yielded 6291 articles. After title screening, 67 articles were further analyzed for abstract review, which resulted in 14 articles eligible for full-text reading. Six articles were finally included based on the exclusion and inclusion criteria with a total of 295 patients. The overall study quality was low, since only two RCTs could be included. One study demonstrated a high risk of bias. Different PROMs were examined and compared such as pain, edema, neurosensory disturbance, Patient-Reported Predominant Symptom, OHIP-14, postoperative analgesic usage, willingness to repeat, and likelihood to recommend. Meta-analysis was not achievable due to a lack of direct comparisons and heterogeneity in terms of PROMs. Evaluation points varied between pretreatment and up to nearly 10-years of follow-up. Conclusions: Despite significant heterogeneity and reporting, this systematic review concluded that ABB and GBR are well-tolerated procedures. Trends such as transient postoperative pain and swelling with a minor occurring of neurosensory disturbances were reported in a few studies. Overall, a good perception of postoperative recovery was reported for both treatment modalities. Good quality of life was noted related to GBR procedures. Patient-reported outcomes were only analyzed for patients who completed the entire follow-up period. This may introduce bias, as patients who dropped out and were more likely to experience complications were not represented, potentially resulting in a more favorable portrayal of the outcomes. Further well-conducted prospective studies with a long follow-up are needed for an evidence-based evaluation and comparison of PROMs for these procedures. Full article

Introduction: Limited access to pulmonary rehabilitation (PR) has contributed to the rise of telerehabilitation (TPR) for COPD patients. Positive comparable effects are observed in exercise tolerance, quality of life (QoL), and dyspnoea with TPR. However, patient adherence to TPR is an outcome that has not been sufficiently analysed. Objective: To analyse adherence, satisfaction, and quality-of-life improvements in COPD patients following the TPR program to determine whether telerehabilitation is comparable to conventional therapy or usual care. Methods: A systematic search was conducted using four electronic databases, retrieving 392 articles. Two independent researchers selected and evaluated these articles based on predefined eligibility criteria. A third researcher was consulted in the event of disagreements. Results: Primary outcomes: Adherence to PR and/or usual care showed a minimum reported value of 62% and a maximum reported value of 91%, while TPR adherence had the lowest reported value of 21% and the highest reported value of 93.5%. Five articles compared TPR to PR and/or usual care, showing that TPR adherence is higher or similar to other interventions, whereas only one article found lower TPR adherence compared to PR. Secondary outcomes: A higher number of dropouts were reported for PR and usual care compared to TPR. Three publications analysed satisfaction and demonstrated that patients are satisfied across groups. Tertiary outcomes: Comparable improvements in QoL were found for TPR and PR, both being superior to usual care. Conclusions: This systematic review reveals heterogeneity in classifying adherence for pulmonary rehabilitation and telerehabilitation. Adherence classification may be standardised in future studies for consistent analysis. Full article

Background/Objectives: The main purpose of the present scoping review was to map and explore the efficacy of computer-controlled intraosseous anesthesia (CCIA) in comparison with conventional dental anesthesia in pediatric dental patients. Secondarily, this study aimed to compare the acceptance and preference factors between CCIA and conventional dental anesthesia in children. Given the limited and heterogeneous nature of the available literature, this review aimed to identify gaps and scope the extent of research conducted in this area, providing a foundation for future, more targeted studies. Methods: The search was conducted in 19 electronic databases, and the appropriate studies were identified according to PRISMA-ScR guidelines. Only split-mouth randomized controlled clinical trials that reported on the clinical outcomes of CCIA in children were included. Two reviewers worked independently on the screening and selection of the studies. The same two reviewers carried out the data extraction and the risk of bias assessment, using the Cochrane risk of bias tool. Due to the exploratory nature, this review focused on mapping the characteristics, outcomes, and research trends rather than synthesizing effect sizes. Results: Out of 841 papers, 2 randomized clinical trials were ultimately included in the scoping review. The outcomes were categorized as primary (including results that answered the focus question) and secondary (relating to additional quality characteristics). Regarding the primary outcomes, in both studies, intraosseous anesthesia was efficacious in achieving the adequate level of anesthesia. One of the secondary outcomes was the acceptance and preference of CCIA in comparison with conventional dental anesthesia in children. The limited number and the high risk of bias in existing studies highlight the necessity for more comprehensive and high-quality research. Conclusions: The selected studies support the assertion that CCIA is a promising technique since it results in less pain perception and is preferred by patients compared to conventional local anesthesia. However, the existing literature is limited and at high risk of bias. Thus, further targeted investigations are needed to evaluate and yield more definitive results regarding the superiority of CCIA. Full article

