STUDY DESIGN: Retrospective analysis using magnetic resonance imaging (MRI). PURPOSE: To identify MRI features that could discriminate benign from malignant vertebral fractures. OVERVIEW OF LITERATURE: Discrimination between benign and malignant vertebral fractures remains challenging, particularly in patients with osteoporosis and cancer. Presently, the most sensitive means of detecting and assessing fracture etiology is MRI. However, published reports have focused on only one or a few discriminators. METHODS: Totally, 106 patients were assessed by MRI within six weeks of sustaining 114 thoracic and/or lumbar vertebral fractures (benign, n=65; malignant, n=49). The fractures were pathologically confirmed if malignant or clinically diagnosed if benign and were followed up for a minimum of six months. Seventeen features were analyzed in all fractures' magnetic resonance images. Single parameters were analyzed using the chi-square test; a logit model was established using multivariate logistic regression analysis. RESULTS: The chi-square test revealed 11 malignant and 4 benign parameters. Multivariate logistic regression analysis selected (i) posterior wall diffuse protrusion (odds ratio [OR], 48; 95% confidence interval [CI], 4.2–548; p=0.002), (ii) pedicle involvement (OR, 21; 95% CI, 2.0–229; p=0.01), (iii) posterior involvement (OR, 21; 95% CI, 1.5–21; p=0.02), and (iv) band pattern (OR, 0.047; 95% CI, 0.0005–4.7; p=0.19). The logit model was expressed as P=1/[1+exp (x)], x=−3.88×(i)−3.05×(ii)−3.02×(iii)+3.05×(iv)+5.00, where P is the probability of malignancy. The total predictive value was 97.3%. The only exception was multiple myeloma with features of a benign fracture. CONCLUSIONS: Although each MRI feature had a different meaning with a variable differentiation power, combining them led to an accurate diagnosis. This study identified the most relevant MRI features that would be helpful in discriminating benign from malignant vertebral fractures.
Diagnosis ; Discrimination (Psychology)* ; Humans ; Logistic Models ; Magnetic Resonance Imaging* ; Multiple Myeloma ; Neoplasm Metastasis ; Osteoporosis ; Retrospective Studies ; Spinal Fractures ; Spine

Eucalyptus (Eucalyptus globulus Labill.) is an evergreen tree found worldwide. The aqueous ethanolic extract of the leaves (eucalyptus leaf extract; ELE) is used as a functional food, and its active constituents are generally polyphenols. Toxicity and mutagenicity of ELE have been previously assessed using rodents, and no adverse effects were observed. Although clinical trials of low-dose ELE ingestion have been conducted on humans, safety evaluation of high-dose ELE has not yet been conducted. We conducted an open-label clinical trial as a pilot study to assess the safety of excessive oral intake of ELE in Japanese adult men. A powdery preparation of ELE, commercially sold as Eucagrandin®, was prepared using spray drying method and contained approximately 80% ELE. Test capsules were packed with the powdery ELE. Six male subjects (aged 47.3 ± 12.4 years, mean ± SD) orally consumed 2,592 mg of ELE per day for 4 consecutive weeks. The subjects were examined at the start of the intervention, 4 weeks after the start, and 2 weeks after the last intake of test capsules. During the study period, 2 adverse events were reported. However, the causal relationship with the consumption of ELE was denied in both events because one event was attributed to a bruise and the other, which was elevated CPK levels, was due to excessive exercise. No unusual changes related to ELE consumption were observed in physical examination and during medical interviews. Further, blood and urine tests were normal during the trial period. These results demonstrated that oral consumption of ELE at the indicated dose is safe for humans.

BACKGROUND/AIMS: Recent developments in analytical techniques including next-generation sequencing have clarified the correlation between intestinal microbiota and inflammatory bowel disease. Fecal microbiota transplantation (FMT) for patients with ulcerative colitis (UC) is proposed as a potential approach to resolving their dysbiosis; however, its safety and efficacy have not been confirmed. This single-arm, open-label, non-randomized study aimed to evaluate the safety and efficacy of FMT for Japanese patients with UC as the first registered clinical trial in Japan. METHODS: We enrolled 10 patients with active UC despite medical therapy. The donors were the patients' relatives and were carefully screened for infectious diseases. Fecal material was administered via colonoscopy, and the primary endpoint was the presence or absence of serious adverse events related to FMT. The secondary endpoint was a change in partial Mayo score at 12 weeks post-FMT. Scores ≤2 were considered a clinical response. Fecal samples were collected to follow changes in gut microbiota, while extracted complementary DNA were analyzed by a next-generation sequencer. We obtained written informed consent from all patients and donors. This study was approved by our Institutional Review Board and is registered in the University hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN 000012814). RESULTS: Five patients with moderate disease and five with severe disease were enrolled. No severe adverse effects were observed. One patient achieved clinical response; however, none of the patients' microbiota diversity recovered to the donor levels. CONCLUSIONS: The use of single FMT for UC was safe; however, we failed to show its clinical efficacy and potential to change the intestinal microbiota.
Asian Continental Ancestry Group* ; Colitis, Ulcerative* ; Colonoscopy ; Communicable Diseases ; DNA, Complementary ; Dysbiosis ; Ethics Committees, Research ; Fecal Microbiota Transplantation* ; Gastrointestinal Microbiome* ; Humans ; Inflammatory Bowel Diseases ; Information Services ; Informed Consent ; Japan ; Microbiota ; Tissue Donors ; Treatment Outcome ; Ulcer*

Fecal microbiota transplantation (FMT) has been reported as a safe and effective therapy in patients with refractory and recurrent Clostridium difficile infection (CDI). FMT has also been reported as a promising therapy in patients with ulcerative colitis (UC). Both, CDI and UC, are believed to be caused by dysbiosis, such as altered compositions or decreased diversity of the intestinal microbiota. This report describes a patient with UC in remission with a second recurrent episode of CDI, who was treated with FMT. A single FMT performed via colonoscopy completely resolved the patient's diarrhea and eradicated C. difficile bacteriologically without any severe complications. Molecular biological analysis of the patient's fecal microbiota showed that FMT could dramatically change the altered composition of intestinal microbiota and restore its diversity. Despite the restoration of the intestinal microbiota, FMT could not prevent a relapse of UC in this patient. However, it improved the intestinal symptoms of CDI and could prevent further recurrences of CDI.
Clostridium difficile ; Clostridium ; Colitis, Ulcerative ; Colonoscopy ; Diarrhea ; Dysbiosis ; Fecal Microbiota Transplantation ; Gastrointestinal Microbiome ; Humans ; Microbiota ; Recurrence ; Ulcer