Background/Objectives: The optimal treatment for femoral neck fractures (FNFs) in the elderly remains unclear. Internal fixation, bipolar hip hemiarthroplasty (BH), standard total hip arthroplasty (THA), or dual mobility (DM-THA) cups have been employed, each presenting various advantages and disadvantages. This systematic review and meta-analysis evaluated comparative studies of BH and DM-THA in FNFs among the elderly, aiming to ascertain differences in outcomes, including functional recovery, patient-reported outcome measures, implant survival, complications, and mortality rates. Methods: This meta-analysis followed PRISMA 2020 guidelines with a pre-registered PROSPERO protocol (CRD420251065762). A comprehensive search of electronic databases and grey literature included only comparative studies of BH and DM-THA in patients over 65 years with FNFs. Results: Sixteen studies were eligible, comprising four randomised controlled trials and twelve retrospective comparative studies involving 11,460 patients (10,036 BH; 1424 DM-THA). Patients with DM-THA exhibited a higher postoperative Harris Hip Score (4.55, p < 0.0001), alongside a lower dislocation risk ([OR] 2.77, p < 0.0001), a reduced revision rate ([OR] 2.36, p < 0.0001), and decreased mortality ([OR] 1.94, p < 0.0001). The operative time was somewhat longer in the DM-THA group, by 12.71 min, and blood loss was greater by 121 mL, indicating significant heterogeneity across the studies. Conclusions: DM-THA for FNFs in elderly patients results in improved functional recovery and lower dislocation, reoperation, and mortality risk. However, longer operative times and increased blood loss remain significant considerations. Further, well-designed comparative studies are required to evaluate overall cost-effectiveness and define the optimal age threshold, beyond which the limitations of DM-THA may outweigh its benefits. Full article

Background and Objectives: Nausea and vomiting (NV) are common and distressing adverse effects among cancer patients undergoing treatment. Despite the widespread use of pharmacological antiemetics, these medications are often insufficient for controlling nausea and may cause medication interactions and side effects. Acupuncture has been proposed as a complementary therapy; however, the comprehensive analysis of its effects on NV across all emetogenic cancer treatments remains limited. This systematic review and meta-analysis aimed to evaluate the effectiveness and safety of acupuncture in managing NV in cancer patients undergoing chemotherapy, radiotherapy, or surgery. Materials and Methods: We conducted a comprehensive search across three electronic databases and two clinical registry platforms from inception to December 2024. Randomized controlled trials (RCTs) evaluating acupuncture for NV in cancer patients were included. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated using a random-effects model. Safety outcomes were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE). Results: Seventeen RCTs met the inclusion criteria, with twelve studies included in the meta-analysis. Acupuncture did not demonstrate significant effects on acute nausea (RR: 0.98; 95% CI: 0.84–1.15; p = 0.80) or acute vomiting (RR: 0.93; 95% CI: 0.65–1.32; p = 0.67). However, it significantly reduced delayed vomiting (RR: 0.76; 95% CI: 0.61–0.95; p = 0.02). Subgroup analysis demonstrated significant effects when acupuncture was administered for at least five days (RR: 0.56; 95% CI: 0.39–0.81; p = 0.002). The most frequently used acupoints were PC6, ST36, CV12, LI4, LR3, and ST25. No serious adverse events related to acupuncture treatments were reported, with only minor AEs such as localized bleeding and mild bruising observed. Conclusions: Acupuncture represents a safe and effective complementary therapy for managing delayed vomiting in cancer patients receiving emetogenic treatments. Clinicians can anticipate optimal benefits from at least five days of treatment, particularly using acupoints PC6, ST36, CV12, LI4, LR3, and ST25. Further high-quality studies are needed to establish standardized treatment regimens and explore its comprehensive effects on NV. Full article

Background: Electronic patient-reported outcomes (ePROs) enable real-time symptom monitoring and early intervention in oncology. Large language models (LLMs), when combined with retrieval-augmented generation (RAG), offer scalable Artificial Intelligence (AI)-driven education tailored to individual patient needs. However, few studies have examined the feasibility and clinical impact of integrating ePRO with LLM-RAG feedback during radiotherapy in high-toxicity settings such as head and neck cancer. Methods: This prospective observational study enrolled 42 patients with head and neck cancer undergoing radiotherapy from January to December 2024. Patients completed ePRO entries twice weekly using a web-based platform. Following each entry, an LLM-RAG system (Gemini 1.5-based) generated real-time educational feedback using National Comprehensive Cancer Network (NCCN) guidelines and institutional resources. Primary outcomes included percentage weight loss and treatment interruption days. Statistical analyses included t-tests, linear regression, and receiver operating characteristic (ROC) analysis. A threshold of ≥6 ePRO entries was used for subgroup analysis. Results: Patients had a mean age of 53.6 years and submitted an average of 8.0 ePRO entries. Frequent ePRO users (≥6 entries) had significantly less weight loss (4.45% vs. 7.57%, p = 0.021) and fewer treatment interruptions (0.67 vs. 2.50 days, p = 0.002). Chemotherapy, moderate-to-severe pain, and lower ePRO submission frequency were associated with greater weight loss. ePRO submission frequency was negatively correlated with both weight loss and treatment interruption days. The most commonly reported symptoms were appetite loss, fatigue, and nausea. Conclusions: Integrating LLM-RAG feedback with ePRO systems is feasible and may enhance symptom control, treatment continuity, and patient engagement in head and neck cancer radiotherapy. Further studies are warranted to validate the clinical benefits of AI-supported ePRO platforms in routine care. Full article

Background: Femoral neck fractures (FNF) have high mortality rates. Surgical delay likely contributes. Dynamic hip screw (DHS) fixation is common for FNF, and the tip–apex distance (TAD) measures screw position in the femoral head. A TAD >20–25 mm is considered a risk factor for screw cut-out. This study investigated the association between (1) surgical delay and complication/mortality rates within two years post-surgery and (2) TAD and postoperative complications following DHS in FNF. Methods: This retrospective study included 325 FNF patients who underwent DHS osteosynthesis at Regional Hospital Randers, Denmark from 2015–2021. The primary composite outcome included complications measured on radiographs (e.g., screw cut-out, avascular necrosis), reoperation, or death within 2 years. Radiographs were evaluated for TAD and postoperative complications/reoperations. Surgical delay was defined as the time from the diagnostic radiograph to the start of the operation. TAD was measured based on radiographs. Electronic patient journals and national SSN registers were used to assess reoperation and death rates. Results: The mortality rate was 16% within 1 year and 26% within 2 years. The complication rate was 16% within 2 years. The median surgical delay was 7.9 h (IQR 5; 14). Surgical delay was significantly associated with the 1-year mortality rate (p < 0.01), but not with the 1-year complication rate (p = 0.77). Surgical delay was associated with complication rates 2 years post-surgery only for undisplaced fractures, p = 0.046. The median TAD was 16.3 mm (13.8; 18.7); no association with complications <1 year (p = 0.56) or <2 years (p = 0.99) was observed. There were 59/325 patients with TAD >20 mm, six of whom had complications, and 6/59 with TAD >25 mm, none of whom had complications. Conclusions: We report a significant association between surgical delay and mortality rates in FNF, despite surgical delays <24 h. Additionally, there was a significant association between surgical delay and risk of complication/reoperation 2 years post-surgery for undisplaced fractures. No association was found between TAD and complication rates following DHS fixation for FNF; however, only a few TAD outliers were observed. Full article

Background and Objectives: Bone regeneration (BR) is a cornerstone technique in reconstructive dental surgery, traditionally using either barrier membranes, titanium meshes, or perforated non-resorbable membranes to facilitate bone regeneration. Recent advancements in 3D technology, including CAD/CAM and additive manufacturing, have enabled the development of customized scaffolds tailored to patient needs, potentially overcoming the limitations of conventional methods. Materials and Methods: A scoping review was conducted according to the PRISMA guidelines. Electronic searches were performed in MEDLINE (PubMed), the Cochrane Library, Scopus, and Web of Science up to January 2025 to identify studies on digital technologies applied to bone augmentation. Eligible studies encompassed randomized controlled trials, cohort studies, case series, and case reports, all published in English. Data regarding digital workflows, software, materials, printing techniques, and sterilization methods were extracted from 23 studies published between 2015 and 2024. Results: The review highlights a diverse range of digital workflows, beginning with CBCT-based DICOM to STL conversion using software such as Mimics and Btk-3D^®. Customized titanium meshes and other meshes like Poly Ether-Ether Ketone (PEEK) meshes were produced via techniques including direct metal laser sintering (DMLS), selective laser melting (SLM), and five-axis milling. Although titanium remained the predominant material, studies reported variations in mesh design, thickness, and sterilization protocols. The findings underscore that digital customization enhances surgical precision and efficiency in BR, with several studies demonstrating improved bone gain and reduced operative time compared to conventional approaches. Conclusions: This scoping review confirms that 3D techniques represent a promising advancement in BR. Customized digital workflows provide superior accuracy and support for BR procedures, yet variability in protocols and limited high-quality trials underscore the need for further clinical research to standardize techniques and validate long-term outcomes. Full article

Non-celiac villous atrophy (NCVA) is a multifaceted and under-recognized clinical entity with an etiology beyond celiac disease. This review critically examines the diverse pathophysiological mechanisms underlying NCVA, including autoimmune enteropathies, immune deficiency-related disorders, infectious processes, drug-induced trauma, and metabolic or environmental influences. A comprehensive synthesis of peer-reviewed literature, clinical studies, and case reports was conducted, adopting a multidisciplinary perspective that integrates immunologic, infectious, metabolic, and pharmacologic insights. The literature search was performed in three phases: identification of relevant studies, critical assessment of selected publications, and synthesis of key findings. Searches were carried out in PubMed, Scopus, Web of Science, and Google Scholar databases. The final search, completed in June 2025, included international, English-language articles, electronic books, and online reports. Studies were included if they addressed NCVA in the context of pathophysiology, clinical manifestations, or management strategies, with priority given to publications from the last ten years (2015–2025). The search strategy used the primary term “non-celiac villous atrophy” combined with supplementary keywords such as autoimmune enteropathy, common variable immunodeficiency, tropical sprue, drug-related enteropathy, pathophysiology, immunological mechanisms, chronic inflammation, genetic factors, environmental influences, and clinical management. Histopathological evaluations reveal that NCVA often manifests with varying degrees of villous blunting, crypt hypertrophy, and intraepithelial lymphocytosis, albeit without the gliadin-specific immune response seen in celiac disease. Various immune pathways are involved, such as autoimmune deregulation and chronic inflammatory responses, while drug-induced and environmental factors further complicate its clinical picture. These findings highlight significant diagnostic challenges and underscore the need to adapt diagnostic algorithms that combine clinical history, serologic evaluations, and histopathologic analysis. In conclusion, an in-depth understanding of the heterogeneous etiology of NCVA is critical to improving diagnostic accuracy and optimizing therapeutic strategies. Future research should prioritize the identification of specific biomarkers and the development of targeted interventions to address the unique mechanisms underlying NCVA, thereby improving patient management and outcomes. Full article

Background/Objectives: Single-port laparoscopy represents a significant advancement in minimally invasive surgical techniques and is designed to reduce surgical trauma and enhance cosmetic outcomes. However, ongoing debate surrounds its relative benefits and limitations as compared with conventional multi-port laparoscopy. This study systematically reviewed and analyzed comparative outcomes between these two approaches. Methods: We conducted a comprehensive systematic search of major electronic databases from January 2000 to October 2023, following PRISMA guidelines. Only randomized controlled trials comparing single-port laparoscopy with conventional laparoscopy were included. We analyzed operative outcomes, postoperative recovery parameters, complications, and patient-reported measures using random-effects models, with heterogeneity explored through subgroup analyses. Results: Forty-three randomized controlled trials involving 5807 patients were analyzed. Single-port laparoscopy demonstrated longer operative times (weighted mean difference: +10.5 min; 95% CI: 7.83–13.18; p < 0.001), superior cosmetic satisfaction (standardized mean difference: +0.61; 95% CI: 0.39–0.83; p < 0.001), and reduced postoperative pain within 24 h (standardized mean difference: −0.58; 95% CI: −0.95 to −0.21; p = 0.002). The overall complication rates showed no significant differences (risk ratio: 0.94; 95% CI: 0.78–1.14; p = 0.31), though incisional hernia risk increased with single-port laparoscopy (odds ratio: 2.26; 95% CI: 1.23–4.15; p = 0.009). Conclusions: Single-port laparoscopy offers meaningful improvements in cosmetic outcomes and early pain relief, balanced against longer operative times and increased hernia risk. The substantial heterogeneity observed underscores the importance of surgeon experience, appropriate patient selection, and optimal technique selection in determining outcomes. Full article

Background and Objectives: Blood-borne inflammatory ratios have been proposed as inexpensive prognostic tools across a range of diseases, but their role in pulmonary tuberculosis (TB) remains uncertain. In this retrospective case–control analysis, we explored whether composite indices derived from routine haematology—namely the neutrophil-to-lymphocyte ratio (NLR), the platelet-to-lymphocyte ratio (PLR), the systemic immune–inflammation index (SII) and a novel CRP–Fibrinogen Index (CFI)—could enhance risk stratification beyond established cytokine measurements among Romanian adults with culture-confirmed pulmonary T. Materials and Methods: Data were drawn from 80 consecutive TB in-patients and 50 community controls. Full blood counts, C-reactive protein, fibrinogen, and four multiplex cytokines were extracted from electronic records, and composite indices were calculated according to standard formulas. The primary outcomes were in-hospital mortality within 90 days and length of stay (LOS). Results: Among TB patients, the median NLR was 3.70 (IQR 2.54–6.14), PLR was 200 (140–277) and SII was 1.36 × 10⁶ µL⁻¹ (0.74–2.34 × 10⁶), compared with 1.8 (1.4–2.3), 117 (95–140) and 0.46 × 10⁶ µL⁻¹ (0.30–0.60 × 10⁶) in controls. Those with SII above the cohort median exhibited more pronounced acute-phase responses (median CRP 96 vs. 12 mg L⁻¹; fibrinogen 578 vs. 458 mg dL⁻¹), yet median LOS remained virtually identical (29 vs. 28 days) and early mortality was low in both groups (8% vs. 2%). The CFI showed no clear gradient in hospital stay across its quartiles, and composite ratios—while tightly inter-correlated—demonstrated only minimal association with cytokine levels and LOS. Conclusions: Composite cell-count indices were markedly elevated but did not predict early death or prolonged admission. In low-event European cohorts, their chief value may lie in serving as cost-free gatekeepers, flagging those who should proceed to more advanced cytokine or genomic testing. Although routine reporting of NLR and SII may support low-cost surveillance, validation in larger, multicentre cohorts with serial sampling is needed before these indices can be integrated into clinical decision-making. Full article

(1) Background: Quality of life (QoL) assessment is a crucial aspect for patients diagnosed with cancer. Over the years, different tools have been developed to measure QoL, both generic and pathology specific, but the inclusion of quality of life among other indicators of efficacy in randomized controlled trials (RCTs) remains a controversial issue. In this review, we aim to review the frequency and modality of QoL assessment in RCTs, enrolling patients diagnosed with mesenchymal tumors. (2) Methods: An electronic literature search of bone and soft tissue sarcoma and GIST-related RCTs published between January 2000 and December 2023 was performed by two independent reviewers using PubMed. English-language phase II and III clinical trials enrolling at least more than 15 patients were included, regardless of the disease stage. Studies involving patients under the age of 18 years or for which the full text was not available were excluded. For each study, data regarding the journal and year of publication, the study design, the primary objective, and the evaluation of quality of life as an endpoint with any type of patient-reported outcomes used were extracted. (3) Results: Among the 742 publications screened, 171 resulted eligible. QoL assessment was listed among the endpoints in 35 trials and QoL results were reported in 29 primary publications. In these trials, 16 included patients with soft tissue sarcomas, 8 Kaposi sarcomas, 6 GIST, and 3 desmoid tumors. Among all the trials included, 10.4% on an adjuvant/neoadjuvant setting and 24.4% on a metastatic setting included QoL as an endpoint. The proportion of trials, including QoL, was variable over time, as follows: 16.9% of trials in 2000–2014 vs. 23.4% in 2015–2023. In 35 trials, including QoL endpoints, 27 had a superiority design and 25 reported a positive result. In the majority of trials (80%), the tools for QoL assessment were generic and those mostly used were the EORTC QLQ-C30, the EQ-5D questionnaire, and the modified Brief Pain Inventory–Short Form. (4) Conclusions: Quality of life has not been assessed or published in many phase II and III trials, despite an improvement over time. QoL evaluation in RCTs should be considered even more carefully in patients with rare tumors, where the low number of patients who can be enrolled makes it difficult to draw statistically significant conclusions on the effectiveness of treatments. Full article

Aim: This systematic review aims to evaluate the effectiveness of microbiota-modulating interventions (such as probiotics, prebiotics, and fecal microbiota transplantation) in reducing cognitive symptoms, pain, and neuroinflammation in human studies relevant to fibromyalgia (FM). The review will investigate the role of gut–brain axis modulation through these interventions and explore the potential therapeutic benefits for FM management. Materials and Methods: A comprehensive search was conducted in electronic databases including PubMed, Scopus, and the Cochrane Library for studies published from 1 January 2015 to 30 April 2025. Studies were eligible if they were randomized controlled trials (RCTs), pilot studies, or observational studies assessing the impact of microbiota-targeted interventions (probiotics, prebiotics, fecal microbiota transplantation) on cognitive function, pain, or neuroinflammation in patients with FM. Studies were excluded if they involved animal models, lacked relevant outcome measures, or were not peer-reviewed. Although only a subset of the included studies directly involved FM patients, all were selected for their relevance to symptom domains (e.g., pain, cognition, mood) and mechanisms (e.g., neuroinflammation, gut–brain axis dysfunction) that are central to FM. A total of 11 human studies were included in the final qualitative synthesis. Results: Preliminary findings from the included studies suggest that microbiota-targeted interventions, particularly probiotics and prebiotics, show promise in reducing cognitive symptoms, pain, and neuroinflammation in FM patients. Improvements in mood and quality of life were also reported, indicating potential benefits for overall well-being. However, heterogeneity in study designs, sample sizes, and outcome measures limit the ability to draw definitive conclusions. Conclusions: This systematic review highlights the potential of microbiota modulation as a therapeutic strategy for managing FM symptoms, particularly cognitive dysfunction and neuroinflammation. Full article